Section 3(d), as introduced in April 2005 into the Indian patent law, represents a unique requirement to be fulfilled for patentability of certain types of pharmaceutical inventions. According to Section 3(d), in order for a new form of a known substance to be patentable, it must show an enhanced efficacy with respect to the known efficacy of the substance concerned.
In its April 1 decision on the Novartis’s Glivec patent, the Supreme Court provides a clarification on certain aspects of Section 3(d) of the Indian Patent Act, 1970; in effect, it further raises the bar on the test of inventiveness and criteria for patentability.
It found that Novartis’ patent application for the beta-crystalline form of Imatinib Mesylate (polymorph B) did not pass the test of Section 3(d) as it did not show any enhanced ‘therapeutic efficacy’.
It held that in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’, and that the physico-chemical properties, namely, more beneficial flow properties, better thermodynamic stability, and lower hygroscopicity, which may otherwise be beneficial, do not render the product therapeutically more efficacious.
As a result, the Supreme Court interpreted ‘enhanced efficacy’ in the explanation to Section 3(d) to mean therapeutic efficacy alone.
TRIPS Article 27.1 requires that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”
The patentability criteria of Section 3(d) are in addition to the internationally accepted criteria of novelty, inventive step and utility.
The Supreme Court in the Novartis case concludes that the Act does set the invention threshold higher for medicines, drugs and other chemical substances. However, the Madras High Court had in 2007 held that the appropriate route to challenge non-compliance with TRIPS is the WTO Dispute Settlement Body and not the Indian courts.
The Supreme Court has taken a narrow view, without appreciating that R&D in the pharma sector is risky, expensive and time-consuming. Changes to molecules that may seem trivial can bring about tremendous benefits to patients.
Research happens in incremental steps on platform technologies with fewer ‘eureka’ moments. Spectacular breakthroughs are few and far between. Extending the effectiveness of an existing medicine can, therefore, represent a significant innovation in itself.
The current nature of R&D is based on incremental inventions, such as new dosage forms or delivery systems, and not on brand new compounds. This is evident from the fact that only seven drug molecules have been discovered and approved in India so far.
However, it is important to note that the Supreme Court did indeed clarify that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances, provided they pass the test of the expanded scope of Section 3(d).
The author is Managing Partner, Corporate Law Group, New Delhi.