News is out, Supreme Court has finally pronounced its verdict in the ‘Glivec’ matter. In a 112 page judgement, Mr. Justice Aftab Alam and Ms. Justice Ranjana Prakash Desai rejected Novartis’s application on grounds that the beta crystalline form of Imatinib Mesylate, sought to be patented by Novartis, does not qualify the test of invention laid down in clause (j) and (ja) of section 2(1) and section 3(d) of the Patents Act, 1970.
Novartis’s application for patent 1602/MAS/1998 was earlier rejected by the patent office, on grounds of lacking novelty, inventive step and being unpatentable in view of section 3(d). Novartis challenged Controller’s decision in a writ petition before the Madras High Court. The matter was transferred to the Intellectual Property Appellate Board which also rejected Novartis’s patent on grounds of being unpatentable under section 3(d) and under 3(b) the invention being against public order and morality. IPAB however acknowledged the novelty and inventive step requirements for the invention. Novartis also challenged the constitutional validity of section 3(d) before the Madras High Court, this please however was also rejected.
Issues that were to be decided by the Court in this judgment were as follows:
- What is the true import of section 3(d) of the Patents Act, 1970
- The interplay of section 3(d) with definition of invention under the Patents Act, 1970.
- Does Novartis product qualify as an invention under the Patent Act. If yes, can patentability still be questioned under section 3(d) of the Patent Act
Definition of Invention: On the definition of invention under the Patents Act, Justice Aftab Alam of the Supreme Court, noted the following in paragraph 90:
“On a combined reading of clauses (j), (ac) and (ja) of section 2(1), in order to qualify as “invention”, a product must, therefore, satisfy the following tests:
i) It must be ‘new’;
ii) It must be ‘capable of being made or used in an industry’;
iii) It must come into being as a result of an invention which has a feature that:
- Entails technical advance over existing knowledge; OR
- Has economic significance; AND
- Makes the invention not obvious to a person skilled in the art.
Justice Aftab Alam further observed that:
“Para 92. Section 3 is in Chapter II of the Act, which initially contained section 3, 4 and 5, but after the deletion of section 5 with effect from January 1, 2005, Chapter II has only two sections: section 3 and 4. The Chapter has the Heading “Inventions Not Patentable” and section 3 has the marginal heading ‘What are not Inventions’. As suggested by the Chapter heading and the marginal heading of section 3, and as may be seen simply by going through section 3, it puts at one place provisions of two different kinds: one that declares that certain things shall not be deemed to be ‘inventions’ (for instance clauses (d) & (e)]; and the other that provides that, though resulting from invention, something may yet not be granted patent for other consideration (for instance clause (b)]
Section 3(d): Finally in relation to the issue of import of section 3(d) into the Patents Act, 1970 and interplay of section 3(d) with the definition of invention, the Court after analyzing the history of the Patent Act and legislative amendments made thereto, held that:
“Para 104. We have so far seen section 3(d) as representing ‘patentability’, a concept distinct and separate from ‘invention’. But if clause (d) is isolated from the rest of section 3, and the legislative history behind the incorporation of Chapter II in the Patents act, 1970, is disregarded, then it is possible to see section 3(d) as an extension of the definition of ‘invention’ and to link section 3(d) with clauses (j) and (ja) of section 2(1). In that case, on reading clause (j) and (ja) of section 2(1) with section 3(d) it would appear that the Act sets different standards for qualifying as ‘invention’ 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.”
The Patent Act allows grant of patent for product that are new and inventive but new product may not necessarily mean something completely new, one which was not existing before. However, in case of pharmaceuticals, if a product for which patent is sought is a new form of a known substance, that the invention must pass the additional test laid down in section 3(d) i.e. the test of enhanced efficacy.
What is Efficacy?: While answering the question as to what is efficacy, the Court observed, that the test of efficacy would depend upon the function, utility or the purpose of the product under consideration, and held that “Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”.” The Court further observed that mere change of form with properties inherent to that form would not qualify as ‘enhancement of efficacy’ of a known substance. The Court however refused to rule on the exact scope of “therapeutic efficacy” and left it to be determined by future courts on a case by case basis.
Decision on Novartis Patent: While deciding on the issue as to whether Novartis’s product qualify as an invention under the Patent Act, the Court observed that Gleevec directly emanates from the Zimmermann patent (prior art) since, the appellant i.e. Novartis has maintained that Gleevec (Imatinib Mesylate) is part of the Zimmermann patent. Novartis obtained drug approval (US) for Gleevec on that basis, it claimed an extension of the term of the Zimmermann patent for the period of regulatory review for Gleevec and stopped Natco Pharma Ltd. from marketing its drug in the UK on the basis of the Zimmermann patent. Further, US board of appeals, in its judgment granting patent for the beta crystal form of Imatinib Mesylate, proceeded on the basis that Zimmermann patent might have covered the beta crystal form of Imatinib Mesylate, however there was no teaching for making of Imatinib Mesylate from Imatinib, and for its use in pharmacological composition for treatment of tumors and thus the appellant is fully bound by the finding and cannot be heard to take any contrary plea.
In view of the above findings, the Court concluded that Imatinib Mesylate is a known substance from the Zimmermann patent and cannot be said to be a new product, having come into being through an ‘invention’ that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art.
On the question of applicability of section 3(d) the Court observed that beta crystal form being a polymorph, Novartis invention also needs to qualify the additional test of ‘enhanced efficacy’ laid down in section 3(d). On this, the Court noted from appellant’s patent specification that pharmacological properties possessed by the beta crystal form of Imatinib Mesylate are equally possessed by Imatinib in the free base form or its salt. Since, Imatinib Mesylate is a known substance, Novartis was obliged to show enhanced efficacy of the beta crystal form 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 solubility, between the beta crystal form of Imatinib Mesylate and Imatinib Mesylate (non-crystalline).The Court further noted that the additional properties of the beta crystal form such as (a) more beneficial flow properties; (b) better thermodynamics stability; and (c) lower hygroscopicity; as pointed out by the Appellant, are physical attributes that would give the subjected product improved processability and better and longer storability. However, on the basis of those properties, the beta crystal form cannot be said to possess enhanced efficacy over Imatinib Mesylate.
In view of the above findings, the Court held that Novartis application for patent for the beta crystalline form of Imatinib Mesylate fails the test of invention and patentability as laid down in clauses (j), (ja) of section 2(1) and section 3(d) and accordingly the appeal was dismissed with cost to the Appellant.
The judgment clarifies, though not entirely, the interpretation of the controversial section 3(d) of the Indian Patent Act which sets up a second tier of qualifying standards for chemical and pharmaceutical products. Section 3(d) provides:
“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” [is not an invention within the meaning of the Patents Act.]
The proviso to Section 3(d) states that:
“For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
In light of the Supreme Court judgement the term ‘efficacy’ referred to in section 3(d) is to be construed only as ‘therapeutic efficacy’ in case of pharmaceutical and medicinal products. Thus claims to polymorphs or enantiomers of known chemical compounds, having enhanced properties, such as bioavailability or reduced toxicity, which do not have a direct bearing on the ‘therapeutic efficacy’ of the compound vis-à-vis the known compound, will not qualify under section 3(d) of the Patent Act and hence will not be termed as inventions within the meaning of the Patent Act.