Resumen de Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act
During the last quarter of the twentieth century, India was known as the “Pharmacy of the Developing World,” a critical source of inexpensive, life-saving drugs for the world’s most impoverished populations.
But when India joined the World Trade Organization in 1995, it became subject to the Agreement on Trade Related Aspects of Intellectual Property (“TRIPS”), which required it, among other things, to restore product patents on drugs by a certain date. India’s 2005 Amendments to the Patents Act did just that, but also included a number of provisions—called “TRIPS flexibilities”—intended to lessen the blow regarding access to medicines. Two critical TRIPS flexibilities were (1) a compulsory licensing provision, which stipulated that public interest needs could compel brand-name pharmaceuticals to agree to license their patented drugs; and (2) an anti-evergreening provision which raised the bar for what pharmaceutical companies had to show to obtain a drug patent in the first place. The Amendments emphasized the purposes of these provisions: the compulsory licensing provision aimed at ensuring public health interests were satisfied, while the anti-evergreening provision intended to eliminate wasteful efforts to maintain weak patents.
In the two most important decisions interpreting the 2005 Amendments to the Patents Act to date, the Intellectual Property Appellate Board in Bayer v. Natco and the Supreme Court of India in Novartis AG v. Union of India sought to reinforce the fundamental rationale of these two key TRIPS flexibilities.
Ultimately, however, Bayer and Novartis interpreted the two flexibilities in ways that may have weakened the principles they set out to bolster.
