The Legal Challenges Faced by the Pharmaceutical Industry Particularly in India: An Analysis of the Compulsory Licensing System and Section 3(D) of the Patents Amendment Act 2005

Abstract

The impact of intellectual property rights in particular patent relating to public health has posed number of challenges faced by developing countries who are members of WTO. This paper will examine impact of TRIPS Agreement in relation to developing countries in general with specification made to India. However significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing have to a certain extent benefited the developing countries. The TRIPS flexibilities by way of amendment have helped countries that do not have manufacturing capacities to import medicines. Importantly this paper will examine the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005 will be looked into especially on the controversy in respect of Section 3(d) of Patent Amendment Act 2005 on the requirement of patentability and comparisons with other jurisdictions on validity of second medical use. The section 84 of the Patent Act 1970 which provides the grounds to invoke TRIPS flexibilities in respect of compulsory licensing will be analysed as to whether Indian government has applied restrictive or broad approach in relation to compulsory licensing in the view of the recent case of NatcoPharma Limited and Bayer Corporation which has brought significant attention on the issue of compatibility with the TRIPS Agreement. India needs to achieve legal certainty by complying with the TRIPS Agreement before adopting those provisions into their patent law.