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Compulsory Licenses under TRIPS: An Introduction

Cynthia M. Ho

in Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights

This chapter aims to bring clarity to the contentious and confusing question of what types of compulsory licenses are permissible under TRIPS. It first clarifies the actual TRIPS rules on compulsory ... More

This chapter aims to bring clarity to the contentious and confusing question of what types of compulsory licenses are permissible under TRIPS. It first clarifies the actual TRIPS rules on compulsory licenses and, in particular, distills the dozen complex provisions regarding compulsory licensing into more logical categories for explanation. It also provides an illustration of how a country can craft a compulsory licensing law to promote access to medicine while simultaneously complying with TRIPS. The chapter concludes with a discussion of issues beyond the scope of TRIPS that countries must consider in connection with the benefits and costs of issuing compulsory licenses. It provides an essential background to understanding a procedure involving a “waiver” of one of the usual TRIPS requirements to help provide low-cost drugs to poor countries.Less

Intellectual Property and Health in Developing Countries

Jean Tirole

in Understanding Poverty

This essay focuses on the impact of intellectual property rights (IPRs) on low- and middle-income countries’ health care. There are two different reasons why poor countries may not have access to ... More

This essay focuses on the impact of intellectual property rights (IPRs) on low- and middle-income countries’ health care. There are two different reasons why poor countries may not have access to needed vaccines and drugs. In the case of global diseases, such as diabetes or cancer, patents may hinder the diffusion of pharmaceuticals. In the case of neglected or tropical diseases, such as malaria, tuberculosis, and leishmaniasis, the corresponding vaccines or drugs are not developed because of low profitability due to the poverty of potential customers. The important role of compulsory licensing for low- and middle-income countries is discussed.Less

Compulsory License Case Study: An Introduction to Competing Patent Perspectives

Cynthia M. Ho

in Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights

This chapter builds upon the basic rules for compulsory licenses under TRIPS (Chapter 5) and also provides a complementary examination of compulsory licenses. It introduces competing patent ... More

This chapter builds upon the basic rules for compulsory licenses under TRIPS (Chapter 5) and also provides a complementary examination of compulsory licenses. It introduces competing patent perspectives; it provides a case study of Thailand's recent compulsory licenses to explain some of the confusion and controversy concerning them. In particular, the lens of competing perspectives is used to provide an enriched understanding of why there has been so much confusion concerning compulsory licensing. In addition, this introduction to competing patent perspectives constructs a framework for subsequent chapters that revisit how such perspectives have played a role in issues involving access to medicine.Less

Complicated Compulsory Licenses: The Waiver/Article 31bis “Solution”

Cynthia M. Ho

in Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights

This chapter explains an important, yet often misunderstood exception to the TRIPS requirement that a compulsory license must be issued predominantly for domestic use (except where issued to address ... More

This chapter explains an important, yet often misunderstood exception to the TRIPS requirement that a compulsory license must be issued predominantly for domestic use (except where issued to address anticompetitive conduct). It assumes an understanding of the usual compulsory licensing requirements addressed in Chapter 5 and builds upon it. The WTO Council has created an official waiver (“the Waiver”) of the usual domestic use requirement to help countries export low-cost generic drugs made under a compulsory license to predominantly poor countries. The chapter explains when the Waiver is relevant, as well as the additional requirements necessary to use it beyond those that apply to all compulsory licenses. It ends with an evaluation of the effectiveness of the Waiver in achieving its intended purpose.Less

The WIPO Development Agenda in an Historical and Political Context

Pedro Roffe and Gina Vea

in The Development Agenda: Global Intellectual Property and Developing Countries

This chapter traces the chain of events and political debate surrounding the evolution of the international intellectual property (IP) architecture from the establishment of the Paris Convention in ... More

This chapter traces the chain of events and political debate surrounding the evolution of the international intellectual property (IP) architecture from the establishment of the Paris Convention in the 19th century, to reform efforts by developing countries in the 1970s, and the recent initiative in WIPO on a Development Agenda. It illustrates that tensions around striking an appropriate balance between public interests and private rights have persisted since the inception of the IP system. Furthermore, it shows that the establishment of the Paris Convention was the result of a strategic compromise between those who wanted to promote the recognition of patents beyond national boundaries, and those who feared that outright protection of foreign inventions might hamper local industrialization. Countries have continued to grapple with IP and development through the five revision conferences of the Paris Convention, waves of national reforms and attempts to rebalance the international IP system, the advent of the TRIPS Agreement, and finally the adoption of the WIPO Development Agenda.Less

Trips Patent Regime: The Poverty Penalty

Srividhya Ragavan

in Patent and Trade Disparities in Developing Countries

This chapter discusses the issue of access-to-medication in developing countries. It notes that these developing countries have struggled to balance patent rights with the issue of ... More

This chapter discusses the issue of access-to-medication in developing countries. It notes that these developing countries have struggled to balance patent rights with the issue of access-to-medication. India and Brazil, for example, have formed detailed compulsory licensing provisions, which are continually questioned by the more developed signatories of TRIPS. It then determines if and how developed countries provided access to medication to the marginalized, and studies the concept of patent balancing and the issue of price control of prescription drugs.Less

Compulsory Licensing: Local Working in Global Economy

Feroz Ali

in The Access Regime: Patent Law Reforms for Affordable Medicines

The shift from working models of inventions to written disclosures allowed patentees to license inventions solely on the basis of the written specification that passed muster at the patent office. ... More

The shift from working models of inventions to written disclosures allowed patentees to license inventions solely on the basis of the written specification that passed muster at the patent office. Harmonization of patent laws across nations allowed patentees to be practising entities in one country and non-practising entities in another. This chapter addresses how compulsory licences solve the problem of picketing patents—patents that are not worked locally. The aspect of patents as negative rights and the concept of working of the patent are explored. This chapter further examines the identification and classification of various types of compulsory licences and details the provisions in the TRIPS that allow for the grant of such licences. An examination of India’s first compulsory licence is followed by an explanation of the features that set apart a market-initiated compulsory licence.Less

The Great Patent Grab

Jonathan M. Barnett

in The Battle over Patents: History and Politics of Innovation

From the late 1930s through the 1970s, the US innovation economy operated under a weak patent regime. This patent-skeptical climate was best illustrated by antitrust enforcement actions resulting in ... More

From the late 1930s through the 1970s, the US innovation economy operated under a weak patent regime. This patent-skeptical climate was best illustrated by antitrust enforcement actions resulting in the compulsory licensing of leading US firms’ patent portfolios. Concurrently, the federal government instituted an implicit compulsory licensing regime through a dramatic infusion of R&D funding into the private sector, accompanied by constraints on firms’ legal exclusivity over technology developed using those funds. The US economy exhibited robust innovation activity for part of this period, followed by a slowdown commencing in the mid-1960s. During this period, R&D funding flowed mostly to large firms, market concentration remained high, and firms targeted by compulsory licensing generally maintained market leadership. The postwar regime of weak patents and public subsidies favored larger firms that could capture returns on innovation through vertically integrated structures and access to government funding. Case studies of two firms targeted by compulsory licensing suggest that this regime may have distorted organizational structures and the mix of innovation projects that were undertaken.Less

Unilateral Refusal to License Patents— A Theoretical Perspective

Thomas K. Cheng

in The Patent-Competition Interface in Developing Countries

This chapter examines the various theoretical issues raised by competition regulation of unilateral refusal to license and compulsory licensing. It begins by clarifying that the unilateral refusal to ... More

This chapter examines the various theoretical issues raised by competition regulation of unilateral refusal to license and compulsory licensing. It begins by clarifying that the unilateral refusal to deal doctrine is usually applied to patented input or product, while the essential facilities doctrine has greater salience in the context of technology licensing. The chapter surveys the various theories of harm for the two doctrines, including enhancement of entry barriers, facilitation of price discrimination, foreclosure of downstream competition, and creation of effective exclusivity. It then addresses the various critiques that have been launched against both doctrines, challenging the conventional wisdom that compulsory licensing undermines innovation incentives. Finally, the chapter considers some of the critiques directed specifically at the essential facilities doctrine and rejects the argument that the doctrine should be inapplicable to intellectual property.Less

Public Policies to Stimulate Development of Vaccines for Neglected Diseases

Michael Kremer

in Understanding Poverty

This essay focuses on the impact of intellectual property rights (IPRs) on low-and middle-income countries’ health care. There are two different reasons why poor countries may not have access to ... More

This essay focuses on the impact of intellectual property rights (IPRs) on low-and middle-income countries’ health care. There are two different reasons why poor countries may not have access to needed vaccines and drugs. In the case of global diseases, such as diabetes or cancer, patents may hinder the diffusion of pharmaceuticals. In the case of neglected or tropical diseases, such as malaria, tuberculosis, and leishmaniasis, the corresponding vaccines or drugs are not developed because of low profitability due to the poverty of potential customers. The important role of compulsory licensing for low- and middle-income countries is discussed.Less

A New Approach to the Compulsory License Conundrum

Cynthia M. Ho

in Patent Law in Global Perspective

This chapter addresses the controversial topic of compulsory licenses by considering the international legal framework in conjunction with insights from social science research. The chapter suggests ... More

This chapter addresses the controversial topic of compulsory licenses by considering the international legal framework in conjunction with insights from social science research. The chapter suggests that there are different perspectives of patent policies which serve as “schemas” through which the same facts or law are viewed differently. This chapter explains and illustrates these schema to provide an explanation for some seeming misrepresentations even by scholars. This approach provides a fresh examination of a contentious topic and also may help provide insights into other areas where patent law and policy are in tension with public health or other social policy objectives.Less

What’s Good for Us is Good for You: The Transnational Pharmaceutical Sector and Mexico’s Internationalist Patent System

Kenneth C. Shadlen

in Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America

This chapter analyses the political economy of continuity in Mexico. High levels of patenting and accentuated transnational dominance of the pharmaceutical industry, both functions of the choices of ... More

This chapter analyses the political economy of continuity in Mexico. High levels of patenting and accentuated transnational dominance of the pharmaceutical industry, both functions of the choices of the 1990s, created an environment that was inhospitable to efforts to reform the new pharmaceutical patent system. The chapter examines a set of revisions to the new pharmaceutical patent regime in the 2000s, all of which were resolved to the benefit of patent-holders seeking greater rights of exclusion. The analysis demonstrates that persistent over-compliance was not because of Mexico’s obligations under NAFTA, but rather despite the opportunities for tailoring that were allowed by this agreement. Within-case comparative analysis offered by these case studies provides variation on the preferences of health officials in the Mexican Executive, the interests and strategies of the local pharmaceutical sector, Mexico’s sensitivity to external pressures, yet the outcomes were similar, as a result of Mexico’s changed social structure.Less

Multilateral Agreements and Policy Opportunities

Carlos M. Correa

in Intellectual Property Rights: Legal and Economic Challenges for Development

The multilateral rules on intellectual property rights set out by the TRIPS Agreement limit the WTO members’ room to use foreign protected technologies for local production. However, governments ... More

The multilateral rules on intellectual property rights set out by the TRIPS Agreement limit the WTO members’ room to use foreign protected technologies for local production. However, governments retain certain policy space under said Agreement to promote local production. They may adopt exceptions to patentability, and rigorously define the concept of ‘invention’ and of inventive step. They may also implement a broad experimentation exception to facilitate ‘inventing around’, the acquisition of voluntary or compulsory licenses, and legal challenges against invalid patents. Compulsory licenses for failure to work a patent or for ‘refusal to deal’ may also open the necessary space for local production in various industries.Less

Patents, Copyright, and Neighboring Rights

in No Law: Intellectual Property in the Image of an Absolute First Amendment

This chapter presents a comparison of copyright and patent law in terms of their constitutional origins, originality, term limits, subject matter, securing protection, and exclusive rights and nature ... More

This chapter presents a comparison of copyright and patent law in terms of their constitutional origins, originality, term limits, subject matter, securing protection, and exclusive rights and nature of infringement. It also discusses protectionist tendencies in copyright, fair use in copyright, the compulsory license, the question of property in copyright and patent law, and moral rights and the public domain.Less

Patent Policy in the Shadows of Over-Compliance: Neo-Developmentalism in Brazil

Kenneth C. Shadlen

in Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America

Brazil altered course in the second period of patent politics, as successive governments introduced revisions to the new patent system to address the consequences of over-compliance in the 1990s. ... More

Brazil altered course in the second period of patent politics, as successive governments introduced revisions to the new patent system to address the consequences of over-compliance in the 1990s. This chapter examines the complementary steps taken to revise how the patent regime functions, including reforms to the compulsory licensing provisions and a new system for examining pharmaceutical patent applications, along with innovation–industrial policy measures to help local firms acquire new production capabilities and adjust to the new status quo of pharmaceutical patents. The chapter examines the political economy of both dimensions of Brazil’s “neo-developmental” response. The analysis shows how these two dimensions of policy have created distinct and rival sets of interests regarding the role of pharmaceutical patents in development, and how these conflicting interests create challenges for a government intent on balancing the dual objectives.Less

TRIPS and TRIPS-Plus Development in India

Reddy T Prashant

in Intellectual Property, Trade and Development

This chapter traces the development of India’s patent and copyright policy over the last sixty years. Shortly after independence, India replaced its British-era copyright and patent legislation with ... More

This chapter traces the development of India’s patent and copyright policy over the last sixty years. Shortly after independence, India replaced its British-era copyright and patent legislation with new laws which significantly whittled down the standards of IP protection. In the 1970s, India had led a developing countries effort to renegotiate standards of copyright protection under the Berne Convention. In the run up to TRIPs, India again led a developing countries effort to dilute the impact of patent standards demanded under TRIPS. While India appears to not have gained much from its partial victories to dilute the Berne Convention, it has had more success in shielding itself from the impact of TRIPS. Most interestingly, the last few decades demonstrate how India’s compulsory licensing provisions in both copyright and patent law have largely failed despite the fact that India made compulsory licensing the central theme in its international treaty negotiations.Less

CCR5 and HIV/AIDS Diagnostics and Therapeutics

Myles W. Jackson

in The Genealogy of a Gene: Patents, HIV/AIDS, and Race

In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the ... More

In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the subject of biomedical research on chemokine receptors and is entangled in the complex political, social, and biomedical lineages of HIV/AIDS with Big Pharma playing the lead role. The gene’s genealogy has been humanized and inextricably linked to the lives of the tens of millions infected worldwide. Once again, intellectual property issues resurface. HIV/AIDS diagnostic tests and medications have been patented by Big and Small Pharma alike, and the ramifications of those patents have been felt worldwide, including India, where attempts are underway to create generic drugs, which bind to the HIV-co-receptor.Less

The Political Economy of Pharmaceutical Patents

Kenneth C. Shadlen

in Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America

The chapter provides brief introductions to intellectual property, patents, and pharmaceuticals to help the reader understand the nature of the enduring conflicts in this area. Prior to the 1990s few ... More

The chapter provides brief introductions to intellectual property, patents, and pharmaceuticals to help the reader understand the nature of the enduring conflicts in this area. Prior to the 1990s few developing countries granted patents on pharmaceutical products, but changes in the global politics of intellectual property made doing so obligatory – the starting point for the analyses in this book. The chapter reviews the policy challenges that countries addressed in deciding how to introduce pharmaceutical patents and then in revising their new patent systems, and then presents the explanatory framework to account for cross-national and longitudinal variation. National forms of compliance with global changes are iterative and path-dependent processes, in that there are successive episodes of conflict, and the policy choices of one period exert influence on the policy choices in subsequent periods. Degrees of over-compliance with the new global order are produced through resolution of these two sets of conflicts.Less