Patentability of Incremental Innovation vis-à-vis § 3(d) of the Indian Patents Act: Striking a Balance
Meghna Banerjee & Yajnaseni Roy
Volume 2 Issue 4 (2009)
The strict standards of patentability envisaged by TRIPS posed a challenge to India’s pharmaceutical industries, whose success depended on the ability to produce generic drugs at much cheaper prices than their patented counterparts. A robust patent system would severely curtail access to expensive life saving drugs. Therefore, although India amended the Indian Patent Act, 1970 to protect genuine innovations, it did not extend protection to “incremental innovation” on existing medicines unless such innovation significantly increased the efficacy of the original drug. This article explores the prevailing tension between § 3(d) of the Indian Patent Act, 1970 which excludes “incremental innovation” from patent protection, and pharmaceutical companies pressing for the recognition of the same. Firstly, the article examines the specific reasons behind excluding “incremental innovation” from § 3(d). Secondly, it distinguishes between “evergreening” and “incremental innovation” and argue that the latter is vital for development of new medicine and thus deserves patent protection. Thirdly, it highlights the ambiguity in the language of § 3(d) and enumerates the changes which are necessary to make the provision workable. In this respect, two recent judgments, namely Novartis AG v. Union of India and F. Hoffman–La Roche v. Cipla are analyzed, in light of the impact of this provision on the pharmaceutical sector. It concludes by emphasizing on the need to strike a balance between two seemingly conflicting interests: general public interest sought to be protected by § 3(d) and the incentive for research and innovation which necessitates protection of “incremental innovation”.