Product Patents and Access to Medicines in India: A Critical Review of the Implementation of TRIPS Patent Regime

In 2005, India amended its Patents Act, 1970 to introduce TRIPS compliant product patent regime. Generally speaking, law and policy makers in India during the time of the amendment were confronted with two major concerns viz. the future of the Indian pharmaceutical industry and access to affordable medicines in India and other developing countries. To address these concerns India along with many other developing countries attempted to incorporate TRIPS flexibilities in their domestic law. However, the success of the TRIPS flexibilities in addressing the question of access to affordable medicines mainly depends on three factors: a) the incorporation of flexibilities in the domestic law; b) the manufacturing capability of a country; and c) the political will to use the public interest safeguards provided in the domestic law. There are only a few countries like India, which satisfy the above-mentioned conditions to a certain extent. This article examines whether these premises hold true after five years into the implementation of the TRIPS compliant patent system in India. In this context the paper identifies and analyzes the legal, policy and institutional challenges that India is currently facing in the implementation of TRIPS flexibilities. It also identifies the main legal, policy and institutional disconnect in the implementation of TRIPS flexibilities in India. It argues that to effectively use TRIPS flexibilities to address access to affordable medicines require changes in three areas viz. law, policy and institutions. It clearly shows that mere incorporation of TRIPS flexibilities in the domestic legislation alone is not enough and the domestic legislation needs to be complemented with policy and institutional framework.