Kudos Pharmaceuticals Limited v Natco Pharma Limited (2024)

Summary

“Kudos Pharmaceuticals Ltd. (‘Kudos’ hereinafter) is the registered proprietor of Indian Patent IN 228720 (IN’ 720) (hereinafter referred to as ’the suit patent’)” (para 1), whose compound “has been assigned the IUPAC name ‘Olaparib’” (para 5), and “even while the suit patent continues to remain alive and subsisting, Natco has manufactured and sold its own generic version of Olaparib under the brand name BRACANAT.” (para 6) Kudos sought “an interlocutory injunction restraining the defendants from manufacturing or selling Olaparib, under any brand name, pending disposal of the present suit” (para 9); Natco, which had filed C.O.(COMM.IPD-PAT) 1/2023 “seeking revocation of the suit patent” (para 4), sought “an interlocutory injunction staying the operation of the suit patent” (para 74). Kudos submitted that “Olaparib was also covered by IN 245218 (IN'218) registered in favor of the plaintiff” and that Olaparib “is merely one of the millions of compounds which fall within the broad Markush coverage of Claim I in IN'218” (para 17).

The Court held that “The standard of credibility is, therefore, a high standard, not a low standard” (para 23); that “in a case where the species patent alone is asserted, and no infringement of the genus patent is pleaded, the decision in FMC-II” (“FMC Corporation v. Best Crop Science LLP”) “would continue to hold the field” (para 39); and that “It cannot, therefore, be said that coverage is the same as disclosure or that, by accepting coverage of the impugned product by the genus patent, the plaintiff also admits disclosure.” (para 45) It held that “The exercise undertaken by Natco is, therefore, clearly an exercise of hindsight reconstruction” (para 48, p 49) and that “no prima facie case of anticipation by prior claiming can be said to exist” (para 53). “As no credible challenge to the validity of the suit patent has been made out, the prayer for interlocutory injunction has necessarily to be granted.” (para 71) Natco was “restrained from manufacturing and selling, or in any manner, dealing with Olaparib ... pending disposal of the present suit, so long as the suit patent continues to remain alive and subsisting” (para 72), and “I.A. 153/2023 is dismissed.” (para 76)

What the court decided

1. The credible challenge. To the contention “that the defendant is only required to raise a credible challenge to the vulnerability of the suit patent in order to succeed in its defence against infringement” (para 20), the Court held: “There is no dispute about this legal position.” (para 21) It recorded that “this court has held, in para 19 of FMC-II” (“FMC Corporation v. Best Crop Science LLP”): “It is sufficient if the defendant is able to make out a case of the suit patent being vulnerable to revocation under the Patents Act. This vulnerability has, however, to be demonstrated by way of a credible challenge. The onus would be on the defendant, therefore, to establish the credibility of the challenge raised by it. The challenge cannot be incredible, fanciful, or moonshine. It must not strain the sinews of acceptability.” (paras 20–22) “Thus, the onus to establish that the challenge raised by it is credible, is on the respondent. A credible challenge, as Mr. Pravin Anand has correctly submitted, is a challenge which is not incredible, fanciful, or moonshine, and must prima facie be acceptable. On its face, the challenge must merit favorable consideration. It is not enough for the defendant to raise a challenge which is worthy of consideration. The challenge must be more than that; it must partake of the character of prima facie acceptability. ‘credibility’, even by itself, connotes a fairly high standard.” (paras 20–23)
2. Reading Astrazeneca-I. Of the Division Bench decision in Astrazeneca v. Intas, (2021) 87 PTC 374 (DB), which it called Astrazeneca-I, the Court held that “had the Division Bench felt that the view expressed by this Bench in FMC-II was wrong, the easiest thing would have to be to overrule it” and that “it would, therefore, be overreaching the decision of the Division Bench if one were to read Astrazeneca-I as overruling FMC-II. It appears, prima facie, incongruous if an interpreter of a judgment were, in the process of interpreting, to rewrite the judgment as doing what the author of the judgment could have done, but did not choose to do.” (para 26) “The Division Bench, therefore, consciously refrained from overruling the view of this Bench in FMC-II.” (para 27) “It would, therefore, be folly, according to me, for any hierarchically subordinate Court, or Bench, to interpret the decision of the Division Bench in Astrazeneca-I as overruling FMC-II, or even as disapproving the view expressed therein.” (paras 26–29) The Court held that “In para 18, the Division Bench holds that, by simultaneously claiming infringement of the genus and the species patent, Astrazeneca had admitted that DAPA” (“Dapagliflozin”) “was the subject matter of both patents” and that “Thus, the act of Astrazeneca, in alleging the manufacture and sale of DAPA by Intas to be infringing the genus as well as the species patent, was found to foreclose Astrazeneca from maintaining any stand that the genus patent did not disclose DAPA.” (para 34) The Court held that “the identifying and distinguishing feature of the judgment of this Bench in FMC-II is, clearly, from the italicised words in para 52 of the report in Astrazeneca-I, the fact that, in FMC-II, only the specie patent was asserted, whereas, in Astrazeneca-I, Astrazeneca asserted both the genie and specie patent, contending that the impugned invention of Intas infringed both patents” (para 28), that “the Division Bench has proceeded almost entirely on the consideration that Astrazeneca had, in its suit, asserted both the genus and the specie patents” (para 30), and that “The obvious sequitur is that, had Astrazeneca restricted its claim of infringement to the species patent, instead of alleging infringement of the genus and species patent both, the outcome of the judgment would have been different.” (para 36) “Practically, the entire reasoning of the Division Bench of this Court in Astrazeneca-I, therefore, revolves around the fact that Astrazeneca was pleading infringement ... of the genus patent IN'147 as well as the species patent IN'625.” (paras 26–38)
3. A species patent asserted alone. “In the present case, there is no dispute that Kudos has claimed infringement only of the species patent IN'720 and has claimed no infringement of the genus patent IN'218. The above observations of the Division Bench in Astrazeneca-I, particularly in conjunction with the manner in which the Division Bench sought to distinguish the judgment of this court in FMC-II, clearly indicates that, in a case where the species patent alone is asserted, and no infringement of the genus patent is pleaded, the decision in FMC-II would continue to hold the field.” (para 39) “In fact, far from Astrazeneca-I overruling FMC-II, or FMC-II being no longer good law after the decision in Astrazeneca-I, my understanding is that, in a case where a species patent alone is asserted, Astrazeneca-I upholds the decision in FMC-II as representing the correct legal position. The decision in Astrazeneca-I having been upheld by the Supreme Court by dismissal of the SLP, in a case where the species patent alone is asserted, the correct legal position would be the position taken by this Court in FMC-II.” (paras 39–40)
4. Coverage and disclosure. Of Novartis v Union of India (2013), the Court held: “The aspect of whether coverage and disclosure are the same, or whether coverage implies disclosure, has to be decided on the basis of the judgment of the Supreme Court in Novartis AG, as the Supreme Court has specifically alluded to the point. Howsoever one may interpret or understand Novartis AG, it is not permissible for any court, lower in the judicial hierarchy to the Supreme Court, to allow its judicial peregrinations to take it outside Novartis AG of that decision, when dealing with the aspect of coverage vis-à-vis disclosure.” (para 43) The Court recorded that “In FMC-II, this Court has analyzed the decision in Novartis AG threadbare, para by para” and reproduced its conclusion there: “The Supreme Court has not held that coverage and disclosure are the same. Nor has it held that there is no distinction between coverage and disclosure.” “In holding that there can be no dichotomy between coverage or claim, on the one hand, and disclosure or enablement or teaching, on the other, the Supreme Court has not, therefore, held that they are identical.” “If, however, there was clear coverage of a product in the claim (as was found to exist in the Zimmerman Patent, qua Imatinib Mesylate), it would be difficult for the patent holder to assert, before the Court, that, despite such coverage, the claim did not disclose the product. That, in my view, is what Novartis AG holds. It does not pronounce that coverage and disclosure are identical or synonymous terms, in patent law.” (para 44) It held: “It cannot, therefore, be said that coverage is the same as disclosure or that, by accepting coverage of the impugned product by the genus patent, the plaintiff also admits disclosure.” (paras 43–45)
5. Olaparib and the genus patent. “A bare glance at the Markush structure claimed in Claim I of the genus patent IN'218, vis-à-vis the chemical structure of Olaparib as claimed in Claim I of the species patent IN'720, makes it apparent that Olaparib cannot be said to have been disclosed in the genus patent.” (para 46)
6. Obviousness from the prior art. “A bare reading of the afore-extracted paragraphs from the written statement of Natco indicates that Natco is arriving at chemical structure of Olaparib, in the case of each of the referred prior art inventions, by choosing select radicals out of the several suggested substitutions in the complete specifications of the prior art patents. There is not a whisper of an averment, in the written statement, to justify such preferential selection.” ... “The exercise undertaken by Natco is, therefore, clearly an exercise of hindsight reconstruction, armed with prior knowledge of the necessary radicals which are to be substituted onto the Markush Claim I of the genus patent IN'218 in order to arrive at claim I of the species patent IN'720, by cherry-picking the appropriate radicals for substitution. Such hindsight operation, prima facie, demolishes the plea, of Natco that Claim I in the suit patent is obvious from the genus patent, or, for that reason, that the species patent is vulnerable to invalidity on the ground of want of inventive step, under Section 64(1)(f) of the Patents Act.” (para 48, p 49) “Indeed, if Olaparib were so obvious from the suggested prior arts, there is no explanation why it took 19 years, after the genus patent had been granted, for Natco to synthesize Olaparib. Even as an old patent, which has weathered 19 years of uninfringed existence, therefore, the suit patent is entitled to protection.” (paras 48–49)
7. Prior claiming. The Court reproduced from FMC-II that “The statutory preconditions, for this clause to apply as a ground for alleging invalidation of the suit patent, are that (i) the invention claimed in the claim, under consideration, of the suit patent, was claimed in another valid claim, (ii) said valid claim was of earlier priority date and (iii) said valid claim was contained in the complete specification of another patent granted in India” and that “An allegation that the prior patent was invalid is fatal to any challenge to the validity of the suit patent under Section 64(1)(a).” (para 48, p 50) The Court reproduced from FMC-II that “the defendant has introduced two new concepts, which find no place in Section 13(1)(b), viz. the concepts of ‘scope’ and ‘coverage’”, that “What is required therefore, prima facie, is comparison of the claims, not whether the claim in the suit patent is covered by or within the scope of the claim in the genus patent”, and that “All that these provisions require the Court - or authority before whom the challenge to the validity is raised - to do is to assess whether the invention, insofar as it has been claimed in the suit patent, was, or was not, claimed in the prior patent.” (para 48, pp 51–52) “As has been correctly contended by Mr. Pravin Anand, a plea of vulnerability of invalidity on the ground of anticipation by prior claiming can successfully be raised only if the claim in the suit patent has been claimed in a patent of an earlier priority date. There must, therefore, be identity of claims.” (para 49, p 52) Of the contention “that a claim of vulnerability of the suit patent to invalidity on the ground of anticipation by prior claiming ‘is dependent on reasonable construction of the claim to assess the scope of its coverage in respect of a product, but is in no way contingent on specific disclosure of the product in the complete specification’” (para 51), the Court held that it “is based on a fundamentally erroneous legal premise” (para 50), and: “In my view, Section 64(1)(a) is clear and categorical in the words it uses. It states that the invention, so far as claimed in the suit patent, has to have been claimed in a valid claim of earlier priority date for the suit patent to be regarded as vulnerable to invalidity on the ground of anticipation by prior claiming. There has, therefore, to be identity of claims. The claim asserted in the suit patent, must have been claimed in a complete specification relating to a patent of earlier priority date. Then, and only then, can a plea of invalidity on the ground of anticipation by prior claiming be successfully laid.” (paras 48–52)
8. Claim and disclosure. “A claim is even more specific than a disclosure. On a plain claim to claim comparison, it is clear that Olaparib, as Claim I in the suit patent IN'720, has never been claimed in any earlier patent to which Mr. Sai Deepak draws attention. The Markush structure claimed in Claim I of the genus patent IN'218 certainly cannot be said to claim Claim I in the suit patent IN'720. As such, no prima facie case of anticipation by prior claiming can be said to exist.” (para 53)
9. Statements made in other jurisdictions. Of Natco’s reliance “on the Forms 27 filed by Kudos in respect of IN'720 and IN'218” (para 54), the Court held: “Particularly when dealing with a challenge to the validity of the suit patent on the ground of anticipation by prior claiming, once the Court finds, on facts, by claim to claim comparison, that there is no anticipation by prior claiming, statements made in other jurisdictions, or in documents filed by the plaintiffs elsewhere, cannot make out a case of anticipation by prior claiming, even at the prima facie stage.” ... “The plaintiffs would have, during the course of trial, every opportunity to explain the circumstances in which such statements were made, and before grant of such opportunity, where a prima facie clear case of lack of anticipation of prior claiming is made out, the matter must rest there, when dealing with an Order XXXIX Rule 1 and 2 applications.” (para 56) “When, on a claim to claim comparison, no case of anticipation of prior claiming is found to exist, it cannot be said that the defendant has raised a credible challenge on that ground.” (paras 54, 56–57)
10. Prior publication. The Court reproduced from FMC-II: “Whether under clause (1)(a) or (2), what Section 13 requires is publication of the invention, claimed in the suit patent, in any document, before the date of filing of the complete specification in the suit patent.” “Section 64(1)(e), therefore, requires satisfaction of two indicia, viz. (i) that there has been anticipation by prior publication and (ii) as a consequence, the invention cannot be treated as a ’new invention’.” “Can there be publication of a patent, relating to an invention without disclosure of the invention in the patent?” “Publication involves making known to the public the patent application. Every application is required to disclose the invention for which it relates.” From Novartis I it reproduced that “The use of the expression ‘so far as claimed’, in Section 13(2) would, therefore, require identity in the extent of claim contained in the specification in the suit patent and in the specification of the prior art which is cited for the purpose of alleging anticipation by prior publication.” (para 58) “In para 126 of FMC-II, this Bench has clearly rejected Mr. Sai Deepak’s contention that the terminus ad quem for determining anticipation by prior publication is the priority date of the suit patent. It is held, in the said para, that the priority date of the suit patent is prima facie irrelevant, while examining vulnerability on the ground of anticipation by prior publication and that, when Section 64(1)(e) is read with Section 13 of the Patents Act, what has to be seen is whether, prior to the date of filing of the complete specification of the suit patent, the asserted invention was published in India or elsewhere in any document.” (paras 58–59)
11. Compound 278 and cherry-picking. Of Natco’s reliance on “Compound 278 in WO'576” (para 60), the Court held: “It is obvious at a bare glance that the product compound 278 is not Olaparib.” (para 61) “It is clear, from a bare glance at the manner in which Natco has arrived at the chemical structure of Olaparib from Claim I in WO'576 that there has been cherry picking of substituents.” ... “Most significantly, perhaps, there is no teaching, in any of the cited prior arts, to lead a person skilled in the art to envision the terminal cyclopropane substitution.” (para 63) “No other prior publication, which publishes Olaparib, has been cited by Mr. Sai Deepak either during oral arguments or in written submissions.” (para 64) “No case for anticipation by prior publication is also, therefore, made out.” (paras 60–65)
12. Section 3(d). “Mr. Sai Deepak has also sought to invoke Section 3(d) of the Patents Act to contend that the specifications for Olaparib do not contain any data to indicate enhanced efficacy over the prior art IN'218.” (para 66) The Court held: “The fallacy of the submission is obvious. Section 3(d), to the extent it is at all relevant to the submission of Mr. Sai Deepak, applies only to ’new forms’ of ‘known substances’. It cannot be said that” “Olaparib is a new form of the Markush Claim I in IN'720. The submission, therefore, merits prima facie rejection.” (paras 66–67)
13. Undisclosed foreign applications. Of the plea that “Kudos did not disclose the fact that its applications for grant of the same patent JP 2006-505955 and JP 2007-226723 were facing rejection”, the Court held: “This, in my opinion, cannot be a basis, in any case, for Kudos to be regarded as disentitled to an injunction. At the very least, the matter would be a question of fact, to be decided on the facts of each individual case.” (para 68) “Besides, Section 8 requires the patent applicant in India, who is prosecuting an application for a patent in another country outside India in respect of the same invention, to file, along with his application, a statement setting out the particulars of the application.” (para 69) “In the present case, Kudos has placed, on record, documents, including correspondences with its patent agent, which, according to it, indicate that the omission to mention the Japanese patents was not deliberate, but was an inadvertent omission on the part of the patent agent.” ... “In any event, in view of the explanation, this cannot be regarded as so overwhelming a factor as would justify rejection of the interim relief that Kudos seeks.” (paras 68–70)
14. Disposition of I.A. 907/2023. “For the purposes of the present application, it is admitted, in the first place, that the defendant is in fact exploiting the suit patent by manufacturing and selling Olaparib. It is also admitted that this exploitation has take place in the 19th year of the life of the suit patent. No credible case of vulnerability of the suit patent to invalidity on any of the grounds contained in Section 64 of the Patents Act can be said to have been made out by the Natco. As no credible challenge to the validity of the suit patent has been made out, the prayer for interlocutory injunction has necessarily to be granted.” (para 71) “For all the aforesaid reasons, the present application succeeds and is allowed. The defendant shall stand restrained from manufacturing and selling, or in any manner, dealing with Olaparib, either under the brand name BRACANAT or under other brand name, pending disposal of the present suit, so long as the suit patent continues to remain alive and subsisting.” (para 72) “I.A. 907/2023 is allowed accordingly.” (paras 71–73)
15. Natco’s application in the revocation petition. “By this application, Natco seeks an interlocutory injunction staying the operation of the suit patent and restraining Kudos from seeking any injunction against Natco exploiting the suit patent.” (para 74) “No separate submissions have been advanced in this application. In any event, the outcome of I.A 907/2023 ... would necessarily also determine the outcome of the present applications.” (para 75) “Resultantly, I.A. 153/2023 is dismissed.” (paras 74–76)

What the court did not decide

The Court held that “aspects which involve detailed examination of facts and which, therefore, would merit an exhaustive analysis after both sides are given an opportunity to lead evidence, are not being addressed, adhering to the discipline of Astrazeneca-I and Pernod Ricard” (para 19). Of the reliance “on the Forms 27 filed by Kudos in respect of IN'720 and IN'218” (para 54), it held: “I have nonetheless reproduced, in this regard, the defence raised by Mr. Anand to the various points raised by Mr. Sai Deepak, and for the purposes of adjudicating the present Order XXXIX Rule 1 and 2 applications, suffice it to state that the challenges have not been left unanswered. The response by Mr. Praveen Anand raises, at the very least, triable issues.” (para 57) Of the omission to mention the Japanese applications, it held: “The issue of whether, in a case where the patent is registered, or being prosecuted, in several other jurisdictions, the omission to mention the” “proceedings before one jurisdiction would invalidate the granted patent altogether is, in my prima facie view, highly arguable. Even more arguable would be the question of whether, if the omission is bona fide, the patentee, whose patent is admittedly infringed, can be refused an interim injunction.” (para 69) “How far this argument would be acceptable is, in my view, a matter which would have to await trial.” (para 70) It recorded that “several incidental contentions were raised, including IC 50 values, dosage data ... and the like, all of which would require a detailed excursion into facts. It would not be justified for this Court to enter into all these areas, once a prima facie case has been found to exist in favour of the plaintiff.” (para 71)

Subsequent treatment

• Appealed — Natco’s appeal, FAO(OS)(COMM) 43/2024, was disposed of by a Division Bench of the High Court of Delhi (Navin Chawla and Shalinder Kaur JJ) on 31 January 2025 without a decision on the merits, both sides agreeing that the suit patent had expired; the Bench left all questions and issues open before the Single Judge trying the suit and recorded that the disposal was not to be treated as an affirmation of the Single Judge’s view.