Author: South Centre

Understanding the Functioning of EU Geographical Indications

[Andrea Zappalaglio] This contribution investigates the functioning of the EU sui generis Geographical Indication (GI) system, with a specific focus on the regime for the protection of agricultural products and foodstuffs within the scope of EU Regulation 1151/2012. In particular, based on the results of the recent “Study on the Functioning of the EU Geographical Indications System” of the Max Planck Institute for Innovation and Competition (February 2022), this paper: (1) clarifies the nature of EU GIs as it emerges from an empirical assessment of the specifications of all the products that appear on the EU register; (2) comparatively analyses the national practices of the EU Member States and explores the discrepancies that exist among them to date; (3) provides an in-depth assessment of the structures of the specifications of EU GIs, highlighting the domestic specificities; (4) investigates the contents and functions of the amendments to the specifications of the registered products. It concludes by emphasizing the importance of the present research in light of the current EU international agenda, with a specific focus on the bilateral agreements recently or currently negotiated.

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South Centre Supports Debates on Developments in Copyright Law and Access to Knowledge in Africa

[Vitor Ido] A conference “A Right to Research in Africa? A Week of Debates on Copyright and Access to Knowledge” took place on 23-27 January 2023 at the University of Pretoria and the University of Cape Town, South Africa. The gathering of scholars, artists, librarians, researchers and government officials had the objective to discuss the evolution of copyright law and the role of limitations and exceptions (L&Es) to advance research in Africa. The week of debates was co-organized by the South Centre, ReCreate South Africa, Program on Information Justice and Intellectual Property (PIJIP) – American University Washington College of Law, Electronic Information for Libraries (EIFL), the University of Pretoria – Future Africa, the University of Cape Town – IP Unit, the Centre for Intellectual Property and Information Technology Law (CIPIT) – Strathmore University, Wikimedia Foundation and Masakhane.

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Analysis of COVID-Related Patents for Antibodies and Vaccines

[Kausalya Santhanam] This paper provides an analysis of patents covering selected antibodies and vaccines used in the treatment or prevention of COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications. The antibody combination considered for the patent analysis in this paper are Casirivimab and Imdevimab. The vaccines considered for the patent analysis are mRNA-1273, Sputnik, ChAdOx1 nCoV-19 vaccine (AZD1222). The analysis was completed in May 2022.

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South Centre Statement on the extension of the TRIPS waiver for diagnostics and therapeutics for COVID-19

[South Centre] 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.

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WHO Proposed Instrument on Pandemics: the Conceptual Zero Draft Needs Substantial Improvement to Address Global Public Health Needs

[South Centre] We welcome the discussions in the WHO on a new instrument on pandemic prevention, preparedness, response and recovery. While we appreciate the preparation and sharing with WHO members of the Conceptual Zero Draft (hereinafter ‘the Draft’), we note that more work is needed to address the insufficiency of the tools at the disposal of the WHO that became evident with the COVID-19 pandemic.

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The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?

[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.

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TRIPS Flexibilities and Access to Medicines: An Evaluation of Barriers to Employing Compulsory Licenses for Patented Pharmaceuticals at the WTO

[Anna S.Y. Wong, Clarke B. Cole, and Jillian C. Kohler] 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.

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Harnessing the Multilateral Patent and Plant Variety Protection Regimes to Advance Food Security: Implications of the EU-ECOWAS Economic Partnership Agreement

[Uchenna Felicia Ugwu] This thesis analyzes the provisions of contemporary intellectual property (IP) and trade agreements to explore whether these provisions advance, or compromise, food security in West Africa. The agreements have been examined for how their provisions integrate IP and food security norms and policies, and the extent to which the IP frameworks are adaptable to the regional conditions that determine food security in the West African context.

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A Breakthrough in Negotiations on Intellectual Property, Protection of Genetic Resources and Traditional Knowledge in WIPO?

[Viviana Muñoz Tellez] This Policy Brief provides a brief summary of the current negotiations in the World Intellectual Property Organization (WIPO) for an international legal instrument or instruments relating to intellectual property to ensure the balanced and effective protection of genetic resources (GRs), associated traditional knowledge (TK) and traditional cultural expressions (TCEs). The General Assembly in June 2022 took a significant decision to schedule a Diplomatic Conference in 2024 to conclude a treaty on the protection of GRs and associated TK. However broader protection for TK and TCEs is not part of the decision.

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Lessons From India’s Implementation of Doha Declaration on TRIPS and Public Health

[Nanditta Batra] Abstract: … 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.

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Competition Law and Intellectual Property: A Study Drawing from The Eli Lilly Case on ‘Sham Litigation’ in Brazil

[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.

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Movement Forward on ABS for the Convention on Biological Diversity: Bounded Openness Over Natural Information

[Joseph Henry Vogel, Manuel Ruiz Muller, Klaus Angerer, and Christopher May] “Access to genetic resources” and “fair and equitable sharing of benefits arising [from their] utilization” is the third objective of the 1992 United Nations Convention on Biological Diversity (CBD). The expression is included in the full title of the 2010 Nagoya Protocol (NP). Neither agreement defined “material” in the phrase “genetic material” which resulted in misinterpretation that the object of access for R&D is tangible. Unfairness ensues.

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Farmers, Seeds & the Laws: Importing the Chilling Effect Doctrine

[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.

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IPR-Related Statistics in WTO Trade Policy Reviews

[Peter Lunenborg] The WTO Secretariat Trade Policy Review (TPR) report is an important tool for a WTO Member which synthesizes objective trade-related information in a single document and enables the monitoring of developments in trade. Relevant statistics are therefore an important element of a TPR report. Currently the practice of using statistical information on intellectual property rights (IPRs) across TPRs is not uniform. This Policy Brief surveys the use of IPR-related statistics in WTO TPRs with a view to exploring possible harmonization and inclusion of common information elements in future TPRs.

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TRIPS WAIVER: AN INSUFFICIENT MULTILATERAL RESPONSE. TRIPS-CONSISTENT NATIONAL ACTIONS ARE CALLED FOR

[South Centre] …The process leading to the Decision confirms the need to fully use the TRIPS flexibilities to address emergency and other situations where public health and other public interests are at stake, and to review the current international IP regime (including article 31bis of the TRIPS Agreement) to accelerate the sharing of technology, including know-how.

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Doha Twenty Years On – Has The Promise Been Betrayed?

[Yousuf Vawda and Bonginkosi Shozi] The Doha Declaration’s twentieth anniversary in November 2021 has taken place in the midst of the COVID-19 pandemic. The experience of the past two years has demonstrated that the very factors that necessitated the Declaration—the problems of inequitable access to medicines and other health technologies for the world’s poor—continue to plague us.

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Manufacturing for Export: A TRIPS-Consistent Pro-Competitive Exception

[Carlos M. Correa and Juan I. Correa] The paper discusses the flexibilization of the sui generis system of supplementary protection certificates (SPCs) under European law recently introduced to allow for the manufacturing, stockpiling and export of covered products. Against this background, it examines the viability under the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) of an exception allowing for the manufacture and export of patent-protected products. It concludes that such an exception would promote competition and enhance access to medicines (including biologicals) for the general public while being consistent with Article 30 of the TRIPS Agreement if read in accordance with the principles of interpretation of customary international law.

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19 Vaccines as Global Public Goods: Between Life and Profit

[Katiuska King Mantilla and César Carranza Barona] Abstract: In the context of a health emergency like the COVID-19 pandemic, the global availability of and access to vaccines are imperative. This research paper provides an analysis from the perspective of international political economy, of the financing of COVID-19 vaccines and of the market strategies adopted by some of the companies that developed them. It notes that the development of vaccines was supported by substantial public funding from countries that later received preferential access to those vaccines through advance purchases. Despite such public support, the vaccines were not deemed as public goods but remained under the control of their developers.

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The Liability of Internet Service Providers for Copyright Infringement in Sri Lanka: A Comparative Analysis

[Justice Dr. Ruwan Fernando] There are laws in force in many countries to limit the liability of an ISP for the infringement of copyright that takes place on its networks. An ISP in Sri Lanka may not enjoy the same privilege for the infringement of unauthorised material initiated by its users or third parties on their networks. The current law is unlikely to provide adequate protection for the legitimate activities of ISPs in an attempt to minimize the vulnerability against copyright infringement claims.

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The WTO TRIPS Waiver and Essential Security Rights in 2022

[Dr. Alexander Beyleveld] Almost two years have passed since the start of the COVID-19 pandemic, and we are still far from bringing the pandemic to an end. One of the main reasons for this is the fact that large vaccine inequities remain worldwide. In order to address this problem, a large subset of World Trade Organization (WTO) members are in favour of waiving certain obligations contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). Against this backdrop, this article contemplates the legal necessity of such a waiver given that Article 73 of the TRIPS Agreement contains essential security exceptions which may render the obligations in question inapplicable under the interpretation that the pandemic affects law and public order interests.

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