Access to medicines and incentives for innovation: The balance struck in the Trans-Pacific Partnership (TPP) on intellectual property (patent and data exclusivity) protection for pharmaceutical products

Abstract

This study addresses the balance struck under the Trans-Pacific Partnership Agreement (TPPA) between the right to health and access to medicines and the need to maintain the economic incentives to spur innovation and research and development through intellectual property protection. The analysis focuses on the patent and data-related intellectual property protection provisions of the TPPA, specifically regarding pharmaceutical (small-molecule and biologic) products, including on patent duration, linkage and term extensions as well as clinical test data protection and market exclusivity. Special attention is paid to the United States and its negotiating position with respect to those aspects of intellectual property rights, as it has been and remains the world’s principal demandeur for high intellectual property rights (IPR) standards in trade agreements, including the TPPA.