Articles and Studies

Comparative Study of Selected Government Policies for Promoting Transfer of Technology and Competitiveness in the Colombian Pharmaceutical Sector

Author: 

Frederick M. Abbott
PowerPoint of Study Presentation - Bogota 2007

United States Agency for International Development - Programa MIDAS, 2007

The overall conclusion of this study is that domestic pharmaceutical producers in Colombia will face increasing challenges from foreign enterprises if and as the market is further opened to competition. If there is a national interest in maintaining or improving the local and global market position of Colombian enterprises, steps should be considered to encourage upgrade of the facilities of private operators to meet standards prevalent among major international generics suppliers. Facilities upgrading would have positive consequences for the Colombian public in terms of improving the quality of products on costs, financial assistance to local firms will be required. Some restructuring of the local industry (in terms of consolidation) should be anticipated.

Trips II, Asia and the Mercantile Pharmaceutical War: Implications for Innovation and Access

Author: 

Frederick M. Abbott

Stanford Center for International Development, Working Paper No. 308, Dec. 2006

A powerful agenda for adoption of high levels of intellectual property protection, including related regulatory protection, is being advanced by the United States (and certain other developed countries) for developing countries, including developing and emerging market countries of Asia. This agenda essentially reflects a TRIPS II exercise, but is largely being carried out in bilateral and regional negotiations, as well as in WTO accession negotiations.

Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of U.S. Federal Law

Author: 

Frederick M. Abbott

UNCTAD - ICTSD Project on IPRs and Sustainable Development, Issue Paper No. 12, Feb. 2006

During the past several years, the United States has concluded a substantial number of bilateral and regional free trade agreements (hereinafter “FTAs”), largely with developing countries. Each of those FTAs includes substantial commitments in the field of intellectual property rights (IPRs) and related regulatory matters. These commitments exceed those required by the TRIPS Agreement which establishes minimum substantive standards of protection and enforcement for all WTO Members.

TRIPS and Human Rights: Preliminary Reflections

Author: 

Frederick M. Abbott

in INTERNATIONAL TRADE AND HUMAN RIGHTS: FOUNDATIONS AND CONCEPTUAL ISSUES, p. 145, F. Abbott, C. Breining-Kaufmann & T. Cottier, eds., University of Michigan Press, 2006

We are considering the relationship between human rights and trade-related aspects of intellectual property rights (TRIPS). Intellectual property rights (IPRs) have always reflected a balancing of general public interests and private stakeholder interests, and in this sense IPRs take into account social welfare concerns as well as those of individual inventors and artists. While the balance struck in the TRIPS Agreement is flawed, it is capable of flexible interpretation and amendment. Human rights represent the values for establishing a global constitutional balance between the interests of the public and the private holders of IPRs.

The Cycle of Action and Reaction: Developments and Trends in Intellectual Property and Health

Author: 

Frederick M. Abbott

in NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES 27-40 (eds. P. Roffe, G. Tansey and D. Vivas-Eugui), Earthscan (2005)

The wheel of the global medicines supply market is broken, but proposals for fixing it are at very early stages.

The WTO Medicines Decision: The Political Economy of World Pharmaceutical Trade and the Protection of Public Health

Author: 

Frederick M. Abbott

American Journal of International Law, Vol. 99, pp. 317-58, 2005

On August 30, 2003, the member countries of the WTO adopted the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This Decision provides flexibility for the export of pharmaceutical products under compulsory license (which flexibility might otherwise have been limited by the terms of the TRIPS Agreement). This article analyzes negotiating strategies used by developing countries to achieve their objectives regarding the Decision at the WTO.

Compulsory Licensing for Public Health: A Guide and Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision

Author: 

Frederick M. Abbott and Rudolph V. Van Puymbroeck

World Bank Working Paper No. 61 (2005)

The Doha Declaration on the TRIPS Agreement and Public Health (in its Paragraph 6) recognized that developing countries with insufficient or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. The WTO’s decision of August 30, 2003 set up a system intended to overcome these difficulties. The present work is a guide to the implementation of that system.

Toward a New Era of Objective Assessment in the Field of TRIPS and Variable Geometry for the Preservation of Multilateralism

Author: 

Frederick M. Abbott

Journal of International Economic Law, Vol. 8, No. 1, pp. 77-100, 2005

The TRIPS Agreement emerged from the Uruguay Round negotiations as one of the three pillars of the WTO. This article offers a preliminary assessment of the first ten years under the TRIPS Agreement. Based on that assessment, it makes suggestions for the future.

Preservation and Use of Genetic Resource Assets and the International Patent System

Author: 

Frederick M. Abbott

Study for the Ministry of Foreign Affairs of Norway, Hong Kong Ministerial Revision, March 31, 2005

In 1992 the Convention on Biological Diversity (CBD) was adopted at the Rio Conference. In 1994 the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was adopted in Marrakech. From the outset, questions were raised as to whether there are conflicts or potential conflicts between the objectives and rules of these two international undertakings.

Are the Competition Rules in the WTO Trips Agreement Adequate?

Author: 

Frederick M. Abbott

Journal of International Economic Law, Vol. 7, No. 3, pp. 687-703, 2004

In connection with the run-up to the Cancun Ministerial Conference, the author was asked whether there are grounds for recommending amendment of WTO TRIPS Agreement rules addressing competition. The general conclusion of the study is that the TRIPS Agreement in its present form provides substantial discretion to WTO Members in the formulation and application of competition rules regulating intellectual property, and this arrangement serves the best interests of developed and developing countries.

Intellectual Property Rights: A Concise Guide (Chapter 2), and Intellectual Property Rights: How They Affect Procurement and What Steps Can Be Taken (Annex B)

Author: 

Frederick M. Abbott

in BATTLING HIV/AIDS: A DECISION MAKER’S GUIDE TO THE PROCUREMENT OF MEDICINES AND RELATED SUPPLIES 11-20, 105-29 (ed. Y. Tayler 2004), World Bank

The procurement of HIV/AIDS–related medicines and supplies is directly affected by rights in intellectual property, most notably patents.

Managing the Hydra: The Herculean Task of Ensuring Access to Essential Medicines

In INTERNATIONAL PUBLIC GOODS AND TRANSFER OF TECHNOLOGY AFTER TRIPS 393-424 (K. Maskus and J. Reichman eds.)(Cambridge Univ. Press 2005)

The task of ensuring access to essential medicines presents a complex and embedded set of problems that will remain a persistent feature of the international governance landscape for the foreseeable future.

The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements

Author: 

Frederick M. Abbott

Quaker United Nations Office (Geneva) (QUNO), Occasional Paper No. 14, April 2004

In the Doha Declaration WTO Members committed themselves to implementing and interpreting the TRIPS Agreement to allow full use of its flexibilities, and to promote access to medicines for all. In the Doha Declaration there was an express acknowledgment of the right of Members to grant compulsory licenses on grounds determined by them.

Trade Diplomacy, the Rule of Law and the Problem of Asymmetric Risks in TRIPS

Author: 

Frederick M. Abbott

Quaker United Nations Office (Geneva) (QUNO), Occasional Paper No. 13, September 2003

The WTO has just finished two and one half years of negotiations on the TRIPS Agreement and Public Health, with an additional tranche of negotiations scheduled to commence soon.

WTO Dispute Settlement Practice Relating to the Agreement on Trade-Related Intellectual Property Rights

Author: 

Frederick M. Abbott

in THE WTO DISPUTE SETTLEMENT SYSTEM 1995-2003, pp. 421-53, F. Ortino & E.-U. Petersmann, eds., Kluwer Law International, 2004

The jurisprudence developed by panels and the Appellate Body (AB) under the TRIPS Agreement during the first six-plus years of implementation reflects a cautious and gradualist approach to interpretation of the agreement. The decisions provide a collective reminder of the importance that WTO Members attach to the use of intellectual property as an instrument of industrial and social policy and the intention of those Members to maintain adequate flexibility to address domestic circumstances. The adoption by Ministers of the Declaration on the TRIPS Agreement and Public Health at Doha on 14 November 2001 was a seminal event in the evolution of WTO law, and will influence jurisprudence under the TRIPS Agreement.

World Trade Organization - TRIPS - Course on Dispute Settlement in International Trade, Investment and Intellectual Property (UNCTAD)

Author: 

Frederick M. Abbott

TRIPS – UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT (UNCTAD), COURSE ON DISPUTE SETTLEMENT IN INTERNATIONAL TRADE, INVESTMENT AND INTELLECTUAL PROPERTY, United Nations Publication, 2003

The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) is the first WTO agreement requiring Members to establish a relatively detailed set of substantive norms within their national legal systems, as well as requiring them to establish enforcement measures and procedures meeting minimum standards. The TRIPS Agreement is sometimes referred to as the first WTO agreement that prescribes “positive law”. This factor alone might account for a more than typical level of controversy as Members deal, in many cases, with adopting rather far-reaching changes to their national legal systems.

The ‘Rule of Reason’ and the Right to Health: Integrating Human Rights and Competition Principles in the Context of TRIPS

Author: 

Frederick M. Abbott

in HUMAN RIGHTS AND INTERNATIONAL TRADE, p. 279, T. Cottier, J. Pauwelyn & E. Bürgi, eds., Oxford University Press, 2003

In August 2001 the first public meeting of the American Society of International Law Project on Human Rights and International Trade (‘Project’) was held at the World Trade Institute in Berne, Switzerland. One session of that meeting was devoted to the relationship between human rights and the WTO Agreement in Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’). As part of the follow-up to that meeting, the team leading the Project decided it would be useful to consider several ‘case studies’ that would seek more specifically to identify and analyze situations in which human rights and trade rules interact with each other. This study looks at the manner in which human rights may affect the application of competition rules and principles in the context of the TRIPS Agreement.

Dispute Prevention and Dispute Settlement in the Field of Intellectual Property Rights and Electronic Commerce, United States-Section 211 Omnibus Appropriations Act 1998 ('Havana Club')

Author: 

Frederick M. Abbott and Thomas Cottier

in DISPUTE PREVENTION AND DISPUTE SETTLEMENT IN THE TRANSATLANTIC PARTNERSHIP - CASE STUDIES, ANALYSES AND POLICY RECOMMENDATIONS, pp. 429-447, E.U. Petersmann and M. Pollack, eds., Oxford University Press, 2003

As a general conclusion this case-study suggests that the dispute between Pernod Ricard, a France-based multinational distiller and distributor, and Bacardi-Martini, a US-based multinational distiller and distributor, should have been resolved as a private commercial dispute and not as a systemic test of world trade system rules. In this regard, third party arbitration or mediation under the auspices of an alternative dispute settlement forum may have proven quite helpful.

The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO

Author: 

Frederick M. Abbott

Journal of International Economic Law, Vol. 5, p. 469, 2002

The adoption by Ministers on 14 November 2001, in Doha, of the Ministerial Declaration on the TRIPS Agreement and Public Health marked a turning point in political and legal relations at the WTO. Developing country Members sent a clear signal that they would take steps to protect and advance their essential interests. These Members demonstrated that by establishing a coalition, and maintaining it throughout a negotiating process, they could prevent themselves from being outmaneuvered by the EU-US block.

WTO TRIPS Agreement and its Implications for Access to Medicines in Developing Countries

Author: 

Frederick M. Abbott

Study Paper 2a, United Kingdom Commission on Intellectual Property Rights, 2002

This study accepts the consensus of experts that developing countries should make use of policy options such as compulsory licensing and parallel importation to increase the supply of low-price medicines and vaccines. The interests of the OECD and its consumers will not be undermined by such action since, inter alia, Pharma is not significantly dependent on profits from developing countries to pursue its research mission.

The Doha Declaration on the TRIPS Agreement and Public Health mandates that the agreement be interpreted in a manner that supports public health interests and promotes access to medicines for all. This study analyzes the TRIPS Agreement in light of that mandate.

Compulsory Licensing for Public Health Needs: The TRIPS Agenda at the WTO after the Doha Declaration on Public Health

Author: 

Frederick M. Abbott

Quaker United Nations Office (Geneva) (QUNO), Occasional Paper 9, February 2002

Paragraph 6 of the Doha Declaration directs the WTO Council for TRIPS (“TRIPS Council”) to address the problems that Members with insufficient or no manufacturing capacity may have in making effective use of compulsory licensing, and to report to the General Council by the end of 2002.

The TRIPS-Legality of Measures Taken to Address Public Health Crises: Responding to USTR-State-Industry Positions That Undermine the WTO

Author: 

Frederick M. Abbott

in THE POLITICAL ECONOMY OF INTERNATIONAL TRADE: ESSAYS IN HONOR OF ROBERT E. HUDEC 311, D. Kennedy and J. Southwick eds., Cambridge University Press, 2002

The main WTO law-related focus of this essay is the treatment of compulsory licensing and parallel trade under the TRIPS Agreement, with emphasis on the AIDS crisis confronting Africa, Asia, and other parts of the world. There are two principal reasons for addressing this subject matter in some detail. First, and paramount, is the exigency of the present situation.

The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference

Author: 

Frederick M. Abbott

QUNO Occasional Paper No. 7, 2001

On June 19, 2001, the WTO TRIPS Council held its first meeting on the implications of the TRIPS Agreement for access to medicines and public health. In connection with that meeting, and a follow on meeting of July 25, 2001, WTO Members have made a number of specific observations regarding the terms, structure and spirit of the Agreement.

Second Report (Final) to the Committee on International Trade Law of the International Law Association on the Subject of the Exhaustion of Intellectual Property Rights and Parallel Importation

Author: 

Frederick M. Abbott

69th Conference of the International Law Association, July 2000

Study of trade-related aspects of intellectual property rights (TRIPS) has formed an integral part of the work program of the Committee on International Trade Law of the International Law Association (ILA) since its inaugural meeting at the headquarters of the GATT in 1993. In June 1995 in Geneva, the Committee decided to undertake a specific work program regarding the exhaustion of rights and parallel importation.

TRIPS in Seattle: The Not-So-Surprising Failure and the Future of the TRIPS Agenda

Author: 

Frederick M. Abbott

Berkeley Journal of International Law (BJIL), Vol. 18, p. 165, 2000

Government trade ministers arrived at that the WTO Seattle Ministerial Conference in late November 1999 without preliminary agreement on the future course of multilateral trade negotiations, and they departed without reaching consensus on a new WTO agenda.

Political Economy of the U.S. Parallel Trade Experience: Toward a More Thoughtful Policy

Author: 

Frederick M. Abbott

in INTELLECTUAL PROPERTY: TRADE, COMPETITION AND SUSTAINABLE DEVELOPMENT 177-88 (eds. T. Cottier, P. Mavroidis and M. Pannizon eds. 2001), Univ. Michigan Press, World Trade Forum Series Nr. 3Download hereFor the past decade, the Office of the United States Trade Representative (“USTR”), more recently in conjunction with the U.S. Department of State (“State”), has aggressively pursued a trade policy condemning (and threatening) foreign governments that open their markets to parallel trade.

The North American Integration Regime and its Implications for the World Trading System

Author: 

Frederick M. Abbott

in THE EU, THE WTO, AND THE NAFTA: TOWARDS A COMMON LAW OF INTERNATIONAL TRADE , pp. 169-200, Joseph H. H. Weiler, ed, 2000

This article examines the complex relationship between the institutions and legal rules of the NAFTA and the World Trade Organization.

NAFTA and the Legalization of World Politics: A Case Study

Author: 

Frederick M. Abbott

International Organization, Vol. 54, No. 3, 2000

This article analyzes the North American Free Trade Agreement (NAFTA) in the context of a broader project examining the causes and consequences of the legalization of world politics. Governments are continuously engaged in the process of negotiating international trade agreements, and in each case negotiators are confronted with choices regarding the best mode of legalization to accomplish their agreed upon objectives. By closely analyzing the choices made by governments over time and correlating those choices with the results achieved (in the context of stated objectives), political scientists and lawyers may aid in directing government negotiators to preferred legalization options.

Distributed Governance at the WTO-WIPO: An Evolving Model for Open-Architecture Integrated Governance

Author: 

Frederick M. Abbott

Journal of International Economic Law, p. 63, 2000

The inter-institutional relationship that has evolved between the WTO and the World Intellectual Property Organization (WIPO) since the conclusion of the Uruguay Round evidences a number of characteristics that might usefully form the basis for relations between the WTO and other international organizations.

Prevention and Settlement of Economic Disputes Between Japan and the United States: Part III: Dispute Avoidance and Dispute Settlement: Incomplete Rule Systems, System Incompatibilities and Suboptimal Solutions: Changing the Dynamic of Dispute Settlement

Author: 

Frederick M. Abbott

Arizona Journal of International and Comparative Law, Vol. 16, p. 185, 1999

This article concerns the avoidance and settlement of trade disputes between Japan and the United States. There are three aspects to the question of dispute settlement and avoidance between Japan and the United States that deserve close attention.

Technology and State Enterprise in the WTO

Author: 

Frederick M. Abbott

in STATE TRADING IN THE TWENTY-FIRST CENTURY 121, T. Cottier and P. Mavroidis, eds., 1998

Download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1924468 

The Silhouette of a Trojan Horse: Reflections on Advocate General Jacobs' Opinion in Silhouette v. Hartlauer

Author: 

Frederick M. Abbott and D.W. Feer Verkade

Journal of Business Law, p. 413, September 1998

The European Court of Justice (ECJ) has been asked to decide whether its own seminal jurisprudence on the prerequisites of the completed internal market may be extended into the international arena of trade, or should instead be mandatorily restricted to the European Union (EU) market itself.

First Report (Final) to the Committee on International Trade Law of the International Law Association on the Subject of Parallel Importation

Journal of International Economic Law, Vol. 1, No. 4, pp. 607-636, 1998

The First Report on Parallel Imports approaches the exhaustion/parallel imports question in broad economic terms, asking whether there may be an economic and social welfare benefit to permitting IPRs holders to block parallel imports that outweighs the potential harm to liberal trade.

The Enduring Enigma of TRIPS: A Challenge for the World Economic System

Author: 

Frederick M. Abbott

Journal of International Economic Law, Vol. 1, Issue 4, pp. 497-521, 1998

This special issue on trade-related aspects of intellectual property rights (TRIPS) is introduced with a perspective that focuses on the urgency of narrowing the gap in living standards between the rich nations and the poor.

Reflection Paper on China in the World Trading System: Defining the Principles of Engagement

Author: 

Frederick M. Abbott

in CHINA IN THE WORLD TRADING SYSTEM: DEFINING THE PRINCIPLES OF ENGAGEMENT, pp. 1-43, F.M. Abbott, ed., Kluwer Law International 1998

China's prospective membership in the World Trade Organization is one of the most significant developments relating to international institutions to take place in the past several decades.

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