Novartis AG v Union of India (2013)

Summary

"What is the true import of section 3(d) of the Patents Act, 1970? How does it interplay with clauses (j) and (ja) of section 2(1)?" (para 3) "On the answer to these questions depends whether the appellant is entitled to get the patent for the beta crystalline form of a chemical compound called Imatinib Mesylate which is a therapeutic drug for chronic myeloid leukemia and certain kinds of tumours and is marketed under the names 'Glivec' or 'Gleevec'." (para 3) "The appellant filed the application (Application No.1602/MAS/1998)" "for grant of" "patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office on July 17, 1998." (para 8) The Court recorded that the Assistant Controller rejected the application, and that "The IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness" but "held that the patentability of the subject product was hit by section 3(d) of the Act." (paras 14, 17)

The Court held that "Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent." (para 131) It held that the "physico-chemical properties of beta crystalline form of Imatinib Mesylate" "cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy" (para 187). "In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost. The other two appeals are allowed." (para 195)

What the court decided

1. Procedure. Direct appeals from the Appellate Board. "However, we, wish to make it clear that any attempt to challenge the IPAB order directly before this Court, side-stepping the High Court, needs to be strongly discouraged and this case is certainly not to be treated as a precedent in that regard." (para 22)
2. Obiter. Haste in drafting the 2005 amendments. "The haste with which the Government was constrained to rush the Bill through Parliament to make the law compatible with the TRIPS Agreement perhaps explains the somewhat unclear drafting of some very important provisions, which called for much greater clarity" (para 86)
3. Three conditions of an invention. "Section 2(1)(j) requires a product to satisfy three conditions to qualify as an invention." "It must be 'new', that is to say it must not have been anticipated;" "Its coming into being must involve an 'inventive step'; and" "It must be 'capable of industrial application', that is to say it must be capable of being made or used in an industry" (para 88)
4. Invention and patentability. "It is, therefore, fundamental that for grant of patent the subject must satisfy the twin tests of 'invention' and 'patentability'. Something may be an 'invention' as the term is generally understood and yet it may not qualify as an 'invention' for the purposes of the Act. Further, something may even qualify as an 'invention' as defined under the Act and yet may be denied patent for other larger considerations as may be stipulated in the Act." (para 91)
5. Two kinds of provision. Section 3 "puts at one place provisions of two different kinds: one that declares that certain things shall not be deemed to be 'inventions'" and "the other that provides that, though resulting from invention, something may yet not be granted patent for other considerations" (para 92)
6. Not ex majore cautela. "We find no force in this submission that section 3(d) is a provision ex majore cautela. To our mind, the submission completely misses the vital distinction between the concepts of invention and patentability – a distinction that was at the heart of the Patents Act as it was framed in 1970, and which is reinforced by the 2005 amendment in section 3(d)." (para 102)
7. A second tier of qualifying standards. "We have, therefore, no doubt that the amendment/addition made in section 3(d) is meant especially" "to deal with chemical substances, and more particularly pharmaceutical products. The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds." (para 103)
8. An extension of invention. "In that case, on reading clauses (j) and (ja) of section 2(1) with section 3(d) it would appear that the Act sets different standards for qualifying as 'inventions' things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in section 3(d) in the year 2005." (para 104)
9. Known from the Zimmermann patent. "In the face of the materials referred to above, we are completely unable to see how Imatinib Mesylate can be said to be a new product" "Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent." (para 131)
10. The patentee's own conduct. "The appellant is, therefore, fully bound by the finding and cannot be heard to take any contrary plea." (para 126)
11. Coverage and disclosure. "The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents." (para 139)
12. An objective finding. "The finding that Imatinib Mesylate is a known substance from the Zimmermann patent is not based on the conduct of the appellant alone" "but the finding has been arrived at on an objective consideration of all the material facts and circumstances. In view of that finding, we fail to see any application of the Hogan decision to the facts of the case." (para 155)
13. Obiter. Artful drafting. "We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers" (para 156)
14. No invention in Imatinib Mesylate. "In light of the discussions made above, we firmly reject the appellant's case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent" "The consequential finding, therefore, is that Imatinib Mesylate does not qualify the test of 'invention' as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970." (para 157)
15. The meaning of known. "There is no sanction to construe the expression 'known' in section 3(d) in the manner suggested by Mr. Subramanium, and the submission is unacceptable both in law and on facts" (para 159), the Court relying on Monsanto Company v. Coramandal Indag Products (P) Ltd. on the expression "publicly known". (para 159)
16. A new form. "The subject product, that is, beta crystalline form of Imatinib Mesylate, is thus clearly a new form of a known substance, i.e., Imatinib Mesylate, of which the efficacy was well known. It, therefore, fully attracts section 3(d) and must be shown to satisfy the substantive provision and the explanation appended to it." (para 161)
17. The substance immediately preceding. "That being the position, the appellant was obliged to show the enhanced efficacy of the beta crystalline form of Imatinib Mesylate over Imatinib Mesylate (non-crystalline). There is, however, no material in the subject application or in the supporting affidavits to make any comparison of efficacy, or even solubility, between the beta crystalline form of Imatinib Mesylate and Imatinib Mesylate (non-crystalline)." (para 171)
18. Therapeutic efficacy. "Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be 'therapeutic efficacy'." "we have no doubt that the 'therapeutic efficacy' of a medicine must be judged strictly and narrowly." "What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy." (para 180)
19. Properties inherent to a form. "While dealing with the explanation it must also be kept in mind that each of the different forms mentioned in the explanation have some properties inherent to that form, e. g., solubility to a salt and hygroscopicity to a polymorph" "Hence, the mere change of form with properties inherent to that form would not qualify as 'enhancement of efficacy' of a known substance. In other words, the explanation is meant to indicate what is not to be considered as therapeutic efficacy." (para 181)
20. Physico-chemical properties excluded. "In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy." (para 187)
21. Bioavailability. "Thus, even if Mr. Grover's submission is not taken into consideration on the question of bioavailability, the position that emerges is that just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not" "an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data." (para 189)
22. Incremental inventions not barred. "We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act." (para 191)
23. The test for new forms. "However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is" "claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation." (para 192)

What the court did not decide

On the beta crystalline form, "Whether or not it involves an 'inventive step' is another matter, and there is no need to go into that aspect of the matter now" (para 158). On the submissions of Mr. Grover and Prof. Basheer on the meaning of efficacy, "we do not propose to make any pronouncement on the issues raised by them, as this case can be finally and effectively decided without adverting to the different points of view noted above." (para 186)

Subsequent treatment

• Followed — Merck Sharp and Dohme v Glenmark Pharmaceuticals (2015) applied the holding that "mere claims, without an enabling disclosure, cannot be sustained" (para 46).
• Explained — Cipla v F Hoffmann-La Roche (2015) relied on the Court's reading of section 3(d) and of therapeutic efficacy (paras 65, 85).