Novartis AG v. Union of India: “Evergreening,” TRIPS, and “Enhanced Efficacy” Under Section 3(d)

Abstract

A decision in Novartis AG v. Union of India, an Indian Supreme Court case, was announced April 1, 2013. The much anticipated decision has rocked the landscape of the pharmaceutical industry and public health in India because it concerns the application of Section 3(d) of the Indian Patents Act of 2005, a controversial provision of the Indian patent law that could limit the ability of pharmaceutical companies to obtain important “secondary patents” on life-saving drugs. My paper presents three different ways, from narrowest to broadest, that the Indian Supreme Court could have interpreted Section 3(d) and argues the legality and policy consequences of each. It is argued that the narrowest interpretation of Section 3(d), the one adopted by both the lower courts and the Supreme Court of India, is the one most inconsistent with the popularly stated rationale of the provision as a means to prevent the “evergreening” of pharmaceutical patents. It is further argued that, as a boundary-defining case, the Supreme Court should not choose the interpretation of Section 3(d) that would preclude the patenting of the drug Glivec in Novartis AG v. Union of India.