Beyond Evergreening: Section 3(d) as a Constitutional Safeguard for the Right to Health

Abstract

India stands at a unique crossroads where public health imperatives and intellectual property rights intersect most visibly in the pharmaceutical sector. With a substantial portion of its population dependent on affordable medicines and a domestic pharmaceutical industry widely acknowledged as the 'pharmacy of the developing world,' India has crafted a patent framework that seeks to balance innovation incentives with the constitutional right to health. At the center of this framework lies Section 3(d) of the Indian Patents Act, 1970 a provision that has attracted both domestic acclaim and international controversy. Section 3(d) prohibits the grant of patents for new forms of known substances unless they demonstrate a significant enhancement in therapeutic efficacy. Introduced through the Patents (Amendment) Act, 2005, the provision was primarily designed to counter 'evergreening' the practice by which pharmaceutical corporations seek to extend their patent monopolies through minor, often clinically insignificant, modifications to existing drugs. By doing so, it directly supports the availability of affordable generic medications. This manuscript undertakes a comprehensive descriptive examination of Section 3(d), situating it within the broader constitutional, legislative, judicial, and international contexts. The analysis spans the constitutional guarantee of health under Article 21 of the Indian Constitution, the India–TRIPS interface, landmark judicial decisions including Novartis AG v. Union of India, and the comparative position of India relative to other nations. The manuscript concludes that Section 3(d) represents a principled and constitutionally grounded tool that places human welfare above commercial patent strategy, offering a replicable model for other developing nations seeking to protect public health within the TRIPS framework.