ABSTRACT
This chapter focuses on the flexibilities adopted by India. The flexibilities contained in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement are intended to improve access to patented medicines. Structural changes—in the form of mergers and acquisitions, and strategic sales alliances—may preclude measures to adopt TRIPS flexibilities. The patent ordinance introduced in December 2004 to meet India's commitment to introduce TRIPS-compliant legislation by 1 January 2005 excluded grounds for pre-grant opposition, but this was reinstated in the third amendment of the Patents Act. Based on the pre-grant opposition filed against Novartis by the generics manufacturers, in 2006 the Chennai patent office rejected Novartis's application. Like most countries, India provides for compulsory licensing in its patent amendments. The chapter shows that providing for measures that facilitate access to medicines depends on individual governments' foresightedness. It concludes with several options that would better enable India to gain access to new medicines in the future.
