The judgment of the Supreme Court of India on the Novartis patent matter comes at a very crucial juncture . Though the last amendment to the Indian Patents Act 1970 was enacted in 2005, many of its nuances are yet to be tested in the Indian Couts. The present judgment therefore etches a significant landmark in the patent and innovation history in modern India.
The IPR debate world over continues to address the balancing of the monopoly granted by the State to the creator(s) of intellectual property with the social obligations of the monopoly holder(s) to make the fruits of their creations accessible to society.
The TRIPS Agreement mandates certain harmonised minimum standards to be adhered to by the Member States of the WTO while framing and implementing their respective IPR Laws. TRIPS Agreement also provides for a set of flexibilities that may be considered by the Member States.
It is to be appreciated that granting the monopoly is the sovereign right of a State. For example in the field of patents, there is no concept of a “World Patent” or “Global Patent”.
The harmonised benchmark for patentability of inventions are novelty, inventive step and capable of industrial application (in some countries also called utility) (Article 27(1) of TRIPS). In addition, a Member State of the WTO as per the TRIPS Agreement may introduce some exceptions to patentability (Article 27(2) and 27(3) of TRIPS).
The Indian Patents Act 1970 was amended in three stages between 1995 and 2005. The third amendment to the Patents Act 1970, effective from January 1, 2005, reintroduced product patents in India (as required by Article 27(1) of TRIPS), introduced defined terms such as ‘Inventions’ [section 2(1)(j)], ‘inventive step’ [Section (2(1)(ja)], ‘new invention’ [Section 2(1)(l)] and ‘pharmaceutical substance’ [Section 2(1)(ta).
Among other changes in the Indian Patents Act 1970, it expanded the Section 3 of the Act listing ‘What are not inventions’ which contains a subsection 3(d) that is of relevance in the context of the Supreme Court Judgment on the Glivec patent application.
Unique Section
Section 3(d) is unique to the Indian Patents Act that has no parallel in patent legislations of other countries.
The key feature that was put to test in the present case was the interpretation of Section 3(d) while deciding on the patentability of Glivec. To bring it in context; it would be prudent to review the wordings of Section 3(d) with its associated explanation:
“3(d) 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.
Explanation.—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.”
The section does not restrict itself to pharmaceutical substances only. The term “efficacy” is not defined in the Act nor is there a guideline on “properties with regard to efficacy”, nor any benchmark on quantification to decide on “differ significantly”.
For example while deciding on the patentability of materials related to matter in different polymorphs (amorphous, crystalline forms) particle sizes of known substances, and their impact on diverse properties, one will have to evaluate the aspect of ‘properties with regard to efficacy’ in the context of the invention and the inventive step.
Interestingly, the Intellectual Property Appellate Board (IPAB) in India in its judgment found that the invention related to the beta crystalline form of Imatinib Mesylate satisfies the combined criteria of novelty, inventive step and industrial applicability due to its thermodynamic stability, lower hygroscopicity, favourable flow properties and better storage properties, but concluded that it is not an invention within the meaning of the Act with regard to Section 3(d).
Restrictive Interpretation
There is no parallel provision to Section 3(d) in the patent laws of other countries. Accordingly, the invention related to Glivec was granted a patent in over 40 countries as it satisfied the required benchmark of novelty, inventive step and industrial applicability in those countries.
The Supreme Court in India has concluded that the invention related to Glivec attracts the section 3(d) despite its unique properties as it has considered the aspect of efficacy as only therapeutic efficacy and hence not patentable in India.
In my opinion, the judgment has given a very restrictive interpretation of the term “efficacy” to only mean “therapeutic efficacy” and therefore has concluded that even though the invented beta crystalline has unique properties, they do not significantly impact the “therapeutic efficacy” of Imatinib Mesylate.
In the context of the Glivec patent application the following questions arise:
•What could be the various options and the width of interpretation of the expression “compound exhibits properties with regard to efficacy significantly different from that of the known compound”?
• Should the beta crystalline form of Imatinib Mesylate which is a new crystalline form (polymorph) of Imatnib Mesylate be considered as the same known compound?
In the context of the present innovation, the invention lies in the very special properties of the new beta crystalline form, the consequence of which is simpler processing to deliver the ultimate product form with better storage properties to a patient. The expression “properties with regard to efficacy” ought to be examined in the context of the spirit of the invention. A broader interpretation of the term “efficacious” or “efficacy” in the context of the invention would be welcome.
It ought to be appreciated that when New Chemical Entities (NCEs) that include new crystalline forms, isomers, etc are invented, they would not necessarily be invented for enhanced therapeutic efficacy but also for “better delivery”, better processing, better storage properties, lower side effects, etc, all effectively converging to “enhanced efficacy”.
Consequences of ruling
The much narrow interpretation of the Section 3(d) by the Supreme Court will have far reaching implications on innovations in India. The present judgment now sets a precedence and possibly closes the minds of the patent examiners and the Courts in India on the patentability of chemical entities and materials, including the emerging field of nanotechnology which would possibly slow down the research, thinking and the innovation process in such areas for the fear of non-protection by patents in the market place.
It is time that the policy makers, and specially the patent office, creates a panel of technical and techno-legal experts with specific tasks to provide detailed guidelines clarifying the meaning of various exceptions to patentability in section 3 of the Indian Patents Act 1970 as amended by the Patents Act (Amendment) Act, 2005. The present Patents Manual of the Patent Office falls short of such an expectation.
Separate issues
Accessibility and affordability are aspects not related to patentability of an invention but are closely linked to the obligations of a patent holder. The Indian Patents Act provides for safeguards against the overuse or misuse of patent monopoly through the provisions of compulsory licence.
Further the aspect of accessibility and affordability is also closely linked to the public healthcare system which the government is expected to create. With an appropriate business and pricing model the government can negotiate with the various drug manufacturing companies to arrive at a workable mode so that the life saving medicines are made available within its healthcare system.
(The author is CEO, Vision-IPR and MHRD IPR Chair Professor, Tezpur University.)