The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes these leaked IPR provisions and makes the argument that in the best interest of global welfare and public-health policy, the United States should not be attempting to incorporate stronger IPR protections in the TPP.

Section 1 provides an introduction to the TRIPS agreement—the first international agreement to set minimum standards for the protection and enforcement of IPRs—and discusses the significance of the “Doha Declaration” in helping to clarify the need to interpret TRIPS from a public-health perspective. Section 2 describes the recent U.S. trend of seeking levels of IPR protection in its FTAs that exceed the minimum standards of TRIPS (referred to as “TRIPS-plus” provisions)—including patent term extensions, patent linkages, and enhanced data protection, as detailed in Section 3 of this paper. Section 4 describes the Bipartisan Trade Deal (BTD) of May 10, 2007, as an attempt by members of Congress to address concerns about the effect that these enhanced IPR protections have on developing countries’ ability to access life-saving medicines. Section 5 outlines the leaked U.S. TPP proposals relating to patent term extensions, patent linkages and data protection, and describes how they will impede TPP countries from gaining access to medicines. In order to better understand the issues and arguments that are at stake from both sides, Section 6 provides the arguments commonly put forth as to why strong patent protection is necessary, while Section 7 examines the significance of generic medicines being accessible in the global marketplace. Section 8 analyzes these arguments and draws the conclusion that, while patent protection of pharmaceuticals is important, it must be fairly balanced against the needs of the developing world to be able to access affordable, life-saving medicines. In conclusion, this paper puts forth the argument that the United States should honor its existing global-health commitments by seeking flexible IPR standards in the TPP to ensure that the health interests of the poorest and sickest people in the developing world are not undermined by the profit-maximizing interests of pharmaceutical companies.