The impact of trips agreement on access to medicines in developing countries: legal challenges faced by the pharmaceutical industry particularly in India

The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specifi cation made to India. Signifi cant changes brought about by the TRIPS fl exibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefi ted the developing countries in the fi eld of public health during national emergency. The TRIPS fl exibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS fl exibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefi t of their citizens. Further, TRIPs fl exibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifi cally examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal weapon for India to manufacture affordable generic medicines. The current challenges faced by India on data exclusivity provision often described as the TRIPS PLUS standard is impliedly stated in Article 39.3 of the TRIPS Agreement on undisclosed information. India needs to achieve legal certainty in complying with the TRIPS Agreement and also bearing in mind the TRIPS-PLUS standards before adopting those TRIPS provisions into its patent law legislation in order to promote innovation and to achieve public health as well as to serve the interest of the developing countries