The Politics of Pharmaceutical Patent Examination in Brazil

Since the 1980s, the world of intellectual property (IP) has undergone a sea change in the direction of harmonization. Reflecting a goal to universalize the high levels of IP protection common throughout the OECD, the United States and the European Union worked to replace the flexible and largely unenforceable rules that had prevailed in the policy area, with more restrictive and enforceable international rules to guide national IP practices. The most important product of this campaign was the inclusion of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as part of the new WTO.

Although TRIPS establishes universal standards for IP policy, countries retain latitude with regard to how they implement the standards. Thus, while TRIPS is part of a broader phenomenon of a movement toward regulatory harmonization, a phenomenon that imposes unprecedented constraints on areas of economic policy where countries historically had significant autonomy (Gallagher 2005; UNDP 2003), developing countries retain opportunities for policy innovation in the field of IP (Reichman 1997; Correa 2000; Watal 2000; CIPR 2002; Shadlen 2005).

This paper examines the challenges to utilizing this remaining (if limited) space, focusing on the politics of patent examination in pharmaceuticals. To be sure, yet another contribution on “policy space” may hardly seem worthwhile, considering the significant amount of attention that the topic has received. Yet most analyses of IP policy space have addressed one particular policy instrument, compulsory licenses (CLs).