SECTION 3(D) AND THE LIMITS OF PATENTABILITY: INDIA’S LEGISLATIVE RESPONSE TO PHARMACEUTICAL EVERGREENING
AUTHOR – BHUMIKA PANDEY, STUDENT AT CHRIST (DEEMED TO BE UNIVERSITY), PUNE, MAHARASHTRA
BEST CITATION – BHUMIKA PANDEY, SECTION 3(D) AND THE LIMITS OF PATENTABILITY: INDIA’S LEGISLATIVE RESPONSE TO PHARMACEUTICAL EVERGREENING, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 6 (8) OF 2026, PG. 716-727, APIS – 3920 – 0001 & ISSN – 2583-2344
One of the most significant and internationally reviewed provisions in the pharmaceutical patenting arena in the world was brought by the Patents (Amendment) Act, 2005 in India, in the form of Section 3(d) of the Patents Act, 1970. The provision was enacted as a direct legislative reaction to the perceived menace of pharmaceutical evergreening and it is categorical in its denying of coverage of patent protection to novel forms of known substances except where a significant enhancement of therapeutic efficacy is proven. The present paper will develop a doctrinal and analytical discussion of Section 3(d) starting with its legislative background of the pre-TRIPS period of the Patents Act, 1970 to the compulsions of the Agreement on Trade-Related Aspects of Intellectual Property Rights and finally its sound jurisprudential interpretation by the Supreme Court of India in Novartis AG v. Union of India. It contends in the paper that Section 3(d) is a reflective, constitutionally acceptable adjustment of the patent law towards promoting the best possible health outcomes rather than gradual pharmaceutical innovation. It also discusses how the provision has helped retain India as the pharmacy of the world, criticisms of the provision by multinational pharmaceutical firms and the United States Trade Representative, and how well the provision balances the flexibilities framework of the TRIPS Agreement. The paper concludes that Section 3(d) is a valid, justified and internationally important tool that other developing countries can contemplate making amendments in their own home based intellectual property systems.
Keywords: Section 3(d), evergreening, TRIPS flexibilities, Novartis v. Union of India, pharmaceutical patent, access to medicines, therapeutic efficacy, compulsory licensing.