PHARMACEUTICAL PATENTING IN INDIA: CHALLENGES OF PUBLIC ACCESS TO HEALTH A CRITICAL LEGAL ANALYSIS
AUTHOR – MR.DON BENNY, STUDENT AT AMITY UNIVERSITY, NOIDA
BEST CITATION – MR.DON BENNY, PHARMACEUTICAL PATENTING IN INDIA: CHALLENGES OF PUBLIC ACCESS TO HEALTH A CRITICAL LEGAL ANALYSIS, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 6 (6) OF 2026, PG. 486-496, APIS – 3920 – 0001 & ISSN – 2583-2344. DOI – https://doi.org/10.65393/IJLRV6I6450
ABSRACT
One of the most controversial frontiers of the modern international trade law is the intersection of patent law in pharmaceuticals and the interests of health. India plays one of the most interesting roles in this discussion, being both a key provider of cheap generic drugs to the developing world, and a sovereign State that must reconcile its local intellectual property regime with the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). [1]
With the Patents (Amendment) Act, 2005, the Indian patent landscape was essentially reorganized in that the pharmaceutical substances were given the protection of product patent in decades. Although such a legislative change is required to conform to the WTO regulations, it has created severe conflicts between the commercial interests of innovation and the constitutional and humanitarian interests of providing access to affordable medicines to the population.
This essay is a critical legal appraisal of the main issues that patenting of drugs in India presents to the access to health by the populace. It looks at the legislative framework of pharmaceutical patents, the critical nature of Section 3(d) of the Patents Act as an anti-evergreening measure, the extent and extent of compulsory licensing, and the ongoing effect of the Doha Declaration. This paper presents an argument that, despite the fact that the legal framework of India has strong flexibilities in the area of public health, structural, judicial and political barriers still exist that hinder the effective use of these flexibilities. The paper ends with normative suggestions to strengthen the primacy of the public health in the structure of Indian pharmaceutical patent law.[2]
Keywords: TRIPS Agreement, Section 3(d), Compulsory Licensing, Evergreening, Access to Medicines, Novartis, Doha Declaration, Indian Patent Law, Public Health Flexibilities
[1] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement].
[2] World Health Organization, ‘Access to Medicines: Making Market Forces Serve the Poor’ (2004), WHO/EDM/2004.2.