World Intellectual Property Organization (WIPO)

Research Paper 125, December 2020

Designing Pro-Health Competition Policies in Developing Countries  

By Vitor Henrique Pinto Ido

Competition law and policy has become an important tool for countries to promote access to pharmaceuticals. How can countries design and enforce competition policies that are suitable to the particularities of developing countries? What are the main anti-competitive tactics in the pharmaceutical sector, and how should they be dealt with? This paper deals with these issues, taking into account the socio-economic relevance of access to health products. It finds that developing countries should apply their competition laws in the pharmaceutical sector more actively, and that there is ample policy space under international law to do so. It provides an overview of the way in which competition policies have been applied in some industrialized and developing countries and explores how such policies can be designed and implemented in the context of developing countries.

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Statement, November 2020

South Centre Statement for the Third Session of the WIPO Conversation on AI and IP

The South Centre is an intergovernmental organization of 54 developing countries working across various policy areas, including intellectual property. This statement focuses on increasing capacity on artificial intelligence (AI) and intellectual property (IP) matters in the context of the widening technological gap and the Fourth Industrial Revolution.

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Research Paper 120, October 2020

Patent Analysis for Medicines and Biotherapeutics in Trials to Treat COVID-19

By Srividya Ravi

This report provides an analysis of patents covering medicines in trials to treat 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 medicines considered for the patent analysis in this report are remdesivir, ruxolitinib and favipiravir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.

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South Centre Semester Report, January-June 2020

South Centre Semester Report, 1 January to 30 June 2020

This Semester Report summarizes the activities undertaken by the South Centre during the period 1st January to 30 June 2020. It is intended to provide information, organized by themes, about recent developments in the areas covered by the Centre’s Work Program, meetings organized or co-organized by the Centre to examine particular issues or provide analytical support for negotiations taking place in various international fora, and conferences and other meetings where the Centre has participated. It also informs about publications made.

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Document de Recherche 100, Septembre 2020

Médicaments et propriété intellectuelle: 10 ans de la stratégie mondiale de l’OMS

Par Dr. Germán Velásquez

Les négociations du Groupe de travail intergouvernemental sur la santé publique, l’innovation et la propriété intellectuelle connu sous le nom de “IGWG” (2006-2008), menées par les Etats Membres de l’OMS, sont le résultat d’une impasse à l’Assemblée mondiale de la santé du 6 décembre 2006 où les Etats Membres n’ont pu parvenir à un accord sur les 60 recommandations du rapport” Santé publique, innovation et propriété intellectuelle “soumis la même année par un groupe d’experts désigné par le Directeur général de l’OMS. Le résultat de ces négociations devint la “Stratégie mondiale et Plan d’action pour la santé publique, l’innovation et la propriété intellectuelle” (GSPOA), approuvé par l’Assemblée mondiale de la santé en 2008. Un des objectifs de la Stratégie mondiale élaboré par l’IGWG était de réformer en profondeur le système d’innovation pharmaceutique, en raison de son incapacité à produire des médicaments abordables contre les maladies qui affligent une grande partie de la population du monde vivant dans les pays en développement. Les droits de propriété intellectuelle (PI) imposés par l’Accord sur les aspects des droits de propriété intellectuelle liés au commerce (ADPIC) et les accords commerciaux pourraient devenir des principaux obstacles à l’accès aux médicaments. Le GSPOA a fait une analyse critique de cette réalité et a mené à la recherche de nouvelles solutions à ce problème. Dix ans après l’approbation du GSPOA, les résultats restent incertains et médiocres.

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Documents de Formation 1, Août 2020

Propriété Intellectuelle et Accès aux Médicaments : Une Introduction aux Grandes Problématiques – Quelques Termes et Concepts de Base

Par Germán Velásquez

La propriété intellectuelle et les brevets en particulier sont devenus l’une des questions les plus débattues sur l’accès aux médicaments, depuis la création de l’Organisation mondiale du commerce (OMC) et l’entrée en vigueur de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC). Les brevets ne sont nullement les seuls obstacles à l’accès aux médicaments qui sauvent des vies, mais ils peuvent jouer un rôle important, voire déterminant. Pendant la durée de protection d’un brevet, la capacité du titulaire du brevet à déterminer les prix, en l’absence de concurrence, peut faire en sorte que le médicament soit inabordable pour la majorité des personnes vivant dans les pays en développement. Ce premier numéro du “South Centre Training Papers” vise, dans sa première partie, à fournir une introduction aux questions clés dans le domaine de l’accès aux médicaments et de la propriété intellectuelle. La deuxième partie décrit et définit certains termes et concepts de base de ce domaine relativement nouveau des politiques pharmaceutiques, qui sont les aspects liés au commerce des droits de propriété intellectuelle qui régissent la recherche, le développement et la fourniture de médicaments et les technologies de la santé en général.

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Book by the South Centre, 2020

Modulos de Introduccion a la Propiedad Intelectual y Salud Pública

Descripción:

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.

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Research Paper 115, July 2020

Special Section 301:US Interference with the Design and Implementation of National Patent Laws

By Dr. Carlos M. Correa

The continuous application of Special Section 301 by the Office of the United States Trade Representative (USTR) undermines the rule of law as a fundamental principle of a multilateral system based on the sovereign equality of states and the respect for international law. Interference with foreign countries’ national intellectual property (IP) policies—which have significant socio-economic effects—negates their right to determine independently the level and modalities of protection of such property within the framework and policy space allowed by the international law. This paper examines the patent-related claims made by the USTR in relation to the developing countries on the USTR Priority Watch List. It argues that the regulations and practices identified by the USTR show a legitimate use of the flexibilities provided for by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and that the ignorance of the public interests of the countries concerned (for instance, with regard to access to affordable medicines) has contributed to the discredit (and ineffectiveness) of the Special Section 301.

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Policy Brief 78, May 2020

The 73rd World Health Assembly and Resolution on COVID-19: Quest of Global Solidarity for Equitable Access to Health Products

By Nirmalya Syam, Mirza Alas and Vitor Ido

The annual meeting of the World Health Assembly (WHA) of the World Health Organization (WHO) held virtually on 18-19 May 2020 discussed the global response to COVID-19 and adopted Resolution WHA73.1 on “COVID-19 Response”. The Resolution reaffirms the role of WHO as the directing and coordinating authority on international health work and it recognizes that all countries should have timely and affordable access to diagnostics, therapeutics, medicines and vaccines as well as to essential health technologies and equipment to respond to COVID-19. However, the Resolution does not define concrete actions to address the pandemic. Though the Resolution makes a commitment of ensuring access to medical products, vaccines and equipment for all countries in a timely manner, there are no concrete actions defined.  In order to ensure global equitable access, WHO Members should make full use of the flexibilities of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS)  and also enhance transparency of costs of research and development (R&D), openness and sharing of data, tools and technologies, and build more capacity through technology transfer.

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COVID-19 Open Letter

COVID-19 PANDEMIC: ACCESS TO PREVENTION AND TREATMENT IS A MATTER OF NATIONAL AND INTERNATIONAL SECURITY

Open letter from Carlos Correa, Executive Director of the South Centre, to

Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization

Francis Gurry, Director-General of the World Intellectual Property Organization

Roberto Azevêdo, Director-General of the World Trade Organization

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Research Paper 106, March 2020

The Comprehensive and Progressive Agreement for the Trans-Pacific Partnership: Data Exclusivity and Access to Biologics

By Dr. Zeleke Temesgen Boru

The test data rule concerning biological medicines (hereafter biologics) has been suspended from the scope of application of the Comprehensive and Progressive Agreement for the Trans-Pacific Partnership (CPTPP). While the suspension is commendable from the general standpoint of access to medicines and biologics in particular, the suspended provision may not provide assurance for the Parties to the CPTPP that they can rely on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to promote access to biologics. In part this is because the Parties may end the suspension if and when they choose to do so. Simply put, the agreement does not promise that the suspended provision will remain suspended; rather, the Parties may revive the provision as originally negotiated under the Trans-Pacific Partnership (TPP) Agreement. The provision, if revived, may inhibit the Parties from implementing an obligation to ensure access to biologics, medicines that target chronic and rare ailments like cancer, clotting factors and several others.

Against this backdrop, this research paper focuses on the test data rule relating to biologics as negotiated under the TPP. In particular, it explores whether the CPTPP Parties would be able to use TRIPS flexibilities effectively to promote access to biologics, as advanced by international human rights instruments, in particular the International Covenant on Economic, Social and Cultural Rights (ICESCR). The paper also provides potential responses to the question of whether the test data rule deters the realization of access to biologics. In response, the author has determined that the rule on test data can limit access to biologics, as it would delay the entry of affordable biologics (biosimilars) into markets.

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SC Submission – IP Policy and AI, February 2020

Submission by the South Centre to the Draft Issues Paper on Intellectual Property Policy and Artificial Intelligence (WIPO/IP/AI/2/GE(20/1)

The South Centre welcomes the opportunity to submit to the WIPO Secretariat input on the draft issues paper on intellectual property policy (IP) and artificial intelligence (AI). The South Centre hereby provides recommendations for the revised Issues Paper. The aim of the Issues Paper should be to provide a framework for informed discussion among Member States on the topic of IP policy and AI, without pre-empting the substance of such discussion, and to complement a process of sharing of views and experiences between different Member States and constituencies. The Development Agenda should also be mainstreamed into the discussion of IP policy and AI.

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