TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

Abstract

This article compares national approaches towards secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures and policies countries have enacted to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyse the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries, the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches towards secondary patents need to be understood in the context of their broader approaches towards Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s.