OTSUKA PHARMACEUTICAL CO LTD  v. THE CONTROLLER OF PATENTS

No. 8198/DELNP/2013 and upon filing a request for examination on 30.03.2015, the Patent Office examined the application and issued the First Examination Report ('FER') on 14.03.2018. Objections were raised in the FER under Section 2(1)(j) of the Act on the ground of lack of novelty and inventive step in respect of the subject claims 1 to 33, citing D1 (WO2006/112464 A1), D2 (JP2008-115172 A), D3 (WO2009/128537 A1) and D4 (2004/060374 A1), as prior art documents. Subject matters of claims 1-18 were also objected to as non-patentable under Section 3(d), while claim 21 was held non-patentable under Section 3(e) and claims 19, 20, 22-33 as non-patentable under Section 3(i) of the Act.

3. Substantive response to the FER was filed by the Appellant within the stipulated period on 11.09.2018 and claim 1 was amended while claims 4, 5, 7, 8, 9, 11, 12, 13, 15 to 20, 22, 24 to 26 and 27 to 33 were deleted. After conclusion of the hearings, Appellant submitted written arguments on 15.02.2020, within the period allowed under the Patent (Amendment) Rules, 2016 (hereinafter referred to as the 'Rules'). Vide the impugned order dated 18.03.2021, Respondent rejected the application for grant of patent.

4. Laying a siege to the impugned order, learned counsel for the Appellant submits that the impugned order suffers from gross illegalities and infirmities. The impugned order is a cryptic and non-reasoned order as a bare reading of the same would reflect. It is the statutory obligation of the Respondent to pass a reasoned and speaking order furnishing reasons for declining to grant the patent. Respondent has failed to appreciate that present invention meets the requirements of inventive step and without considering that the claimed medicament combination is not known from any of the prior arts or its combinations, Respondent has rejected the

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application. Elaborating the arguments, it is submitted that Respondent failed to support his conclusion by showing that a skilled person would be able to arrive at the claimed invention based on the cited prior art D1 to D4 and wrongly applied hindsight analysis to pick and choose from numerous possibilities, without looking to the fact that synergy is an unpredictable phenomenon. This approach is against the decision by the Board of Appeals of the European Patent Office T-0970 dated 15.09.2004 ruling that prior disclosure must not be distorted or misinterpreted based on hindsight knowledge. In F. Hoffmann-La Roche Ltd. & Anr. Petitioners v. Cipla Ltd., 2015 SCC OnLine Del 13619, this Court has held that hindsight is impermissible while conducting an enquiry into obviousness and the legal conclusion must be reached on the basis of facts gleaned from the prior art and should not include knowledge from patent disclosure.

5. The impugned order stands vitiated, on account of violation of principles of natural justice, embodying the doctrine of audi alterem partem, that no person shall be condemned unheard. Respondent has considered documents D2 and D3, which were never cited in the hearing notice, for rejecting the application on ground of lack of inventive step, despite unequivocally mentioning that the objections were based only on documents D1 and D4. This anomaly finds reflection in the order itself, relevant part of which states that "subject matter of Claims 1 to 8 lacks inventive step under Section 2(i)(ja) of the Patents Act, 1970 in view of the prior art D-1 and D-4". By re-introducing documents D2 and D3 at the time of final adjudication, Respondent has deprived the Appellant of an opportunity and a valuable right to meet the objections raised.

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6. On technical aspects, it is submitted that Respondent's evaluation of the inventive merits qua documents D1 and D4 is erroneous. Respondent has failed to appreciate the crux of the invention as also the fact that there is no clear and explicit suggestion either in D1 and/or D4, which would specifically direct a skilled man towards the claimed invention. D1 discloses a compound in a Markush-type claim, including Brexpiprazole, for use and treatment of Central Nervous System disorders, but does not disclose that synergistic effects can be obtained by combination use of Brexpiprazole with other drugs. Moreover, D1 does not disclose that Brexpiprazole can be used in combination with other drugs. D4 relates to Aripiprazole and does not disclose that Brexpiprazole can be used in combination with other drugs or the synergistic effects shown by combination of Brexpiprazole and other drugs. Aripiprazole and Brexpiprazole are structurally different and these differences have a huge impact on the receptor binding profile and consequently, on the physiological effects of the drugs. Appellant had invited Respondent's attention to various 'articles' by renowned authors on the subject, which have not been considered, while passing the impugned order, though noticed in the impugned order.

7. Respondent has erroneously refused the claimed medicament (composition) under Section 3(d) of the Act, without considering the decision by IPAB in Ajantha Pharma Limited v. Allergan Inc. and Others,

ORA/21/2011/PT/KOL, copy of which was filed with the written submissions and was relevant, since the claim medicament consists of two or more different substances, which are not derivatives of each other. Respondent has come to a conclusion that subject matter of claims 1-6 lacks inventive step under Section 2(1)(ja) of the Act by relying on certain categories of

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inventions which fall under Section 3(d) and not under Section 2(1)(j) or 2(1)(ja). Section 3(d) is meant to prevent ever-greening of patents. Impugned order is based on application of incorrect standards for determining inventive step requirement. It is settled that 'inventive step' has to be judged independent of Section 3(d) and even assuming the invention falls under the scope of Section 3(d), it is not automatically disqualified from meeting the requirements of Section 2(1)(j) of the Act.

8. Mr. Harish Vaidyanathan, learned Central Government Standing Counsel, on the other hand, submits that there is no infirmity in the impugned order and the patent registration has been rightly refused on the ground that it does not involve inventive step, under Section 2(1)(j) and falls under Section 3(d) of the Act. The patent application is a mere combination of Brexpiprazole with already known drugs only with new therapeutic uses. There is no inventive step as the compositions and combinations of products are known in the cited prior art documents. Subject matter of claims 1 to 6 lack inventive step under Section 2(1)(ja) of the Act, in view of documents D1 to D4, with regard to efficacy over the parent/base compound and the data provided is not sufficient to establish significant improvement in properties over the prior art parent compounds. Insofar as the contention of the Appellant that documents D2 and D3 which were never cited in the hearing notice, have been considered by the Respondent while finally adjudicating the matter, is concerned, Mr. Harish fairly concedes that this is an error on the face of the record.

9. I have heard the learned counsels for the parties and examined the impugned order passed by the Respondent.

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10. Perusal of the hearing notice reflects that objection to the grant of patent was predicated on lack of inventive step, citing prior art documents D1 and D4. There is no mention of D2 and D3 as rightly pointed by learned counsel for the Appellant. Relevant part of the hearing notice is extracted hereunder:-

"The reply submission by the applicant is not persuasive as D4 discloses a pharmaceutical composition comprising: (i) at least onecarbostyril derivatives (i.e. i.e. aripiprazole) in combination with (ii) at least one serotoninreuptake inhibitor, and (iii) a pharmaceutically acceptable carrier (p. 6, line 6-11). It also discloses that the serotonin reuptake inhibitor can be fluoxetine, citalopram, fluvoxamine, paroxetine, sertraline and escitalopram, and salts thereof (p.7, line 22-26). D4 also discloses a method for treating major depressive disorder by administering to a patient with major depressive disorder said composition (p.12, line 19-25). D1 discloses a heterocyclic compound of formula (I) or salts thereof, which the preferable compound (I) is 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1- yl)butoxy]-1 H-quinolin-2-one (p.12, line 10-14: see Compound (1)). D1 discloses that the above compound of formula (I) can be provided in a pharmaceutical composition as an active ingredient mixed with a pharmaceutically acceptable carrier for the treatment or prevention of central nervous system disorders, i.e. major depression (p. 13, line 16-23; & p. 14, line 4 ). A person skilled in the art would have been motivated to combine the teachings of D1 with D4 to produce a new composition for use in the very same treatment of major depressive disorder, and it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. Hence the subject matter of claims 1-8 lacks inventive step u/s 2(1)(ja) of the Patents Act, 1970 in view of the prior art D1 and D4."

11. However, while finally adjudicating the application, Respondent has considered D2 and D3 also, without affording an opportunity to the

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Appellant to respond to them and put forth its stand. As per the well-settled practice and judicial precedents, Respondent was required to communicate all outstanding objections to the Appellant at the threshold, i.e. in the hearing notice. This is fortified from a reading of Clauses 3(k) and 3(l) of the Notification dated 21.09.2021, issued by the Controller General of Patents, which are as follows:-

"k. If upon examination of the response submitted by the Applicant, the Examiner reports that some objections are still outstanding or raises further objection(s), such objections

shall he communicated along with the notice of hearing, giving reasonable time to the Applicant. It is clarified that there is no need to send a second examination report."

l. i. At the time of hearing, the Examiner may be present. However, the Examiner shall not communicate with the Applicant and no further objections can be raised at the time of hearing…"

12. Learned counsel had relied on several decisions passed by the erstwhile IPAB in this regard and I may refer to two, in order to avoid burdening this judgement. In Thomson Reuters Global Resources v. The Controller General of Patents, Designs & Trade Marks & Ors., IPAB Case No. OA/38/2011/PT/KOL, it was held that when notice for hearing is sent, Appellant should clearly know the objections and the prior art that the Controller will be relying on during the hearing. In yet another matter in

Resprotect GmbH vs The Controller of Patents & Designs & Anr., IPAB Case No. OA/23/2010/PT/DEL, it was held that the Patent Office while dealing with grant of patent, exercises quasi-judicial power and a quasi- judicial authority is not an adversary of the patent applicant. Therefore, any objection to prior art must be known to the applicant before the date of

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hearing. The argument of the Appellant is clearly reinforced by these decisions and is imbedded in the principles of natural justice.

13. I thus find merit in the contention of the Appellant that if the Respondent had consciously chosen to raise objections only citing D1 and D4 as prior art documents, it was not open to the Respondent to rely on D2 and D3 while finally adjudicating the patent application and that too without affording an opportunity to the Appellant to respond to the prior arts D2 and D3. This action of the Respondent is clearly in the teeth of the doctrine of audi alterem partem and is sufficient to remand the matter for fresh adjudication. This Court also finds that the Appellant had specifically objected to application of Section 3(d) of the Act in determining claims 1 to

6. However, the impugned order shows that the Respondent has not dealt with the arguments made by the Appellant or the judgments cited in this context. Respondent has come to a conclusion on non-patentability under Section 3(d) of the Act by simply observing that claims 1 to 6 are mere new use of known substances, with no significant difference with regard to efficacy over the parent/base compound. No reasons are discernible in the order which weighed with the Respondent to arrive at the said conclusion and the impugned order cannot be termed anything but cryptic and unreasoned.

14. Appellant is also correct in its submission that the impugned order does not give any reasons for rejecting the invention claimed, for lack of inventive step. The invention sought to be patented by the Appellant is based on the finding that synergistic effects can be obtained by the combination of 'Component-1': 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl) butoxy]-lH- quinolin-2-one (hereinafter Brexpiprazole) or a salt thereof and

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'Component-2': at least one drug selected from the group consisting of (i) serotonin reuptake inhibitor (SSRI); or (ii) a serotonin and norepinephrine reuptake inhibitor (SNRI); or (iii) an anti-anxiety drug selected from diazepam or a salt thereof. D1 and D4 were cited as prior art. Appellant had brought out that D1 does not disclose that synergistic effects can be obtained by combination use of Brexpiprazole with other drugs and also does not disclose that Brexpiprazole can be used in combination with other drugs. D4 related to Aripiprazole and it was brought out that D4 does not disclose that Brexpiprazole can be used in combination with other drugs. Moreover, D4 does not disclose synergistic effects by the combination of Brexpiprazole and other drugs. In order to distinguish the prior art, Appellant had categorically pointed out that Aripiprazole and Brexpiprazole are structurally different on three points, viz: (1) the presence or absence of a double bond in the carbostyril structure; (2) the substituent on the Piperazine ring (phenyl group in Aripiprazole vs. Benzothiophene in Brexpiprazole); and (3) the presence or absence of the substituents on the substituent (2) above (2,3-dichloro-substituted in Aripiprazole vs. unsubstituted in Brexpiprazole) and also that such differences have a large impact on the receptor binding profile and consequently, on the physiological effects of the drugs.

15. In support of this stand, Appellant had referred to a post published article (J. Pharmacal. Exp. There. 350:589-604, September 2014), which provides a detailed comparison of the experimental in vitro and in vivo binding profiles of Aripiprazole and Brexpiprazole. It was thus the stand of the Appellant that Brexpiprazole is functionally different from Aripiprazole and, therefore, synergistic effects of the combination of Brexpiprazole with

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a serotonin reuptake inhibitor; or a serotonin and norepinephrine reuptake inhibitor; or an anti anxiety drug, cannot be expected in view of D4 disclosing Aripiprazole, which is structurally and functionally different from Brexpiprazole. Appellant had also pointed out the effects of the invention which have been noticed in the impugned order. However, the Respondent has failed to deal with the arguments and/or furnish a reason as to how a person skilled in the art would move from the existing knowledge to the subject invention captured in the patent application before rejecting the application for grant of patent.

16. Section 2(1)(ja) of the Act defines 'inventive step' as follows:-

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

17. It has been held by this Court that while rejecting an invention for lack of inventive step, Controller has to consider three elements: (a) invention disclosed in the prior art; (b) invention disclosed in the patent application; and (c) the manner in which subject invention would be obvious to a person skilled in the art. The Controller has to thus analyse the existing knowledge and how the person skilled in the art would move from the existing knowledge to the subject invention captured in the application under consideration. (Ref.: Agriboard International LLC v. Deputy Controller of Patents and Designs, C.A. (COMM.-IPD-PAT) 4/2022, Date of Decision: 31.03.2022)

18. In Agriboard International LLC (Supra), Court remanded the matter to the Controller for a consideration afresh, on the ground that the impugned

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order was an unreasoned one, placing reliance on the decisions of the Supreme Court in Assistant Commissioner, Commercial Tax Department v. Shukla and Brothers, (2010) 4 SCC 785 and Manohar v. State of Maharashtra & Ors., AIR 2013 SC 681. In Competition Commission of India v. Steel Authority of India Ltd. and Anr., (2010) 10 SCC 744, the Supreme Court held that recording of reasons is an essential feature of dispensation of justice as reasons are the soul of orders. Non-recording of reasons could lead to dual infirmities, firstly, it may cause prejudice to the affected party and secondly, hamper proper administration of justice. A judgment without reasons causes prejudice to the person against whom it is delivered as the litigant is unable to know the grounds which weighed with the Court in rejecting his claim as also caused impediments in his taking adequate and appropriate grounds before the higher Court in case of challenge to the judgment. In fact, the Supreme Court has equated the obligation of giving reasons for arriving at a conclusion with the requirement of following the principles of natural justice.

19. The impugned order thus suffers from several infirmities, including procedural. The order is a non-speaking and unreasoned order; takes into account prior arts D2 and D3, while finally adjudicating on the patent application albeit they did not form a part of the objections referred to in the Hearing Notice and that too without giving an opportunity to the Appellant to respond to them. Vital issues and documents relied upon by the Appellant have not been considered, including applicability of Section 3(d) of the Act, seriously contested by the Appellant.

20. I may also take note of a relevant and important fact brought out by the Appellant that the inventive step involved in the subject application has

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been acknowledged in corresponding applications in major jurisdictions inter alia Japan, Indonesia, Australia, Malaysia, etc. which has led to grant of patents in all these jurisdictions. This, according to the Appellant, affirms the patentability of the present inventions and ought to have been taken into account by the Respondent. I agree.

21. Accordingly, the impugned order dated 18.03.2021 is set-aside and the matter is remanded back to the Respondent for fresh consideration. Needless to state the Respondent shall hear the parties after permitting them to place on record their replies/response to prior art documents D2 and D3, in case the Respondent wishes to place reliance on them, as agreed by learned counsel for the Appellant.

22. It is made clear that the Controller shall decide the matter on merits, in accordance with law, uninfluenced by any observations in the present judgment or in the impugned order dated 18.03.2021. The decision shall be taken as expeditiously as possible, but not later than four months from today.

23. Appeal is disposed of accordingly.

JYOTI SINGH, J

SEPTEMBER 22, 2022/shivam/rk

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