Do Trips Flexibilities Matter? An Empirical Analysis of Pharmaceutical Patenting in Developing Countries

Since the 1990s developing countries have introduced pharmaceutical patent regimes to comply with their obligations as members of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). As developing countries have adopted new pharmaceutical patent regimes, many have included special provisions to restrict “secondary patents,” which can extend periods of exclusivity and thus have worrisome effects on public health. The measures adopted, which we label “pre-emptive” as they aim to prevent unwarranted secondary patents from being issued at the stage of examination, differ in terms of their form.

Does variation in institutional form yield variation in outcomes? If not, why not? To assess these questions we adopt a mixed-methods approach. We start with a dataset of all pharmaceutical patent applications filed internationally between 2000-2002, and we code these to identify which applications are “secondary” (and thus presumably the target of pre-emptive measures). We then identify the national-phase versions of the applications in a range of developing countries with pre-emptive systems of diverse form (Argentina, Brazil, Chile, India, Thailand) and a pair of countries without pre-emptive systems (Mexico, South Africa), and we track the outcomes of the examination processes in each country. In doing so we examine the prosecution processes to investigate the role of particular provisions countries have in place to address secondary patents. The analyses reveal considerable differences in outcomes, both in terms of aggregate grant rates, and moreover in terms of the incidence of the pre-emptive mechanisms on these outcomes. We complement the quantitative analyses with qualitative research in three countries (Argentina, Brazil, and India) to understand how the new patent systems are functioning in practice. Our object is to account for the variation observed in what the new patent systems are designed to do relative to what they are achieving. Our work points to the importance of inter-agency coordination, the availability of resources for enforcement of the rules, and, critically, asymmetries of information between public actors charged with applying the new rules and private actors applying for pharmaceutical patents.