Intellectual Property Rights And The Protection Of Public Health In Developing Countries

Author:Carlos M. Correa
Profession:Technology Policy and Management of the University of Buenos Aires, Argentina

    Carlos M. Correa is director of the Master's Program on Science and Technology Policy and Management of the University of Buenos Aires, Argentina, where he also directs the post-graduate course on intellectual property and the quarterly journal Temas de Derecho Industrial y de la Competencia. He is a member of the United Kingdom's Commission on Intellectual Property Rights (2001), and has been a consultant in the field of science and technology and intellectual property to numerous international organizations. He was director of the UNDP/UNIDO Regional Programme on Informatics and Microelectronics for Latin America and the Caribbean (1990-95). Among other positions in the Argentine national government, he was Undersecretary of State for Informatics and Development (1984-89), and a delegate in the negotiations of the Washington Treaty on Integrated Circuits and the TRIPS Agreement (1988-91). He is the author of numerous articles and books, among which are: El regimen de patentes tras la adopción del Acuerdo sobre los Derechos de la Propriedad Intelectual Relacionados con el Comercio, (6239 Jurisprudencia Argentina 2001), Integrating Public Health Concerns into Patent Legislation in Developing Countries (South Centre 2000); Developpements recents dans le domaine des brevets pharmaceutiques: mise en oeuvre de l'accord sur les ADPIC, 1 Revue Internationale de Droit Economique (University of Louvain 2000); Implementing national public health policies in the framework of the WTO Agreements, 34 J. of World Trade 89 (No. 5, 2000); Emerging trends: new patterns of technology transfer in S. Patel, P. Roffe and A. Yusuf (eds.), The International Transfer of Technology. The origins and aftermath of the United Nations negotiations on a Draft Code of Conduct (Kluwer Law International 2000). Prof. Correa holds a Ph.D. degree (Law, Economics) from the University of Buenos Aires, Argentina. Without further attribution, the author has drawn substantially on two of his previous publications: Integrating Public Health Concerns into Patent Legislation in Developing Countries (South Centre 2000) and The TRIPS Agreement: how much room for maneuver? which appeared in the Journal of Human Development (Vol. 2, Number 1, UNDP/Carfax Publishing, Taylor & Francis, Ltd. 2001) available at .

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1. Introduction

The international framework on intellectual property rights (IPR) underwent dramatic changes during the 1990s. The adoption of the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement or Agreement)1as one of the outcomes of the GATT Uruguay Round, represented a "monumental change,"2 due to its broad coverage and the availability of a system of dispute settlement that may lead to the imposition of trade sanctions. In addition, new treaties on copyright and related rights were developed under the auspices of the World Intellectual Property Organization (WIPO),3 and many instruments dealing with IPR were adopted at the regional and bilateral levels.

The changes in IPR protection were driven by the concerted action of various industrial sectors (such as the pharmaceuticals, recording, semiconductors, and software industries), actively supported by the governments of developed countries, notably the United States. Such action aimed at both increasing and universalizing the standards of protection for IPR. Underlying this trend were growing private research and development (R&D) budgets, the vulnerability to copying of some R&D intensive products, and the perceived gaps and weaknesses of IPR protection in developing countries.

Developing countries reluctantly accepted the negotiation of IPR standards within the GATT framework. Though the developed countries largely prevailed in establishing standards of IPR protection comparable to those in force in their jurisdictions, developing countries strove to retain a certain flexibility so as to be able to adopt pro-competitive measures that mitigate the powers conferred to IPR holders. A number of World Trade Organization (WTO) members used such flexibility by establishing, for instance, exceptions to exclusive rights and compulsory licensing in their national laws. Despite the relatively large number of complaints submitted to WTO under the Dispute Settlement Understanding in relation to the Page 162 TRIPS Agreement, the legality of such pro-competitive measures was only formally tested in two cases. In a case initiated by the European Union against Canada,4the panel addressed the TRIPS-consistency of Section 55(2)(1) and (2) of the Canadian Patent Act (as revised in 1993) regarding the "early working" or "Bolar" exception. Upon a complaint by the European Union, a panel also examined section 110(5)(b) of U.S. copyright law " relating to the enjoyment of certain works by customers in business premises " in light of article 13 of the TRIPS Agreement.5

The emergence of HIV/AIDS epidemics and the actions and pressures exerted on some developing countries (as illustrated by the case of South Africa),6 created considerable tension and a growing demand by developing countries to reaffirm and clarify the right of any WTO member to use the flexibility allowed by the TRIPS Agreement, particularly in order to implement public health policies. As a result, the Fourth WTO Ministerial Conference adopted a "Declaration on the TRIPS Agreement and Public Health,"7 which clarifies certain aspects of the TRIPS Agreement of interest to developing countries.

This article describes first the main characteristics of the TRIPS Agreement.8Second, it examines the ways in which WTO member countries can use the flexibility of the agreement to promote competitive access to goods and technologies. Given the public health importance of access to pharmaceuticals and the concerns expressed by developing countries, the analysis focuses on the protection of IPRs in the pharmaceutical field.

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2. The TRIPS Agreement Standards of Protection

The agreement establishes minimum standards on copyright and related rights, trademarks, geographical indications, industrial designs, patents, integrated circuits, and undisclosed information (trade secrets). Hence, by its coverage, it is the most comprehensive international instrument on IPR. It deals with all types of IPR, with the sole exceptions of breeders' rights (only incidentally referred to) and utility models (or "petty patents").

The agreement is based on and supplements, with additional obligations,9 the Paris, Berne, Rome, and Washington10 conventions in their respective fields. In other words, the agreement is not to be viewed as a completely new and separate convention, but rather as an integrative instrument which provides "convention- plus" protection to IPR.11

The standards of protection set forth relate both to the availability of rights as well to their enforcement. The inclusion of detailed provisions on "enforcement" is one of the main innovations of the TRIPS Agreement with respect to pre-existing conventions on IPR. WTO member countries cannot, in the specific areas and issues covered by the agreement, confer a lower (or ineffective) protection. In exchange, members cannot be obliged to provide a "more extensive" protection (article 1.1.).

With the approval of the TRIPS Agreement, any controversy as to compliance with the minimum standards should be subject to a multilateral procedure of dispute settlement within the WTO, in accordance with the Dispute Settlement Understanding (DSU). Once the existence of a violation is determined, the affected country can apply trade retaliatory measures to the non-complying country, in any Page 164 area covered by the WTO Agreement (for instance, it may increase tariffs on exports from the non-complying country). This mechanism provides an institutionalized, multilateral means to address disputes relating to IPR. It is aimed at preventing unilateral actions, such as those taken by the United States under Section 301 of its Trade and Tariffs Act.

The main stated goal of the agreement is "to reduce distortions and impediments to international trade, taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become a barrier to legitimate trade."12

The paradigm of protection adopted by the agreement aims at achieving a balance between the exclusive rights conferred to innovators and the interests of society in the diffusion of and further innovation on existing technology. Though it is recognized that intellectual property rights are "private rights," the underlying public policy objectives of national systems for the protection of intellectual property, including "developmental and technological objectives" are also recognized.13 More specifically, articles 7 and 8 provide a framework for the interpretation and implementation of intellectual property rights. Article 6 addresses the tension between free trade and the protection of IPR...

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