Eccleston-Turner & Rourke: The TRIPS Waiver is Necessary, but it Alone is not Enough to Solve Equitable Access to COVID-19 Vaccines

Mark Eccleston-Turner (Keele Univ.) & Michelle Rourke (Griffith Univ.) have posted an ASIL Insight on The TRIPS Waiver is Necessary, but it Alone is not Enough to Solve Equitable Access to COVID-19 Vaccines.

Grosse Ruse-Khan: TRIPS to FTAs and Back: Re-Conceptualising the Role of a Multilateral IP Framework in a TRIPS-Plus World

Henning Grosse Ruse-Khan (Univ. of Cambridge - Law) has posted From TRIPS to FTAs and Back: Re-Conceptualising the Role of a Multilateral IP Framework in a TRIPS-Plus World (Netherlands Yearbook of International Law, forthcoming). Here's the abstract:

International intellectual property (IP) protection is increasingly governed by a network of bilateral and regional treaties. Most of these contain obligations on the protection and enforcement of IP that set significantly higher standards than those of the TRIPS Agreement, commonly referred to as ‘TRIPS-plus’. Human rights bodies, NGOs, and academic commentators often criticise these standards for undermining flexibilities available under TRIPS. Such policy space, however, is critical to design national IP laws in light of domestic needs. This chapter makes a case for the continued relevance of the TRIPS Agreement as an overarching, multilateral framework. My argument is based on the role treaty law affords to the object and purpose expressed in Articles 7 and 8 TRIPS. They have not only been recognised as essential for promoting access to medicines in the Doha Declaration on TRIPS and Public Health. As integral objectives and principles of TRIPS, Articles 7 and 8 limit the ability of WTO Members to modify their IP-related treaty obligations inter se. Based on their negotiation history and common understandings expressed by WTO Members, I argue for an enhanced role of TRIPS’ object and purpose as a loose constitutional frame for IP commitments in bilateral and regional treaties.

Gervais: Climate Change, the International Intellectual Property Régime, and Disputes Under the TRIPS Agreement

Daniel J. Gervais (Vanderbilt Univ. - Law) has posted Climate Change, the International Intellectual Property Régime, and Disputes Under the TRIPS Agreement. Here's the abstract:

This study considers intellectual property rules contained in the WTO TRIPS Agreement as they might affect climate change regulatory efforts. The TRIPS Agreement rules that are most directly applicable in this context are patents; confidential information, and enforcement of IP rights before national courts. With respect to patents, the Agreement provides rules on subject matter eligibility and compulsory licensing that may affect which climate-related technologies get patented and how they are applied. The rules concerning confidential information are less precise. The Study then considers how a WTO dispute-settlement panel might apply WTO rules (especially TRIPS) to climate change initiatives that a WTO Member might take.

Land: Adjudicating TRIPS for Development

Molly Land (New York Law School) has posted Adjudicating TRIPS for Development (in TRIPS and Developing Countries: New Perspectives, Gustavo Ghidini et al. eds., forthcoming). Here's the abstract:

This book chapter considers the development impact of the decision to subject the international intellectual property standards established by the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) to the mandatory dispute resolution process of the World Trade Organization (WTO). This decision has had two important consequences for developing countries. First, it has contributed to the creation of a “pro intellectual property climate” in which countries have foregone flexibilities to which they would otherwise be entitled. Second, it has also led adjudicators to miss the unique need for internal balancing associated with intellectual property, resulting in overly restrictive interpretation of TRIPS flexibilities. For the least-developed countries (LDCs), the loss of flexibilities is particularly problematic.

This chapter seeks to revive the special and differential provisions available to developing and LDCs in WTO dispute resolution to counter this loss of flexibilities. Specifically, it recommends using a little-known provision of the Dispute Settlement Understanding, Article 24.1, to benefit LDCs in TRIPS disputes. The chapter argues that Article 24.1 could and should be used in TRIPS disputes to provide LDCs with greater flexibility in implementing their obligations under the treaty, including through a more lenient standard of review, shifting the burden of proof with respect to exceptions and limitations, and requiring injury as part of a prima facie case against an LDC.

Gangjee: Relocating the Law of Geographical Indications

Dev Gangjee (London School of Economics - Law) has published Relocating the Law of Geographical Indications (Cambridge Univ. Press 2012). Here's the abstract:

There is considerable variation in the nature, scope and institutional forms of legal protection for valuable geographical brands such as Champagne, Colombian coffee and Darjeeling tea. While regional products are increasingly important for producers, consumers and policy makers, the international legal regime under the TRIPS Agreement remains unclear. Adopting a historical approach, Dev Gangjee explores the rules regulating these valuable geographical designations within international intellectual property law. He traces the emergence of geographical indications as a distinct category while investigating the key distinguishing feature of the link between regional products and their places of origin. The research addresses long-standing puzzles, such as the multiplicity of regimes operating in this area; the recognition of the link between product and place and its current articulation in the TRIPS definition; the varying scope of protection; and the extent to which geographical indications ought to be treated as a category distinct from trade marks.

Ruse-Khan: The (Non) Use of Treaty Object and Purpose in Intellectual Property Disputes in the WTO

Henning Grosse Ruse-Khan (Max Planck Institute for Intellectual Property and Competition Law) has posted The (Non) Use of Treaty Object and Purpose in Intellectual Property Disputes in the WTO (in Sustainable Development in the Decisions of International Courts and Tribunals 1992-2012, forthcoming). Here's the abstract:

Dispute settlement Panels and the Appellate Body of the World Trade Organization (WTO) have long been criticised for a ‘textual’ approach to treaty interpretation which focuses too much on the ordinary meaning of treaty provisions. Arguably this approach responded to fears of judicial activism and overreach by the judicial bodies which in turn may encroach upon sovereignty and national autonomy of WTO Members. In some decisions however, especially the Appellate Body has taken a more pro-active role, using for example object and purpose of the WTO Agreements to fill gaps and clarify ambiguities. For example in the famous US – Shrimp dispute, the Appellate Body emphasised that the sustainable development objective enshrined in the WTO preamble ‘must add colour, texture and shading to our interpretation of the Agreements annexed to the WTO Agreement’.

This of course includes the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). With its Articles 7 and 8, TRIPS is probably the only WTO Agreement which contains explicit textual expressions of its object and purpose. In the Doha Declaration on TRIPS and Public Health, all WTO Members stressed the importance of these norms for interpreting TRIPS. In substance, they align with the principle of integration and reconciliation of economic, social and environmental objectives. This principle is at the core of the notion of sustainable development as a concept in international law. It has been expressed in the ILA Declaration of Principles of International Law Related to Sustainable Development.

Against this background, one would expect Articles 7 and 8 TRIPS to play a prominent role in WTO dispute settlement related to TRIPS. Anyone familiar with IP-related disputes in the WTO however knows that this is not the case. This paper analyses when and how TRIPS jurisprudence has utilised these norms and tries to offer explanations for their (non) use.

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

Cynthia Ho (Loyola Univ., Chicago - Law) has published Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights (Oxford Univ. Press 2011). Here's the abstract:

Access to medicine is a topic of widespread interest. However, some issues that impact such access are presently inadequately understood. In particular, international laws require most nations to provide patents on drugs, resulting in premium prices that limit access. In Access to Medicine in the Global Economy, Professor Cynthia Ho explains such laws and their impact for a diverse group of readers, from scholars and policy makers to students in a variety of disciplines. This book explains and interprets important international agreements, beginning with the landmark Agreement on Trade Related Aspects of Intellectual Property (TRIPS), but also including more recent free trade agreements and the pending Anti-Counterfeiting Trade Agreement (ACTA). Professor Ho addresses controversial topics, such as when a nation can provide a compulsory license, as well as whether a nation may suspend in-transit generic goods. The book also discusses how patent-like rights (such as "data exclusivity") prevent lower-cost generic medicines from entering into the marketplace and provides strategies for minimizing the harm of such rights. Clear explanations and diagrams, frequently asked questions, and case studies make these topics accessible to any reader. The case studies also provide a theory of patent perspectives that helps explain why access to medicine, though a universal goal, remains elusive in practice. The book aims to provide an important first step toward eventual workable solutions by promoting a better understanding of existing and future laws that impact access to medicine.

Yamane: Interpreting TRIPS: Globalisation of Intellectual Property Rights and Access to Medicines

Hiroko Yamane has published Interpreting TRIPS: Globalisation of Intellectual Property Rights and Access to Medicines (Hart Publishing 2011). Here's the abstract:

Protection of intellectual property rights (IPRs) has become a global issue. The Trade-Related Aspects of Intellectual Property (TRIPS) Agreement outlines the minimum standards for IPR protection for WTO members and offers a global regime for IPR protection. However, the benefits of TRIPS are more questionable in poorer countries where national infrastructure for research and development (R&D) and social protection are inadequate, whereas the cost of innovation is high. Today, after more than a decade of intense debate over global IPR protection, the problems remain acute, although there is also evidence of progress and cooperation.

This book examines various views of the role of IPRs as incentives for innovation against the backdrop of development and the transfer of technology between globalised, knowledge-based, high technology economies. The book retraces the origins, content and interpretations of the TRIPS Agreement, including its interpretations by WTO dispute settlement organs. It also analyses sources of controversy over IPRs, examining pharmaceutical industry strategies of emerging countries with different IPR policies.

The continuing international debate over IPRs is examined in depth, as are TRIPS rules and the controversy about implementing the 'flexibilities' of the Agreement in the light of national policy objectives. The author concludes that for governments in developing countries, as well as for their business and scientific communities, a great deal depends on domestic policy objectives and their implementation. IPR protection should be supporting domestic policies for innovation and investment. This, in turn requires a re-casting of the debate about TRIPS, to place cooperation in global and efficient R&D at the heart of concerns over IPR protection.

Pauwelyn: The Dog that Barked but Didn’t Bite: 15 Years of Intellectual Property Disputes at the WTO

Joost Pauwelyn (Graduate Institute of International and Development Studies) has posted The Dog that Barked but Didn’t Bite: 15 Years of Intellectual Property Disputes at the WTO. Here's the abstract:

Hope as well as fear was running wild when in 1995 the multilateral trading system incorporated the protection of intellectual property (IP) rights. As one author put it, “the [IP] component of the WTO [World Trade Organization] Agreement represented a revolution in international intellectual property law.” This article provides a reality check 15 years after the fact with a particular focus on how the WTO performed in terms of settling IP disputes under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It compares conventional expectations associated with the creation of TRIPS and WTO dispute settlement to (i) the number and types of TRIPS disputes actually filed and decided, (ii) institutional and substantive decisions and interpretations reached by WTO panels and the Appellate Body in their application of the TRIPS agreement and, finally, (iii) the status of implementation of adverse WTO rulings under TRIPS.

The article offers a number of hypotheses that may explain these descriptive results centered on (i) the rather unique features of WTO dispute settlement, (ii) the TRIPS Agreement itself as compared to other trade agreements and (iii) an escalating cycle of IP-skepticism, due in no small part to the hard-line position taken by many IP industries themselves, and culminating in the 2001 Doha Declaration on TRIPS and Public Health which confirmed and slightly expanded TRIPS flexibilities in the context of the access to essential medicines debate.

The core message of this article is that based on 15 years of operation both the hopes and fears traditionally linked to TRIPS and WTO dispute settlement, not just in 1995 but to this day, were and continue to be largely exaggerated. TRIPS as conventionally portrayed by many is in this sense “the dog that barked but did not bite”. A caveat to this core message is, however, that it says something about the role and impact of formal dispute settlement under TRIPS, less about the broader changes brought about by the TRIPS agreement, in particular, sweeping (and often costly) legislative amendments in many developing countries, monitoring through the TRIPS Council and bargaining “in the shadow” of TRIPS both to weaken and to strengthen global IP protection (be it in the Doha Declaration on TRIPS and Public Health, certain preferential trade agreements, WIPO or the WHO).

Gervais: L'Accord sur les ADPIC

Daniel Gervais (Vanderbilt Univ. - Law) has published L'Accord sur les ADPIC (Larcier 2010). Here's the abstract:

La société de l’information et l’économie du savoir et de l’innovation qui la sous-tend reposent sur le droit de la propriété intellectuelle, qui a pour mission de protéger les actifs intangibles produits de la créativité et de l’ingéniosité humaines. Les études les plus récentes montrent que près de 80% des actifs des entreprises des pays les plus industrialisés sont composés de ces intangibles : logiciels, marques et brands, brevets, know-how, secret de fabrique et informations confidentielles. Depuis 1995, un accord de l’Organisation mondiale du commerce (OMC), connu comme Accord sur les ADPIC, contient des normes précises et strictes qui régissent tous les aspects de la protection et de la mise en œuvre des droits de propriété intellectuelle dans les 150 pays membres de l’OMC. Cet Accord encadre les lois nationales et les directives européennes en matière de propriété intellectuelle et est régulièrement utilisé par les tribunaux nationaux (dont la Cour de cassation en France) et la Cour européenne de justice afin d’interpréter les dispositions européennes ou nationales d’une manière compatible avec les règles internationales. Tout étudiant ou praticien de la propriété intellectuelle doit connaître cet important Accord, qui fait dorénavant partie intégrante du droit de la propriété intellectuelle.

Dans la première partie de cet ouvrage, rédigé par un des rares experts à avoir travaillé de l’intérieur à la rédaction et la négociation de l’Accord sur les ADPIC, l’histoire et le contexte de l’Accord sont expliquées en détails, ainsi que les plus récents développements du cycle de Doha, notamment en matière de protection des indications géographiques et les amendements adoptés en matière de santé publique. Dans la seconde, chacun des 71 articles de l’Accord est analysé en profondeur afin d’offrir au lecteur toutes les clés pour comprendre l’Accord. Chaque décision de groupe spécial ou de l’Organe d’appel de l’OMC rendue entre 1995 et 2007 est également explique et mise en contexte. Enfin, les annexes contiennent les dispositions d’autres accords intégrés à l’Accord sur les ADPIC, offrant ainsi au lecteur un guide complet pour bien comprendre et utiliser l’Accord sur les ADPIC.

Gervais: The Google Book Settlement and the TRIPS Agreement

Daniel J. Gervais (Vanderbilt Univ. - Law) has posted The Google Book Settlement and the TRIPS Agreement (Stanford Technology Law Review, forthcoming). Here's the abstract:

The proposed amended settlement in the Google Book case has been the focus of numerous comments and critiques. This “perspective” reviews the compatibility of the proposed settlement with the TRIPS Agreement and relevant provisions of the Berne Convention that were incorporated into TRIPS, in particular the no-formality rule, the most-favored nation (MFN) clause, national treatment obligations, and the so-called three-step test, which constrains the ability of WTO Members to provide new exceptions and limitations to copyright rights.

Helfer & Austin: Human Rights and Intellectual Property: Mapping the Global Interface

Laurence R. Helfer (Duke Univ. - Law) & Graeme W. Austin (Univ. of Arizona - Law) have posted Human Rights and Intellectual Property: Mapping the Global Interface. Here's the abstract:

'Human Rights and Intellectual Property: Mapping the Global Interface' explores the intersections between intellectual property and human rights law and policy. The relationship between these two fields has captured the attention of governments, policymakers, and activist communities in a diverse array of international and domestic political and judicial venues. These actors often raise human rights arguments as counterweights to the expansion of intellectual property in areas including freedom of expression, public health, education, privacy, agriculture, and the rights of indigenous peoples. At the same time, the creators and owners of intellectual property are asserting a human rights justification for the expansion of legal protections.

The book explores the legal, institutional, and political implications of these competing claims in three ways: (1) by offering a framework for exploring the connections and divergences between these subjects; (2) by identifying the pathways along which jurisprudence, policy, and political discourse are likely to evolve; and (3) by serving as a teaching and learning resource for scholars, activists, and students. This pre-publication excerpt contains the table of contents, the Preface, and the Conclusion.

Kapczynski: Harmonization and its Discontents: A Case Study of TRIPS Implementation in India's Pharmaceutical Sector

Amy Kapczynski (Univ. of California, Berkeley - Law) has posted Harmonization and its Discontents: A Case Study of TRIPS Implementation in India's Pharmaceutical Sector (California Law Review, Vol. 97, p. 1571, 2009). Here's the abstract:

In 2005, India amended its patent law to provide product patents on medicines, to comply with the WTO’s TRIPS Agreement. In order to mitigate the impact on access to medicines, India at the same time adopted an expansive menu of flexibilities in its patent law. Reviewing these important flexibilities, some of which are entirely novel, this article argues that at a formal level TRIPS leaves developing countries far more policy space than is commonly recognized. But while TRIPS as a formal matter cannot produce deep harmonization, it nonetheless channels a strong harmonizing force, because it inserts countries into a transnational circuit that fills in the gaps in the Agreement and that works against the use of TRIPS flexibilities. Limits on administrative resources, the influence of transnational legal networks, and the threat of unilateral retaliation from high-protection jurisdictions all make it difficult for countries like India to implement an autonomous vision of patent law.

The paper also identifies compensating strategies that may facilitate the effective use of TRIPS flexibilities, responding to the transnationalized pressures that TRIPS implementation sets up. I call these strategies fragmentation, mimicry, and counter-harmonization. As I demonstrate, counter-harmonization shows the most promise for developing countries, because it offers countries safety in numbers, can lower the administrative costs of implementing an alternative patent law, and can generate a transnational legal counterculture.

Lastly, the paper engages with the literature about the implications of the legalization of the global trading regime. The case study offered here suggests that legalization cannot simply be identified, as some prominent trade law scholars have argued, with the substitution of politics for principle, and with the leveling of power differences between states. It also suggests a new perspective on the debate over whether the WTO has a “constitutional” form, and if so, what this means. To date, those who claim a constitutional nature for the WTO have identified that nature with a move beyond politics. The analysis offered here suggests that if the WTO has a constitutional nature, it lies in its capacity to mobilize and channel, rather than to suppress or transcend, political disagreement.

Dreyfuss: The Role of India, China, Brazil and Other Emerging Economies in Establishing Access Norms for Intellectual Property

Rochelle Dreyfuss (New York Univ. - Law) has posted The Role of India, China, Brazil and Other Emerging Economies in Establishing Access Norms for Intellectual Property and Intellectual Property Lawmaking. Here's the abstract:

This paper discusses the role that emerging economies could play in rendering intellectual property law and lawmaking more responsive to changing conditions. At present, neither the North nor the South is likely to challenge the accommodations made in the TRIPS Agreement. In the North, the politics of change is complex; the South largely lacks expertise. But emerging economies have the political will to improve access to the world’s intellectual output on behalf of their poorest citizens. At the same time, they have growing creative sectors and thick legal and political cultures, capable of striking new and imaginative balances between proprietary and access interests. Because the goals of these economies are best served by partnering with least-developed countries and members of civil society interested in IP issues, these nations also have an incentive to improve another type of access norms — norms of participation, fairness and transparency in international lawmaking. These nations are, in other words, in a unique position to contribute to the reforms that are the cornerstone of the global administrative law agenda.

Kumar: Freedom of Transit and Trade in Generic Pharmaceuticals

Shashank Kumar (National Law Univ., Jodhpur) has posted Freedom of Transit and Trade in Generic Pharmaceuticals: An Analysis of EU Border Enforcement Law and Implications for the International Intellectual Property Regime (European Intellectual Property Review, forthcoming). Here's the abstract:

A recent dispute involving the suspension of release of a consignment of generic drug in transit from India to Brazil by Dutch Customs raises some important issues for the future of the international intellectual property regime. The dispute is only too timely as some countries resort to bilateralism and Free Trade Agreements for extending intellectual property protection beyond the minimum contained in TRIPS. It provides a classic stage for studying the conflict of interests between developing and developed countries on the issues of access to medicine and standard of protection, and thus deserves closer and independent scrutiny of facts and law. On a cursory glance EC Regulation 1383, which provides for border enforcement of rights in cases of patent infringement, seems to be in consistence with the TRIPS Agreement. A closer analysis, however, reveals that the law, in providing for a TRIPS-Plus standard of protection, may run afoul of Part III, Section IV of the TRIPS Agreement. This conclusion, however, rests on a contextual interpretation, which as this work argues, is provided by the Doha Declaration on Public Health and TRIPS and the subsequent Decision to implement paragraph 6 of the Declaration.

The analysis deals with the interpretation of Articles 51 and 52 of the TRIPS Agreement besides addressing the possibility of using the language of the Agreement itself as providing “ceilings” for maximum protection. The work offers some policy and symptomatic recommendations, but, and perhaps more importantly, shows how the incident serves as another litmus test for testing the efficacy of the intellectual property regime under the TRIPS and the promise of a “balance” the Doha Declaration had promised.

New Volume in the Max Planck Commentaries on World Trade Law

A new volume has been published in the Max Planck Commentaries on World Trade Law (Maritinus Nijhoff Publishers): WTO - Trade-Related Aspects of Intellectual Property Rights, edited by Peter-Tobias Stoll, Jan Busche, & Katrin Arend.

Yusuf & Correa: Intellectual Property and International Trade: The TRIPS Agreement (Second Edition)

Abdulqawi A. Yusuf (UNESCO) & Carlos M. Correa (Univ. of Buenos Aires) have published the second edition of Intellectual Property and International Trade: The TRIPS Agreement (Wolters Kluwer 2008). Here's the abstract:

Now into its second decade, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) continues to meet challenges raised by ongoing technological changes as it affirms an increasing degree of latitude to national authorities in its implementation. Important developments and controversies witnessed in the nine years since the first edition of this much-welcomed treatise include issues of public health, implications of the Agreement on the realization of human rights, and continuous debates on geographic indications and the appropriation of genetic resources. This second edition incorporates the analysis of key provisions of the Agreement resulting from dispute settlement procedures under WTO rules.

Arup: The World Trade Organization Knowledge Agreements

Christopher Arup (Monash Univ. - Business Law and Taxation) has published the second edition of The World Trade Organization Knowledge Agreements (Cambridge Univ. Press 2008). Here's the abstract:

The WTO intellectual property and services agreements (TRIPs and GATS) form the global legal framework in which governments now regulate trade in knowledge. This second edition analyses the provisions of the agreements and examines closely the thirteen years of implementation and revision. Gathering together the interpretations placed on the agreements by the WTO dispute settlement bodies, it reports on the initiatives taken by the members both to liberalise trade in knowledge and to shape international business regulation. Drawing on this, Christopher Arup assesses the future of the WTO as a global law-making institution. Three expanded case studies (legal services, genetic codes/essential medicines, and on-line media) illustrate the impact of the agreements and highlight the challenges faced by the WTO in reconciling free trade with social regulation.