Regulatory and Judicial Implementations of Patent Law Flexibilities

Abstract

Director-General of the WTO Pascal Lamy recently suggested that a fundamental change taking place in international trade is "the rise of key emerging economies and the shift in economic realities that this implies." Indeed, during the long course of the Doha round negotiations, these emerging economies have been grouped at times with developed countries and at times with other developing countries, indicating their unique needs and interests as countries in transition. The standpoint of emerging countries can be seen in portions of the WTO agreement, with flexibilities negotiated that allow for the medical needs of their populations and simultaneously further economic development. With India in the spotlight for its recent grant of a compulsory license and for its patent eligibility rules, it is a good time to reflect on the flexibilities negotiated into the TRIPS Agreement and their implementation through domestic legal regimes. Although world focus is on developing countries, these flexibilities are also present to some degree in the United States, albeit judicially determined and applied. To the extent some flexibility in implementation is inevitable, these instances raise universally applicable questions about the proper role of administrative agencies and courts in implementing policies that are influenced by both trade and patent policies.

Keywords: Patent, WTO, TRIPS, Flexibilities