Articles and Studies

China Policies to Promote Local Production of Pharmaceutical Products and Protect Public Health

Author: 

Frederick M. Abbott

Published by: Geneva: World Health Organization; 2017

Indian Policies to Promote Local Production of Pharmaceutical Products and Protect Public Health

Author: 

Frederick M. Abbott

Published by: Geneva: World Health Organization; 2017

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Brief of Amicus Curiae (Frederick M. Abbott) in Support of Petitioner in Impression Products v. Lexmark International, US Supreme Court, No. 15-1189, filed January 20, 2017

Author: 

Frederick M. Abbott

Download Amicus Brief here

 

Summary of Arument

Parallel Trade in Pharmaceuticals: Trade Therapy for Market Distortions

Author: 

Frederick M. Abbott

Pharmaceutical products are developed, approved, manufactured, traded, and used under complex and demanding regulatory schemes. While the intensity of regulation varies substantially among countries, lightly regulated markets are the exception, particularly from an economic standpoint. In this regard, pharmaceuticals are not generally traded in what might be described as a "free market" in the sense of absence of regulation, and this includes import restrictions which are generally consistent with the overall regulatory schemes. A drug that is not approved for marketing in a particular country does not become so because it is imported.

Parallel trade (i.e., imports and exports) in pharmaceuticals takes place in markets that are "distorted" by regulation.

Excessive Pharmaceutical Prices and Competition Law: Doctrinal Development to Protect Public Health

Author: 

Frederick M. Abbott

Forthcoming in UC Irvine Law Review, Volume 6, Issue 3, Spring 2017

This article is divided into two parts. The first addresses competition policy and why it is appropriate to develop the doctrine of excessive pricing to address distortions in the pharmaceutical sector. The second addresses the technical aspect of how courts or administrative authorities may determine when prices are excessive, and potential remedies.

The policy prescription of this article is twofold: first, the United States should incorporate excessive pricing doctrine in its antitrust arsenal, and; second, other countries should maintain the status quo with respect to multilateral competition rules that allow them flexibility to develop and refine doctrine, including excessive pricing doctrine, that is best suited to their circumstances and interests.

Submitted to Senate Finance Committee on March 3, 2016 in response to request feedback regarding the report on “The Price of Sovaldi and its impact on the U.S. Health Care System” of December 1, 2015 (Senate Print 114-20). Transmittal letter accompanies abstract and download.

Rethinking Patents: From ‘Intellectual Property’ to ‘Private Taxation Scheme’

Author: 

Frederick M. Abbott

in KRITIKA: ESSAYS ON INTELLECTUAL PROPERTY, vol. 1, pgs. 1-16 (eds. P. Drahos, G. Ghidini, H. Ullrich), Edward Elgar 2015

This essay addresses a fundamental issue, that is, the basis on which public discourse concerning patents takes place.

Trade in medicines

Author: 

Frederick Abbott

in Trade and Health: Towards building a National Strategy 117-40 (eds. R. Smith et al.), World Health Organization (2015)

This is a chapter of a book published by the World Health Organization to assist governments in developing trade strategies to promote public health.

The Generics Pathway in the USA: The American Experience, a Model for the World?

Author: 

Frederick M. Abbott

Collected Papers on the Pharmaceutical Industry of the National Autonomous University of Mexico (UNAM), forthcoming 2015

This paper was initially presented at the Annual Meeting of the Association of Latin American Pharmaceutical Producers (ALIFAR - Asociación Latinoamericana de Industrias Farmaceuticas) and the National Pharmaceutical Producers Association of Mexico (ANAFAM) in Mexico City in May 2012. It has been revised and updated for publication by the National Autonomous University of Mexico (UNAM) in a forthcoming collection (2015).

An Overview of the Agreement Contents and Features

Author: 

Frederick M. Abbott

Chapter in The ACTA and the Plurilateral Enforcement Agenda 31-45, eds. P. Roffe and X. Zeuba, Cambridge Univ. Press (Dec. 2014)

Transfer of Technology and a Global Clean Energy Grid

Author: 

Frederick M. Abbott

Prepared for International Trade in Electricity and the Greening Economy
World Trade Forum, World Trade Institute, 26-27 September 2014
Paper as delivered September 27, 2014; to be revised for publication in 2014 World Trade Forum volume by Cambridge University Press

The LDC Medicines Extension Question: Contemplating next steps

Author: 

Frederick M. Abbott

Bridges Africa, Vol. 3, No. 8, pgs. 15-17 (International Centre for Trade and Sustainable Development, Geneva, Switzerland 2014)

The WTO previously authorised least developed country (LDC) members not to implement or enforce patent and regulatory data rules until January 1, 2016. Should LDCs seek renewal of the pharmaceutical-related extension at the TRIPS Council before it expires, or does the recent “general” extension for LDC implementation of the TRIPS Agreement until July 1, 2021 already cover the necessary ground?

Anti-Competitive Behaviours and the Remedies Available for Redress

Author: 

Frederick M. Abbott

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed.

Emerging Markets and the World Patent Order: The forces of change

Author: 

Frederick M. Abbott, Carlos M. Correa and Peter Drahos

Chapter 1 of Emerging Markets and the World Patent Order, eds. Frederick M. Abbott, Carlos M. Correa and Peter Drahos, Edward Elgar Publishing (Cheltenham UK and Northampton USA), 2013, pgs. 3-33 (made available with permission of the publisher)

Review: The Trilateral Study on Health, Intellectual Property, and Trade: The Virtue in Paving a Cleared Roadway

Author: 

Frederick M. Abbott

Journal of International Economic Law, Vol. 16, No. 2, Pgs. 493-503 (Oxford University Press 2013)

This contribution reviews an important study—"Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade" (the "Trilateral Study") jointly prepared by the Secretariats of the World Health Organization, World Intellectual Property Organization and World Trade Organization, and released in February 2013.

On the Duality of Internet Domain Names: propertization and its discontents

Author: 

Frederick M. Abbott

3 N.Y.U. JOURNAL OF INTELL. PROP. & ENT. LAW 1 (2013)

Domain names may have substantial economic and social value. They are often the object of dispute, whether based on allegations of abuse, or in contests over ownership. There is a recent judicial trend, particularly in the Court of Appeals for the Ninth Circuit, toward characterizing domain names as “property” (and more specifically, “intangible property”) subject to rules of sale and transfer typical of personal property. This judicial characterization identifies “alienability” as a fundamental characteristic of domain names. This sets up a real or potential conflict with jurisdictions or forums where domain names have been judicially or administratively characterized as “contract rights” based on the legal relationship between the domain name registrant and the registrar.

Trade Costs and Shadow Benefits: EU Economic Partnership Agreements as Models for Progressive Development of International IP Law

Author: 

Frederick M. Abbott

in EU BILATERAL TRADE AGREEMENTS & INTELLECTUAL PROPERTY FOR BETTER OR WORSE? (eds. J. Drexl, H. Grosse Ruse-Khan and S. Nadde-Phlix, Max Planck Institute Studies (Springer 2013 forthcoming)

This paper addresses the specific question whether “development-friendly” provisions incorporated in recent European Union (EU) economic partnership agreements (EPAs) may serve as models for the progressive development of international intellectual property law.

Respect for Copyright Sovereignty in Transit: The European Court of Justice Decision in the Joined Philips/Nokia Cases

Author: 

Frederick M. Abbott

FSU College of Law, Business and Economics Paper

The decision by the ECJ in Philips/Nokia is welcome on a number of grounds. The Court affirmed that each country has the sovereign authority to make and apply IP rules for its own territory, and that applying IP rules governing the domestic market of transit countries would impair that authority. The Court rejected the production fiction approach that had been adopted by the Dutch Supreme Court, and advocated by Phillips and the Belgian government in the joined Philips/Nokia proceeding.

Trends in Local Production of Medicines and Related Technology Transfer

Author: 

Frederick M. Abbott

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer.

Intellectual Property and Public Health: Meeting the Challenge of Sustainability

Author: 

Frederick M. Abbott

Global Health Programme Working Paper No. 7/2011, November 15, 2011

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of new research and development (R&D) mechanisms. There has been enhanced cooperation among WHO, WIPO and the WTO. Nevertheless, significant gaps remain in placing the development and supply of medicines to the world’s population on a sustainable footing; gaps that are exacerbated by the present trend toward restrained government spending. This paper reflects on the political and legal constellation making progress on global public health matters difficult, and on economic and scientific trends in the medicines sector that may affect policy over the next decade.

An International Legal Framework for the Sharing of Pathogens: Issues and Challenges

Author: 

Frederick M. Abbott

ICTSD Programme on IPRs and Sustainable Development, No. 30, October 2010

Access to biological material with human pathogenic potential (pathogen materials) is important because research directed toward the development of new drugs and vaccines is dependent on scientific analysis of the underlying causes of disease.

NAFTA Entries in the Max Planck Encyclopedia of Public International Law

Author: 

Frederick M. Abbott

The North American Free Trade Agreement (NAFTA): Structure, Dispute Settlement and Case Law

This paper combines three entries regarding the North American Free Trade Agreement (NAFTA) prepared by the author for the Max Planck Encyclopedia of Public International Law.

Intellectual Property, International Protection Entry in Max Planck Encyclopedia of Public International Law

Author: 

Frederick M. Abbott

Intellectual property, International Protection

VII MAX PLANCK ENCYCLOPEDIA OF PUBLIC INTERNATIONAL LAW 776 (Rüdiger Wolfrum ed.) (Oxford 2012)

Intellectual property rights perform a variety of functions. They promote innovation and creative expression, and they protect investment. The promotion of innovation and protection of investment are important objectives for the global economy. New products and methods for producing them improve the quality of life and enhance productivity. It is important, however, to bear in mind that IPRs protection also imposes social and economic costs.

Emerging Market Pharmaceutical Supply: A Prescription for Sharing the Benefits of Global Information Flow

Author: 

Frederick M. Abbott

in THE GLOBAL FLOW OF INFORMATION: LEGAL, SOCIAL, AND CULTURAL PERSPECTIVE 175-189 (eds. R. Subramanian & E. Katz), New York Univ. Press, 2011

New information technologies enable individuals in disparate locations to conduct cutting-edge research, to move that research into the development and testing of new medicines, to manufacture high-quality products, and to move those products to patients around the world. Conceptually, the world pharmaceuticals supply market may become increasingly competitive at all stages: basic research, product development, manufacturing and distribution. The diffusion of technological competence to major developing country actors in the pharmaceutical sector, such as India and China, as well as to more specialized actors such as Bangladesh (manufacturing) and Singapore (research), could result in a significant expansion of the pool of products available to treat disease, as well as more affordable prices to consumers.

Regional Assessment of Patent and Related Issues and Access to Medicines: Caricom Member States and the Dominican Republic (HERA)

Author: 

Frederick M. Abbott, Ryan Abbott, Wilbert Bannenberg, Marianne Schürmann

Health Research for Action Final Report- Main Report, Vol. 1, 2009

The objectives of this study were: (a) to explore the possibilities of developing a harmonized, pro-public health regional (Caribbean) IP regulation and drug policy (to include generic drugs) framework; (b) to make recommendations on the promulgation/up-dating of IP legislation and regulation that will maximize TRIPS flexibilities while being TRIPS compliant; (c) to identify the requirements and process for establishing a regional negotiating platform for drugs; (d) to identify mechanisms for building/strengthening coalitions and negotiating positions at the WTO, and in bilateral and regional fora for ensuring access to drugs; and (e) to make recommendations on the adequacy of the systems in Member States for regulation of the pharmaceutical market to ensure the timely supply of safe, effective and quality medicines.

Innovation and Technology Transfer to Address Climate Change: Lessons from the Global Debate on Intellectual Property and Public Health

Author: 

Frederick M. Abbott

ICTSD Programme on IPRs and Sustainable Development, Issue Paper No. 24

This paper examines issues surrounding the development and transfer of technologies for addressing the problem of climate change based on the experience of developing countries in addressing problems of innovation and access in the field of medicines.

The Challenges We Face

Author: 

Frederick M. Abbott and Graham Dukes

in Frederick M. Abbott and Graham Dukes, GLOBAL PHARMACEUTICAL POLICY: Ensuring Medicines for Tomorrow's World 1-15 (2009)(Edward Elgar Publishing)

Pharmaceutical products play a central role in the prevention and treatment of disease. Making safe and effective pharmaceutical products available and affordable to individuals around the world is a central challenge to the global governance system. There are however myriad obstacles to achieving and maintaining effective worldwide availability of medicines.

Cross-Retaliation in TRIPS: Options for Developing Countries

Author: 

Frederick M. Abbott

ICTSD Programme on Dispute Settlement and Legal Aspects of International Trade, Issue Paper No. 8, April 2009

This paper addresses a World Trade Organization (WTO) dispute settlement remedy commonly known as 'cross-retaliation', and specifically the mechanism by which a WTO Member can suspend concessions in the field of trade-related intellectual property rights (TRIPS) to redress an injury suffered with respect to trade in goods or services.

Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare

Author: 

Frederick M. Abbott

1 W.I.P.O.J. 43 (2009)

This essay addresses the legitimacy of seizures by the customs authorities of some European Union member states of pharmaceutical products moving in transit through European ports and airports based on patents in force in the transit countries.

A New Dominant Trade Species Emerges: Is Bilateralism a Threat?

Author: 

Frederick M. Abbott

Journal of International Economic Law, Vol. 10, No. 3, pp. 571-583, 2007

Over the past decade, government trade and finance ministries have increasingly turned toward negotiating bilateral and regional trading arrangements, and away from negotiations in multilateral forums like the WTO. There are several reasons for this shift, including changes in the global political environment and negotiating obstacles encountered by the multinational business community at the multilateral level.

Parallel Importation: Economic and Social Welfare Dimensions

Author: 

Frederick M. Abbott

International Institute for Sustainable Development (IISD), Swiss Agency for Development and Cooperation (SDC), June 2007

This paper was prepared at the request of the Swiss Agency for Development and Cooperation for use in dialogue with members of the Swiss Federal Assembly as that legislative body considered proposals to modify Switzerland's law on patents and parallel importation.

World Trade Organization Accession Agreements: Intellectual Property Issues

Author: 

Frederick M. Abbott and Carlos Correa

Quaker United Nations Office Global Economic Issues Publication, May 2007

This paper addresses intellectual property issues that arise in the context of the accession process with a view toward assisting prospective WTO Members involved in negotiations.

China in the WTO 2006: 'Law and its Limitations' in the Context of TRIPS

Author: 

Frederick M. Abbott

in the WTO 2006: 'Law and its Limitations' in the Context of TRIPS (August 30, 2011). WTO LAW AND DEVELOPING COUNTRIES, pp. 59-81, G. Bermann, P. Mavroidis, eds., Cambridge Univ. Press, 2007

China's transition from a statist to market economy over the past 15 years and its successful establishment of globally competitive industry are unprecedented historical events. Although China's entry into the WTO is not responsible for that transformation, it has played an important role. Accession to the WTO was used by the government as a means not only to stabilize access to foreign markets and increase the attractiveness of China to foreign investors but also to reorient internal policies in a way that deemphasized a profound shift in government attitudes.

The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions

Author: 

Frederick M. Abbott and Jerome H. Reichman

Journal of International Economic Law, Vol. 10, pp. 921-87, 2007

The entry into force of the WTO TRIPS Agreement in 1995 transformed the international intellectual property system. Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against restrictive elements of the TRIPS Agreement. Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a ¿net benefit¿ for countries seeking to improve access to medicines.

Patents, Biotechnology and Human Rights: The Preservation of Biodiverse Resources for Future Generations

Author: 

Frederick M. Abbottdownload: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922851 The patenting of biotechnological inventions potentially affects human rights in a number of ways. Human rights to identity and the practice of religion may be affec

in BIOTECHNOLOGIES AND INTERNATIONAL HUMAN RIGHTS, p. 315, F. Francioni, ed., Hart Publishing, 2007

The patenting of biotechnological inventions potentially affects human rights in a number of ways. Human rights to identity and the practice of religion may be affected by the availability of patents on genetically modified human beings (or elements of the human body). Patents as mechanisms for market exclusion affect access to new medicines, including those based on biotechnological innovation. Access to medicines and health care are part of the panoply of human rights.

Intellectual Property Rights in World Trade

Author: 

Frederick M. Abbott

in Research Handbook in International Economic Law 444-84 (A. Guzman & A. Sykes) (Edward Elgar 2007)

Technology has always played a significant role in economic development and the shifting fortunes of nations. Yet when the GATT was established in 1947, very limited attention was paid to 'intellectual property.' This is largelyexplained by the evolution of an international system for the regulation of intellectual property (IP) under the auspices of what today is known as the World Intellectual Property Organization (WIPO). As a subject of international regulation, intellectual property had not been overlooked. In fact, it was perhaps the first element of world trade subject to truly multilateral discipline with the Paris Convention for the Protection of Industrial Property of 1883 and the Berne Convention for the Protection of Literary and Artistic Work of 1886.

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