Pharmaceutical Evergreening, Access To Medicines And Patent Law: Re-Examining The Indian Model In A Post-Trips World
- IJLLR Journal
- 24 hours ago
- 1 min read
Dr Urvashi Sharma, Assistant Professor, Symbiosis Law School, Noida, Symbiosis International (Deemed University), Pune
ABSTRACT
The pharmaceutical patent system sits at the intersection of two competing imperatives, incentivising innovation and ensuring affordable access to medicines. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) globalised minimum standards of patent protection, it also intensified concerns regarding “evergreening” a strategic practice whereby pharmaceutical patentees extend market exclusivity through secondary and incremental patents. India responded to this challenge through a consciously public-health-oriented patent regime, most notably through Section 3(d) of the Patents Act, 1970, which restricts the patentability of new forms of known substances absent demonstrable therapeutic efficacy. This paper undertakes a comprehensive doctrinal, constitutional, and policy analysis of the Indian anti-evergreening framework in the post-TRIPS era. It critically examines the jurisprudence of the Supreme Court and High Courts, particularly the Novartis decision and its progeny, and evaluates whether the Indian model has succeeded in preserving access to medicines without undermining genuine pharmaceutical innovation. The paper further situates India’s approach within a comparative international context, analysing the regulatory and judicial treatment of secondary patents in the United States and the European Union. It argues that while the Indian framework represents a globally significant experiment in balancing patent monopoly and public health, emerging trade pressures, incremental innovation strategies, and regulatory capture threaten to dilute its normative foundations. The paper concludes by proposing a principled recalibration of patentability standards, evidentiary thresholds, and institutional scrutiny mechanisms to preserve India’s constitutional commitment to health while remaining compliant with its international obligations.
Keywords: Pharmaceutical Patents, Evergreening, Section 3(d), Access to Medicines, TRIPS, Public Health, Incremental Innovation, Novartis Case, Patent Policy.
