Patent Evergreening: Balancing Pharmaceutical Innovation And Access To Medicines Under Indian And Comparative Patent Law
Jatin Malhotra, B.B.A. LL.B., Bharati Vidyapeeth University
ABSTRACT
Patent law is founded on a bargain between the inventor and the State: full public disclosure of an invention in exchange for a time-bound exclusive right, ordinarily twenty years, upon whose expiry the invention passes into the public domain for unrestricted use. In the pharmaceutical sector, however, originator companies have increasingly relied on a cluster of strategies collectively termed “patent evergreening” to prolong effective market exclusivity beyond the life of the original patent, often without any accompanying therapeutic advance. Such strategies include the patenting of new salts, polymorphs, isomers, particle sizes, formulations, and methods of use of an already known molecule, the assembly of dense “patent thickets” comprising dozens or hundreds of overlapping patents, and the use of reverse-payment settlements to postpone generic or biosimilar entry. This paper undertakes a doctrinal and comparative examination of patent evergreening, situating the practice within the flexibilities available to member States under Article 27 of the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health, 2001. It closely analyses India's principal statutory response, Section 3(d) of the Patents Act, 1970, and its authoritative judicial interpretation by the Supreme Court in Novartis AG v. Union of India, alongside the Delhi High Court's treatment of secondary pharmaceutical patents in F. Hoffmann-La Roche Ltd. v. Cipla Ltd. and the compulsory licensing regime illustrated in Bayer Corporation v. Natco Pharma Ltd. The paper further considers comparative developments in the United States, including the tightened non-obviousness standard under KSR International Co. v. Teleflex Inc. and the antitrust dimensions of patent thickets illustrated by the Humira litigation. It argues that India's efficacy- based screening mechanism, complemented by its compulsory licensing framework, offers a globally significant model for reconciling patent protection with public health imperatives, while identifying persistent gaps in patent examination capacity, transparency, and patent–competition law coordination that require further reform. The paper concludes that a calibrated combination of rigorous substantive examination, procedural transparency, and cross-disciplinary regulatory coordination offers the most sustainable path to curbing evergreening without undermining genuine pharmaceutical innovation.
Keywords: Patent Evergreening; Section 3(d); TRIPS Agreement; Compulsory Licensing; Pharmaceutical Patents; Access to Medicines
