Border Enforcement of IP Rights Against in Transit Generic Pharmaceuticals: An Analysis of Character and Consistency
European Intellectual Property Review, Forthcoming
25 Pages Posted: 16 Apr 2009 Last revised: 15 Jul 2010
Date Written: April 15, 2009
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. On 19 May 2010, India and Brazil submitted their requests for consultation with the EU and the Netherlands to the WTO. The dispute is only too timely as 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.
This work begins by noting certain facts relating to the border enforcement of IP rights against in transit generics by European customs. The purpose of this factual appraisal is three fold: to study the international reaction; to ascertain the true nature of action by the customs; and to establish a systemic trend of such enforcement against generic drugs. The analysis then charts the evolution and scope of the European law relating to border measures and its application by the courts. After an analysis of the character of the law and its application, the work seeks to study the consistency of EC Regulation 1383 and its application by customs and the courts with provisions of the WTO TRIPS Agreement and principles of international IP law. The analysis begins by noting arguments establishing inconsistency. An analysis of the counter arguments includes the author's response to some contemporary scholarship on the issue. The work concludes with a note on the systemic, policy and practical implications of the dispute.
Keywords: TRIPS, WTO, pharmaceuticals, transit, public health, EC Regulation 1383
JEL Classification: K32, K33
Suggested Citation: Suggested Citation