Shri D.P.S Parmar, Technical Member (Patents):— This is a petition filed by Tata Tea Limited for revocation of patent No. 184038 entitled “A Method of Making A Tea Composition” granted to Hindustan Lever Private Limited. This revocation application was originally filed in the Hon'ble High Court of Bombay under Miscellaneous Petition No. 9 of 2004. The Hon'ble High Court of Bombay in its order dated 5.10.2006 framed the following issues:
(i) Whether the Petitioner proves that Patent No. 184038 dated 28th May, 1997 granted to the First Respondent ought to be revoked?
(ii) Whether the Petitioner proves that the invention as claimed in any claim of the complete specification was not new as alleged?
(iii) Whether the Petitioner proves that the invention so far as claimed in the claims of the complete specification was obvious and did not involve any inventive steps as alleged?
(iv) Whether the Petitioner proves that the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed and/or does not disclose the best method of performing it as alleged?
(v) Whether the Petitioner proves that the scope of the claims of the complete specification are not sufficiently and clearly defined and/or the claims are not fairly based on the matter disclosed in the specification as alleged?
(vi) Whether the subject of the claims of the complete specification No. 184038 are not invention within the meaning of the Act?
(vii) Whether the Petitioner proves that the patent was obtained on false suggestion or representation as alleged?
(viii) Whether the Petitioner proves that the 1st Respondent has failed to disclose to the Controller the information required by Section 8 or has furnished information, which in any material particular was false as alleged?
(ix) Whether the 1 Respondent proves that the petition is barred by the law of limitation?
2. On 7.07.2007 the Hon'ble High court of Bombay transferred this application to the IPAB in view of the notification dated 02.04.2007 and 0304.2007 issued by the Central Government. Accordingly, this application was numbered as TRA/1/2007/PT/MUM by the IPAB registry. This matter came up for hearing on 28.05.2012 Learned counsel H.W Kane along with Dr. P. Ganguli appeared for the applicant and Learned counsel Mr. S. Majumdar assisted by Mr. Dominic Alverez and Mr. Suman Bhattacharya appeared for the respondent No. 1.
Preliminary objection
3. The counsel for the respondent No. 1 submitted that the instant transferred rectification application is time barred as it is filed beyond the statutory time limit despite statutory public knowledge. He submitted that the issue of limitation of the instant revocation petition was before the Hon'ble High Court of Bombay. According to the counsel, in absence of any infringement suit against the petitioner, it cannot be said that the cause of action arose on any day other that on which it was statutorily brought to public knowledge. According to the counsel filing of patent application 825 BOM 1997 was notified on 02.11.1997 through the Gazette Notification. Further, the counsel submitted that on 03.06.2000 the public was made aware about the acceptance of the Patent Application No. 184038 for filing opposition. Again on 13.01.2001, public had been made aware of sealing of this patent through the Gazette Notification. Therefore, the counsel argued that right to apply for revocation of the said patent accrue from the date of publication of notification of sealing on 13.01.2001 The counsel submitted that three years time to comply with requirement of Article 137 of the Limitation Act, 1963 expired on 13.01.2004 Therefore, the instant revocation petition filed in April 2004 is clearly beyond the limitation period and thus time barred.
4. The counsel for the applicant submitted that it came to learn about the impugned patent in May, 2003 when it received copies of the first respondent's reply statement and evidence in support of application No. 186347 which was opposed by the applicant. In view of this the counsel submitted that the present petition is filed on 19.04.2004 The counsel for the applicant submitted that Article 137 of the Limitation Act provides that in respect of any other application for which no period of limitation is provided elsewhere, the period of limitation is three years from the time when right to apply accrues. The counsel for the applicant submitted that since the present application has now been transferred to the IPAB, and the IPAB is not a Court within the meaning of Limitation Act, 1963, the provisions of the said Act do not apply to the present revocation application. The counsel submitted that upon conferment of powers to try and entertain the petition for revocation of patent by the IPAB, the IPAB became entitled to try and entertain a petition for revocation of impugned patent. The counsel contended that it is possible for the applicant to withdraw the revocation application filed before the Hon'ble High Court and file a fresh revocation application before the IPAB. In such an event the counsel argued that the Limitation Act would not apply as the applicant would be entitled to file revocation petition much in time. This would, the counsel contended, lead to multiplicity of proceedings in the interest of justice.
5. The counsel for the applicant submitted that if the contention of the respondent is accepted, then the revocation petition would be filed after three years from sealing of the patent irrespective of whether the applicant became aware of the grant of patent at a later date. The counsel contended that this would amount to reading into the Patent Act a limitation to filing application for revocation of patent which is impermissible. The counsel submitted that had the Legislative intent been to incorporate into the Patent Act such a limitation it would have made a provision to that effect. The counsel submitted that according to the Patent Act, there is no limitation prescribed for filing revocation petition before IPAB. Although a limitation of one year from the date of publication of grant is prescribed where the post-grant opposition is desired to filled before the Controller u/S 25(2) of the Patent Act. He referred to the decision of the Hon'ble Supreme Court in Balwant Singh v. Gurbachan Singh, (1993) 1 SCC 442 wherein it is held
“that the answer to the question when a right to apply accrues will depend on the facts and circumstances of each case. In paragraph 5 of the said judgment, after analyzing the facts of the said case in paragraphs 1 and 2 of the said judgment, the Court held that the right to apply accrued to the Petitioner when the Respondent tried to interfere in the possession of the Petitioner in the year 1973 and not in the year 1963 when an order granting symbolical possession to the decree holder was passed. Thus, the knowledge of the facts (in this case about the impugned patent) which would lead to filing of an application is relevant from the point view of the accrual of right to apply.”
The Petitioner relied upon to the judgment of the Hon'ble Kamataka High Court in Madappa v. Lingappa, AIR 1987 Kant 60. In paragraph 28 of the said judgment the Hon'ble Kamataka High court has held that:
“Thus these allegations and material on record would show that the revision petitioner came to know about the Court auction sale for the first time on 14-1975. Therefore, in my opinion, the limitation would start running from 14-1975 itself. The Miscellaneous Case has been filed on 3-12-1976 i.e well within three years from the date of coming to know about it.”
6. The counsel of Petitioner submitted that In view of above circumstances, the present petition is not barred by the law of limitation.
7. We agree with the applicant that section 64 of the Patents Act, 1970 does not provide any time limit for filing the application for revocation before Appellate Board. Section 64 states that “…….a patent whether granted before or after the commencement of this Act, may be revoked on a petition by any person interested …………..by the Appellate Board……..”. We do not agree with the argument of the counsel of the respondent that since the right to apply for revocation of the impugned patent accrued from the date of publication of notification of sealing on 13.01.2001 and the revocation petition filed in April 2004 is clearly beyond the limitation period of three years time under Article 137 of the Limitation Act, 1963 which expired on 13.01.2004 The right to revoke patent any time after the grant of patent under section 64 cannot be extinguished after three years from the date of the publication of the grant by applying limitation of three years under Article 137 of the Limitation Act. This will run contrary to the scheme of the patent law. It is immaterial as to when the applicant for revocation came to know about the existence of patent or when the right to revoke the patent accrued. Thus the application for revocation can be filed before Appellate Board any time after the grant of a patent. This application is therefore not time barred.
8. The applicant challenged the patent on the grounds of invention not being new invention, not having inventiveness, being obvious, insufficiency of disclosure and false suggestion. The applicant relies on US patents 3,950,553, 3,163,539, 3,809,769, 3,787590, 3,151,985, 3,787590, 4,156,024; GB 1311255, 1461726; the chapter 16 of a book titled ‘Tea and soluble tea products manufacture’ by N.D Pintauro, ‘Tea cultivation to consumption edited by KC Nicholas and M N Clifford; Perry's chemical Engineering hand book; Industrial and Engineering Chemistry by H A Pray, E E Schweickert and B H Minnich; Colloid Chemistry of black tea in food colloids by Harbon: Royal Society of chemistry.(Exhibits 1-14). Tata Tea Company interested in manufacturing and trading of cold water soluble instant tea powder is also engaged in research and development of various processes and methods for making tea and tea products including cold water soluble instant tea powder. The counsel for the applicant submitted that Patent No. 175964, 176202, 184077 in respect of inventions relating to machines for tea and tea products are owned by the petitioner. Hence the applicant is the person interested under section 64 of the Act.
Admissibility of Expert Evidence
9. The counsel of the applicant refers to and relied on the expert's evidence filed by Dr Madhvan Pillai.
Verification of affidavits
10. The counsel of the Respondent contended that affidavits referred to and relied upon by the Petitioner have not been properly verified and therefore should not be taken into consideration. The counsel, in support of his contention relied upon the judgments of the Hon'ble Supreme Court in A.K.K Nambiar v. Union of India, (1969) 3 SCC 864 : AIR 1970 SC 652 and V. Narayanaswamy v. C.P Thirunavukkarasu., (2000) 2 SCC 294 : AIR 2000 SC 694.
Petitioner's response
11. The counsel of the applicant submitted that the affidavits filed by the Petitioner are primarily in the form of opinions of the experts. According to the New Oxford Dictionary of English “opinion” means a view or judgment formed about something, not necessarily based on fact or knowledge; and “knowledge” means the theoretical and practical understanding of a subject; - Certain understanding as opposed to opinion. The verification of the said affidavits filed by the Petitioner have to be appreciated in light of the fact that they contain opinions and not the facts. Now, it is the facts which have to be either to the personal knowledge of the deponent or on the basis of information received by the deponent from the records or documents and the deponent has to disclose the source of information. However, in the affidavits filed by the Petitioner, since the deponents have expressed their opinion, the question of deposing facts to their personal knowledge or derived from any source does not arise.
12. The counsel of the applicant submitted that so far as the two judgments cited by the Respondent are concerned, the Hon'ble Supreme Court came to conclusion that the affidavits therein were not admissible in evidence due to the peculiar facts and circumstances of the respective cases. In the abovementioned first case neither the petition nor the affidavit in support of the petition containing allegations against the Chief Minister of Andhra Pradesh were verified by the Appellant (Paragraph 11 of the judgment). The Court held that the affidavit evidence assumed important in that case because of allegations of malafide on the part of the Respondent. The Court found that the Appellant had to prove either that the order of suspension was made malafide or that the order was made for collateral purpose (paragraph 12 of judgment). In the 2nd judgment, the Court held that in case of the election petition which was based on the rights, which were purely statutory and which statute rendered the particular requirement to be mandatory (paragraph 24 of the judgment), the Court could not exercise dispensing powers to waive non-compliance. The Court relied upon Sections 31, 83(1)(c) and 86 of the Representation Of The People Act, 1951 read with Rule 94- A of the Rules there under to hold that non-compliance of the said provisions would leave the Court with no option except to dismiss the petition. The Court further held that charge of corrupt practice being quasi-criminal in nature the Court must always insist on strict compliance with the provisions of law. The Court also held that where neither the verification of the petition nor of the affidavit gives any indication of the sources of information of the petitioner as to the facts stated in the petition which are not to his knowledge and the petitioner persists that the verification is correct and affidavit in the form prescribed does not suffer from any defect, the allegations of corrupt practice cannot be inquired and tried. Thus, issue before the Court was the verification of the facts which is not so in the present case. In the circumstances, both the judgments relied upon by the 1st Respondent are not applicable to the facts and circumstances of the present case. On the contrary, as held by the Hon'ble Supreme Court in Associated Journals Ltd. v. Mysore Paper Mills Ltd.., (2006) 6 SCC 197 : AIR 2006 SC 2695 Paragraph 23, Rules of procedure cannot be a tool to circumvent the justice. The Court held that assuming without admitting that the affidavit was not verified as per the Companies Rules, yet it was a technical plea which could not be considered to review the order passed by the Lower Court.
13. The expert evidence is one of the relevant facts which the court has to consider and while deciding the patentability of some inventions, this may be very crucial. It is observed that as a rule the experts called upon by the parties before us file affidavits. The verification clause in an affidavit is also essential. These affidavits are drafted by the advocates and if the verification clause is not properly drafted error lies on the part of the advocate. We are accepting the expert evidence in the present case although the verification is not properly done as it would not in any way make any difference in the opinion of the expert. This opinion is vital as it deals with the prior art, the common general knowledge in respect of this invention and why the expert is of the opinion that it is anticipated or not, it is obvious or not. Each expert gives his opinion and the reasons therefore and the Court/Board will apply its mind and decide how relevant the evidence is for proving the case. The experts are respected academicians in their fields and mere absence of verification in the affidavit may not desists us from taking into consideration of expert evidence which otherwise is meant to assist us. It will be against the principle of natural justice. However, we hope the members of the Bar will be more cautious to avoid such errors in future when they draft affidavits for experts to assist us.
Invention
14. Before we delve upon the merits of the case let us see what the invention in question relates to. This invention relates to a process of oxidation of the cold water soluble part of the tea infusion which is substantially free of cold water insolubles. Under the heading ‘Summary of the Invention’ the terms “cold water soluble tea solids” and ‘cold water insoluble tea solids’ are defined as “The term “cold water soluble tea solids” as used herein is intended to refer to substances present in a hot water infusion prepared from tea leaves, which substances remain soluble when the infusion is chilled to 3-10°C. In contrast, “cold water insoluble tea solids” is intended to refer to substances present in a hot water infusion prepared from tea leaves, which generally precipitate when the infusion is chilled to 3-10°C. Typically the aqueous mixture comprising cold water soluble tea solids will be derived or formed from the decreamed fraction of an aqueous tea infusion.
15. The specification discloses that the method of the invention may successfully be performed on aqueous mixtures comprising suspensions of cold water soluble tea solids in the range 0.3-20.0% (w/v). Conveniently a concentration in the range 3-10% (w/v) may be selected, which gives a reasonable amount of tea solids without making the solution unmanageably viscous. It also discloses that, “Black leaf tea infusions may be used to produce “instant” teas and other products which are preferably soluble in cold water.
16. It is known to separate the insoluble tea cream from the “decreamed” fraction (which is the term given to the cold water soluble materials after removal of the cold water insoluble cream). This is typically accomplished by centrifugation of the chilled (3-10°C) extract. The insoluble cream fraction represents a significant proportion of the tea fraction (which contains desirable flavour components) going to waste. It is known to treat this cream fraction, in number of ways to render it soluble in cold water and then to recombine the solubilized cream with the decreamed fraction.
17. The object of the present invention is to provide a process, applicable to the decreamed fraction of a tea infusion, which serves to improve the colour characteristics of the mixture. It also stated that the processing of the present invention on the cold water soluble portion hitherto discouraged yielded desirable and unexpected results. The present inventors claimed to have found that such processing has a highly desirable effect on the colour of mixture, which becomes much darker (i.e less luminous) and more highly red coloured, than mixtures which have not undergone the process of the invention. The specification further contended that this invention cannot be considered obvious because one skilled in the art would have no motivation to apply such a process to cold water soluble solids. In addition, the chemical composition of cold water soluble solids is very different to that of cold water insoluble solids, such that similar treatment of the two materials would not necessarily be expected to produce the same results.
18. The prior art disclosed by the patentee suggests that it is known to treat the cream fraction to prevent the cream fraction (which contains desirable flavour components) going to waste. “Various treatments of the cream fraction of tea infusions are described, for example, in GB 1,311,255, GB 1,461,726, US 3,787,590 and US 4,156,024. In particular, US 3,787,590 discloses a method of solubilizing tea cream, the method comprising oxidation of the cream using hydrogen peroxide (H2O2) in an autoclave at 240 °F (115.6°C) at 50 pounds per square inch (0.35 MPa), at a pH of 3.2
19. Further specification giving reference to a book titled “Tea and Soluble Tea Products Manufacture” (1977 Noyes Data Corporation, USA) by N.D Pintauro at page 96 disclosed a “batch reactor method” for solubilizing cold water insoluble tea tannins, the method comprising treatment with pressurized oxygen (2.1 to 14 kg/cm2, equivalent to 0.2-1.35 MPa) at a temperature of 71 to 107°C and at a pH in the range 5.5 to 7.5 According to the inventor these conditions are not sufficient to significantly increase the solubility of oxygen in the aqueous mixture, and the use of higher pressures is generally to be avoided because of the cost of creating and maintaining the necessary pressure. Additionally, in the method disclosed by Pintauro, bleaching with hydrogen peroxide is taught to reduce the amount of color formation.
20. In contrast to the foregoing, very little is known according to patentee about oxidation of the decreamed fraction of tea infusions, which contains the cold water soluble components. As the constituents of the decreamed tea are already soluble, there has been no motivation whatsoever to apply to decreamed tea those processes applied to the cream fraction for the purpose of solubilizing cold water insoluble material.”
21. The specification also disclosed that the process of the present invention is performed at the natural (acidic) pH of the cold water soluble tea solids composition, although the pH of the composition may be varied, if desired, without adverse effect.
22. Claim 1 of the patent is reproduced below:
“A method of making a tea composition, comprising treating an aqueous infusion of black tea that contain cold water soluble black tea solids but is substantially free of cold water insoluble black tea solids, with an oxidizing agent in a reaction vessel at a temperature and pressure in excess of the ambient temperature and pressure.”
GROUNDS OF REVOCATION:
ANTICIPATION [Section 64(1)(e)]:
Case of the applicant
23. According to the applicant it is case of the patentee that the starting material of the process contains variable quantities of the cold water soluble solids and cold water insoluble solids as the claimed process comprises of treating an aqueous infusion of black tea that contain cold water soluble black tea solids but is substantially free of cold water insoluble black tea solids. Thus the decreamed extract which is the staring material of the invention is not totally free from insolubles. Therefore this is very similar to the starting material for the processes for enhancing solubility and colour enhancement of tea extracts which contain the components of the creamed and de creamed parts known and published in the prior art.
Starting material is same
24. The counsel for the applicant argued that since the starting material is not a new material as the chemical species in the cream and de-creamed portion are same and the existing knowledge on oxidation of the cream is applicable to the de-creamed portion. Mr. Kane argued that the de-creamed tea extract is not free of tannins. The chemical contents of the cream and the de-creamed portion are the same differing only-in their percentages and therefore have the same oxidation chemistry. He argued that the subject matter of the alleged invention cannot be classified as ‘new invention’.
25. The counsel relied on the following documents to prove his point. The counsel submitted that teaching in Chapter 16 Instant tea by M Maltmarsh [D10] on page 545-546 (pages 75-76 of the compilation) quotes a paper by Roberts who identified caffeine, thearubigins, theaflavins in cream and showed that the cream formed from different teas are different. D10 further quotes a paper of Harbron (1989) “The Colloid chemistry of tea” [D12 in the compilation], who demonstrated that cream is a colloidal substance containing the same components as the extract.
26. According to the counsel Opening text of “Tea and Soluble Tea Products Manufacture” (1977 Noyes Data Corporation, USA) by N.D Pintauro (D9) under the heading Tannin-caffeine precipitate (cream) it is stated that
• Theaflavin-caffeine complexes are responsible for the astringency characteristics
• Thearubigin-caffeine complexes are less soluble than theaflavin-caffeine complexes and cause sedimentation and turbidity in tea beverages
• Thearubigins are produced, atleast in part as a further oxidation of theaflavins
• Theaflavins and Thearubigins are generally referred to as tea tannins and as a group account for about 25% of the water soluble ingredients in tea
• When tea extract is cooled a turbidity develops and in tea (instant tea) manufacture a heavy flocculent precipitate forms in extracts. Precipitate is called cream
• General practice in industry is to remove portion of tannins, leaving sufficient for complexing with caffeine to produce the desirable and characteristic astringency of brewed tea
• Tannins complexes with variety of chemical agents such as proteins, carbohydrates and with certain polyamides
• Oxidation cleaves tannin-caffeine insoluble complexes According to the counsel further teachings on page 87 of D9
• Tea extract when cooled at temperature below 100F (37 centigrade) clouding occurs. Separation of a part of the extracted solid material from the solution occurs
• Referring to graph on page 89 of D9 (i.e page 44 of the compilation), total soluble tea solids removed varies from about 4 to about 22 at temperatures from 35 degrees to 4.4 degrees centigrade.
27. Mr Kane submitted that when the temperature is held, equilibrium between the solution and the separated solids is reached. The expression equilibrium signifies that the species are both in solution and in the solid and that a dynamic exchange takes place at a constant rate at equilibrium. He further submitted that the general state of knowledge is that theaflavins produce orange-red colours and thearubigins produce red-brown colours.
28. According to the counsel even after de-creaming (i.e removal of the precipitated solids form the extract) at least 78% of the tea solids remain in de-creamed solution (refer Figure 4.1 in D9 page 49 corresponding to Page 44 of compilation). The equilibrated de-creamed solution contains substantial quantities of the theaflavin-caffeine complexes and thearubigin-caffeine complexes. He further submitted that the de-creamed portion and the cream both contain the same molecules but varying in their quantity. A person skilled in the art understands from the above that due to the differences in solubility of the various chemical species (in aggregated or non-aggregated form) the relative quantities of the species will vary in the de-creamed portion and in the cream depending on the temperature and time the tea extract is held. The counsel submitted that Claim 1 of the impugned patent is a restatement of known common knowledge of oxidation of known components of a tea extract.
Respondents reply
29. The Counsel for the respondent submitted that the chemical composition of cold water soluble solids is very different to that of cold water insoluble solids, such that similar treatment of the two materials would not necessarily be expected to produce the same results.
30. Let us see what the expert evidence states in this respect.
(a) Dr P Jose David [in support of opponent] in para 14 and then in para 18 repeated the ditto statement that
“It is well established that the general constituents of creamed and decreamed portions of the tea extracts are very similar and generally vary in terms of the percentage of these constituents.” Expert has not elaborated further on this aspect
(b) Dr R Seshadhri [in support of applicant] stated that
“In my considered opinion, the chemical nature of cream and decreamed extract are same and hence they follow similar chemistry. It is well known in Tea Chemistry that the aqueous tea extract contains TF molecules, TR molecules of various molecular weights, carbohydrates, caffeine, soluble chlorophyll degradation products, small quantities of unoxidised polyphenols and small quantities of soluble amino acids from protein degradation. The cream and decrearned extracts both contain these molecules, the only difference being their percentages. Caffeine and proteins form complexes with polyphenols and appear in colloidal form. When the tea extract is cooled, some of these colloidal substances begin to aggregate to form a larger amorphous mass spherical in shape leading to precipitation as cream. Cream is therefore a colloidal substance containing the same components as the tea extract. He particularly refered to Page 47 of RD Bee, MJ Izzard, RS Harbron and JM Stubbs! Food Microstructure, 6, 47-56 (1987), it states, “colloidal precipitate known as cream” and Tea cream is a colloidal precipitate formed by black tea liquors as the cool. In addition to the above mentioned publication, M Saltmarsh in the book on “Tea: Cultivation to Consumption” edited by K C Willson and M N Clifford, published by Chapman and Hall, U.K in 1992 on page 546 states “…, Cream (Tea cream) is a colloidal substance containing the same components of the extract (tea extract).” It is acknowledged that the process of creaming removes a part of caffeine, proteins and polyphenols as insoluble polyphenol complexes of caffeine and proteins and the extent of creaming depends on the temperature. Thus a decreamed extract is different from the whole extract only in tile relative content of these constituents.”
(c) Dr PD Virkar [in support of the respondent] disagreed with Dr Seshadhri Dr. David's in that the chemical nature of cream and decreamed extract are same and so they follow similar chemistry. Dr Virkar stated
“The constituents of the creamed fraction are generally known to contain TF molecules and TR molecules among a host of other compounds. Although it is true that, generally, the molecular weight of the compounds in the creamed fractions is higher than the decreamed fractions, this statement in no way renders a complete understanding or characterization of the hundreds, if not thousands of molecules in these fractions. To this day, TR molecules have not been fully characterized. In the absence of such knowledge, I say that, it is incorrect to say that “the cream and decreamed extracts both contain these molecules, the only difference being their percentages”. Such an averment is unfounded and unsupported by authentic details and authorities and is a result of presumption.”
31. However if we see the prior art documents Mr. Kane's argument that the decreamed and the cream fraction have same chemical nature is belied by the disclosure in the prior art that the cold water insoluble materials are known as ‘cream’ and consists essentially of highly colored tannin-caffeine complexes. ‘Tannin-caffeine precipitates’ (cream) essentially refers to all water insoluble solids and oxidation in fact is done to cleave the tannin-caffeine insoluble complexes. Harbron also discussed the morphology of the black tea cream where it is specifically stated that tea cream is a colloidal precipitate formed by black tea liquors as they cool. When this colloidal precipitate is removed by the centrifugation the supernatant solution will be free from the tannin-caffeine insoluble complexes. Even the experimental at page 90 in para under subhead electron microscopy it is stated that “for examining tea cream particles……….after allowing particle to fix………..they were spun ………..bench centrifuge ………5 min. The supernatant was then decanted and the particles were rinsed with distilled water.” In the introduction it is disclosed that “The composition of tea cream ……….is extremely complex and particles are known to contain quantities of all the substances present in the infusion from which it is separated. However major constituents are theaflavins, thearubigins and caffeine and it has been postulated that it is the complexation amongst these species that is responsible for tea cream formation.” In other words the supernatant will not have constituents such as complexation amongst these species. This also suggests that cold water soluble solids are different from the cold water insoluble solids as they do not contain the complexes of the Tannin — caffeine complexes which separate out as colloidal precipitate (tea Cream). Chilling of hot water tea extract results in precipitation of unoxidized tannins therefrom which on centrifugation separates out as colloidal precipitate (tea Cream) leaving behind pale coloured supernatant (de-creamed fraction). Having said so it is clear that the tea cream is different from the supernatant (de-cream). It is this supernatant (de-creamed fraction) which has been used by the impugned invention for treatment by the method claimed.
Substantially free
The position of the Applicant
32. It is the case of the applicant that the term “substantially free of cold water insoluble solids” is not defined in the specification therefore the patentee starting material is vague and non quantifiable. The counsel submitted that one therefore concludes that the starting material itself is an undefined material containing variable quantities of cold water soluble solids and cold water insoluble solids. The counsel submitted that the main contention of the petitioner is the lack of clarity of the term ‘substantially free of cold water insoluble black tea solids’ when describing the starting material subjected to the process of the invention claimed in the patent under revocation. Thus, according to the petitioner the lack of quantification of the term ‘substantially free’ would indicate that there could be the presence of a substantial amount of cold water insoluble black tea solids and therefore the starting material would be the same as that subjected to the prior art processes.
The Position of the Respondent
33. The counsel for the respondent submitted that the term ‘substantially free’ ought to be read as ‘essentially free’ and that the industrial process for centrifugation as available is such that it is not possible to render the cold water soluble fraction completely free of the insolubles. However, the soluble fraction is essentially free i.e the soluble fraction is substantially pure. Thus, the term ‘suspension’ as used in the specification of the patent under revocation ought to be understood in light of the fact that there may be trace amounts of cold water insoluble black tea solids present although cold water soluble fraction is essentially free of the cold water insoluble black tea solids i.e cold water soluble fraction substantially free of cold water insoluble black tea solids. Thus, the specification ought to be to be read in its entirety to understand the context of the words used therein.
34. The counsel for the respondent relied upon following authorities to demonstrate the manner in which terms such as ‘substantially free’ in patent drafting ought to be understood in context and on whether the claim delineates to a skilled artisan the bounds of the invention. The passages from page 5 under the heading “Said compound or Salt being substantially free of Other Isomers” to page 14 from Aventis Pharma Deutschland GMBH and King Pharmaceuticals Inc. v. Lupin Pharmaceuticals, Inc.; 2006 U.S Dist. LEXIS 31960 are placed to bring out the Rules of Claim construction and use of the phrase “substantially free of” and the Conclusion is set-out below for ready reference:
“C. “Said Compound or Salt Being Substantially Free of Other Isomers”
…………………………………….
IV. Conclusion
While the parties' [*47] arguments concerning “substantial” have been substantial, and while the Court's resulting analysis is not a pithy one, the Court has little difficulty concluding that “substantially free of other isomers” means what it says, namely, that the compound modified-ramipril-is largely free of other isomers and is not guaranteed to be 100% pure. For the reasons the Court has explained, the Court FINDS the following:
“A compound” is a fairly broad term meaning a chemically distinct substance formed by union of two or more ingredients (as elements) in definite proportion by weight and definite structural arrangement. “Said compound or salt being substantially free of other isomers” means that ramipril, the “said compound,” is largely but not necessarily free of other isomers. In other words, “substantially free of other isomers” qualifies the compound by indicating that it may not be 100% pure or 100% free of other isomers. The phrase “substantially free of other isomers” is not indefinite.”
The relevant passages from UCB Societe Anonyme and UCB Pharma, Inc. v. Mylan Laboratories, Inc, et al.; In the United States District Court For the Northern District of Georgia Atlanta Division; 1:04-cv-683-WSD (
B. (S)-enantiomer “substantially free” of (R)-enantiomer
1. Claim language
The Court begins its construction of the phrase at issue with the express language of Claim 1, which provides: “(S)-[enantiomer] substantially free of R- [enantiomer].” (‘639 patent, col. 10, 11. 18-20.)5 The term “substantially” is commonly used in patents. “[W]ords of approximation, such as ‘generally’ and ‘substantially,’ are descriptive terms commonly used in patent claims to avoid a strict numerical boundary to the specified parameter.” Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc., 340 F.3d 1298; 1310-11 (Fed. Cir. 2003) (quotation and citation omitted). To the extent the term “substantially” has been interpreted to have more than one meaning, the “cases recognize the dual ordinary meaning of this term as connoting a term of approximation or a term of magnitude.” Deering Precision Instruments, L.L.C v. Vector Distribution Sys., Inc., 347 F.3d 1314, 1323 (Fed. Cir. 2003); see also Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1366 (Fed. Cir. 2001) (“[O]rdinarily ‘substantially’ means considerable in extent, or largely but not wholly that which is specified.”). Here, the claim language urges interpreting the term “substantially” within the phrase “substantially free” as a term of approximation. 6 See Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1031 (Fed. Cir. 2002) (“The phrase ‘substantially constant’ denotes language of approximation, while the phrase ‘substantially below’ signifies language of magnitude, i.e, not insubstantial.”); see also Deering, 347 F.3d at 1323 (noting the term “substantially” has numerous definitions, including, inter alia, “largely” or “essentially”). That is, “substantially” is used to modify and qualify the word “free” with which the term “substantially” is associated. This interpretation is consistent with the manner in which the word is customarily defined. See Blacks Law Dictionary, 1428 (6th ed. 1990) (defining substantially as “essentially, without material qualification, in the main”); Webster's Encyclopedic Unabridged Dictionary 1897 (1 ed. 2001) (defining “substantial” as “of or pertaining to the essence of a thing; essential, material, or important”).
The ordinary and customary meaning of “free” is without, or devoid of. This comports with the relevant definition of “free,” which is “uncombined chemically” or “not containing a specified substance.” Webster's Encyclopedic Unabridged Dictionary 763 (1st ed. 2001). Because the claim language explicitly ties the adverb “substantially,” used as a term of approximation, to the adjective “free,” the ordinary meaning of the phrase “substantially free” necessarily envisions some amount of deviation from a completely free state. See Anchor Wall Sys., Inc., 340 F.3d at 1311 (holding the phrase “‘generally parallel’ envisions some amount of deviation from exactly parallel”).
How to Write a Patent Application; Jefferey G. Sheldon; Incorporating Release No. 18, April 2006; Practising Law Institute New York City, pages 6-108 to 6-110:
“§ 6.5.12 Use of “About” and other terms of Approximation
Terms of approximation are frequently used in the claims when the invention does not lend itself to absolute precision. For example, the word “about” is commonly used in claims where there are no numerical limitations, to indicate that the precise number is not critical. Typical uses include:
• a temperature of from about 50°C to about 60°C
• a temperature of less than about 60°C
• at a pressure greater than about 2 atmospheres
• a distance of at least about 60 centimeters
Generally the use of the word “about” does not render a claim indefinite. The term “about” has an ordinary meaning of “approximately” in the absence of a clear expression and description to the contrary. 158:1 Moreover, use of “about” is helpful during litigation to broaden the scope of a claim. However. Use of “about” does not create difficulties when prosecuting an application. It is more difficult to argue that a particular numerical limitation is critical to the patentability of an invention when the word “about” is sued. For example, if the prior art teaches operating a process at 80°C and the claim uses the language “less than about 75°C,” it is more difficult to argue for the criticality of the 75°C limitation than if the claim merely said “less than 75°C.” A claim requiring use of a bath having a cyanate content of between “about 25 and 40%” encompasses a bath having a cyanate content in the range of 46 % and 50%,159 but the phrase “about 40:1” does not encompass a four-fold increase to 162.9:1.160
Use of “about” inevitably results in some ambiguity in a claim since it “avoids a strict numerical boundary to the specified parameters.”161 It is clear that use of the word “approximately” broadens the scope of a claim. 162 and accordingly, use of “about” likewise broadens a claim.
The use of “about” to broaden a claim term can backfire if it is not used throughout a claim. A numerical limitation in a claim that does not use “about” has been narrowly construed when other numerical limitations in the same claim used “about.”162.1
The term “generally” can be used to impart a lack of precision to a claim, such as “generally parallel” envisioning some amount of deviation from exactly parallel.162.2
The claim language “generally convex” means that a majority of points are convex.162.3
The term “substantially” can be a term of approximation or a term of magnitude. For example, the phrase “substantially constant” can be language of approximation, while the phrase “substantially below” can signify language of magni-tude, that is, not insubstantial.162.4
The term “substantial” can be a modifier that implies “approximate” rather than “perfect.” Thus “substantially flatened” rather than “perfect.” Thus “substantially flatened” requires neither a perfectly flat surface nor one that is flat within a manufacturing tolerance.162.5”
35. If we apply the definition of term ‘substantially free’ used in the patent specification as understood in above case laws it would mean that presence of traces of water insoluble solids in the supernatant cannot be eliminated. We do not agree with Mr Kane that the term ‘substantially free’ would indicate that there could be the presence of a substantial amount of cold water insoluble black tea solids. In no case it could mean to represent the presence of a substantial amount of cold water insoluble black tea solids in the supernatant liquid.
Case of the applicant for anticipation:
Publically known and publically used
36. The counsel for applicant submitted that the invention so far as claimed in any claim of the Complete Specification was not new, having regard to what was publicly known or publicly used in India before the priority date of the claim or to what was published in India or elsewhere.
37. The counsel for the respondent submitted that applicant has failed to appreciate that such a ground of prior public knowledge and use has to be exclusively within India and the applicant has merely made statements without any proof thereof of prior public knowledge or use in India. We agree with the respondent that in absence of conclusive evidence of public use within India this ground fails.
Anticipation - Prior Art
38. The Counsel for applicant relied on the 14 prior art documents listed in para ante to prove that the invention claimed in the impugned patent anticipated. He argued that since the cream and de-creams fraction follows the same oxidation chemistry the impugned invention is fully disclosed in and/or is anticipated by various prior publications, as also in the literature. The counsel submitted that he has established that the alleged invention was anticipated on the relevant date based essentially on a single document namely D9 which clearly teaches that the cream portion among other components contains TF, TR, Caffeine which are also present in the de-creamed portion. The same reference also discloses that oxidation of the TF and TR lead to the enhancement of colour (please see pages 90-98 of D9 corresponding to pages 45-53 of the compilation). He argued that a person skilled in tea chemistry and equipped with the common general knowledge inherently based on D9 anticipates the enhancement of colour of the de-creamed portion on oxidation. The person skilled in the art of tea chemistry therefore inherently anticipates that the de-creamed extract which contains theaflavins and thearubigin caffeine complexes, on oxidation will lead to colour development, due to the increase in chromophores (supported by affidavit of Prof Pillai in which he discusses the creation of chromophores during oxidation) as a result of oxidation of the de-creamed portion. Additionally the other cited prior art provide details of the oxidative chemistry of the cream that a person skilled in the art is aware of prior to the date of application of the patent under revocation which further supports his inherent anticipation. According to the counsel Illustrative teachings from cited prior art on oxidation on cream portion under diverse conditions to darken colour:
• Oxidation of solubilised cream (therefore containing the tannins TF and TR) are carried out both in alkaline and acidic conditions above ambient temperatures and pressures using oxidising agents that include oxygen, ozone and hydrogen peroxide leading to darkening of the solutions.
• US 3950553 (D1) teaches oxidative solubilisation of cream which is initially dispersed in aqueous medium that is mildly basic and then oxidising the same using oxidising agents, preferably oxygen at temperature of atleast 50@C and stopping the reaction when the pH reaches 5-6 after which the solution exhibits a darkened colour. The first step in the mildly alkaline medium induces solubilisation and then the oxidation proceeds to create acidic conditions under which the oxidation continues.
• US 3151985 (D4) teaches oxidation of tannin solutions at pH 5.5 to 7.5 in the presence of oxidising agents oxygen, ozone, hydrogen peroxide at operating pressure of 2.1 to 14 kg/cm2 at 71-110 degrees centigrade when the colour of the solution darkens US 3787590 (D5) teaches oxidation of cream at pH (2 - 3.5) in the absence of alkali at a temperature of 88 to 132@C at 50 psi pressure using hydrogen peroxide, oxygen or ozone as oxidising agent.
• US 4156024 (D6) teaches oxidative solubilisation at pH 4.5 to 6 using oxygen as an oxidising agent, wherein the oxygen partial pressure is 5-50 kg/cm2 at 80 to 100 degrees centigrade. After the reaction the solubilised or oxidised tannins are ordinarily somewhat darkened in colour as compared to native or unoxidised tannins.
• GB 1311255 (D7 teaches oxidation of cream with oxygen or air at a temperature of 35 to 80 Deg C at pH of 9 - 10, to get a solution that is too dark and therefore needs to be bleached using sulphite to achieve the a good colour intensity and redness. This prior art therefore teaches that oxidation under very high alkaline medium is to be avoided.
• GB 1461726 (D8) teaches oxidation of cream initially at mildly basic condition pH (7 - 9) using oxygen or ozone or hydrogen peroxide at temperature between 60 to 120 Deg C when the pH of the medium falls as the tannins get solubilised and the reaction is allowed to continue for sometime at pH reaching 5 - 8 preferably in the acidic range of 5 to 6 when the reaction is stopped.
• D9 under the heading “Oxidation Processes” from page 90 to 104 (page 45 to page 59 of the compilation) discloses oxidation of the cream and solubilised cream under acidic and alkaline conditions, at temperatures and pressures above ambient using oxidizing agents such as oxygen, ozone, hydrogen peroxide including dissolved and/or entrained oxygen.
• It has been reported in prior art (GB 1311255) that the decreamed portion has a pale colour.
39. The counsel submitted that the de-creamed extract contains theaflavin and thearubigin caffeine complexes, which on oxidation leads to colour improvement as explained above. Thus a person skilled in the art expects that the colour will get enhanced when the de-creamed portion is oxidised.
Response of the respondent
40. The counsel for the respondent submitted that the chart indicating the difference between the invention claimed in the respondent patent and the prior artis given below.
41. The counsel for the applicant submitted that the differentiation of the said prior art documents is set-out in a Table below which identify the features of the patent under revocation and the distinguishing features of the prior art patent documents relied upon by the petitioner
Patent Number
What is the patent about?
Treating what?
What kind of treatment?
Temperature and/or pressure?
Effect of the invention
Distinguishing feature
Patent under Revocation (184038)
Method of making a tea composition
Aqueous infusion of black tea that contains water soluble black tea solids (substantially free of cold water insoluble tea solids)
Reaction with an oxidizing agent
In excess of ambient temperature and pressure (60°C to 160°C, 0.11 4.0MPa)
Improved colour of the product (a value, which means the redness of the liquor)
Concerned with the treatment of the soluble fraction for improving colour characteristics.
D1 US3950553
Improved process for producing a soluble tea product
Tea cream (tannins) which precipitates out while chilling the tea infusion.
Oxidizing the cream and then combining it with the unoxidized fraction (equilibrium) to decolourize the oxidized (darkened) tannins.
50°C to 90°C
Decolourizatlon of the darkened tannins.
Concerned with the treatment of the insoluble part and not with the soluble part.
D2 US3163539
Process of preparing instant tea
The cold water insolubles
Cold water insolubles are rendered soluble in cold water by treatment with ‘NaOH, KOH or NH4OH preferably in presence of molecular oxygen.
Preferably carried out at atmospheric pressure and at a temperature within the range of about 110 to 160°F.
Make the insolubles to a soluble product.
Concerned with the treatment of the insoluble portion and not with the soluble portion. The object is to make the insoluble portion soluble.
D3 US3809769
Treatment of spent tea leaf
Spent tea leaf
Treating the spent leaf with an oxidizing agent like H2O2. O3 and O2.
240 to 260°F.
Improve the yield of soluble solids.
Concerned with the treatment of spent leaf to improve the yield of soluble solids.
D4 US 3151985
Improved process for preparing a cold water soluble powdered tea extract.
The cold water insolubles (tannins)
Tannins are subjected to oxidation reaction by adding oxygen, oxygen containing gas, ozone, hydrogen peroxide etc in presence of alkali.
Oxidation by Continuous column method: 71- 107@ C at a pressure of 8.5 kg/cm2. Oxidation by Batch Reactor method: 71- 107° C at a pressure of 2.1-14 kg/cm Oxidation by Stagewise solubilization method: 71- 107° C at a pressure of 2.1 - 14 kg/cm The aforesaid oxidation (solubilization) is followed by bleaching
To overcome the problem of the prior arts associated with introduction of considerable amount of foreign matter into the final product when recovering tannins by addition of alkali sulfites.
Concerned with the treatment of the insoluble part and not with the soluble part.
D5 US3787590
Increasing the yield of soluble tea solids
Tea cream
Increased yield of soluble lea solids are obtained by oxidizing the cream in absence of alkali.
190 to 270°F (88° to 132° C)
To improve the yield of soluble solids.
Concerned wilth the treatment of the insoluble part and not with the soluble part.
D6 US4156024
Process for increasing the solubility of tea products
Tea cream (Tannins)
Increased yield-of soluble tea solids are obtained by oxidizing the cream without addition of substantial amounts of alkaline and/or acidic agents.
80°C to 11°C.
To stop the losses caused because of discarding insoluble tannins and to improve the yield of soluble solids.
Concerned with the treatment of the insoluble part and not with the soluble part.
D7 GB13H255
Cold water soluble tea extract and process for preparation of the same.
Tea cream
Treatment of cold water insoluble tea solids at alkaline pH with a sulfur compound selected from sulfur dioxide, sulphurous acid, a sulphite or a bisuiphate.
25 to 80@C
If the cream fraction is discarded, the remaining de-creamed material (although cold water soluble) is characterized by an unsatisfactory visual and organoleptic property. To stop this loss was the target of this invention.
Concerned with the treatment of the insoluble part and not with the soluble part.
D8 GB1461726
Improved process for preparing a soluble tea product
The cream (Tannins)
Tannins are solubilized under conditions which are initially only mildly basic and which becomes more acidic, incident to oxidation of tannins. These are then mixed with the solubilized part in order to reduce the darkening that is produced while oxidation of tannins.
At least 50°C.
The invention eliminates the addition of additional bleaching agent required to subside the darker colour of solubilized tannins.
Concerned with the treatment of the insoluble part and not with the soluble part.
Non-Patent Literature:
42. In respect of non patent literature the counsel for the respondent submitted as follows:
1. Document number 9 which is a chapter “TANNIN-CAFFEINE PRECIPITATES (CREAM)” from the book “Tea And Soluble Tea Products Manufacture” by Pintauro the counsel for the respondent submitted that this document like the previous prior art documents is directed to removal of cold water insolubles i.e de-creaming followed by solubilization of the cream component. Various processes for precipitation as well as for solubilization and decolourization of the oxidized cream component is outlined in detail in the aforesaid document. It is also taught in this document that (page 93 of the article) that “the oxidation produces a darkening of the tannins. To restore the original tea color, it becomes necessary to bleach the product after oxidation”. The document is concerned with the treatment of the cold water insoluble solids and not with the cold water soluble part.
2. Regarding Document D10 (Tea Cultivation to Consumption; K.C Willson & M.N Clifford Chapter 16; Instant Tea by M. Saltmarsh)thecounsel for the respondent submitted that this document relates to the process for the production of instant tea which consists of the following operations: selection of raw materials, extraction; aroma stripping; cream processing; concentration; and drying. The document like previous prior art documents is concerned with treating the tea cream (which contains caffeine, theaflavins and thearubigins) by solubilizing it and then bleaching. This document is concerned with the treatment of the insoluble part and not with the soluble part. The document teaches how to produce instant tea i.e how to solubilize the cream fraction for increasing the yield of the instant tea product.
3. In respect of Document D11 (Chemical Engineers' Handbook; John H. Perry; Fourth Edition) the counsel submitted that this document is a very important handbook for chemical engineers. This book is used to calculate different values required for design purposes. The document provides a reference for the values for maximum solubility of oxygen in water at elevated pressure at a given temperature. He added that in a process is it not possible to measure everything, that's why this book comes into the picture. By using some equation and providing value of some parameters measured in a particular process, one is able to calculate some other parameters (like dissolved oxygen concentration). It is a well-known practiced procedure in processing industry.
4. According to the counsel Document D12 (The Colloid Chemistry of Black Tea by R.S Harbron, R.H Ottewill, R.D Bee relates to the colloid chemistry of black tea. The document is a report on the investigation of the colloidal properties of tea cream particles. This document discloses that the coagulation and electrophoretic behaviour of the tea cream particles indicate that their behaviour is essentially that of lyophobic colloids, even though the particles contain a considerable proportion of water. It is related to black tea chemistry and the cream treatment. It discloses about the electrochemical behavior of tea cream. This document does not at all disclose the treatment of the soluble fraction.
5. The counsel submitted that Document D13 (Solubility of Hydrogen, Oxygen, Nitrogen, and Helium in Water At Elevated Temperatures; H.A Pray et al) relates to solubility of hydrogen, oxygen, Nitrogen and helium in water and provides a reference for the values for maximum solubility of oxygen in water at elevated pressure at a given temperature. The document makes no reference to tea let alone cold water soluble tea solids and insolubles.
6. Document D14 (The Morphology of Black Tea Cream; Food Microstructure, Vol. 6 (1987), pp 47 to 56) according to the counsel is related to colloidal tea 15 chemistry and is concerned with the chemistry of tea cream. It provides an overall view of chemistry of tea cream e.g the particle size, the chemical nature, the process of preparation of cream etc. It doesn't at all whisper about the treatment of the soluble part to produce a rich red colored tea product.
43. The counsel for the respondent contended that it is evident that none of the 14 prior art documents anticipates the invention claimed in the patent under revocation. Instead, the petitioner has sought to interpret the term ‘substantially free’ out of context in order to artificially seek to meet the requirement of anticipation. It is submitted that the prior art document ought to be clear and unambiguous in its disclosure so as to anticipate, which is clearly not the case.
44. The counsel submitted that the respondent throughout its submissions stated that the constituents of the cold water soluble and insoluble tea solids especially with respect to the types of thearubigins (TR) molecules (an important molecule) in these fractions have not been completely characterized. The chemistry with regard to TR molecules is not wholly understood in the tea science and therefore there is no basis made out for making a sweeping statement that with varying quantities of the solubles and the insolubles, the chemistry will not change. Furthermore, the structure and molecular weights of the molecules may differ largely and therefore it is not correct to say that the cream and decreamed extracts both contain the same molecules and that the reactions carried out with respect to the decreamed and cream extracts are same and follow the same chemistry. Dr. David Jose in his affidavit dated 3rd December 2008 in paragraph 18 of his affidavit expressly states that, “It is accepted that the understanding of the chemistry is not complete…..” and yet conclusive statements are sought to be made in respect of the chemistry of the two fractions especially of TR molecules which are not fully characterized. Thus, the behaviour in the soluble and insoluble fractions can at best be speculative.
45. The counsel submitted that the express teachings of the various prior art documents in respect of the two fractions are setout below for ready reference:
“TANNINS”, “COLD WATER INSOLUBLES” and “TEA CREAM” AS DESCRIBED BY THE PRIOR ART DOCUMENTS OF THE PETITIONER
Document 1 (US3950553):
Column 1 paragraph 3 discloses that, “During the production of tea products, substances of varying solubility in cold water are extracted from the tea leaves. One fraction of the extracted solids is readily soluble in cold water. A second fraction, referred to herein as the tea “tannins”, is essentially insoluble in, and separable from, cold water. The constituents of this second fraction are not necessarily all tannins in a chemical sense, but they behave as tannins and are customarily and collectively referred to in the art as “tannins”.”
Document 2 (US3163539):
Column 1 discloses that, “One commercial method used heretofore to prepare instant tea involves making a hot water extract of tea leaves which is dried, either as such, or after it has been concentrated. Generally, the leaf tea blends used in this method include a significant proportion of black tea in order to obtain the flavor characteristics…… Products obtained in this manner from partially or fully fermented tea are largely insoluble in cold water and, therefore, are not suitable for the preparation of iced tea…….The cold-water insoluble portions of such of such instant teas are of a complicated and not fully characterized nature. They are highly colored and are comprised of polyphenols and polyphenyl quinines of various types, flavonol glycosides, and complexes of the polyphenols and flavanol glycosides with caffeine and the other purine alkaloids occurring in tea. Depending upon the processing conditions and upon the particular blend of leaf teas employed, the instant tea produced in the above described manner may contain between 3% and 35% by weight of cold-water insoluble materials….. However, the removal and discarding of cold-water insoluble constituents entails a considerable loss of yield as well as of valuable flavoring and coloring constituents. Moreover, beverages made from these instant teas are characterized by a very light, pale color, and lack the astringency and body which are typical of freshly brewed tea.”
Document 3 (US3809769):
Document relates to treating of spent leaf. No specific definition of insolubles. The document however discloses in column 2 lines 35 to 42, “…….treating insolubles to recover soluble material therefrom……”
Document 4 (US3151985):
Column 1 discloses, “This invention relates to a new and improved process for preparing a cold water soluble powdered tea extract, and more particularly to the preparation of a powdered tea extract which is easily and completely soluble in water having a temperature ranging between 5 and 15°C, to form a clear aqueous solution which may be chilled to 0°C, without precipitation of any tea solids… When referring to cold water in the following specification, it is referred to water having a temperature of substantially 5 and 15°C………………During the production of instant tea, substances of varying solubility in cold water are extracted from the tea leaves. One fraction of extracted solids is immediately soluble in cold water. The second fraction, referred to here as “tea tannins,” is partially or wholly insoluble in cold water. Cold water soluble tea extracts may be produced by separating the second fraction from the cold water soluble fraction, concentrating the cold water soluble fraction and spray drying it. Thus, the insoluble fraction is discarded….”
Document 5 (US3787590):
Column 1 under the heading ‘Abstract of the Disclosure’, “An increased yield of tea solubles is obtained by subjecting the insoluble precipitate or tea cream obtained by cooling a dilute tea extract to an oxidizing treatment in the absence of added alkali”.
Document 6 (US4156024):
Abstract, “Raw tea tannins which are cold-water insoluble are catalytically oxidized to improve their solubility. The oxidized tannins may then be employed in tea beverages products which are more convenient and desirable.”
Column 1 paragraph 1 under the heading ‘Background Of The Disclosure’ discloses, “One fraction of the extracted solids is readily soluble in hot or cold water. The remaining fraction, referred to herein for convenience as tea “tannins”, is soluble in hot water but essentially insoluble in cold water. The constituents of this second fraction are not necessarily all tannins in a chemical sense, but behave as tannins and are customarily and collectively referred to in the art as “tannins”. “….. Cold and iced tea drinks containing these raw or native tannins, however, are rendered less desirable by the precipitation and cloudiness resultant from their solubility limitations…..”
Document 7 (GB1311255):
Column 1 discloses that, “It is well known that a tea extract prepared by hot water extraction of tea leaf contains materials which precipitate out on cooling and are capable of giving an ice tea beverage an undesirable turbid appearance. These cold water insoluble materials are known as ‘cream’ and consist essentially of highly coloured tannin-caffeine complexes……If the cream is discarded, the remaining decreamed material, although cold water soluble, is characterized by an unsatisfactory pale colour and an unnatural aroma, body and flavour, as compared with freshly brewed tea…..”
Document 8 (GB1461726):
Column 1 discloses that, “During the production of tea products, substances of varying solubility in cold water are extracted from the tea leaves. One fraction of the extracted solids is readily soluble in cold water. A second fraction, referred to herein as the tea “tannins”, is essentially insoluble in, and separable from, cold water. The constituents of this second fraction are not necessarily all tannins in a chemical sense, but they behave as tannins and are customarily and collectively referred to in the art as “tannins”.”
Document 9 (Tea and Soluble Tea Products Manufacture; Nicholas D. Pintauro):
Paragraph 1, 2 and 3 on page 37 of the compilation of documents discloses that, “Theaflavins and thearubigins are generally referred to as tea tannins and as a group they account for about 25% of the water-soluble ingredients in tea leaves………When a tea extract is cooled a turbidity develops and in tea manufacture a heavy flocculent precipitate forms in extracts. This precipitate is commonly called cream and normally it has to be removed or solubilized for tea extract concentrates or for tea powders. Soluble tea is widely used for iced beverages and the cream will cause objectionable turbidity or sediment in the iced beverage. The general approach to this problem is to remove a portion of tannins, leaving sufficient for complexing with caffeine to produce the desirable and characteristic astringency of brewed tea. Tannins can be complexed with a variety of chemical agents such as proteins, carbohydrates and with certain polyamides. Other processes involve procedures to solubilize the cream or for oxidation to cleave the tannin-caffeine insoluble, complexes.” Thus, clearly the document teaches that the tannins left behind are done so deliberately. The document also discloses the treating of a fraction referred to as tea tannins which are essentially insoluble in, and separable from, cold water to render it soluble and even bleaching so that the desired characteristics such as color can be achieved (Page 54 of the compilation of prior art document)
Document 10 (Tea Cultivation to consumption; K.C Willson and M.N Clifford; Chapter 16: Instant Tea; Saltmarsh): Paragraph bridging pages 74 and 75 of the compilation of prior art documents, “When a solution of tea cools down it becomes opaque and changes to pale brown in a phenomenon known as ‘creaming’. This was first described by Roberts (Roberts, 1963) who identified caffeine, theaflavins and thearubigins in cream and showed that tea can be characterized by the amount of cream formed on cooling. Smith (1968) has shown that the amount of cream formed in different teas differ even though their caffeine contents are similar. Rutter and Stainsby (1975) demonstrated the heterogeneous nature of tea cream, and showed that a cold water extract does not cream………..”
Document 12 (The Colloid Chemistry of Black Tea; R.S Harbron, R.H Ottewill, R.D Bee):
Paragraph 1 on Page 89 of the compilation of documents, “When infusions of black tea, prepared using hot water, are allowed to cool a colloidal dispersion is formed which is commonly termed ‘tea cream.’ The composition is extremely complex and the particles are known to contain quantities of all the substances present in the infusion from which it separated. However, it has been established that the major constituents are theaflavins, thearubigins, and caffeine, and it has been postulated that it is the complexation amongst these species that is responsible for cream formation….”
Document 14 (The Morphology of Black Tea Cream; R.D Bee, M.J Izzard, R.S Harbron and J.M Stubbs; Food Microstructure, Vol. 6 (1987), pp. 47–56: Column 2, “Tea cream is a colloidal precipitate formed by black tea liquors as they cool…….Tea cream composition is known to be complex. It has been reported by Roberts (8) to consist largely of a mixture of theaflavins, thearubigins and caffeine. It also contains other components such as bisflavanols, unoxidised flavanols, pectin (9), caffeine, gallic and ellagic acids and several other compounds (14, 18). In addition, non-caffeine nitrogen and chlorophyll…… Specific interactions between caffeine and polyphenols resulting in their incorporation into the tea cream phase have also received much attention 9, 14).”
46. The counsel argued that the applicant has thus all along been relying on documents which either expressly disclose the complete removal of ‘tannins’ or deliberately leaving behind a portion of tannins in the cold water soluble fraction, which art defines the tannins as ‘cold water insolubles’ and also defines it as ‘tea cream’.
47. The counsel argued that the suggestion of the applicant that the cold water insoluble fraction which have a specific composition would behave chemically in a manner that is similar to cold water soluble fraction which has its own specific composition is without taking into consideration the various factors and chemical interactions and lack of characterization of many components especially when the art is express in differentiating the two fractions and it is clearly an artificial attempt at portraying anticipation. The counsel submitted that since the prior art considered treating the insoluble fraction as imperative as the soluble fraction does not provide the necessary characteristics and hence the two fractions are essentially different.
48. The counsel for the respondent submitted that various authorities relied upon by the applicant to demonstrate the essential requirement required to make out a case of anticipation and which the petitioner has miserably failed to achieve are set-out below.
In the matter of Lowndes' Patent; Reports of Patents, Design and Trade Mark Cases; Vol. XLV no. 2, page 57:
“Before examining the question as to whether this allegation of disclosure in those prior art documents is well founded, it may be well to make this observation, that I think, that, where an application is being made for the revocation of a patent which has been granted, there is no doubt that the applicant is under the duty or burden of making out his case in the clearest way. It seems to me that that must follow from the very nature of the proceeding. This may also be said, that where you are seeking to rely upon disclosure, it is not open to you to take a packet of prior documents and, as it were, by means of some process of putting a puzzle together, produce what you say is a disclosure in the nature of a combination of the various elements which have been contained in the prior documents. I think it is necessary to point to a clear and specific disclosure of something which is said to be like the patentee's invention, there is a description of its use and the manner in which the patentee intends it to be read.”
In General Tire & Rubber Co Ltd, Sachs LJ stated (at pp. 485–486):
“If the earlier publication, so construed, discloses the same device as the device which the patentee by his claim, so construed, asserts that he has invented, the patentee's claim is anticipated, but not otherwise. ….The earlier publication and the patentee's claim must each be construed as they would be at the respective relevant dates by a reader skilled in the art to which they relate having regard to the state of knowledge in such art at the relevant date…. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented. … A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must clearly be shown to have planted his flag at the precise destination before the patentee.”
In the judgment of Verathon Medical (Canada) ULC v. Aircraft Medical Limited [2011] CSOH the following passages are relevant:
[130] The notion behind anticipation is that it would be wrong to enable a patentee to prevent a man from doing what he has lawfully done before the patent was granted: Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd (supra), Oliver LJ at p. 77. [131] A challenge to validity based on anticipation requires the court to address two concepts, namely, prior disclosure and enablement. In Arrow Generics Ltd v. Akzo NV 2008 SC 518; the Lord President (Lord Hamilton) at paragraph 104 stated:
“A party seeking revocation of a patent on the ground that it has been anticipated by the prior art has to satisfy the court on two points, namely, whether the prior art disclosed the invention which had been patented (‘disclosure’) and whether the ordinary skilled man would be able to perform the disclosed invention if he attempted to do so using the disclosed matter and common general knowledge (‘enablement’) (see Smith Kline Beecham, per Lord Hoffmann, para 14).”
49. The counsel for the respondent contended that from the aforesaid authorities, it is evident that various authorities has defined the ingredients of anticipation in different words but all leading to the same conclusion. The authorities above go to laydown:
• A claimed subject-matter would lack novelty only if it were derivable as a whole directly and unambiguously from a prior art disclosure and if a “clear and unmistakable teaching” of the combination of all claimed features (and not only the essential ones) could be found in said disclosure.
• The earlier publication should disclose the same device as the device which the patentee by his claim asserts so as to be anticipated, but not otherwise.
• To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented.
• A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must clearly be shown to have planted his flag at the precise destination before the patentee.
• A challenge to validity based on anticipation requires the court to address two concepts, namely, prior disclosure and enablement.
• A party seeking revocation of a patent on the ground that it has been anticipated by the prior art has to satisfy the court on two points, namely, whether the prior art disclosed the invention which had been patented (‘disclosure’) and whether the ordinary skilled man would be able to perform the disclosed invention if he attempted to do so using the disclosed matter and common general knowledge (‘enablement’) The petitioner has failed to satisfy any of the conditions of lack of novelty as laid down by various authorities and therefore the ground of lack of novelty clearly fails.
50. The case of the applicant is resting on the basic premise that de-creams and cream fraction is same. Since we have already stated in para ante that de-cream and cream fraction is not same. We have no hesitation to hold that the claimed invention is not anticipated by the prior art citations D1, D4-D7, D9 as all these citations disclose and are related to oxidation of the cream fraction only. Therefore the case of the applicant falls on anticipation.
OBVIOUSNESS AND LACK OF INVENTIVE STEP [Section 64(1)(f)]:
Applicants Argument
51. The counsel for the applicant contended that the teachings from above cited prior art on oxidation of cream portion under diverse conditions leads to darken colour. According to the counsel the de-creamed extract also contains theaflavin and thearubigin caffeine complexes, which on oxidation leads to colour improvement. He further submitted that the Oxidation of solubilised cream (therefore containing the tannins TF and TR) is carried out both in alkaline and acidic conditions above ambient temperatures and pressures using oxidising agents that include oxygen, ozone and hydrogen peroxide leading to darkening of the solutions. He relied on the D1, D4-D8, D9 to prove claimed invention is obvious.
52. The counsel for the applicant submitted that impugned patent stated on page 8 lines 10-11, that “Generally prior art teaches the oxidation of the tea cream is performed at alkaline pH.” However, the continuing sentences on page 8 lines 11-15 also state “In contrast, the process of the present invention may be performed at neutral (acidic) pH of the cold water soluble tea solids composition, although the pH of the composition may be varied, if desired without adverse effect. The patentee in the specification does indicate the insensitivity of the process of oxidation to the pH conditions. The prior art cited clearly demonstrate the diverse pH conditions under which the oxidation of the tannins can be carried out to enhance colour. Thus a person skilled in the art expects that the colour will get enhanced when the de-creamed portion is oxidized.
Respondents reply
53. The counsel for the respondentsubmitted that applicant alleges that the patent under revocation is obvious since the entire process is well known in the prior art and at the same time alleges that it is insufficient. Thus clearly contradicting itself.
54. The counsel submitted that the applicant in its attempt to portray that the invention claimed in the patent under revocation as obvious has sought to artificially apply isolated teachings from the prior art documents clearly out of its context. It is submitted that in the absence of cogent and clear evidence demonstrating that it would be reasonable to expect that the desired results as achieved by the process of the patent under the revocation would be secured especially in view of such artificial statements by the petitioner of difference in proportions of constituents between the cold water insoluble and cold water soluble fraction so as to warrant a reasonable expectation especially when the very prior art documents relied upon by the petitioner expressly dissuade such an attempt.
55. The counsel submitted that the applicant has completely turned a blind eye to the teachings of the documents relied upon by it which also includes teachings such as in Document 7 (GB1311255) at page 1 lines 28 to 37 (Page 37 of the compilation of prior art documents) i.e “If the cream is discarded, the remaining de-creamed material, although cold water soluble, is characterized by an unsatisfactory pale colour and an unnatural aroma, body and flavour, as compared with freshly brewed tea. The invention is thus particularly concerned with the treatment of cold water insoluble tea solids to render them cold water soluble and suitable for addition to a decreamed tea extract” which demonstrates that the art expressly teaches away from the invention claimed in the patent under revocation i.e the art (a document relied upon by the petitioner) expressly discourages working on the soluble fraction to obtain good colour, and instead teaches that suitably treating the cold water insolubles to obtain the desired characteristics is necessary. Even document 2 (US3163539) at page 6 of the compilation of prior art documents at column 1 lines 61 to 67 as set out hereinabove discloses, “However, the removal and discarding of cold-water insoluble constituents entails a considerable loss of yield as well as of valuable flavoring and coloring constituents. Moreover, beverages made from these instant teas are characterized by a very light, pale color, and lack the astringency and body which are typical of freshly brewed tea.” Thus, clearly the prior art document (US3163539) which while disclosing that the cold water insoluble portion is complicated and not fully characterized and sets out the various constituents that are present in the insoluble portion also acknowledges that there is a considerable loss of valuable coloring constituents from the soluble portion on removal of the insoluble portion. Thus, the art specifically taught that the loss of coloring constituents is such that the soluble portion is not suitable for instant tea and expressly required the treating of the insoluble portion to render it soluble and capable of being re-combined with the soluble portion in order to give the instant tea its desired characteristics. The prior art expressly discouraged the use of the soluble fraction without the treated insoluble portion/tannin/cream for obtaining a desirable color. In fact even document 9 (Pintauro) i.e a document relied upon by the petitioner as the closest prior art document teaches that the general approach is to remove a portion of tannins while deliberately leaving sufficient behind for complexing with caffeine to produce the desirable and characteristic astringency of brewed tea (Page 37 of the compilation of documents paragraph 3). Thus, clearly the art is express in its teachings of removal of “tannins” and after treatment adding the soluble tannins back to the soluble fraction to achieve the various desired characteristics of tea. Therefore, it is evident that the petitioner after having miserably failed to make out its case after having relied on a packet of 14 documents is trying instead to shift its burden onto the Respondent by repeatedly taking the submissions of the Respondent out of context while turning a blind eye to the prior art documents on which it relies on. In fact the respondent acknowledged that if at all the cold water insolubles are present they may be present in small quantities (trace amounts). The suggestion by the petitioner that the chemistry of the two fractions which have varying amounts of components is the same has no basis and that no one would even imagine that the soluble fraction subjected to the process of the patent under revocation would yield such surprising results has no basis in view of the clear and express teachings of the prior art documents. Furthermore, the suggestion that the cold water insoluble fraction which have a specific composition would behave chemically in a manner that is similar to cold water soluble fraction which has its own specific composition without taking into consideration the various factors and chemical interactions and lack of characterization of many components especially when the art is express in dissuading the treating of the soluble fraction, is clearly an artificial attempt in the absence of clear and cogent evidence. Nevertheless, the prior art considered treating the cold water insoluble fraction as imperative since the cold water soluble fraction does not provide the necessary characteristics. It is also known that oxidation of the cream fraction results in darkening of tannins (Cold water insolubles or tea cream) and thus it is necessary to bleach it after the oxidation to achieve the desired color (as it becomes totally unacceptable to the consumers). Thus, the chemistry of the cold water insolubles is such that after oxidizing bleaching is required, unlike the treatment of the cold water soluble fraction of the patent under revocation wherein there is no disclosure of bleaching. The invention of the process claimed in the patent under revocation produces a product with high redness (a*value), and therefore understanding the L*a*b* value becomes very important to appreciate the invention. The cold water insoluble fraction and the cold water soluble fraction obviously differs in terms of chemistry, therefore the two fractions behave differently (e.g one separates out while cooling while other does not).
56. The counsel contended that from the analysis of the prior art documents of the applicant he has been demonstrated that oxidation of cream fraction results in very high (unnatural) darkening of the resulting solution and would not have any consumer appeal. To restore its appeal one has to bleach it to get back the original tea colour. The counsel submitted that in fact in the invention covered by the patent, by treating the cold water soluble fraction a highly red coloured product is produced, thus increasing the economic value of the product as red coloured black tea liquor are always preferred by the consumer. Therefore, The counsel submitted that in the absence of any proper evidence such as showing that oxidizing the creaming part and the decreamed fraction produces the same results it is not justified to make any conjecture about the chemistry and the results of the both fractions since tea has thousands of uncharacterized molecules. In fact there is no reasonable expectation that the cold water soluble fraction would yield the red colour and not the unnatural dark colour or pale colour as discussed in the prior art.
57. The counsel submitted that none of the prior art documents even slightly point towards or disclose the possibility of processing the cold water soluble fraction in order to obtain a highly desirable effect on the colour i.e highly red colour. The prior art documents relied upon by the petitioner do not at all provide a hint of the surprising effect of the process of the patent under revocation. Therefore, the oxidation reactions of the aflavins and thearubigins set-out by the experts of the petitioner are not relevant to the invention claimed in the patent under revocation.
58. The Counsel for the respondent submitted that the description of the impugned patent itself acknowledges most of the prior art documents relied upon by the petitioner including Pintauro.
59. The counsel for the respondent citing the object of the invention as disclosed in the specification stated that “the processing of the present invention on the cold water soluble portion hitherto discouraged yielded desirable and unexpected results i.e “However, the present inventors have found that such processing has a highly desirable effect on the colour of mixture, which becomes much darker (i.e less luminous) and more highly red coloured, than mixtures which have not undergone the process of the invention.”
60. According to the counsel the invention cannot be considered obvious because one skilled in the art would have no motivation to apply such a process to cold water soluble solids. In addition, the chemical composition of cold water soluble solids is very different to that of cold water insoluble solids, such that similar treatment of the two materials would not necessarily be expected to produce the same results.
61. The counsel further submitted that even the prime document of the petitioner i.e Pintauro discloses the use of alkali for solubilization of cream. The specification also discloses that, “Generally, the prior art teaches that oxidation of tea cream is performed at alkaline pH. In contrast, the process of the present invention may be performed at the natural (acidic) pH of the cold water soluble tea solids composition, although the pH of the composition may be varied, if desired, without adverse effect.”
62. The counsel contended that the petitioner has wholly failed to appreciate the true premises of the invention and the process to which the invention actually relates to. Invention in question which the petitioner has failed to appreciate relates to
1. A process involving oxidation of essentially the cold water soluble substances.
2. The invention aims at subjecting to oxidation of the cold water soluble part of the infusion which is substantially free of cold water insolubles [the clear definition of the terms “cold water soluble tea solids” and ‘cold water insoluble tea solids’ is provided At page 4 of the specification under the heading ‘Summary of the Invention’]
a. “The term “cold water soluble tea solids” as used herein is intended to refer to substances present in a hot water infusion prepared from tea leaves, which substances remain soluble when the infusion is chilled to 3-10°C.
b. In contrast, “cold water insoluble tea solids” is intended to refer to substances present in a hot water infusion prepared from tea leaves, which generally precipitate when the infusion is chilled to 3-10°C.
63. The counsel contended that the aqueous mixture of the invention typically comprising of cold water soluble tea solids will be derived or formed from the decreamed fraction of an aqueous tea infusion. The counsel submitted that the specification discloses that method of the invention may successfully be performed on aqueous mixtures comprising suspensions of cold water soluble tea solids in the range 0.3-20.0% (w/v). Conveniently a concentration in the range 3-10% (w/v) may be selected, which gives a reasonable amount of tea solids without making the solution unmanageably viscous as seen from the paragraph bridging pages 7 and 8 and paragraph 2 on page 8 of the specification. The specification also discloses that, “Black leaf tea infusions may be used to produce “instant” teas and other products which are preferably soluble in cold water. He argued that for this reason, it is known to separate the insoluble tea cream from the “decreamed” fraction (which is the term given to the cold water soluble materials after removal of the cold water insoluble cream). This is typically accomplished by centrifugation of the chilled (3-10°C) extract. The insoluble cream fraction represents a significant proportion of the tea fraction (which contains desirable flavour components) going to waste, it is known to treat the cream fraction, in one of a number of ways, so as to render it soluble in cold water and then to recombine the solubilized cream with the decreamed fraction.
64. The counsel submitted that the description of the patent itself acknowledges most of the prior art documents relied upon by the petitioner including its prime document (Pintauro) and specifically distinguishes the invention of the patent under revocation from the said documents. The said paragraphs from disclosing the prior art is reproduced below for ready reference:
“……….Accordingly to prevent the cream fraction (which contains desirable flavour components) going to waste, it is known to treat the cream fraction, in one of a number of ways, so as to render it soluble in cold… water and then to recombine the solubilized cream with the decreamed fraction. Various treatments of the cream fraction of tea infusions are described, for example, in GB 1,311,255, GB 1,461,726, US 3,787,590 and US 4,156,024. In particular, US 3,787,590 discloses a method of solubilizing tea cream, the method comprising oxidation of the cream using hydrogen peroxide (H2O2) in an autoclave at 240 °F (115.6°C) at 50 pounds per square inch (0.35 MPa), at a pH of 3.2……Further discussion is provided by N.D Pintauro in “Tea and Soluble Tea Products Manufacture” (1977 Noyes Data Corporation, USA). For example, at page 96 is disclosed a “batch reactor method” for solubilizing cold water insoluble tea tannins, the method comprising treatment with pressurized oxygen (2.1 to 14 kg/cm2, equivalent to 0.2-1.35 MPa) at a temperature of 71 to 107°C and at a pH in the range 5.5 to 7.5 Again, these conditions are not sufficient to significantly increase the solubility of oxygen in the aqueous mixture, and the use of higher pressures is generally to be avoided because of the cost of creating and maintaining the necessary pressure. Additionally, in the method disclosed by Pintauro, bleaching with hydrogen peroxide is taught to reduce the amount of color formation… In contrast to the foregoing, very little is known about oxidation of the decreamed fraction of tea infusions, which contains the cold water soluble components. As the constituents of the decreamed tea are already soluble, there has been no motivation whatsoever to apply to decreamed tea those processes applied to the cream fraction for the purpose of solubilizing cold water insoluble material.”
65. The counsel relied upon the following authorities to indicate that teachings of prior art documents ought not to be isolated out of its context to artificially make out a case of obviousness or on the basis of hindsight and also the question to be asked is not whether the skilled person could have treated the cold water soluble fraction but whether he would have done so in the expectation of obtaining a satisfactory product in the light of the teachings in the prior art document.
In T 0359/99, the Board of Appeal of the EPO held:
“8.1 It should be recalled that the technical teaching in a prior art document should be considered in its entirety and that it is not justified arbitrarily to isolate parts of such document from their context in order to derive therefrom technical information which would differ from or even be in contradiction with the integral teaching of that document (see decision T56/87, OJ EPO 1990, 188).”
In T 0970/00, the Board of Appeal of the EPO held:
“4.1.2 In the assessment of inventive step according to the problem-solution approach knowledge of the invention and its effects is not only inevitable by the very nature of the assessment, but also necessary, in particular when proceeding to the identification of the closest prior art and to the determination of the technical contribution achieved by the invention over the prior art. However, as repeatedly stressed by the Boards of Appeal (see “Case Law of the Boards of Appeal”, 4th ed, 2001, chapter I, section D-2), the primary purpose of the problem-solution approach is the objective assessment of inventive step and consequently any ex-post facto analysis, and in particular any conclusion going beyond what the skilled person would have objectively inferred, without the benefit of hindsight knowledge of the invention, from the prior art is of necessity at variance with a proper application of the problem-solution approach (see decision T 967/97, not published in OJ EPO, point 3.3 of the reasons). This applies not only to — among others - the determination of the closest prior art (“Case Law of the Boards of Appeal”, supra, chapter I, sections D-3.3 and D-3.5), the formulation of the technical problem solved by the invention (supra, chapter I, section D-4.2), and the assessment of what would have been obvious to the skilled person in the light of the state of the art (supra, chapter I, section D-6.1), but also to the determination of the technical contribution of the invention to the prior art. Accordingly, the determination of the technical contribution achieved by the invention over the closest state of the art requires an objective and technically meaningful and consistent comparison of the claimed combination of structural and functional features with the technical information conveyed to the skilled person by the closest state of the art (point 4.1.3 below). Any attempt to interpret the disclosure of the closest prior art so as to distort or misrepresent, based on hindsight knowledge of the invention, the proper technical teaching of the disclosure in such a way that it artificially meets specific features recited in the claim under consideration (point 4.1.4 below) must therefore fail, especially as this would risk unfairly and tendentiously concealing the technical contribution of the invention (point 4.2.2 below) and prejudice the subsequent objective determination of the technical problem solved by the claimed invention.”
In General Tyre & Rubber Company v. The Firestone Tyre & Rubber Co. Ltd [1972] R.P.C the following passages are relevant:
“……..has been held from the earliest times that a new manufacture may be created, although such manufacture when dissected may consist of individual items all of which formed part of public knowledge”(Page 504 lines 30 to 36)
“That leaves the question as to whether a skilled addressee who is assumed to have read and remembered amongst all other available material the three specifications… would have by reason of these have come to regard the plaintiff's solution of the problem as obvious, despite the fact that his common general knowledge would have biased him against exploring the chances of oil-extended rubber providing a solution. In this behalf we agree with the approach adopted by the trial judge when he correctly said ([1970] F.S.R at page 312:
“It seems to me to be very dangerous and in law not permissible to assess obviousness in the light of carefully selected pieces of prior knowledge only.”
Whether or not in that particular passage he had in mind the three specifications as being the “carefully selected pieces”, it is in our judgment right to apply to them the process of reasoning adopted by the trial judge. Bearing in mind what has, when discussing anticipation, already been said as regards each of these three specifications, we have come to the conclusion that, assuming Mr. Templeman's submissions as to their position in this case to be correct, they would not have affected a skilled addressee's mind in the way that he submits.
Having regard to our assessment of the evidence on the issue of obviousness we do not find it necessary to examine in detail the authorities cited to us on this subject. It is sufficient to refer to two passages in judgments that have been much cited and are of high authority.
The first is that in the judgment of Fletcher Moulton, L.J in British Westinghouse v. Braulik (1910) 27 R.P.C 209. Though it was quoted in the first instance judgment, (1970), F.S.R at page 313-C,* it provides such an apt warning against an ex post facto analysis of an invention of the type which the appellants sought to apply in the instant case that it merits citation.
“I confess that I view with suspicion arguments to the effect that a new combination, bringing with it new and important consequences in the shape of practical machines, is not an invention, because when it has once been established, it is easy to show how it might be arrived at by starting from something known, and taking a series of apparently easy steps. This ex post facto analysis of invention is unfair to the inventors and in my opinion it is not countenanced by English patent law.”
The second is in the judgment of Tomlin, J. (as he then was) in Samuel Parkes & Co. Ltd. v. Cocker Bros. Ltd. (1929), 46 R.P.C 241 at 248.
“Nobody, however, has told me, and I do not support anybody ever will tell me, what is the precise characteristic or quality the presence of which distinguishes invention from a workshop improvement….. The truth is that, when once it had been found…. That the problem had waited solution for many years and that the device is in fact novel and superior to what had gone before and has been widely used, and used in preference to alternative devices, it is, I think, practically impossible to say that there is not present that scintilla of invention necessary to support the patent.”
In our judgment the evidence in the instant case shows that there is far more than a “scintilla of invention” in the process for which protection is claimed in the patent-insuit. The appellants have failed by a considerable margin to establish their plea of obviousness. On the contrary, the plaintiffs have positively established that the invention for which protection is claimed in the patent was not obvious.……” (Pages 505 — 506 lines)
In Verathon Medical (Canada) ULC against Aircraft Medical Limited [2011] CSOH the following passages are relevant:
“[133] The philosophy behind obviousness is that a patent is granted only for an invention and that which is obvious is not inventive”………
“[134] The courts in the United Kingdom have generally adopted a structured approach to the analysis of a challenge to the validity of a patent based on an allegation of obviousness. Case law has recognised four steps in this process. The first three orientate the tribunal before it tackles the fourth step, which has been described as “the key, statutory step”: Actavis UK Ltd v. Novartis AG [2010] FSR 18; Jacob LJ at paragraph 21. Those four steps, which originated in Windsurfing, are as follows:
(1) identify the notional skilled person and what was the relevant common general knowledge in the art at the priority date;
(2) identify the inventive concept embodied in the claim in question or, if that cannot readily be done, construe the claim; (It may not be appropriate in all circumstances to attempt to identify the inventive concept as, for example, when there is an involved dispute as to what that concept is. The court will wish to avoid a prolonged satellite debate.)
(3) identify the differences, if any, between matter forming part of the state of the art and the alleged invention; and
(4) assuming no knowledge of the alleged invention, decide whether the steps to reach the alleged invention were (technically and practically) obvious or required any degree of invention. (The skilled person is not allowed to look with the benefit of hindsight at what is known once the alleged invention is known. Commercial obviousness is not a relevant consideration.)”
“[135] …… in Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. [2008] RPC 28,
Lord Hoffmann warned against watering down the claimed invention and stated at paragraph 19:
“In my opinion, however, the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based on the extent of his disclosure in the description.”…….
“(iv) Applying the law in this case [136] I deal with the question of anticipation below when I discuss the matters in the prior art which are said to be prior disclosure. I have sought to identify the skilled person in paragraphs [72]-[83] above. I have also discussed the common general knowledge in paragraphs [84]-[97]. When considering the test of obviousness, the skilled person has to take account of the prior art in the context of the common general knowledge”.
66. The counsel relied upon the following authority to indicate evaluate obviousness in light of discouragement in the prior art:
In T 255/85 the European Patent Office Board of Appeal held (copy handed out during hearing):
4.3 …………Thus the teachings of this document represents a very clear warning to the skilled person that any attempt to incorporate an alumina antacid compound in a sugarbase product would fail in the absence of a protective colloidal material and would serve to actively discourage the skilled person from investigating the incorporation of alumina antacid compounds into sugar-based products. The Board is of the opinion that the question to be asked is not whether the skilled person could have used a fondant confectionery base to produce a candy-like product containing an alumina antacid compound but whether he would have done so in the expectation of obtaining a satisfactory product in the light of the teachings in document (40 (cf. T 2/83, OJ 6/84, page 265, particularly point 7 on page 270)…..”
67. If we read US 3950553 we find that it is known in the prior art of preparing a soluble tea that substances of varying solubility in cold water are extracted from the tea leaves. One fraction of the extracted solids is readily soluble in cold water. A second fraction [cold water insoluble fraction] referred to as tea “tannins” is essentially insoluble in and separable from cold water. The constituents of second fraction are not necessarily all tannins in a chemical sense but they behave as tannins and are customarily and collectively referred to in the art as “tannins”. One method of prior art for producing cold water soluble tea product was to remove the second tannin fraction [cold water insoluble fraction] from cold water soluble fraction; concentrating the cold water soluble fraction; and drying it to particulate form. Pursuant to this practice, however the cold water insoluble fraction is discarded. The term ‘cream’ was used to denote the second fraction [cold water insoluble fraction] and the first soluble fraction was denoted by term ‘decreamed’ fraction. Prior art also disclose various methods of treating this cream fraction to render it cold water soluble and suitable for addition to a de-creamed tea extract. Prior art also teaches to oxidize this insoluble fraction (which was earlier discarded) and this was done to yield essentially the same appearance and colour as fresh tea beverage.
68. If we see prior art process for preparing a soluble tea product described in US 3950553 it teaches the use of insoluble tannin fraction (previously discarded). The oxidation process described therein aimed at rendering the tannins soluble in cold water under conditions of pH. It also referred to US patent 3163539 and 3,151,985 relating to the retreatment of insoluble tannin constituents (cream portion). US patent 3,809,769 teaches use of extracted tea/spent tea leaves for increasing the yield of tea extract. In US 3,787,590 method of solubilizing tea cream is disclosed. US 4,156,024 discloses that raw tea tannins which are cold water insoluble are categorically oxidized to improve their solubility. UK patent 1,311,255 relating to preparation of instant tea where it is disclosed that “the cold water insoluble materials are known as ‘cream’ and consists essentially of highly colored tannin-caffeine complexes. It also disclosed that ………it is necessary to de-cream the extract …. and to either discard the separated cream or solubilise it and recombine it with de-creamed extract. If the cream is discarded, the remaining decreamed material although cold water soluble is characterised by an unsatisfactory pale colour and an unnatural aroma, body and flavour as compared with freshly brewed tea. The invention is thus particularly concerned with the treatment of cold water insoluble tea solids to render them cold water soluble and suitable for addition to a de-creamed tea extract.” The process of UK 1,461,726, referring to US' 539 and US' 985 seeks “to avoid the prior arts highly basic oxidative conditions for solubilization of tannins. Additionally it eliminates the need for the special bleaching and acidification step which have been utilized tom obtain desirable appearance and flavour in the eventual tea products.”
69. If we see the impugned invention we find it particularly uses the first fraction (supernatant/de-creamed fraction) as starting material. None of the prior patents documents uses the de-creamed fraction for further treatment. This clearly indicates that none of the prior art cited by the applicant teaches oxidative treatment of the de-creamed fraction [cold water soluble fraction]. When we see Pintauro we find it also referred to Tannin-caffeine precipitate (cream) (page 82) and various methods of removing portion of tannins which inter-alia includes processes involving ‘procedure to solubilise the cream or for oxidation to cleave the tannin — caffeine insoluble complexes.’
70. This clearly indicates that the prior art teaches away from the invention. The de-creamed extract is not used for further treatment as disclosed in the impugned invention. In US patent 4,156,024 [col 3 line 1-5 page 23] of compilation it is stated that The separated precipitate of insolubles is then desirably washed…………This precipitate ordinarily contains from 15 to 30% by solid weight of entrained cold-water soluble material. This wash reduces the weight of non tannin solubles in the precipitate so that they will not be subjected to subsequent conditions of oxidative solubilization.” This also confirms that prior art teaches away from the invention.
EXPERT EVIDENCE
71. Counsel for the applicant has referred to and relied upon the two affidavits of (Dr.) Madhavan Pillai. Dr. Madhavan Pillai is an independent person unconnected with the business or interest of the Petitioner. 1st Respondent filed expert evidence of Dr. Prakash Virkar who is in the employment of the 1st Respondent.
72. The Counsel for the applicant submitted that the evidence filed by the 1st Respondent is of Dr. Prakash Virkar who is in the employment of the 1st Respondent. He argued that Dr. Prakash Virkar is therefore not an independent and unbiased person. He submitted that the Hon'ble Tribunal should disregard the evidence of Dr. Prakash Virkar on the ground that because of his close relationship with the 1st Respondent (employee - employer) he is not independent and unbiased. He submitted that considering the relationship between Dr. Prakash Virkar and the 1st Respondent he is bound to have personal sympathies for the 1st Respondent. Accordingly his evidence should not be accepted by the Hon'ble Tribunal as an evidence of expert on the grounds of public policy that justice must be seen to be done as well as done. He relied upon the judgments of the Chancery Divison, in Liverpool Roman Catholic Archdiocesan Trustees Inc. v. Goldberg, (2001) 1 WLR 2337.
Dr. Madhavan Pillai (Supporting Applicant)
73. Dr. Madhavan Pillai is visiting professor at various universities in India and the USA with experience in most aspects of chemistry and processing of natural products including tea. He observed that inventors essentially claim to have a process to alter the colour characteristics of a tea composition by treating an aqueous mixture comprising cold water soluble tea solids and substantially free of cold water insoluble tea solids, with an oxidizing agent in a reaction vessel at a temperature and pressure in excess of the ambient temperature and pressure. According to him basic chemistry related to composition of tea infusions and tea processing to enable a person skilled in the art to appreciate my analysis that is to follow.
a. It is well known in Tea Chemistry that the aqueous tea extract contains TF molecules, TR molecules of various molecular weights, carbohydrates, caffeine, soluble chlorophyll soluble components” which is the very basis of their alleged degradation products, small quantities of unoxidised polyphenols (tannins) and small quantities of soluble amino acids from protein degradation. The cream and decreamed extracts both contain these molecules, the only difference being their percentages.
b. Caffeine and proteins form complexes with polyphenols and appear in colloidal form. When the tea extract is cooled, some of these colloidal substances begin to aggregate to form a larger amorphous mass spherical in shape leading to precipitation as cream. Cream is therefore a colloidal substance containing the same components as the tea extract. This aspect is well supported by authoritative texts as reference on Page 47 of RD Bee, MJ Izzard, RS Harbron and JM Stubbs, Food Microstructure, 6, 47-56 (1987), where it states, “…….colloidal precipitate known as cream, .v… and Tea cream is a colloidal precipitate formed by black tea liquors as they cool”. Further M Saltmarsh in the book on “Tea: Cultivation to Consumption” edited by K C Willson and M N Clifford, published by Chapman and Hall, U.K in 1992 on page 546 states “…. Cream (Tea cream) is a colloidal substance containing the same components of the extract (tea extract).”
74. Dr Pillai also stated that the processes for the development of colour of tea extracts is also well known and well documented. He further stated that, oxidation of the tea extracts also lead to improvement of colour due to the formation of chromophers with increased conjugation. Thus oxidation of the tea extracts (soluble and insoluble components) leads to increase jn the solubility of the solids and/or improvement in the colour of the extract. The Theaflavin (TFs) molecules formed during the process are further condensed with unoxidised catechins if present or undergo self-condensation to form Thearubigin (TRs) molecules. The colour intensity depends on the extent of condensation of the TF molecules. Theaflavin molecule (1) in the tea extract for example undergoes oxidation to produce molecule (2) which has more solubility because of the introduction of polar groups. Also Compound 2 will have more dark colour because of the presence of an orthoquinone moiety. Similar reactions occur with Thearubigin molecules, as they are higher analogues of TFs, resulting in increased solubility.
75. Dr Pillai further submitted that “Literature is filled with methods for oxidation of tea extracts (soluble and insolubles) both to enhance solubilisation of the insolubles and also to improve the colour of the Tea extracts as given below:
(i) Food Technology Review No 38 on “Tea and Soluble Tea Products Manufacture” by Nicholas D Pentauro published in 1997 by Noyes Tea Corporation, USA is one of the comprehensive reviews on the subject.
(ii) US Patent No. 3,151,985 and 3,950,553 teach the oxidation of extracts containing partially or wholly insoluble components in cold water (tannins), leading to the development of colour.
(iii) US Patent No. 3787590 teaches the use of oxidizing agents such as oxygen, ozone, hydrogen peroxide etc. at temperatures above the ambient.
(iv) US Patent No. 3,151,985 that oxidation is carried out at a pressure of about 8.5 kg/cm2 operating at a temperature range of 70-107° C, which are well above the ambient conditions. This pressure is built upto about 14 kg/cm2. Similarly, pressure reactors have been used in US patent 3809769.
(v) US Patent No. 3787590, describes oxidative processes without the use of alkali and carrying out the reactions at a pH of about 2 to 3.5
(vi) US patent No 3163539 and Food Technology Review No 38 on “Tea and Soluble Tea Products Manufacture” by Nicholas D Pintauro published in 1997 by Noyes Tea Corporation, USA shows that tea extracts generally contain some dissolved or entrained oxygen (air) which is sufficient to bring about the solubilization of major portion of cold water insoluble solids and increased temperature and pressure would enhance the process. It is quite obvious to a person skilled in the art to refer to appropriate databases of oxygen solubility in water and arrive at the temperature and pressure required to achieve the required concentration of oxygen.”
76. He concluded the oxidation chemistry of tea extracts, consisting of the hot water solubles, the cold water solubles, the cold water insolubles, etc are well documented and process of oxidation using oxidizing agents under conditions of temperature and pressures higher than the ambient were well known and established making the alleged invention in patent no. 184038 obvious to a person skilled in the art.
Dr. Prakash Virkar (Supporting Respondent)
77. Dr. Prakash Dattatraya Virkar, who holds the position of Beverages R&D Programme Director - India/S. Asia, in Hindustan Unilever Limited the patentee herein have been engaged in the research in tea among other areas.
78. Dr Virkar stated that method to increase colour as taught by the patentee's invention was not known for decreamed fraction of tea infusions which contains the cold water soluble components. The patentee has clearly stated that “as the constituents of the decreamed tea are already soluble, there has been no motivation whatsoever to apply to decreamed tea those processes applied to the cream fraction for the purpose of solubilising cold water insoluble materials”.
79. Dr Virkar submitted that US3163539 relates to solubilization of cold-water insolubles by treating with inter-alia alkali; a disclosure that has no relevance to the novelty of the claims of the patent 184038. US3787590 describes a method for obtaining tea solubles from tea cream consisting essentially of heating to a temperature of about 1900 F. to about 2700 F. a mixture consisting essentially of tea cream, water and an oxidizing agent at a pH of from about 2 to about 3.5 for a period of from about minutes to about 75 minutes. GB1311255 describes cold water insoluble tea solids (tea cream) which have been separated from an extract obtained by hot water extraction of tea leaf are rendered cold water soluble by oxidising them in aqueous dispersion at a pH of 9 to 10, for example by means of air, and there after treating the resulting solution with a compound selected from sulphur dioxide, sulphurous acid, a sulphate, or a bisulphite. Therefore, all the citations cited by the expert describe treatment of tea-cream, i.e treatment of water-insoluble residue whereas the claimed invention of 184038 resides in oxidation of the de creamed fraction of tea infusions, which contains the cold water soluble components, for altering the colour charactersitics. As the constituents of the decreamed tea are already soluble, there has been no motivation whatsoever to apply to decreamed tea those processes applied to the cream fraction for the purpose of solubilising cold water insoluble materials, for the purpose of altering the colour characteristics which is a very different objective.
80. Dr Virkar did not agree with Experts statements that “the cream and decreamed extracts both contain these molecules, the only difference being their percentages”. He stated that the constitutents of the creamed fraction are generally known to contain TF molecules and TR molecules among a host of other compounds. Although it is true that, generally, the molecular weight of the compounds in the creamed fractions is higher than the decreamed fractions, this statement in no way renders a complete understanding or characterization of the hundreds, if not thousands of molecules in these fractions. To this day, TR molecules have not been fully characterized. In the absence of such knowledge, he submitted that it is incorrect to say that. Such an averment is unfounded and unsupported by authentic details and authorities and is a result of presumption.
81. Dr Virkar submitted that the applicant's expert has mis-interpreted the invention. The invention does not claim the treatment of starting material containing cold-water soluble solids and some quantity of cold-water insoluble solids with an oxidizing agent. He asserted that oxidation process using oxidizing agents is already acknowledged as prior art by the patentee, but the invention of the patentee relates to a process for an aqueous mixture comprising cold water soluble tea solids and substantially free of cold water insoluble tea solids, as against treatment of tea-cream solids or insolubles, taught in prior art.
82. Dr Virkar submitted that the citations identified by the expert relates to the treatment of tea-cream (insoluble fraction), whereas the invention of 184038 relates to process for an aqueous mixture comprising cold water soluble tea solids and substantially free of cold water insoluble tea solids. Thus, this is teaching away from the cited documents and other documents in this field which describe methods of treating the insoluble component of tea, rather than soluble fractions. He added that most of the prior art in the area of solubilisatjon of cream is carried out at alkaline pH to maximize yield. The patentee's invention, on the other hand is carried out at the natural pH of the decreamed fraction with is in the acidic range. It is for this very specific reason that the colour has been measured in the examples at a pH of 3.7 so as to demonstrate the acid stable colour of desired product. Thus the patentee's invention is unobvious' over the prior art which all are related to solubilisation of cream fractions.
83. We find that the Dr Pillai evidence is useful to understand the basic chemistry of tea extracts. The citations referred to by him were for treatment of the cream fraction. These citation teaches away from use of decreamed fraction. In US 3950553 for example in Col line 9-14 it is disclosed that
“These insolubles are then desirably washed with water, preferably at a temperature less than about 15C suitably about 10C the wash liquid will remove any entrained solubles from the precipitates, and may be recombined with the supernatant from the precipitation step.”
84. This clearly indicates that only cream fraction is used for oxidative solubilization of tannins. Further this oxidized tannin solution is required to be decolorized. In US 3151985 it is also disclosed that “The experimental work carried out shows that the oxidation produces a darkening of the tannins. To restore the original tea colour, it becomes necessary to bleach the product after oxidation.”
85. If we see Expert's evidence of the applicant we find it merely did ex post facto analysis of the impugned method which at best can be said to be an attempt to equate the oxidative solubilization of tea cream to make it soluble with the oxidation of the supernatant already containing cold water soluble solids which is not relevant for ascertaining the inventive step. It is obvious for an expert to draw such conclusion once the invention is known. In view of above analysis we find the method claimed in impugned patent is novel and inventive.
86. We cannot agree with applicant's contention that the cream and the decreamed portion are same and hence follow the same chemistry. The invention as claimed in the alleged patent is for oxidation of the decreamed fraction at acidic pH [preferred 3.7]. We do agree with the applicant on two counts. Firstly the starting material is new (decreamed fraction). Secondly the oxidation of this fraction does not lead to excessive darkening as it happens when the cream portion is oxidized. The product of oxidation of decreamed fraction does not require the additional bleaching step. We therefore find that the invention as claimed is non-obvious and involve inventive step.
INSUFFICIENCY OF DESCRIPTION AND CLAIMS [Section 64(1)(h) and 64(1)(i)]:
87. The counsel for the applicant submitted that only one example to work the given by the invention is not sufficient. The description in the specification and the sole example therein does not enable a person skilled in the art to exercise the invention as claimed in claim 1. The counsel submitted that Professor Pillai in his affidavit affirmed on January 7th 2008 paras 14–16 has established that the experiment in the patent specification provides only one set of data at one dissolved oxygen concentration at three different temperatures. Further there is no comparative data on colour of a reference sample which has not undergone the process of the invention. In the absence of a comparative data, it is wrong to conclude on any quantitative improvement in colour resulting from the process of the invention. Further the expert has shown that turbidity plays a significant role in colour measurement and without any reference to the turbidity of the samples, Lab values are not meaningful (affidavit affirmed on Janaury 7, 2008 and para 10 of affidavit affirmed on 28th January 2012). The counsel submitted that Professor Seshadri in his affidavit affirmed on 20th July 2002 in para nos 23-25 has also opined on the insufficiency of the experimental data and the importance of turbidity in the Lab measurements.
88. The counsel for the applicant relied upon the case law of Biogen Inc. v. Medeva PLC [1997] R.P.C to indicate that since there is only one example in the patent under revocation therefore the breadth of the claim exceeded the technical contribution to art made by the invention described. The counsel for the applicant submitted that in the absence of any control data of the colour of the starting material, the specification lack in establishment of any “improvement” related thereto. Futher according to his expert Dr. Pillai in the absence of measurement of turbidity values the measurement of L, a, b cannot be considered as true colour values. Therefore the specification is not sufficiently disclosed to carry out the invention.
89. The counsel for the respondentsubmitted that contrary to what is sought to be projected by the petitioner, an applicant for a patent is statutorily required to only disclose the best working method for performing the invention which is known to the applicant and for which he is entitled to claim protection and that there is no need for providing an example over the entire range claimed in the patent.
Section 10(4)(b) of the Patents Act is set-out below for ready reference:
(4) Every complete specification shall-
(b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection;………”
90. The counsel submitted that that the example given in the patent specification discloses that the supernatant substantially free of cold water insoluble black tea solids is freeze-dried and that re-constituted powder of the freeze-dried decreamed fraction is used to prepare an aqueous solution of decreamed black tea solids for subjecting to the process claimed in the patent under revocation and thus the said process is not in accordance with the claims where no freeze drying is required. The counsel submitted that the said step ought to be viewed in context i.e with reference to the first paragraph on page 9 of the complete specification of the patent under revocation (Page 36 of the revocation petition) where it is disclosed that, “In practice, on an industrial scale, it is envisaged that the aqueous mixture used in the process of the invention will be an aqueous decreamed tea extract, without having gone through an initial free-drying stage. The aqueous decreamed extract may conveniently be concentrated prior to processing according to the method of the invention……”.
91. According to the counsel out of the three documents relied to prove insufficiency only the first one [Annexure A] relates to tea (although a herbal tea) and the objective of which was to determine the relationship between soluble solid content of tea extract and colour parameters of different colour scales as measured by transmission. In the paper the solids concentration was varied (hence turbidity) and the transmission values were measured. In fact the document clearly states in its conclusion that, “Turbidity affected objective colour parameters of rooibos tea extracts, especially the lightness of the extracts. However, turbidity, if not excessive, is ignored by the subjective evaluation procedure practiced by industry”. It is important to note, that from the conclusion, it is clearly evident that the lightness (L) values are generally affected by the varied concentration of solids and not redness (a) value. More importantly, the document teaches that if the turbidity is not excessive then one can ignore it while measuring the transmission value. Thus, a tea infusion with only 3% (w/v) of solids is known by a person skilled in the art to not have excessive turbidity and thus turbidity is not relevant. It is thus submitted that the petitioner has failed to adduce any evidence on the lack of support or insufficiency of the patent under revocation.
92. The counsel for the respondent relied on the following authorities to indicate that the onus of proving insufficiency by adducing proper evidence is on the party alleging such insufficiency and also that the provision of examples over the entire range claimed is not needed.
The Boards of Appeal of the European Patent Office in case no. T 0671/05
“4.2 The subject-matter of claim 1 of the main request concerns a tablet which has been defined by including in the claim several functional definitions such as “fast disintegrating”, “substantially water insoluble”, “substantially water soluble”, “water soluble”, “water insoluble” and “superdisintegrants”. Functional features are commonly used for defining subject-matter in claims in order not to deprive inventions of due protection. Functional terms provide for a generalisation of specific aspects of an invention which would otherwise be protected too restrictively.
However, it is a fact that functional definitions are broad and relative in their nature, with boundaries which are not sharp or specific. The subject-matter defined by means of functional features in a claim has to be read in its broadest technically meaningful sense. For this purpose the general common knowledge of the skilled person of the particular technical field can be invoked. However, a line has to be drawn to distinguish the assessment of the requirements of sufficiency of disclosure according to Article 83 EPC from the assessment of the requirements of clarity of the claims and support in the description set out in Article 84 EPC. To make a clear distinction is of particular relevance in opposition and opposition appeal proceedings, since Article 84 EPC is not a ground for opposition.
In the present case the appellant has not provided any substantiation for casting reasonable doubts on sufficiency of disclosure. The technical data submitted by the appellant with its grounds of appeal do not point to a lack of reproducibility or feasibility of the claimed “invention”. On the contrary, the data show that the skilled person would be able to prepare further tablets according to the patent in suit. In fact, the appellant employed the technical data submitted with the grounds of appeal only in support of its argument against the presence of an inventive step (i.e in order to demonstrate that an improvement in the disintegration time with simultaneously maintenance of a good friability was not achieved).
The patent in suit states that the “invention” deals with a fast disintegrating tablet, i.e relates to tablets which disintegrate rapidly but also have good friability characteristics (paragraph [0001] of the patent in suit).
Furthermore, the patent in suit teaches in a clear and complete manner, following the description and the twenty-three illustrative examples, how to prepare the fast disintegrating tablets according to the claims.
Therefore, the fact that the functional definitions in the claims are relative in their nature (and that some of them include intrinsically relative terms such as “fast” or “substantially”) is insufficient for a successful attack of lack of sufficiency of disclosure within the meaning of Article 83 EPC.
In fact, the appellant has not contested the reproducibility of the examples of the patent in suit. It has only disputed that the claimed “invention” was reproducible in the whole scope claimed. To this effect the appellant submitted that the claim encompasses water soluble and water insoluble drugs, whereas none of the specific examples uses a water soluble drug.
This appellant's argument overlooks however the fact that the claim's wording requires the drug to be in a multiparticulate form and that the formulations illustrated by the examples employ the drug in the form of microcapsules, or in the form of coated microcapsules. Therefore, the skilled person following the description and the examples would use a microencapsulated or coated microencapsulated form in the case of a water soluble drug. The appellant itself has acknowledged that it would be feasible to use soluble drugs with a water insoluble coating. This statement demonstrates that the skilled person does not face an insoluble technical problem when providing fast disintegrating tablets in which the active drug is a water soluble drug. Hence, the board sees no reason to doubt the reproducibility of the “invention” when the active drug is water soluble.
Moreover, it has to be stressed that the claims represent a generalisation of the examples and that it is not a prerequisite for fulfilling the requirements of sufficiency of disclosure to provide an illustrative example for every possible specific combination encompassed by the claims. The claims represent generalisations of the examples and have to be read in a broad, technically meaningful way, but the functional terms should not be read in open contradiction with the whole content of the description.
Hence, the board is convinced of the completeness of the description and that the skilled person in the field of pharmaceutical technology is able to carry out the claimed invention.”
The Boards of Appeal of the European Patent Office in case no. T 0103/00:
“2.3 Sufficiency of disclosure - Article 83 EPC In the disputed decision the Examining Division came to the conclusion that the burden of experimentation to find proper reaction conditions and selection of the kind of acid put to the public was acceptable in view of the information given in the description. However, the Examining Division contended, that Article 83 was contravened, since the expressions “hydrocarbyl” and “substituted hydrocarbyl” put an undue burden on the public to find out the scope of protection of claim 1 insofar as the operability of the process is concerned, since not only the reaction conditions have to be varied but also the kind of reactants.
However, in the judgment of the boards, the disclosure of the process for preparing a 1, 3-disubstituted imidazolium salt as claimed is sufficient if the technical features necessary for carrying out that process by a skilled person are identified and characterised in a way such that a person skilled in the art can put that process into practice by using no more than the information contained in the description and/or common general knowledge. The decision under appeal is silent in this respect and raises an objection of undue burden solely on the basis of the terms “hydrocarbyl” and “substituted hydrocarbyl”. Without any substantiation of the objection of insufficiency of disclosure by some verifiable facts, as is the case here, the scope of the claim cannot be challenged under Article 83 EPC by merely referring to some broad but unambiguous terms of art (see point 2.2.1).
It is true that according to the established jurisprudence of the Boards of Appeal, the requirement of sufficient disclosure means that the whole subject-matter that is defined in the claims must be capable of being carried out by a skilled person without the burden of an undue amount of experimentation or the application of inventive ingenuity. As a matter of principle, however, the burden of proof for showing a deficiency in this respect is upon the party or the department relying on it. Since, in the present case, the Examining Division did not substantiate its allegation of insufficiency of disclosure, the Board does not have any reason to accept it.”
The Boards of Appeal of the European Patent Office in case no. T 0456/91:
“4. Sufficiency (Article 83 EPC)
4.1 The provision of Article 83 EPC that the disclosure of a patent must be sufficiently clear and complete for the invention to be carried out by a person skilled in the art, is, as has been stated by the Board of Appeal in Decision T 292/85, “Polypeptide expressions”, (OJ EPO 1989, 275), satisfied “if at least one way is clearly indicated enabling the skilled person to carry out the invention”. It is not necessary for the purpose of Articles 83 and 100(b) EPC that the disclosure of a patent be adequate to enable the skilled person to carry out all conceivable ways of operating the invention embraced by the claims. In view of the examples still remaining in the description and the additional experimental data submitted by the Respondent (see submission of 30 August 1990, in particular page 18, last paragraph and page 19, Table 3) showing that following the instructions of the patent, compositions for two other peptides, Leuprolide and Buserelin, with at least one months sustained release were made, the Board is satisfied that a prima facie caseexists that the disclosure is sufficient to enable the skilled person without undue burden to carry out the invention as claimed.
4.2 The mere argument of the Appellants that because the Claim 1 covers an extremely large number of polypeptides, whereas the examples of the patent in suit all relate to a single polypeptide, Nafarelin, is not adequate to make out this ground of invalidity, in the absence of any evidence that there exists at least one polypeptide falling within the definition of Claim 1 for which a one month sustained release composition cannot be made following the teaching of the patent. Here the Appellants who are asserting this ground of invalidity have the burden of proof, and they have failed to discharge it (see T 219/83, OJ EPO 1986, 211)………”
93. The counsel further argued that that another case law relied upon by the petitioner i.e Generics (UK) Limited v. H Lundbeck A/S; [2009] UKHL 12 which clearly indicates that the Biogen insufficiency is not applicable in the instant case. The relevant paragraphs of the said case law are set out below:
92. Of the seven passages in the speech of Lord Hoffman Mr Thorley particularly relied on, I shall limit myself to three, although the observations which follow apply equally to the other passages. At [1997] RPC 1, 48, Lord Hoffman said that “if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them”. But in this case the claim is to a single product, and it is clear that the product is enabled by the disclosure in the Patent.
93. At [1997] RPC 1, 50, there is this: “[The issue] is not whether the claimed invention could deliver the goods, but whether the claims cover other ways in which they might be delivered; ways which owe nothing to the teachings of the patent or any principle which it disclosed”. This is perhaps the most important of the three passages fr present purposes. The vital point is that Lord Hoffmann was not dealing with a simple product claim, as is involved in this patent. As he explained at [1997] RPC 1, 40, the claim in that case was “to a product, molecule identified partly by the way in which it has been made… and partly by what it does”. In that case, the patentee could claim neither the product (a DNA fragment of the so-called Dane particle), as it had already been made (see per Aldous J at first instance at [1995] RPC 25, 57), nor the process (recombinant DNA technology enabling expression in a cell), as it had already been invented (see at [1995] RPC 25, 58 and 65). Nor could he identify the product in any other way, as it had not been mapped or sequenced (see e.g at [1995] RPC 25, 65).
94. Accordingly, the invention claimed in Biogen [1997] RPC 1 was, as it were, the notion of subjecting the product (the unsequenced DNA fragment from the Dane particle) to the process (recombinant DNA technology) in order for it to be expressed to produce HBV antigens. It was therefore at least as much as a process claim as a product claim. In those circumstances, one can well see why the claim was held to be insufficient. The patent disclosed one way in which the DNA fragments could produce HBV antigens, but the claim “cover[ed] other ways in which they might be delivered, ways which owed nothing to the teaching of the patent or any principle which it disclosed”- [1997] RPC 1, 50. Accordingly, the claim was very different from a simple product claim as in the present case. This analysis of the facts in Biogen [1997] RPC 1 also explains why Lord Hoffman said at pp. 51–52 that “the excessive breadth” of the patent in that case was due “to the fact that the same results could be produced by different means” from that disclosed by the patent…………
…….99. In my opinion, therefore, in agreement with the Court of Appeal, the opinion of Lord Hoffmann in Biogen [1997] RPC 1, though a tour de force as Lord Walker says, is of no assistance to the appellants in this case. It applied in the light of the very unusual nature of the claim in that case. Far from being a straightforward product claim (as in this case) or even a product-by-process claim (as discussed in Kiri-Amgen [2005] RPC 9, paras 86–91 and 101), the claim was to a product identified in part by how it was made and in part by what it did — almost a process-by-product claim.
100. Kitchin J is by no means alone in having taken the mistaken view that the reasoning in Biogen [1997] RPC 1 is of much wider application, and in particular that it applies to any product claims (at least where they are claims to chemical compounds). I made exactly the same mistake at first instance in the Kiri-Amgen case — see at [2002] RPC 1, 300–312. A number of articles to which reference was made in the written cases also appear to have proceeded upon the same view.
101. It may be this in part attributable to the focusing by Lord Hoffmann in Biogen [1997] RPC 1, 42–46 on the “inventive step” involved in the alleged invention in that case. There is a difference between the “inventive step” or “inventive concept”, on the one hand, and the “technical contribution to the art”, on the other hand. I respectfully agree with the explanation of the difference between the two concepts given in paras 29 to 31 of Lord Walker's opinion. When considering the validity of a simple product claim (such as is under scrutiny on this appeal), it may be that concentrating on the identification of the inventive step rather than the technical contribution can lead to error. “Inventive step” suggests how something has been done, and, in the case of a product claim at any rate, one is primarily concerned with what has been allegedly invented, not how it has been done. On the other hand where the claim is for a process or (as in Biogen [1997] RPC 1) includes a process, the issue of how the alleged invention has been achieved seems to be more in point.”
94. So far as the ground of insufficiency is concerned the applicant must prove that information given in the specification is insufficient to work the claimed invention. The sufficiency requirement is met if at least one way of working the invention is clearly indicated enabling the skilled person to carry out the invention. The applicant only submitted that in the absence of any control data of the colour of the starting material, the specification lack in establishment of any “improvement” related thereto. The expert also argued that condition of turbidity has not been taken into consideration while arriving at the results of Table 1 in the specification. It is not necessary for the purpose of section 10(4) that the disclosure of a patent be adequate to enable the skilled person to carry out all conceivable ways of operating the invention. If the best method known to the patentee is disclosed it satisfies the requirement of sufficiency. Since the appellant has not contested the reproducibility of the example of the patent in question we find it sufficient for the purpose of section 10. We find that the appellant has not provided any substantiation for casting reasonable doubts on sufficiency of disclosure and the technical opinion submitted by the appellant do not point to a lack of reproducibility or feasibility of the claimed “invention”. Therefore this ground also fails.
95. Miscellaneous Petition No. 24/2012 for change in address of the Respondent No. 1, Miscellaneous Petition No. 29/2012 for change in name of the applicant, Miscellaneous Petition No. 28/2012 for filing evidence in reply and rebuttal by Affidavit and Extension of time for filing evidence beyond the time specified in IPAB order dated 8.12.2007 are allowed.
96. In view of the above analysis and findings we do not find applicants evidence and reasons convincing enough to persuade us to interfere with the grant of this patent. The revocation application is therefore disallowed.