Freedom of Transit and Trade in Generic Pharmaceuticals: An Analysis of EU Border Enforcement Law and Implications for the International Intellectual Property Regime

Abstract:     
A recent dispute involving the suspension of release of a consignment of generic drug in transit from India to Brazil by Dutch Customs raises some important issues for the future of the international intellectual property regime. The dispute is only too timely as some countries resort to bilateralism and Free Trade Agreements for extending intellectual property protection beyond the minimum contained in TRIPS. It provides a classic stage for studying the conflict of interests between developing and developed countries on the issues of access to medicine and standard of protection, and thus deserves closer and independent scrutiny of facts and law. On a cursory glance EC Regulation 1383, which provides for border enforcement of rights in cases of patent infringement, seems to be in consistence with the TRIPS Agreement. A closer analysis, however, reveals that the law, in providing for a TRIPS-Plus standard of protection, may run afoul of Part III, Section IV of the TRIPS Agreement. This conclusion, however, rests on a contextual interpretation, which as this work argues, is provided by the Doha Declaration on Public Health and TRIPS and the subsequent Decision to implement paragraph 6 of the Declaration.

The analysis deals with the interpretation of Articles 51 and 52 of the TRIPS Agreement besides addressing the possibility of using the language of the Agreement itself as providing "ceilings" for maximum protection. The work offers some policy and symptomatic recommendations, but, and perhaps more importantly, shows how the incident serves as another litmus test for testing the efficacy of the intellectual property regime under the TRIPS and the promise of a "balance" the Doha Declaration had promised.

Keywords: TRIPS, WTO, pharmaceuticals, transit, public health, confiscation, EU, India, Brazil

JEL Classifications: K32, K33

Accepted Paper Series