A TRIPS-COVID Waiver and Overlapping Commitments to Protect Intellectual Property Rights Under International IP and Investment Agreements
by Henning Grosse Ruse-Khan and Federica Paddeu
This paper considers legal implications that are likely to emerge from the implementation of a TRIPS Waiver decision. Assuming that a Waiver is adopted in the form presented in the May 2021 proposal by South Africa and India et al, we review the interaction between the Waiver and other commitments to protect IP rights under international IP and investment treaties. Our principal research question is to analyze whether domestic measures implementing the Waiver are compatible with the implementing State’s other obligations to protect IP rights established under multilateral IP treaties, IP and Investment Chapters of FTAs as well as BITs. In light of typical examples for such overlapping commitments, we first focus on (1) defences directly affecting compatibility with these treaty commitments (here referred to as ‘internal’ defences). In a second part, we review (2) potential defences under general international law that may serve to justify (in other words, to preclude the wrongfulness of) such measures. We conclude that often internal and/or general defences will operate to support the implementation of the Waiver despite overlapping commitments in international IP and investment law. This conclusion is reinforced by a purpose-oriented understanding of the TRIPS Waiver as authorizing measures necessary to achieve the goal of “unimpeded, timely and secure access” for all to covered medical technologies “for the prevention, treatment or containment of COVID-19”.
The Doha Ministerial Declaration on TRIPS and Public Health on its Twentieth Anniversary
By Nirmalya Syam, Viviana Munoz, Carlos M. Correa and Vitor Ido
This Policy Brief reviews the role of the Doha Declaration on TRIPS and Public Health in the twenty years since its adoption. It finds that the Doha Declaration has contributed to advance the use of the TRIPS flexibilities to promote public health and should be considered an important subsequent agreement to the TRIPS Agreement, despite the continuing challenges for WTO members to implement the TRIPS flexibilities in full. This brief also analyses the extent to which the Paragraph 6 System that became an amendment of the TRIPS Agreement as a new article 31 bis, pursuant to the Doha Declaration, has facilitated access to medicines and vaccines for countries with none or insufficient pharmaceutical manufacturing capacity. It finds that the system to date has not lived up to its promise. The Policy Brief recommends that WTO members assess and identify the challenges for the full use of the TRIPS flexibilities to promote public health, and advances that supplementary tools will need to be designed to never again allow such inequity in access to life saving vaccines and treatments as in the present COVID-19 pandemic.
Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law
This book is an outcome of a partnership between the Max Planck Institute (MPI) for Innovation and Competition and the South Centre, which jointly organized a Global Forum on Intellectual Property, Access to Medicine and Innovation in Munich on 9– 10 December 2019.
This book examines topics of particular relevance for shaping intellectual property regimes that take into account public health concerns. It provides not only deep analyses but options for the interpretation of existing regulations or the adoption of new legislation that, being consistent with the TRIPS Agreement, can allow the judiciary and policy makers to take such concerns into account. In different chapters, the book addresses various dimensions of the flexibilities allowed under the TRIPS Agreement. Although there is a significant literature and statements on the subject, such as the ‘Declaration on Patent Protection. Regulatory Sovereignty under TRIPS’ elaborated under the auspices of the MPI, the book contains new reflections and examines recent developments in case law and legislation.
The covered issues include how the TRIPS Agreement can be interpreted to implement its flexibilities, the use of competition law to promote access to medicines, the role of cooperation in the examination of patent applications, patentability requirements, the impact of TRIPS plus provisions (such as the linkage between patents and drug regulatory approvals), the patentability in the area of CRISPR genome editing technologies, as well as an analysis of the scope of exceptions and limitations to exclusive rights provided for by the Agreement, such as the exhaustion of rights and parallel imports, compulsory licenses, the ‘Bolar exemption’, and procedural mechanisms like pre-grant oppositions. The implications of the protection of test data are also examined.
While celebrating the opportunity of working together in organizing the Global Forum, we hope that this book will assist policy makers and judges and provide new inputs for academic research. While, as mentioned, there is a differentiated impact of intellectual property rights depending on the level of development of the country where it applies, the reconciliation of such rights with public health interests, particularly in relation to access to medicines, is a matter of concern for all countries.
Editors: Carlos M. Correa and Reto M. Hilty
TRIPS Flexibilities and TRIPS-plus Provisions in the RCEP Chapter on Intellectual Property: How Much Policy Space is Retained?
By Vitor Henrique Pinto Ido
The Regional Comprehensive Economic Partnership (RCEP) was signed on 15 November 2020 by 15 Asian-Pacific countries (ASEAN—Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam—, and China, Japan, South Korea, Australia and New Zealand), comprising about one third of the world’s population and economy. India was a crucial party to the negotiations but opted out of the agreement. Ratification of the agreement is still pending, subject to more Parties ratifying it at the national level. This paper provides a broad overview of the RCEP agreement and discusses the details of the intellectual property (IP) Chapter. Significantly, it does not contain substantive TRIPS-plus provisions that undermine public health in developing countries—although it does contain such provisions in other areas such as copyrights, trademarks, and IP enforcement.
Emerging Trends in FTAs and Public Health: Investment Agreements and Intellectual Property
Friday, 28 May 2021 – 16:00-17:30 (CET)
The inclusion of TRIPS-Plus provisions in developing country IP laws, as a result of negotiations of free trade agreements (FTAs) continues to be of concern. In addition, there are various emerging areas that require attention from developing countries, where accumulated knowledge and institutional learning are more limited. These include investment agreements that include ‘intellectual property’ as a category of investment – with subsequent ISDS mechanisms, as well as competition and investment chapters or agreements that may restrict the policy space, such as the China-EU Comprehensive Investment Agreement. There are several important developments to consider for the upcoming years. New negotiations in the period of Covid-19 crisis, when countries are in dire financial situations, may lead to even more unbalanced negotiations. The UK is pursuing new agreements after Brexit with developing countries, while the USA has signaled renewed attention to multilateralism and at the same time is continuing to make use of Section 301 of its trade law to advance reforms in third countries. The AfCFTA negotiations of the intellectual property chapter are set to start this year. Moreover, the RCEP Agreement is to be implemented via national law amendments and attention must be given in particular to the process for Least Developed Countries (LDCs) and the technical assistance offered.
In this context, the South Centre is holding a series of webinars on emerging trends related to free trade agreements (FTAs) and investment agreements that impact public health. In this first session, we will discuss the topic of investment agreements and intellectual property, including varied angles to the issue, such as perspectives for post Covid-19 agreements, the legal construction of IP as a category of investment, the challenges of ISDS and policy reform options, and the analysis of a concrete case.
Intellectual Property in the EU–MERCOSUR FTA: A Brief Review of the Negotiating Outcomes of a Long-Awaited Agreement
In collaboration with Juan I. Correa
This paper provides a first glance at the Intellectual Property Chapter of the Free Trade Agreement (FTA) between the Southern Common Market (MERCOSUR) and the European Union (EU). It is not intended to provide an exhaustive analysis of the commitments involved but rather to briefly review the scope of intellectual property in the bi-regional negotiations, which took more than 20 years and ended in June 2019 with an “agreement in principle.” It also aims to put the Chapter into context with the whole commitments covered by the FTA and, finally, to highlight its most relevant aspects.
Modulos de Introduccion a la Propiedad Intelectual y Salud Pública
Este libro contiene cuatro módulos para la capacitación en materia de propiedad intelectual y salud pública. Su objetivo es presentar una introducción a las diversas categorías de derechos de propiedad intelectual y, en particular, ilustrar sobre los derechos aplicables a la producción y comercialización de medicamentos en el marco de las llamadas ‘flexibilidades’ contenidas en el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio de la Organización Mundial del Comercio. Los módulos proporcionan elementos para comprender el alcance y las implicaciones de los derechos de propiedad intelectual, especialmente las patentes de invención, en el acceso a los medicamentos. Ellos brindan asimismo pautas para el diseño y la aplicación de esos derechos en una manera consistente con dicho Acuerdo y con políticas de protección de la salud pública. Los módulos contienen información general y enfoques prácticos para orientar a los encargados de formular y aplicar políticas públicas en el tratamiento del tema, tanto en el campo administrativo como judicial.
Non-Violation and Situation Complaints under the TRIPS Agreement: Implications for Developing Countries
By Nirmalya Syam
While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provided for the applicability of non-violation and situation complaints to the settlement of disputes in the area of intellectual property (IP), when the World Trade Organization (WTO) agreements were adopted in 1994, a moratorium was put in place until WTO Members could agree on the scope and modalities for the application of such complaints. However, for more than two decades, discussions in the TRIPS Council on the subject have remained inconclusive. The biannual WTO Ministerial Conference has granted extensions of the moratorium with regularity. This paper reviews the debate on the applicability of non-violation and situation complaints under the TRIPS Agreement, including the arguments consistently held by two WTO Members that if the moratorium is not extended by consensus, non-violation and situation complaints would become automatically applicable. This paper argues that a consensus decision by the WTO Ministerial Conference is required to determine the scope and modalities and, hence, the applicability of such complaints under the TRIPS Agreement. Even if the moratorium was not extended, the WTO Ministerial Conference should still adopt a decision calling on the TRIPS Council to continue examination of the scope and modalities of such complaints. It also argues that in the absence of an extension of the moratorium on initiating such complaints—and although they would not be applicable—a situation of uncertainty would be created that may lead to a de facto limitation in the use of flexibilities allowed under the TRIPS Agreement.