The Effects of Restrictions on Secondary Pharmaceutical Patents in Brazil and India: Brazil and India in Comparative Perspective

The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced unprecedented convergence in national patent policies. Prior to TRIPS few developing countries granted pharmaceutical product patents, though all but the very poorest are now required to do so. As countries established pharmaceutical patent systems, some have introduced measures designed specifically to address patents on “secondary” patents, which can increase periods of exclusivity. Policies restricting secondary patenting aim to ameliorate the perceived harmful effects of TRIPS. The two most prominent examples of such policies are in India and Brazil. Yet while these two countries' approaches have received a great deal of attention, cited as both models to emulate and avoid, little is known about their effects on patent examination outcomes. This paper offers the first large-sample empirical analysis of the effects of restrictions on secondary patents. We follow the filing and granting of over 5,000 drug patent applications filed in India, Brazil, and six other developing and developed countries, we code the claims of each application as secondary or primary, and we analyze how national grant rates for these two types of patents differ. In the cases of India and Brazil we also undertake detailed examination of the patent prosecution processes to shed light on the specific roles of these countries’ policies. Neither India nor Brazil shows greater differences between primary and secondary grant rates than countries without specific measures targeting secondary patents. Both the comparison of grant rates and evidence from the prosecution process suggest that India and Brazil’s much-publicized restrictions on secondary patents have had little direct effect on patent examination outcomes.