The case for flexible intellectual property protections in the Trans-Pacific Partnership.

AuthorSilverman, Matthew E.
PositionOf pharmaceuticals
  1. INTRODUCTION II. THE TRIP S AGREEMENT AND THE "DOHA DECLARATION" III. "TRIPS-PLUS" IN U.S. FREE TRADE AGREEMENTS IV. PATENT TERM EXTENSIONS, PATENT LINKAGES, AND DATA PROTECTION V. INTELLECTUAL PROPERTY RIGHTS IN THE BIPARTISAN TRADE DEAL VI. PHARMACEUTICAL IPRS IN THE TRANS-PACIFIC PARTNERSHIP A. Proposal #1 Patent Term Extensions B. Proposal #2 Patent Linkages C. Proposal #3 Data Protection VII. WHY PATENT PROTECTION OF PHARMACEUTICALS IS IMPORTANT VIII. THE SIGNIFICANCE OF GENERIC MEDICINES IX. PATENT PROTECTION AND ACCESS TO MEDICINES X. CONCLUSION I. INTRODUCTION

    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). (1) 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. (2) 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.

  2. THE TRIPS AGREEMENT AND THE "DOHA DECLARATION"

    At the center of the international IPR system is the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). (3) TRIPS sets minimum standards of protection and enforcement for copyrights, trademarks, patents and other forms of intellectual property. (4) All WTO member countries are required to comply with these standards by modifying their national regulations to be consistent with the rules of the agreement. (5) TRIPS strikes a balance between the "rights of patent holders to benefit from their inventions and the rights of countries to address health priorities through the provision of affordable medicines." (6)

    Among the debates about the implications of TRIPS is its impact on public health. (7) Prior to TRIPS, developing countries regulated public health with little involvement from an international IPR system. (8) Critics of TRIPS asserted that developed countries, which are the major producers of intellectual property, would be the prime beneficiaries of the agreement. (9) Opponents also argued that TRIPS would raise the costs of public-health goods, constrain the ability of governments to provide health services to their populations, and hinder innovation and economic development for low-income countries. (10) In an effort to alleviate developing countries' concerns with TRIPS, trade ministers adopted a Declaration on the TRIPS Agreement and Public Health (the "Doha Declaration") committing WTO member states to "interpret and implement the agreement to support public health and to promote access to medicines for all." (11)

    The Doha Declaration was an important step toward making TRIPS more development friendly and emphasizing the need to interpret TRIPS from a public-health perspective. (12) Specifically, the Doha Declaration clarified that TRIPS does not and should not prevent WTO members from taking measures to protect public health. (13) The IPR flexibilities allowed under TRIPS and the Doha Declaration are internationally recognized as important public policy and legal tools in the efforts to protect public health and promote access to medicines in the developing world. (14)

  3. "TRIPS-PLUS" IN U.S. FREE TRADE AGREEMENTS

    In recent years, the United States has increasingly focused on FTAs as a tool to promote stronger international IPR protections. (15) In negotiating FTAs since the implementation of TRIPS, the United States Trade Representative (USTR) has frequently sought levels of IPR protection that exceed the minimum standards of TRIPS (so-called "TRIPS-plus" provisions). (16) These new and higher IPR standards arguably favor the short-term business interests of U.S. pharmaceutical companies at the expense of public-health interests in developing countries. (17)

    The United States' pursuit of TRIPS-plus protections for pharmaceutical patents in recent FTAs is well recognized. (18) This pursuit has been driven, at least in part, by a desire to achieve levels of protection it anticipated from TRIPS but failed to secure. (19) The U.S. pharmaceutical industry viewed TRIPS as falling short of its objectives, and as a result, there has generally been a progressive increase in IPR protection for pharmaceuticals in U.S. FTAs since TRIPS. (20)

    Proponents of stronger IPR provisions in FTAs argue that they ultimately promote access to medicines for developing countries by encouraging innovation. (21) However, the incorporation of TRIPS-plus provisions in recent U.S. FTAs has attracted criticism from public-health advocates and developing countries, which have expressed concerns that the enhanced protections run contrary to the spirit of the Doha Declaration and severely limit access to life-saving medicines in the developing world. (22) Both of these arguments are addressed in greater detail in Section 8 of this paper.

  4. PATENT TERM EXTENSIONS, PATENT LINKAGES, AND DATA PROTECTION

    The most prominent TRIPS-plus patent provisions in U.S. FTAs are patent term extensions, patent linkages, and data protection. (23)

    Patent Term Extensions. Many U.S. FTAs include provisions for mandatory patent term extensions beyond the TRIPS obligation of patent protection terms of twenty years from the filing date. (24) Extensions are allowed in cases of "unreasonable" delays in the issuance of patents due to the regulatory review or administrative process. (25) Patent holders contend that such extensions allow them to recoup the costs of research and development (R&D) of new products, while critics argue such extensions delay the entry of generic drugs into the marketplace. (26)

    Patent Linkages. Patent linkage refers to the attachment of regulatory approval for the marketing of a drug with the status of a patent. (27) If a patent exists, the U.S. Food and Drug Administration (FDA) and its counterparts in other countries may only grant marketing approval for a generic drug that is patented in the country with the permission of the patent holder. (28) Patent linkage is a common provision in U.S. FTAs. (29) Patent linkage is considered to be TRIPS-plus because under TRIPS generic drug manufacturers are able to apply for marketing approval without the patent owner's permission and prior to the expiration of the patent, thereby reducing the time it takes for the generic drugs to enter the marketplace once the patent expires. (30)

    Data Protection. To bring a patented drug to market, a pharmaceutical company must demonstrate through costly clinical trials that the drug is both safe and effective. (31) In cases where the patent holders must submit undisclosed data regarding the safety or effectiveness of these drugs in order to market them, TRIPS requires WTO members to take measures to protect such data from disclosure and unfair commercial use; TRIPS does not prescribe any specific time period for this protection. (32) However, recent U.S. FTAs generally require a five-year period of marketing exclusivity for the patent holder, which typically begins from the date the product is approved in the country. (33) Under this TRIPS-plus provision, generic drug manufacturers wanting to market and distribute their drug while the data exclusivity period is in effect must conduct their own clinical trials and submit their own findings to the national drug regulatory authority (they cannot rely on the findings submitted by the patent holder). (34) Increased data protection/exclusivity, therefore, raises the cost of manufacturing generic drugs and delays...

To continue reading

Request your trial