ABSTRACT
India’s TRIPS-compliant Patent (Amendment) Act 2005 saw the transformation of its laws from a process patent regime to a product patent regime. The amendments have had a direct impact on India’s generic drugs manufacturing sector, which was developed through the process patent regime introduced under the 1970 Act. A number of developing countries have come to rely strongly on Indian generics, and the ripple effect of the transformation is being felt, both domestically and globally, as drug prices soar. This chapter will query whether developing countries in the WTO can possibly benefit from the model set up by India for the issuance of compulsory licences, and to check the practice of evergreening by pharmaceutical patent holders. The discussion of the topic includes the recent decisions by the Indian judiciary and quasi-judicial authorities, along with the procedures and policies put in place by the government of India. The key discussion focuses on the effectiveness of the Act of 2005, and whether it can be seen as an instance of success of the TRIPS provisions in Articles 7 and 8, read along with the Doha Declaration.
