Novartis Ag v. Union Of India And Others

SUMMARY OF ARGUMENTS

I. Mr T.R Andhyarujina, Senior Advocate, for the appellant, Novartis AG …………………………………………………………………….. p. 23 II. Mr Gopal Subramanium, Senior Advocate, for the appellant, Novartis AG ……………………………………………………………………. p. 28 III. Mr Harish N. Salve, Senior Advocate, for Respondent 6, Cipla Ltd. …………………………………………………………………………. p. 40 IV. Dr Rajeev Dhavan, Senior Advocate, for Respondent 6, Cipla Ltd. ………………………………………………………………………….. p. 72 V. Ms Prathiba M. Singh, Advocate, for Respondent 7, Ranbaxy Laboratories Ltd. …………………………………………………… p. 83 VI. Prof. Shamnad Basheer, Intervenor-cum-Amicus ……………………. p. 90

I. Mr T.R Andhyarujina, Senior Advocate, for the appellant, Novartis AG

1. The basic question before the Court is whether Novartis is entitled to a patent for its invention of the beta crystalline form of Imatinib Mesylate, a drug for curing cancer, etc.

2. The first question is, does the invention come within the purview of Sections 2(j) and (j)(a) of the Patents Act? It is submitted that Novartis product of beta crystalline form confirms to the definitions in Sections 2(j) and (j)(a) of the Act. The second question is what is the effect of Section 3(d) of the Act?

Whether beta crystalline form of Imatinib Mesylate is an invention.

3. The beta crystalline form of Imatinib Mesylate is a new product (novelty).

4. No one produced such a product before Novartis did. Only Imatinib free base was a known substance for the purposes of prior art or existing knowledge. The alpha and beta forms of Imatinib Mesylate was produced for the first time by Novartis. The beta form had superior advantageous of few properties, thermodynamic stability and less hygroscopicity than alpha form thus contributing to the efficacy of the drug.

5. It was capable of industrial application.

6. It was an inventive step as it involved technical advance as compared to the existing knowledge. The existing knowledge was only Imatinib as a compound which was published in the Zimmermann patent, namely, Imatinib free base.

7. Even if the existing knowledge is considered as Imatinib Mesylate (which is denied) there was a technical advance in the crystallisation of Imatinib Mesylate.

Summary of Arguments

8. There was also economic significance of the invention as a cancer curing drug.

9. It cannot be said that such an invention was obvious to a person skilled in the art.

10. Apart from the application of Section 3(d), which is considered separately, the only objection to the beta crystalline form being considered as an invention is that it was anticipated by the Zimmermann patent.

The Zimmermann patent—does not anticipate and disclose any crystalline form of any compound or Imatinib Mesylate.

11. The Zimmermann patent unquestionably does not refer to any crystalline forms of any compound.

12. The Zimmermann patent does not disclose Imatinib Mesylate.

13. It is well settled that disclosure of an invention must be in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art. London 2006) 51 See Annexure 1 hereto.

14. No working method of converting Imatinib to Imatinib Mesylate is stated in the Zimmermann patent. It only states that the salt forming compounds can be carried out by acid without any method. The method is stated to be “per se” (p. 76).

15. The Zimmermann patent mentions multiple choices of compound including Imatinib free base but not any salt of any compound much less of Imatinib Mesylate.

Claim No. 23 refers to Imatinib but does not disclose Imatinib Mesylate. By the words “or a pharmaceutical acceptable salt thereof” there is no indication that methane sulphonic acid only should be used on Imatinib out of over 50 acids.

16. The application by Novartis under the US Food and Drug Administration Act by referring to the Zimmermann patent states that the Imatinib Mesylate was “covered” by the Zimmermann patent (not disclosed). (Vol. U-1 of Government, p. 129).

17. There is a difference between something which is “covered” and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann patent but not disclosed. (See A.C Edwards v. Acme Signs 1992 RPC 131 and Astellas Pharma Inc. v. Comptroller-General of Patents 2009 EWHC 1916 in Vol. R of Novartis. In these decisions it is stated that “a claim may cover a product without disclosing it”.)

18. In the application of patent term extension for Zimmermann patent in USA it is also stated that Imatinib Mesylate is covered (Vol. U-1 of Government, pp. 61 and 71).

19. In any case in Patent law subsequent conduct of the patentee is irrelevant in construing the patent. 1993 RPC 90

20. The Cancer Research article of 1996 (Vol. B, p. 85) though it refers to Imatinib Mesylate does not teach how it is to be prepared (The footnote for the separate publication by Zimmermann which was not published).

21. Nor is there any enabling disclosure in it (an enabling disclosure is the type which one finds in the Novartis specification at p. 322).

22. The Nature Medicine article published in May 1996 (Vol. B, p. 94) has no reference to Imatinib Mesylate but only Imatinib.

It is significant that the parties opposing Novartis application have themselves made applications for patent and secured patent for crystalline forms of Imatinib Mesylate as a novel invention.

23. Thus Natco Pharma applied for an Indian patent for what it called a2 form of Imatinib Mesylate on 20-7-2004. Again Natco Pharma applied for a patent for a novel Crystalline Form I and II of Imatinib Mesylate acknowledging that Imatinib Mesylate exists in forms alpha and beta in Novartis Patent WO99/03854 (pp. 1-32, Vol. N).

24. In fact, Natco obtained a patent in the United States for a novel crystalline form designated as a2 form of Imatinib Mesylate by an application filed on 16-11-2011 in the United States (pp. 33-34, Vol. N).

25. Hetero Drugs Limited also obtained a patent for a novel polymorph of Imatinib Mesylate calling it H-1 form (pp. 50-56, Vol. N)

26. Cipla obtained an international patent for a suitable crystalline form of Imatinib Mesylate on 2-9-2005 for what it called the alpha form of Imatinib Mesylate (pp. 57-82, Vol. N).

27. The above facts prove that a crystalline form of Imatinib Mesylate is a novel invention on the showing of opposing respondents themselves in this case. The respondents are estopped from raising an objection that the beta form of Imatinib Mesylate by Novartis is not a novel invention.

Section 3(d)

Section 3(d) as amended in 2005 is a provision for negativing, out of abundant caution, a product which is otherwise an invention within the terms of Sections 2(j) and (a) and (ja).

28. Section 3(d) in essence it is meant to negative a trifling advance which is claimed to be an advance or what is generally considered as “the strategy of evergreening”. “Evergreening” implies a certain tactic to obtain a patent by a trifling measure. The justification for Section 3(d) was stated to be to prevent evergreening by the Minister Kamal Nath in the parliamentary debates on the 2005 Amendment.

29. It is in the light of the avoidance of the strategies of evergreening that Section 3(d) has to be considered.

30. On the facts as pleaded by Novartis, Section 3(d) on its own terms is inapplicable.

(a) Novartis's claim is that Imatinib free base was a “known substance”. It is from Imatinib free base that Novartis first created a solution of Imatinib Mesylate, and from Imatinib Mesylate it has derived crystalline forms of alpha and beta. Hence there is not one step single form but a successive dual steps forms from a known substance viz. from Imatinib free base to Imatinib Mesylate to beta form. Section 3(d) applies only to a single step discovery of a new form of a known substance. Section 3(d) will therefore not apply to dual stages of an invention.

(b) There is a considerable significance to the word “mere” in Section 3(d). It contemplates a trifling change of a new form. It cannot be said that in any case the invention of the beta crystalline form was a “mere change of form” from any known substance whether it is Imatinib free base or Imatinib Mesylate.

(c) The requirement of the words “which does not result in enhancement of the known substance” is a favourable reservation in favour of the patentee who is otherwise carrying out a mere trifling change to create a new form of a known substance. If it is shown by the patentee applicant that despite the mere discovery of a new form of a known substance there is in fact enhancement of the known efficacy of a known substance then it is patentable. Hence, the question is — was there any known efficacy of a known substance in Novartis' invention?

(d) The known substance in Novartis invention was Imatinib free base. The efficacy which is referred to in Section 3(d) in relation to pharmaceutical products is a functional efficacy and not merely a theoretical efficacy on paper. Imatinib free base had no functional efficacy. Imatinib free base was not in a form which was administrable to humans. Thus while Imatinib free base had anti-tumor properties, it did not lead to the development of a drug administrable to humans. The words “known efficacy” must have an established concept in pharmacology. The known substance with known efficacy is a tangible, real substance not a mere theoretical possibility and its creation must be known to the public. This was not the case of Imatinib.

(e) Even in the Cancer Research article, Imatinib is only stated as a possible candidate for a certain leukaemia.

(f) The reason why Imatinib free base was not suitable for a drug is stated in Dr Bertrand Sutter's affidavit (Vol. G, p. 284).

(g) By the Explanation to Section 3(d) a salt of a known substance is considered the same substance. Applying this, Imatinib Mesylate would be considered as the same substance as Imatinib free base. However, a deeming provision cannot create a known substance which does not exist in reality. Imatinib Mesylate was not known until it was invented in Novartis's specification. Hence, the Explanation does not apply.

(h) Assuming that Novartis's invention was a new form of Imatinib Mesylate for argument sake, Imatinib Mesylate was not significantly different from Imatinib free base. This was stated in the Cancer Research Paper of 1996. Imatinib Mesylate also had no known efficacy. There was no pharmaceutical product of Imatinib Mesylate having any efficacy.

(i) Hence, whether the known substance is taken as Imatinib free base or Imatinib Mesylate neither of them had any “known efficacy”. Novartis's beta crystalline form is the first product of Imatinib launched as a drug in 2001 which was administrable to human beings and hence Section 3(d) does not apply.

Re Efficacy — its applicability in Section 3(d)

31. Assuming against Novartis that the terms of Section 3(d) apply and the question of efficacy is to be considered, Novartis submits as follows:

(a) Section 3(d) is not limited in its application to pharmaceutical products. The 2005 Amendment was conscious of a pharmaceutical product as it defined it in Section 2(ta). Despite that it did not include pharmaceutical substances as a substance under Section 3(d).

(b) Section 3(d) also is not limited to chemicals.

(c) The word “substance” therefore is to be given its usual dictionary meaning as every matter or material.

(d) In the light of this, efficacy cannot be limited to therapeutic efficacy. There cannot be a therapeutic efficacy for chemicals like insecticides, weedicides, dyes.

(e) The Explanation to Section 3(d) states — “differs significantly in properties with regard to efficacy”. This clearly implies that the efficacy is not identical to therapeutical efficacy itself. There can be physical properties which contribute to efficacy. Hence, physical properties like advantage of flow properties, thermo-dynamically more stability and less hygroscopicity which contribute to the efficacy of a drug. Novartis's patent states these advantages for the beta crystalline form of Imatinib Mesylate. Hence, even if the question of efficacy was to be considered the Novartis patent application shows advantages which contribute to administration of the drug.

(f) Even, if efficacy was to be considered as a therapeutic efficacy, the expert Massimini in his affidavit has proved that the beta crystalline form had 30% more bioavailability than Imatinib as the known substance which contributed to the efficacy of the product of Novartis.

(g) Clinical efficacy can never be within the scope of Section 3(d) as at the time of application for the patent clinical trials are never made. Such clinical tests are only made under the Drugs and Cosmetics Act for approval as a drug under that Act.

(h) All the aforesaid factors clearly show that even if beta form of Imatinib Mesylate was to be considered for enhanced efficacy over either Imatinib or Imatinib Mesylate Novartis has demonstrated the efficacy of Gleevec and hence Section 3(d) does not apply to it.

Conclusion

32. It is respectfully submitted that the Novartis' application for the patent must be allowed:

(1) As it is an invention and inventive step within the meaning of Section 2(j) and Section 2(j)(a).

(2) Even if Section 3(d) is to be applied, on the facts of Novartis's case, Section 3(d) is inapplicable for the reasons stated above.

(3) Without prejudice to the submission of non-applicability of Section 3(d), even if Section 3(d) is applicable to Novartis product the requirement of enhanced efficacy of the beta form over Imatinib or Imatinib Mesylate is proved.

Introduction

1. The petitioner has filed Patent Application No. 1602.MAS/1998 for a “ß-crystalline form of Imatinib Mesylate”. The petitioner submits that this invention resulted in a first of its kind miracle drug that cured chronic myeloid leukaemia. The invention has been granted patent protection in over 35 countries at the time of filing of this special leave petition, but has been denied patent protection by the orders of the Assistant Controller, Patents and the Intellectual Property Appellate Board (IPAB). It is respectfully submitted that, had the respondents' allegation of the petitioner's invention being anticipated and obvious from the prior art been true, a drug performing the miraculous functions of Glivec ought to have been made years before Glivec was even conceptualised. This was not to be.

2. It is submitted that:

(a) The subject invention is novel and it involves an inventive step over existing knowledge making it patentable under Section 2(1)(j) and Section 2(1)(ja) of the Patents Act, 1970 (hereinafter “the Act”).

(b) Section 3(d) is ex majore cautela having no application to a product which complies with the requirements of Sections 2(1)(j) and 2(1)(ja). It only applies where there exists a predecessor drug (in the context of pharmaceuticals) with known efficacy, enabling protection if there is enhancement of that efficacy.

3. The petitioner's invention is patentable under Sections 2(1)(j) and 2(1)(ja) of the Act.

3.1 Priority date:

3.1.1 Documents evidencing existing knowledge must be in existence prior to the priority date of the patent application. The respondents objected to the claimed Swiss priority date of 18-7-1997 on the grounds that at the time of filing of the patent application. However, the patent application is being judged in the light of Section 3(d) and other amendments that were enacted subsequent to the patent filing 17-7-1998. Switzerland had become a Convention country by the time the patent application was considered. It is submitted that the IPAB has rightly held that the petitioner's application will be entitled to the Swiss priority date of 18-7-1997.

3.2 Cited prior art (existing knowledge):

3.2.1 As per the Swiss priority date argued above, the relevant prior art for the purpose of judging novelty and non-obviousness are contained in three documents. These documents must be considered in light of accepted principles of anticipation 2005 UKHL 59 at Vol. A, 1972 RPC 457 (CA) at Vol. A and non-obviousness 2007 EWCA Civ 588 at Vol. A, 1985 RPC 59 at Vol. A, 492 F 3d 1350 (2007) at Vol. K.

3.2.2 For a document to be anticipated, that single document on its own must be considered, without recourse to any other document. Mosaicing of documents is not permitted when evaluating anticipation. This single document must specifically teach the subsequent invention. A document does not anticipate the invention if it is only mentioned as a possible outcome. Further, an invention is obvious if it could have been made from prior art without inventive activity. The very fact of experimentation being required implies that a person does not know the results of the process from prior art. The result is therefore, not obvious. Mere trial and error methods will also not support a finding of obviousness when the range of possibilities can be endless.

3.2.3 Each document will be taken in turn, and is to be interpreted strictly for the purpose of the inquiry into whether it is anticipatory or renders the invention obvious:

3.2.3.1 (a) US Patent No. 5521184 of 1993

This patent and its equivalent patents in other jurisdictions (hereinafter referred to as “Zimmermann” is a patent for “pyrimidine derivatives and processes for the preparation thereof”. The patent relates to a genus of compounds, and each of the said compounds within the genus share a common chemical structure (Markush structure) and common properties with respect to the inhibition of certain tyrosine kinases (there are a total of 518 kinases in existence).

3.2.3.1.1 Zimmermann patent does not teach or suggest or motivate a person of skill in the art to select example 21 in preference to other compounds of which examples were given. There is no comparison between Example 21 and the other examples to suggest this. In fact, Dr Zimmermann and others worked on Example 20 (CGP 53716) for nearly one year before selecting Example 21 for conducting further research. Thus, experimentation was required, resulting in an inventive identification (1930) 47 RPC 289 at Vol. A, 1982 FSR 303 at Vol. A, 2008 EWHC 2345 (Pat) at Vol. F of first, Example 21.

3.2.3.1.2 Even if Example 21 is selected, the Zimmermann patent does not teach a person to select one particular salt. In fact, the hydrochloride salt was first selected, but was found to be too corrosive. The basic chemical structure disclosed in Zimmermann covers millions of compounds. Zimmermann itself only contained a specific disclosure of 34 of those compounds, i.e the examples. Further, the Zimmermann patent does not teach a person how to prepare a Mesylate salt of Example 21.

3.2.3.1.3 It can only be concluded that there was no teaching in Zimmermann that could predict which of several million compounds will be the right candidate (lead compound) that would result in a drug substance. Or which of the salts listed therein along would make the said compound administrable, so that its anti-tumoral properties on a human being could be measured, utilised and prescribed as an accepted method of treatment.

3.2.3.1.4 The Zimmermann patent states that pharmaceutically acceptable salts may be formed in the customary manner that is known per se. An illustrative list of non-toxic acids if mentioned. However, there is no guarantee that just because the stated acid is non-toxic, that the resultant salt will also be non-toxic. Zimmermann does not give a list of salts, but only a list of possible acid additions. This is merely to state the possibility that such acids could be added to make a salt. The quantity and concentration of each reactant is not mentioned. The characteristics of a salt that would make it administrable are not mentioned.

3.2.3.1.5 The respondent has, at the fag end of the arguments, produced a patent application wherein a Mesylate salt was used in the context of preparing emulsion paint. It is submitted that the preparation of a salt for the purpose of emulsion paint is vastly different from preparation for the purpose of a pharmaceutical substance. The article by Berge (et al) only suggests that the Mesylate salt is a possible candidate for a salt. It is in fact, an instance of teaching away i.e a person reading Berge would not try to make a Mesylate salt as the article states that the Mesylate is only used in 2% of cases. The knowledge to make the Mesylate salt of Imatinib was disclosed for the first time in the petitioner's present patent application. This infers anticipation of an invention by “mosaicing” information from various documents which is not permitted in law.

3.2.3.1.6 There is certainly no mention of polymorphism or crystalline structures. The relevant crystalline form of the salt that was synthesised needed to be invented. There was no way of predicting that the ß-crystalline form of Imatinib Mesylate would possess the characteristics that would make it orally administrable to humans, without going through the inventive steps above. All subsequent patent applications for various polymorphic forms have consistently stated that Imatinib in Zimmermann is only exemplified in the freebase form i.e in the examples. In other words, Example 21 of Zimmermann stops at the synthesis of the freebase. Therefore there was no disclosure in the prior art documents of Imatinib Mesylate, leave alone ß-crystalline form of Imatinib Mesylate to anticipate the petitioner's patent application so as to render the said application as lacking in novelty.

3.2.3.2 (b) The article in Cancer Research, 56, pp. 100-104, 1-1-1996 (Cancer Research) also does not have an enabling disclosure or teach a person skilled in the art how to prepare Imatinib Mesylate salt, or indeed any crystal form of the salt. The purpose of the article was in fact to test the candidature of Imatinib freebase as a pharmaceutical substance. It concludes in such terms stating that the freebase and not the salt is a drug candidate. At Footnote 3 of the Article it is stated very clearly that the method of preparation of Mesylate salt is not contained in that paper. The solution of the Mesylate salt as described was prepared for the purpose of injecting such solution into the belly of mice, and not for the creation of a solid oral dosage form for human patients. The conclusion/discussion section of the article is very indicative when it mentions that Imatinib free base may be considered as a candidate for drug development, and not the Mesylate salt. In terms of teaching, the Cancer Research Article goes no further than what is taught in Zimmermann. There is a close nexus between the form of the substance and its efficacy. It is a case where efficacy does not exist in any other form.

3.2.3.3 (c) The article in Nature Medicine, Vol. 2, No. 5, May 1996 pp. 561-566 (Nature Medicine) does not even contain any reference to Imatinib Mesylate and consequently cannot be considered as novelty destroying. The article specifically states “Ultimately clinical trials will be required to determine the potential therapeutic benefit of this compound.”

3.3 The invention of the ß-crystalline form of Imatinib Mesylate:

3.3.1 The prior art only disclosed, at its highest, how to prepare Imatinib freebase, and that this freebase would have anti-tumoral properties with respect to the BCR ABL kinase. Arrival at a ß-crystalline form of Imatinib Mesylate for a viable treatment of CML required further invention. Imatinib freebase had to be selected through extensive research from the Zimmermann patent, which was the starting point. A pharmaceutically acceptable acid had to be selected through research. A method of successfully combining the freebase and the acid had to be established through research. That the salt form by itself would not be viable had to be established through research.

3.3.2 Once the salt form of Imatinib was arrived at through research as disclosed in the petitioner's application, the inventors had to further research to be able to ensure that the said salt form of Imatinib is suitable for administration as a solid oral dosage form. This research further required defining the process parameters that led to ß-crystalline form of Imatinib Mesylate. It is this particular crystalline structure that possessed properties that made it suitable as an administrable substance, which is easy to handle in the manufacture of millions of capsules or tablets.

3.3.3 The different methods for the preparation of the invention from the freebase are disclosed in the examples to the specification. In the specification, passages from Zimmermann cited to demonstrate that the crystalline form, despite the processes it has undergone, has not lost the anti-tumoral properties of the freebase. The specification further contrasts the novel properties of the ß-crystal form with the alpha form. This was also for the first time disclosed in the petitioner's application, as it is only the alpha form that has comparable properties. The freebase only has negligible properties with respect to administrability. This is why the freebase was never used as a drug substance. Thus the specification states that the invention begins from the freebase, which is converted into a solution form. It is transformed to an aqueous form of Imatinib Mesylate which is later transformed to the crystalline form of Imatinib Mesylate.

3.3.4 The respondents have argued that properties like hygroscopicity, flow properties and thermodynamic stability are possessed by all salts and therefore these properties would have been obvious and known to a person ordinarily skilled in the art. It is respectfully submitted that the inventive effort of the petitioner is reflected in the selection and synthesis of the salt which will have these properties in optimal quantities so as to make an oral drug formulation. Pharmacopeia shows that it is one of the toughest tasks in chemistry to identify salts which do not compromise one quality for the other. It is further submitted that the inventive journey from properties mentioned in text books to properties actualised in a real drug is very long.

3.3.5 Such properties are essential to the safety of a drug substance. If a substance does not have the ideal flow properties, there can be no consistency in the manufacture of the drug tablet. This is because the drug substance stays in the machine instead of being filled in the capsule. It leads to a situation where it is impossible to predict the amount of active ingredient, in for example, a 50 mg capsule. Considering that the anti-tumoral properties of the active ingredient are linked to its concentration, this is vital. Similarly, the choice of an unstable drug substance, leads to unpredictability and lack of safety. A hygroscopic substance changes its composition and texture, which also has a bearing on safety.

3.3.6 The inventive step of the ß-form of Imatinib Mesylate is also demonstrated by the following factors:

(a) Long-felt need: The need for an oral dosage form of medication for CML patients was not met till the subject invention.

(b) The petitioner expended significant amount of money into research and development of the subject invention.

(c) No other inventor could develop an oral drug formulation to treat CML between the years 1993 and 2001, till the petitioner introduced Glivec into the market.

(d) The unprecedented commercial success enjoyed by the subject invention in the market.

3.3.7 The respondent's arguments betray an improper hindsight bias. It is easy to assert, after the selection of Example 21, that it was obvious to do so. Similarly, the choice of methane sulphonic acid, the synthesis of the Mesylate salt and its crystalline forms seemed evident only after it was done. If the hindsight bias was correct, the world would not have had to wait for Glivec to be launched to have a magic drug curing CML. It is therefore submitted that the claimed invention is neither anticipated nor does it lack inventive step in light of the existing knowledge as evidenced by the prior art and is clearly a technical advance over existing knowledge.

3.4 The Scope of coverage is distinct from the scope of the disclosure in a patent:

3.4.1 The petitioner, in its applications before the US Food and Drug Administration Authority has made a reasonable assertion as required by the law that the Zimmermann patent covers the product that has been made out of the ß-crystal form of Imatinib Mesylate, i.e Glivec. On the basis of US FDA approval, the petitioner has obtained an extension of the period of protection under the Zimmermann patent with respect to Glivec.

3.4.2 Further, at the time when the extension application was filed with the US Patent and Trademark office (has to be filed within 60 days of the marketing approval by the USFDA of the drug product), the only granted patent for which an extension based on the Glivec approval could be sought was that of the Zimmermann patent as the US application for ß-crystalline form was pending and had not been granted a patent.

3.4.3 It has been argued that such coverage can be used to presume an enabling disclosure of the ß-crystalline form of Imatinib Mesylate in the Zimmermann patent. Disclosure in a specification can never be presumed and is a question of the clear teaching contained in the specification. The teaching of a patent lies in the disclosure/specification that supports the claim. The disclosure describes the invention. The claim defines through language the various ways the invention could be used i.e possible but not actualised products. This is the scope of protection granted under the patent. For the purpose of prior art, it is the disclosure in the specification supporting the claim and not the written description or the claims themselves, that must be assessed. The claim can never be the teaching. There was no guarantee from Zimmermann alone, that a pharmaceutically acceptable product would emerge. It required further research. This is recognised in that very same jurisdiction, where the US Appellate Board has granted a patent for the ß-crystalline form, while still affording coverage since it uses Imatinib.

3.4.4 It is submitted that the argument of “presumed disclosure” proceeds on a flawed understanding of the relevant laws. Coverage that is granted in respect of a patent, is not always coextensive with what is disclosed in that patent 166 USPQ 18 (1970) at Vol. U. This is based on the facts of each application, and in certain circumstances whether it is a pioneering invention 559 F 2d 595 (1977) at Vol. T, 865 F 2d 1247 (1989) at Vol. T, 315 F 3d 1335, 65 USPQ 2d 1452 (2003) at Vol. U, 363 F 3d 1247, 70 USPQ 2d 1321 (2004) at Vol. U that may be entitled to greater coverage than what is specifically disclosed. The respondent's argument is a misplaced double patenting argument i.e the same invention is being sought to be patented twice. It is two different inventions that are patented, though the invention in the first may be necessary to arrive at the invention in the second patent. The product as a whole does not come into existence without both inventions. The principle is that if a product is covered, it means that it infringes a patent. Whether the patent infringed disclosed every aspect of the product in its specification is a separate inquiry.

3.4.5 This is commonly seen not only in pharmaceutical inventions but in all areas of technology such as telecom, in which case cross-licensing of related patents is contemplated by Indian law. (2007) 35 PTC 377 (Del) at Vol. U Any individual, and not just the proprietors of the Zimmermann patent can use the invention disclosed in Zimmermann to come up with a further invention. A product containing both inventions will then need the permission of both inventors to be commercially exploited i.e cross licenses. It cannot be stated that the Zimmermann patent prevented further research. It had quite the opposite effect.

3.4.6 There are two possible illustrations; one is the “temporal paradox” explained in the majority opinion in Hogan, In re See 559 F 2d 595 (1977) at Vol. T. According to this illustration, the claim on the date of the original application if enabled could also embrace later inventions. However, the latter illustration is based on the utilisation of the basic invention/pioneering invention for arriving at the second invention. It is submitted that the same does not lead to an imputative or attributable disclosure of the second invention in patent for the pioneering invention.

3.4.7 The meaning of “enablement” is “how to make the invention”. However, written description is the actual composition and description of the invention.

In order to comply with 35 USC 112, both enablement and written description need to support and justify the claim as on the date of the original application. The explanations added to Hogan, In re See 559 F 2d 595 (1977) at Vol. T in later decisions do limit the extent of broad coverage in the original application. But these decisions do not abandon Hogan, which means that the essential test is whether on the date of the original or first application, was it all that could be conceived of with existing knowledge.

3.4.8 Hence, even dehors Hogan, In re See 559 F 2d 595 (1977) at Vol. T, the actions of the petitioner were in accordance with American law. They cannot lead to an imputative or attributive disclosure of the second invention. What can only be presumed is that in the Zimmermann patent, a method of producing the freebase is disclosed. It is presumed that this method is accurate, and does not have to be verified in the laboratory.

3.4.9 Therefore, if Imatinib Mesylate could not be arrived at except by starting from Imatinib freebase which is patented, as long as the claim in Zimmermann covers any salt arising out of a compound of Formula 1, it could be reasonably asserted that the Zimmermann patent covers Imatinib Mesylate.

3.4.10 The effect of the specification read with the claim of Zimmermann, is to protect the inventor against all uses of his invention including the use of Imatinib freebase. The synthesis of a salt form of a compound of Formula 1 could not have been possible without the discovery of formula 1 in the first place, and is a use of the invention of the first inventor. It is for this reason that jurisdictions recognise that infringement may be reasonably asserted.

4. Section 3(d) has no application to the facts of the present case.

4.1 Section 3(d) is ex majore cautela:

4.1.1 Section 3(d) was introduced as part of a series of amendments to the Patents Act, 1970, pursuant to India's international obligations on the signing of the Trips. Articles 27 to 34 set out the framework for the patent regime to be implemented in signatory states. The public health concerns of developing countries were reflected in the Doha Declaration of 2001. It stated that the Trips agreement should not be read to imply an inability on the part of Member States to protect public health and access to medicines.

4.1.2 It is these very same concerns that are reflected in the various bills proposed in Parliament by successive governments. Further, a consideration of the Lok Sabha and Rajya Sabha debates on the Patents (Amendment) Act, 2005 shows clearly that there is a concern over the effect of the Product patent regime on access to medicines. The Amendment Act as a whole is expected to address these concerns.

4.1.3 It is submitted that issues of access to medicines, reasonable affordability of medicinal products and the protection of public health are explicitly addressed in the 2005 amendments to the Compulsory Licensing provisions contained in the Patents Act, 1970. The Act even permits compulsory licensing in the event of a foreign country requiring assistance. It is submitted that any attempt to state that these concerns, either internationally, or domestically in the Parliamentary debates, are incorporated in Section 3(d) is misconceived and not in accordance with the Executive's stated reasons for introducing the Amendment, and the Statement of Objects and Reasons of the Amendment Act. These cannot be grounds for declaring an invention unpatentable.

4.1.4 The primary purpose of Section 3(d), as is evidenced by the legislative history is to prevent evergreening but yet encourage incremental inventions. Evergreening is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee's exclusivity over the product, preventing competition.

4.1.5 The concept of evergreening is not attracted by an invention that is not a trifling change, but is a significant technological advance over existing knowledge, as a result of which, for instance, a new medicinal substance could actually be administered for the first time. It is worth mentioning that the concepts of “evergreening” or “double patenting” are internationally well known and inventions of such nature are at the very threshold not permitted the grant of a patent by any country worldwide.

4.1.6 It is submitted that by definition, a trifling change, or in the words of the Section a “a mere discovery of a new form of a known substance” can never ordinarily meet the threshold of novelty and inventive step under Sections 2(1)(j) and 2(1)(ja). An invention cannot be characterised by the word “mere”. The word invention is distinct from the word discovery. It is therefore, submitted that Section 3(d) operates only as ex majore cautela ensuring that mere discoveries as above, can never, by an effort at interpretation of Ss. 2(1)(j) and 2(1)(ja), be considered an invention.

4.1.7 It is further submitted that this interpretation of Section 3(d) is in consonance with the avowed Parliamentary intention of preventing evergreening. It renders unpatentable mere discoveries of new forms of known substances. However in certain cases discovery of a new form of a known substance will be also be granted patent protection if there is an enhancement of the known efficacy of a known substance. Therefore, Section 3(d) is an enabling provision as argued below.

4.2 Section 3(d) is only applicable “when there is a known substance with known efficacy”:

4.2.1 It is submitted that the use of the expression “new form of a known substance” in Section 3(d) presupposes that there exists as on priority date a “known substance” i.e a substance which is publicly known and having proven efficacy as opposed to being known to the inventor or to the applicant. The use of the words “enhancement” and “differ significantly” in Section 3(d) means that the provision requires efficacy to be measured empirically.

4.2.2 The substance must already be in use as a drug i.e it is a real tangible substance where efficacy is empirically known, or at the very least have been tested on human beings. The Explanation to Section 3(d) was to deal singularly with chemical patents including pharmaceutical patents. The said Explanation has been adapted from EC Directive 2004.EC/27 i.e the EC Guidelines for giving marketing approval for medicinal products. The relevant provision is in the context of granting marketing approval to generic medicinal products which show similar bio-equivalency results when compared with a “reference medicinal product” i.e an already existing product in the market, that has gone through the rigours of drug approval.

4.2.3 Section 3(d) functions in precisely the same terms. If an existing substance has been cleared for use on humans, a new substance need only to show at the time of patent filing that it is not merely equivalent to, but enhances the efficacy of the known substance at the pre-clinical stage. It cannot be otherwise, as it is impractical as well as novelty destroying to expect a patent application for a pharmaceutical substance to be supported by human trial data at the time of filing.

4.2.4 It is submitted that if “known efficacy” is understood to mean pre-clinical test data, that would result in permitting rampant evergreening, contrary to the purpose of Section 3(d). It would lead to situations where the functioning of a substance at the in vitro petri dish stage is known, and a patent is obtained for that contribution to science. A second inventor or the same inventor may then claim inventiveness in the enhancement of the functioning of the substance at the same petri dish stage. The patent law would fail to fulfil its purpose, providing patent protection for minor laboratory improvements with no bearing on treatment of diseases. The beta form is the first substance whose efficacy is known as all predecessor compounds including Imatinib and Imatinib Mesylate (in any form other than the ß-crytalline form) have no known efficacy.

4.2.5 Further, the petitioner submits that “efficacy” as mentioned in Section 3(d) does not merely mean “therapeutic efficacy”. The main provision of Section 3(d) has no indication whatsoever that it applies only to the chemical world but in fact uses expressions like “machine or apparatus” implying a coverage wide enough to include mechanical, electrical and other inventions. The word “substance” simply means a particular kind of matter with uniform properties and in this context does not exclude any field of technology from its purview.

4.2.6 The Explanation, on the other hand, uses expressions like salts, ethers, esters, etc. which are only relevant for chemical substances. The Explanation, however, is broad enough to include fungicides, pesticides, fertilizers (even rat poison!) apart from pharmaceuticals and drugs. The word efficacy for pharmaceuticals must have the same meaning as it has for pesticides, weedicides, fungicides, etc. For these reasons, efficacy cannot be limited to therapeutic efficacy if the expression is understood in a narrow sense.

4.2.7 Even the word therapeutic has not been used to qualify the word efficacy in Section 3(d) whereas Section 3(i) specifically uses the same and the legislature was alive to the said expression. On the contrary, Section 3(i) uses words like “medicinal, surgical, prophylactic and diagnostic” in addition to therapeutic. It would therefore appear that an invention could relate to surgical efficacy or medicinal efficacy or prophylactic or diagnostic efficacy and there is nothing in the act to indicate that it ought to be limited.

4.2.8 The use of the expression “properties with regard to efficacy” appearing in the Explanation implies physical, chemical, biological or other properties which may have some impact on the efficacy of the alleged new form.

4.2.9 Bioavailability is a property which enables a substance such as an insoluble or low-solubility substance to pass through the stomach into the blood stream and reach the target site, namely, receptors at which binding of the drug results in a chain of reactions which prevent proliferation of cells leading to cessation of cancer.

4.2.10 Hence bioavailability is certainly a property that impacts efficacy or else the substance would sit like a pebble in the stomach and pass through without absorption. Similarly, other physical properties like thermodynamic stability, flow ability (better flow properties), etc. are properties that practically impact the manufacture, storage and consumption of drugs on a day-to-day basis by cancer patients. If the drug converts into a liquefied form in a bottle sitting on the shelf, it is useless and hence the importance of these properties is the administration of drugs.

4.2.11 The use of certain words like pure form and particle size in the Explanation of Section 3(d) demonstrate that the comparison being made is of an impure form of a substance when it is pure form or a substance with bigger particles with a substance with finer particles. These comparisons illustrate that a difference in efficacy which is contemplated in the explanation cannot possibly be due to the impurity and if the substances remain the same, efficacy must mean effectiveness as the only difference between a pure and impure form or two forms having different particle size can be effectiveness. Hence inclusion of these forms within the explanation implies that efficacy could not have been confined to therapeutic efficacy in the strict medical sense.

5. It is respectfully submitted that the subject-matter of the petitioner's patent application is a patentable invention under the provisions of the Indian law. The special leave petition may kindly be allowed in light of the arguments advance hereinabove.

III. Mr Harish N. Salve, Senior Advocate for Respondent 6, Cipla Ltd.

1. There are two broad issues that arise for consideration. They are as follows:

(a) Whether β form is not an invention as defined in Sections 2(1)(j) and 2(1)(ja);

(b) Whether on a correct construction of Section 3(d) the IPAB was right in holding that even if the β form of Imatinib Mesylate (hereinafter referred to as “the β form”) was an invention as defined, it would nonetheless be disentitled to registration on account of the bar in Section 3(d).

2. The first issue involves the construction to be placed upon Sections 2(1)(j) and 2(1)(ja).

3. At the outset, it is submitted that the language of the Indian statute must predominate the construction to be placed upon these provisions. Decisions of the Courts of United Kingdom and United States of America can certainly provide some guidance in relation to concepts that are engrafted in the Indian statue such as:

(i) what constitutes “obvious to a person skilled in the art”.

(ii) what is the connotation of the expression “anticipated by publication”.

4. The two broad propositions viz. that something which is already published is anticipated; and that something which, even if not published, may be obvious to a person skilled in the art, are general to the law of patents, and for this, guidance can definitely be sought from the decided cases of UK and US Courts.

5. There are however nuances in the language of the Indian statute and these must be given primacy. The attempt to steamroll the Indian jurisprudence by seeking a wholesale adoption of the Western jurisprudence irrespective of the conscious departure in the statutory language adopted in the Indian law is untenable in law.

6. The following features of the Indian statute are significant:

(a) The expression ‘invention’ is defined as a “new product”. This new product is the result of an inventive step, and the ‘invention’ has to be capable of industrial application. Abstract inventions that do not result in a “new product” would not qualify as an “invention” under the Indian law.

(b) The expression “inventive step” also has been consciously drafted in language which is a departure from the UK statute. In order to constitute an inventive step, it is not sufficient that there is an invention (i.e something that is not anticipated and is also not obvious to a person skilled in the art). In addition to satisfying these two requirements (which is common between the Indian law and the English law) in order to constitute an “inventive step” under the Indian statute, the invention must

(i) involve a technical advance as compared to the existing knowledge, or

(ii) involve economic significance,

(iii) or both.

7. In other words, there must be a key feature which qualifies as a technical advance compared to the existing knowledge. The mere fact that the invention is neither obvious nor anticipated is not sufficient—this condition of “technical advance” or “economic significance” has been added and must be given importance.

8. The expression “economic significance” cannot mean more profit to the inventor that is something which would follow from any new product (which may even not be a new invention). The expression “economic significance” must mean economic significance to the society for example if an invention leads to significant reduction in costs or significant reduction in the consumption of imported components thereby saving foreign-exchange, it may be considered an invention of economic significance.

9. The claims made by the appellants did not even assert any of these elements.

β form of Imatinib Mesylate is not an invention as per Section 2(1)(j) and Section 2(1)(ja)

10. The two-step invention argument as canvassed by Novartis is false which is evident from the following documents:

(a) Zimmermann patent (which discloses, enables and claims Imatinib and all its pharmaceutically acceptable salts which includes Mesylate). Further, also in the light of the fact that Zimmermann is a pre-1995 invention, no monopoly qua Imatinib or Imatinib Mesylate can be claimed by Novartis; p. 66 of Vol. B handed over by Novartis.

(b) Cancer Research article published on 1-1-1996 i.e prior to the priority date of the impugned patent application which discloses that the product Imatinib Mesylate has been synthesised and the same has been used for testing its efficacy both in vivo and in vitro for inter alia treatment of leukaemia; p. 86 of Vol. B handed over by Novartis.

11. The concept of publicly known has been laid down by this Hon'ble Court in Monsanto Co. v. Coramandal Indag Products (P) Ltd. (1986) 1 SCC 642 at para 6 which holds that the requirement of being publicly known is satisfied if it is known to persons who are engaged in pursuit of knowledge of patented product. It is not necessary to be in actual use; p. 27 of Vol. C-11 handed over by Respondent 6.

12. Thus Imatinib Mesylate along with its efficacy towards treatment of leukaemia was known prior to the date of filing of the impugned patent application (1602.MAS/1998).

13. Further, development of different crystal forms (polymorphs) would be obvious to a person skilled in the art based on the existing knowledge.

Construction of Section 3(d)

14. Section 3(d) should be construed in the light of its legislative history. Section 3(d) was deliberately inserted, and it would be

“best understood if we know the reason for it. The reason for a statute is the safest guide to its interpretation. The words of a statute take their colour from the reason for it. How do we discover the reason for a statute? There are external and internal aids. The external aids are Statement of Objects and Reasons when the Bill is presented to Parliament, the reports of committees which preceded the Bill and the reports of Parliamentary Committees. … Having discovered the reason for the statute and so having set the sail to the wind, the interpreter may proceed ahead. No provision in the statute and no word of the statute may be construed in isolation. Every provision and every word must be looked at generally before any provision or word is attempted to be construed. The setting and the pattern are important. It is again important to remember that Parliament does not waste its breath unnecessarily. Just as Parliament is not expected to use unnecessary expressions, Parliament is also not expected to express itself unnecessarily. Even as Parliament does not use any word without meaning something, Parliament does not legislate where no legislation is called for. Parliament cannot be assumed to legislate for the sake of legislation; nor can it be assumed to make pointless legislation. Parliament does not indulge in legislation merely to state what it is unnecessary to state or to do what is already validly done. Parliament may not be assumed to legislate unnecessarily. Again, while the words, of an enactment are important, the context is no less important.” (Utkal Contractors & Joinery (P) Ltd. v. State of Orissa (1987) 3 SCC 279)

15. As was held by this Hon'ble Court:

“33. Interpretation must depend on the text and the context. They are the bases of interpretation. One may well say if the text is the texture, context is what gives the colour. Neither can be ignored. Both are important. That interpretation is best which makes the textual interpretation match the contextual. A statute is best interpreted when we know why it was enacted. With this knowledge, the statute must be read, first as a whole and then section by section, clause by clause, phrase by phrase and word by word. If a statute is looked at, in the context of its enactment, with the glasses of the statute-maker, provided by such context, its scheme, the sections, clauses, phrases and words may take colour and appear different than when the statute is looked at without the glasses provided by the context. With these glasses we must look at the Act as a whole and discover what each section, each clause, each phrase and each word is meant and designed to say as to fit into the scheme of the entire Act. No part of a statute and no word of a statute can be construed in isolation. Statutes have to be construed so that every word has a place and everything is in its place. It is by looking at the definition as a whole in the setting of the entire Act and by reference to what preceded the enactment and the reasons for it….” (RBI v. Peerless General Finance & Investment Co. Ltd. (1987) 1 SCC 424)

16. The construction of Section 3(d) is elaborately dealt with in the note already submitted, and a copy of which is attached.

17. There are three key issues which need to be addressed.

(a) The construction of this provision in the manner suggested by the appellants i.e that it must be for all practical purposes ignored once the test of being an invention in Section 2(1)(j) is satisfied, (or that the provision provides a gateway for securing a patent even if the test of invention is not satisfied) runs counter to the language of the provision, its context, and its legislative history.

(b) The suggestion that the word “known” as appearing in the section must be construed in a manner different from that which appears in other parts of the statute, and must therefore be construed as a product which is in public use, again is an ex-cathedra assertion without any principle of authority in its support. The statute at multiple places uses two distinct expressions “publicly known” and “publicly used”. These two expressions obviously must have different meanings. Secondly, when Parliament inserted this provision, it must be presumed to have been aware of the judgment of this Hon'ble Court in Monsanto case (1986) 1 SCC 642 cited above, and the expression must be construed in the light of that decision.

(c) Once the notion of what is “known” is fixed, it becomes obvious that the “efficacy” in the context of drugs must mean “therapeutic efficacy”.

(d) It is submitted that the two broad reasons for the enactment of this provision was concerns relating to the protection of agriculture, and the protection of pharmaceuticals (i.e to protect evergreening of patents.)

(e) It is clear that the language of the provision is general and in the context of different industries, different paradigms may have to be evolved into relation to gauging efficacy for the purposes of this provision. In relation to drugs, the defining feature is therapeutic efficacy.

(f) It may not be possible to give an exhaustive definition of what constitutes therapeutic efficacy—it may have to be seen in the facts of every case as to whether the advance in knowledge leads to enhanced therapeutic efficacy. It may be easier to point out what does not constitute improved therapeutic efficacy.

(g) The Explanation provides a good statutory guide for construing the section. A changed form of the same molecule is not considered as passing the test of Section 3(d). It is possible that changed forms of organic molecules may have fallouts such as making it more soluble or thermodynamically stable or having greater or lesser hygroscopicity. Such changes may improve bioavailability. None of these features impact the therapeutic efficacy of the original invention namely, Imatinib.

(h) The expression “known substance”, the efficacy of which should stand enhanced in order to be beyond the disqualification under Section 3(d) is that known substance, the new form of which has been discovered.

18. Respondent 6, Cipla Limited has previously filed the following notes (which are also being annexed) during the course of arguments to aid and assist this Hon'ble Court:

(a) List of dates handed over on 4-10-2012;

(b) Two Notes on analysis of Section 3(d) handed over on 10-10-2012;

(c) Note on analysis of Sections 2(j) and 2(ja);

(d) Extract from the Nature Medicine article handed over on 10-10-2012;

(e) Summary of arguments of Respondent 6 along with annexures handed over on 11-12-2012.

19. It is thus submitted that the present appeal of Novartis deserves to be dismissed as the beta form of Imatinib Mesylate is:

(a) not a new substance as it is both anticipated and obvious;

(b) not a new form of a known substance which exhibits significant enhancement of efficacy.

Annexure A

20.

List of dates

3-4-1992 First application filed in Switzerland for pyrimidine derivatives and process for their preparation. Note.— Pyrimidine is broad family of compounds containing 2 nitrogen atoms at Positions 1 and 3. The title of the Zimmermann patent is Pyrimidine derivatives and processes for the preparation thereof. 25-3-1993 An application (EP 93810219.1) was filed by Ciba Geigy (predecessor of Novartis) claiming priority from the date of the Swiss Application CH 1083/92 dated 3-4-1992 for grant of patent in respect of Pyrimidine derivatives and process for their preparation (this application contained Imatinib and its pharmaceutically acceptable salts, one of which is methane sulphonic acid—addition salt). Note.— This is the application which was filed in Europe for grant of the patent in the Zimmermann invention. In Europe it is filed in the name of the assignee and not the inventor. 2-4-1993 An application similar to the aforesaid European application was also filed in the United States of America by Ciba Geigy being US Patent Application Serial No. 08/042.322 on 2-4-1993 @ p. 346.III. Note.— This is the origin of the Zimmermann patent specification and this was published. 6-10-1993 European Patent being EP 0564409 (corresponding to later granted US Patent No. 5521184) was published. 28-4-1994 A continuation application was filed in respect of Pyrimidine derivatives and process of preparation of the same by Ciba Geigy (as a continuation application of US Patent Application Serial No. 08/042.322 claiming priority from the Swiss Application dated 3-4-1992) @ p. 345.III now referred to as the Zimmermann Patent. 28-5-1996 US Patent No. 5,521,184 (Zimmermann Patent) granted in favour of Ciba Geigy on the basis of the continuation application. The aforesaid application claims Imatinib free base along with its various pharmaceutically acceptable salts including Imatinib Mesylate @ pp. 347 and 359.III Note.— The claim relates to: (i) derivatives N Phenyl Pyrimidine Amino (NPPA) (markush) (ii) compounds of NPPA derivatives (NPPAD) (iii) salts of compounds of NPPAD (having at least one salt forming group). Compounds which do not have a salt forming group appear to be left out. (iv) salt forming groups are those which have acid or basic properties. (v) one of the examples of creation of salts (by those of basic properties) is by use of methane sulfonic acid. (vi) non-toxic salts preferred for therapeutic purposes. (vii) specification states that all references to compounds include salts.

16-7-1998 Patent Cooperation Treaty Application for beta form of Imatinib Mesylate filed by Novartis in the PCT Office at WIPO. Note.— Single window application for simplifying identification of countries where patents may be available from such an application. Application thus names all potential countries. Further Note: After EMR was granted to Novartis in 2003 and ex parte injunctions obtained on the premise that polymorphs would be entitled to patents on their own right, to protect their position, Indian pharma companies filed patent applications in India and through the PCT route post January 2004. Post 2005 [amendment of Section 3(d)] Cipla confined its claim to Process patent. 17-7-1998 Impugned patent application for β form filed by way of mailbox at Chennai. Patent Office (Application No. 1602.MAS/98) @ p. 1.Vol. II The initial application which was filed was for “Crystal modification of a N-phenyl-2-pyrimidineamine derivative process for manufacture and its use”. This application included the alpha and the beta crystalline forms. Subsequently during the course of prosecution of the patent, the claims of this application were restricted only to the beta form and a separate divisional application was voluntarily filed for the alpha form in 2004. The corresponding US Patent US 6894051 B1 has been granted in favour of Novartis qua both alpha and beta form of Imatinib Mesylate. 26-3-1999 Patents (Amendment) Act, 1999 brought into effect retrospectively from 1-1-1995 This Amendment Act brought in Chapter IV-A of the Act thereby introducing mailbox applications for product patents as also exclusive marketing rights (EMRs) for those patents filed in the mailbox. Note.— An ordinance was promulgated deleting introducing EMR's from 1-1-1995 in respect of inventions post 1-1-1995. Since this ordinance lapsed, the amendment was made retrospective from 1-1-1995. No patent can be granted to inventions prior to 1995. Thus the Zimmermann patent is not actionable in India. 18-1-2000 National phase application for beta form of Imatinib Mesylate filed in USA. Note.— This is post-international search report. 11-1-2001 New drug application filed by Novartis before the Federal Drug Authority of US. Circa May, 2001 Launch of Gleevec in the market. 5-7-2001 Application for beta form of Imatinib Mesylate rejected in USA. 18-7-2001 Patent term extension application, in respect of the Zimmermann patent, filed by Novartis in USA. 30-1-2002 Compulsory licensing application filed in Korea, in respect of Gleevec.

10-11-2003 EMR granted in favour of Novartis by the patent office for 1Mβ in accordance with Sections 24-A and 24-B as contained in Patents Act, 1970 (as amended by the 1999 Act). It is granted for a period of 5 years or till the grant or rejection of the patent whichever is earlier. 23-11-2003 US Appellate Board order allowing patent application beta form of Imatinib Mesylate. January 2004 On the basis of the EMR granted in favour of Novartis infringement suit against 9 entities (including Cipla) filed in Chennai and Mumbai. CS No. 5 of 2004 filed against Cipla Limited. 20-1-2004 An ex parte interim injunction order is passed against Cipla and in favour of Novartis in the aforesaid suit by the Madras High Court. 13-2-2004 Infringement notice served on Natco by Novartis in the United Kingdom. 12-8-2004 799.CHE/2004 — a divisional application (out of 1602.MAS/1999) is filed claiming alpha form of Imatinib Mesylate. Note.— The old application was continued for the β form. 26-12-2004 The Patents (Amendment) Ordinance, 2004 notified. Section 3(d) amended by the said Ordinance. 1-1-2005 Product patents in all fields of technology allowed and examination of mailbox applications commenced. 4-4-2005 The Patents (Amendment) Act, 2005 enacted with retrospective effect from 1-1-2005. Section 3(d) further amended by the said Act. May to September 2005 Pre-grant opposition filed by 5 entities (Cipla Limited included). 30-9-2005 Supplementary Protection Certificate (SPC) granted in Europe. 25-1-2006 Orders passed by the Assistant Controller of Patents, rejecting the impugned application on the following grounds: - impugned patent application has been anticipated. - the same is obvious in nature. - it disqualifies for a patent, in view of Section 3(d). - applicant ought not to have got the convention priority since Switzerland was not a Convention country vis-à-vis India. @ p. 231.Vol. II Cipla's submissions 26-5-2006 7 WP (C) filed by Novartis before the vacation Bench of the Madras High Court. (i) Five of them challenged the decision of the Assistant Controller dated 25-1-2006. (ii) Two of them challenging the constitutional validity of Section 3(d) of the Act. May 2006 The Madras High Court returned all the seven WPs (C) with remark “no urgency hence rejected”. 21-6-2006 All 7 writs were refiled. 7-8-2006 All seven writ petitions admitted. Notice on the writ petitions as well as on miscellaneous petitions for stay issued by the High Court (WPs Nos. 24754-58 of 2006).

23-2-2007 Writ petition challenging the Assistant Controller's order converted into appeals. 2-4-2007 The 2005 Amendment related to constitution of IPAB brought into force. 3-4-2007 The Central Government vide a Notification [S.O 514(E)] directed that all appeals against orders or decisions of the Controller pending before any High Court be transferred to IPAB under Section 117-G. 4-4-2007 The High Court directed transfer of appeals challenging the Controller's order dated 25-1-2006 on merits to IPAB (whose technical member was Mr S. Chandrasekaran). 18-6-2007 IPAB praying that Mr S. Chandrasekaran be directed not to hear the appeals as a technical member as he had deposed an affidavit on behalf of the patent office in one of the matters before the High Court. 20-7-2007 Order passed by the IPAB dismissing the above miscellaneous petitions which sought removal of Mr Chandrasekaran as the technical member. 1-8-2007 Writ petitions filed by Novartis before the Madras High Court against the aforesaid order of dismissal passed by IPAB. 6-8-2007 The Madras High Court dismisses4 writ petitions challenging Section 3(d). No appeal preferred by Novartis. 13-11-2007 The Madras High Court allowed the writ petitions filed by Novartis against the order dated 20-7-2007 passed by IPAB. 28-1-2008 Natco Pharma Limited moved an SLP against the aforesaid order passed by the Madras High Court and obtained a stay. The IPAB adjourned the appeals sine die with the liberty to the parties to mention the matter as and when the SLP is disposed of by the Hon'ble Supreme Court. 1-10-2008 The Supreme Court orders constitution of Special Bench of IPAB with Mr P.C Chakraborti as the technical member and directed continuous hearing of the appeals. Mr Chakraborti was to act as the technical member only for the purposes of the Novartis appeals. 24-12-2008 Arguments before the IPAB completed orders reserved. 30-3-2009 Order passed by the Deputy Controller of Patents whereby Novartis' application qua alpha form of Imatinib Mesylate (799.CHE/2004) was rejected on several grounds including Section 3(d). No appeal preferred by Novartis. 26-6-2009 Impugned judgment5 passed by the IPAB. August 2009 Present SLP

21.

Annexure B

Analysis of Sections 2(1)(j) and (ja)

Inventive step

Means a feature

Of an invention (new product or process)

That involves

Technical advance as compared to the existing knowledge

Or having economic significance

Or both

And that makes

The invention not obvious to a person skilled in the art.

Invention means

A new product or process

Involving

(a feature that involves)

that makes

The invention not obvious to a person skilled in the art

And capable of industrial application.

Inventive step

Means a feature

Of an invention [new product or process]

That involves

Technical advance as compared to the existing knowledge

Or having economic significance

Or both

And that makes

The invention not obvious to a person skilled in the art.

22.

Annexure C (Colly)

Analysis of Section 3(d)

The mere discovery

Of a new form

Of a known substance

Which does not result in

The enhancement of the known efficacy of that substance.

Or

The mere discovery or

New use

For a known substance

Or the mere use of a known process….

For the grant of a patent, in respect of what may qualify as

an invention of [pharmaceutical substance], what is required

is

Discovery of

A new substance

A new form of a known substance which has enhanced

efficacy of the known substance.

If the efficacy of the substance for which the initial patent is

granted is therapeutic efficacy obviously the enhancement

has to be of this very efficacy.

(Pharmaceutical substance defined as meaning any new

entity involving one or more inventive steps)

Interpretation of Section 3(d) of the Act

23. (1) Section 3 of the Act has been in the statute book from the time of the enactment of the 1970 Act.

(2) It is based upon similar provisions in the English law. In the 1977 Act (UK) there is a provision analogous to Section 3. Section 1(1)(d) provides that a patent would be granted for an invention inter alia where “the grant of a patent for it is not excluded by sub-sections (2) and (3) or Section 4-A below”.

(3) Sub-sections (2) and (3) of Section 1 of the UK Act contain provisions somewhat similar to the various sub-sections of Section 3 of the Indian Act.

(4) The Commentary on the English Act [Terrell] explains the provision in the following words:

An initial consideration of the language of Section 1 might properly lead to the conclusion that anything could be an invention provided:

(a) it satisfied the requirements of sub-sections (1)(a) to (c); and

(b) it was not excluded from being patented by virtue of sub-section (1)(d).

(5) The Commentary then explains that sub-section (1)(d) is not exhaustive since its language suggests that it is an inclusive list.

(6) Section 3 thus always contained a list of factors which, if satisfied would defeat an application for patent. It opens with the words “the following are not inventions within the meaning of this Act”.

(7) It is clear that only where a new product satisfies the rigour of the definition of invention (including inventive step) would the question arise of ascertaining whether patentability of such invention is further inhibited by Section 3.

(8) Section 3 was designed to defeat an application for patent which passed through the definition of invention. The contention that construing Section 3 does not apply where Section 2(1)(j) read with Section 2(1)(ja) is satisfied, is misconceived for the reason that Section 3 was designed to be a disqualification in respect of what otherwise might constitute inventions.

(9) The language of the newly inserted Section 3(d) also calls for careful interpretation for the reason that the provision was consciously inserted to deal inter alia with the problems of evergreening in relation to pharmaceuticals.

(10) The first important feature is that (unlike the definition of invention which uses the expression “new product”), Section 3(d) uses the expression “substance”. In relation to pharmaceuticals, a definition has been inserted of the expression “pharmaceutical substance” as meaning “any new entity involving one or more inventive steps”. The suggestion that a known substance within the meaning of Section 3(d) must be a product known to the market is contrary to the express language of the provision.

(11) It is submitted that the word substance would include any entity that is involving an inventive step. In relation to inventions as in the present, a reading of the claim and the specifications would establish what is that known substance.

(12) The expression “enhancement of the known efficacy” relates to the efficacy “of that substance”. It does not relate necessarily to the efficacy of the marketable product i.e the downstream product created out of the pharmaceutical substance.

(13) The expression “known substance”, the efficacy of which should stand enhanced in order to be beyond the disqualification under Section 3(d) is that known substance, the new form of which has been discovered.

(14) The Explanation clarifies that salts and other derivatives of known substance shall be considered to be the same substance “unless they differ significantly in properties with regard to efficacy”. This further raises the bar in relation to the disqualification in the patenting of new forms.

(15) The word efficacy is preceded by the word “known” and it is the efficacy of “that substance” which requires to be enhanced. In other words, interspersing the words of Section 2(ta), it is the known efficacy of that new entity which involved one or more inventive steps which should stand enhanced by the new form discovered.

(16) The efficacy of the new form, for purposes of comparison, must be in relation to the same matter for which the efficacy of the known substance was asserted at the time of grant of the patent. The efficacy of the new form cannot obviously be its efficacy proved in the market for the reason that it is at this stage of grant of patent. To suggest that the efficacy of the new form can be ascertained without it being marketed, but the efficacy of the known substance should be the efficacy of its downstream products as established in the market, would result in giving a chameleon like meaning to the word efficacy.

(17) It is obvious that Section 3(d) cannot apply to new substances. A known substance must have therapeutic efficacy where it is a “pharmaceutical substance”. Where a new form in the form of a salt is discovered, then unless the efficacy of the new salt differs significantly “in properties with regard to efficacy”, the grant of a patent would stand disqualified.

(18) The efficacy of the known substance was not in relation to bioavailability. The reference to the bioavailability of the salt is irrelevant.

(19) In the instant case the new form that was discovered was the beta crystalline form of Imatinib Mesylate. It must be so for the reason that Imatinib Mesylate is a substance that was expressly one of the claims (Claim 23) in the Zimmermann Patent.

(20) However in order to suggest that there was a “two-step” invention in arriving at the beta crystalline form, it was suggested that the known substance was only Imatinib in free form.

(21) In either event it is clear that the pharmaceutical substance, the new entity—the qualities of which made it an invention was Imatinib —Imatinib Mesylate was, one of the compounds suggested in the Zimmermann patent.

(22) The 1996 research paper argues that there is no real difference in the therapeutic efficacy of Imatinib and Imatinib Mesylate.

(23) In either event the fact is that the patent now claimed is on its own's assertion, for a new form and unless there is clear proof that there is enhancement of the known efficacy of the known substance, the disqualification of Section 3(d) is not displaced.

24.

Annexure D

Extracts being relied upon by Respondent 6, CIPLA from Nature Medicine, Vol. 2, Number 5, May 1996, pp. 561-66

(at p. 94 of Vol. B handed over by Novartis)

The abstract

24.1 The Bcr-Abl oncogene, present in 95% of patients with chronic myelogenous leukaemia (CML), has been implicated as the cause of this disease. A compound, designed to inhibit the Abl protein tyrosine kinase, was evaluated for its effects on cells containing the Bcr-Abl fusion protein. Cellular proliferation and tumor formation by Bcr-Abl- expressing cells were specifically inhibited by this compound, in colony-forming assays of peripheral blood or bone marrow, from patients with CML, there was a 92-98% decrease in the number of Bcr-Abl colonies formed but no inhibition of normal colony formation. This compound may be useful in the treatment of Bcr-Abl-positive leukemias.

Right column

24.2 As the tyrosine kinase activity of the Bcr-Abl proteins is known to be essential to their transforming abilities, a specific inhibitor of the Abl protein kinase might be useful as a therapy for CML and other Bcr-Abl-positive leukemias. et al. ……………

24.3 We have produced a novel compound of the 2-phenylaminopyrimidine class that was selected for specificity against the Abl tyrosine kinase. This compound is more active against the Abl tyrosine kinase than other tyrosine kinase inhibitors previously reported, and we have extended the studies by Anafl et al, by showing that not only are K562 cells killed by this compound, but cellular proliferation of Bcr-Abl-expressing cells was specifically inhibited by this compound with no effects on normal cells. Activity was also demonstrated in vivo against Bcr-Abl-induced tumors. Further, in colony forming assays of peripheral bold or bone marrow from patients with CML, there was a 92%-98% decrease in the number of Ber-Abl colonies formed with no inhibition of normal colony formation. Thus, this compound may be useful in treatment of Bcr-Abl-positive leukemias.

Design of CGP 57148

24.4 Using the known structure of the ATP binding site of protein kinases, a series of compounds of 2-phenylaminopyrimidine class were synthesised and screened for the ability to inhibit a panel of protein kinases. CGP 57148 (fig. 1) was found to be a potent inhibitor of the Abl protein tyrosine kinase that was identified from this screen. Inhibitors of this class act as competitive inhibitors of protein kinases with respect to ATP….

Left column

In vitro profiling of CGP 57148

24.5 … Results presented in Table 1 show that CGP 57148 is a potent inhibitor of the Abl protein tyrosine kinase with an IC50 of 0.038 μM in vitro for substrate phosphorylation by v-Abl, 0.025 μM for Bcr-Abl (Table 1)….

Right column

Inhibition of tumor formation

24.6 32Dc13 cells expressing Bcr-Abl or v-Src are capable of forming tumors in syngeneic C3H/HEJ mice….

Inhibition of colony formation

24.7 … with 1 μM of CGP 57148. There was no inhibition of colony formation at this dose (Fig. 5). At a dose of 10 μM, colony formation of normal bone marrow was inhabited by approximately 15%-20% (data not shown). In contrast, when peripheral blood or bone marrow was obtained from CML patients known to have the t(9;22) chromosomal translocation, a 60%-80% inhibition of colony formation of committed progenitor cells was seen by incubation with CGP 57148 at a concentration of 1 μM (Fig. 5). When colonies that formed were assayed for the presence of bcr-abl transcripts by reverse-transcriptase polymerase chain reaction (RT-PCR), 92%-96% of the colonies formed in the absence of inhibitor contained bcr-abl. However, of the colonies that formed in the presence of 1 μM CGP 57148, less than 20% of the colonies contained bcr-abl transcripts. This represented in Fig. 5 as the solid portion of the graph of CML colonies. Combining this data with the 60%-80% inhibition of colony formation, there was an overall decrease of bcr-abl positive colonies of 92%-98%….

Right column

Discussion

24.8 In this study, we have outlined the preclinical studies of a compound designed specifically for the treatment of bcr-abl positive leukemias. A compound of the 2-phenylaminopyrirnidine class was synthesised that was based on the structure of the ATP binding site of protein kinases, and a series of structurally modified congeners were produced. CGP 57148 was found to be a potent inhibitor of the Abl protein tyrosine kinase identified from this screen. Although several tyrosine kinase inhibitors have been demonstrated to inhibit Bcr-Abl-induced proliferation, little information regarding their specificity for Bcr-Abl-expressing cells has been presented. In this study, we have demonstrated that CGP 57148 selectively inhibits the proliferation of Bcr-Abl-expressing cells in vitro and in vivo….

Left column

24.9 … The intended use of this compound would be for the in vivo therapy of CML and other bcr-abl-positive leukemias. In support of this intended use, preliminary data have shown little, if any, toxicity in animals. However, if this compound proves too toxic in vivo, another possible use would be in vitro purging of Bcr-Abl-expressing cells for use in autologus bone marrow transplantation….

24.10 This compound serves as an example of a drug that was rationally designed to inhibit the function of a specific protein when the protein's function was known to be involved in the pathogenesis of a specific disease state. It is hoped that by directing therapy toward the underlying disease mechanism, this will result in more effective and less toxic therapies. Ultimately, clinical trials will be required to determine the potential therapeutic benefit of this compound.

Right column

Colony-forming assays

24.11 Normal bone marrow or CML bone marrow or peripheral blood samples were assayed for colony formation as described, either without inhibitor or in the presence of 1 μM CGP 57148. Assays were performed on six normal bone marrow samples and seven CML patients, of which five patients were in the stable phase of the disease and two patients in accelerated phase or blast crisis. Assays of each patient was performed in triplicate….

25. The following issues are being covered in the present note:

A. Coverage and disclosure;

B. Construction of Zimmermann;

C. Whether the word “known” for the purpose of Section 3(d) is different from known for the purpose of prior art;

D. Construction of the patent specification of the beta crystalline form;

E. Meaning of expressions used in Section 3(d) and meaning of “efficacy”;

F. Scheme of the Patents Act and the correlation between Section 2(1)(j) and Section 2(1)(j)(a) and Chapter II (Sections 3 and 4);

G. Patent filed by the respondent Cipla;

H. Evergreening and its relevance to the present case — various patents filed by Novartis for Imatinib and its forms.

25.1 A. Coverage and disclosure:

25.1.1 Whether a patentee can claim more than what has been disclosed in his patent specification? The simple, logical and correct answer is “No” as it is against the very fundamental principle of patent law, which mandates that one cannot claim more than what has been disclosed by him. Novartis has argued as follows:

(i) Claims mean the scope of coverage of the invention.

(ii) Coverage/claims can be wider than the disclosure.

(iii) The test for infringement is whether the infringing article falls within the claim.

(iv) There exists a difference between test of infringement and test of patentability.

25.1.2 The abovementioned stand of Novartis is contrary to well-settled principles of patent law. It is the settled position that claims of a patent define the invention for the purpose of patentability as well as for the purpose of infringement. (Chisum on Patents, Para 8.01). This position is well known across the world and has remained the same over time. Therefore, any argument to the contrary would be a futile attempt to seek the laying down of a principle which lacks legal basis. The general principle with respect to interpretation of claims is the same whether they relate to infringement or to patentability. This is confirmed in the following commentaries:

25.1.3 ‘Chisum on Patents’, Paras 7.03 and 8.01

Ҥ 7.03 The enablement requirement

Since 1790, the patent laws have required that the inventor set forth in a patent specification sufficient information to enable a person skilled in the relevant art to make and use the invention.

The ‘invention’ that must be enabled is that defined by the particular claim or claims of the patent or patent application. This is consistent with the general principle of patent law that the claim defined the invention for purposes of both patentability and infringement.

An enabling disclosure is all that is required. The applicant need not describe actual embodiments or examples….”

(emphasis added)

25.1.4 In UK also the position remains the same. Para 9.05 of Terrell on Patents, 17th Edn., clearly states the UK law on the point:

“Principles equally applicable to infringement and validity:

Section 125(1) defines an “invention” as (unless the context otherwise requires) that specified in a claim of the specification, and both validity (see Sections 1 to 4 and 72 of the Act) and infringement (see Section 60) are to be tested by reference to the ‘invention’. It is, of course, a fundamental principle that the construction of a claim is the same whether validity or infringement is to be considered; no patentee is entitled to the luxury of an ‘elastic’ claim which has narrower meaning in the former case but a wider meaning for infringement in the latter…..”

25.1.5 Justice Jacob, illustrated the above conduct of patentees by means of the following illustration 2008 EWCA Civ 192:

“Professor Mario Franzosi likens a patentee to an Angora cat. When validity is, challenged, the patentee says his patent is very small the cat with its fur smoothed down, cuddly and sleepy. But when the patentee goes on the attack, the fur bristles, the cat is twice the size with teeth bared and eyes ablaze.”

25.1.6 It is also the settled position that specific examples are not expected to be made in order to comply with the enablement under Section 112 of the US Patent Act (35 U.S.C § 112).

25.1.7 According to Para 7.05 (Para 3) of Chisum:

Ҥ7.05

[3] What is a mode — The specific embodiment rule — Examples

Generally, an applicant need not include in her specification a specific working example in order to comply with the enablement requirement of Section 112. The specification need only teach to one with ordinary skill in the relevant art how to make and use the invention in question. Specific examples are often included in patent specifications because examples can be the best method of teaching how to make and use the invention. Examples need not necessarily be based on actual experiments.”

25.1.8 Also as per The Law of Chemical and Pharmaceutical Invention, by Jerome Rosenstock. 3rd Edn., 2011 Aspen Publisher, Para 9(B)(i) of Chapter 9 at pp. 9-30:

Ҥ 9.01[B]

(i) Sufficiency of examples disclosed in the specification : A specification need not contain a working example if the invention is otherwise disclosed in such a manner that one skilled in the art will be able to practice it without an undue amount of experimentation. Long, In re 151 USPQ 640 (CCPA 1966);”

Copies of the all abovementioned commentaries are being annexed and marked herewith as Annexure A (colly).

25.1.2 Hogan, In re 559 F 2d 595 (CCPA 1977) and Phillips Petroleum Co. 865 F 2d 1247 (Fed Cir 1989), cited by Novartis:

25.1.2.1 Novartis has cited: these judgments to argue that in the US there exists a doctrine of temporal paradox because of which it was permissible for a patentee to claim a broader protection than the disclosure which was enabled in the specification. This argument of Novartis is based on the judgment of Hogan 559 F 2d 595 (CCPA 1977) which according to Novartis upholds a broader interpretation of claims for infringement purposes and narrower interpretation for validity/patentability.

25.1.2.2 The reliance placed by Novartis on Hogan 559 F 2d 595 (CCPA 1977) is misplaced because the manner in which Hogan 559 F 2d 595 (CCPA 1977) is sought to be applied to the facts of our case is incorrect. Both Hogan 559 F 2d 595 (CCPA 1977) and Phillips 865 F 2d 1247 (Fed Cir 1989) laid down and upheld settled principles of law of patents i.e for the purpose of assessing sufficiency of disclosure of a patent later developments or inventions should not be taken into account. Unlike Novartis arguments, Hogan 559 F 2d 595 (CCPA 1977) and Phillips 865 F 2d 1247 (Fed Cir 1989) uphold the principle that on the date of the filing of a patent every aspect which a skilled addressee can understand from the reading of the patent stand enabled.

25.1.2.3 It is pertinent to note that both Hogan 559 F 2d 595 (CCPA 1977) and Phillips 865 F 2d 1247 (Fed Cir 1989) related to patentability and infringement of the subject-matter claimed in continuation/continuation-in-part applications. The mechanism of continuation applications allows an applicant for patent to file continuation applications for the same invention and claim a priority of the first application provided:

(i) the first application satisfy the requirement of enabling disclosure as enshrined in 35 U.S.C § 112: and

(ii) nothing new has been added, into the disclosure of the parent application's invention, in the subsequent applications.

Continuation applications are primarily filed to effect change in the claims.

25.1.2.4 Under the mechanism of continuation applications some time it happens that during the pendency of the patent applications there might be some development in the relevant technological field. Both Hogan 559 F 2d 595 (CCPA 1977) and Phillips 865 F 2d 1247 (Fed Cir 1989) only preclude the consideration of such subsequent developments in determining the sufficiency of a patent application which has a filing date prior to any subsequent developments.

25.1.2.5 The two judgments i.e Hogan, In re 559 F 2d 595 (CCPA 1977) and the United States Steel Corpn. v. Phillips Petroleum Co. 865 F 2d 1247 (Fed Cir 1989), broadly relate to the same basic application of 1953 relating to crystalline polypropylene. The said 1953 application disclosed various solid polymers and the method of making the same. Various continuation and divisional applications were filed with respect to 1953 application. This process of filing continuation and divisional applications in 1954, 1956, 1967 and 1971 continued. The 1971 application came to be considered by the USPTO which rejected Claims 13-15. The same was affirmed by the Board of Appeal and it was finally considered by the US Court of Customs and Appeals, which was the judgment relied upon by Novartis in Vol. T at p. 10.

25.1.2.6 The question in the 1977 judgment at p. 10 was whether the rejection of Claims 13-15 on the ground of lack of enabling disclosures, on the basis of subsequent documents, was correct or not. The Patent Office and the Board relied upon 4 documents viz. Haven, Edwards-I and Edwards-ll and another document described as Natta. On the basis of these 4 documents, the Patent Office had held that Claims 13-15 were invalid due to insufficiency. These rejections were affirmed by the Board.

25.1.2.7 The principle which came to be considered before the Appellate Court was whether sufficiency in a patent application is to be adjudged as on the date of filing of the application. The consequential question which the Court answered was whether the subsequent documents/developments could be considered to judge as to whether the claims were invalid due to insufficiency or due to lack of enabling disclosures. The Court, after discussing the entire matter, held in para 9 as follows:

“9. A later state-of-the-art is that state coming into existence after the filing of an application. This Court has approved use of later publications as evidence of the state of art existing on the filing date of an application. (FN17) That approval does not extend, however, to the use of a later (1967, Edwards) publication disclosing a later (1962) existing state-of-the-art in testing an earlier (1953) application for compliance with Section 112, first paragraph. The difference may be described as that between the permissible application of later knowledge about art-related fact existing on the filing date and the impermissible application of later knowledge about later art-related facts (here, amorphous polymers) which did not exist on the filing date. Thus, if the appellants' 1953 application provided sufficient enablement, considering all available evidence (whenever that evidence became available) of the 1953 state-of-the-art i.e of the condition of knowledge about all art-related facts existing in 1953, then the fact of that enablement was established for all time and a later change in the state-of-the-art cannot change it.”

To put it simply, the later documents/developments could be taken into consideration to decide as to what was the state-of-the-art on the date of filing of the application However, the later documents and developments could NOT be taken into consideration to plug a vacuum of insufficiency or lack of an enabling disclosure as on the date of filing of the application. By the same test, it was also not permissible to argue in an invalidity proceeding that the patent could be invalidated due to lack of enabling disclosure on the basis of subsequent developments.

25.1.2.8 The entire discussion, in Hogan 559 F 2d 595 (CCPA 1977) is whether new matter could be added subsequently which could contain developments which were in existence on the date of filing, of the application. The Court also holds that by filing a patent application by subsequent continuation applications, an applicant cannot in effect attempt to monopolise an invention which was unobvious in comparison with the first application and that inventors should be entitled to apply for patents for unobvious improvements. By filing continuation applications, an attempt cannot be made to monopolise inventions which have subsequently come into being. This is clear from the following extract from the Hogan 559 F 2d 595 (CCPA 1977) judgment:

“… Consideration of a later existing state-of-the-art in testing for compliance with Section 112, first paragraph, would not only preclude the grant of broad claims, but would wreak havoc in other ways as well. The use of a subsequently existing improvement to show lack of enablement in an earlier filed application on the basic invention would preclude issuance of a patent to the inventor of the thing improved, and in the case of issued patents would invalidate all claims (even some ‘picture claims’) therein. Patents are and should be granted to later inventors upon unobvious improvements. Indeed, encouragement of improvements on prior inventions is a major contribution of the patent system and the vast majority of patents are issued on improvements. It is quite another thing, however, to utilise the patenting or publication of later existing improvements to ‘reach back’ and preclude or invalidate a patent on the underlying invention….”

25.1.2.9 On analysing the prior art, the Court held that 2 of the documents are not prior art references qua Claims 13 and 14 and, therefore, the rejection of Claims 13 and 14 was incorrect. However, the Court treated Claim 15 differently. Since there was a clear gap in the continuity of the disclosure i.e Claim 15 had support in the 1953 and 1967 applications and not in the 1963 application, thus the rejection of Claim 15 was upheld. After giving an opinion on Claims 13 and 14, the Court remanded the matter to the Patent Office.

25.1.2.10 United States Steel Corpn. v. Phillips Petroleum Co. 865 F 2d 1247 (Fed Cir 1989): (Vol. T, pp. 29-36)

25.1.2.11 The judgment relied upon by Novartis in United States Steel Corpn. v. Phillips Petroleum Co. 865 F 2d 1247 (Fed Cir 1989) relates to the same 1953 application. This case was first decided in the District Court of Delaware and is reported as Phillips Petroleum Co. v. United States Steel Corpn. 673 F Supp 1278, 6 USPQ 2d 1065, (D Del 1987) The 1953 Patent bearing No. US 4376851 was admitted to have been infringed by the defendant. However, the invalidity continued to be challenged by the US Steel Corporation. The District Court had held that the US '851 patent is valid and infringed. A copy of the aforesaid judgment is being annexed and marked herewith as Annexure B.

25.1.2.12 This matter was then decided by the Appellate Court which is a judgment relied upon by Novartis at p. 29 of Vol. T. The defendant had preferred an appeal against the said order. The challenge to the patent was made by the defendant on the ground that the 1953 Patent did not have adequate disclosures of the specific utility as per 35 USC 101 and 112. The defendant did admit all the facts as captured in para 1, p. 32 qua anticipation, however, the defendant's argument was that the claims were too broad in comparison with the disclosures in the specifications. The defendant argued that the claim tried to take into its fold new matter which came into existence after the date of filing of the application and hence the claim is over broad. The court held that the language in a specification has to be understood for its meaning to an ordinary person skilled in the art at the time when the application was filed (p. 34). The invalidity action, therefore, failed and since infringement had been admitted, the District Court judgment 673 F Supp 1278, 6 USPQ 2d 1065, (D Del 1987) was affirmed.

25.1.2.13 Thus, the argument of Novartis that infringement was held on the basis of subsequent developments, though the patent was held to be valid qua enabling disclosures made on the date of filing, to support its argument that a claim can be construed broadly for infringement and narrowly for invalidity, is not borne put from this judgment. In fact, the defendant in this case had admitted literal infringement in the District Court. The defendant, inter alia, challenged the patent on the basis of insufficiency and lack of enabling disclosure. This challenge was not accepted by the court as the patent on the date of filing had an enabling disclosure.

25.1.2.14 Conclusion on Hogan 559 F 2d 595 (CCPA 1977) and Phillips 865 F 2d 1247 (Fed Cir 1989):

25.1.2.14.1 Both these judgments do not canvas the proposition which Novartis is seeking to canvas. Therefore, in both aforesaid cases, nowhere does the court lay down a precedent that a patentee can claim something more than its disclosure. Thus, the petitioner's argument that Hogan 559 F 2d 595 (CCPA 1977) has changed the law, in respect of enabling disclosure, is false and misleading.

25.1.2.14.2 Both Hogan 559 F 2d 595 (CCPA 1977) and Phillips 865 F 2d 1247 (Fed Cir 1989) bases do not lay down any new principle as is being argued by Novartis except that later developed technologies cannot be used to interpret the sufficiency of an already granted patent or already filed patent application. The fact and situation in Hogan 559 F 2d 595 (CCPA 1977) and Philips 865 F 2d 1247 (Fed Cir 1989) also have no relevance to the facts in issue and have been cited only to confuse the issue.

25.1.3 UK position

25.1.3.1 Two judgments and an extract from Terrell on Patents, 16th Edn. have been cited by Novartis to rely on the proposition that even in the UK, coverage can be broader than disclosure.

25.1.3.2 ‘Terrell on Patents, 16th Edn. — Handed across on 29-11-2012

25.1.3.3 Interestingly, Novartis relied upon extracts from the 16th Edition of Terrell to argue and buttress the position that disclosure and coverage are different under UK law. It is unfortunate that an earlier edition of the commentary on Terrell on patent is being relied upon in order to canvas an incorrect and misleading position in UK. Even the said 16th Edn. of Terrell at p. 123 states as follows:

Para 6-06:

“Principle equally applicable to infringement and validity: It is, of course, a fundamental principle that the constructions of a claim is the same whether validity or infringement is to be considered;”

Page 123 is not part of the extracts handed over by Novartis but the extract starts from p. 124 and could be completely misconstrued. The relevant paragraphs which specifically state to the contrary are contained in Chapter 9, paras 9.05 and 9.06 The latest commentary of Terrell and the judgments in the UK of 2007 and 2008 have clearly laid down that it is impermissible to construe patents claims with a wider meaning for the purpose of infringement and a narrower meaning for the purpose validity.

25.1.3.4 A.C Edwards Ltd. v. Acme Signs & Displays Ltd. 1992 RPC 13, Vol. R pp. 1 to 17

25.1.3.5 This judgment, in fact, disproves the very argument that Novartis is trying to raise in patent law that there is no such thing as an “implicit disclosure”. The case relates to a display board for displaying the price of petrol at petrol stations in a digital manner. The digital board had flaps which showed the digits. The patent related to how the flaps were attached to the board. The patent claimed that the flap had to be attached to the board with a stud. The defendant alleged that the plaintiff had by amendment of the claims in the course of prosecution of the application, amended beyond the disclosure in the application. It was in this context that disclosure was being looked at by the Court. The Court holds:

“Disclosures are normally a matter for the specification. One looks, no doubt, at the whole of the issues patent in determining what it discloses….” (p. 13, lines 48 to 50)

The question was whether the patent would be infringed by the manufacture of a board of similar kind where each flap needed one stud. The Court held by purposive interpretation that it was not necessary for the patent to disclose that each flap needed a stud, it was sufficient that if the patent disclosed flaps attached to the board by means of studs. (Exact language of the patent is not being used for the purpose of simplifying the facts).

25.1.3.6 The Court of Appeal in fact holds that there was an “Implicit Disclosure”. (p. 14, Vol. R, lines 20 to 27).

“But if I am wrong about that there is a further aspect. That is the question whether the three matters in question were, in any event, implicitly disclosed to a man skilled in the art by the contents of the specification as filed, Aldous, J. concluded that they were.

The principle of such implicit disclosure is accepted in the decisions of the European Technical Boards of Appeal to which I have referred (and which we have to take judicial notice. Section 130(7) of the Patents Act, 1977).”

Thus, the doctrine of implicit disclosure very, much exists in law inasmuch as an invention is deemed to be disclosed if the skilled addressee can understand the same on the date of patent.

25.1.3.7 Astellas Pharma Inc. v. Comptroller General of Patents 2009 EWHC 1916 (Pat)

25.1.3.8 This judgment also does not support the proposition argued by Novartis that coverage can be wider than disclosure. In this case, the patentee had applied for a “Supplementary Protection Certificate” (SPC) for a veterinary product to treat cats against tapeworms and roundworms. The basic patent was for emodepside. The final product was a combination drug of emodepside and praziquantel. The question before the Court was whether a patent term extension could be granted for the patent of emodepside in view of regulatory delays in the combination drug. The Court held that since the patent did not relate to emodepside and praziquantel as a combination, no extension could be granted to a patent which did not relate to the marketed product. Thus, the issue was relating to combination drugs and extension certificates and not whether praziquantel was disclosed or covered in the patent for emodepside or not. This judgment has no relevance in the present case. Novartis relied upon p. 25, paras 22 to 27 in a manner which did not represent the true facts.

25.1.3.9 Thus, both the judgments cited by Novartis including the extract from Terrell (16th Edn.) are liable to be rejected.

25.1.4 Conclusion on coverage and disclosure interpretation of Section 10 of the Patents Act, 1970:

25.1.4.1 From the above it is clear that the artificial distinction being sought to be made between the scope of claims for infringement purposes and validity proceedings i.e the difference between disclosure and coverage is completely incorrect.

25.1.4.2 The entire attempt has been made to confuse the issue by citing judgments from USA which have revolved on the facts of the respective cases. In all judgments, the aspects as to coverage and disclosure have involved a nuanced discussion on facts and technical issues. Thus such judgments which are so fact-based cannot be generalised to be the settled principles of law. Therefore, all these cases are not applicable in the present case.

25.1.4.3 Indian law relating to claims is contained in Section 10 and insufficiency is a ground in opposition and revocation proceedings. A reading of Section 10 clearly provides the following:

(i) that the best method of performing the invention has to be disclosed i.e it is not necessary that all methods have to be disclosed; and

(ii) that the specification has to end with a claim or claims defining the scope of the invention for which protection is claimed;

25.1.4.4 Thus Indian law recognises the same principle that the scope of claims determine the invention. It is only that invention that is disclosed which can be claimed. Beyond this it is unnecessary to venture into any other doctrines like “temporal paradox”, etc. which have no applicability in the context of the Indian statute.

25.2 B. Construction of Zimmermann:

25.2.1 The Zimmermann patent has been granted in several jurisdictions of the world including USA, Europe, etc. It is misleading for Novartis to argue that there was a short period when the law in the US was different and hence Novartis had claimed patent term extension on the basis of Hogan, In re 559 F 2d 595 (CCPA 1977) judgment. This is not just a misleading argument but to say the least, it is a completely incorrect representation of the prevalent position in the patent law. All the commentaries annexed by the respondent clearly reiterate and re-affirm the fundamental principle of patent law that a patent is granted for the disclosures made by it and the claims have to be within the disclosures made. Even the position in the UK is same. Patent term extensions have been taken by Novartis not merely in the US but even in Europe. Thus, reliance on a so-called “hiatus” in the law is completely wrong.

25.2.2 The Zimmermann patent clearly claims Imatinib and its pharmaceutically acceptable salts. It clearly states that pharmaceutically acceptable salts can be prepared in a “customary manner”. It is known to anyone in the field that for the administration of an API, a carrier is required and that salts (which possess higher solubility and other properties) are normal carriers of any API. In fact, pharmaceutically acceptable salts are generally known in the field to include hydrochloride, sulphate, phosphate, succinate, benzoate, acetate, pamoate, fumarate, Mesylate. This is clear from a patent US 4384975’ dating back to 1983 granted in favour of Sandoz. Copy of the aforesaid US patent is being annexed and marked herewith as Annexure C. Preparation of these salts is known to persons skilled in the art and hence need not to be exemplified i.e specific examples need not be given. That is the reason Zimmermann specifically uses terms like “customary manner” and “processes known per se”, etc. Pharmaceutically acceptable salts are completely enabled in Zimmermann and are claimed not just in Claim 23 but in large number of other claims and that is why no subsequent patent, even in the US, specifically claims Imatinib Mesylate per se. Imatinib Mesylate is covered, disclosed and enabled in Zimmermann. Even in India, the patent for beta form claims only the beta crystalline form of Imatinib Mesylate instead of Imatinib Mesylate per se. Therefore, all patents, subsequent to Zimmermann, only claims different forms of Imatinib Mesylate and not Imatinib Mesylate. Thus, the entire change in the rejoinder arguments by Novartis to show that Imatinib Mesylate was only covered but not disclosed in Zimmermann is a complete afterthought.

25.2.3 Terms such as constructive enablement, implicit disclosures are all irrelevant in the present context inasmuch as:

(i) In the Zimmermann patent, the acid addition salts are specifically mentioned.

(ii) It is also mentioned that salts can be manufactured in a customary manner.

25.2.4 For Novartis to argue at this stage that Imatinib Mesylate was not enabled in Zimmermann and hence the Zimmermann patent can be challenged on the ground of insufficiency also lacks bona fides inasmuch as Novartis has enjoyed the monopoly of Zimmermann from 1993 till date i.e a full span of 19½ years. To say that the Zimmermann patent can be challenged to the extent that Imatinib Mesylate has not been enabled is an argument of deception and ought not to be accepted by this Hon'ble Court.

25.3 C. Whether the word “known” for the purpose of Section 3(d) is different from “known” for the purpose of prior art:

25.3.1 This is not borne out from a reading of the Act. In the context of patent law, “known” can be either by publication or by way of use. The Hon'ble Apex Court in Monsanto Co. v. Coramandal Indag Products (P) Ltd. (1986) 1 SCC 642 has clearly held as follows:

“6. … To satisfy the requirement of being publicly known as used in clauses (e) and (f) of Section 64(1), it is not necessary that it should be widely used to the knowledge of the consumer public. It is sufficient if it is known to the persons who are engaged in the pursuit of knowledge of the patented product or process either as men of science or men of commerce or consumers. The section of the public, who, as men of science or men of commerce, were interested in knowing about herbicides which would destroy weeds but not rice, must have been aware of the discovery of Butachlor.”

(emphasis supplied)

(P. 27 of Volume C-11 handed over by Respondent 6)

25.3.2 The Act uses the words “known”, and used it differently. For e.g in Sections 25 and 64, the terms “publicly known” and “publicly used” are separately used. The Supreme Court while interpreting “publicly known” in Monsanto (1986) 1 SCC 642 has clearly held as stated above. Therefore, to interpret “known substance” for the purpose of Section 3(d) as a product which ought to have been tested, marketed and used by patients is contrary to the legislative intent as also to the understanding of the term “known” in the context of patent law.

25.3.3 Moreover beyond Zimmermann, various publications had already discussed and mentioned Imatinib and Imatinib Mesylate before the priority date of the impugned patent. The said publications clearly show that Imatinib and Imatinib (Mesylate) were even synthesised well before the filing of impugned patent application:

Cancer Research article dated 1-1-1996. (at p. 86 of Vol. B handed over by Novartis)

“… Materials and methods: Materials CGP 57148 and its methane sulfonate salt (CGP 57148B) were synthesised by CIBA Pharmaceuticals Division, as will be described elsewhere. For in vitro and cellular assays, a stock concentration of 10mM CGP 57143 was prepared in Me2SO and stored at 20° C. No significant difference in results could be seen between the two forms of CGP 57148. The form used in in vitro experiments is indicated in the text and legends. All in vivo experiments were performed using CGP 57148B….”

It is the admitted position that CGP 57148B is Imatinib Mesylate. This article of 1996 dearly mentions Imatinib Mesylate and this specific salt of Imatinib was clearly known before the priority date of beta form application.

25.4 D. Construction of the patent specification of the beta crystalline form:

25.4.1 Beta crystal form application in India was a divisional application from the original application which was filed for both alpha and beta. The specification of the alpha form and beta form are identical. There is only difference in relation to claims. A reading of this beta form application clearly establishes that the application relates to crystal forms of Imatinib Mesylate and not to Imatinib Mesylate per se.

25.4.2 At p. 54, the advantages of beta crystal form are compared with the alpha crystal forms and are as follows:

(a) flow properties are more favourable,

(b) thermodynamically more stable,

(c) less hygroscopic than alpha form and thus, better storage.

At p. 54, the specification mentions that it relates to the non-needle shaped crystal form of Imatinib Mesylate. At pp. 57 and 58, it is specifically mentioned that the beta form is prepared by digesting the alpha crystal form or an amorphous form, which is the starting material of Imatinib Mesylate. Thus Imatinib free base is not the starting material in this application. At p. 58, the specification uses the word educt i.e the starting material is the alpha crystal form pp. 58-59, the processability, beneficial flow properties, stability and hygroscopicity are compared with the alpha crystal form. At p. 62, the specification acknowledges that another medicine specifically discloses the salt of Imatinib which inhibits Bcr-Abl kinase.

25.4.3 At pp. 67-68, it is admitted that the inhibitory and pharmacological facts of the beta form are also find in the free base or other salts thereof. The specific admission at p. 68 is as follows:

“… The antiproliferative especially anti-tumor, activity of the methane sulfonic acid addition salt of a compound of Formula I in vivo is, for example, described for the treatment of abl-dependent tumors in Nature Med. 2.561-6(1996)….”

From the above extract, it is clear that the effectiveness of Imatinib Mesylate already stood disclosed in the 1996 publication and this is acknowledged in the specification itself. Thus, to argue that the beta form specification actually discloses how to manufacture Imatinib Mesylate is a misleading argument, Imatinib Mesylate and its pharmacological properties were well known in 1996 itself.

25.4.4 Example 1 — Reliance was placed on the second paragraph of Example 1 to argue that the beta form specification starts with Imatinib free base and discloses how to make the salt. This is also misleading inasmuch as a reading of the second paragraph of the Example 1 at p. 70 clearly reveals that second paragraph deals with preparation of the starting material i.e from the free base to the alpha form. Thus, alpha form is being prepared in Example 1 and the said alpha form is being converted to the beta form.

25.4.5 Example 2 — In Example 2, an attempt was made to portray that beta form is being directly made from the free base. This is again incorrect. A reading at p. 71 clearly reveals that the free base is converted to beta form by adding the seed of beta form. This is a process called seeding. In order to conduct the process of seeding, the beta form already ought to be available. Thus, clearly it is the alpha form which is the starting material in the beta form specification and not free base. The required quantity of beta form which is used for seeding has to be obviously prepared as per Example 1.

Thus, even Example 2 does not discloses a direct conversion of free base to beta form it uses the seeding method with the beta form and arrive at the higher quantity of beta form. The specification does not claim Imatinib Mesylate per se but only the beta modification.

25.5 E. Meaning of expressions used in Section 3(d) and meaning of efficacy:

25.5.1 Elaborate arguments have been heard on what should be the meaning of efficacy in the context of medicines. According to the respondent, the term “efficacy” can be construed differently for different products. However, when it comes to the question of medicines, efficacy of a medicine is primarily its ability to cure a disease. The word efficacy in pharmacology is understood and accepted to mean “therapeutic efficacy”.

25.5.2 The Madras High Court in its judgment reported as Novartis AG v. Union of India (2007) 4 MLJ 1153 has rightly arrived at the following conclusions:

(a) That the first part of Section 3(d) applies to all fields of technology.

“13. … Therefore, the amended section is a comprehensive provision covering all fields of technology including the field of pharmacology.” (MLJ p. 1177, para 13)

(b) Explanation in Section 3(d) operates only in the pharmacology field.

“13. … In our opinion, the Explanation would come in aid only to understand what is meant by the expression ‘resulting in the enhancement of a known efficacy’ in the amended section and therefore we have no doubt at all that the Explanation would operate only when discovery is made in the pharmacology field.” (MLJ p. 1177, para 13)

(emphasis in original)

(i) Efficacy as defined, in the Dorland's Medical Dictionary in the field of pharmacology is “the ability of a drug to produce the desired therapeutic effect”.

(ii) Efficacy is independent of the potency of the drug.

(iii) Therapeutic is healing of the disease — having a good effect on the body.

25.5.3 The question that has been raised before this Hon'ble Court as to whether interpreting the word efficacy as therapeutic efficacy and further whether interpreting therapeutic efficacy in a stricter sense since would result in raising the bar of patentability in the field of pharmacology. The apprehension expressed is as to whether by interpreting therapeutic to mean, for example, the inhibitory character of the product in the case of a cancer medicine would disqualify a large number of patentable inventions from being granted patents. Such an apprehension is completely unfounded inasmuch as since 2007, when the Madras High Court laid down the meaning of efficacy as therapeutic efficacy technical bodies across the country have applied the test of therapeutic efficacy in the facts of each case and have granted or rejected patents.

25.5.4 Instead of attempting to define as to what can qualify as “therapeutic”, it is easy to understand as to what does not constitute “therapeutic” from a reading of the section.

25.5.5 The words contained in the Explanation, namely, salts, esters, ether, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, etc. have some inherent properties. Salts are known to have greater solubility. Polymorphs exhibit higher stability, higher bioavailability and these are known properties to a person skilled in the art. The properties which are inherently exhibited by these forms of substances have to be contrasted with the properties with regard to efficacy. Thus, properties like solubility and stability, etc. are not the same as properties with regard to efficacy. The legislature uses them in contrast and contradistinction with efficacy.

25.5.6 Once the API (active pharmaceutical ingredient) is identified, the following are the presumptions qua any API.

(a) Salt — is a combination of acid and a base. If the API is an acid, it is then reacted with a Base to obtain a Salt and vice versa (p. 197 of Cipla's Vol. C-4) and “Salt Forms of Drugs and Absorption” by Berge et al [Natco's Compilation of Documents filed on 7-9-2012 - copy attached as Annexure D]. Relevant portion extracted below:

“The ideal characteristics of a salt are that it is chemically stable, not hygroscopic, presents no processing problems, dissolves quickly from solid dosage forms (unless it is formed with the intent to delay dissolution), and exhibit good bioavailability.”

Thus these properties of salts are inherent.

(b) Ester — is a chemical compound resulting from an acid and an alcohol.

(c) Ether — An ether is an organic compound that contains two alkyl or aryl groups joined by an oxygen atom.

It is generally known that salts, esters and ethers are prepared to increase the solubility of the API. Thus, solubility cannot be a property for granting a patent.

(d) Polymorphs — different crystalline forms of the same product. Polymorph is a different physical form of the drug. Crystalline forms are known to be purer, less, hygroscopic, thermodynamically more stable, free flowing and assist in making better dosage form. They are generally more bioavailable. Thus, properties like stability, hygroscopicity, bioavailability. dosage forms, etc. are not patentable (p. 308 of Cipla's Vol. C-4 — Novartis' patent for Delta and Epsilon forms).

“With other words, preparing consecutive different crystal forms of the same material increases the purity of the finally obtained substance. Furthermore, distinct crystal forms display different physical properties such as melting points, hygroscopicities, solubilities, flow properties or thermodynamic stabilities, and, hence, distinct crystal forms allow the choice of the most suitable form for a certain use or aspect …”

(e) Metabolites — Any substance produced by metabolism or by a metabolic process. Examples — when a drug is administered to the human body, it breaks into its active metabolite. Metabolites is the form in which the drug is absorbed by the human body e.g in Imatinib whenever an Imatinib is administered, it converts into des methyl Imatinib when it is absorbed by the human body. This is the natural conversion in the human body and hence this form should not be given a patent.

(f) Pure form: A pure form of a known substance is like rock salt and purified salt pure form is a purer form than the naturally occurring form of a substance. Thus, purification cannot be granted a patent. (p. 361 of Cipla's Volume C-4)

(g) Particle sized: reduction or increase in the size into particles — e.g crystalline sugar, cubes and cane sugar. Particle size in general is known to enhance solubility and hence particle size which in turn effects solubility cannot be patentable.

(h) Isomers: Mirror image of the same structure of a compound. Any of two or more substances that are composed of the same elements in the same proportions but differ in properties because of differences in the arrangement of atoms e.g n-butane and isobutane are the two C4H10 isomers as given below:

Isomers have no critical property and are hence not patentable.

(i) Compliex — A combination of two known compounds or a combination of a drug and an exponent. Since the compounds are known, their efficacy is also known, any such new property is also known. A complex is mainly made to stabilise one of the compound's stability. Thus, stability is not a patentable property.

Any combination of the above and other derivatives of the known substances, like pro-drugs which are mere carriers, are also not patentable.

25.5.7 While the Legislature included these terminologies in the Explanation to Section 3(d), the legislature was conscious of the properties of these different forms. These properties, therefore, were not to be given a patent by themselves unless they differ significantly with regard to efficacy. Thus, “efficacy” and “properties of these forms” are to be understood in contrast with each other. Since, these properties were in the knowledge of pharmacologists and were understood to contain greater advantages over the known substance, they were deemed to be the same substance. Thus, efficacy has to be in contrast with factors like solubility, stability, hygroscopicity, bioavailability, etc. Greater bioavailability, solubility, hygroscopicity therefore, are not part of efficacy.

25.5.8 Therapeutic efficacy has to be something different than these properties which are inherently contained in these forms and has to be interpreted accordingly.

25.5.9 Even safety is different from efficacy as captured by Section 3(d) inasmuch as while deriving some part of the Explanation from the EU Drug Regulatory provisions, the term safety has been specifically excluded. Thus, properties relating to safety are in contradistinction with efficacy and mere increased safety cannot be equated with efficacy.

25.5.10 Section 3(d) has to be interpreted differently in different situations and any attempt to define efficacy in Section 3(d) would in fact lead to limiting the Section in the context of pharmaceuticals, therapeutic efficacy has to be tested on the facts of each case. Therefore, depending upon the invention, depending upon the ailment which is to be targeted, the factors affecting efficacy will vary. Broadly it is sufficient to hold that in the context of medicine, efficacy does not include all the inherent and known properties of all the derivatives mentioned in the explanation of Section 3(d) and for pharmaceutical substances efficacy should mean therapeutic efficacy.

25.5.11 Conclusion

25.5.12 Thus, while giving meaning to the term “efficacy”, known inherent properties of salts and other derivatives ought to be excluded. That was the intention of the legislature.

25.6 F. Scheme of the Patents Act and the correlation between Sections 2(j) and 2(ja) and Chapter 2 (Sections 3 and 4):

25.6.1 It is irrelevant whether an invention is to be first tested under Section 2(j) or 2(ja) or under Section 3(d). The sequence in which these three sections have to be applied is not important. In either case, invention has to satisfy the tests of patentability under Sections 2(j) or 2(ja) as well as under Section 3(d). Whether they are taken sequentially, simultaneously or in any other order is up to the technical body which is the Patent Office. For example, if an invention relates to atomic energy, the patent office may not even examine other grounds and can refuse the patent on the ground of Section 4 itself. If the molecule is known or is in public domain and the claimed invention is a form of the molecule then Section 3(d) may be applied first.

A note handed over by Mr Harish Salve, Senior Advocate on the interpretation of Section 3(d) on 10-10-2012 is attached herewith.

25.7 G. Note on the patent filed by the respondent Cipla:

25.7.1 Novartis has relied upon one patent application filed by Cipla at p. 57 of Vol. N. The position qua this application is as follows:

The said application has a priority date of 2-9-2004. By this time, Indian applicants were permitted to file PCT applications. The said application was primarily filed for a process for the preparation of alpha form of Imatinib Mesylate which had been invented by Cipla. The necessity for filing process patents arises due to the fact that if a new process is devised and the same is to be exported by Cipla to different countries where the final product is not protected by a patent, customers always prefer that the manufacturer has devised its own process for manufacturing the product in order to avoid any allegation of infringement of any other process patents. These are in effect defensive process patents and nothing more.

The Indian patent application for this invention was rejected. In the US only process claims have been granted.

25.8 H. Evergreening and its relevance to the present case — Various patents filed by Novartis for Imatinib and its forms:

25.8.1 The present case is a classic case of evergreening which Section 3(d) seeks to prevent. A perusal of the various patents contained in Vol. C-4 clearly reveals that Novartis has filed and/or obtained in different jurisdictions including India, patents for different forms of Imatinib. In these patents, several admissions have been made by Novartis which lead to the incontrovertible conclusion that Novartis is engaged in evergreening.

25.8.2 The Zimmermann patent at pp. 8-25 of C-4 covers the Markush formula and a large number of compounds and derivatives. As per the chart handed over by Novartis it covers 4 billion compounds, 200 billion compound salts, 34 example compounds, 3 specifically claimed compounds (including Imatinib and its pharmaceutically acceptable salts), etc.

25.8.3 Having covered the entire footprint under the Markush formula, Novartis applied for crystalline forms of Imatinib Mesylate (pp. 39-50) in 1997. In this patent, the claims relate to various crystalline forms of Imatinib Mesylate. In India the alpha and beta crystalline form have also been applied for. Thereafter, a patent is applied for in 2001 for a new use of Imatinib Mesylate i.e for treatment of gastrointestinal stromal tumors (pp. 116-120). This is a patent for a new use of Imatinib to treat gastro intestinal tumors. At pp. 135 to 150 another Markush patent is filed for the N-oxides of the derivatives disclosed in the Zimmermann patent. This was filed in the year 2003. A corresponding Indian application has also been filed (pp. 152-135).

25.8.4 In 2005, a patent application is filed in the US for further salts of Imatinib for which a corresponding application is also pending in India (pp. 196-203). In 2008, a PCT application (p. 219) is filed for sustained release formulation of Imatinib i.e a salt release tablet solid dosage form and the corresponding application was also filed in India (p. 228). At p. 252, a further application is filed for a metabolite of Imatinib and the corresponding application in India is at p. 266.

25.8.5 In 2005-2006, a PCT application is filed for the delta and epsilon form of Imatinib Mesylate wherein it is specifically stated that the delta and epsilon crystal forms are used as intermediates to prepare the beta crystalline form (pp. 306-12). The corresponding Indian application is at pp. 313-31.

25.8.6 In 2006, an application is filed for the F, G, H, I and K crystal forms of Imatinib Mesylate in the US. There are 8 claims in the US patent at p. 344, however, the Indian patent application starting at p. 346 has 73 claims. Finally, another patent application is filed in 2008 with respect to stabilised amorphous form of Imatinib Mesylate wherein it is acknowledged that Imatinib Mesylate naturally exists either as the alpha or the Deta crystalline form at p. 381. The corresponding Indian application is at pp. 337-406.

25.8.7 A reading of the patent applications filed by Novartis for Imatinib and various forms and new uses of the same in the US and in India clearly reveals that the purpose behind filing these patents is to extend the protection for Imatinib as much as possible. The 20-year monopoly which was originally grantable/protectable in the US from 1993 to 2013. The Zimmermann patent is not a patentable invention in India and hence all the subsequent applications though relating back to Zimmermann directly are being filed only to indirectly obtain a monopoly on Imatinib and on its forms as also to extend the period. The various subsequent patents filed for Imatinib would extend the period of monopoly by almost 15 years i.e till 2028. This is nothing but evergreening which Section 3(d) seeks to prevent. The therapeutic efficacy in all these patent applications is Imatinib and thus, such evergreening ought not to be permitted.

Conclusion

26. It is thus submitted that the present appeal of Novartis deserves to be dismissed as the beta form of Imatinib Mesylate is:

(i) not a new substance as it is both anticipated and obvious;

(ii) not a new form of a known substance which exhibits significant enhancement of efficacy.

The patent application does not satisfy the test of either Sections 2(j) and 2(ja) or of Section 3(d).

IV. Dr Rajeev Dhavan, Senior Advocate, for Respondent 6, Cipla Ltd.

I. Issues

1. Whether Novartis is disentitled to a patent for Gleevec on the grounds of lack of (i) novelty and (ii) inventive step and by virtue of fulfilling (iii) Section 3(d) of the Act? Further (iv) what priority date may be assigned to it?

II. Submission on facts

2. In this case, the impugned patent application was filed by the black box procedure on 17-7-1998, granted an exclusive marketing right (EMR) on 10-11-1998 and examined on 1-1-2005. Following pre-grant opposition between May to September 2005, on 25-1-2006, the Assistant Controller denied a patent on grounds of (i) anticipation (ii) obviousness (iii) non-fulfilment of Section 3(d) of the Patents Act, 1970 and (iv) denial of convention priority. The writ petitions against the Assistant Controller's orders were converted into appeals. Following government orders to transfer HC cases to the IPAB (Board) on 3-4-2007 and the Supreme Court order of 1-10-2008 (2013) 7 SCC 241, the Board delivered the impugned order of 26-6-2009 partly allowing the appeals by reversing Grounds (i), (ii) and (iv) but denying patentability on grounds of Section 3(d). It is clear from the Madras High Court order of 6-8-2007 (2007) 4 MLJ 1153 that the validity of Section 3(d) is no longer in question.

3. From the facts placed before the Controller, Board and Supreme Court the following facts may be noted:

(i) The Zimmermann patent claims different N-phenyl-2-pyrimidineamine derivatives of Formula I, including pharmaceutically acceptable salts thereof with at least one salt forming group. The specification specifically mentions methanesulfonic acid as one of the salt forming acids. Significantly, there is enough indication recognising the salt and making it in the usual customary manner (See Zimmermann Novartis, Vol. B, pp. 67, 68, 76, 79 Example 21 and 23).

(ii) Various articles and notices before the Novartis application affirm the synthesisation of IM, [namely, Cancer Research dated 1-1-1996; Blood Article, 1-11-1997 and 15-12-1997; Nature, Vol. II (No. 5), pp. 561-566 dated 5-5-1996].

(iii) In 1977, Berge et al in the Journal of Pharmaceutical Sciences studied different salts including Mesylate approved by the FDA (see SLP Paper Book (PB) 147). US patent 4,384,575 by Sandoz states that drugs may be in free base or pharmaceutical acceptable salts including, inter alia, Mesylate (see Cipla Rejoinder Vol. pp. 90-91).

(iv) It cannot be disputed that Zimmermann was the basis for applications anthologised in Vol. C-4 [see Chart (pp. 1-4) from Zimmermann 1993 (pp. 8-25); US Terms Extension 2001 (pp. 26-38); Gleevec Drug Application 2001 (pp. 38A-38C); replication for alpha/beta forms in the US 2005 (pp. 39-50)]. Attention is also drawn to US Patent Apps. 2007 (pp. 121-150); 2008 (pp. 219-227): 2009 (pp. 252-266); 1-2-2011 (pp. 303-312); 22-2-2011 (pp. 332-345) on the basis of Zimmermann and its salts.

(v) Indian specifications for alpha (Vol. C-4, pp. 82-107) and beta form (ibid., pp. 51-78) show lack of novelty or inventive step or enhanced efficiency. Patent for the alpha form was refused by the Controller on 30-3-2009 on the bases of obviousness and, inter alia, observing that for the purpose of Section 3(d) comparing the sparing solubility of IM free base and freely solvable alpha form was “atrocious” (Vol. C-4, pp. 108 at 113-4).

(vi) Novartis's explanation that these alleged uses and abuses of Zimmermann are explicable on the basis that the test for infringement and patentability are different and coverage is wider than disclosures should be rejected because:

(a) The Indian Patents Act requires complete disclosure for the claim (Sections 7, 9, 10 and 11).

(b) Such a distinction is illogical and produces an unwarranted litigational “elasticity (see Terrell, 17th Edn. Pt. 9.05 referring to European Central Bank v. Document Security Systems Inc. 2007 EWHC 600 (Pat)).

(c) The so-called “temporal paradox” is speculatively academic invented for sustaining patent monopolies and cannot confound common sense or offend statutory provisions.

(vii) It is well know that:

“The ideal characteristics of a salt are that it is chemical stable, not hygroscopic, presents no processing problems, dissolves quickly from solid dosage forms unless it is formed with the intent to delay dissolution; and exhibits good bioavailability”. [Bergeet al: 1996 in Cipla Rejoinder Note: pp. 94 and 97]

(viii) No evidence has been laid to claim more than these efficacies.

(ix) Cipla's application led only to a process patent which has also been granted to Novartis.

(x) Novartis admits the salt is disclosed but not enabled (see SLP, PB p. 138), overlooking that the specifications teach a skilled person to achieve the results through the customary manner.

(xi) The priority date of 18-7-1997 as conventional priority for the Indian application of 17-7-1998 is wrong because India did not join the Paris Convention till 17-12-1998 and Switzerland was recognised by India as a convention country on 20-5-2003. If this is accepted the “Blood” article and other publications and application's themselves are prior art.

(xii) It will, thus, be clear that Novartis seeks evergreening and disingenuously seeks to change the rules by using and abusing Zimmermann, justifying this on the basis of unacceptable submissions distinguishing different tests for infringement and patentability.

III. Background treaties, rights and social interests

A. Interpretation

4. Interpretation in this case should follow Heydon case (1584) 3 Co Rep 7a, and invoke purposive interpretation which have been followed in India (G.P Singh: Statutory Interpretation, 12th Edn. pp. 124-132) to seek a harmonious resolution of all provisions (ibid., pp. 144-151).

B. Indian patent background

5. The background to the Patent Amendment Act, 1970 and its amendments in 1999-2005 is as follows:

(i) There were incessant foreign monopolies from the mid 19th century (see Dhavan et al articles: Table at pp. 69, 71, 73, 76, 79, 82, 83, 85, 86, 87, 88 and 89).

(ii) The Tek Chand Committee 1949 (Vol. C-8, p. 3) Patents Bill 1950 debates on (Id p. 30) 1952, 1953 (Id. pp. 3, 8-9, 11), Ayyangar Committee (Id. 15-22). Debates on the 1965 and 1967 Bill (Vol. C-8, pp. 22-44) show the concerns about monopolism, food, health, chemicals and agriculture. For Ayyangar details see Vol. C-1, pp. 1, 11-12, 13, 15, 16, 20, 22-27, 36-38, 41-43, 45, 60, 70 and 133.

(iii) These fears were repeated in 1998, 1999 and especially in the 2005 debates (Vol. C-3, pp. 6, 9, 10, 11, 12, 14, 15, 18-19, 22, 24-5, 30, 47, 59 and 67 specifically referring to Novartis patent and the high price of drugs.

(iv) From 1949 to 2005 till now there was an unabated concern about patents as monopolistic and predatory and undermining the right to health and other public interests.

(v) Section 5 of the original Patents Act (providing process patent for medicine and chemicals) and Section 3(d) introduced by the 2005 Amendment (requiring greater “efficacy” for chemical and medicine substances) share a common concern fundamental to the Act. Section 3(h) continues to exclude a method of agriculture and horticulture from patentability.

C. WTO and Trips

6. Trips is a part of the extensive revision of GATT by the Uruguay Round (1987-1995) creating the powerful WTO and covering not just trade and tariffs but also Textile Multifibre Agreements (TRIMS), Trade Related Intellectual Property (Trips), Trade in Services (GATS) and agriculture.

7. WTO has its own dispute settlement machinery which was invoked by the US twice to coerce India into enacting a new patent law (Vol. H; 5-9-1997, p. 217; 19-12-1997, p. 108; 24-8-1998, p. 134). Further the US put India on a watch list for scrutiny of Trips and other non-fulfilments of WTO.

8. It is clear WTO and Trips were patently predatory and used to coerce India. It was a means for globalised economic imperialism with no holds barred.

9. However Trips allowed some lee way for social and public interest flexibilities (Articles 7, 8, 27, see Vol. H). This was further reflected in the Doha declaration. Various changes/deviations in the Indian Patents Act exploit these exceptions to interpose anti-monopolistic and welfare concerns.

D. Treaties, fundamental rights and directive principles

10. The Union Government is exclusively competent to negotiate treaties, agreements and the like as part of its executive power (see Ram Jawaya Kapur v. State of Punjab AIR 1955 SC 549; Article 73 read with Schedule VII List I Entries 13 and 14 of the Constitution). But it is well established that the executive power cannot infringe any rights especially fundamental rights (see Ram Jawaya Kapur v. State of Punjab AIR 1955 SC 549, Kharak Singh v. State of U.P AIR 1963 SC 1295, Naraindas Indurkhya v. State of M.P (1974) 4 SCC 788, Bishambhar Dayal Chandra Mohan v. State of U.P (1982) 1 SCC 39 and Bijoe Emmanuel v. State of Kerala (1986) 3 SCC 615).

11. It logically follows that India rightly follows the incorporation theory whereby (a) enforceable rights in India have to be created by legislation; (b) national law will override treaties or international law which conflict with it; but (c) courts may use international law as an aid to interpretation (Gramophone Co. of India Ltd. v. Birendra Bahadur Pandey (1984) 2 SCC 534, SCC at para 5 and paras 3-7).

12. However a distinction can be made whereby “Human Rights Enhancing Treaties” read into Article 21 and other Fundamental Rights are enforceable in India and an aid to the construction of statutes of these rights into which these treaties are read (People's Union for Civil Liberties v. Union of India (1997) 3 SCC 433)

“13. … In our opinion, this aspect requires deeper scrutiny than has been possible in this case. For the present, it would suffice to state that the provisions of the covenant, which elucidate and go to effectuate the fundamental rights guaranteed by our Constitution, can certainly be relied upon by courts as facets of those fundamental rights and hence, enforceable as such.”

[Other examples of such process include Vishaka v. State of Rajasthan (1997) 6 SCC 241, People's Union for Civil Liberties (PUCL) v. Union of India (1997) 1 SCC 301 and Society for Unaided Private Schools of Rajasthan v. Union of India (2012) 6 SCC 1.]

13. In our present case, the right enhancing treaties include the right civil liberties and socio-economic rights as for example in the Universal Declaration (1948); and also International Covenant on Civil and Political Rights (1906) and Economic, Social and Cultural Rights (1966) to which India is a party from 1979 and various other international human rights concerns.

14. Trips is not per se rights enhancing because it creates monopolies in a free trade treaty, thus giving multinational and corporate control over a slice of India's political economy. In another context, America's purchase of Costa Rica's biodiversity is another predatory example. Further human rights treaties have to be read along with Articles 7-8, 27 of Trips and the Patent monopoly must yield to human rights. Section 3(d) and other provisions of the Patents Act, 1979 have to be read up or down accordingly. The court may also take note of international concern by report to UNDP and International Scholarship excluding human rights concerns over patent right especially for the right to health (UNDP Volume handed over pp. 13-17, 19, 21, 26, 27, 28, 68, 69, 76, 79, 80, 83, 88, 89, 92, 101 and 103). Attention is also drawn to international and national concerns in Vol. C-5).

15. The right to health is recognised as part of Article 21 read with Articles 39(e), 41, 43, 48-A (Vincent Panikurlangara v. Union of India (1987) 2 SCC 165, SCC at para 16; Consumer Education & Research Centre v. Union of India (1995) 3 SCC 42, SCC at paras 18, 20, 21, especially para 25; Air India Statutory Corpn. v. United Labour Union (1997) 9 SCC 377, SCC at paras 15, 25, 38, 39, 41-45 and 49) [See Volume C-13] and Printers (Mysore) Ltd. v. CTO (1994) 2 SCC 434 and G.P Singh: Statutory Interpretation, 12th Edn., pp. 627-32, 644-49.

IV. Interpreting the Patents Act, 1970

A. Relevant principles

16. The following relevant principles may be noted:

(i) Parts of the Patents Act, 1970 (as amended) is a human rights protecting and enhancing social welfare legislation to the extent that they discipline the patent monopoly holders and provide limitations on granting continuing or enjoying patents (see Sections 2(h), (j), (ja), (6) (6-a), 3(d), 11-A(7), 47, 54(3), 55, 63-66 (revocation) 83-94 (compulsory licensing) 99-103 (Government Patents).

(ii) A harmonious interpretation requires that no provisions be made redundant or superfluous (G.P Singh (supra) pp. 73-5, 144-152).

(iii) Word, including definitional clause which begin with the phrase “unless the context otherwise requires”, may have different meanings in the same Act, or even section [Printers (Mysore) Ltd. v. Asstt. CTO (1994) 2 SCC 434, SCC at paras 18-19 (Vol. C-13) used this to protect free speech in a tax statute].

(iv) Rights enhancing treaties and those fulfilling Directive Principles have to read into fundamental rights and limitations founded on this public interest.

(v) Despite similarity of subject-matter, foreign decisions are not definitive or ex cathedra in dealing with Indian Statutes and Indian conditions [M.V Elisabeth v. Harwan Investment and Trading (P) Ltd. 1993 Supp (2) SCC 433; Gian Devi Anand v. Jeevan Kumar (1985) 2 SCC 683].

B. Exclusion from patentability

17. A somewhat specious arguments was made that if the requirements of patentability (under Sections 2(j), (ja), (l), (ta) are met, the operation of Section 3(d) were inapplicable. This is not correct because:

(a) Section 3 imperatively indicates what are not inventions including Section 3(d)

(b) Section 3(d) cannot be redundant

(c) Section 25(1)(f) (opposition), Section 25(2)(f) (opposition after one year) Section 65(d)(k) (revocation) affirm fulfilling a dual statutory requirement so that the claimant has to reveal an invention within the meaning of the Act and as well as show that the “invention” or claim is not excluded from patentability under Section 3.

It is obvious that two gateways exist to determine grants of patentability. Both gateways operate independently and concurrently.

C. Multiple independent safeguards

18. Equally specious is the argument that even if a patent granted there are many subsequent provisions to protect government's use (Sections 47, 99-103), supply pharmaceutical products to countries with public health needs (Section 92-A) and enable compulsory licensing or revocation (Sections 83-94). In fact the scheme of the Act envisages these possibilities as independent and exclusive procedures which cannot obviate the rigorous conditions attached to the grant or refusal of patentability. Each one of these is an independent, exclusive procedure and empowerment without any one being a substitute for or off-setting the other.

D. Priority date: Criteria

19. The requirements for determining priority dates are as follows:

(i) reciprocity [Section 133 and Section 2(1)(c)(d)].

(ii) recognition by gazette notification (unamended Section 133 applicable before 1-1-2005).

(iii) mutuality between the countries concerned or through agreements or conventions (Section 136).

(iv) Specification and Identification of patent details and priority date claimed (Sections 136, 138).

(v) temporality requiring claims to be made in 1 year of priority date (Section 135).

Priority date is relevant as a cut-off after which “prior art” may not be looked at.

20. This argument totally fails in Novartis claiming a Swiss priority date of 18-7-1997 because

(i) the Indian claim was filed on 17-7-1998.

(ii) India did not join the Paris Convention till 7-12-1998 belying any mutuality or reciprocity till that date.

(iii) Till 1-1-1995, the recognition requirement mandatorily entailed a Gazette Notification which was issued on 20-5-2003.

(iv) The specification and indication requirement had to be fully met which has not been demonstrated.

21. The consequences of denial of a Swiss priority date means that (i) the Swiss prior art till 17-7-1998 was in public domain (ii) articles as in Blood and other literature are to be treated as prior art (iii) the Novartis claim would fail.

E. Section 3(d)

22. The purpose of Section 3(d) is a social welfare provisions to prevent evergreening and continuing monopolism and requiring stricter scrutiny test to be rigorously applied so as to exclude claims which do not meet its standards. Any other approach would trivialise its intent and purpose.

23. This Section 3(d) must be interpreted bearing in mind

(i) the social welfare purpose.

(ii) that even a product or process is otherwise patentable; such a patent could not be granted if Section 3 including Section 3(d) requirements are not met.

(iii) that Section 3(d) applies to new forms or any new property of a known substances or (new) use of a known process.

The term “known” does not mean in use, or existence part industrial application but simply means “known of” [in this case the IM and its salts and their putative efficacy were known].

(iv) Further the Explanation makes an illustrative list of what is treated as the “same” substance of a known substance to include “salts polymorphs contributions of known substance namely salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance [from Section 3(d) explanation].

This is a deeming fiction even if the word ‘deemed’ “is missing”. (CIT v. Urmila Ramesh (1998) 3 SCC 6) It is well settled that once its purpose is ascertained “full effect must be given to the statutory fiction and it should be carried to its logical conclusion (State of Bombay v. Pandurang Vinayak AIR 1953 SC 244 at p. 246, AIR p. 246, para 5) (State of Travancore-Cochin v. Shanmugha Vilas Cashewnut Factory AIR 1953 SC 333 at p. 342)

(v) The concept of enhanced, efficacy cannot be trivialised as meaning “any efficacy” because the “efficacy” must increase “significantly”. If this cannot be shown it will be treated as the “same substance”.

(vi) A purposive interpretation of “efficacy” is not just new bioavailability for easier administration. The test for both chemicals and pharmaceutical necessarily individuates in terms of the purpose for which the substance claims to be an invention. In the case of pharmaceuticals, the purpose of the invention is to cure, implying “therapeutic efficacy”. Without this the purpose of Section 3(d) will be defeated.

(vii) Process patenting may come under Section 3(d) unless the use of known process results in a new “product or employs at least one reactant”. The word “known substance” “new product”, “same substance” in Section 3(d) have been used advisedly to make Section 3(d) confront evergreening and ground realties.

(viii) Section 3(d) may be read with Section 3(e) except the former is more elaborate and requires strict scrutiny.

24. Attention may be drawn to Indian decisions which demand rigorous test greater than “workshop improvements” [Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries (1979) 2 SCC 511; Monsanto Co. v. Coramandal Indag Products (P) Ltd. (1986) 1 SCC 642, SCC at paras 5 and 6; Novartis AG v. Mehar Pharma (2005) 30 PTC 160 (Bom), PTC paras 3, 9, 16, 19, 28); Glochem Industries Ltd. v. Cadila Health Care AIR 2010 Bom 76, MIPR paras 47, 49, 51 esp. 52, 53, 55; Asian Electronics Ltd. v. Havells India Ltd. (2010) 2 MIPR 0001, IA No. 8205 of 2009 in CS (OS) No. 1168 of 2009, MIPR paras 61, 65, 66; F. Hoffmann la Roche v. Cipla Ltd. (2008) 37 PTC 71 (Del), PTC paras 74, 78, 82, 85, 87, 89, 91; Dhanpat Seth v. Nil Kamal Plastic Crates Ltd. (2008) 36 PTC 123 (HP), PTC paras 111, 112] These cases which are of persuasive significance may be found in Volume C-11.

25. In the Novartis case, IM, IM and its salt forms were known. The existing efficacious quality of IM, IM and its salts forms were also known.

V. Submission on Board's judgment

26. The Board's judgment suffers from inherent contradicts:

1. While dealing with preliminary issues, the Board (at SLP, PB) finds:

(i) Dr Manley and Dr Massimini have “lost their partiality” (p. 140).

(ii) The “relative bioavailability” of beta crystal form of Imatinib Mesylate and simple Mesylate (say amorphous) are the same or at least comparable (p. 142).

(iii) it is known that all salt forms improve bioavailability and other properties substantially (pp. 142-43).

(iv) The Massimini Affidavit contains no specific reference to 30% higher effectiveness for the beta crystal form over Imatinib (pp. 143 also 144).

(v) Efficacy is to be tested “against the illness for which it is prescribed” (p. 144).

(vi) IIT (Delhi) IICT (Hyderabad) reports show IM exists only in the crystal forms (pp. 144-45) to explain known properties for the purpose of Section 3(d).

(vii) Novartis admitted that beta salt form of IM was a new invention but it also continued to be covered by the 1993 patent also. (p. 146).

(viii) Disclosure of prior art is a requirement of Section 10(4) and must be disclosed (p. 147).

(ix) Novartis “failed to meet” the obligation to disclose prior art (p. 148).

(x) Novartis tried to “mislead” the Board about the Cancer Research article (p. 149).

(xi) Novartis admits that IM was a known substance (p. 150-52).

(xii) Given the object of its alleged invention the claim has not demonstrated the enhanced efficacy of the IM beta form.

(xiii) “Bioavailability” and “efficacy” are not the same. Efficacy is to be “tested against the illness for which it is prescribed” (pp.154-55).

(xiv) India has stricter forms of protections (pp. 156-58).

(xv) Presentability of a drug is solid formulations “has nothing to do with its effectivity or disease curing effect” (p. 158).

(xvi) Novartis's extension application in the US shows that Gleevec is nothing but a code name for the beta crystalline form of IM (p. 158).

(xvii) Beta form in particular has no role to play for curing the cancer for which it is meant (p. 159).

(xviii) IM and its beta form are the same substance with respect to efficacy (p. 160). Any substance containing Imatinib Mesylate moiety will have cancer curing property (p. 161). Even if there is 30% bioavailability. IM and its Mesylate salt “are the same substance with respect to therapeutic efficacy” (p. 162).

27. Although these conclusions clearly establish that Section 3(d) efficacy is not established (SLP PB pp. 185-191). But the Board accepted novelty (pp. 164-173) and inventive step (pp. 173-178). This is inconsistent with its preliminary findings. Specifically, there are fallacies in its reasoning:

(i) While the 1993 Patent has not given a working example of how a salt of Imatinib could be made (p. 168), this ignores that Zimmermann was addressed to a person skilled in the art.

(ii) It ignores that IIT and IICT publications as not relevant though they establish that IM exists in its beta form (pp. 168, 171).

(iii) It wrongly treats 18-7-1997 as the priority date (p. 169).

(iv) Uses the narrow test of “definite certainty”.

(v) It projects an “uninventive man” as lacking motivation (p. 170).

(vi) It hold that though “there is no reference to selection patent as such in Indian Patent law” (p. 179) it can be introduced (see pp. 179-82).

(vii) It uses an ambiguous test of “some substantial advantage” (p. 182).

(viii) It wrongly asserts contradictingly that “the said crystalline form (the beta form) is not known or disclosed or published anywhere though the use of Imatinib Mesylate was known before” (p. 184).

But the Board rightly concludes that uses the test of therapeutic efficacy and not simply bioavailability for determining efficacy under Section 3(d).

28. It may thus be concluded on the Board's real findings establish that

(i) IM was a known substance.

(ii) Zimmermann 1993 remains the basis of future claims.

(iii) The word “significantly” prefixing “efficacy” means that therapeutic efficacy and not bioavailability is the test.

VI. Conclusion

29. It is submitted that:

(a) If the Swiss priority date is not accepted all the prior art including the Swiss application will obviate novelty and inventive step.

(b) Special provisions of the Patents Act should be seen as social welfare legislation.

(c) The framework of construction for the Act is not Trips (which permits deviations) but the “constitution and rights enhancing treatise”.

(d) The Zimmermann patent discloses salts of IM and their making in the customary manner.

(e) Novartis has blown hot and cold in its uses of Zimmermann.

(f) Significant enhanced efficacy has not been shown.

(g) The claims must fail in not meeting the requirements of novelty, anticipation, inventive step, non-obviousness, no enhanced efficacy and lack of priority date.

V. Ms Prathiba M. Singh, Advocate, for Respondent 7, Ranbaxy Laboratories Ltd.

1. The present written note of submissions is being divided into the following sub-heads:

(a) β form of Imatinib Mesylate is not an invention within the meaning of the Patents Act, 1970;

(b) β form does not satisfy the test of Section 3(d);

(c) Scope and construction of Zimmermann Patent;

(d) Meaning of the term “efficacy”: Interpretation of Section 3(d);

(e) Scheme of the Patents Act and the correlation between Section 2(1)(j) and Section 2(1)(j)(a) and Chapter II (Sections 3 and 4);

(f) Evergreening and its relevance to the present case — various patents filed by Novartis for Imatinib and its forms;

A. β form of Imatinib Mesylate is not an invention within the meaning of the Patents Act, 1970

2. β form of Imatinib Mesylate fails the test of Sections 2(1)(j) and 2(1)(ja) inasmuch as

- Imatinib Mesylate has been disclosed, enabled and claimed by the Zimmermann Patent in the year 1993;

- Cancer Research article specifically discloses that Imatinib Mesylate was prepared and tested qua its efficacy;

- Based on the aforesaid two documents, it would have been patent to a person skilled in the art that Imatinib Mesylate was existing and that the Mesylate salt of Imatinib can be prepared by following the customary procedure existent in the field;

- Preparation of different polymorphs is known to a person skilled in the art as the said knowledge was already prevalent in the existing field;

B. β form does not satisfy the test of Section 3(d)

3. Various advantages of β form have been claimed by Novartis over the ‘a’ form of Imatinib Mesylate and not over Imatinib Mesylate per se. On the contrary, it has been admitted in the impugned complete specification that all the inhibitory and pharmacological effects of Imatinib free base are necessarily retained by the β crystal form and Imatinib Mesylate.

4. In Cancer Research article it has been admittedly stated that there is no difference in the result (qua the efficacy towards treatment of leukaemia) between Imatinib and Imatinib Mesylate.

5. The fact that all the inhibitory and curing properties are possessed by Imatinib and the various crystal forms play no role towards treatment of leukaemia is evident from a perusal of the product insert literature of Glivec being marketed by Novartis (which does not even find a bare mention of the β crystal form).

6. Better flow properties, thermodynamic stability, less hygroscopicity and bioavailability are physical properties that are inherent in a crystalline form of a free base and as such the same cannot be regarded as factors which affect efficacy of the drug (manufactured using the crystal or salt form of a free base).

7. Affidavit of Dr Bertrand Sutter (employee of Novartis) - was filed to counter the IIT and IICT report on the ground that beta crystal seeds were previously present in the sample provided by Natco to both IIT and IICT. However, in the said affidavit it has been specifically stated by Dr Sutter that in 1995 a team was coordinated by him which was involved in the solid state characterisation of Imatinib Mesylate and that during the early phase of solid state characterisation of Imatinib Mesylate only the alpha modification of Imatinib Mesylate was known. Thus, when efficacy data was disclosed by Zimmermann to the general public in Cancer Research article in the year 1996 — it was in respect of alpha crystal form of Imatinib Mesylate; (p. 284 of Vol. G filed by Novartis)

8. Affidavit of Dr William Manley (employee of Novartis) filed to establish that prior to the 1998 subject application, Imatinib was known only in its free base form and not as a salt is in direct contradiction with Dr Sutter's affidavit. Further, in the present affidavit various properties such as flow properties, hygroscopicity, etc. has been defined as physical properties and not as physio-chemical properties (as argued by Novartis). Also the various advantages of Imatinib Mesylate as elaborated over Imatinib Free base are all inherent properties of a salt, however, the contention of Dr Manley that Imatinib Mesylate differs significantly from the free base in properties with regard to efficacy is again in direction contradiction to Cancer Research article (p. 289 of Vol. G filed by Novartis)

9. Affidavit of Dr Giorgio Massimini (employee of Novartis) was allegedly filed to meet the requirement of Section 3(d). However, a comparison of bioavailability was done between Imatinib Mesylate beta form and Imatinib free base. Such a comparison is extremely misleading in nature inasmuch as it was incumbent on Novartis to perform comparative analysis with the closest prior art (Imatinib Mesylate). Instead, the comparison was performed between a crystalline form (which by the very nature of its inherent properties would have a higher bioavailability as compared to a free base) and Imatinib free base. (p. 294 of Vol. G of Novartis)

10. Thus, Novartis has failed to establish any enhancement of therapeutic efficacy (in contrast to better physical properties which are inherent to a crystalline form) which has resulted from the development of Imatinib Mesylate beta form over the closest prior art, Imatinib Mesylate.

C. Scope and Construction of Zimmermann Patent

11. The Zimmermann patent clearly claims Imatinib and its pharmaceutically acceptable salts.

12. It clearly states that pharmaceutically acceptable salts can be prepared in a “customary manner”. It is known to anyone in the field that for the administration of an API, a carrier is required and that salts (which possess higher solubility and other properties) are normal carriers of any API. In fact, pharmaceutically acceptable salts are generally known in the field to include hydrochloride, sulphate, phosphate, succinate, benzoate, acetate, pamoate, fumarate, Mesylate.

13. Preparation of these salts is known to persons skilled in the art and hence need not to be exemplified i.e specific examples need not be given. That is the reason Zimmermann specifically uses terms like “customary manner” and “processes known per se”, etc. Pharmaceutically acceptable salts are completely enabled in Zimmermann and are claimed not just in Claim 23 but in large number of other claims and that is why no subsequent patent, even in the US, specifically claims Imatinib Mesylate per se as Imatinib Mesylate was already covered, disclosed and enabled in Zimmermann.

14. Even in India, the patent for beta form claims only the beta crystalline form of Imatinib Mesylate instead of Imatinib Mesylate per se. Therefore, all patents, subsequent to Zimmermann, only claims different forms of Imatinib Mesylate and not Imatinib Mesylate. Thus, the entire change in the rejoinder arguments by Novartis to show that Imatinib Mesylate was only covered but not disclosed in Zimmermann is a complete afterthought.

15. Terms such as constructive enablement, implicit disclosures are all irrelevant in the present context inasmuch as

- In the Zimmermann patent, the acid addition salts are specifically mentioned.

- It is also mentioned that salts can be manufactured in a customary manner.

16. For Novartis to argue, at this stage, that Imatinib Mesylate was not enabled in Zimmermann and hence the Zimmermann patent can be challenged on the ground of insufficiency also lacks bona fides inasmuch as Novartis has enjoyed the monopoly of Zimmermann from 1993 till date i.e a full span of 19½ years. To say that the Zimmermann patent can be challenged to the extent that Imatinib Mesylate has not been enabled is an argument of deception and ought not to be accepted by this Hon'ble Court.

D. Meaning of the term “efficacy”: Interpretation of Section 3(d)

17. Concerns addressed by the amended Section 3(d) are not new as they were also addressed in the Ayyangar Committee Report, old Section 5 of the Patents Act, 1970 (which prevented grant of product patents for agricultural and pharmaceutical goods).

18. In interpreting the various provisions of the Patents Act, 1970 a balance is required to be maintained between the need to promote and protect an invention and public interest of limiting monopolies qua frivolous patents especially in the field of healthcare and public welfare. The question to be answered is whether the contribution of the invention as disclosed qua a new form of a known drug substance is entitled to a patent monopoly of 20 years which outweighs the right of life of a citizen.

19. An argument which requires that certain provisions like Sections 2(l), 2(ta) and some parts of Section 3(d) of the Act are to be ignored or are superfluous ought not to be countenanced. Further, in cases where there is an overlap of provisions, an effort ought to be made to reconcile such provisions.

20. The term “efficacy” is to be interpreted and its meaning is to be gauged for different fields as per the industry standard prevalent in the concerned field. Thus, the legal paradigm remains the same. Further, an effort to specifically define the term “efficacy” may result in either narrowing or widening the scope. As a result, it is pertinent that the same is interpreted on a case-to-case basis depending on the empirical data/evidence filed thereby resulting in growth and development of Indian jurisprudence qua Section 3(d) which is a departure that India has adopted.

21. For pharmaceuticals, “efficacy is therapeutic efficacy” as per the public/industry's understanding qua drugs/medicines.

22. Mere reduction in toxicity or side effects without a separate independent relationship being established between toxicity/side effects and therapeutic efficacy cannot be regarded as standard criteria which will ipso facto establish therapeutic efficacy. Thus, the importance of toxicity, potency, reduced side effects for the purpose of interpreting Section 3(d) is to be gauged on a case-to-case basis depending upon the evidence lead as in certain cases any changes in the aforesaid may lead to an enhancement in therapeutic efficacy whereas in other cases there may not be any change in therapeutic efficacy.

What is not therapeutic efficacy

23. Instead of attempting to define as to what can qualify as “therapeutic”, it is easy to understand as to what does not constitute “therapeutic” from a reading of the Section. The words contained in the Explanation, namely salts, esters, ether, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, etc. have some inherent properties.

24. Salts are known to have greater solubility. Polymorphs exhibit higher stability, higher bioavailability and these are known properties to a person skilled in the art. The properties which are inherently exhibited by these forms of known substances have to be contrasted with the properties with regard to efficacy. Thus, properties like solubility and stability, etc. are not the same as properties with regard to efficacy. The legislature uses them in contrast and contradistinction with efficacy.

25. While the legislature included these terminologies in the Explanation to Section 3(d), the legislature was conscious of the inherent properties of these different forms. These properties, therefore, were deemed to be the same substance and were not to be given a patent by themselves unless they differ significantly with regard to efficacy. Thus, “Properties with regard to Efficacy” and “Properties of these forms” are to be understood in contrast with each other. Since, these properties were in the knowledge of pharmacologists and were understood to contain greater advantages over the known substance, they were deemed to be the same substance. Thus, efficacy has to be in contrast with factors like solubility, stability, hygroscopicity, bioavailability, etc. Greater bioavailability, solubility, hygroscopicity, therefore, are not part of efficacy.

26. Therapeutic efficacy has to be something different and in fact more than these properties which are inherently contained in these forms and has to be interpreted accordingly.

27. Even safety is different from efficacy as captured by Section 3(d) inasmuch as while deriving some part of the Explanation from the EU Drug Regulatory provisions, the term safety has been specifically excluded. Thus, properties relating to safety are in contradistinction with efficacy and mere increased safety cannot be equated with efficacy.

28. The expression “enhancement of the known efficacy” relates to the efficacy “of that substance”. It does not relate necessarily to the efficacy of the marketable product i.e the downstream product created out of the pharmaceutical substance.

E. Scheme of the Patents Act and the correlation between Sections 2(j) and 2(ja) and Chapter II (Sections 3 and 4)

29. It is irrelevant whether an invention is to be first tested under Section 2(j) or 2(ja) or under Section 3(d). The sequence in which these three sections have to be applied is not important. In either case, invention has to satisfy the tests of patentability under Sections 2(j) or 2(ja) as well as under Section 3(d). Whether they are taken sequentially, simultaneously or in any other order is up to the technical body which is the Patent Office. For example, if an invention relates to atomic energy, the patent office may not even examine other grounds and can refuse the patent on the ground of Section 4 itself. If the molecule is known or is in public domain and the claimed invention is a form of the molecule then Section 3(d) may be applied first.

F. Evergreening and its relevance to the present case — various patents filed by Novartis for Imatinib and its forms

30. The present case is a classic case of evergreening which Section 3(d) seeks to prevent. A perusal of the various patents contained in Vol. C-4 clearly reveals that Novartis has filed and/or obtained in different jurisdictions including India, patents for different forms of Imatinib. In these patents, several admissions have been made by Novartis which lead to the incontrovertible conclusion that Novartis is engaged in evergreening.

31. The Zimmermann patent at pp. 8-25 of C-4 covers the Markush formula and a large number of compounds and derivatives. As per the chart handed over by Novartis it covers 4 billion compounds, 200 billion compound salts, 34 example compounds, 3 specifically claimed compounds (including Imatinib and its pharmaceutically acceptable salts), etc.

32. Having covered the entire footprint under the Markush formula, Novartis applied for crystalline forms of Imatinib Mesylate (pp. 39-50) in 1997. In this patent, the claims relate to various crystalline forms of Imatinib Mesylate. In India, the alpha and beta crystalline form have also been applied for. Thereafter, a patent is applied for in 2001 for a new use of Imatinib Mesylate i.e for treatment of gastrointestinal stromal tumors (pp. 116-120). This is a patent for a new use of Imatinib to treat gastro intestinal tumors. At pp. 135 to 150, another markush patent is filed for the N-oxides of the derivatives disclosed in the Zimmermann patent. This was filed in the year 2003. A corresponding Indian application has also been filed (pp. 152-195).

33. In 2005, a patent application is filed in the US for further salts of Imatinib for which a corresponding application is also pending in India (pp. 196-203). In 2006, a PCT application (p. 219) is filed for sustained release formulation of Imatinib i.e a salt release tablet solid dosage form and the corresponding application was also filed in India (p. 228). At p. 252, a further application is filed for a metabolite of Imatinib and the corresponding application in India is at p. 266.

34. In 2005-2006, a PCT application is filed for the delta and epsilon form of Imatinib Mesylate wherein it is specifically stated that the delta and epsilon crystal forms are used as intermediates to prepare the beta crystalline form (pp. 306-312). The corresponding Indian application is at pp. 313-31.

35. In 2006, an application is filed for the F, G, H, I and K crystal forms of Imatinib Mesylate in the US. There are 8 claims in the US patent at p. 344, however, the Indian patent application starting at p. 346 has 73 claims. Finally, another patent application is filed in 2008 with respect to stabilised amorphous form of Imatinib Mesylate wherein it is acknowledged that Imatinib Mesylate naturally exists either as the alpha or the beta crystalline form at p. 381. The corresponding Indian application is at pp. 387-406.

36. A reading of the patent applications filed by Novartis for Imatinib and various forms and new uses of the same in the US and in India clearly reveals that the purpose behind filing these patents is to extend the protection for Imatinib as much as possible. The 20-year monopoly which was originally grantable/protectable in the US from 1993 to 2013. The Zimmermann patent is not a patentable invention in India and hence all the subsequent applications though relating back to Zimmermann directly are being filed only to indirectly obtain a monopoly on Imatinib and on its forms as also to extend the period. The various subsequent patents filed for Imatinib would extend the period of monopoly by almost 15 years i.e till 2028. This is nothing but evergreening which 3(d) seeks to prevent. The therapeutic efficacy in all these patent applications is Imatinib and thus, such evergreening ought not to be permitted.

Conclusion

37. It is thus submitted that the present appeal of Novartis deserves to be dismissed as the beta form of Imatinib Mesylate is:

- not a new substance as it is both anticipated and obvious;

- not a new form of a known substance which exhibits significant enhancement of efficacy.

38. The patent application does not satisfy the test of either Sections 2(1)(j) & 2(1)(ja) or of Section 3(d).

VI. Prof. Shamnad Basheer, Intervenor-cum-Amicus

1. The intervenor seeks to assist the Court in evolving a framework and a set of propositions for resolving patent disputes, particularly disputes around pharmaceutical patents and Section 3(d). Being an academic, the interests of the intervenor lie in the robust development of sound patent jurisprudence for India that appropriately balances the competing interests of drug originators against that of generic companies and patients.

I. Section 3(d) standard

2. Section 3(d) currently reads as under:

“3. What are not inventions.—The following are not inventions within the meaning of this Act—

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;”

3. In essence, Section 3(d) stipulates that a new form of a known substance would be patentable only when the said new form demonstrates significantly enhanced efficacy when compared with the known substance. The key issues in interpreting the scope and ambit of Section 3(d) are:

1. What does “efficacy” mean?

2. Does increased bioavailability qualify as enhanced “efficacy”?

3. What is the standard of proof required to establish “efficacy”?

4. When must proof of efficacy be produced?

5. What is the meaning of the term “known substance” under Section 3(d)?

A. Meaning of “efficacy”

4. The term “efficacy” is central to interpreting the scope and ambit of Section 3(d). More specifically, the issue is whether or not efficacy ought to be interpreted narrowly to mean only “therapeutic” efficacy or whether it ought to be broadened out to include any kind of advantageous property attributable to the new form in question.

5. The Madras High Court held that “efficacy” meant only “therapeutic” efficacy and not every advantageous property claimed for the new drug derivative in question. The IPAB endorsed this interpretation.

6. The intervenor submits that, based on the history of Section 3(d) and its current structure, this appears to be a correct reading of Section 3(d). However, one important caveat needs to be borne in mind; Section 3(d) is not limited to pharmaceutical technology alone. Rather, it applies also to chemicals (such as paints) and agro-chemicals (such as pesticides), for which therapeutic efficacy cannot be an appropriate standard.

7. A nuanced interpretation of efficacy would therefore suggest that it be defined in a technologically specific way i.e while it would mean therapeutic efficacy in the pharmaceutical context, it would translate to an ability to destroy pests in a pesticide context.

8. In other words, efficacy has to be construed in accordance with the predominant function/utility/purpose of the claimed substance/invention in question. This function is often adduced from the patent specification itself, where the alleged utility is cited. Such an interpretation is in conformity with prevailing patent jurisprudence in countries such as the US and EU which have been known to interpret facially neutral patent standards in a technologically specific way.

9. The structure of Section 3(d) as also its legislative history supports a narrow reading of the term “efficacy”.

10. Illustratively, the Explanation to Section 3(d) clearly states that all pharmaceutical derivatives would be considered the same “substance”, unless “they differ significantly in properties with regard to efficacy.”

11. The above clause refers to only those “properties” that have some bearing on “efficacy” and not all properties. If “all properties” were to qualify, it would effectively render the term “efficacy” redundant.

12. Had Parliament intended “any property” to qualify under Section 3(d), the Explanation would simply have stated “unless they differ significantly in properties”. And the main part of Section 3(d) would have been rephrased as “the mere discovery of a new form of a known substance which does not result in the enhancement of the known “properties” of that substance.”

13. Therefore, not all advantageous properties of a new form (such as improved processability or flow characteristics, storage potential, etc.) ought to qualify under Section 3(d), but only those properties that have some bearing on efficacy.

14. Although this precise line of argument pointing to the phrase “properties with regard to efficacy” does not appear to have been explicitly made by either the Madras High Court or the IPAB to support their conclusion, it is one that compellingly supports a restrictive interpretation of the term “efficacy”.

15. This interpretation is further buttressed by the objectives of the Act, which suggests that Section 3(d) was introduced to prevent evergreening. The Madras High Court states in this regard: (2007) 4 MLJ 1153

“19. … We have borne in mind the object which the amending Act wanted to achieve, namely, to prevent evergreening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens.”

16. Although the term “evergreening” does not have a scientific definition as yet, it is widely understood to mean an inappropriate extension in patent monopoly which does not convert to a significant benefit for the patient.

17. Put another way, “evergreening” is a patenting strategy “consisting of acquiring patents on minor, often trivial, modifications of existing pharmaceutical products or processes in order to indirectly extend the period of patent protection over previously patented compounds.”

B. Exploring the contours of therapeutic efficacy

18. Section 3(d)'s lineage can perhaps be said to embody concepts of both patent law and drug regulatory norms.

19. I will examine the patent concept linkage later while discussing the overall scheme of the Act and the links between Section 2(1)(j), Section 2(1)(ja) and Section 3.

20. In terms of the link with drug regulatory concepts, it is important to note that Section 3(d) borrows extensively from a EU drug regulatory directive. Article 10(2)(b) of Directive 2004/27.EC defines a “generic medicinal product” as:

“10. 2(b) … a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters, or derivatives of an authorised active substance must be supplied by the applicant.”

21. Given this history, there is a real danger in interpreting the provision in a strictly drug regulatory sense, which might prove problematic within a patent ecosystem. It is therefore submitted that the drug regulatory meaning must not be transposed wholly to the patent context, without suitable adaptation. For the purpose of these two regimes are distinct. While the patent system is meant to grant protection to inventions that demonstrate technical/technological merit with a view to incentivising innovation, a drug regulatory regime seeks to ensure that only “safe” and “effective” drugs are sold to consumers.

22. Firstly, given that the intention behind Section 3(d) appears to be to provide protection to those inventions providing a genuine advantage to patients (as opposed to evergreened varieties), efficacy ought to be defined as any “therapeutic advantage” and not just “efficacy” as strictly understood in a drug regulatory sense.

23. It is pertinent to note in this connection that under most drug regulatory regimes, the notion of “efficacy” is used quite distinctly from that of “safety”. It is a truism that almost all allopathic drugs are blessed with toxicity. A regulator's job essentially entails a risk: benefit analysis i.e determining whether or not the costs/risks of toxicity are clearly outweighed by the benefits offered by efficacy of the drug in question. In its review of a New Drug Application (NDA), the American Food and Drug Administration (FDA) considers inter alia “[w]hether the drug is safe and effective in its proposed use, and whether the benefits of the drug outweigh the risks.” Safety of a drug is assessed relative to risks and benefits.

24. The intervenor therefore submits that the term “efficacy” under Section 3(d) ought to be interpreted to mean any “therapeutic advantage” including one that flows from significantly reduced toxicity.

An illustration — The Orphan Drug Act, 1983

25. The Orphan Drug Act (ODA) is illustrative in this regard and could be used to delineate the contours of “therapeutic advantage”. The ODA was enacted by the US Congress to help incentivise the creation of what are known as “orphan drugs” i.e any drug used to treat a rare disease or condition that affects fewer than 200,000 patients in the US or for which there is no reasonable expectation that the cost of developing the drug for a disease will be recovered from sales. 21 USC §360ee(b) (2) (1994)

26. Given that pharmaceutical companies generally shy away from research on orphan drugs, owing to the lack of large markets for such drugs, the ODA was brought into existence to grant additional incentives for creating such drugs to benefit minority patient populations. The incentive is in the form of a seven year marketing exclusivity to drug originators, so that they are able to recover their R&D costs and also make a healthy profit during this period of exclusive protection. Contrast this with regular data exclusivity regimes, which grant drug originators a period of exclusivity lasting only 5 years from the date of their approval. Further, such exclusivity is limited to preventing the use of and reliance upon “data” submitted by the drug originator to regulatory authorities, such that no follow-on drug manufacturer's drug can be approved using this very same data during the time of protection. However, follow-on manufacturers are free to conduct their own clinical trials and procure drug marketing approval during this time period.

27. On the other hand, the ODA which offers complete and absolute “market” exclusivity, independent of the clinical trial data that is submitted. In other words, the protection is against all follow-on drug manufacturers, who cannot enter the market, even if they repeat the clinical trials and are able to submit independently generated data.

28. Complete market exclusivity, as opposed to mere data exclusivity, would mean that no follow-on manufacturer can make or sell a version containing the same active ingredient or claiming the same “indication” or “use”, even if they are able to generate their own data for the same. However, the issue of “sameness” has been a highly contentious one under the ODA.

29. The FDA Regulations on this count suggest that “clinical superiority” would render a structurally similar drug molecule “different” from the original drug entitled to orphan drug exclusivity. 081 (1992) at 62

30. The regulations define a “clinically superior” drug as one that “is shown to provide a significant therapeutic advantage over and above that provided by an approved orphan drug ….”

31. Therapeutic advantage, or clinical superiority, can be shown in one of three ways: (1) greater effectiveness; (2) greater safety; or, (3) demonstration that the drug makes a major contribution to patient care in “unusual cases.”

32. It bears noting that the ODA norms abovementioned are not strictly “regulatory” in nature. Rather, they act as incentives for innovation in a manner similar to patents. Therefore these norms seem appropriate for providing guidance in a patentability context, such as in interpreting efficacy under Section 3(d).

33. However, a key limitation must be noted in this regard: In order to evaluate “sameness” under the ODA, one is always likely to have two drugs i.e the drug which is protected for seven years under the ODA and the new drug which is allegedly similar to the old “known” drug under protection.

34. In a Section 3(d) context however, the old substance against which the therapeutic advantage comparison is made, may not be a drug (as is the case with Imatinib or Imatinib Mesylate in a form other than beta crystalline). Further, in some cases where patent applications are filed to claim new forms, such a new form may not be a fully developed drug at the time that the patent application is filed. In fact, in most cases, it is likely that the point of time at which a new form is claimed as a patent is prior in time to its being developed as a drug and submitted to the drug regulator for regulatory approval.

35. It is therefore submitted that the standard of proof required to demonstrate significant therapeutic advantage cannot be as onerous as that expected for drug regulatory regimes such as the ODA, an aspect dealt with in a later section.

C. Does increased bioavailability amount to significantly enhanced efficacy?

36. It is humbly submitted that the short answer to this is this: it depends. As noted earlier, efficacy ought to be interpreted to mean a definite “therapeutic advantage”. As to whether or not a showing of increased bioavailability also converts to an added therapeutic advantage has to be assessed on a case-by-case basis; the answer cannot be a blanket yes or no.

37. Bioavailability means “the rate and extent to which the active drug ingredient or active moiety is absorbed from a drug product and becomes available at the site of drug action”. It is usually determined by measuring the concentration of a substance in biological fluids as a function of time, or by excretion of a substance as a function of time, or by acute pharmacology effect.

38. Bioavailability in short relates to “absorption”. The IPAB decision reproduced a submission from one of the counsels that captured this aspect quite well:

“The drug action process in the body was explained by Shri Parthasarathy, learned counsel appearing also on behalf of R 6 and R 7. Shri Parthasarathy explained that the drug action process which broadly be divided into three categories — absorption, binding and response. The absorption related to the amount of active ingredient that had been absorbed by the body. However, this absorption did not automatically translate into therapeutic response. After the active ingredient was absorbed by the body, for it to act, it must bind with the relevant reception of the target cell. This binding was the crucial step that determined effect, where there were less number of receptor sites, increased availability of the active ingredient did not produce any therapeutic response. Therefore, binding and not absorption was the key to healing the disease. Subsequently, after the receptor-drug binding occurs, the subsequent response could be measured. The response was typically in the form of increase or decrease of some parameter (in this case the white blood cell count). Bioavailability was related to the absorption and not the binding stage of the drug action and therefore was not a measure of the efficacy of drug.” M.P No. 33/2008 IN TA/1/2007/PT/CH, and TA/1 TO 5/2007.PT/CH

39. The intervenor wishes to adopt the above proposition, with the caveat that it is theoretically possible for increased bioavailability to result in increased enhanced efficacy in some cases. However, this must be independently established, without assuming that an increase in bioavailability automatically translates to enhanced efficacy.

40. Illustratively, in few cases, a new form with increased bioavailability might confer significant benefits in terms of reduced toxicity. Assume that the earlier known substance had to be administered at 10gm to be therapeutically effective, but that this 10 gm was significantly toxic to the patient. If the new form now enables 5 gm to deliver the same therapeutic impact with greatly reduced or no toxicity at all, this is a significant clinical advantage insofar as the patient is concerned. Such enhanced patient advantage ought to count as “efficacy” under Section 3(d). It is pertinent to note in this regard that the regulations in relation to the ODA state that a “diminution in adverse reactions may be sufficient to allow a finding of clinical superiority.”

41. In other cases, it is possible that an increase in bioavailability does not convert to any significant therapeutic advantage at all.

42. In the specific facts of the case under dispute before this Hon'ble Court, the petitioner sought to establish that when compared with the Imatinib free base, the beta crystalline form demonstrates a 30% increase in bioavailability. However, this by itself does not demonstrate any therapeutic advantage in relation to the patient. Such advantage has to be independently established and has not been done in this case.

43. A commentator rightly notes: “It is not the intent of a bioavailability study to demonstrate effectiveness, but to determine the rate and extent of absorption. If a drug product is not bioavailable, it cannot be regarded as effective. However a determination that a drug product is bioavailable is not in itself a determination of effectiveness. 42 FR 1640 (1977). Cf. Moffitt

D. Proving efficacy

44. When it comes to evidentiary requirements, it is submitted that Section 3(d) ought not to be interpreted in the same way as a regulatory standard.

45. The drug innovation process could be broadly divided into two phases, namely “drug discovery” and “drug development”. Patents are typically filed at the upstream drug discovery stage, when all that the applicant has is a potentially viable drug molecule. It is only later that the drug is developed and tested through a series of clinical trials and finally brought into the market after procuring regulatory approval. The time gap between discovering a drug molecule and developing it into a marketable drug can take several years. This is borne out by the present case itself, where the parent molecule (Imatinib) was first discovered in 1993, but the final regulatory approval for a drug based on this molecule issued only in the year 2001.

46. Therefore, in many cases, it is unlikely that at the patenting (drug discovery) stage, the applicant would possess any clinical trial data at all. It would be irrational and even unethical to insist on clinical trial evidence only for the purpose of satisfying patentability requirements under Section 3(d). For any such clinical trial testing would involve testing a less than optimal substance (the known substance) against its allegedly superior derivative.

47. One might even argue that insisting on clinical trial type proof under Section 3(d) would contravene the Helsinki Declaration, Principle 21 of which states that trials and other experiments on humans can be performed only if the importance of the objective outweighs the inherent risks and burdens to the research subjects. Subjecting human subjects to clinical trials for the sole purpose of crossing the threshold of Section 3(d) is unethical and unwarranted.

48. One suggestion for the standard of proof could be as under:

“The applicant need not prove “efficacy” under Section 3(d) as a matter of statistical certainty. Nor does the applicant have to provide actual evidence of trials in humans. Instead, the applicant has to demonstrate a reasonable correlation between the efficacy claimed and the data provided in support of this. Such reasonable evidence of the correlation can be established by relying on, inter alia, statistically relevant data documenting the activity of the new form and/or known substance, documentary evidence (e.g articles in scientific journals), data generated using in vitro assays, or from testing in an animal model, other pre-clinical test data or any combination thereof”.

E. When can proof of efficacy be submitted?

49. Insofar as pharmaceutical patent applications were filed prior to the introduction of the 2005 Patent Amendments, the Patent Office must permit patent applicants an opportunity to file documentation/evidence in support of Section 3(d) at the time that it reviews the application for the first time. This is only fair and just, as the patent applicant could not have known of the future existence of Section 3(d) at the time of filing her patent application. However, insofar as applications filed after the coming into force of the Patents (Amendment) Act, 2005 are concerned, no such opportunity need be provided. In such cases, if the filed specification does not contain any evidence of increased efficacy, the patent office is entitled to reject the application.

F. What is the “known substance” for the purpose of Section 3(d)?

50. For an appropriate determination under Section 3(d), the primary issue is: what is the “known substance” against which the enhanced “efficacy” comparison ought to be made?

51. It is submitted that the standard for determining “known” substance under Section 3(d) ought to be the same as that used for determining novelty and anticipation under traditional patent law i.e whether substance x that is claimed in a patent application is already part of the prior art and therefore anticipated? The test thus far employed in the US and EU suggests that x is anticipated only if the prior art teaches a person skilled in the art to reproduce x without undue experimentation.

52. In this regard, the intervenor wishes to draw the attention of the Court to a British case, Synthon BV v. SmithKline Beecham plc (2006) 1 All ER 685, 2006 RPC 10 (HL). In Synthon, the appellant Synthon BV applied to revoke Smith Kline's patent for a particular crystalline form of the blockbuster drug paroxetine, based on Synthon's own earlier patent application. Although Synthon was successful at the first instance, the Court of Appeals reversed the decision. Synthon accordingly appealed to the House of Lords.

53. The leading opinion of the House of Lords was given by Lord Hoffman, who held that anticipation required proof of two distinct matters (1) the invention had been disclosed (2) the invention had been enabled viz. an ordinary skilled man would have been able to perform the disclosed invention if he attempted to do so by using the disclosed matter and common general knowledge.

54. On the issue of “enablement”, Lord Hoffmann observed that enablement means “that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure”. Enablement in the context of novelty, according to Lord Hoffman was the same as enablement for the purpose of determining sufficiency.

55. It is important to note that disclosure and anticipation are distinct requirements, and proof needs to be submitted on both. In assessing disclosure, no aspect of trial or error is permitted. In assessing whether or not the disclosure is enabled, a reasonable degree of experimentation can be expected and is permissible. Depending on the concept under consideration, the role of the skilled person is different. In assessing disclosure, the skilled person is attempting to discern what the author of the prior document art meant.

56. In assessing enablement, the skilled person is not concerned with what the prior art may have meant, but rather, whether the invention disclosed by the prior art could be made to work. As such, disclosure is an inquiry as to construction. Enablement is an inquiry as to what the skilled man would or would not be able to achieve. The importance of the separation of these two concepts is evident particularly in cases of simple “low-tech” inventions, where a simple disclosure of an invention will probably be enough to enable it, but in cases of high-tech inventions, the basic assertion of the existence of an invention may disclose it, but it may well require additional detailed description to enable a skilled person to perform it.

57. On the facts of the present case, it would appear based on the several admissions made by the petitioner in various documents including its patent applications, (including wording such as preparation of salts “known per se”), the amorphous form of Imatinib Mesylate could be made by a person skilled in the art as on 1997 (the priority year of the application pertaining to the beta crystalline form) by referring to the disclosures in the 1993 Zimmermann patent and the 1996 articles authored by Zimmermann and using common general knowledge.

II. Conceptualising Section 3(d): Building a bridge?

58. While the intent behind Section 3(d) is laudable in that it seeks to impose a rigorous patentability threshold to prevent evergreening (within the chemical arts) such that only truly meritorious inventions are granted patents, its execution leaves much to be desired. It is submitted that from an interpretative perspective, this Hon'ble Court is left with two broad choices:

1. To treat Section 3(d) criterion as separate and distinct from traditional patentability criteria, such as novelty, inventive step and utility.

2. To create a bridge between Section 3(d) and the traditional patent criteria, namely novelty, inventive step and utility. Under this approach, Section 3(d) would be seen as a species of the general “inventive” step or non-obviousness test. In this sense, an invention that flunks Section 3(d) test would not amount to an “invention” within the meaning of Section 2(j).

Each of these choices are explicated below.

A. Independent patent standard under Section 3(d)

59. This choice is easier to implement than its alternative, in that the patent office is at liberty to qualify an alleged invention as “inventive”, whilst at the same time holding that it flunks the Section 3(d) test. This is precisely what the IPAB did in the present case and the advantage is that one need not go out of the way to interpret Section 3(d) in consonance with other criteria.

60. However, this choice might open India up to a potential Trips challenge. Article 27 of Trips reads as below:

“27. (1) … patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

(emphasis supplied)

61. One might argue that Section 3(d) amounts to the imposition of a new patentability criteria i.e a pharmaceutical derivative, which qualifies as an invention and is new, inventive and useful is now subjected to a further test, namely whether or not it satisfies the requirements of Section 3(d). This therefore violates the mandate under Trips to grant patents to inventions that are new, inventive and useful.

62. However, one might counter this by suggesting that those claims falling within the scope of Section 3(d) are not really “inventions”.

1. The “invention” definition

63. Given that the term “invention” is not defined under Trips, Member States have some degree of flexibility in defining this term.

64. Practice of Member States reveal that the term “invention” does not admit of a precise meaning. An English judgment is illustrative in this regard, where Peter Prescott, J. held as below:

“How, then, does the law define what is an ‘invention’? The answer is that nobody has ever come up with a satisfactory, all-embracing definition and I do not suppose anybody will. By its very nature, therefore, the subject cannot be reduced to a precise verbal formula. It is, indeed, something of a moving target, because the progress of technology continues apace.”

65. At best, the term could be understood to mean something having a “technical” or “technological” character of some sort. The fact that Article 27 uses this term in close conjunction with the phrase “fields of technology” makes this nexus even more evident. The Indian Patents Act also veers towards this suggestion by its use of the term “technical advance” in Section 2(ja).

66. Peter Prescott, J. again tellingly notes: “… If something is an invention … we can call it ‘technology’ for short.” 2005 EWHC 1589 (Pat)

67. Owing to this definitional difficulty, most Member States resort to a ‘negative’ or exclusionary definition. 1961 RPC 162 Thus for example, in Europe, ‘invention’ is defined to exclude the following: discoveries, scientific theories and mathematical methods; literary, dramatic, musical and artistic works, and any other aesthetic creations whatsoever; schemes, rules and methods for performing a mental act, playing a game or doing business, and programs for a computer; presentations of information; and methods of medical treatment.

68. Indian law follows a similar format and Section 3 excludes from the ambit of patent protection a diverse range of subject-matter. It reads as below:

2. What are not inventions: Evaluating Section 3

“3. What are not inventions.—The following are not inventions within the meaning of this Act,—

(a) an invention which is frivolous or which claims anything obviously contrary to well-established natural laws;

(b) an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;

(c) the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;

(f) the mere arrangement or rearrangement or duplication of known devices each functioning independently of one another in a known way;

(g) Omitted by Patents (Amendment) Act, 2002

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic, or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products;

(j) plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;

(k) a mathematical or business method or a computer program per se or algorithms;

(l) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions;

(m) a mere scheme or rule or method of performing mental act or method of playing game;

(n) a presentation of information;

(o) topography of integrated circuits;

(p) an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.”

The definitional exclusions

69. A careful evaluation of these various exclusions reveal a diversity of rationales underlying them. Some exclusions flow from the meaning of the term “invention” (hereafter “definitional exclusions”). Thus, one might argue that the term “invention” connotes a man-made creation within the technical or the technological field.

70. The exclusion of literary works (such as poems) under Section 3(l) of the Patents Act comports well with this rationale. As an English Judge notes:

“Some kinds of ideas cannot be patented at all — even if new and very ingenious. For example, you could not patent the plot of a detective story. It would not be considered to be an ‘invention’ under patent law.”.

71. Similarly, a mere discovery of a scientific principle or a natural product [as excluded under section 3(c)] will fall outside the purview of the term “invention”. For one has not “created” or “invented” anything new by human intervention: but merely discovered something that was not known earlier. This is best expressed in the language of Lord Kenyon in Hornblower v. Boulton 101 ER 1285:

“… having now heard everything that can be said on the subject, I have no doubt in saying, that this is a patent for a manufacture, which I understand to be something made by the hands of man.” 101 ER 1285

(emphasis supplied)

And later, he states:

“Courts in the United States, as well, have emphasised on the human intervention aspect of an invention. Illustratively, in Morton v. New York Eye Infirmary 17 F Cas 879 (SDNY 1862), the New York Circuit Court expressed the opinion that,

In its naked ordinary sense, a discovery is not patentable. A discovery of a new principle, force, or law operating, or which can be made to operate, on matter, will not entitle the discoverer to a patent. It is only where the explorer has gone beyond the mere domain of discovery, and has laid hold of the new principle, force, or law, and connected it with some particular medium or mechanical contrivance by which, or through which, it acts on the material world, that he can secure the exclusive control of it under the patent laws. He then controls his discovery through the means by which he has brought it into practical action, or their equivalent, and only through them. It is then an invention, although it embraces a discovery. Sever the force or principle discovered from the means or mechanism through which he has brought it into the domain of invention, and it immediately falls out of that domain and eludes his grasp. It is then a naked discovery, and not an invention.”

72. Secondly, in order to constitute an invention, one might argue that the subject matter must necessarily be new, inventive and useful. The Indian Patents Act explicitly recognises this definitional component and articulates it in Section 2(j), which defines invention as “a new product or process involving an inventive step and capable of industrial application.”

73. Some of Section 3 exclusions draw from this definitional component and categorically exclude certain subject matter from the purview of patentable inventions.

74. Section 3(e) encapsulates such a rationale by suggesting that merely combining existing substances (when the combination does not yield a result greater than the sum total of the additions) is not patentable. It excludes “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance”. This is a kind of “inventive step” or non-obviousness test.

The policy based exclusions

75. The second broad category of Section 3 exclusions are those that are made for “policy” reasons, whether explicit or implicit (hereafter “policy” based exclusions). The subject-matter may be an “invention” from the definitional standpoint, having a significant nexus with technology and being new, inventive and useful. Yet, it may be denied patents for reasons of policy.

76. Section 3(b) is an excellent illustration of this, where subject matter is inventive, new and useful is still excluded since it is “immoral” in some way. This section excludes from patentability, “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.” Examples might include a new and inventive device that aids in theft.

77. Similarly, Section 3(i) excludes methods of medical treatment from the scope of patentability for policy reasons. Section 3(h) is also illustrative of this, where the act deems a new and inventive method of agriculture of a process of treatment to be a non-invention and therefore not patentable.

78. This is a clear “deeming” provision under the law, where although technically the said subject matter may amount to an invention, the law deems them to be non-inventions and therefore not patentable.

79. If Section 3(d) is treated as separate and distinct from other patentability criteria and not a species of the inventive step test, then it qualifies as an exclusion made for policy reasons. The key question then is: to what extent can Member States carve out exclusions from the term “invention” based on policy reasons?

80. Prima facie, Trips appears to carve out very specific cases where one might bring in a policy based exclusion. Articles 27(2) and 27(3) states:

27. (2) Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

27. (3) Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

81. One might argue that any further policy exclusions are not sustainable under Trips. Therefore, a Section 3(d) type exclusion, if viewed as a policy based exclusion, might run foul of Trips. Panels are known to hew close to overly textual meanings of treaty terms and if the term “invention” is understood to mean something of a technical or technological nature, then new forms of known chemical substances under Section 3(d) would qualify as “inventions” within the meaning of Trips.

82. However, as one cannot predict with absolute certainty the outcome of a Trips challenge, given the fact that there is no consensus on what the term “invention” means. Suffice it to suggest that there is some risk of a Trips challenge and a finding of contravention, should Section 3(d) be divorced from regular patentability criteria and be seen as an independent stand alone test for patentability.

83. It also bears noting that if this line of reasoning were adopted (namely, that the only kind of policy-based exclusions compatible with Trips are those that are explicitly carved out in Articles 27.2 and 27.3), then Section 3(h) which excludes a method of agriculture from patentability may also be held to contravene Trips.

B. The alternative: Bridging Section 3(d) and inventive step

84. The second alternative is to interpret Section 3(d) as nothing than a specific adaptation of the inventive step test to suit the specificities of chemicals/pharmaceuticals.

85. To this extent, it is seen as a species of the broader genus called “inventive step” or non-obviousness. Such technologically specific applications of general patentability standards and the evolution of sector specific tests are common in leading patent jurisdictions such as the US. Within the chemical arts, courts in the US and EU have evolved a specific obviousness test that bears close similarly to Section 3(d). The courts have held that structural similarities between a pharmaceutical substance that is sought to be patented and an earlier known substance trigger off a presumption of prima facie obviousness. 919 F 2d 688 (Fed Cir 1990) This presumption can be dislodged only if the patent applicant demonstrates that the applied for substance exhibits “unexpected or surprising results.” 492 F 3d 1350 (Fed Cir 2007), 692 (Fed Cir 1990), 51 F 3d 1552, 1558 (Fed Cir 1995)

86. Although unexpected results are ordinarily not limited to “therapeutic” advantages alone, 630 F 2d 120 (1980) courts have been known to discount advantages that are mere physical advantages. Illustratively, in Pfizer Inc. v. Apotex Inc. 480 F 3d 1348 (2007), the CAFC (Court of Appeals for the Federal Circuit) strikes a distinction between therapeutic properties and other properties (physical properties such as process-ability) of a pharmaceutical substance and appears to give the latter relatively much less weight while assessing non-obviousness. The Court holds:

“Finally, we do not see the trial court's finding that amlodipine besylate had adequate physicochemical characteristics as sufficient to uphold the court's ultimate holding of unexpected superiority…. At most, then, Pfizer engaged in routine, verification testing to optimize selection of one of several known and clearly suggested pharmaceutically-acceptable salts to ease its commercial manufacturing and marketing of the tablet form of the therapeutic amlodipine. Creating a “product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient … to enhance commercial opportunities … is universal—and even commonsensical.”

A scholar notes in this regard:

“The Pfizer opinion repeatedly emphasised that the besylate part of the claimed compound was merely a drug delivery vehicle that did not improve amlodipine's therapeutic effect. “Because the Federal Circuit discounted the physical properties of improved stability and tablet processing, Pfizer was unable to rebut the prima facie case of obviousness based on the prior art.”

87. Therefore, one might argue that Section 3(d) simply asks whether or not a structurally similar new form demonstrates unexpected properties (such properties relating specifically to “efficacy”).

88. To this extent, it is nothing more than a species of the overall inventive step test laid down in Section 2(1)(ja). One might also see it as a short cut for determining whether or not something is inventive.

89. A patent office faced with an alleged invention which potentially claims a new form of an existing substance would do well to therefore use Section 3(d) as a short cut to determining inventive step. If the alleged new form fails the test of Section 3(d), that is evidence enough of the fact that it is not “inventive”. To this extent, one would avoid the incongruous ruling such as the one handed down by the IPAB and potentially avoid a Trips challenge as well.

90. However, it bears noting that Section 3(d) alone is not dispositive of the “inventive step” test. Rather, it might so happen that even despite the existence of significantly enhanced therapeutic efficacy, the new form was “obvious to try” with some reasonable expectation of success (it followed an “obvious” train of thought or came out of trial and error and fairly routine experimentation by the skilled person).

91. In such a case, the new form does not merit a patent, despite satisfying Section 3(d).

92. In Pfizer v. Apotex, the Court noted:

“Alternatively, we hold that even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.

… patentability is not imparted where ‘the prior art would have suggested to one of ordinary skill in the art that this process should be carried out and would have a reasonable likelihood of success.’” Merck and Co. v. Biocraft Laboratories Inc. 874 F 2d 804 (Fed Cir 1989) F 2d at 809 (quoting Dow Chemical Co., In re 837 F 2d 469 (Fed Cir 1988), F 2d at 473). For these reasons, we hold that Apotex introduced clear and convincing evidence that a skilled artisan would have had a reasonable expectation of success with the besylate salt form of amlodipine at the time the invention was made.”

93. In other words, after using Section 3(d) as a short cut for determining whether or not a claimed new chemical form is inventive, the patent office would still need to subject the claimed form to the inventive step test in Section 2(1)(ja), which reads as below:

“2. (1)(ja) ‘inventive step’ means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;”

As I had noted earlier in an article 1 Ind J L Tech 15 (2005):

“As can be seen from this definition, while the fundamental yardstick for measuring an ‘inventive step’ remains that which is ‘not obvious to a person skilled in the art’, a requirement that the invention involve a ‘technical advance’ or have an ‘economic significance’ of some sort has been added.

This change in the standard seems odd, given that the very purpose of the ‘inventive step’ criterion is to determine whether an invention sufficiently advances the technical arts so as to warrant an exclusive right. This is no doubt achieved in an optimal manner by the simple test of whether the invention, though novel, is non-obvious to a person skilled in the art.

… Contrary to suggestions by some commentators, the addition of ‘technical advance’ or ‘economic significance’ to the ‘non obviousness’ test does not dilute the ‘inventive step’ requirement….. 1 Ind J L Tech 15 (2005)

94. In other words, given that the term “invention” relates essentially to technological arts (as earlier discussed), any alleged invention that represents a sufficient leap from the prior art will ipso facto amount to a “technical advance”.

95. It bears noting that a determination of inventive step, considered as the key patentability filter, is prone to a high degree of fact specific assessment, and evaluative analysis, making for considerable variation in results.

96. WTO Member States are free to devise appropriate standards and principles for determining inventive step, since the term is not defined under Trips. While some countries may opt for a lower threshold and permit a greater range of inventions to be patented, others may opt for a stricter standard. The Indian Patents Act, 1970, premised on the Ayyangar Report in large part, arguably supports a much higher threshold, particularly for pharmaceutical technology, as made evident by Section 3(d).

The Viagra example is illustrative in this regard. The chemical substance, Sildenafil Citrate, sold as Viagra by Pfizer, was the first effective oral treatment for MED (male erectile dysfunction), with up to 82% of patients experiencing benefits. At the time of this path-breaking discovery, Sildenafil Citrate was already a known substance and was being tested by Pfizer for its ability to cure angina (blood pressure) and a specific form of heart ailment. Upon discovering its potential new use as a cure for MED, Pfizer immediately filed a patent.

97. The UK courts, however, invalidated the patent on the ground that the new use would have been obvious to a person skilled in the art. The Court based its reasoning on the ground that the prior art included an article by Rajfer et al. and published patents, EP 0463 756 and EP 0526 004 that would have prompted the person skilled in the art to evaluate the possibility of using Sildenafil Citrate, for the treatment of MED. Famously, the court noted that it was worth a try.

98. However, the Federal Court of Appeals in Canada rejected the above line of reasoning and held that a mere “worth a try” possibility did not preclude inventiveness. Rather, the claimed invention would be obvious, only when the “try” was a matter of routine and required no significant thinking or effort.

99. The divergent conclusions on obviousness discussed above stem not only from a differential subjective assessment of the same facts, but also due to a difference in legal standards. As can be seen from the above discussion, Canada preferred a lower non-obviousness or inventive step threshold that would have found in favour of the patentability of a larger number of inventions than the UK regime. 2009 FCA 8, (2009) 4 FCR 223

100. India is free to therefore devise her own standard for obviousness or inventive step without necessarily toeing the US, EU or any other country on this count.

C. Making sense of the patent terminology

101. The Patents Act is creased in several parts, particularly in the aftermath of the 2005 Amendments. Some of these creases can be ironed out by interpreting terms by drawing meaning from other provisions in the Act.

The Act uses the following terms:

(i) invention

(ii) product

(iii) process

(iv) substance

(v) entity

(vi) pharmaceutical substance

(vii) pharmaceutical product

102. Most patent regimes including Trips uses the terms: invention, product and process. Product and process have fairly standard connotation and are often used in contradistinction to each other.

103. The Indian Patents Act also uses these terms in the following sections:

Section 2(j):

“2. (1)(j) ‘invention’ means a new product or process involving an inventive step and capable of industrial application;”

Section 48 stipulates that:

48. Rights of patentees.—… a patent granted under this Act shall confer upon the patentee—

(a) where the subject-matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India:

(b) where the subject-matter of the patent is a process the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India:”

104. Therefore the registrability of a patent and its rights really apply to only two broad categories: “product” and “process”. And one has to fit in all claimed subject matter within these terms. To this extent, terms such as “substance”, article, entity, etc., have to be read in conformity with these terms.

105. Section 3(d) outlines what is a patentable invention: any new form that demonstrates significantly enhanced efficacy is an invention and gets protection as a product. In other words, a new form qualifies as a patentable product (and a new substance) only when it demonstrates significantly enhanced efficacy. As to the kind of protection that a product is entitled to, Merrel Dow Pharmaceuticals Inc. v. H.N Norton & Co. Ltd. 1995 UKHL 14 is illustrative:

“The scope of the monopoly conferred by a product claim is defined by Section 60(1)(a), which provides that where the invention is a product, a person infringes the patent if, without the consent of the proprietor, he “makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise.” For this purpose it does not matter how the product is made or what form it takes. The monopoly covers every method of manufacture and every form which comes within the description in the claim”. 1995 UKHL 14

And later:

“It is generally accepted as a principle underlying the EPC that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context. … It follows that if it can be shown that such physical entity (that is, a compound) is already in the state-of-the-art (for example in the context of a particular activity), then a claim to the physical entity per se lacks novelty”. 1995 UKHL 14

106. Needless to add the very process of creating the new form may itself be patentable independently, if it is demonstrated to be “new” and “inventive”.

Whither Section 2(1)(ta)?

107. The term pharmaceutical substance has been defined in Section 2(1)(ta) to mean:

“2. (1)(ta) ‘pharmaceutical substance’ means any new entity involving one or more inventive steps;”

108. This is a rather curious definition, since the term does not find mention anywhere else in the Act. As noted in an earlier article: 1 Ind J L Tech 15 (2005)

“The term ‘pharmaceutical substances’ has been rather strangely defined in Section 2(1)(ta) as “any new entity involving one or more inventive steps”. Defined in such a broad way, one is forced to query: would a mobile phone that deploys advanced technology be a pharmaceutical substance if it is shown that such entity is new and involves one or more inventive steps?

What is even more perplexing about this definition is the fact that the term ‘pharmaceutical substance’ does not find mention anywhere else in the Patents Act. In the absence of such a term in the Act, one wonders why the legislature, in all its wisdom, did not see it fit to clarify this concept.” 1 Ind J L Tech 15 (2005)

109. It is pertinent to note in this regard that Section 92-A, which deals with compulsory licenses in the context of exports to countries with minimal manufacturing capabilities, uses the term ‘pharmaceutical products’. However this term is used in a different sense than ‘pharmaceutical substances’, as is made evident by the fact that it is defined in Section 92-A itself.

110. The absurd definition in Section 2(1)(ta) cannot therefore apply to ‘pharmaceutical products’ under Section 92-A.

111. If one were keen on investing some meaning in this insertion of a term that finds no mention anywhere else in the act, one might argue that it offers some support for the proposition that Section 3(d) is a species of the inventive step test, as applied specifically to the pharmaceutical arts.

112. The definition of pharmaceutical substance as a new entity involving one or more inventive steps essentially means that in order to constitute a new pharmaceutical substance, an allegedly new form must necessarily entail one or more inventive steps.

III. Inherent anticipation and appointment of expert

113. The key issues are:

1. Was the beta crystalline version of Imatinib Mesylate effectively enabled by the 1993 patent and subsequent literature that preceded the priority date of the 1998 patent application covering the beta crystalline version (the priority date for the 1998 application is 18-7-1997)

2. Even if it was not enabled by the prior art, could the beta crystalline form have been said to be obvious to a skilled person from the prior art?

114. If the person skilled in the art attempting to produce Imatinib Mesylate (as per the disclosure in 1993 patent and other relevant prior art existing up to July 1997) would necessarily produce the beta crystalline version (since the compound naturally expresses itself in this form), then the beta crystal will be found to have been anticipated. Such a conclusion holds good even if such a skilled person obtaining the beta crystalline form is unable to characterise it as a beta crystalline form.

115. It is submitted that in such cases, the beta crystalline form is anticipated under the doctrine of inherent anticipation, a doctrine explicated well in Schering Corpn. v. Geneva Pharmaceuticals Inc. 339 F 3d 1373, 1382 (Fed Cir 2003) In this case, Schering had a patent covering loratadine, an antihistamine marketed as Claratin. Schering subsequently filed a second patent on descarboethoxyloratadine (“DCL”) that is naturally produced by the human body as a metabolite of loratadine. 339 F 3d 1373 Notwithstanding the lack of any prior art teaching of DCL, or any other metabolite of loratadine, the Court held that Schering's prior art patent claiming loratadine inherently anticipated its subsequent patent. This is because DCL was “necessarily and inevitably” formed upon the metabolism of loratadine.

116. Inherent anticipation does not require that the inherent feature be appreciated or recognised at the time of the earlier patent, as long as the disclosure is a “necessary and inevitable” consequence of the earlier invention. Para 38 at 1378-80

117. Based on the above, if the beta crystalline version automatically results from the teachings of the prior art, it is anticipated, even if the skilled person is unable to identify or characterise it. Conversely, if the beta crystalline version does not automatically result from the teachings of the prior art, it cannot be held to be anticipated. However, it may still be held to be obvious to a person skilled in the art, in the light of prior art.

118. In order to optimally resolve such complicated technical issues for the future, the intervenor requests that this Hon'ble Court suggest that lower courts and tribunals appoint independent experts under Section 115 of the Patents Act. In the case at hand, such an expert could, at the very least, have been tasked with helping determining whether or not the prior art would have rendered Imatinib Mesylate inherent.

IV. Patents, public order and excessive pricing

119. The IPAB held that the beta crystalline form of Imatinib Mesylate was not eligible for a patent under Section 3(b), since a drug corresponding to the patent had been priced excessively. Section 3(b) currently reads as under:

“3. What are not inventions.—The following are not inventions within the meaning of this Act—

(b) an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;”

120. According to the IPAB, the excessive price of Glivec would create public disorder and was therefore ineligible for a patent under Section 3(b) of the Indian Patents Act. In the words of the IPAB:

“… But as per information furnished in its written counter-argument by R 3 that when the Appellant was holding the right as EMR on Gleevec it used to charge Rs 1,20,000 per month for a required dose of the drug from a cancer patient, not disputed by the Appellant, which in our view is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create a havoc to the lives of poor people and their families affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before us, we observe that the Appellant's alleged invention won't be worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of Section 3(d) of the Act, but also for its possible disastrous consequences on such grant as stated above, which also is being attracted by the provisions of Section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things.”

121. It is submitted that this is a wrong legal proposition. Under current Indian patent law, the excessive price of a drug cannot be a ground for denying a patent to an invention underlying the said drug. The key issue at the time of granting a patent is whether the invention represents a good enough technical/scientific advance to merit a twenty year monopoly?

121.1 Any potential for patent abuse is redressable through a number of ex-post (prospective) mechanisms such as compulsory licensing and price control and ought not to factor in during the stage of grant of a patent, not least because very often, there is no product at the stage of grant of a patent.

121.2 Secondly, such an additional patentability criterion could fall foul of Trips. Under Article 27 of Trips, all inventions (barring those mentioned in paragraphs 2 and 3 of that Article) are patentable. Although the terms ordre public or morality are fairly subjective and dependent on the particular socio-cultural mores of a country at a given point in time, an exception based on “public ordre” and “morality” in Article 27.2 can be applied only when it is necessary to prevent the “commercial exploitation” of the invention. In other words, Article 27.2 of the Trips applies only if a prohibition against the commercial exploitation of the invention is necessary to protect ordre public or morality and only if the exclusion from patentability will likewise contribute to the protection of that ordre public or morality. This could suggest, as some have argued, that in order to justify a patent as immoral or against public order, one must first have a law which prevents the commercial exploitation of the particular product. Hague 2005) 209 Or one must at least show the existence of circumstances necessitating such a law or ban. June 1997) Under such an interpretation, unless India bans the sale of Glivec or shows that Glivec is otherwise harmful, it cannot exclude a patent covering it on the grounds of public order or morality.

121.3 Thirdly, Article 27.2 appears to be predicated on a “necessity test” to assess whether protection of an overriding social interest is justified. Therefore, any measure taken is justified only if no reasonable alternative is available to a member. Here, as stated above, alternatives such as compulsory licensing, price control mechanisms are ‘reasonably available’. Hence in this case, one might argue that the conditions of Article 27.2 of Trips have not been satisfied.

121.4 For all the above reasons, it is submitted that the rejection of a patent based on excessive price of the final patent product has no basis in Indian patent law.

The Judgment of the Court was delivered by

Aftab Alam, J.— Delay condoned. Leave granted in all the special leave petitions.

Background

2. What is the true import of Section 3(d) of the Patents Act, 1970? How does it interplay with clauses (j) and (ja) of Section 2(1)? Does the product for which the appellant claims patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention “not obvious” to a person skilled in the art? In case the appellant's product satisfies the tests and thus qualifies as “invention” within the meaning of clauses (j) and (ja) of Section 2(1), can its patentability still be questioned and denied on the ground that Section 3(d) puts it out of the category of “invention”? On the answer to these questions depends whether the appellant is entitled to get the patent for the beta crystalline form of a chemical compound called Imatinib Mesylate which is a therapeutic drug for chronic myeloid leukaemia and certain kinds of tumours and is marketed under the names “Glivec” or “Gleevec”.

3. These questions were debated at the Bar intensely and at great length. The debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an “aberration” under our constitutional scheme) at the minimum. The arguments were made about India's obligation to faithfully comply with its commitments under international treaties and counter-arguments were made to protect India's status as “the pharmacy of the world”. The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and underdeveloped countries, dependent on generic drugs from India. We will advert to these and a number of other arguments at their proper place but we must first take note of the facts that give rise to the above questions and provide the context for the debate.

4. Jürg Zimmermann invented a number of derivatives of N-phenyl-2-pyrimidine-amine, one of which is CGP 57148 in free base form (later given the international non-proprietary name “Imatinib” by the World Health Organisation). These derivatives, including Imatinib, are capable of inhibiting certain protein kinases, especially protein kinase C and PDGF (platelet-derived growth factor)-receptor tyrosine kinase and thus have valuable anti-tumour properties and can be used in the preparation of pharmaceutical compositions for the treatment of warm-blooded animals, for example, as anti-tumoral drugs and as drugs against atherosclerosis. The N-phenyl-2-pyrimidine-amine derivatives, including Imatinib, were submitted for patent in the US. The application was made on 28-4-1994 and the patent was granted on 28-5-1996 under the US Patent No. 5,521,184 (hereinafter referred to as “the Zimmermann Patent”). The Zimmermann compounds (i.e derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under Patent No. EP-A-0 564 409.

5. The appellant claims that beginning with Imatinib in free base form (as the “e-duct”), in a two-stage invention they first produced its methanesulfonic acid addition salt, Imatinib Mesylate, and then proceeded to develop the beta crystalline form of the salt of Imatinib. According to the appellant, starting from Imatinib free base they could reach to the beta crystal form of Imatinib Mesylate in two ways: one “by digesting another crystal form, especially the alpha crystal form, or an amorphous starting material of the methanesulfonic acid addition salt of compound of Formula I …”; and second “by dissolving another crystal form, especially the alpha crystal form, or an amorphous starting material of the methanesulfonic acid addition salt of compound of Formula I …”. Describing the different processes, step by step, for producing Imatinib Mesylate starting from Imatinib, it is stated that in the first process they would first arrive at Imatinib Mesylate in amorphous form, as the intermediate stage, and thereafter, following further processes, reach the beta crystalline form of Imatinib Mesylate. Following the second process, they would reach the beta crystalline form of Imatinib Mesylate directly, skipping the intermediate stage in which Imatinib Mesylate first appears in amorphous form. In the third process, they would start with the alpha crystalline form of Imatinib Mesylate and arrive at its beta crystalline form.

6. It was stated in course of the submissions, however, that for practical purposes, the best way to produce the beta form is by proceeding directly from the free base form to the beta form, as in Examples 2 and 3 given below, by introducing a specified amount of the beta crystals at the step specified. The three processes are described by the appellant under the following three examples:

Example—1

Step 1 — 98.6 gm of Imatinib free base is added to 1.4 litres of ethanol. Step 2 — To the above, 19.2 gm of methanesulfonic acid is added dropwise for over 20 minutes. Step 3 — Solution obtained in Step 2 is heated under reflux (i.e boiling). It is heated in a manner to preserve the solution from escaping as a gas, so the gas is captured, condensed and obtained as a liquid. This solution is heated for 20 minutes. Step 4 — Filtering the solution — the filtrate (which is obtained after filtering the resulting liquid) is evaporated down to 50%. In other words, half of the filtrate is allowed to vaporise. Step 5 — Residue is again filtered at 25 degrees Celsius. Step 6 — Mother liquor (the liquid filtrate of Step 5) is evaporated to dryness. Step 7 — Residue obtained after Step 6, and residue obtained after Step 5 are suspended in 2.2 1 ethanol. Step 8 — The suspension obtained after Step 7 is dissolved under reflux and it becomes clear upon heating. Thereafter, 30 ml water is added to it. Step 9 — Substance is cooled overnight to 25 degrees Celsius, filtered and dried at 65 degrees Celsius, until weight is constant. This results in alpha crystalline form. Step 10 — Alpha form is stirred in methanol for two days at about 25 degrees Celsius. Then the crystals are isolated by filtration and dried overnight at room temperature. This results in beta crystalline form.

Example — 2

Step 1 — 50 gm of Imatinib free base is added to 480 litres (sic millilitres!) of methanol. Step 2 — To the above, 9.71 gm of methanesulfonic acid and 20 ml methanol is added. This mixture (sic is heated) at 50 degrees Celsius. Step 3 — To the solution obtained from Step 2, 5 gm of activated carbon is added and the mixture is boiled for 30 minutes under reflux, filtered and evaporated.

Step 4 — The residue obtained from Step 2 (sic 3) is dissolved in 150 ml methanol and inoculated (introduced) with a few mgms (sic mg) of beta form of Imatinib Mesylate leading to crystallisation of the product. Step 5 — The product is dried at 50 megabars (unit to measure pressure) and at 60 degrees Celsius. This leads to crystallisation of beta form of Imatinib Mesylate. Step 6 — The retention values (distance travelled by each chemical component in relation to the distance the solution front moves) obtained are as follows: Methylene chloride: ethyl acetate: Methanol: concentrated aqueous ammonium hydroxide solution = 6:10:30:2 (sic 60:10:30:2) Step 7 — To the above, high pressure chromatography (technique for separation of mixtures) is applied for 10.2 minutes.

Example — 3

Step 1 — 670 gm of alpha form of Imatinib Mesylate is heated in 1680 ml of methanol. Step 2 — The solution obtained from Step 1 is then inoculated at 60 degrees Celsius with 55 (sic mg of) beta form of Imatinib Mesylate. Upon this, the product starts to crystallise. Step 3 — Thereafter, the crystals are dried at 50 megabars and at 100 degrees Celsius. This leads to crystallisation of beta form of Imatinib Mesylate. Step 4 — The retention values (distance travelled by each chemical component in relation to the distance the solution front moves) obtained are as follows: Methylene chloride: ethyl acetate: Methanol: concentrated aqueous ammonium hydroxide solution = 6:10:30:2 (sic 60:10:30:2) Step 5 — To the above, high pressure chromatography is applied for 10.2 minutes.

[Examples are also given for preparation of 100 mg tablets and 100 mg capsules of Imatinib Mesylate but there is no need to go into that at this stage.]

7. The appellant filed the application (Application No. 1602.MAS/1998) for grant of patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office on 17-7-1998. In the application it claimed that the invented product, the beta crystalline form of Imatinib Mesylate, has (i) more beneficial flow properties; (ii) better thermodynamic stability; and (iii) lower hygroscopicity than the alpha crystalline form of Imatinib Mesylate. It further claimed that the aforesaid properties makes the invented product “new” (and superior!) as it “stores better and is easier to process”; has “better processability of the methanesulfonic acid addition salt of a compound of Formula I”, and has a “further advantage for processing and storing”.

8. It is significant to note that the comparison of the aforesaid properties of the beta crystalline form of Imatinib Mesylate was made with its alpha crystalline form. In the patent application, there is no claim of superiority of the beta crystalline form of Imatinib Mesylate in regard to the aforesaid three properties, or any other property, over the starting material Imatinib, or even over Imatinib Mesylate in amorphous form or any form other than the alpha crystalline form. On the contrary, insofar as Imatinib in free base form is concerned, it was unambiguously stated in the patent application as under:

“It goes without saying that all the indicated inhibitory and pharmacological effects are also found with the free base, 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl) (pyrimidin-2-ylamino)phenyl] benzamide, or other cells thereof. The present invention relates especially to the ß crystal form of the methanesulfonic acid addition salt of a compound of Formula I in the treatment of one of the said diseases or in the preparation of a pharmacological agent for the treatment thereto.”

(emphasis supplied)

9. In fairness to the appellant, however, it should be stated that the application was made at the time when there was a different patent regime. After the application was made and before it was taken up for consideration, a number of amendments were introduced in the Indian Patents Act, 1970, which brought about fundamental changes in the patent law of the country. The appellant was, however, fully aware of these changes in the law and, in order to reinforce its claim for patent for the subject product and to bring its claim within the four corners of the changed law, it filed four (4) affidavits of certain experts, two of which stated that the beta crystalline form of Imatinib Mesylate has much higher bioavailability as compared to Imatinib in free base form. In due course, we shall examine how far the properties attributed to the subject product in the patent application and the affidavits make it “new” and entitled to grant of patent, but for the moment we may note how the case has come to the present stage.

10. As noted above the patent application was made on 17-7-1998, giving 18-7-1997, the date on which the appellant had applied for grant of patent for the subject product in Switzerland, as the “priority date”. On 18-7-1997, Switzerland was not one of the “Convention countries” as defined under Section 2(1)(d) read with Section 133 of the Act and it was notified as a Convention country as per Section 133 of the Act on 30-11-1998.

11. In 1997, when the appellant filed its application for a patent, the law in India with regard to product patent was in a transitional stage and the appellant's application lay dormant under an arrangement called “the mailbox procedure”. Before the application for the patent was taken up for consideration, the appellant made an application (Application No. EMR/01/2002) on 27-3-2002, for grant of exclusive marketing rights (EMR) for the subject product under Section 24-A of the Act, which was at that time on the statute book and which now stands deleted. The Patent Office granted EMR to the appellant by order dated 10-11-2003.

12. The appellant's application for a patent was taken out of the “mailbox” for consideration only after amendments were made in the Patents Act, 1970 with effect from 1-1-2005. But before it was taken up for consideration, the patent application had attracted five (5) pre-grant oppositions in terms of Section 25(1) of the Act, and it was in response to the pre-grant oppositions that the appellant had filed the affidavits on the issue of bioavailability of Imatinib Mesylate in beta crystalline form.

13. The Assistant Controller of Patents and Designs heard all the parties on 15-12-2005, as provided under Rule 55 of the Patent Rules, 2003, and rejected the appellant's application for grant of a patent to the subject product by 5 (five) separate, though similar, orders passed on 25-1-2006 on the 5 (five) opposition petitions. The Assistant Controller held that the invention claimed by the appellant was anticipated by prior publication i.e the Zimmermann Patent; that the invention claimed by the appellant was obvious to a person skilled in the art in view of the disclosure provided in the Zimmermann Patent specifications; and further that the patentability of the alleged invention was disallowed by Section 3(d) of the Act; and also that 18-7-1997, the Swiss priority date, was wrongly claimed as the priority date for the application in India and hence, the alleged invention was also anticipated by the specification made in the application submitted in Switzerland.

14. At that time, the appellate authority under the Act had yet to become functional. The appellant, therefore, challenged the orders passed by the Assistant Controller in writ petitions filed directly before the Madras High Court. Apart from challenging the orders of the Assistant Controller, the appellant also filed two writ petitions (one by the appellant and the other by its Indian power-of-attorney holder) seeking a declaration that Section 3(d) of the Act is unconstitutional because it not only violates Article 14 of the Constitution of India but is also not in compliance with the Trips Agreement. After the formation of the Intellectual Property Appellate Board (IPAB), the five writ petitions challenging the five orders of the Assistant Controller were transferred from the High Court to IPAB by order dated 4-4-2007, where these cases were registered as appeals and were numbered as TA/1 to 5/2007.PT/CH. The other two writ petitions assailing Section 3(d) of the Act were finally heard by a Division Bench of the High Court and dismissed by the judgment and order dated 6-8-2007 (2007) 4 MLJ 1153. The appellant did not take that matter any further.

15. The appellant's appeals against the orders passed by the Assistant Controller were finally heard and dismissed by IPAB by a long and detailed judgment dated 26-6-2009.

16. IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness. It held that the appellant's invention satisfied the tests of novelty and non-obviousness, and further that in view of the amended Section 133, the appellant was fully entitled to get 18-7-1997, the date on which the patent application was made in Switzerland, as the priority date for its application in India. IPAB, however, held that the patentability of the subject product was hit by Section 3(d) of the Patents Act, 1970. Referring to Section 3(d) IPAB observed:

“Since India is having a requirement of higher standard of inventive step by introducing the amended Section 3(d) of the Act, what is patentable in other countries will not be patentable in India. As we see, the object of the amended Section 3(d) of the Act is nothing but a requirement of higher standard of inventive step in the law particularly for the drug/pharmaceutical substances.”

17. IPAB also referred to the judgment (2007) 4 MLJ 1153 of the Madras High Court, dismissing the appellant's writ petitions challenging the constitutional validity of Section 3(d) where the High Court had observed: (MLJ p. 1188, para 19)

“19. … We have borne in mind the object which the amending Act wanted to achieve, namely, to prevent evergreening; to provide easy access to the citizens of the country to life-saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.”

18. In light of the High Court's observation, IPAB also referred to the pricing of the drug Gleevec by the appellant while it enjoyed EMR over it, and held that the patentability of the subject product would also be barred by Section 3(b) of the Act and in this regard observed as follows:

“We are fully conscious of the appellant's benevolent Gipap programme for free distribution of Gleevec to certain cancer patients. But as per information furnished in its written counter-argument by R-3 that when the appellant was holding the right as EMR on Gleevec it used to charge Rs 1,20,000 per month for a required dose of the drug from a cancer patient, not disputed by the appellant, which in our view is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create a havoc to the lives of poor people and their families affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before us, we observe that the appellant's alleged invention would not be worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of Section 3(d) of the Act, but also for its possible disastrous consequences on such grant as stated above, which also is being attracted by the provisions of Section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things (sic.) We, therefore, uphold the decision of R-8 on Section 3(d) of the Act to the extent that product patent cannot be made available to the appellant….”

19. Though agreeing with the Assistant Controller that no product patent for the subject patent could be allowed in favour of the appellant, IPAB held that the appellant could not be denied the process patent for preparation of Imatinib Mesylate in beta crystalline form. IPAB ordered accordingly.

20. Against the order of IPAB the appellant came directly to this Court in a petition under Article 136 of the Constitution. When the matter was first taken up before this Bench, we first thought of dismissing the SLPs at the threshold as the appellant had an alternative remedy to challenge the judgment and order of IPAB before the Madras High Court. However, Mr Gopal Subramanium, the Senior Advocate appearing for the appellant, submitted that the SLPs were filed on 11-8-2009, and the Court issued notice to the respondents on 11-9-2009. Further, before coming to this Bench, the matter was listed before another Bench, where it was heard on merits on different dates from 9-8-2011 to 6-9-2011. Mr Subramanium further submitted that relegating the appellant to the High Court might render the matter infructuous inasmuch as the period for the patent applied for would come to end after 20 years from the date of the application i.e in July 2018. He submitted that the High Court would take at least 2-3 years before a final decision would be rendered and then, whatever be the High Court's decision, the matter was bound to come to this Court. In this to and fro whatever remains of the patent period would also lapse. Mr Subramanium further submitted that the case involved a number of seminal issues and it was in the larger interest that an authoritative pronouncement on those issues be made by this Court.

21. Initially some of the respondents strongly opposed the maintainability of the petitions made directly to this Court bypassing the High Court, but in the end all agreed that given the importance of the matter, this Court may itself decide the appeals instead of directing the appellant to move the High Court. It is in such circumstances that we agreed to hear the parties and decide the appeals on merits. However, we wish to make it clear that any attempt to challenge the IPAB order directly before this Court, side-stepping the High Court, needs to be strongly discouraged and this case is certainly not to be treated as a precedent in that regard.

22. As this Court now proceeds to decide the case on merits, it needs to be noted that after notice was issued in the SLPs filed by Novartis AG, all the five parties who had filed pre-grant oppositions before the Controller (hereinafter referred to as “the objectors”) filed their respective counter-affidavits. Two of the objectors, namely, Natco Pharma Ltd. and M/s Cancer Patients Aid Association, additionally filed special leave petitions, challenging the findings recorded by IPAB in favour of Novartis AG. Leave to appeal has also been granted in all those SLPs, and hence, all the issues are open before this Court and this Court is deciding the case unbound by any findings of the authority or the tribunal below.

23. In connection with the case of the appellant, the first and foremost thing that needs to be kept in mind is that it falls in the transitional period between two fundamentally different patent regimes. In 1998, when the application was made on behalf of the appellant, the Patents Act, 1970, had a provision in Section 5 with the marginal heading, “Inventions where only methods or processes of manufacture patentable” that barred grant of patent to substances intended for use, or capable of being used, as food or medicine or drug, or prepared or produced by chemical processes. The application was then put in the “mailbox” and was taken out for consideration when many changes had been made in the Patents Act, 1970, with effect from 1-1-2005, to make the patent law in the country compliant with the terms of an international agreement entered into by the Government of India. Following the international agreement, the Patents Act, 1970, was subjected to large-scale changes in three stages; and finally, by the Patents (Amendment) Act, 2005, Section 5 was altogether deleted from the parent Act (Patents Act, 1970). Between 1-1-1995 and 1-1-2005, the Patents Act, 1970, underwent wide-ranging changes, but if we are asked to identify the single most important change brought about in the law of patent in India as a result of the country's obligations under the international agreement, we would unhesitatingly say the deletion of Section 5 from the Patents Act, which opened the doors to product patents in the country. It is, however, important to note that the removal of Section 5 from the statute book was accompanied by amendments in clauses (j) and (ja) of Section 2(1), apart from some other ancillary clauses of Section 2(1), as well as amendments in Section 3, which redefined the concepts of invention and patentability.

24. Some important provisions of the Patents Act, 1970, as they stand after the amendment of the Act in 2005, and with which we are especially concerned in this case, indeed present a problem of interpretation. Why was Section 5, which, in one sense, was the distinctive feature of the patent law in India, taken off the statute book? What does the legislature wish to say through clauses (j) and (ja) of Section 2(1), Section 3 and several other sections? How is it that some of the provisions of the Act apparently seem to be of no use or purpose e.g Sections 2(1)(1) and 2(1)(ta)? Why is it that some of the crucial provisions in the Act appear to be wanting in precision and clarity?

25. It is easy to know why Section 5 was deleted but to understand the import of the amendments in clauses (j) and (ja) of Section 2(1) and the amendments in Section 3 it is necessary to find out the concerns of Parliament, based on the history of the patent law in the country, when it made such basic changes in the Patents Act. What were the issues the legislature was trying to address? What was the mischief Parliament wanted to check and what were the objects it intended to achieve through these amendments?

26. The best way to understand a law is to know the reason for it. In Utkal Contractors and Joinery (P) Ltd. v. State of Orissa (1987) 3 SCC 279, Chinnappa Reddy, J. speaking for the Court, said:

“9. … A statute is best understood if we know the reason for it. The reason for a statute is the safest guide to its interpretation. The words of a statute take their colour from the reason for it. How do we discover the reason for a statute? There are external and internal aids. The external aids are Statement of Objects and Reasons when the Bill is presented to Parliament, the reports of committees which preceded the Bill and the reports of Parliamentary Committees. Occasional excursions into the debates of Parliament are permitted. Internal aids are the Preamble, the scheme and the provisions of the Act. Having discovered the reason for the statute and so having set the sail to the wind, the interpreter may proceed ahead.”

(emphasis supplied)

27. Again in RBI v. Peerless General Finance and Investment Co. Ltd. (1987) 1 SCC 424 Reddy, J. said:

“33. Interpretation must depend on the text and the context. They are the bases of interpretation. One may well say if the text is the texture, context is what gives the colour. Neither can be ignored. Both are important. That interpretation is best which makes the textual interpretation match the contextual. A statute is best interpreted when we know why it was enacted. With this knowledge, the statute must be read, first as a whole and then section by section, clause by clause, phrase by phrase and word by word. If a statute is looked at, in the context of its enactment, with the glasses of the statute-maker, provided by such context, its scheme, the sections, clauses, phrases and words may take colour and appear different than when the statute is looked at without the glasses provided by the context. With these glasses we must look at the Act as a whole and discover what each section, each clause, each phrase and each word is meant and designed to say as to fit into the scheme of the entire Act. No part of a statute and no word of a statute can be construed in isolation. Statutes have to be construed so that every word has a place and everything is in its place. It is by looking at the definition as a whole in the setting of the entire Act and by reference to what preceded the enactment and the reasons for it that the Court construed the expression ‘Prize Chit’ in Srinivasa (1980) 4 SCC 507 and we find no reason to depart from the Court's construction.”

(emphasis supplied)

28. In order to understand what the law really is, it is essential to know the “why” and “how” of the law. Why the law is what it is and how it came to its present form? The adage is more true in case of the law of patents in India than perhaps any other law. Therefore, in order to correctly understand the present law it would be necessary to briefly delve into the legislative history of the law of patents in the country.

Legislative history

29. At the time of Independence, India's patent regime was governed by the Patents and Designs Act, 1911, which had provisions both for product and process patents. It was, however, generally felt that the patent law had done little good to the people of the country. The way the Act was designed benefited foreigners far more than Indians. It did not help at all in the promotion of scientific research and industrialisation in the country, and it curbed the innovativeness and inventiveness of Indians.

30. Shortly after Independence, therefore, in 1949, a committee was constituted under the chairmanship of Justice (Dr) Bakshi Tek Chand, a retired Judge of the Lahore High Court, to undertake a comprehensive review of the working of the 1911 Act. The Committee submitted its interim report on 4-8-1949 and the final report in 1950 making recommendations for prevention of misuse or abuse of patent rights in India. It also observed that the Patents Act should contain a clear indication that food and medicine and surgical and curative devices were to be made available to the public at the cheapest price commensurate with giving reasonable compensation to the patentee. Based on the Committee's recommendations, the 1911 Act was amended in 1950 (by Act 32 of 1950) in relation to working of inventions, including compulsory licensing and revocation of patents. In 1952, a further amendment was made (by Act 70 of 1952) to provide for compulsory licence in respect of food and medicines, insecticide, germicide or fungicide, and a process for producing substance or any invention relating to surgical or curative devices. The Committee's recommendation prompted the Government to introduce a Bill (Bill No. 59 of 1953) in Parliament, but the Bill was not pressed and it was allowed to lapse.

31. In 1957, another committee came to be appointed under the chairmanship of Justice N. Rajagopala Ayyangar to take a fresh look at the law of patent and to completely revamp and recast it to best subserve the (contemporary) needs of the country.

32. Justice Ayyangar painstakingly collected valuable data (taking the figures for the years 1930 to 1939 from the Bakshi Tek Chand Report) and, compiling them into a number of tables, showed the share of Indians in the field of patents. He analysed the figures in the tables and pointed out that during the period 1930-1937, the grant of patents to Indians and foreigners was roughly in the ratio of 1:9. Even after Independence, though a number of institutions for postgraduate training were set up and several national laboratories were established to encourage a rapid growth of scientific education, the proportion of Indian and the foreign patents remained substantially the same, at roughly 1:9. Justice Ayyangar further pointed out that this ratio does not take into account the economic or industrial or scientific importance of the inventions. If these factors are taken into account, Indians would appear to be lagging even further behind. Further, taking into reckoning the number of inventions for which renewal fees were paid beyond the 6th year, which would give a rough idea of the value attached to the invention by the patentee, the patents taken by the Indians would appear to be of little worth as compared to the patents held by the foreign nationals.

33. Justice Ayyangar examined the nature of the patent right and considered the arguments advanced as justifications/rationalisations for grant of patents. He described the patent law, in his report, as an instrument for managing the political economy of the country. He observed:

“It would not be an exaggeration to say that the industrial progress of a country is considerably stimulated or retarded by its patent system according as to whether the system is suited to it or not.” (p. 9, Para 16)

He also quoted from Michel with approval as under:

“… Patent systems are not created in the interest of the inventor but in the interest of national economy. The rules and regulations of the patent systems are not governed by civil or common law but by political economy.”

34. Observing that industrial countries and underdeveloped countries had different demands and requirements, Justice Ayyangar pointed out that the same patent law would operate differently in two countries at two different levels of technological and economic development, and hence the need to regulate the patent law in accordance with the need of the country. Commenting upon the Patents and Designs Act, 1911, (even after its post-Independence amendments) Justice Ayyangar said:

“It is further obvious however that the system would not yield the same results when applied to underdeveloped countries. I entirely agree with the views of the Patents Enquiry Committee that ‘the Indian patent system has failed in its main purpose, namely, to stimulate invention among Indians and to encourage the development and exploitation of new inventions for industrial purposes in the country so as to secure the benefits thereof to the largest section of the public’.” (Interim Report, p. 165.)

35. Justice Ayyangar observed that the provisions of the patent law have to be designed with special reference to the economic conditions of the country, the state of its scientific and technological advancement, its future needs and other relevant factors, and so as to minimise, if not to eliminate, the abuses to which a system of patent monopoly is capable of being put. Bearing in view the matters set above, he recommended retaining the patent system, but with a number of improvements. One of the improvements suggested was to define, with precision, those inventions which should be patentable and equally clearly identify certain inventions, the grant of patents to which would retard research, or industrial progress, or be detrimental to the national health or well-being, and to make those inventions non-patentable.

36. Justice Ayyangar's report specially discussed (a) patents for chemical inventions; and (b) patents for inventions relating to food and medicine:

36.1 In regard to patents for chemical substances, he examined the history of the law in other countries and pointed out that Germany was the first to adopt the system of confining the patentability of inventions relating to chemical products or substances to process claims. The law was then followed in many other countries in the world, for instance Austria, Brazil, Czechoslovakia, Holland, Hungary, Japan, Mexico, Norway, Poland and the USSR. The products produced by chemical process were not patentable though processes for making such products were patentable, if, of course, they satisfied the other tests of patentability e.g novelty, subject-matter, etc. In light of the experience of the other countries, Justice Ayyangar recommended:

“I have considered the matter with the utmost care and have reached the conclusion that the chemical and pharmaceutical industry of this country would be advanced and the tempo of research in that field would be promoted if the German system of permitting only process claims were adopted.”

36.2 Coming next to the patents for inventions relating to food and medicine, Justice Ayyangar pointed out that barring the United States, there was hardly any country that allowed unrestricted grant of patents in respect of articles of food and medicines, or as to the licensing and working of patents in this class. In none of the countries of Europe were patents granted for product claims for articles of food or medicine, and in a few (Denmark for articles of food; and Italy, under the law of 1957, for medicinal products) even claims for processes for producing them were non-patentable. He explained that the reason for this state of law is stated to be that the denial of product claims is necessary in order that important articles of daily use such as medicine or food, which are vital to the health of the community, should be made available to everyone at reasonable prices and that no monopoly should be granted in respect of such articles. It is considered that the refusal of product patents would enlarge the area of competition and thus result in the production of these articles in sufficient quantity and at the lowest possible cost to the public.

37. Justice Ayyangar submitted a comprehensive report on Patent Law Revision in September 1959 and the new law of patent, namely, the Patents Act, 1970, came to be enacted mainly based on the recommendations of the Report, and came into force on 20-4-1972, replacing the Patents and Designs Act, 1911.

37.1 Section 1 of the new Act gave it its name and territorial extent and provided that it would come into effect on such date as the Central Government may appoint by notification in the Official Gazette. Section 2 contained the definition and interpretation clauses; it defined the terms “invention” and “medicine” in clauses (j) and (l) respectively as under:

“2. (1)(j) ‘invention’ means any new and useful—

(i) art, process, method or manner of manufacture;

(ii) machine, apparatus or other article;

(iii) substance produced by manufacture,

and includes any new and useful improvement of any of them, and an alleged invention;

(l) ‘medicine or drug’ includes—

(i) all medicines for internal or external use of human beings or animals,

(ii) all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals,

(iii) all substances intended to be used for or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals,

(iv) insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants;

(v) all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines or substances above referred to;”

(emphasis supplied)

37.2 Sections 1 and 2 comprised Chapter I, following which Chapter II was headed “Inventions not patentable”. Chapter II had three sections which, as originally framed, are as under:

“3. What are not inventions.—The following are not inventions within the meaning of this Act—

(a) an invention which is frivolous or which claims anything obviously contrary to well-established natural laws;

(b) an invention the primary or intended use of which would be contrary to law or morality or injurious to public health;

(c) the mere discovery of a scientific principle or the formulation of an abstract theory;

(d) the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant;

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;

(f) the mere arrangement or rearrangement or duplication of known devices each functioning independently of one another in a known way;

(g) a method or process of testing applicable during the process of manufacture for rendering the machine, apparatus or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture;

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products.

4. Inventions relating to atomic energy not patentable.—No patent shall be granted in respect of an invention relating to atomic energy falling within sub-section (1) of Section 20 of the Atomic Energy Act, 1962 (33 of 1962).

5. Inventions where only methods or processes of manufacture patentable.—In the case of inventions—

(a) claiming substances intended for the use, or capable of being used, as food or as medicine or drug, or

(b) relating to substances prepared or produced by chemical processes (including alloys, optical glass, semi-conductors and inter-metallic compounds),

no patent shall be granted in respect of claims for the substances themselves, but claims for the methods or processes of manufacture shall be patentable.”

37.3 It is significant to note that Section 5 in Chapter II of the Act expressly excluded product patents for substances intended for use and capable of being used as food or as medicine or drug, and substances prepared or produced by chemical process, and made these substances non-patentable. Section 4 similarly prohibited grant of patent in respect of an invention relating to atomic energy. The Act thus clearly recognised and maintained the distinction between invention and patentability.

38. We have briefly examined some aspects of the legislative history of the patent law in India. We may now take a look at how the Patents and Designs Act, 1911, and the Patents Act, 1970, impacted the pharmaceutical industry and the availability of drugs in the country.

39. Sudip Chaudhuri in his book titled, The WTO and India's Pharmaceuticals Industry describes the market shares of multinational companies and Indian companies in India by means of a table as under:

Market shares of MNCs and Indian companies in the pharmaceutical industry in India

Year MNCs (%) Indian companies 1952 38 62 1970 68 32 1978 60 40 1980 50 50 1991 40 60 1998 32 68 2004 23 77

40. The fall and rise of the Indian pharmaceutical industry is explained as the result of certain factors, not the least important of which was the change in the patent law in the country, which made medicines and drugs and chemical substances non-patentable. Chaudhuri explains that before the introduction of sulfa drugs (1930s) and penicillin (1940) that brought about the therapeutic revolution, drugs of natural origin were more important than synthetic ones. Also, medicinal plants (that is, raw materials) for about three-fourths of the drugs mentioned in British and other pharmacopoeias actually grew in India.

41. By the time the Second World War started (1939), several indigenous firms were engaged in manufacturing drugs, and indigenous producers met 13% of the medicinal requirements of the country. They still had a long way to go to attain self-sufficiency but in terms of the range of operations they were already manufacturing all types of drugs. By the early 1950s, because of the spread of manufacturing activities, the indigenous sector dominated the pharmaceutical industry in India. It accounted for about 62% of the market in 1952 (the Table above). However, the rise and growth of multinational corporations (MNCs) worldwide in the post-Second World War period, as well as the therapeutic revolution changed these dynamics. MNCs started research for developing new drugs in the 1930s-1940s. As a result, in the late 1940s and during the 1950s and even after that at a slower rate, new drugs discovered by MNCs began to be available for medical use. The indigenous sector was not equipped for research for developing new drugs, that is, for developing a new chemical entity. With the introduction of new drug at a rapid rate by MNCs, the role of patents became important. Because of the patent regime under the 1911 Act and the unsupportive industrial policy, the indigenous sector lost its status in the 1950s and the 1960s. In contrast to 62% of the market in the early 1950s, the market share of the indigenous sector declined to 32% by 1970. In contrast, the market share of MNCs increased from 38% in 1952 to 68% in 1970 (the Table above). However, according to Chaudhuri, the situation changed in the 1970s. Several official initiatives were taken in the 1970s, of which the most important one was the enactment of the Patents Act, 1970, which changed the environment in favour of the indigenous sector.

42. In regard to the Patents Act, 1970, Chaudhuri maintains that patent “reforms” contributed directly to the transformation of the pharmaceutical industry. He points out that under the Patents Act, 1970, articles of food, medicines and drugs and chemical substances could be patented only for a new method or process of manufacture, not for the products as such (Section 5 of the 1970 Act). Further, unlike in the previous patent regime, for each particular drug only one method or process—the best known to the applicant—could be patented (Sections 5 and 10 of the 1970 Act). Also, even in case of a process patent for an article of food, medicine or drug, the term of the patent was brought down from fourteen (14) years to five (5) years from the date of sealing of the patent, or seven (7) years from the date of patent whichever was earlier.

43. Chaudhuri then examines the growth of the Indian pharmaceutical industry driven by the new patent regime in three phases:

• Till the early 1970s;

• The late 1970s and the 1980s; and

• Since the 1990s

43.1 Till the early 1970s the industry was dominated by MNCs who commanded 68% of the market share. India was dependent on imports for many essential bulk drugs. This import dependence constricted consumption in a country deficient in foreign exchange, and inhibited the growth of the industry. Drug prices in India were very high.

43.2 In the late 1970s and 1980s, Indian companies started large-scale production of bulk drugs. The development of the bulk drugs sector is actually the most important achievement of the pharmaceutical industry in India. This led to the transformation of the industry.

43.3 The most rapid growth of the Indian pharmaceutical industry took place from the 1990s onwards. Both production and exports grew remarkably fast. The production of both bulk drugs and formulations started increasing sharply and steadily. From Rs 6400 million in 1989-1990, bulk drugs production increased to Rs 77,790 million in 2003-2004; and from Rs 34,200 million in 1989-1990, formulation productions increased to Rs 2,76,920 million in 2003-2004. The growth was most remarkable from 2000 to 2005, when production increased much more than it had in the last two decades. Indian companies further consolidated their domination in the domestic market. Their market share increased from 60% in 1991 to 68% in 1998 and 77% in 2003.

44. The growth was also very fast in the export markets. India became a net exporter by 1988-1989, and since then there has only been an increase in the Indian exports. As a result, net exports as a percentage of exports have increased from 4.4% in 1988-1989 to about 50% in the early 1990s and more than 75% in the early 2000s. More than three-fourths of bulk drug production and almost one-fourth of the formulations production are exported. USA, which has the toughest regulatory requirements, has emerged as India's largest export partner in pharmaceuticals.

45. Dealing with the growth of the Indian pharmaceutical industry after the change in the patent law, Chaudhuri writes:

“Because of the rapid growth and structural transformation in the last three decades or so, India now occupies an important position in the international pharmaceutical industry.… India has received worldwide recognition as a low cost producer of high quality bulk drugs and formulations. India produces about 350 bulk drugs ranging from simple painkillers to sophisticated antibiotics and complex cardiac products. Most of the bulk drugs are produced from basic stages, involving complex multistage synthesis, fermentation and extractions. For more than 25 bulk drugs, India accounts for more than 50% of the international trade. India is a major force to reckon with in the western markets for such drugs as ibuprofen, sulphamethoxasole….”

46. Even as the country's pharmaceutical industry, helped by the basic changes made in the patent system by the Patents Act, 1970, was going from strength to strength, certain developments were taking place at the international level that would deeply impact the patent system in the country. Following the Uruguay round of multilateral negotiations under the General Agreement on Tariffs and Trade (GATT), the Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) was arrived at and it came into force on 1-1-1995. The Trips Agreement is the most comprehensive multilateral agreement to set detailed minimum standards for the protection and enforcement of intellectual property rights, and aims at harmonising national intellectual property systems. All members of the World Trade Organisation (WTO) are bound by the obligations under the Trips Agreement. India is one of the founding members of the GATT and thus a member of WTO from its inception from 1-1-1995, and is bound by the obligations under the Trips Agreement like all other members of WTO.

47. Some of the articles of the Agreement, which have a bearing on our discussion, are reproduced below:

“1. Nature and scope of obligations.—(1) Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

(2) For the purposes of this Agreement, the term ‘intellectual property’ refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II.

“3. National treatment.—(1) Each member shall accord to the nationals of other members treatment no less favourable than that it accords to its own nationals with regard to the protection of intellectual property, subject to the exceptions already provided in, respectively, the Paris Convention (1967), the Berne Convention (1971), the Rome Convention or the Treaty on Intellectual Property in Respect of Integrated Circuits.. In respect of performers, producers of phonograms and broadcasting organisations, this obligation only applies in respect of the rights provided under this Agreement. Any member availing itself of the possibilities provided in Article 6 of the Berne Convention (1971) or para (1)(b) of Article 16 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for Trips.

(2) Members may avail themselves of the exceptions permitted under para (1) in relation to judicial and administrative procedures, including the designation of an address for service or the appointment of an agent within the jurisdiction of a member, only where such exceptions are necessary to secure compliance with laws and regulations which are not inconsistent with the provisions of this Agreement and where such practices are not applied in a manner which would constitute a disguised restriction on trade.

7. Objectives.—The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

8. Principles.—(1) Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

(2) Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

PART II

Section 5: Patents

27. Patentable subject-matter.—(1) Subject to the provisions of paras (2) and (3), patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to para (4) of Article 65, para (8) of Article 70 and para (3) of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

(2) Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

(3) Members may also exclude from patentability—

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this sub-paragraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

28. Rights conferred.—(1) A patent shall confer on its owner the following exclusive rights—

(a) where the subject-matter of a patent is a product, to prevent third parties not having the owner's consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product;

(b) where the subject-matter of a patent is a process, to prevent third parties not having the owner's consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.

(2) Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.

PART V

Dispute Prevention and Settlement

63. Transparency.—(1) Laws and regulations, and final judicial decisions and administrative rulings of general application, made effective by a member pertaining to the subject-matter of this Agreement (the availability, scope, acquisition, enforcement and prevention of the abuse of intellectual property rights) shall be published, or where such publication is not practicable made publicly available, in a national language, in such a manner as to enable governments and right holders to become acquainted with them. Agreements concerning the subject-matter of this Agreement which are in force between the Government or a governmental agency of a member and the Government or a governmental agency of another Member shall also be published.

(2) Members shall notify the laws and regulations referred to in para (1) to the Council for Trips in order to assist that Council in its review of the operation of this Agreement. The Council shall attempt to minimise the burden on members in carrying out this obligation and may decide to waive the obligation to notify such laws and regulations directly to the Council if consultations with WIPO on the establishment of a common register containing these laws and regulations are successful. The Council shall also consider in this connection any action required regarding notifications pursuant to the obligations under this Agreement stemming from the provisions of Article 6ter of the Paris Convention (1967).

(3) Each member shall be prepared to supply, in response to a written request from another member, information of the sort referred to in para (1). A member, having reason to believe that a specific judicial decision or administrative ruling or bilateral agreement in the area of intellectual property rights affects its rights under this Agreement, may also request in writing to be given access to or be informed in sufficient detail of such specific judicial decisions or administrative rulings or bilateral agreements.

(4) Nothing in paras (1), (2) and (3) shall require members to disclose confidential information which would impede law enforcement or otherwise be contrary to the public interest or would prejudice the legitimate commercial interests of particular enterprises, public or private.

64. Dispute settlement.—(1) The provisions of Articles XXII and XXIII of GATT, 1994 as elaborated and applied by the Dispute Settlement Understanding shall apply to consultations and the settlement of disputes under this Agreement except as otherwise specifically provided herein.

(2) Sub-paras (1)(b) and (1)(c) of Article XXIII of GATT, 1994 shall not apply to the settlement of disputes under this Agreement for a period of five years from the date of entry into force of the WTO Agreement.

(3) During the time period referred to in para (2), the Council for Trips shall examine the scope and modalities for complaints of the type provided for under sub-paras (1)(b) and (1)(c) of Article XXIII of GATT, 1994 made pursuant to this Agreement, and submit its recommendations to the Ministerial Conference for approval. Any decision of the Ministerial Conference to approve such recommendations or to extend the period in para (2) shall be made only by consensus, and approved recommendations shall be effective for all members without further formal acceptance process.

PART VI

65. Transitional arrangements.—(1) Subject to the provisions of paras (2), (3) and (4), no member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date of entry into force of the WTO Agreement.

(2) A developing country member is entitled to delay for a further period of four years the date of application, as defined in para (1), of the provisions of this Agreement other than Articles 3, 4 and 5.

(3) Any other member which is in the process of transformation from a centrally planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in para (2).

(4) To the extent that a developing country member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that member, as defined in para (2), it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years.

(5) A member availing itself of a transitional period under paras (1), (2), (3) or (4) shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement.

PART VII

70. Protection of existing subject-matter.—(1)-(6) ***

(7) In the case of intellectual property rights for which protection is conditional upon registration, applications for protection which are pending on the date of application of this Agreement for the member in question shall be permitted to be amended to claim any enhanced protection provided under the provisions of this Agreement. Such amendments shall not include new matter.

(8) Where a member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that member shall:

(a) notwithstanding the provisions of Part VI, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed;

(b) apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that member or, where priority is available and claimed, the priority date of the application; and

(c) provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in sub-para (b).

(9) Where a product is the subject of a patent application in a member in accordance with para (8)(a), exclusive marketing rights shall be granted, notwithstanding the provisions of Part VI, for a period of five years after obtaining marketing approval in that member or until a product patent is granted or rejected in that member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another member and marketing approval obtained in such other member.”

48. The Trips Agreement (vide Part V: Article 64) provides for a mechanism for resolution of disputes between the members of WTO. In case of a dispute, a panel of specially appointed trade experts interprets the provisions of the Agreement and issues a report. The panel's decision may be subjected to appeal before the WTO Appellate Body. If a party to the decision fails to abide by a decision, the other party can impose trade sanctions on the member in breach, upon authorisation by the Dispute Settlement Body. The dispute resolution mechanism in Trips is strong and effective as was proved in the case of India herself.

49. Article 65 [paras (1) and (2)] allowed India to delay the application of the provisions of the Agreement for a period of 5 years, that is, till 1-1-2000; para (4) allowed India to delay for a further period of five years, that is, till 1-1-2005, the application of the provision relating to product patent, in respect of all articles excluded by the Patents Act, 1970, which included pharmaceuticals and agricultural chemical products. But, Article 70 [paras (8) and (9)] enjoined that in the meanwhile it should provide for a means by which applications for patents for inventions in respect of pharmaceutical and agricultural chemical products could be filed and also for the grant of “exclusive marketing rights” for such products. In discharge of its obligations under the Trips Agreement, the Government of India promulgated the Patents (Amendment) Ordinance, 1994 (Ordinance 13 of 1994), on 31-12-1994, amending the Patents Act, 1970. The Ordinance provided for making “a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug” [as required by sub-para (a) of Article 70(8) of the Trips Agreement] and for the grant of exclusive marketing rights with respect to the product that is the subject-matter of such a patent claim [as required by Article 70(9) of the Agreement]. The Ordinance, however, lapsed on 26-3-1995, on expiration of six weeks from the commencement of the next session of Parliament, without being replaced by any corresponding Act. The Patents (Amendment) Bill, 1995, which was intended to give permanent legislative effect to the provisions of the Ordinance, was introduced in the Lok Sabha in March 1995. The Bill was passed by the Lok Sabha and it was then introduced in the Rajya Sabha where it was referred to a Select Committee of the House for examination and report. The Select Committee was unable to give its report before the dissolution of the Lok Sabha on 10-5-1996. The Patents (Amendment) Bill, 1995, lapsed with the dissolution of the Tenth Lok Sabha.

50. In this state of the patent law in the country, India was twice taken to the WTO Panel, first on a complaint by USA (WT/DS50.AB/R, dated 19-12-1997) and the second time on a complaint filed by the European Communities (WT/DS79.R, dated 24-8-1998). The complaint by USA was in regard to the absence, in India, of either patent protection for pharmaceutical and agricultural chemical products under Article 27 of the Trips Agreement, or of a means for the filing of patent applications for pharmaceutical and agricultural chemical products pursuant to Article 70(8) of the Trips Agreement and of the legal authority for the grant of exclusive marketing rights for such products pursuant to Article 70(9) of the Trips Agreement. The WTO Panel returned the finding that India had not complied with its obligations under Article 70(8)(a) and, in the alternative, paras (1) and (2) of Article 63 and also Article 70(9) of the Trips Agreement. India took the matter in appeal. By a decision dated 19-12-1997, the Appellate Body affirmed the Panel's findings that India had not complied with its obligations under Article 70(8)(a) and Article 70(9) of the Trips Agreement, but set aside the Panel's finding relating to the alternative claim by the United States under Article 63 of the Trips Agreement. In conclusion, the Appellate Body recommended “that the Dispute Settlement Body request India to bring its legal regime for patent protection of pharmaceutical and agricultural chemical products into conformity with India's obligations under Articles 70(8) and 70(9) of the Trips Agreement”.

51. In the proceedings arising from the complaint filed by the United States, the European Communities were added as the Third Party before the panel and as the Third Participant before the Appellate Body. Nonetheless, the European Communities and their members filed a similar but separate complaint against India (WT/DS79.R, dated 24-8-1998). The WTO panel, accepting the complainant's request, extended the findings in the earlier dispute (WT/DS50), as modified by the Appellate Body, to the complaint filed by the European Communities and their member States as well. This matter did not go to the WTO Appellate Body.

52. The Trips Agreement also provides for a built-in mechanism for review through the biennial Ministerial Conference (vide Article 71). The Ministerial Conference is the highest decision-making body of WTO and it can make decisions on all matters under any of the WTO agreements, including the Trips Agreement. The fourth WTO Ministerial Conference in Doha on 14-11-2001, adopted the Doha Declaration on the Trips and Public Health. The Doha Declaration is as follows:

“1. We recognise the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

2. We stress the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips Agreement) to be part of the wider national and international action to address these problems.

3. We recognise that intellectual property protection is important for the development of new medicines. We also recognise the concerns about its effects on prices.

4. We agree that the Trips Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the Trips Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the Trips Agreement, which provide flexibility for this purpose.

5. Accordingly and in the light of para 4 above, while maintaining our commitments in the Trips Agreement, we recognise that these flexibilities include:

(a) In applying the customary rules of interpretation of public international law, each provision of the Trips Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.

(b) Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.

(c) Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

(d) The effect of the provisions in the Trips Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.

6. We recognise that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the Trips Agreement. We instruct the Council for Trips to find an expeditious solution to this problem and to report to the General Council before the end of 2002.

7. We reaffirm the commitment of developed country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66(2). We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the Trips Agreement or to enforce rights provided for under these sections until 1-1-2016, without prejudice to the right of least-developed country members to seek other extensions of the transition periods as provided for in Article 66(1) of the Trips Agreement. We instruct the Council for Trips to take the necessary action to give effect to this pursuant to Article 66(1) of the Trips Agreement.”

53. In the course of the hearing, we were told that the Doha Declaration effectively reflected and addressed the deep disquiet of the developing and the least-developed countries regarding their obligation under Trips to grant patent protection for pharmaceutical and agricultural chemical products and the likelihood of its highly adverse consequence on public health. Dr Dhavan, appearing for Cipla (one of the objectors), was particularly severe in his criticism of the Trips Agreement and called it a “predatory and coercive” agreement. The other counsel, though appearing for the different objectors, were more muted in their criticism of the Trips Agreement. Mr Kuhad, the learned Additional Solicitor General appearing for the Union of India, and Mr Grover, Senior Advocate, appearing on behalf of M/s Cancer Patients Aid Association (one of the objectors), especially adapted their submissions, taking the Trips Agreement as a fact that cannot be simply wished away. However, all the counsel representing the Union of India and the different objectors unanimously took the stand that the Trips Agreement has sufficient flexibility (vide Articles 7, 8 and 27), which was further reaffirmed by the Doha Declaration (in Paras 4 to 6), to enable the member States to control the patent rights in a manner as to avoid any adverse impact on public health. It was contended on behalf of the Union of India and the objectors that the Trips Agreement coupled with the Doha Declaration leaves it open to the member States to adjust their respective patent systems by regulating the grant of patents and to set up higher standards for patent protection for pharmaceutical and agricultural chemical products. The Union of India and all the objectors maintained that the patent law in India, as it stands today after major changes were brought about in the Patents Act, 1970 in 2005, is fully Trips compliant. But they insisted that the Indian law must be judged and interpreted on its own terms, and not on the basis of standards of patentability prescribed in some countries of the western world.

54. We have referred to the Trips Agreement and certain developments arising from it not to comment upon the fairness or otherwise of the Agreement nor to examine the correctness and wisdom of the decision of the Government of India to subscribe to the Trips Agreement. That is farthest from our mind. We have referred to the Trips Agreement as being the main reason behind the basic changes brought about in the patent law of the country by legislative action. We have also referred to the Trips Agreement as being the cause of a good deal of concern not only in this country but also (as we shall see presently) in other parts of the world; the concern being that patent protection to pharmaceutical and agricultural chemical products might have the effect of putting life-saving medicines beyond the reach of a very large section of people. In the following lines we shall see how the Indian legislature addressed this concern and, while harmonising the patent law in the country with the provisions of the Trips Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the developing countries and the least-developed countries).

55. We have seen above that, simultaneously with Trips coming into force, the Government of India had brought an Ordinance to comply with the provisions of Articles 70(8) and (9), but the Ordinance lapsed without being replaced by any enactment. Complaints were then filed on which pronouncements were made against India. On the complaint filed by USA, the decision of the Appellate Body was rendered on 19-12-1997; and on the complaint filed by the European Communities, the report of the panel came on 24-8-1998. Thus faced with the threat of trade sanctions, Parliament passed the Patents (Amendment) Act, 1999 (Act 17 of 1999) on 26-3-1999, which amended the provisions of the Patents Act, 1970 retrospectively, with effect from 1-1-1995, the date when the Trips Agreement came into force. By the Amendment Act of 1999, Section 5 of the parent Act was amended to provide for making “a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug”. The Amendment Act further incorporated in the parent Act, Chapter IV-A, which contained the provisions for grant of exclusive marketing rights in respect of pharmaceutical substances for which a claim for patent was made under Section 5 of the Act. The Amendment Act of 1999 thus complied with Articles 70(8) and (9) of the Trips Agreement.

56. Three years later the Patents (Amendment) Act, 2002 (Act 38 of 2002) came to be enacted on 25-6-2002. It brought large-scale amendments in the Patents Act, 1970. The Statement of Objects and Reasons for the Amendment Act of 2002 is stated as under:

“Amendment Act 38 of 2002 — Statement of Objects and Reasons.—The law relating to patents is contained in the Patents Act, 1970 which came into force on 20-4-1972. The Act was last amended in March 1999 to meet India's obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (Trips) which forms part of the Agreement establishing the World Trade Organisation (WTO). … Development of technological capability in India, coupled with the need for integrating the intellectual property system with international practices and intellectual property regimes, requires that the Act be modified into a modern, harmonised and user-friendly legislation to adequately protect national and public interests while simultaneously meeting India's international obligations under the Trips Agreement which are to be fulfilled by 31-12-1999.

2. ***

3. While considering amendment to the Act, efforts have been made to make the law not only Trips compliant but also to provide therein necessary and adequate safeguards for protection of public interest, national security, biodiversity, traditional knowledge, etc. Opportunity is also proposed to be availed of for harmonising the procedure for grant of patents in accordance with international practices and to make the system more user-friendly.

4. Some of the salient features of the Bill are as under:

(a) to define the term ‘invention’ in consonance with international practices and consistent with the Trips Agreement;

(b) to modify Section 3 of the present Act to include exclusions permitted by Trips Agreement and also subject-matters like discovery of any living or non-living substances occurring in nature in the list of exclusions which in general do not constitute patentable invention;

(c) to align rights of patentee as per Article 28 of the Trips Agreement;

(d)-(k)***

(l) to amend several provisions of the Act with a view to simplifying and rationalising the procedures aimed at benefiting users.”

(emphasis supplied)

57. The Amendment Act of 2002 greatly expanded the definition clause in Section 2 of the parent Act by including a number of new expressions and terms and redefining some earlier terms.

58. “Invention” was defined in the parent Act as under:

“2. (1)(j) ‘invention’ means any new and useful—

(i) art, process, method or manner of manufacture;

(ii) machine, apparatus or other article;

(iii) substance produced by manufacture,

and includes any new and useful improvement of any of them, and an alleged invention;”

(emphasis supplied)

59. “Invention” was redefined by the Amendment Act of 2002 as under:

“2. (1)(j) ‘invention’ means a new product or process involving an inventive step and capable of industrial application;”

60. The expressions “capable of industrial application” and “inventive step” were separately defined in clauses (ac) and (ja) respectively which are as under:

“2. (1)(ac) ‘capable of industrial application’, in relation to an invention, means that the invention is capable of being made or used in an industry;

(ja) ‘inventive step’ means a feature that makes the invention not obvious to a person skilled in the art;”

61. Section 3 of the parent Act, which provided for exclusions from patentability, was recast. In Section 5 of the parent Act, an explanation was added after sub-section (2). Chapter XVI was substituted with the chapter heading “Working of Patents, Compulsory Licences and Revocation”. Section 83 in this Chapter laid down the general principles applicable to working of patented inventions; Section 84 provided for compulsory licences; and Section 85 for revocation of patents for non-working. Here, it may not be out of place to take note of Section 83 which provided as under:

“83. General principles applicable to working of patented inventions.—Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely—

(a) that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay;

(b) that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;

(c) that the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;

(d) that patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio-economic and technological development of India;

(e) that patents granted do not in any way prohibit the Central Government in taking measures to protect public health;

(f) that the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and

(g) that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.”

62. The many amendments to and enlargement of the parent Act by the Amendment Act of 2002 laid most of the groundwork, but India was yet to take the one final step to make its patent law compliant with the mandate of Trips. And that was to amend the Act to allow for grant of product patents for pharmaceutical and agricultural chemical substances. Steps were taken to finally amend the Patents Act, 1970, but the draft Bill lapsed in February 2004. Further efforts were made but the legislature was unable to bring an enactment to make that final amendment in the Act by December 2004; thus, the Government of India had no option but to amend the law through an Ordinance. Therefore, in order not to default on its obligations under the Trips Agreement, the Government brought the Patents (Amendment) Ordinance, 2004 (Ordinance 7 of 2004) with effect from 1-1-2005. By this Ordinance, Section 5 of the Patents Act, 1970, which barred the grant of patent for substances intended for use or capable of being used as food or as medicine or drugs or substances prepared or produced by chemical processes was done away with, opening the doors for grant of patents to, amongst others, pharmaceutical products.

63. But the troubles were far from over, because the Ordinance was to lapse on 31-3-2005. Hence, it was imperative for Parliament to pass an enactment, replacing the Ordinance before it lapsed on 31-3-2005. The pressure of time under which Parliament was obliged to deal with the matter and pass the Act, replacing Ordinance 7 of 2004 and amending the Patents Act, 1970, is best stated in the Statement of Objects and Reasons for the Patents (Amendment) Act, 2005 (Act 15 of 2005). In Para 5 of the Statement of Objects and Reasons it is stated as under:

“Amendment Act 15 of 2005 — Statement of Objects and Reasons.—

5. The time-frame for this set of amendments was most crucial as any slippage in meeting the 1-1-2005 deadline had the potential of inviting retaliatory action under the WTO disputes mechanism. Having availed of the entire ten-year transition period provided under the Trips Agreement, India had no legal basis to defend its default on the deadline. The past record of delayed implementation would also not have helped the Indian case. This default would also have created a legal vacuum for the ‘mailbox’ applications, as there would not be any mechanism to deal with them from 1-1-2005. This would have amounted to a specific default on the international commitment to examine and dispose of these cases, and might have again provided an opportunity to WTO member countries to raise a dispute against India in WTO. There would also have been a legal vacuum in respect of fresh applications after 1-1-2005, as the law was silent on whether the ‘mailbox’ provision would subsist or whether it would have ceased. Finally, there would have been an erosion of India's credibility in the international field. In the circumstances it was considered necessary to bring in the required amendments in time and as Parliament was not in session, the President promulgated the Patents (Amendment) Ordinance, 2005 (7 of 2004) on 26-12-2004.”

64. Parliament had an absolutely unenviable task on its hands. It was required to forge, within a very limited time, an Act that would be Trips compliant without, in any way, compromising on public health considerations. It is seen above that the Trips Agreement had aroused grave concerns about its impact on public health. India had learnt from experience the inverse relationship between product patents and the indigenous pharmaceutical industry, and its effects on the availability of essential drugs at affordable prices. It is also seen above that after the patent system in India barred the grant of patents for pharmaceutical and chemical substances, the pharmaceutical industry in the country scaled great heights and became the major supplier of drugs at cheap prices to a number of developing and underdeveloped countries. Hence, the reintroduction of product patents in the Indian patent system through the Trips Agreement became a cause of alarm not only in this country but also for some international agencies.

65. Our attention was invited to a letter of the HIV/AIDS Director of WHO, dated 17-12-2004, to the Minister of Health and Family Welfare, Government of India. The letter deserves to be noted in full:

“17-12-2004

Dr A. Ramadoss

Minister of Health and Family Welfare,

Government of India,

Nirman Bhawan, Maulana Azad Road,

New Delhi 110 001,

India.

Dear Dr Ramadoss,

We would like to bring to your attention that several of our member States have expressed their concern that in the future, generic antiretroviral drugs from India may no longer be available to them. Among other places, these concerns were expressed by the delegations of Ghana, Lesotho, Malawi, and Namibia at our recent Procurement & Supply Management (PSM) Workshop in Nairobi, Kenya (2-12-2004 to 9-12-2004), and by Bangladesh, Cambodia, China, Indonesia, Korea, Laos, Thailand, Papua New Guinea, and Vietnam at the Asian Regional Workshop on the WTO/Trips Agreement and Access to Medicines held in Kuala Lumpur, Malaysia (28-11-2004 to 30-11-2004).

As you are aware, WHO has been actively monitoring the implications of trade agreements on public health. One key issue is the impact of the end of the transition period at 1-1-2005 allowed under the Trips Agreement, which delayed the application of product patents, on the local production and supply of generic antiretroviral agents.

The WTO Ministerial Declaration on the Trips Agreement and Public Health adopted in Doha, 2001 affirmed that ‘the Trips Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.' In line with this, recent resolutions of the World Health Assembly have also urged that national legislation should be adapted in order to use to the full the flexibilities contained in the Trips Agreement (WHA 56.27, May 2003 and 57.14, May 2004). In accordance with its mandate, WHO will therefore seek to provide technical assistance and support to member States to promote implementation of the Trips Agreement consistent with the public health objective of ensuring access to medicines.

As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian Government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need access to antiretrovirals, without adopting unnecessary restrictions that are not required under the Trips Agreement and that would impede access to medicines.

We thank you for your attention to this issue and send our best regards.

Sincerely,

Dr Jim Yong Kim

Director,

Department of HIV/AIDS.”

(emphasis supplied)

66. We were also shown another letter dated 23-2-2005, from the Director of Advocacy, Communication and Leadership for Unaids, to the Minister of Commerce and Industry, Government of India. This letter is also useful as reflecting the concern of the international community over the impending change in the patent system in India. This letter is as under:

“Honourable Minister

Mr Kamal Nath

Ministry of Commerce and Industry,

Udyog Bhavan,

New Delhi 110 001,

India.

23-2-2005

Reference: ACL/AD/lp

Excellency,

I have the honour to refer to India's leadership in promoting access to and supplying affordable essential generic HIV medicines to those most in need in developing countries, which has long been recognized and applauded by the international community. India can rightly take pride in the fact that it has significantly supported the response to the global AIDS emergency through helping to ensure AIDS medicines are more affordable and accessible.

Affordable HIV medications from India have so far saved thousands of lives yet more than 8000 people around the world continue to die every day because they have no access to treatment. Despite concerted efforts across the world, only about one in ten people in urgent need of HIV antiretroviral treatment in low- and middle-income countries has access to existing medicines.

Current legislative proposals intended to take the 1970 Indian Patents Act beyond the commitments agreed in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) threaten to undermine India's leadership in providing affordable medicines. For example, the requirement that countries wishing to import from India under the WTO 30-8-2003 decision must issue a compulsory licence in every case goes far beyond the WTO decision. This requirement in the Indian Ordinance places a cumbersome and often unnecessary administrative burden on the importing country. Often, there will be no patent in the importing country and compulsory licenses are only required where a valid patent has been issued. Under the WTO Declaration on Trips and Public Health (the Doha Declaration) of November 2001, least-developed countries are not even required to issue patents in the pharmaceutical sector until 2016. In addition, the limitations under the Ordinance of the pre-grant opposition rule contained in the previous law removes an important opportunity for people living with HIV and other members of civil society to participate in an open and transparent process.

The implications of the current Ordinance are potentially devastating: the vast majority of countries hardest hit by AIDS do not have sufficient manufacturing capacity in the pharmaceutical sector and must rely upon imports from major producing countries such as India if they are to succeed in scaling up access to HIV treatment to the millions of their people in need.

Unaids strongly supports the rights of the governments to avail themselves of the flexibilities in Trips in promoting the widest possible access to affordable medicines and technologies.

Therefore, we would respectfully urge you to consider all appropriate legal means to protect and scale up access to essential affordable medicines. The Doha Declaration, in which India played an important role, makes clear that the interests of public health and equitable access to medicines for all should be primary concerns in the application of the Trips Agreement and related trade and intellectual property rules.

Unaids has learnt that a global day of action is planned for 26-2-2005 against the Indian Patent Ordinance. Civil society, organisations of people living with HIV and AIDS and the media will be watching closely. This day presents an opportunity for India to send out a strong message in support of both research innovation and access to affordable HIV-related pharmaceuticals and other essential medicines, while fully complying with the applicable multilateral trade and intellectual property agreements.

Please accept, Excellency, the assurance of my highest consideration.

Achmat Dangor

Director,

Advocacy, Communication and Leadership.

cc: Dr Prasada Rao, Unaids Regional Director, Regional Support Team, Bangkok.

Permanent Mission of India to the United Nations and other International Organizations in Geneva.”

67. It was thus under the twin pressure of time and anxiety to safeguard the public health objectives that Parliament was called upon to deliberate over the amendments required to be made in the patent law to make it fully compliant with the Trips Agreement.

68. On 18-12-2004, the Bill to further amend the Patents Act, 1970, which was materially the same as Ordinance 7 of 2004, was introduced in Parliament. The Bill evoked a highly insightful and informed debate on the subject. To anyone going through the debate on the Bill, Parliament would appear keenly alive to national interests, human rights considerations and the role of India as the producer and supplier of drugs to different parts of the world where impoverished humanity is critically in need of those drugs at cheap and affordable prices. Cutting across party lines, Member after Member from the Opposition Benches highlighted the grave risk in creating private monopolies in an area like pharmaceuticals, the abuses to which product patents in pharmaceutical products were vulnerable, and the ploys used by big companies to artificially extend the period of patent to keep competitors out and keep the prices of the patented product high. It was strongly argued that, while fulfilling its commitment under the Trips Agreement, the Government must not bring in a patent regime where all the gains achieved by the Indian pharmaceutical industry are dissipated and large sections of Indians and people in other parts of the world are left at the mercy of giant multinational pharmaceutical companies:

68.1 One of the members from the Opposition Benches said:

“Sir, even if this were a Bill, which affects only India, still it would be an extremely important one. But it is a Bill, which affects most parts of the world. We are supplying 50% of the cheapest drugs in the world to places like Papua New Guinea, Laos, Kenya, Africa, etc. All these countries have complained to WHO about this Bill.

The two biggest international health organisations in the world, namely, WHO, and the Medicines Sans Frontiers have written to the Government saying that this is a very very serious matter. This has been the subject of editorials all over the world right from America onwards to every country from Bangladesh, Cambodia, China, Indonesia, Nairobi, Korea, Laos, Thailand, Vietnam, etc. All of them have complained about our Bill. It is a Bill that affects so many parts of the world. Do you not think that we should have a slightly more serious discussion on it, rather than attempting to pass it through?”

68.2 The same Member speaking at a later stage in the debate said:

“India has benefited from the low cost generic industry to dominate 30% of the low cost drugs in the world….

Secondly, it (the Bill) is vague about the evergreening effect in which companies extend their patent rights by switching from capsules to tablets, for instance. This extends monopolies. Parliament must make sure that it protects the rights of India to make these generic drugs. We should remove the provision that allows this evergreening. … What should and what should not be patentable has also been left open to interpretation. Earlier, the new use for a substance could not be patented. Now this has been qualified to allow it by putting ‘mere new use’ instead of ‘new use’.

Sir, I am going to limit my speech to six points only. This is what we need:

1. We need to limit the scope of patentability to only new chemical entities.

2. No patents for new usage and dosage of known drugs.

3. Retain pre-grant opposition in its original form.

4. Simple procedures with a time-limit for grant of compulsory licences.

5. Immunity for generic drugs which are already available in the market.

6. Introduction of ceiling on royalty to pharmaceutical companies.”

68.3 Another Member, also from one of the parties in the Opposition, had this to say:

“Sir, a lot of things have been said for and against the Bill. Certain basic positions have to be restated even now. That is, in India, we had legislation in 1891 on the patents and designs. That was product regime, under which it had been told that in India, in relation to medicines, at that time, 85% of our medicinal requirements was met by import of medicines from abroad. In those days, probably, the transnational corporations were not as big as they are today. But even then, with the product regime that was there up to 1911, the situation in this country was such that we had to depend upon imports for the 85% of our medicinal requirements.

After 1970, when India adopted a new patent legislation, where we had adopted a process regime, the situation was reversed. This 85% of our country's medicinal requirement was met by our own products. That was a remarkable achievement. Not only that, we started exporting to countries which does not have the facility of infrastructure to produce their own medicines. We supplied medicine to meet their requirements. But will the Minister now assure that we will be able to meet our own requirements at a cheaper rate after adopting this product regime? Can it be assured that we would be able to meet the requirements of medicine of our people? Because, that was not our experience in the past. …”

68.4 It is interesting to note that in the Parliamentary debate, the names of the appellant Company (Novartis) and the drug (Gleevec) being the subject-matter of this case were repeatedly mentioned, and the excessively high price fixed for the drug after the grant of “exclusive marketing rights” to the appellant was expressly cited as the likely result of bringing in the product patent regime in pharmaceuticals. One of the Members said:

“Sir, a company which obtains a patent by changing their chemicals, before the expiry of the patent, they will again apply for a patent and again get a patent. So, in this way, they will continue to get a patent for the same medicine. For example, the drug called ‘Glevic’ (sic Gleevec/Glivec), is used for the treatment of leukaemia. It is patented by Novartis. This was originally patented in 1993. The cost of the drug for the treatment of this disease comes to about Rs 1,20,000 per month in India. At the same time, the generic versions are available in the country which cost only Rs 8000 to Rs 10,000.”

69. As the deliberations were going on in Parliament, negotiations were also held between the ruling party and some of the Opposition parties, in course of which certain amendments were suggested in the Bill. And in order to allay the apprehensions and fears voiced by the Opposition, one of the Members from the Government said:

“Madam, I am concluding. I would only like to refer to the amendment which is being incorporated in Clause 3 which talks of the known inventions, the products which are not considered to be inventions and therefore cannot be covered by the patent and patents cannot be sought for them. A good amendment is being introduced to that effect in Clause 3 of the Bill which says:

‘The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance of (sic or) the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.’

The explanation to that should completely allay the fears of our friends on the other side. I hope they would accept that.”

70. Speaking at the conclusion of the debate, the Minister who had sponsored the Bill also referred to the amendment proposed in Section 3(d). He said:

“There are so many provisions here. In regard to evergreening, I just want to read out Section 3(d) which says that a mere discovery of a new property or a new use for a known substance or the mere use of known process in a new product—these are exceptions, these will not be granted any patent—and substances obtained by a mere admixture resulting only in aggregation of properties of the components thereof or, processes of producing such substances will not be given patents….”

71. Finally, after three days of the debate (March 18, 21 and 22) the Bill, along with the amendments proposed by the Minister, was passed by the Lok Sabha on 22-3-2005. Some of the very important amendments that were incorporated in the Bill related to Section 2(1)(ja) and Section 3(d), and the insertion of the provision for pre-grant opposition to grant of patent. After being passed by the Lok Sabha, the Bill was presented in the Rajya Sabha where it was passed on 23-3-2005. It received the assent of the President on 4-4-2005, and was published in the Official Gazette of 5-4-2005.

72. Thus, after deliberations that took place for just four days, the Patents Act, 1970, came in a completely new avatar. The haste with which the Government was constrained to rush the Bill through Parliament to make the law compatible with the Trips Agreement perhaps explains the somewhat unclear drafting of some very important provisions, which called for much greater clarity; the presence of some terms and expressions in the definition section that are nowhere used in the Act; and a few loose ends that could have been properly tied up if more time and attention was given to the drafting.

The extant law

73. We have seen in some detail the “why” and the “how” of the law. Let us now examine what the law is in the light of its “why” and “how”. In order to understand the meaning of “invention” under the Patents Act, 1970, as it stands today after its amendment by the amending Act of 2005, we must refer to clauses (ac), (j) and (ja) of Section 2(1) of the Act:

“2. Definitions and interpretation.—(1) In this Act, unless the context otherwise requires—

(ac) ‘capable of industrial application’, in relation to an invention, means that the invention is capable of being made or used in an industry;

(j) ‘invention’ means a new product or process involving an inventive step and capable of industrial application;

(ja) ‘inventive step’ means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;”

74. Section 2(1)(j) requires a product to satisfy three conditions to qualify as an invention:

(i) It must be “new”, that is to say it must not have been anticipated;

(ii) Its coming into being must involve an “inventive step”; and

(iii) It must be “capable of industrial application”, that is to say it must be capable of being made or used in an industry [Section 2(1)(ac)].

75. “Inventive step” is separately defined in Section 2(ja) to mean a feature of an invention that involves technical advance as compared to the existing knowledge, or having economic significance or both and that makes the invention not obvious to a person skilled in the art. To paraphrase, the invention that creates the product must have a feature that involves technical Edn. 1998 advance as compared to the existing knowledge or having economic significance or both and this feature should be such as to make the invention not obvious to a person skilled in the art.

76. On a combined reading of clauses (j), (ac) and (ja) of Section 2(1), in order to qualify as “invention”, a product must, therefore, satisfy the following tests:

(i) It must be “new”;

(ii) It must be “capable of being made or used in an industry”;

(iii) It must come into being as a result of an invention which has a feature that:

(a) entails technical advance over existing knowledge;

or

(b) has an economic significance;

and

(c) makes the invention not obvious to a person skilled in the art.

77. We have seen the meaning of “invention”; we have also seen earlier that the Patents Act, 1970, dealt with “invention” and “patentability” as two distinctly separate concepts. The duality of the two concepts is best illustrated by Section 4 of the Act, which prohibits the grant of patent (either process or product) “in respect of inventions relating to atomic energy falling within sub-section (1) of Section 20 of the Atomic Energy Act, 1962”, and which has not undergone any change since inception. It is, therefore, fundamental that for grant of patent the subject must satisfy the twin tests of “invention” and “patentability”. Something may be an “invention” as the term is generally understood and yet it may not qualify as an “invention” for the purposes of the Act. Further, something may even qualify as an “invention” as defined under the Act and yet may be denied patent for other larger considerations as may be stipulated in the Act. Having, therefore, seen the meaning of “invention”, we may now advert to Section 3 as it stands after the amendment of the Act in 2005.

78. Section 3 is in Chapter II of the Act, which initially contained Sections 3, 4 and 5, but after the deletion of Section 5 with effect from 1-1-2005, Chapter II has only two sections: Sections 3 and 4. The Chapter has the heading “Inventions not patentable” and Section 3 has the marginal heading “What are not inventions”. As suggested by the chapter heading and the marginal heading of Section 3, and as may be seen simply by going through Section 3, it puts at one place provisions of two different kinds: one that declares that certain things shall not be deemed to be “inventions” [for instance clauses (d) and (e)]; and the other that provides that, though resulting from invention, something may yet not be granted patent for other considerations [for instance clause (b)].

79. For the purpose of these appeals, however, we need only to focus on clause (d) of Section 3.

80. We have seen earlier that, in course of the debate in Parliament, an amendment (by way of addition) in clause (d) of Section 3 was proposed by the Government in order to allay the fears of the Members from the Opposition concerning the introduction of product patents for pharmaceuticals and agricultural chemicals, and it was on the Government's assurance that the proposed amendment in Section 3(d) (besides some other changes in the Act) would take care of the apprehensions about the abuse of product patent in medicines and agricultural chemical substances that the Bill was passed by Parliament. We once again examine here what was the amendment introduced in Section 3(d) by the amending Act of 2005:

80.1 Immediately before its amendment in 2005, Section 3(d) was, in the Patents (Amendment) Ordinance, 2004 (Ordinance 7 of 2004), as under:

“3. What are not inventions.—The following are not inventions within the meaning of this Act—

(d) the mere discovery of any new property or mere new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant;”

(emphasis supplied)

80.2 After the amendment with effect from 1-1-2005, Section 3(d) stands as under:

“3. What are not inventions.—The following are not inventions within the meaning of this Act—

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;”

(emphasis supplied)

80.3 As may be seen, the amendment:

(i) adds the words “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or” at the beginning of the provision;

(ii) deletes the word “mere” before “new use”; and

(iii) adds an explanation at the end of the clause.

81. A perusal of the Parliamentary debate would further reveal that the whole debate centred on medicines and drugs. It would not be an exaggeration to say that eighty per cent of the debate was focused on medicines and drugs and the remaining twenty per cent on agricultural chemicals. In the entire debate, no substance of any other kind came under discussion.

82. The aforementioned amendment in Section 3(d) is one of the most crucial amendments that saw the Bill through Parliament and, as noted, the amendment is primarily in respect of medicines and drugs and, to some extent, agricultural chemical substances.

83. In regard to Section 3(d) both Mr Andhyarujina and Mr Subramanium, learned counsel appearing for the appellant, strenuously argued that Section 3(d) is not meant to be an exception to clauses (j) and (ja) of Section 2(1) of the Act. Both the learned counsel insisted that Section 3(d) has no application to the case of the subject product. The subject product, having satisfied the tests of invention as provided in clauses (j) and (ja) of Section 2(1), cannot be denied patent for allegedly failing to satisfy the tests under Section 3(d). Mr Andhyarujina submitted that Section 3(d) is a provision put in ex abundanti cautela non nocet to remove all doubts.

84. Mr Subramanium submitted that Section 3(d) is ex majore cautela. The learned counsel submitted that the primary purpose of Section 3(d), as is evidenced from the legislative history, is to prevent “evergreening” and yet to encourage incremental inventions. “Evergreening” is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee's exclusive rights over the product, preventing competition. Mr Subramanium submitted that, by definition, a trifling change, or in the words of the section “a mere discovery of a new form of a known substance”, can never ordinarily meet the threshold of novelty and inventive step under clauses (j) and (ja) of Section 2(1). An invention cannot be characterised by the word “mere”. The word “invention” is distinct from the word “discovery”. He, therefore, submitted that Section 3(d) operates only as ex majore cautela, ensuring that mere discoveries can never, by an effort at interpretation of clauses (j) and (ja) of Section 2(1), be considered inventions.

85. In regard to the concerns about public health issues and the flexibility of the Trips Agreement coupled with the Doha Declaration, allowing the scope to address the issues of public health, Mr Subramanium submitted that those concerns are addressed in the Act, in provisions relating to compulsory licensing, revocation of patents, and the multiple stages for opposition to the grant of patent.

86. The submission may appear plausible if the scrutiny of the law is confined only to the Act as it stands today after undergoing the amendments in 2005. But examined in the larger perspective of the development of the law of patent over the past 100 years and especially keeping in mind the debates in Parliament preceding the 2005 amendment, it would appear completely unacceptable. We find no force in this submission that Section 3(d) is a provision ex majore cautela. To our mind, the submission completely misses the vital distinction between the concepts of invention and patentability—a distinction that was at the heart of the Patents Act as it was framed in 1970, and which is reinforced by the 2005 Amendment in Section 3(d).

87. We are clearly of the view that the importance of the amendment made in Section 3(d), that is, the addition of the opening words in the substantive provision and the insertion of the Explanation to the substantive provision, cannot be underestimated. It is seen above that, in course of the Parliamentary debates, the amendment in Section 3(d) was the only provision cited by the Government to allay the fears of the Opposition members concerning the abuses to which a product patent in medicines may be vulnerable. We have, therefore, no doubt that the amendment/addition made in Section 3(d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products. The amended portion of Section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.

88. We have so far seen Section 3(d) as representing “patentability”, a concept distinct and separate from “invention”. But if clause (d) is isolated from the rest of Section 3, and the legislative history behind the incorporation of Chapter II in the Patents Act, 1970, is disregarded, then it is possible to see Section 3(d) as an extension of the definition of “invention” and to link Section 3(d) with clauses (j) and (ja) of Section 2(1). In that case, on reading clauses (j) and (ja) of Section 2(1) with Section 3(d) it would appear that the Act sets different standards for qualifying as “inventions” things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in Section 3(d) in the year 2005.

The Zimmermann Patent: Contentions of the appellant

89. Admittedly, the genesis of this patent application lies in one of the derivatives of N-phenyl-2-pyrimidine-amine in free base called Imatinib, vide Example 21 of the Zimmermann Patent. According to the appellant, beginning with Imatinib, the subject product i.e Imatinib Mesylate in beta crystalline form, was brought into being by not one but two inventions.

90. The first invention lies in selecting Example 21 out of the 37 examples given in the Zimmermann Patent and then choosing methanesulfonic acid to produce the methanesulfonic acid addition salt of the free base Imatinib, called Imatinib Mesylate. It was emphasised by both Mr Gopal Subramanium and Mr Andhyarujina, Senior Advocates appearing for the appellant, that the Zimmermann Patent did not teach or suggest to a person skilled in the art to select Example 21 in preference to other compounds of which examples were given in the Zimmermann Patent. Further, even if Example 21 was selected, the Zimmermann Patent did not teach a person to select one particular salt. The Zimmermann Patent did not teach a person how to prepare Mesylate salt of Example 21. Hence, the coming into being of Imatinib Mesylate from Imatinib in free base was the result of an invention that involved technical advance as compared to the existing knowledge and brought into existence a new substance.

91. In the second invention, the appellant arrived at the beta crystalline form of methanesulfonic acid addition salt of Imatinib. It was contended on behalf of the appellant that once the salt form of Imatinib was arrived at, the inventors had to further research to be able to ensure that that particular salt form of Imatinib is suitable for administration in a solid oral dosage form. This research further required defining the process parameters that brought into being the beta crystalline form of Imatinib Mesylate. It was argued on behalf of the appellant that there is certainly no mention of polymorphism or crystalline structure in the Zimmermann Patent. The relevant crystalline form of the salt that was synthesised needed to be invented. There was no way of predicting that the beta crystalline form of Imatinib Mesylate would possess the characteristics that would make it orally administrable to humans without going through the inventive steps. It was further argued that the Zimmermann Patent only described, at most, how to prepare Imatinib free base, and that this free base would have anti-tumour properties with respect to the BCR ABL kinase. Thus, arriving at the beta crystalline form of Imatinib Mesylate for a viable treatment of chronic myeloid leukaemia required further invention—not one but two, starting from Imatinib in free base form, as stated above.

92. The subject product admittedly emerges from the Zimmermann Patent. Hence, in order to test the correctness of the claim made on behalf of the appellant, that the subject product is brought into being through inventive research, we need to examine in some detail the Zimmermann Patent and certain developments that took place on that basis.

93. An application for grant of patent for the Zimmermann invention (pyrimidine derivatives and processes for the preparation thereof) was filed in the United States of America on 2-4-1993, by Ciba Geigy In 1996 (US Patent Application No. 08/042, 322). This application was abandoned and another continuation-in-part application was then filed on 28-4-1994 (US Patent Application No. 5,521,184). The Zimmermann invention related to N-phenyl-2-pyrimidine-amine derivatives (called “Formula I” in the patent application), and the compounds thereof, the process for their preparation, and to their therapeutic uses:

93.1 In the patent application, it was expressly stated that the compounds of Formula I included their respective salts:

“Salt-forming groups in a compound of Formula I are groups or radicals having basic or acidic properties. Compounds having at least one basic group or at least one basic radical, for example a free amino group, a pyrazinyl radical or a pyridyl radical, may form acid addition salts, for example with inorganic acids, such as hydrochloric acid, sulphuric acid or a phosphoric acid, or with suitable organic carboxylic or sulfonic acids….”

(emphasis supplied)

93.2 Further:

“Owing to the close relationship between the novel compounds in free form and in the form of their salts, including those salts that can be used as intermediates, for example in the purification of the novel compounds or for the identification thereof, hereinbefore and hereinafter any reference to the free compounds should be understood as including the corresponding salts, where appropriate and expedient.”

(emphasis supplied)

93.3 As regards the pharmacological properties of the compounds of Formula I it was stated in the application:

“The compounds of Formula I have valuable pharmacological properties and can be used, for example, as anti-tumoral drugs and as drags (sic drugs) against atherosclerosis.”

93.4 The application also described the tests undertaken for determining the protein kinase C-inhibiting activities of compounds of Formula I and their pharmaceutically acceptable salts as follows:

“To determine protein kinase C-inhibiting activity, protein kinase C from pig brain purified in accordance with the procedure described by T. Uchida and C.R Filburn in J. Biol. Chem. 259, 12311-4 (1984) is used. The protein kinase C-inhibiting activity of the compounds of Formula I is determined by the method of D. Fabbro et al., Arch. Biochem. Biophys. 239, 102-111 (1985). In that test the compounds of Formula I inhibit protein kinase C at a concentration IC50 of as low as approximately from 0.1 to 10 μmol/liter, especially approximately from 0.05 to 5 μmol/liter. On the other hand, the compounds of Formula I inhibit other enzymes, for example protein kinase A, phosphorylase protein kinase and certain types of tyrosine protein kinase, for example the tyrosine protein kinase of EGF (epidermal growth factor) receptors, only at a far higher concentration, for example 100 times higher. That is an indication of the selectivity of the compounds of Formula I. With a view to reducing undesired side-effects, it is important for the protein kinase C-inhibitors to be as selective as possible i.e inter alia to have as little effect as possible on other enzymes, especially when the effect of the activity of those other enzymes has no equivalent or synergistic effect on the disease to be treated.

As might already be expected on the basis of the inhibiting action on protein kinase C described above, the compounds of Formula I wherein R4 and R8 are hydrogen, and their pharmaceutically acceptable salts, have anti-proliferative properties which can be demonstrated directly in the following, different test. In that test the inhibiting action of compounds of Formula I on the growth of human T24 bladder carcinoma cells is determined.”

93.5 It was also stated:

“The tumour-inhibiting activity of the compounds of Formula I can also be demonstrated in vivo.

The tumour-inhibiting activity is determined using female Balb/c nude mice in which human T24 bladder carcinoma has been transplanted.”

93.6 The application further claimed:

“Owing to the properties described, compounds of Formula I can be used not only as tumour-inhibiting active ingredients but also as drugs against non-malignant proliferative diseases e.g atherosclerosis, thrombosis, psoriasis, sclerodermitis and fibrosis. They are also suitable for the further applications mentioned above for protein kinase C-modulators and can be used especially in the treatment of diseases that respond to the inhibition of PDGF-receptor kinase.

Some of the compounds of Formula I e.g N-[3-(1, 1, 2, 2-tetrafluoroethoxy)phenyl]-4-(3-indolyl)-2-pyrimidine-amine, furthermore inhibit the tyrosine kinase activity of the receptor for the epidermal growth factor (EGF). This receptor-specific enzyme activity is a key factor in the signal transmission in a host of mammalian cells, including human cells, especially epithelial cells, cells of the immune system and cells of the central and peripheral nervous system.”

93.7 It was also said in the application:

“These compounds of Formula I, which inhibit the tyrosine kinase activity of the receptor for the epidermal growth factor (EGF) are therefore useful, inter alia, for the treatment of benign or malignant tumours. They are able to effect tumour regression and to prevent metastasic spread and the growth of micrometastases. In particular, they can be used for treating epidermal hyperproliferation (psoriasis), for treating neoplasms of epithelial character e.g mastocarcinomas, and leukaemias. In addition, the compounds of Formula I are useful for treating diseases of the immune system and inflammations, subject to the involvement of protein kinases. These compounds of Formula I can also be used for treating diseases of the central or peripheral nervous system, subject to the involvement of signal transmission by protein kinases.”

93.8 It was further stated in the application:

“Acid addition salts can be convened into the free compounds in customary manner, for example by treatment with a suitable basic agent.

The processes described above, including the processes for removing protecting groups and the additional process steps, are, unless otherwise indicated, carried out in a manner known per se, for example in the presence or absence of preferably inert solvents and diluents, if necessary in the presence of condensation agents or catalysts….”

(emphasis supplied)

93.9 It was also affirmed in the application:

“The invention relates also to a method of treating warm-blooded animals suffering from a tumoral disease, which comprises administering to warm-blooded animals requiring such treatment an effective, tumour-inhibiting amount of a compound of Formula I or of a pharmaceutically acceptable salt thereof…. Effective doses, for example daily doses of approximately from 1 to 1000 mg, especially from 50 to 500 mg, are administered to a warm-blooded animal of approximately 70 kg body weight according to species, age, individual condition, mode of administration and the individual syndrome.

The invention relates also to pharmaceutical compositions comprising an effective amount, especially an amount effective in the prevention or therapy of one of the abovementioned diseases, of the active ingredient together with pharmaceutically acceptable carriers that are suitable for topical, enteral, for example oral or rectal, or parenteral administration, and may be inorganic or organic, solid or liquid. For oral administration there are used especially tablets or gelatin capsules comprising the active ingredient together with diluents, for example lactose, dextrose, sucrose, mannitol, sorbitol, cellulose and/or glycerol.… Tablets may also comprise binders, for example magnesium aluminium silicate, starches, such as corn, wheat or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone, and, if desired, disintegrators, for example starches, agar, alginic acid or a salt thereof, such as sodium alginate, and/or effervescent mixtures, or adsorbents, dyes, flavourings and sweeteners.”

(emphasis supplied)

93.10 The application gave examples to illustrate the invention, making it clear at the same time that those illustrations did not limit the invention in any way. Example 21, which admittedly relates to Imatinib, the “e-duct” for the subject product, is as under:

“Example 21

Analogously to Example 20, N-{5-[4-(4-methyl-piperazinomethyl)-benzoylamido]-2-methylphenyl}-4-(3-pyridyl)-2-pyrimidine-amine is prepared from 10.68 g (32.8 mmol) of 4-(4-methyl-piperazinomethyl)-benzoyl chloride; m.p 211°-213°, Rf=0.33 (methylene chloride:methanol:25% aqueous ammonia solution=95:5:1).”

Examples 35 to 37 were in respect of tablets in different doses.

93.11 In the claim at the end of the application under Serial No. 23, it was stated as follows:

“The compound according to Claim 1 of the Formula I, said compound being N-{5-[4-(4-Methyl-piperazino-methyl)-benzoylamido]-2-methyl-phenyl}-4-(3-pyridyl)-2-pyrimidine-amine or a pharmaceutically acceptable salt thereof.”

(emphasis supplied)

94. The US Patent No. 5,521,184 (the Zimmermann Patent) was granted on 28-5-1996.

95. Later, the appellant made the application for patent for the beta crystalline form of Imatinib Mesylate (the subject of the present appeals) in the US on 18-1-2000. The US patent for beta crystalline form of Imatinib Mesylate was granted to the appellant about five-and-a-half years later on 17-5-2005 following the order of the US Appellate Court dated 23-11-2003. It is, however, interesting to note that Gleevec, the drug was launched much earlier in the market, on the basis of the Zimmermann Patent itself.

96. On 9-4-1998, the appellant filed the investigational new drug application (IND # 55,666) for Gleevec and on 27-2-2001, the original new drug application (NDA # 21-335) before the Food and Drug Administration (FDA), USA, for Imatinib Mesylate, formerly STI571, CGP57148B (capsules) for the treatment of patients with chronic myeloid leukaemia. The application contained results of extensive preclinical, technical and clinical research, and it stated as under:

“The clinical studies discussed in this NDA include one multiple dose tolerability/dose-finding study (Phase I) and three large open, uncontrolled efficacy and safety studies (Phase II), as an accelerated development to allow early registration in CML patients. A total of 1234 patients with CML and other Ph+ leukaemias have been enrolled in these trials. The results of the Glivec studies are discussed in the perspective of the current state of knowledge in the treatment of CML as described with a comprehensive review of the literature for each target population (Appendix 4-6 of the Integrated Summary of Efficacy).”

97. In the patent information furnished in connection with the NDA as required under (US Code) 21 C.F.R § 314.53, the active ingredient of the drug was stated as Imatinib Mesylate. The drug substance (active ingredient), drug product (composition/formulation) and method of use were declared to be covered by the US Patent No. 5,521,184 (i.e the Zimmermann Patent). It was further declared that the United States Patent No. 5,521,184 covered the composition, formulation, and/or method of use of Imatinib Mesylate (STI571).

98. In the chemistry review(s) of the NDA # 21-335 (drug approval for capsules) made on 27-3-2001, there was again a reference to the US Patent No. 5,521,184 (expiration date—28-5-2013).

99. The FDA approval for the drug Gleevec (Imatinib Mesylate) 50 mg and 100 mg capsules was granted vide letter dated 10-5-2001. Following this, the drug was commercially launched in the market long before the grant of patent for beta crystalline form of Imatinib Mesylate.

100. In the package insert of Gleevec™ (Imatinib Mesylate capsules) the description of the drug was stated as follows:

“Gleevec™ capsules contain Imatinib Mesylate equivalent to 100 mg of Imatinib free base. Imatinib Mesylate is designed chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate….”

101. After the grant of drug approval for Gleevec, on 3-7-2001, the appellant made a patent term extension application for the Zimmermann Patent (US Patent No. 5,521,184) under 35 U.S.C § 156(g)(1)(B), for extending the term of the patent for the time taken in the regulatory review for Gleevec. This application leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann Patent. In Column 4 of the application, it was stated that the sole active ingredient in Gleevec is Imatinib Mesylate. Further, it was stated that Imatinib, or any salt thereof, including Imatinib Mesylate, had not previously been approved for commercial marketing under the Federal Food, Drug and Cosmetic Act prior to the approval of NDA # 21-235. In Column 9 of the application, it was stated as under:

“(9) Statement showing how the claims of the patent for which extension is sought cover the approved product:

The operative claims in question are Claims 1-5, 10-13, and 21-23. Each of Claims 1-5, 10-13 and 23 claim a compound or compounds which include the approved product, Imatinib Mesylate. Claim 21 claims a composition containing a compound or compounds which include the approved product, Imatinib Mesylate. Claim 22 claims a method of treating tumors in warm-blooded animals with a compound or compounds which include the approved product, Imatinib Mesylate.”

(emphasis supplied)

102. The application was accepted and the term of the patent, which was due to expire on 28-5-2013, was extended for the period of 586 days.

103. It is noted above that the appellant had made Application No. 09/463,097 in USA for grant of patent for beta crystalline form of Imatinib Mesylate. The application was rejected by the examiner and, against the examiner's decision, the appellant preferred an appeal (that is, Appeal No. 2003-0919) before the Board of Patent Appeals and Interferences. The Board of Patent Appeals, by its judgment and order dated 23-11-2003, allowed the appellant's appeal and reversed the examiner's decision, rejecting Claims 1 through 8, 10, and 13 through 16. Dealing with the examiner's rejection of the appellant's Claim 14 under 35 U.S.C § 112, the Board of Patent Appeals referred to Claims 21 and 22 of the Zimmermann Patent. With reference to those claims in the Zimmermann Patent, the Board of Patent Appeals observed and held as under:

“Under the provisions 35 U.S.C § 282, a patent shall be presumed valid; and each claim of a patent shall be presumed valid independently of the validity of other claims.

Accordingly, Claims 21 and 22 of the US Patent No. 5,521,184 (the Zimmermann Patent), shall be presumed valid. We may presume, therefore, that Claims 21 and 22 are based on an enabling disclosure; and that the specification of the Zimmermann Patent teaches any person skilled in the art how to use a compound of Formula I, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. In Claim 23, Zimmermann recites Imatinib, a specific compound within the scope of Formula I, or a pharmaceutically acceptable salt thereof. In light of 35 U.S.C § 282, therefore, we may presume that the specification of the Zimmermann Patent teaches any person skilled in the art how to use Imatinib, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. On these facts, we disagree that the examiner has set forth adequate reasons or evidence to doubt the objective truth of statements in the applicants' specification that an effective amount of the ß crystal form of Imatinib Mesylate may be administered to a patient as the manipulative step in a method for treating tumour disease in a patient.

The rejection under 35 U.S.C § 112, first paragraph, is reversed.”

(emphasis supplied)

From the above passage from the judgment, it is evident that, according to the US Board of Patent Appeals, the Zimmermann Patent teaches any person skilled in the art how to use Imatinib, a compound of Formula I, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. However, the US Board of Patent Appeals held that the teaching in the Zimmermann Patent did not go beyond Imatinib Mesylate and did not extend to the beta crystalline form of Imatinib Mesylate, which represented a manipulative step in a method of treating tumor disease in a patient.

104. Further, Natco Pharma Ltd., one of the objectors to the grant of patent to the appellant in this country, had marketed a drug called Veenat 100 (capsules) in UK. A legal notice on behalf of the appellant was given to Natco Pharma Ltd. on 13-2-2004. The notice stated that the appellant was the proprietor of the European patent EP-A-0 564 409 (the Zimmermann Patent) and that this patent claimed, among other things, the compound Imatinib and acid addition salts of that compound such as the Mesylate salt. In the notice it was pointed out that Natco Pharma Ltd. was selling, in the UK market, Veenat 100 capsules, the active pharmaceutical ingredient of which was Imatinib Mesylate as claimed in the Zimmermann Patent. The importation, sale and offer to sell Veenat 100 capsules in the UK market infringed the Zimmermann Patent and Natco Pharma Ltd. was therefore warned to immediately cease the importation, sale and promotion of Veenat 100 capsules and other pharmaceutically substances containing “Imatinib”. The matter was finally settled out of court, we are told, at considerable expense to Natco Pharma Ltd. which of course had to stop marketing its drug Veenat 100 capsules in UK.

105. From the above discussion it would be clear that the drug Gleevec directly emanates from the Zimmermann Patent and comes to the market for commercial sale. Since the grant of the Zimmermann Patent, the appellant has maintained that Gleevec (that is, Imatinib Mesylate) is part of the Zimmermann Patent. It obtained drug approval for Gleevec on that basis. It claimed extension of the term of the Zimmermann Patent for the period of regulatory review for Gleevec, and it successfully stopped Natco Pharma Ltd. from marketing its drug in UK on the basis of the Zimmermann Patent. Not only the appellant but the US Board of Patent Appeals, in its judgment granting patent for beta crystalline form of Imatinib Mesylate, proceeded on the basis that though the beta crystalline form might not have been covered by the Zimmermann Patent, the Zimmermann Patent had the teaching for the making of Imatinib Mesylate from Imatinib, and for its use in a pharmacological compositions for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. This finding was recorded by the US Board of Patent Appeals, in the case of the appellant itself, on the very same issue that is now under consideration. The appellant is, therefore, fully bound by the finding and cannot be heard to take any contrary plea.

106. We have looked, so far, at the Zimmermann Patent and the developments that have taken place on its basis. We now propose to take a look at certain publications.

107. A journal called Cancer Research, in its issue of January 1996, published an article under the title “Inhibition of the Abl Protein-Tyrosine Kinase in Vitro and in Vivo by a 2-Phenylaminopyrimidine Derivative”. This article was authored by several people, including Jürg Zimmermann. In this article there is a detailed discussion about the anti-tumoral properties of Imatinib and its methanesulfonate salt i.e Imatinib Mesylate. In the abstract at the beginning of the article, it is stated as under:

“Abstract

Oncogenic activation of Abl proteins due to structural modifications can occur as a result of viral transduction or chromosomal translocation. The tyrosine protein kinase activity of oncogenic Abl proteins is known to be essential for their transforming activity. Therefore, we have attempted to identify selective inhibitors of the Abl tyrosine protein kinase. Herein we describe an inhibitor (CGP 57148) of the Abl and platelet-derived growth factor (PDGF) receptor protein-tyrosine kinases from the 2-phenylaminopyrimidine class, which is highly active in vitro and in vivo. Submicromolar concentrations of the compound inhibited both v-abl and PDGF receptor autophosphorylation and PDGF-induced c-fos mRNA expression selectively in intact cells. … Furthermore, anchorage-independent growth of v-abl- and v-sis-transformed BALB/c 3T3 cells was inhibited potently by CGP 57148. When tested in vivo, CGP 57148 showed anti-tumor activity at tolerated doses against tumorigenic v-abl- and v-sis-transformed BALB/c 3T3 cells. In contrast, CGP 57148 had no anti-tumor activity when tested using src-transformed BALB/c 3T3 cells. These findings suggest that CGP 57148 may have therapeutic potential for the treatment of diseases that involve abnormal cellular proliferation induced by Abl protein-tyrosine kinase deregulation or PDGF receptor activation.”

(emphasis supplied)

108. Under the heading “materials and methods”, it is stated as under:

“Materials. CGP 57148 and its methane sulfonate salt (CGP 57148B) were synthesized by CIBA Pharmaceuticals Division, as will be described elsewhere. For in vitro and cellular assays, a stock concentration of 10 mM CGP 57148 was prepared in Me2SO and stored at—20°C. No significant difference in results could be seen between the two forms of CGP 57148. The form used in in vitro experiments is indicated in the text and legends. All in vivo experiments were performed using CGP 57148B. …”

109. The article goes on to discuss the in vivo experiments and the in vitro selectivity of CGP 57148 for inhibition of protein kinases: identification of CGP 57148 as an inhibitor of v-abl kinase. The article also discussed the in vivo anti-tumour activity of CGP 57148B and it states as follows:

“In vivo anti-tumor activity.

The maximally tolerated dose for a single p.o or i.p administration of CGP 57148B in BALB/c mice was >500 mg/kg. BALB/c AMuL V and BALB/c 3T3 v-sis cells, which were sensitive in the colony-forming assay, were used to test CGP 57148B for anti-tumor activity in female BALB/c nude mice. Once daily i.p applications of 50, 12.5, or 3.13 mg/kg CGP 57148B given for 30 consecutive days resulted in a strong anti-tumor effect against AMuLV-transformed BALB/c 3T3 tumors (Fig. 5A). Similarly, anti-tumor experiments using v-sis-transformed BALB/c 3T3 cells revealed dose-dependent anti-tumor activity (Fig. 5B). Maximal T/C (X100%) values of 4% (AMuL V tumors) and 11% (v-sis tumors) were obtained when CGP 57148B was administered at 50mg/kg body weight. In contrast, CGP 57148B showed no anti-tumor activity against tumors derived from NIH-527src cells when 50 mg/kg were administered p.o once daily for 30 days (T/C, 102%). Using the same route of application, T/C values of 7 and 22% against AMuL V and v-sis tumors, respectively, were obtained when 50 mg/kg CGP 57148B were given.”

It is further stated in the article:

“CGP 57148 selectively inhibited the in vitro activity of the v-Abl protein-tyrosine kinase and showed preferential inhibition of v-Abl autophosphorylation in cells. We have examined the specificity of CGP 57148 by analyzing its effects on signal transduction via different tyrosine kinase receptor-mediated pathways. Although the ligand-induced activation of the EGF, bFGF, insulin, and IGF-1 receptor tyrosine kinases were not affected by CGP 57148, the PDGF pathway was sensitive to inhibition by the compound. The anti-proliferative activity of CGP 57148 against both v-abl- and v-sis-transformed BALB/c 3T3 support the selectivity profile of CGP 57148 further.”

The article concludes by observing as follows:

“The reported findings with CGP 57148 suggest that it may be a development candidate for use in the treatment of Philadelphia chromosome-positive leukaemias. Additional potential applications for CGP 57148 may include proliferative diseases that involve abnormal PDGF receptor activation.”

110. Another article was published in Nature Medicine magazine of the year 1996 under the title “Effects of a Selective Inhibitor of the Abl Tyrosine Kinase on the Growth of Bcr-Abl Positive Cells”. This article, too, was authored by several people, including Jürg Zimmermann. In this article also, there is a discussion about Imatinib as a compound designed to inhibit Abl protein tyrosine kinase.

111. In the face of the materials referred to above, we are completely unable to see how Imatinib Mesylate can be said to be a new product, having come into being through an “invention” that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art. Imatinib Mesylate is all there in the Zimmermann Patent. It is a known substance from the Zimmermann Patent.

112. That Imatinib Mesylate is fully part of the Zimmermann Patent is also borne out from another circumstance. It may be noted that after the Zimmermann Patent, the appellant applied for, and in several cases obtained, patents in the US not only for the beta and alpha crystalline forms of Imatinib Mesylate, but also for Imatinib in a number of different forms. The appellant, however, never asked for any patent for Imatinib Mesylate in non-crystalline form, for the simple reason that it had always maintained that Imatinib Mesylate is fully a part of the Zimmermann Patent and does not call for any separate patent.

113. We thus find no force in the submission that the development of Imatinib Mesylate from Imatinib is outside the Zimmermann Patent and constitutes an invention as understood in the law of patent in India.

114. Mr Andhyarujina and Mr Gopal Subramanium, learned Senior Advocates appearing for the appellant, strenuously argued that the patent information furnished by the appellant before the US FDA, or its patent term extension application, or the legal notice given at its behest to Natco Pharma Ltd. should not be construed to mean that Imatinib Mesylate was anticipated in the Zimmermann Patent. Mr Andhyarujina submitted that the Zimmermann Patent did not disclose Imatinib Mesylate. That the Zimmermann Patent did not describe any working method for converting Imatinib to Imatinib Mesylate. It only stated that a salt may be formed by acid without disclosing any method, but simply calling the method to be “per se”. The Zimmermann Patent mentioned multiple choices of compounds including Imatinib free base but not any salt of any compound, much less Imatinib Mesylate. Mr Andhyarujina further submitted that it is well settled that the disclosure of an invention must be in a manner clear enough and complete enough for the invention to be performed by a person skilled in the art (Terrell on Law of Patents, 16th Edn., p. 51, Para 3.2/7). The learned counsel further submitted that there was a difference between that which is covered and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann Patent but not disclosed therein. He further submitted that, in any case, in patent law subsequent conduct of the patentee is irrelevant in construing the patent [Terrell on Law of Patent, 16th Edn., p. 192 citing Glaverbel S.A v. British Coal Corpn. (No. 2) 1993 RPC 90]. Referring to the two articles in Cancer Research and Nature Medicine, Mr Andhyarujina submitted that though in the first article there was a reference to Imatinib Mesylate, there was no teaching as to how it is to be prepared. In the Nature Medicine article there was no reference to Imatinib Mesylate but only to Imatinib.

115. Mr Gopal Subramanium submitted that the Zimmermann Patent is a patent for “pyrimidine derivatives and processes for the preparation thereof”. The patent is related to a genus of compounds, and each of the compounds within the genus shares a common chemical structure (Markush structure) and common properties with respect to the inhibition of certain tyrosine kinases (there being a total of 518 kinases in existence). Mr Subramanium further submitted that the appellant in its application before the US Food and Drug Administration Authority had made a reasonable assertion that the Zimmermann Patent covers the product that was made out of the beta crystalline form of Imatinib Mesylate i.e Gleevec. Further, on the basis of the US FDA approval, the appellant obtained an extension of the period of protection under the Zimmermann Patent with respect to Gleevec.

116. Mr Subramanium further submitted that the scope of coverage is distinct from the scope of disclosure in a patent. Imatinib Mesylate could be said to be not new and known from the Zimmermann Patent only in case there was a complete disclosure of the method of its preparation in the Zimmermann Patent. The learned counsel strongly contended that coverage under a patent of the Markush kind cannot lead to any presumption of disclosure, much less any enabling disclosure of all the compounds within the genus. The learned counsel further contended that coverage that is granted in respect of a patent is not always coextensive with what is disclosed in that patent. In certain circumstances, where it is a pioneering invention (as in the case of the Zimmermann invention), the patent may be entitled to larger coverage than what is specifically disclosed in it. The learned counsel argued that coverage cannot be used to presume an enabling disclosure of the beta crystalline form of Imatinib Mesylate in the Zimmermann Patent. Disclosure in a specification can never be presumed, and that is a question of the clear teaching contained in the specification. The teaching of a patent lies in the disclosure/specification that supports the claim. The disclosure describes the invention. The claim defines through language the various ways the invention could be used i.e possible but not actualised products. This is the scope of protection granted under the patent. For the purpose of prior art, it is the disclosure in the specification supporting the claim and not the written description or the claims themselves, that must be assessed. The claim can never be the teaching. He further contended that it would be wrong to say that the appellant's claims for beta crystalline form of Imatinib Mesylate is a case of double or repeat patenting, that is, the same invention is being sought to be patented twice. The claim for patent for beta crystalline form of Imatinib Mesylate relates to a second and different invention. Though the invention in the first part (Imatinib) may be necessary to arrive at the invention in the second part, the final product does not come into existence without inventions. The principle is that if a product is covered, it means that it infringes a patent. Whether the patent infringed disclosed every aspect of the product in its specification is a separate inquiry.

117. Mr Subramanium maintained that the boundary of the Zimmermann Patent was extended up to Imatinib Mesylate but the enablement or disclosure made therein ended at Imatinib. He submitted that it was possible for Zimmermann himself, or for anyone else, to invent Imatinib Mesylate starting from Imatinib. The inventor of Imatinib Mesylate, be it Zimmermann or anyone else, would also be entitled to get patent for Imatinib Mesylate, but in case the inventor was anyone other than Zimmermann, he would require Zimmermann's permission for marketing Imatinib Mesylate, since Imatinib had the protection of the Zimmermann Patent.

118. The submissions of Mr Andhyarujina and Mr Subramanium are based on making a distinction between the coverage or claim in a patent and the disclosure made therein. The submissions on behalf of the appellant can be summed up by saying that the boundary laid out by the claim for coverage is permissible to be much wider than the disclosure/enablement/teaching in a patent.

119. The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.

120. In India, Section 10(4) of the Patents Act, 1970 mandates:

“10. Contents of specifications.—(1)-(3) ***

(4) Every complete specification shall—

(a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed;

(b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and

(c) end with a claim or claims defining the scope of the invention for which protection is claimed;

(d) be accompanied by an abstract to provide technical information on the invention:

Provided that—

(i) the Controller may amend the abstract for providing better information to third parties; …”

And, Section 10(5) provides as under:

“10. (5) The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification.”

121. The UK Patents Act, 1977, in sub-sections (2), (3) and (5) of Section 14, provides as under:

“14. Making of an application.—(1)-(1-A) ***

(2) Every application for a patent shall contain—

(a) a request for the grant of a patent;

(b) a specification containing a description of the invention, a claim or claims and any drawing referred to in the description or any claim; and

(c) an abstract,

but the foregoing provision shall not prevent an application being initiated by documents complying with Section 15(1) below.

(3) The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.

(5) The claim or claims shall—

(a) define the matter for which the applicant seeks protection;

(b) be clear and concise;

(c) be supported by the description; and

(d) relate to one invention or to a group of inventions which are so linked as to form a single inventive concept.”

122. Further, Section 112(a) of the Title 35 of the US Code provides as under:

“35 U.S.C § 112

(a) In general.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.”

123. Terrell on Law of Patents (17th Edn., 2011) in Chapter 9: “Construction of the Specification and Claims”, under the heading “Principles equally applicable to infringement and validity” states:

“9.05.—Section 125(1) defines an ‘invention’ as (unless the context otherwise requires) that specified in a claim of the specification, and both validity (see Sections 1 to 4 and 72 of the Act) and infringement (see Section 60) are to be tested by reference to the ‘invention’. It is, of course, a fundamental principle that the construction of a claim is the same whether validity or infringement is to be considered; no patentee is entitled to the luxury of an ‘elastic’ claim which has a narrow meaning in the former case but a wide meaning in the latter. Under English procedure, infringement and validity are normally litigated at the same time and therefore the court is astute to avoid such a result. …”

(emphasis supplied)

124. Chisum on Patents: A Treatise on the Law of Patentability, Validity, and Infringement (Vol. 3-6-2007) in chapter “Adequate Disclosure” notes:

“§ 7.03 — The enablement requirement

Since 1790, the patent laws have required that the inventor set forth in a patent specification sufficient information to enable a person skilled in the relevant art to make and use the invention.

The ‘invention’ that must be enabled is that defined by the particular claim or claims of the patent or patent application. This is consistent with the general principle of patent law that the claim defines the invention for purposes of both patentability and infringement.”

125. Nevertheless, both Mr Andhyarujina and Mr Subramanium strenuously argued that the coverage or the claim, and the disclosure or the teaching, have different parameters in a patent, and that the former may have an extended boundary within which disclosure or teaching may be confined to a narrower extent. In support of the submission, Mr Andhyarujina relied upon a decision of the Court of Appeal in A.C Edwards Ltd. v. Acme Signs & Displays Ltd. 1992 RPC 131 and another of the High Court of Justice, Chancery Division, Patent Court in Astellas Pharma Inc. v. Comptroller General of Patents 2009 EWHC 1916 (Pat).

126. Mr Gopal Subramanium strongly relied upon the decision of the United States Court of Customs and Patent Appeals in Hogan, In re 559 F 2d 595 (CCPA 1977) in support of his contention.

127. In Hogan 559 F 2d 595 (CCPA 1977), the Court of Customs and Patent Appeals held that a patent application that disclosed and enabled a method of making the crystalline form of polymer was entitled to a claim for the method of making a solid polymer, because the only known method for making a solid polymer at the time was the applicants' method of making the crystalline form.

128. The Hogan 559 F 2d 595 (CCPA 1977) decision was rendered in a jurisdiction that has the historical background of blocking patents. Further, Hogan 559 F 2d 595 (CCPA 1977) that relates to the saga of acrimonious litigation over the claim of priority of invention for crystalline polypropylene among five competing companies was a rather unusual decision even in the US.

129. In Hogan 559 F 2d 595 (CCPA 1977), , the Court of Customs and Patent Appeals had before it an appeal from the decision of the Board of Appeals, affirming the rejections by the Patent and Trademark Office (PTO) of the applicant's Claims 13-15 for “Solid Polymers of Olefins” under 35 U.S.C § 102, 103, 112 (first paragraph) and 132. The application, though filed in 1971, was in continuation of the first application filed on 27-1-1953. One of the main issues involved in the case was whether a “later state of the art” could be taken as evidence to support a rejection of the patent claim. Among the reasons given by the Board for rejecting the claim of the applicant was that the disclosure in the original 1953 Hogan and Banks' application was not enabling, because the disclosure was limited to making crystalline polymers. But the claims which the Board rejected included an amorphous polymer as well, which was manifestly outside the scope of the enabling teaching present in the case. The Court of Customs and Patent Appeals reversed the decision of the Board of Patent Appeals, observing and holding as under:

“The PTO has not challenged the appellants' assertion that their 1953 application enabled those skilled in the art in 1953 to make and use ‘a solid polymer’ as described in Claim 13. The appellants disclosed, as the only then existing way to make such a polymer, a method of making the crystalline form. To now say that the appellants should have disclosed in 1953 the amorphous form which on this record did not exist until 1962, would be to impose an impossible burden on inventors and thus on the patent system. There cannot, in an effective patent system, be such a burden placed on the right to broad claims. To restrict the appellants to the crystalline form disclosed, under such circumstances, would be a poor way to stimulate invention, and particularly to encourage its early disclosure. To demand such restriction is merely to state a policy against broad protection for pioneer inventions, a policy both short-sighted and unsound from the standpoint of promoting progress in the useful arts, the constitutional purpose of the patent laws.”

130. The Court in Hogan 559 F 2d 595 (CCPA 1977) seems to have taken the view that the amorphous form did not exist at the time of the patent application and therefore, the patentee could not have been expected to claim the amorphous form at that time. The Court further took the view that the broad claim for a solid polymer would satisfy the enablement requirement under the state-of-the-art, as that was known at the time of the filing of the patent application, because the amorphous form was not known at that time. The Court observed:

“Consideration of a later existing state-of-the-art in testing for compliance with § 112, first paragraph, would not only preclude the grant of broad claims, but would wreak havoc in other ways as well. The use of a subsequently-existing improvement to show lack of enablement in an earlier-filed application on the basic invention would preclude issuance of a patent to the inventor of the thing improved, and in the case of issued patents, would invalidate all claims (even some ‘picture claims’) therein. Patents are and should be granted to later inventors upon unobvious improvements. Indeed, encouragement of improvements on prior inventions is a major contribution of the patent system and the vast majority of patents are issued on improvements. It is quite another thing, however, to utilize the patenting or publication of later existing improvements to ‘reach back’ and preclude or invalidate a patent on the underlying invention.”

131. The polypropylene case in the US gave rise to an extraordinary legal precedent for the enablement requirement, according to which a patentee is free to claim a genus that includes unknown species that may be discovered in the future, if the specification describes and enables all the species that are known at the time of filing the patent application. The rationale on which the decision is based is described by Professors Merges and Duffy as the “temporal paradox”. The Professors explain that, approached in this way, the description and enablement requirements for the genus are determined as of the date of filing the patent, and the patentee gets the benefit of any addition to the genus discovered later.

132. It needs to be noted here that even in the US, Hogan 559 F 2d 595 (CCPA 1977) represents a decision given in the context of the special set of facts and circumstances of the litigation over polypropylene. In later decisions, the Federal Circuit appears to have drastically narrowed Hogan case's 559 F 2d 595 (CCPA 1977) scope as a precedent. In Plant Genetic Systems, N.V v. DeKalb Genetics Corpn. 315 F 3d 1335, 1341 (Fed Cir 2003) the effect of Hogan 559 F 2d 595 (CCPA 1977) was considerably constricted and its effect is virtually eliminated in Chiron Corpn. v. Genentech Inc. 363 F 3d 1247, 1257 (Fed Cir 2004) Since Chiron 363 F 3d 1247, 1257 (Fed Cir 2004), the Federal Circuit has not referred to Hogan 559 F 2d 595 (CCPA 1977) in any of its cases that involved claims to a genus where a single species was enabled.

133. Mr Subramanium refers to the Hogan 559 F 2d 595 (CCPA 1977) decision in order to support his contention that the Zimmermann Patent is a patent covering a genus with certain known species, and many other species that were unknown at that time, but which are equally covered by the patent, even though there is no enabling disclosure in the patent in respect thereof. But it is already found and held earlier that Imatinib Mesylate is a known substance from the Zimmermann Patent. The finding that Imatinib Mesylate is a known substance from the Zimmermann Patent is not based on the conduct of the appellant alone, as objected to by Mr Andhyarujina, but the finding has been arrived at on an objective consideration of all the material facts and circumstances. In view of that finding, we fail to see any application of the Hogan 559 F 2d 595 (CCPA 1977) decision to the facts of the case. We have also considered the two decisions relied upon by Mr Andhyarujina. Those two decisions also have no application to the facts of the present case, for the same reason as in case of Hogan 559 F 2d 595 (CCPA 1977).

134. However, before leaving Hogan 559 F 2d 595 (CCPA 1977) and proceeding further, we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.

135. In light of the discussions made above, we firmly reject the appellant's case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann Patent. We hold and find that Imatinib Mesylate is a known substance from the Zimmermann Patent itself. Not only is Imatinib Mesylate known as a substance in the Zimmermann Patent, but its pharmacological properties are also known in the Zimmermann Patent and in the article published in the Cancer Research journal referred to above. The consequential finding, therefore, is that Imatinib Mesylate does not qualify the test of “invention” as laid down in Section 2(1)(j) and Section 2(1)(ja) of the Patents Act, 1970.

136. This leaves us with the beta crystalline form of Imatinib Mesylate, which, for the sake of argument, may be accepted to be new, in the sense that it is not known from the Zimmermann Patent. (Whether or not it involves an “inventive step” is another matter, and there is no need to go into that aspect of the matter now). Now, the beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, it directly runs into Section 3(d) of the Act with the Explanation appended to the provision. Mr Subramanium, however, contended that Section 3(d) has no application in this case. The main ground on which he denied the applicability of Section 3(d) to decide the question of grant of patent to the beta crystalline form of the Imatinib Mesylate is earlier held to be untenable. He, however, questioned the applicability of Section 3(d) on another ground. Mr Subramanium submitted that in order to attract Section 3(d), the subject product must be a new form of a known substance having known efficacy. The learned counsel laid some stress on the expression “known” that equally qualifies the substance of which the subject product may be another form, and the efficacy of that substance. The learned counsel submitted that a “conceivable” substance is not a “known substance” within the meaning of the provision. He contended that the word “known” here connotes proven and well-established; “known efficacy” implies efficacy established empirically and proven beyond doubt. He further contended that neither Imatinib nor Imatinib Mesylate had any known efficacy and that, therefore, there was no question of showing that the beta crystalline form of Imatinib Mesylate had any enhanced efficacy over Imatinib or Imatinib Mesylate.

137. There is no sanction to construe the expression “known” in Section 3(d) in the manner suggested by Mr Subramanium, and the submission is unacceptable both in law and on facts. It may be noted here that clauses (e) and (f) of Section 64(1) of the Act, which contain two of the grounds for revocation of patents, also use the expression “publicly known”. The expression “publicly known” may normally be construed more widely than “known”, and in that sense it is closer to the submission made by Mr Subramanium. But even the expression “publicly known” received quite the opposite interpretation by this Court in Monsanto Co. v. Coramandal Indag Products (P) Ltd. (1986) 1 SCC 642 In para 6 of the judgment, Chinnappa Reddy, J., speaking for the Court, held and observed as under:

“6. … To satisfy the requirement of being publicly known as used in clauses (e) and (f) of Section 64(1), it is not necessary that it should be widely used to the knowledge of the consumer public. It is sufficient if it is known to the persons who are engaged in the pursuit of knowledge of the patented product or process either as men of science or men of commerce or consumers. The section of the public, who, as men of science or men of commerce, were interested in knowing about herbicides which would destroy weeds but not rice, must have been aware of the discovery of Butachlor. There was no secret about the active agent Butachlor as claimed by the plaintiffs since there was no patent for Butachlor, as admitted by the plaintiffs. Emulsification was the well-known and common process by which any herbicide could be used. Neither Butachlor nor the process of emulsification was capable of being claimed by the plaintiff as their exclusive property. The solvent and the emulsifier were not secrets and they were admittedly not secrets and they were ordinary market products. From the beginning to the end, there was no secret and there was no invention by the plaintiffs. The ingredients, the active ingredients the solvent and the emulsifier, were known; the process was known, the product was known and the use was known. The plaintiffs were merely camouflaging a substance whose discovery was known throughout the world and trying to enfold it in their specification relating to Patent No. 125381. The patent is, therefore, liable to be revoked.”

138. On facts also we are unable to accept that Imatinib Mesylate or even Imatinib was not a known substance with known efficacy. It is seen above that Imatinib Mesylate was a known substance from the Zimmermann Patent. In the NDA submitted by the appellant before the US FDA, it was clearly stated that the drug had undergone extensive preclinical, technical and clinical research. The clinical studies included one multiple dose tolerability/dose-finding study (Phase I) and three large open, uncontrolled efficacy and safety studies (Phase II); and a total of 1234 patients with CML and other Ph+ leukaemias were enrolled in the studies. The efficacy of Imatinib was equally known, as is evident from the Zimmermann Patent itself, besides the two articles referred to above.

139. The subject product, that is, beta crystalline form of Imatinib Mesylate, is thus clearly a new form of a known substance i.e Imatinib Mesylate, of which the efficacy was well known. It, therefore, fully attracts Section 3(d) and must be shown to satisfy the substantive provision and the Explanation appended to it.

140. We now proceed to examine how far the beta crystalline form of Imatinib Mesylate stands up to the test of Section 3(d) of the Act.

141. It is noted in the earlier part of the judgment that the patent application submitted by the appellant contains a clear and unambiguous averment that all the therapeutic qualities of the beta crystalline form of Imatinib Mesylate are also possessed by Imatinib in free base. The relevant extract from the patent application is once again reproduced here:

“It goes without saying that all the indicated inhibitory and pharmacological effects are also found with the free base, 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl) pyrimidin-2-ylamino)phenyl] benzamide, or other cells thereof. The present invention relates especially to the ß crystal form of the methanesulfonic acid addition salt of a compound of Formula I in the treatment of one of the said diseases or in the preparation of a pharmacological agent for the treatment thereto.”

(emphasis supplied)

142. Now, when all the pharmacological properties of the beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form?

143. It may also be stated here that while going through the Zimmermann Patent one cannot but feel that it relates to some very serious, important and valuable researches. The subject patent application, on the other hand, appears to be a loosely assembled, cut-and-paste job, drawing heavily upon the Zimmermann Patent. As a matter of fact, Mr Kuhad, learned Additional Solicitor General, submitted before us a tabular chart showing over a dozen statements and averments made in the subject application that are either lifted from the Zimmermann Patent or are very similar to corresponding statements in the Zimmermann Patent. The aforesaid chart is appended at the end of the judgment as Appendix II.

144. It further needs to be noted that, on the issue of Section 3(d), there appears to be a major weakness in the case of the appellant. There is no clarity at all as to what is the substance immediately preceding the subject product, the beta crystalline form of Imatinib Mesylate. In course of the hearing, the counsel appearing for the appellant greatly stressed that, in terms of invention, the beta crystalline form of Imatinib Mesylate is two stages removed from Imatinib in free base form. The same is said in the written notes of submissions filed on behalf of the appellant. But this position is not reflected in the subject application, in which all the references are only to Imatinib in free base form (or to the alpha crystalline form of Imatinib Mesylate in respect of flow properties, thermodynamic stability and lower hygroscopicity). On going through the subject application, the impression one gets is that the beta crystalline form of Imatinib Mesylate is derived directly from Imatinib free base. This may, perhaps, be because once the beta crystalline form of the methanesulfonic acid salt of Imatinib came into being, the Imatinib free base got seeded with the nuclei of Imatinib Mesylate beta crystalline form and, as a result, starting from Imatinib one would inevitably arrive directly at the beta crystalline form of Imatinib Mesylate. But all this is nowhere said in the subject application.

145. Apart from the subject application, the appellant filed four affidavits before the Controller. Two of the affidavits are meant to explain and refute the results of the experiments conducted by IICT at the instance of one of the objectors, Natco Pharma Ltd. But the other two, one by Paul William Manley, dated 22-7-2005, and the other by Giorgio Pietro Massimini, dated September 2005, were filed to meet the requirements of Section 3(d), which was amended while the application lay in the “mailbox”.

146. Massimini, in Para 8 of the affidavit, explained that it was being filed to meet the conditions under Section 3(d) of the Act. He stated that the proviso to Section 3(d) was unique to India and there was no analogous provision in any other country of the world. The appellant was, therefore, never called upon to satisfy the tests laid down in Section 3(d) of the Act to establish the patentability of the patent subject. He further stated that since no occasion to do so had arisen earlier, no study relating to the efficacy of the free base was carried out in the past. Upon coming to know the requirement of Section 3(d), the deponent, asked by the appellant, immediately commenced such a study, ensuring that accuracy and universally accepted scientific and ethical guidelines were not sacrificed.

147. Manley, in Para 8 of his affidavit, stated:

“The physical properties of the free base and Imatinib Mesylate differ in that the free base is only very slightly soluble in water (0.001 g/100 ml) while Imatinib Mesylate is very soluble in water (beta crystalline form: 130 g/100 ml). Other physical characteristics of the subject compound are described at pp. 2-3 of the specification. The attendant advantages because of these properties are also simultaneously described therein. These characteristics and hence the attendant properties/advantages are not shared by the free base. Furthermore, the beta form significantly differs from the alpha form:

Physical attributes:

(a) The beta crystal form has substantially more beneficial flow properties and thus results in better processability than the alpha crystal form.

(b) The beta crystal form of the methanesulfonic acid addition salt is the thermodynamically more stable form at room temperature. Greater stability is thus to be expected.

(c) The beta crystal form is less hygroscopic than the alpha crystal form of the methanesulfonic acid addition salt of a compound of Formula I.

(d) The lower hygroscopicity is a further advantage for processing and storing the acid addition salt in the beta crystal form.”

(emphasis supplied)

148. Massimini, in Para 9 of his affidavit stated:

“A study conducted on rats provided statistical evidence for a difference in the relative bioavailability of the free base and Imatinib Mesylate in the beta crystalline form. In such study, a mean AUC (0-48h) value of 264.000 h*ng/mL was found for the free base compared with a mean AUC (0-48h) value of 344000 h*ng/mL for Imatinib Mesylate having the beta crystal form. In other words, an about 30% improvement in bioavailability was observed for the beta crystalline form of Imatinib Mesylate compared to the free base. The test results are attached herewith as Annexure ‘A’.”

149. It is to be noted that the higher solubility of the beta crystalline form of Imatinib Mesylate is being compared not to Imatinib Mesylate but, once again, to Imatinib in free base form. The whole case of the appellant, as made out in the subject application and the affidavits, is that the subject product, the beta crystalline form of Imatinib Mesylate, is derived from Imatinib, and that the substance immediately preceding the beta crystalline form is not Imatinib Mesylate but Imatinib in free base form. This position is sought to be canvassed in the subject application and the affidavits on the premise that the Zimmermann Patent ended at Imatinib in free base and did not go beyond to Imatinib Mesylate. Not only is this premise unfounded as shown earlier, but the appellant itself appears to take a somewhat different stand, as before this Court it was contended that the subject product, in terms of invention, is two stages removed from Imatinib in free base, and the substance immediately preceding the subject product is Imatinib Mesylate (non-crystalline).

150. That being the position, the appellant was obliged to show the enhanced efficacy of the beta crystalline form of Imatinib Mesylate over Imatinib Mesylate (non-crystalline). There is, however, no material in the subject application or in the supporting affidavits to make any comparison of efficacy, or even solubility, between the beta crystalline form of Imatinib Mesylate and Imatinib Mesylate (non-crystalline).

151. As regards the averments made in the two affidavits, for all one knows, the higher solubility that is attributed to the beta crystalline form of Imatinib Mesylate may actually be a property of Imatinib Mesylate itself. One does not have to be an expert in chemistry to know that salts normally have much better solubility than compounds in free base form. If that be so, the additional properties that may be attributed to the beta crystalline form of Imatinib Mesylate would be limited to the following:

(i) More beneficial flow properties,

(ii) Better thermodynamic stability, and

(iii) Lower hygroscopicity.

The aforesaid properties, (“physical attributes” according to Manley), would give the subject product improved processability and better and longer storability but, as we shall see presently, on the basis of those properties alone, the beta crystalline form of Imatinib Mesylate certainly cannot be said to possess enhanced efficacy over Imatinib Mesylate, the known substance immediately preceding it, within the meaning of Section 3(d) of the Act.

152. We have so far considered the issue of enhanced efficacy of the subject product in light of the finding recorded earlier in this judgment that Imatinib Mesylate (non-crystalline) is a known substance from the Zimmermann Patent and is also the substance immediately preceding the patent product, that is, Imatinib Mesylate in beta crystalline form.

153. Let us now consider the case of the appellant as made out in the subject application and the supporting affidavits, and examine the issue of enhanced efficacy of the beta crystalline form of Imatinib Mesylate vis-à-vis Imatinib in free base form. It is seen above that all the pharmacological effects of Imatinib Mesylate in beta crystalline form are equally possessed by Imatinib in free base form. The position is not only admitted but repeatedly reiterated in the patent application. Mr Subramanium, with his usual fairness and candour, explained the position by stating that Imatinib free base is actually the active therapeutic ingredient, but in free base form Imatinib has very little or no solubility. It is, therefore, not capable of being administered as a drug to human beings. In the words of Mr Subramanium, if given in solid dosage form, Imatinib free base would sit in the stomach like a brick and would pass out with no therapeutic effect. The invention of the methanesulfonic acid addition salt of Imatinib makes the therapeutic ingredient (that continues to be the same) highly soluble, and therefore very suitable for being administered as a drug to humans. The further invention of the beta crystalline form of Imatinib Mesylate adds to its properties and makes it an even better drug than Imatinib Mesylate. The subject product, that is, the beta crystalline form of Imatinib Mesylate, thus demonstrates a definite and tangible enhancement of efficacy over Imatinib in free base form.

154. The way in which the case is presented by Mr Subramanium is an entirely new case made before this Court for the first time. Nevertheless, let us consider the case of the appellant as presented by Mr Subramanium.

155. The portion added in Section 3(d) by the 2005 amendment reads as under:

“3. (d) The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance … [is not invention within the meaning of the Act].”

156. The Explanation to Section 3(d) also added by the 2005 amendment provides as under:

“Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;”

It may be seen that the word “efficacy” is used both in the text added to the substantive provision as also in the Explanation added to the provision.

157. What is “efficacy”? “Efficacy” means “the ability to produce a desired or intended result” Edn. 1998. Hence, the test of efficacy in the context of Section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”. The question then arises, what would be the parameter of therapeutic efficacy and what are the advantages and benefits that may be taken into account for determining the enhancement of therapeutic efficacy? With regard to the genesis of Section 3(d), and more particularly the circumstances in which Section 3(d) was amended to make it even more constrictive than before, we have no doubt that the “therapeutic efficacy” of a medicine must be judged strictly and narrowly. Our inference that the test of enhanced efficacy in case of chemical substances, especially medicine, should receive a narrow and strict interpretation is based not only on external factors but there is sufficient internal evidence that leads to the same view. It may be noted that the text added to Section 3(d) by the 2005 Amendment lays down the condition of “enhancement of the known efficacy”. Further, the Explanation requires the derivative to “differ significantly in properties with regard to efficacy”. What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy.

158. While dealing with the Explanation it must also be kept in mind that each of the different forms mentioned in the Explanation have some properties inherent to that form e.g solubility to a salt and hygroscopicity to a polymorph. These forms, unless they differ significantly in property with regard to efficacy, are expressly excluded from the definition of “invention”. Hence, the mere change of form with properties inherent to that form would not qualify as “enhancement of efficacy” of a known substance. In other words, the Explanation is meant to indicate what is not to be considered as therapeutic efficacy.

159. We have just noted that the test of enhanced therapeutic efficacy must be applied strictly, but the question needs to be considered with greater precision. In this connection, we take note of two slightly diverging points of view urged before this Court.

160. Mr Anand Grover, learned counsel appearing for one of the objectors, Cancer Patients Aid Association, took a somewhat rigid position. The learned counsel submitted that in the pharmaceutical field, drug action is explained by “pharmacokinetics” (effect of the body on the drug) and “pharmacodynamics” (effect of the drug on the body). He further submitted that efficacy is a pharmacodynamic property, and contended that, in the field of pharmaceuticals, efficacy has a well-known meaning. Efficacy is the capacity of a drug to produce an effect. The IUPAC describes efficacy as “the property that enables drugs to produce responses”. It is that property of a drug which produces stimulus. When comparing the efficacy of two substances, efficacy describes “the relative intensity with which agonists vary in the response they produce even when they occupy the same number of receptors”. [IUPAC Glossary of Terms Used in Medicinal Chemistry, 1998 in CPAA Compilation, Vol. 9, at p. 7.] In the words of Goodman and Gilman, “the generation of response from the drug receptor complex is governed by a property described as efficacy”. They further clarify that “efficacy is that property intrinsic to a particular drug that determines how good an agonist the drug is” [Goodman and Gilman in CPAA Compilation, Vol. 9, at p. 22, LHC]. Another source describes efficacy as “the ability of the drug to produce the desired therapeutic effect” [Dorland's Medical Dictionary in Novartis' Vol. P, at p. 19.]

161. Mr Grover further submitted that in pharmacology, efficacy is distinct from affinity, potency and bioavailability. Affinity, a pharmacodynamics property, “is the tendency of a molecule to associate with another”. The affinity of a drug is its ability to bind to its biological target (receptor, enzyme, transport system, etc.). Potency is “the dose of drug required to produce a specific effect of given intensity as compared to a standard reference”. Bioavailability, on the other hand, is a pharmacokinetic property. It “is the term used to indicate the fraction extent to which a dose of drug reaches its site of action or a biological fluid from which the drug has access to its site of action” [Goodman and Gilman in CPAA Compilation, Vol. …, internal p. 4]; or “the degree to which a drug or other substance becomes available to the target tissue after administration” [Dorland's Medical Dictionary in Novartis' Vol. B, at p. 65]. A demonstration of increase in bioavailability is not a demonstration of enhanced efficacy.

162. Prof. Basheer, who appeared before this Court purely in academic interest as an intervenor-cum-amicus, agreed that not all advantageous properties of a new form (such as improved processability or flow characteristics, storage potential, etc.) ought to qualify under Section 3(d), but only those properties that have some bearing on efficacy. However, taking a less rigid position than Mr Grover, Prof. Basheer argued that safety or significantly reduced toxicity should also be taken into consideration to judge enhanced therapeutic efficacy of a pharmaceutical product in terms of Section 3(d).

163. We have taken note of the submissions made by Mr Grover and Prof. Basheer in deference to the importance of the issue and the commitment of the counsel to the cause. However, we do not propose to make any pronouncement on the issues raised by them, as this case can be finally and effectively decided without adverting to the different points of view noted above.

164. In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of the beta crystalline form of Imatinib Mesylate, namely, (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of Section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy.

165. This leaves us to consider the issue of increased bioavailability. It is the case of the appellant that the beta crystalline form of Imatinib Mesylate has 30% increased bioavailability as compared to Imatinib in free base form. If the submission of Mr Grover is to be accepted, then bioavailability also falls outside the area of efficacy in case of a medicine. Leaving aside the submission of Mr Grover on the issue, however, the question is, can a bald assertion in regard to increased bioavailability lead to an inference of enhanced therapeutic efficacy? Prof. Basheer quoted from a commentator 42 FR 1640 (1977). Cf. Moffitt on the issue of bioavailability as under:

“It is not the intent of a bioavailability study to demonstrate effectiveness, but to determine the rate and extent of absorption. If a drug product is not bioavailable, it cannot be regarded as effective. However a determination that a drug product is bioavailable is not in itself a determination of effectiveness.”

(emphasis supplied)

166. Thus, even if Mr Grover's submission is not taken into consideration on the question of bioavailability, the position that emerges is that just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model.

167. Thus, in whichever way Section 3(d) may be viewed, whether as setting up the standards of “patentability” or as an extension of the definition of “invention”, it must be held that on the basis of the materials brought before this Court, the subject product, that is, the beta crystalline form of Imatinib Mesylate, fails the test of Section 3(d), too, of the Act.

168. We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that Section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of Section 5 from the parent Act. That is not said in this judgment.

169. Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind” Edn. 1998. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of Section 2(1), the test of enhanced efficacy as provided in Section 3(d) read with its Explanation.

170. Coming back to the case of the appellant, there is yet another angle to the matter. It is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystalline form. It is also seen above that even while the appellant's application for grant of patent lay in the “mailbox” awaiting amendments in the law of patent in India, the appellant was granted exclusive marketing rights on 10-11-2003, following which Gleevec was marketed in India as well. On its package, the drug was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film-coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the package there is no reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate.

171. If that be so, then the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.

172. In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of Section 2(1) and Section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with costs. The other two appeals are allowed.

173. Before putting down the records of this case, we would like to express our deep appreciation for the way the hearing of the case took place before the Court. Every counsel presented the issues under consideration from a different angle and every counsel who addressed the Court had something important and valuable to contribute to the debate. It was also acknowledged that the illuminating addresses of the counsel were the result of the hard work and painstaking research by the respective teams of young advocates working for each senior advocate. The presence of those bright young ladies and gentlemen in the courtroom added vibrancy to the proceedings and was a source of constant delight to us.

Appendix I

174.

Table (1)

Comparative Table of Applications for Patents in India during the Periods (a) 1930-1938; (b) 1949-1958

1930-1938 1949-1958 Year Total number of applications filed By Indians By other than Indian Year Total number of applications filed By Indians By other than Indians 1930 1099 114 985 1949 1725 345 1380 1931 940 109 831 1950 1851 352 1499 1932 928 162 766 1951 2108 422 1686 1933 954 199 755 1952 2272 473 1799 1934 1007 203 804 1953 2235 406 1829 1935 980 156 824 1954 2497 403 2094 1936 1068 199 869 1955 2736 403 2333 1937 1246 202 1044 1956 3067 482 2585 1938 1243 220 1023 1957 3456 527 2929 1939 1060 238 822 1958 3572 529 3043 10,525 1802 (17%) 8723 25,519 4342 (17%) 21,177

175.

Table (2)

Patents Granted from 1950-1957 — Analysed according to the Subject of the Inventions

Food Year Indian Foreign Total No. Percentage No. Percentage 1950 22 16.5 111 83.5 133 1951 35 28.6 87 71.4 122 1952 18 18.9 77 81.1 95 1953 30 18.8 129 81.2 159 1954 31 8.3 341 91.7 372 1955 48 10.0 430 90.0 478 1956 30 7.0 402 93.0 432 1957 8 13.5 51 86.5 59 Total 222 1628 1850 Chemical 1950 13 4.5 271 95.4 284 1951 33 8.7 378 91.3 411 1952 36 8.0 414 92.0 450 1953 27 7.1 351 92.9 378 1954 44 9.7 409 90.3 453 1955 56 12.5 448 87.5 504 1956 34 6.6 479 93.4 513 1957 68 9.3 656 90.7 724 Total 311 3406 3717

176.

Table (3)

Applications for Patents relating to Drugs and Pharmaceuticals

Pharmaceuticals Year Indian Foreign No. Percentage No. Percentage Total 1947 12 7.7(sic 17.7) 143 72.3 155 1948 7 5.5 121 94.5 128 1949 5 3.5 139 96.5 144 1950 8 5.0 151 95.0 159 1951 17 7.7 203 92.3 220 1952 18 6.2 224 93.8 242 1953 18 6.3 267 93.7 285 1954 13 4.1 300 95.9 313 1955 7 2.1 325 97.9 332 1956 13 2.6 476 97.4 489

1957 25 5.3 543 94.7 568 Total 143 2892 3035

177.

Table (4)

Number of Patents in force on 1-1-1958 Total number 13,774 Owned by Indians 1157 Owned by Indians and foreigners jointly 21 Owned by foreigners 12,596

Appendix II

178. Comparative Chart of Zimmermann Patent and Application for Beta Crystalline Form of Imatinib Mesylate in India

Zimmermann Patent (Vol. C-4) Beta crystal Application in India (Vol. C-4) 1. Column 4: The compounds of Formula I have valuable pharmacological properties and can be used, for example, as anti-tumoral drugs and as drags (sic drugs) against atherosclerosis… Page 60: The methanesulfonic acid addition salt of a compound of Formula I, which is preferably used in the ß-crystal form … possesses valuable pharmacological properties and may, for example, be used as an anti-tumour agent, as an agent to treat atherosclerosis. 2. Column 5: “… and anti-bacterial active ingredients…” Page 60: “… preventing the invasion of warm-blooded animal cells by certain bacteria, such as porphyromonas gingivalis.” 3. Column 4: The phosphorylation of proteins has long been known as an important step in the differentiation and proliferation of cells. The phosphorylation is catalysed by protein kinases which are divided into serine/threonine kinases and tyrosine kinases. The serine/threonine kinases include protein kinase C and the tyrosine kinases the PDGF (platelet-derived growth factor)-receptor tyrosine kinase. Page 60: The phosphorylation of proteins has long been known as an essential step in the differentiation and division of cells. Phosphorylation is catalysed by protein kinases subdivided into serine/threonine and tyrosine kinases. The tyrosine kinases include PDGF (platelet-derived growth factor) receptor tyrosine kinase. 4. Column 7: PDGF (platelet-derived growth factor) is a very frequently occurring growth factor which plays an important role both in normal growth and in pathological cell proliferation, such as in carcinogenesis and disorders of the smooth muscle cells of blood vessels, for example in atherosclerosis and thrombosis. Page 60: PDGF (platelet-derived growth factor) is a very commonly occurring growth factor, which plays an important role both in normal growth and also in pathological cell proliferation, such as is seen in carcinogenesis and in diseases of the smooth-muscle cells of blood vessels, for example in atherosclerosis and thrombosis.

5. Column 7: The inhibition of PDGF-stimulated receptor tyrosine kinase activity in vitro is measured in PDGF receptor immunocomplexes of BALB/c 3T3 cells, analogously to the method described by E. Andrejauskas-Buchdunger and U. Regenass in Cancer Research 52, 5353-5358 (1992). The compounds of Formula I described in detail above inhibit PDGF-dependent cell-free receptor phosphorylation at concentrations of from 0.005 to 5 μmol/liter, especially from 0.01 to 1.0, more especially from 0.01 to 0.1 μmol/liter. The inhibition of PDGF-receptor tyrosine kinase in the intact cell is detected by means of Western Blot Analysis, likewise analogously to the method described by E. Andrejauskas-Buchdunger and U. Regenass in Cancer Research 52, 5353-5358 (1992). In that test the inhibition of ligand-stimulated PDGF-receptor autophosphorylation in BALB/c mouse cells is measured with the aid of anti-phosphotyrosine antibodies. The compounds of Formula I described in detail above inhibit the tyrosine kinase activity of the PDGF receptor at concentrations of from 0.005 to 5 μmol/liter, especially from 0.01 to 1.0 and more especially from 0.01 to 0.1 μmol/liter. At concentrations below 1.0 μmol/liter, those compounds also inhibit the cell growth of a PDGF-dependent cell line, namely, BALB/c 3T3 mouse fibroblasts. Page 60: The inhibition of PDGF-stimulated receptor tyrosine kinase activity in vitro is measured in PDGF receptor immune complexes of BALB/c 3T3 cells, as described by E. Andrejauskas-Buchdunger and U. Regenass in Cancer Research 52, 5353-5358 (1992). A compound of Formula I described in more detail hereinbefore, such as especially its ß-crystal form, inhibits PDGF-dependent acellular receptor phosphorylation. 6. Column 8: The compounds of this invention inhibit enzyme activity by 50% (IC50) typically in a concentration of 0.1 to 10 μm. Page 61: “… the corresponding methanesulfonate salt inhibit the tyrosine kinase activity of the PDGF receptor at an IC50 (concentration at which activity is inhibited by 50% compared with the control) of about 120 nM and about 100 nM, respectively.”

7. Column 7: Owing to the properties described, compounds of Formula I can be used not only as tumour-inhibiting active ingredients but also as drugs against non-malignant proliferative diseases e.g atherosclerosis, thrombosis, psoriasis, sclerodermitis and fibrosis. They are also suitable for the further applications mentioned above for protein kinase C-modulators and can be used especially in the treatment of diseases that respond to the inhibition of PDGF-receptor kinase. Page 61: On the basis of the described properties, the methanesulfonic acid addition salt of a compound of Formula I, such as especially the ß-crystal form thereof, may be used not only as a tumour-inhibiting substance, for example in small cell lung cancer, but also as an agent to treat non-malignant proliferative disorders, such as atherosclerosis, thrombosis, psoriasis, scleroderma, and fibrosis… It may especially be used for the treatment of diseases which respond to an inhibition of the PDGF receptor kinase. 8. Column 9: In addition, the compounds of Formula I prevent the development of resistance (multi-drug resistance) in cancer treatment with other chemotherapeutic drugs or remove existing resistance to other chemotherapeutic drugs. Page 62: In addition, the methanesulfonic acid addition salt of a compound of Formula I, such as especially its ß-crystal form C, prevents the development of multidrug resistance in cancer therapy with other chemotherapeutic agents or abolishes a pre-existing resistance to other chemotherapeutic agents. 9. Column 6: Some of the compounds of Formula I wherein R4 and R8 are hydrogen inhibit not only protein kinase C but, at a concentration IC50 as low as approximately from 0.01 to 5 μmol/liter, especially approximately from 0.05 to 1 μmol/liter, also certain tyrosine kinases, such as especially PDGF-receptor kinase or abl-kinase, for example v-abl kinase. Page 62: Also abl kinase, especially v-abl kinase, is inhibited by 4-(4-methylpiperazin-1-ylmethyl) -N-(4-methyl-3-(4-pyridin-3-yl) pyrimidin-2-ylamino) phenyl] benzamide and its methanesulfonate salt. 10. Column 7: The abovementioned inhibition of v-abl tyrosine kinase is determined in accordance with the methods of N. Lydon et al., Oncogene Research 5, 161-173 (1990) and J.F Geissler et al., Cancer Research 52, 4492-4498 (1992). In those methods [Val5]-angiotensin II and [y-32P]-ATP are used as substrates. Page 62: The inhibition of v-abl tyrosine kinase is determined by the methods of N. Lydon et al. Oncogene Research 5, 161-173 (1990) and J.F Geissler et al., Cancer Research 52, 4492-8 (1992). In those methods [Val5]-angiotensin II and [y-32P]-ATP are used as substrates. 11. Column 20: The invention relates also to a method of treating warm-blooded animals suffering from a tumoral disease, which comprises administering to warm-blooded animals requiring such Page 68: The invention relates also to a process for the treatment of warm-blooded animals suffering from said diseases, especially a tumour disease, … is administered to warm-blooded

treatment an effective, tumour-inhibiting amount of a compound of Formula I or of a pharmaceutically acceptable salt thereof. animals in need of such treatment. 12. Column 20: The invention relates further to the use of a compound of Formula I or of a pharmaceutically acceptable salt thereof for inhibiting PDGF-receptor kinase or to the use of a compound of Formula I wherein R4 and R8 are each hydrogen, or of a pharmaceutically acceptable salt thereof, for inhibiting protein kinase C in warm-blooded animals or for preparing pharmaceutical compositions for use in the therapeutic treatment of the human or animal body. Page 68: The invention relates moreover to the use of the ß-crystal form of the methanesulfonic acid addition salt of a compound of Formula I for the inhibition of the abovementioned tyrosine kinases, especially PDGF receptor kinase, v-abl kinase, and/or c-kit receptor kinase, or for the preparation of pharmaceutical compositions for use in treating the human or animal body. 13. Column 20: Effective doses, for example daily doses of approximately from 1 to 1000 mg, especially from 50 to 500 mg, are administered to a warm-blooded animal of approximately 70 kg body weight according to species, age, individual condition, mode of administration and the individual syndrome. Page 68: Depending on species, age, individual condition, mode of administration, and the clinical picture in question, effective doses, for example daily doses of about 1-2500 mg, preferably 1-1000 mg, especially 5-500 mg, are administered to warm-blooded animals of about 70 kg body weight. 14. Column 20: The invention relates also to pharmaceutical compositions comprising an effective amount, especially an amount effective in the prevention or therapy of one of the abovementioned diseases, of the active ingredient together with pharmaceutically acceptable carriers that are suitable for topical, enteral, for example oral or rectal, or parenteral administration, and may be inorganic or organic, solid or liquid. For oral administration there are used especially tablets or gelatin capsules comprising the active ingredient together with diluents, for example lactose, dextrose, sucrose, mannitol, sorbitol, cellulose and/or glycerol, and/or lubricants, for example silicic acid, talc, stearic acid or salts thereof, such as magnesium or calcium stearate, and/or polyethylene glycol. Tablets may also comprise binders, for example magnesium aluminium silicate, starches, such as corn, wheat Page 68: The invention relates also to pharmaceutical preparations which contain an effective amount, especially an effective amount for prevention or treatment of one of the said diseases, of the methanesulfonic acid addition salt of a compound of Formula I in the −crystal (sic ß-crystal) form, together with pharmaceutically acceptable carriers which are suitable for topical, enteral for example oral or rectal, or parenteral administration and may be inorganic or organic and solid or liquid. Especially tablets or gelatin capsules containing the active substance together with diluents, for example lactose, dextrose, sucrose, mannitol, sorbitol, cellulose and/or glycerin, and/or lubricants, for example silicic, talc, stearic acid, or salts thereof, typically magnesium or calcium stearate, and/or polyethylene glycol, are used for oral administration. Tablets may likewise

or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone, and, if desired, disintegrators, for example starches, agar, alginic acid or a salt thereof, such as sodium alginate, and/or effervescent mixtures, or adsorbents, dyes, flavourings and sweeteners. The pharmacologically active compounds of the present invention can also be used in the form of parenterally administrable compositions or in the form of infusion solutions. Such solutions are preferably isotonic aqueous solutions or suspensions, which, for example in the case of lyophilised compositions that comprise the active ingredient alone or together with a carder, for example mannitol, can be prepared before use. The pharmaceutical compositions may be sterilised and/or may comprise excipients, for example preservatives, stabilisers, wetting agents and/or emulsifiers, solubilisers, salts for regulating the osmotic pressure and/or buffers. The present pharmaceutical compositions which, if desired, may comprise further pharmacologically active substances, such as antibiotics, are prepared in a manner known per se, for example by means of conventional mixing, granulating, confectioning, dissolving or lyophilising processes, and comprise approximately from 1% to 100%, especially from approximately 1% to approximately 20%, active ingredient(s). contain binders, for example magnesium aluminium silicate, starches, typically corn, wheat or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone, and, if so desired, disintegrants, for example starches, agar, alginic acid or a salt thereof, typically sodium alginate, and/or effervescent mixtures, or adsorbents, colouring agents, flavours, and sweetening agents. The pharmacologically active compounds of the present invention may further be used in the form of preparations for parenteral administration or infusion solutions. Such solutions are preferably isotonic aqueous solutions or suspensions, these possibly being prepared before use, for example in the case of lyophilised preparations containing the active substance either alone or together with a carrier, for example mannitol. The pharmaceutical substances may be sterilised and/or may comprise excipients, for example preservatives, stabilisers, wetting agents and/or emulsifiers, solubilisers, salts for regulation of the osmotic pressure, and/or buffers. The present pharmaceutical preparations which, if so desired, may contain further pharmacologically active substances, such as antibiotics, are prepared in a manner known per se, for example by means of conventional mixing, granulating, coating, dissolving or lyophilising processes, and contain from about 1% to 100%, especially from about 1% to about 20%, of the active substance or substances. 15. Column 21: The following examples illustrate the invention but do not limit the invention in any way. The Rf values are determined on silica gel thin-layer plates (Merck, Darmstadt, Germany). The ratio to one another of the eluants in the eluant mixtures used is given in proportions by volume (v/v), and temperatures are given in degrees Celsius (°C). Page 69: The following examples illustrate the invention without limiting the scope thereof. R1−values are determined on TLC plates coated with silica gel (Merck, Darmstadt, Germany). The ratio of the solvents to one another in the solvent systems used is indicated by volume (v/v), and temperatures are given in degrees Celsius (°C).

179.