Cipla v F Hoffmann-La Roche (2015)

Summary

The Bench recorded that "Roche claims that on March 31, 1991, it filed an application for grant of patent in USA pertaining to Erlotinib Hydrochloride" and that "The marketable physical form of the molecule comprised polymorph A and B. Further research revealed that polymorph B was more thermodynamic" (para 1). Roche "moved this Court on its original side seeking to injunct Cipla from marketing Erlocip." (para 4) "Roche's plea for interim injunction against Cipla was dismissed by a learned Single Judge of this Court on March 19, 2008" (F Hoffmann-La Roche v Cipla (2008), para 5); "Roche's appeal to the Division Bench of this Court against the order passed by the learned Single Judge was dismissed on April 24, 2009" (F Hoffmann-La Roche v Cipla (2009), para 6); and "Roche's subsequent agitation of the matter on special leave before the Supreme Court was also denied. And the case moved to trial." (para 8) After trial, in F Hoffmann-La Roche v Cipla (2012), "The learned Single Judge has answered two main questions in the impugned decision" (para 9), on revocation and infringement. "At the forefront of the attack of Cipla was the argument that inventions are required to be product specific; where products have to have commercial manifestation." (para 38)

The Bench held that "The correct test of infringement in this case is to map Cipla product against the Roche's patent claims, which we find has not been done by the learned Single Judge" (para 109), and that Claim 1 "is a sufficiently broad claim that is clearly not limited to any polymorphic version of Erlotinib Hydrochloride, but to Erlotinib Hydrochloride itself" (para 114). It found "no reason to revoke the suit patent for non-compliance of Section 8 under Section 64(1) (m) of the Patents Act" (para 129) and held that "the action of Cipla seeking invalidity of the suit patent on the ground of obviousness fails" (para 169). It set aside "the impugned decision dismissing suit for injunction filed by Roche", but "keeping in view the fact that the life of the patent in favour of Roche in India would expire in March, 2016 we do not grant the injunction as prayed for by Roche against Cipla" and decreed "that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip" (para 183).

What the court decided

1. Section 3 as a threshold. "Section 3 of the Act lays down a threshold for patent eligibility and is not an exception to Section 2(1)(j) as urged by learned Senior counsel for Cipla. Section 2(1)(j) provides a theoretical definition of an invention while Section 3 illustratively outlines what are not inventions." (para 61)
2. Section 3(d) and incremental innovation. "This provision is not a patent term extension or an evergreening provision but in fact recognizes incremental innovations in pharmaceutical patents" (para 62). "A new chemical entity (NCE) that is structurally dissimilar but functionally similar to an existing chemical entity is thus merely a substance under Section 3(d). If the substance has an added layer of enhanced efficacy then it would be treated as a" new product "and would be eligible for assessment under Section 2(1)(j) to ascertain whether its formation involved an inventive step. If the new product involved one or more inventive steps, then it would qualify as a pharmaceutical substance." (para 62)
3. Product patents and forms. "A product essentially comprises a substance (active ingredient) or composition (combination of active ingredients). A product patent protects the product in any form however it is made, or however it is formulated." (para 64)
4. Principles of claim construction. The Bench summarised "principles of claim construction", including that "Claims define the territory or scope of protection" and that "For someone wishing to invalidate a patent the said person must invalidate each claim separately and independently as it is quite likely that some claims may be valid even while some are invalid." (para 67)
5. Section 3(d) and infringement. "What Section 3(d) certainly does NOT do, is doubly penalize the innovator" (para 72). "The inherent assumption in this is that an infringement of the resultant product would therefore be an infringement of the original i.e. the known substance and by no stretch of imagination can Section 3(d) be interpreted as constituting a defence to infringement." (paras 72–73)
6. A molecule, not a crystal form. "It is a single molecular structure which is protected in the present patent and therefore, irrespective of which polymorphic form it appears it would have the same chemical structure as contained in Claim-1 of the suit patent." (para 77)
7. Rejection of the polymorph application. "The interesting thing is that the Cipla's argument would shoot down the polymorph because of Section 3(d) and also attempts to shoot down the main compound, because of the polymorphs rejection. This cannot be done." (para 87)
8. Polymorphs with non-therapeutic gains. "If there are polymorphs, which improve only the non-therapeutic properties, then there may be a difficulty in obtaining a patent for the same in India." (para 85)
9. Diffraction data in a molecule patent. Cipla's "argument that X-Ray Diffraction Data (XRD) was not specified for the suit patent is also not plausible because XRD shows the manner in which the molecules are arranged in a crystal lattice. This is only important for a polymorphic patent but not for a main molecule where irrespective of the polymorphs, it is the chemical structure which is the sum and substance of the invention." (para 88)
10. Commercial and patentable utility. "This argument ignores the fundamental truth about breakthrough inventions, which at the time they are invented may not be commercially the most viable for immediate marketing. They are useful and are industrially applicable as without them there would be no stepping stone to achieve the next lot of improvements." (para 90)
11. Construction on the claim's own language. "It is a cardinal principle of claim construction that the claim must be interpreted on its own language and if it is clear then resort cannot be had to subsequent statements or documents either to enlarge its scope or to narrow the same." (para 94)
12. Claims, not products, are compared. "X-ray diffraction is certainly not an accurate method to ascertain product patent infringement in the present case as the issue is not and indeed cannot be whether Roche and Cipla's products are identical but whether Cipla's product is covered in the claims of Roche's patent" (para 107). "The correct test of infringement in this case is to map Cipla product against the Roche's patent claims" (para 109). "This subtle distinction is important to be kept in mind because the holder of a patent is by no means limited to only manufacture and sell only those products that are disclosed in the claims of the patent" "the very product disclosed in the patent claims must be used." (paras 107–110)
13. Claim 1 covers every polymorph. "This is a sufficiently broad claim that is clearly not limited to any polymorphic version of Erlotinib Hydrochloride, but to Erlotinib Hydrochloride itself. This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent." (paras 112–114)
14. Pleading non-disclosure. "It is trite that a pleading concerning suppression of a fact or failure to disclose a relevant fact has to be specific by highlighting what was required to be disclosed or informed. A general and a bald allegation that the opposite party had failed to disclose information required by law is no pleadings in the eyes of law." (para 119)
15. Section 8 mandatory, revocation discretionary. The Bench recorded that in Maj.(Retd.) Sukesh Behl this Court held "that though it is mandatory to comply with the requirement under Section 8(1) of the Patents Act and non-compliance of the same is one of the grounds for revocation of the patent under Section 64(1)(m)", the "power conferred thereunder is discretionary and consequently it is necessary for the Court to consider the question as to whether omission on the part of the applicant was intentional or whether it was a mere clerical and bona-fide error" (para 123), and held that "Section 64(1) is directory in nature and thus noncompliance of Section 8 would not automatically result in revocation of the patent" (para 124). (paras 123–124)
16. Substantial compliance under section 8. "Be that as it may, it is a case of substantial compliance inasmuch as even if Roche did not inform about the pending application" for the polymorph B patent, "NATCO in its pre-grant opposition application to the suit patent duly informed about the same" (para 126). "Thus, we find no reason to revoke the suit patent for non-compliance of Section 8 under Section 64(1) (m) of the Patents Act." (paras 126–129)
17. Judging obviousness. "Whether an invention involves 'novelty' and an 'inventive step' or is 'obvious' is a mixed question of law and fact, depending on the facts and circumstances of each case. Though no absolute or uniform formula can be laid down to ascertain obviousness however certain broad criteria have been laid down in the various decisions" (para 143). "Obviousness has to be strictly and objectively judged", and in Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries (1978) "the Supreme Court laid down the principles to test 'inventive step'" (para 144). (paras 143–144)
18. The person skilled in the art. "The features of a person skilled in the art are that of a person who practices in the field of endeavour, belongs to the same industry as the invention, possesses average knowledge and ability and is aware of what was common general knowledge at the relevant date." (para 145)
19. The five steps. "From the decisions noted above to determine obviousness/lack of inventive steps the following inquires are required to be conducted:" "To identify an ordinary person skilled in the art," "To identify the inventive concept embodied in the patent," "To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date." "To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary application of law or involve various different steps requiring multiple, theoretical and practical applications," "To decide whether those differences, viewed in the knowledge of alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hideside approach." (para 151)
20. Hindsight. The Bench recorded that "the Bombay High Court in F.H. & B. Corp. (supra) guarded the Courts of law against the common human failing of being wise after the event in regarding something that has been discovered by research as obvious", and that "a patent challenger however must demonstrate the selection of a lead compound based on its promising useful properties, not a hindsight driven search for structurally similar compounds." (para 150)
21. Structural similarity not enough. "Thus prior art disclosure should not merely be structurally similar compound but also at least to some degree demonstrate the same desired property which is relied on for the patentability of the new compound." (para 157)
22. Burden of proof in obviousness. "Thus obviousness is a question of law based on facts and the burden to prove is on the party which alleges however after the party which alleges makes out a prima facie case of invalidity on the ground of obviousness, the burden shifts on the inventor to disprove obviousness." (para 158)
23. The expert witness. From the evidence of DW-3 ("Defendants Expert Witness"), the Bench concluded that he "was not an ordinary person skilled in the art being a professor of the Chemistry and not a medicinal Chemist", that his "evidence was beyond the pleadings", that he "based his theory of obviousness only on the basis of structural similarity" and that "The evidence of DW-3 was a hindsight evidence" (para 168). "The onus was on Cipla to show prima facie obviousness whereafter the burden would have shifted to Roche." "Consequently, the action of Cipla seeking invalidity of the suit patent on the ground of obviousness fails." (paras 168–169)
24. Title not a ground of revocation. "Thus, the claim of Cipla qua the invalidity of the suit patent on the ground of lack of title cannot be decided in suit proceedings before this Court" (para 174). "We also note that lack of title is not a ground for revocation under Section 64 of the Patents Act." (paras 174, 182)
25. Retrospective assignment. "Even assuming no right could be created retrospectively in favour of Pfizer Products Inc., right certainly vested on May 18, 2005 the date of assignment agreement and from which date it vested in OSI" ("OSI Pharmaceuticals, Inc."). (para 177)
26. Unregistered assignment. "The Registration Act does not envisage a deed of assignment of a trademark/copyright or patent to be compulsorily registered not being an immovable property." (para 178)
27. A co-patentee may sue alone. "Each of the co-patentee being entitled by itself or by its agent to enforce rights conferred under Section 48 of the Patents Act, 1970 and there being no challenge to the ownership of OSI, plaintiff No.2 in the suit and a co-patentee, the objection in terms of Section 50 of the Patents Act thus fails." (paras 181–182)
28. Procedure. Relief on imminent expiry. "But keeping in view the fact that the life of the patent in favour of Roche in India would expire in March, 2016 we do not grant the injunction as prayed for by Roche against Cipla" "We decree that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip, for which purpose suit filed by Roche against Cipla is restored with direction that it be listed before the learned Joint Registrar" (para 183). "Costs allowed in favour of Roche and against Cipla" (paras 183–184)

Subsequent treatment

• Appealed — Cipla's special leave petition to the Supreme Court was withdrawn on 16 June 2017, after the parties settled on 30 May 2017. The Supreme Court did not decide the merits.
• Followed — Calico Life Sciences v Joint Controller of Patents and Designs (2026) held that "The Division Bench of this Court in F. Hoffmann (supra), has elucidated a five-step test for determining lack of inventive step in a claimed invention" (para 18).
• Explained — In Sulzer Mixpac v Assistant Controller of Patents and Designs (2026) the Division Bench held that the five steps "merely provide guidance as to how, in a particular case, the court has to proceed" and "cannot be regarded as commandments cast in stone" (para 24).