South Centre Statement on the extension of the TRIPS waiver for diagnostics and therapeutics for COVID-19
Developing countries should consider options that can be implemented now to deal with IP barriers to expand production and access to COVID-19 therapeutics and diagnostics, while the so far elusive decision on whether to extend a TRIPS waiver to cover these products is taken by WTO.
Left on Our Own: COVID-19, TRIPS-Plus Free Trade Agreements, and the Doha Declaration on TRIPS and Public Health
By Melissa Omino and Joanna Kahumbu
The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter “the Declaration”) was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter “TRIPS”) Article 31 bis, should have helped to contain the devastation in least developed and developing countries. The reality is that the pandemic is still ongoing, and the Global South led by South Africa and India are seeking a waiver of provisions to the TRIPS Agreement to ensure that COVID-19 therapeutics, diagnostics, and vaccines reach their citizens in order to contain the spread of the COVID-19 virus (“the TRIPS waiver”). These citizens are especially vulnerable because of their inability to access vaccines due to their prices and supply shortages caused by the refusal to share manufacturing technology. The Doha Declaration aimed at reaffirming the interpretation and implementation of the TRIPS Agreement to support WTO members’ right to protect public health and promote access to medicines. However, the operationalization of the Declaration via Article 31bis of TRIPS has been cumbersome and procedurally difficult to navigate. This paper argues that the current iteration of the Doha Declaration within TRIPS fails to meet the objectives of the Declaration as demonstrated by the need for a further waiver of the TRIPS agreement. It also attempts to “reimagine” Article 31 bis in light of the TRIPS waiver from the position of the Global South to make it more equitable and practicable and maintain the spirit of the Declaration.
International Clean Technology Diffusion: Pathways and Prospects
By Wenting Cheng
International clean technology diffusion is essential to mitigate and adapt to climate change, while fast and optimal diffusion can be prevented by the paywall of patents. This article examines three pathways to foster international clean technology diffusion: through restriction of intellectual property, including imposing external restraints in environmental law; striking an internal balance in maximizing TRIPS flexibilities; and keeping the status quo. It finds that the first two treaty-based pathways may not work, and an operable pathway to promote clean technology diffusion is to maximize and consolidate TRIPS flexibilities in national laws. This option challenges the popular proposal of a “Doha-like” declaration on TRIPS and climate change due to the paralysed multilateral trade mechanism, asymmetrical negotiation power of developing countries, prolonged negotiation process, and categorization problem in treaty negotiations.
Technology Transfer and Climate Change: A developing country perspective
By Nicolás M. Perrone
The role of technology transfer in climate change negotiations is vital. If technology is to help us mitigate and adapt to climate change, the international community needs to ensure sufficient innovation and technology transfer. One of the main challenges of the technology transfer regime for environmentally sound technologies is that a private and market-led model may not meet global technology transfer needs. This policy brief suggests that governments should explore market, hybrid and non-market approaches to accelerate the transfer of environmentally sound technologies. Developing countries’ governments should also explore cooperative approaches to improve their bargaining power, reduce costs and ensure adaptation and innovation capacity in the developing world.
The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?
By Carlos M. Correa and Nirmalya Syam
The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.
TRIPS Flexibilities and Access to Medicines: An Evaluation of Barriers to Employing Compulsory Licenses for Patented Pharmaceuticals at the WTO
By Anna S.Y. Wong, Clarke B. Cole, Jillian C. Kohler
Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner’s authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have historically employed compulsory licenses to compel originator manufacturers to license their patents to generic manufacturers before patent expiry, increasing the supply and reducing the price of patented pharmaceuticals domestically.
This paper evaluates the three primary barriers to employing compulsory licenses for pharmaceuticals underscored by members during TRIPS waiver discussions at the WTO: (1) a lack of enabling domestic legislation, (2) a lack of domestic manufacturing capacity coupled with an unworkable Article 31bis importation system, and (3) consistent political pressure from other members to refrain from issuing compulsory licenses. A survey of members’ domestic compulsory license legislation finds that virtually all members have enacted enabling legislation under Article 31 for the issuance of compulsory licenses to supply their local markets. However, implementation of Article 31bis is limited by a lack of enabling compulsory license export legislation, streamlined administrative processes, or both across all members, preventing members lacking domestic manufacturing capacity from importing pharmaceuticals. An analysis of USTR Special 301 Reports from 1994-2021 further reveals that countries have consistently been placed on the Special 301 Report Priority Watch List for issuing pharmaceutical compulsory licenses, with instances as recent as 2020. As such, general reluctance by members to issue compulsory licenses due to overt political pressure through the Special 301 Report is likely warranted. These results highlight a range of barriers preventing the full use of compulsory licenses for pharmaceuticals under the current Article 31 and 31bis framework, with the effects disproportionately borne by member states lacking domestic manufacturing capacity.
Lessons From India’s Implementation of Doha Declaration on TRIPS and Public Health
By Nanditta Batra
The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil, India and other countries. Ample evidence, including patented AZT for HIV/AIDS treatment, showed that patents could make life saving drugs prohibitively expensive. Notwithstanding the effect of patents on access to medicines, Article 27 of the TRIPS Agreement ordained patents for inventions “in all fields of technology”. While the genie was out of the bottle in the form of patents for pharmaceuticals, the developing countries were able to extract some procedural and substantive flexibilities like transition period, parallel importation and compulsory licensing to leverage the IP system to further public health. However, there was uncertainty with respect to the interpretation of TRIPS agreement, scope of the flexibilities and Member States’ rights to use them. It is in this background that the historic Doha Declaration on the TRIPS Agreement and Public Health assumed importance as it reaffirmed the rights of the Member States to take measures to protect public health, reconciled the interpretative tensions in the text of TRIPS Agreement and clarified the scope of some of the flexibilities and attempts to find solutions to the problems faced by countries that do not have sufficient manufacturing facilities. The Declaration which was initially dismissed by some scholars as “non-binding,” “soft law” has been held by WTO Dispute Settlement Body (DSB) to constitute a “subsequent agreement” which must be followed in interpreting the provisions of TRIPS Agreement (Australia-Tobacco Plain Packaging Case).
Webinar: The Future of the TRIPS Agreement (Part 2)
11 October 2022
Time: 10:00 – 11:30 CET
Sustainable recovery from the COVID-19 pandemic requires availability of medical technologies in all countries. To date, inequity in access continues. The interface of intellectual property and promotion of public health is central to this question. This session is a follow-up to the South Centre’s 2021 WTO Public Forum working session, which kick-started a discussion on the future of the TRIPS Agreement after the Covid-19 pandemic.
This session will bring together various stakeholders to discuss whether a reform of the TRIPS Agreement and/or authoritative interpretations of some its key provisions are needed, having in view the proposals made in response to a request for a waiver for the Covid-19 pandemic and other possible public-health oriented solutions. What are the existing limitations and opportunities within the current framework? What further actions could be taken under the WTO rules in order to promote access to medical technologies for a sustainable and equitable future?
Competition Law and Intellectual Property: A Study Drawing from The Eli Lilly Case on ‘Sham Litigation’ in Brazil
By Pablo Leurquin
Competition authorities may be the best equipped institutions to penalize certain illicit practices that involve intellectual property rights. This article analyzes the decision by the Brazilian Administrative Council for Economic Defense (Conselho Administrativo de Defesa Econômica – CADE) in the Eli Lilly case, in which the company was convicted for abusive use of the right to petition (sham litigation) with anti-competitive effects. It examines general aspects of technological dependence in the Brazilian pharmaceutical industry, presents the legal premises necessary for the understanding of the decision made by the competition authority, and analyzes the legal grounds for the sanction imposed on Eli Lilly.
Statement by the South Centre to the 2022 Assemblies of the Member States of WIPO
The South Centre is the intergovernmental organization of developing countries based in Geneva that supports developing countries’ efforts to build up a fair and inclusive multilateral system conducive to the achievement of the Sustainable Development Goals (SDGs). We are of the view that a central objective of World Intellectual Property Organization (WIPO) as part of the United Nations (UN) UN system should be to support the achievement of such goals through the promotion of a balanced international intellectual property (IP) system that reflects the interests of countries at different levels of economic and technological development, and in line with the WIPO Development Agenda.
Reaping the Fruits of Research on Microorganisms: Prospects and Challenges for R&D and Industry in Sri Lanka
by Ruwan Fernando
When the Intellectual Property Bill designed to secure compliance with the Agreement on Trade Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) was challenged in the Supreme Court of Sri Lanka, the Court determined that the patenting of naturally occurring microorganisms by right holders would result in the increase of the prices of diagnoses and cures. The Supreme Court found that in the absence in the Bill of mitigatory measures -as allowed by the TRIPS Agreement- and of a working definition of the term “microorganism”, there was a violation of the right to equal protection under Article 12 (1) of the Constitution. In the circumstance, the patent protection for microorganisms was narrowed down to transgenic microorganisms.
The policy makers do not appear to have disregarded the positive impact of the Supreme Court determination by making the necessary statutory provisions and policy changes to facilitate the patent applications on transgenic microorganisms, while ensuring that local researchers are not restrained from gaining access to naturally occurring microorganisms for research and development.
Farmers, Seeds & the Laws: Importing the Chilling Effect Doctrine
By Saurav Ghimire
As an increasing number of countries are formulating Plant Variety Protection (PVP) laws, a growing number of farmers are affected by plant breeders’ rights. In addition, the seed certification law also affects farmers’ relations with seeds. Discussing the farmers’ interaction with the PVP law and seed certification law in Indonesia, this article establishes that the farmers have internalised the law beyond the scope of the legal text, such that they self-limit breeding, saving, and exchanging of seeds even in legally permissible situations. Based on the chilling effect doctrine, this article argues that the related laws should be relaxed to ensure that they do not over deter farmers from exercising their rights. This article calls for both negative and positive state obligations to address the chilling effect on farmers arising from both state and private actors.