TRIPS Council Research Articles

Temporary Waiver of Patent Rights in Public Health Emergencies: Inadequacy of Provisions during the COVID-19 Crisis

Abstract After more than two decades of disagreement relating to the affordability of drugs against the HIV/AIDS crisis, particularly in developing countries, the outbreak of the COVID-19 pandemic is now another global public health crisis with the desperate need for pharmaceutical and medical products for a public health emergency. The COVID-19 outbreak has again highlighted the question of how to balance patent protection with the need to ensure access to, and affordability of medicines as a corollary of the right to life, during a public health emergency. In October 2020, India and South Africa submitted an application to the WTO TRIPS Council for the temporary waiver of intellectual property protection on pharmaceutical and medical products. The aim of this application is to facilitate the importation of medical products, by developing countries seeking to do so, in response to the pandemic. This waiver application accounts for the considerable difficulties developing and least developed countries are facing in using the compulsory licensing system to import pharmaceutical products for the pandemic. The COVID-19 pandemic has challenged the principles of ‘multilateralism’ and its institutions by reintroducing ‘nationalism’ to international trade regulation. This analysis relies on existing literature to illustrate the problem under investigation. The key findings in the analysis include among others the rejection of patent protection waiver and the limitations of patent rights protection to the needs of public health emergencies. The analysis ends with a conclusion and some recommendations.

COVID-19 Vaccines as Global Common Goods: An Integrated Approach of Ethical, Economic Policy and Intellectual Property Management

Abstract The article deals with the current debate about COVID-19 Vaccines as global public/common goods. After a brief introduction on the global epidemiological and economic implication of the pandemic, the problem of the correct characterization of either vaccine or immunization/herd immunity as global public/common good, according to the necessary characteristics outlined by the pertinent economic theories, is addressed. The conclusion is that the term “global public good”/global common goods” has been extensively used in the last two years by policy makers, political leaders, academics, economists, international organizations, NGOs and others health groups, in a sort of “loose way”. Substantially, in order to underscore that equitable access to health products, including vaccines, health and biomedical technologies, medical services, medical devises, whose availability, accessibility, acceptability, affordability to the world is fundamental to tackling the pandemic. The current legal proprietary regime applied to vaccines, extensively covered by IPRs, has transformed an intrinsically non-excludable common/public good (the vaccines, due to their nature and characteristics) in something excludable and rival in consumption. Consequently, the article argues that what is needed is a swift in their legal governance. The current legal discipline of vaccines and health technologies must be changed to bring it into line with the non-excludable nature of these goods. The richest countries in the world, in pursuit of their “vaccine nationalisms”, have already collectively preordered 8.8 billion doses of vaccine, far in excess of need, thus obliging billions of people in the Global South to wait years to be vaccinated. In this respect, the article investigates the EU vaccines strategy and analyzes the Advanced Purchase Agreements signed by the European Commission with the major vaccine producers, enlightening the untenable secrecy and opacity with which the European Union’s executive has handled COVID-19 vaccine supply contracts, and how it has simply paid no more than lip-service to the concept of global common/public good by attributing a broad “private governance” to the pharmaceutical companies. Then, the various arguments, for and against, the Waiver Proposal to several sections of the WTO TRIPS agreement, introduced by India and South Africa on the TRIPS Council on October 2020, have been briefly summarized, accounting the current luck of needed consensus among the various members of the WTO. The article however describes an important number of new global and collaborative efforts already put in place by a myriad public and private actors to allow efficient development and production of vaccines in order to enhance a global access to vaccines. The article concludes by stressing the major developments in the U.S. patent’s landscape and in the Biden Administration’s attitude towards the current global health crisis, that leave hope for “extraordinary measures” to be agreed by the international community in near future. The auspice is that the time has finally arrived for the international community to develop reliable and long term solutions to tackle future global pandemic, preferably by the negotiation of a new WHO global health treaty, to secure universal fair access to essential technologies and vaccines and protecting them as global public/common goods.

‘No-one is Safe Until Everyone is Safe’ – Patent Waiver, Compulsory Licensing and COVID-19

Recent months have seen intensified global calls for an intellectual property waiver of COVID-19 related vaccines, treatments and related products. Where one side of the debate elevates Intellectual Property Rights as on obstacle to affordable and expeditious global access to vaccines and treatments, the other side of the debate points to the existing TRIPS flexibilities such as compulsory licensing, the necessity of Intellectual Property Rights for future innovation as well as other factors such as manufacturing capacity and know-how being of greater importance. This dualistic approach risk ignoring the manifold law, economics, and policy nuances inherent in the intersection of intellectual property law and Right-to-Health, as well as innovation and health policy. A balanced approach guided by real world indicators regarding law and economics of pharmaceutical innovation, procedural feasibility of compulsory licensing and legal applicability of an IPR waiver is needed. Thus, the key to understanding the current debates lies in a holistic approach to ratio legis of intellectual property rights, innovation policy and health policy. The innovation inducing facets of monopoly rights, and interconnected monopoly profits, need to be balanced against public policy rationales such as Right-to-Health, but also against the ratio legis of IPRs, which focuses on maximizing societal welfare. After the introduction framing the background regarding unequitable global access to COVID-19 vaccines and treatments paving the way to the current debates on patent waiver and compulsory licensing, the Article proceeds as follows. Section II briefly sketches the main contours of the debate on right-to-health and intellectual property rights from a law and policy perspective. Section III details the legal, historical and procedural background of international codification of patents and the compulsory licensing instrument within the TRIPS agreement, as well some instances of compulsory licensing during COVID-19. Section IV recounts the patent waiver proposal at TRIPS Council and the arguments for and against the proposal. Section V concludes with some law and policy reflections on the balance between Right-to-Health, intellectual property rights and innovation policy.

Geneva Rhetoric, National Reality: The Political Economy of Introducing Plant Breeders' Rights in Kenya

The article is about implementing obligations under Article 27.3(b) of the Agreement on Trade Related Aspects of Intellectual Property (TRIPS). However, concerned with the fragmentation of international law in a globalised world, the article uses Kenya as a case study to interrogate the apparent choice and latitude in Article 27.3(b). At the TRIPS Council, Kenya has sought to locate Article 27.3(b) within a wider frame by adroitly norm-borrowing, and it canvassed for integrating norms and principles from other multilateral agreements into TRIPS. Yet, when introducing plant breeders' rights into domestic law, Kenya fails to either explore the apparent latitude or deliver on its rhetoric in Geneva. I explain this decoupling between Geneva rhetoric (ritual) and domestic law (behaviour) as another symptom of what Steinberg [(2002), ‘In the Shadow of Law or Power? Consensus-Based Bargaining and Outcomes in the GATT/WTO’, International Organization, 56 (2), pp. 339–74)] characterises as ‘organised hypocrisy’ of the World Trade Organisation. In demonstrating that fragmentation in global legal architecture may not automatically emerge in domestic law, the article draws out the significance of attending to a domestic political economy of law-making.

Tobacco giant sues the Australian Government

The tobacco company Philip Morris launched legal action on Nov 21, 2011, against the new Australian law enforcing that tobacco products must be sold in plain packaging, effective from Dec 1, 2012. The legislation consists of two bills: the Tobacco Plain Packaging Bill 2011 and Trade Marks Amendment (Tobacco Plain Packaging) Bill 2011. Philip Morris stated that they are taking legal action as “the government has passed this legislation despite being unable to demonstrate that it will be effective at reducing smoking and has ignored the widespread concerns raised in Australia and internationally regarding the serious legal issues associated with plain packaging”. The company also argues that the legislation will encourage counterfeiting of their products. Cigarettes and plain packaging: the battle lines are drawnOn July 6, 2011, Australia became the first country to send a bill to their parliament on plain packaging for cigarettes. The legislation aims to reduce the number of current and new smokers by increasing the effectiveness of the health warnings and also by reducing the appeal of the product. If voted through, and it has cross-party support, the legislation will be enacted next year. As expected, even before the announcement, a counter-offensive had been launched by the tobacco industry. The legislation has been referred to the TRIPS council and the Technical Barriers to Trade committee in the World Trade Organisation (WTO) in an intellectual property rights battle, but rather than being headed-up by the tobacco companies, this move is spearheaded by low-income and middle-income countries. Full-Text PDF Australia to be first country to use plain cigarette packagingEarly in April, Australia's Federal Health Minister, Nicola Roxon, announced plain packaging of all cigarettes from July, 2012, removing one of the last opportunities of tobacco companies to advertise their brand. Cigarettes from all manufacturers will be packaged in the same olive green packet. Huge health warnings will dominate each side, with the brand name in standard font on the front. “Cigarette packs will now only show the death and disease that can come from smoking”, says Roxon. “The new packs have been designed to have the lowest appeal to smokers and young people, and to make clear the terrible effects that smoking can have on your health.” Full-Text PDF

Cigarettes and plain packaging: the battle lines are drawn

Cigarettes and plain packaging: the battle lines are drawn

Protection of Bio-Cultural Property in the Cradle of Traditional Knowledge

Human communities have always generated, refined and passed on knowledge from generation to generation. Such “traditional” knowledge” is often an important part of their cultural identities. Traditional knowledge encompasses the beliefs, knowledge, practices, innovations, arts, spirituality, and other forms of cultural experience and expression that belong to indigenous communities worldwide. Since the adoption of the Universal Declaration of Human Rights in 1948, intellectual property has been considered a fundamental human right of all people. Only recently, however, has the need to protect, preserve and provide for the fair use of indigenous intellectual property ‘traditional knowledge’ entered the domestic and international debate on intellectual property rights. Non-indigenous groups, such as corporations, have been exploiting the traditional knowledge that has been developed by indigenous beings over centuries. However, the international community has sought to recognize and protect such traditional knowledge. Many developing countries, holders of traditional knowledge, and campaigning organizations are pressing in a multitude of fora for traditional knowledge to be better protected. Such pressure has led, for example, to the creation of an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in WIPO. Such knowledge and folklore is also being discussed within the framework of the CBD and in other international organizations such as UNCTAD, WHO, FAO and UNESCO. In addition, the Doha WTO Ministerial Declaration highlighted the need for further work in the TRIPS Council on protecting traditional knowledge.

Traditional knowledge, the CBD and the TRIPS regime: synthesising the discordant discourses at the WTO

This paper evaluates the discussions in the WTO on the issues of Traditional Knowledge, the CBD and the TRIPS. A highly textual and an equally teleological interpretation of the TRIPS and the CBD by WTO members has led to arguments that characterise their relationship as either being in mutual harmony or conflict. I submit that much of this inconclusive exercise is unnecessary and can be overcome if the TRIPS is expressly amended to provide for CBD requirements. The paper tries to amalgamate the best from the various approaches to suggest a model regime for TK protection. It recommends that the implementation process be monitored by the TRIPS Council, obliging states to report whenever appropriate and for periodical review of the provisions.

The status of WTO non-members: A review in light of the 6 December 2005 proposed amendment to the TRIPs Agreement

On 6 December 2005 the General Council of the World Trade Organization (WTO) approved a proposed amendment to Article 31 of the Agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS Agreement), to be proposed as amendment Article 31bis. The proposed amendment, which remains open for acceptance by Members until 1 December 2007, is the culmination of at least four years of debate within the WTO and more years of incessant campaign in other circles. The proposed amendment endorses a General Council decision (30 August 2003), which was drafted in response to Paragraph Six of the 14 November 2001 Ministerial Conference Declaration on the TRIPS Agreement and Public Health, instructing the TRIPS Council to ‘find an expeditious solution’ to the long-debated conflict between patent rights to drugs and the right of victims of public health crises to have affordable access to drugs.

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

On November 14,2001, the Ministerial Conference of the World Trade Organization, meeting in Doha, Qatar, adopted the Declaration on the TRIPS Agreement and Public Health (Doha Declaration). The declaration affirms that the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all,” and it reaffirms that the Agreement “provide[s] flexibility for this purpose.” The Doha Declaration mandated further negotiations on one important subject, providing in its paragraph 6: “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem … .“

Bioprospecting or Biopiracy?

“We instruct the Council for Trips, in pursuing its work programme… to examine… the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore and other relevant new developments… In undertaking this work, the Trips Council… shall take fully into account the development dimension.”Paragraph 19, Doha Ministerial Declaration.1

La brevetabilité dans les récents traités de libre-échange américains

INTERNATIONAL PATENT REGIME IN RECENT FREE TRADE US INTERNATIONAL AGREEMENTS The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the World Trade Organization (WTO) is no longer the « new frontier » of the international patent regime. Indeed, the United States and other developed countries negotiate bilateral « TRIPs-plus » treaties with developing countries. Arguably, bilateralism allows to bypass the dead-end debates at the TRIPs Council and to build alliances for upcoming multilateral negotiations at the World Intellectual Property Organization. This article compares patentability provisions of the recentlyconcluded U.S. Free Trade Agreements with the TRIPs Agreement. Although most of the provisions of the TRIPs Agreement are integrated in bilateral treaties, we identify five significant changes : 1) bilateral treaties provide a 12 months grace period to inventors ; 2) the industrial application requirement is defined has a « specific, substantial, and credible utility » ; 3) a ceiling to the disclosure requirement is introduced ; 4) the plant protection regime is reinforced ; 5) the non-discrimination rule is omitted. Our comparative analysis shows that bilateralism allows the US to consolidate existing multilateral treaties, such as the TRIPs Agreement and the UPOV Convention, and to fortify its negotiating position for future multilateral treaties, such as the WIPO Substantive Patent Law Treaty. The new features of bilateral treaties indicate that the international patent regime is still oriented through the US patent law model.

Information Feudalism: Who Owns the Knowledge Economy?

1 Introduction: Why Information Feudalism'? * The Risks * Health-Hell in Africa * Why Sign TRIPS? * Efficiency * Freedom, Democracy and Intellectual Property * Overview. 2 Piracy: Cultural Trespassers * 'A pyrate and a rover on the sea' * Intellectual Property Piracy * A Little Intellectual Property History. 3 The Knowledge Game: Knowledge Profits * Laboratories of Knowledge * Patent Locks on Public Goods * Patent Locksmiths - the Patent Profession * Global Knowledge Cartels * The Knowledge Game * The Changing Knowledge Game. 4 Stealing from the Mind: Messages * Last Rites * The Problems * Pfizer's World of Ideas * Getting on Committees. 5 The Illusion of Sovereignty: Sovereign Poverty * Most wanted * The Caribbean. 6 The Bilaterals: The Trade Defence Initiative * The US Generalized System of Preferences * Section 301 * Designers, Lobbyists and Petitioners * Pinocchio's Nose * The Wolf at the Door. 7 Agendas and Agenda-setters - The Multilateral Game: The GATT * The WIPO Talkshop * Getting Intellectual property on the Trade Agenda: the Quad and the IPC * Punta del Este * 8 Persuasion and Principles Becoming a Community Standing on Principle: the 'Basic Framework' The Coalitionist Sweeping House. 9 At the Negotiating Table: Kick-off and Final Siren * Circles of Consensus * The Joy of Text * The Great Hero * 'DDT' * When the Chips are Down. 10 Biogopolies: Patent Privatization * Patent Addiction * Mother Nature's Software * Patent Engineering * The University-Industrial Knowledge Complex * Hard Core Cartels. 11 Infogopolies: Private Copyright * Software Blues * Hollywood Trade Ballyhoo * 'Mary had a little lamb'. 12 Democratic Property Rights: Good and Bad Property * Democratizing Intellectual Property * The puzzle of TRIPS. 13 Resisting the New Inequality The New Inequality Rethinking Piracy Reforming Patent Office Regultion Deliberation on the Council for TRIPS. 14 On the Importance of the Publicness of Knowledge: Propertyless Creativity * Protecting Private Property, Protecting Public Universities * Global Publics, Public Goods and Knowledge.

Draft Convention on Jurisdiction and Recognition of Judgments in Intellectual Property Matters

Draft Convention on Jurisdiction and Recognition of Judgments in Intellectual Property Matters

The Trips Agreement, Access to Medicines, and the Wto Doha Ministerial Conference

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. This report analyzes issues presented by the TRIPS Agreement and its present and prospective impact on access to medicines. A number of these issues have previously been raised and analyzed by this author and other commentators, and the discussions initiated in the TRIPS Council already focus on several of them. Nevertheless, it may be useful to consider in a relatively concise and systematic format the central elements of discussion in connection with the prospective Ministerial Conference in Doha on November 9-13, 2001. There are two ultimate objectives of this report. The first is to assist Members in formulating recommendations regarding a possible Doha Ministerial Declaration on TRIPS and Public Health, or a near-term formal interpretation of the TRIPS Agreement. The second is to raise issues that might more appropriately be the subject of a longer-term review of the TRIPS Agreement.

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

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. This report analyzes issues presented by the TRIPS Agreement and its present and prospective impact on access to medicines. A number of these issues have previously been raised and analyzed by this author and other commentators, and the discussions initiated in the TRIPS Council already focus on several of them. Nevertheless, it may be useful to consider in a relatively concise and systematic format the central elements of discussion in connection with the prospective Ministerial Conference in Doha on November 9-13, 2001. There are two ultimate objectives of this report. The first is to assist Members in formulating recommendations regarding a possible Doha Ministerial Declaration on TRIPS and Public Health, or a near-term formal interpretation of the TRIPS Agreement. The second is to raise issues that might more appropriately be the subject of a longer-term review of the TRIPS Agreement.

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

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. There was ample warning that the WTO Ministerial Conference in Seattle would face serious difficulties, with or without the public protests that disrupted the meeting. Only a few months before, WTO Members had completed the selection of a new Director-General – in fact the selection of two new Director-Generals to serve sequentially – in a tortuous process that lasted nearly a year. The Seattle agenda included a host of divisive issues involving serious substantive differences that Members had been unable to resolve in months of pre-meeting negotiations. Beyond hope in some quarters that pressure to maintain “momentum” would cause Members to abandon or compromise strongly held views, it is not clear why the Seattle Ministerial might have been approached with optimism about a comprehensive result. The failure to reach consensus on a WTO negotiating agenda in Seattle left considerable unfinished business on the table. In a number of areas, such as agriculture, existing WTO texts prescribed that negotiations would be resumed. Since the ministerial, the WTO General Council has agreed to move forward with negotiations in agriculture and services, at least to the extent of seeking to clarify the subject matter to be pursued. There has been no agreement on a future agenda for negotiations regarding trade-related aspects of intellectual property rights (or TRIPS), although a number of “built-in” agenda items remain before the TRIPS Council. The lack of agreement on a “new” TRIPS agenda is not surprising in view of the wide gulf in perspectives on this subject among WTO Members.This essay seeks to explain the absence of consensus on TRIPS, and why the near-to-medium term prospects for the setting of an ambitious agenda are not too bright. It reflects in modest detail on the particular controversy surrounding the potential for non-violation nullification or impairment complaints to be brought in the TRIPS dispute settlement context. This essay suggests that WTO Members might be best served in the near term by concentrating their efforts on establishing improved multilateral mechanisms to aid in the transfer of information and technology to developing and newly-industrialized countries.

WTO dispute settlement practice relating to the trips agreement

This paper provides some statistical information on the 16 TRIPS disputes initiated to date and discusses the Panel and Appellate Body Reports issued and adopted to date. Some of the procedural issues that have arisen are addressed, but the main focus is on the interpretation of the TRIPS provisions in question and the interpretative issues that the Panels and the Appellate Body were faced with, and how the Panels and the Appellate Body approached the questions raised. Information is also provided about a pending panel procedure, the mutually agreed solutions reached to date and the pending consultations. Finally, dispute prevention under the TRIPS Agreement and the role of the review of implementing legislation in the Council for TRIPS in this connection is addressed. Copyright 1999 by Oxford University Press.

Implementation of the TRIPS agreement and prospects for its further development

WTO Members can look back on the first three and a half years of the TRIPS Agreement with some satisfaction. Implementation by developed countries has been broadly satisfactory, although not without its gaps and delays. The TRIPS Council has developed and run-in important mechanisms for monitoring compliance. The dispute settlement mechanism has, in general, worked well and has already yielded positive results in the TRIPS area. A huge amount has been done by developing countries in anticipation of the end of their transition periods. Cooperation with WIPO has been established and is going well. Some useful work has been done on the built-in agenda. However, the principal challenges probably remain for the future. Much still has to be done by developing countries to bring themselves into compliance. The mechanisms of the WTO, in particular the TRIPS Council and the dispute settlement system, have to show that they have the capacity to deal with compliance issues arising from implementation by more than 130 Members as opposed to the 30 plus countries so far. As for the further development of the Agreement, the coming period leading to the possible launching of broad-based negotiations, in the WTO at the end of 1999 will be a critical period for reflection and consensus-building on the way in which the TRIPS Agreement should evolve in the future.