Submission by the South Centre to the USITC hearing on Covid-19 diagnostics and therapeutics
India, South Africa and co-sponsors made a proposal for a waiver to certain provisions of the provisions of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in March 2020. In June 2022, the WTO Ministerial Decision on the TRIPS Agreement provided a partial waiver to obligations in Article 31, namely an exception to the 31.f export restrictions, in relation to patents for Covid-19 vaccines. No decision has yet been made with respect to diagnostics and therapeutics for Covid-19.
In this context, the U.S. Trade Representative (USTR) requested the U.S. International Trade Commission (USITC) to prepare a report on Covid-19 diagnostics and therapeutics.
Read below the submission by the South Centre to the USITC investigation: COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596).
El debate sobre la exención de los derechos de propiedad intelectual en tiempos de pandemia
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El 11 de marzo de 2020 la Organización Mundial de la Salud (OMS) comunicó que la enfermedad por coronavirus de 2019 (COVID-19), podía ser considerada una pandemia. A medida que el contagio de la enfermedad aumentaba se hizo evidente la insuficiencia de los recursos sanitarios, vacunas y métodos de diagnóstico y tratamiento para enfrentar con éxito la pandemia. En este contexto, en la Organización Mundial del Comercio (OMC) se reavivó la tensión entre las reglas de propiedad intelectual y la salud pública.
Como consecuencia de ello, el 2 de octubre de 2020, Sudáfrica e India, presentaron ante la OMC una propuesta para que ciertas disposiciones del Acuerdo sobre los ADPIC no resultaran de aplicación para cualquier producto o procedimiento destinado a la prevención, contención y tratamiento de la COVID-19. Esta propuesta de exención (waiver), contó con la férrea oposición de la Unión Europea que presentó una propuesta alternativa. Para intentar llegar a un acuerdo se formó una comisión cuadrilateral conformada por Sudáfrica, India, la Unión Europea y EEUU. Finalmente, luego de dos años de negociaciones y en el marco de la 12ª Conferencia Ministerial (MC12) celebrada en Ginebra el 17 de junio de 2022, se aprobó un proyecto de exención de los derechos de propiedad intelectual que dista mucho de la propuesta original de 2020.
El presente trabajo, analiza detalladamente el proceso de discusión – en torno al tema del “waiver” – dado en el Consejo de los ADPIC de la OMC: estudia los antecedentes de la propuesta de exención, analiza los documentos presentados por las partes en pugna, revisa los argumentos esgrimidos a favor y en contra del waiver, los instrumentos propuestos y, asimismo, muestra cómo se desenvolvieron las distintas posiciones hasta alcanzar el acuerdo final.
Autores: Alejandra Aoun, Juan Correa, Martín A. Cortese, Vanesa Lowenstein, Sandra C. Negro, Guillermo E. Vidaurreta
Analysis of COVID-Related Patents for Antibodies and Vaccines
By 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.
Directives pour l’examen des demandes de brevet relatives aux produits pharmaceutiques
Par Carlos M Correa
Ce document fait suite à un document antérieur, Directives applicables à l’examen des brevets pharmaceutiques: examen des brevets pharmaceutiques du point de vue de la santé publique, publié en 2007 comme document de travail par le Centre international pour le commerce et le développement durable (CICDD), la Conférence des Nations Unies sur le commerce et le développement (CNUCED) et l’Organisation mondiale de la santé (OMS).
Le présent document tient compte des évolutions survenues depuis la publication du document de travail CICDD-CNUCED-OMS en 2007. Il comprend de nouveaux exemples de demandes et/ou de délivrance de brevets, ainsi qu’une analyse et des références aux initiatives d’un certain nombre de pays qui ont adopté des lois et/ou des politiques visant à prendre en compte les considérations de santé publique dans l’examen des demandes de brevets.
Avec ce document, l’objectif est de fournir des orientations pour l’élaboration ou la révision de directives sur les processus d’examen des brevets dans les pays en développement, en réponse aux préoccupations concernant l’augmentation du nombre de brevets dans le secteur pharmaceutique. À cette fin, un certain nombre de recommandations sont formulées en ce qui concerne l’examen des demandes de brevetabilité relatives aux produits et procédés pharmaceutiques.
Ce document est une traduction de la version originale des “Directives pour l’examen des demandes de brevet relatives aux produits pharmaceutiques” publiées en anglais par le Programme des Nations Unies pour le Développement (PNUD). Le South Centre remercie le PNUD pour l’aimable autorisation de publier cette version non officielle. Traduit pour le South Centre par M. Natanael França.
Pautas para el Examen de Solicitudes de Patentes Relacionadas con Productos Farmacéuticos
Por Carlos M Correa
Este documento representa un seguimiento de un documento anterior, Pautas para el examen de patentes farmacéuticas – Una perspectiva desde la Salud Pública, que se publicó en 2007 como documento de trabajo por el Centro Internacional de Comercio y Desarrollo Sostenible (ICTSD), Estados Unidos, Conferencia de las Naciones Unidas sobre Comercio y Desarrollo (UNCTAD) y la Organización Mundial de la Salud (OMS).
El presente documento toma en cuenta los desarrollos desde la publicación del documento de trabajo ICTSD-UNCTAD-OMS en 2007. Incluye nuevos ejemplos de solicitudes y/o subvenciones de patentes, además analiza y hace referencia a las iniciativas de varios países que han adoptado leyes y/o políticas dirigidas a considerar temas de salud pública en el examen de solicitudes de patentes.
El objetivo de este documento es proporcionar orientación para el desarrollo o la revisión de directrices sobre los procesos de examen de patentes en países en desarrollo en respuesta a las preocupaciones sobre el aumento del número de patentes en el sector farmacéutico. A tal fin, se formulan varias recomendaciones con respecto al examen de la patentabilidad de las solicitudes relativas a productos y procesos farmacéuticos.
Este documento es una traducción de la versión original de las “Directrices para el examen de solicitudes de patentes relacionadas con productos farmacéuticos” publicadas en inglés por la Programa de las Naciones Unidas para el Desarrollo (PNUD). El South Centre agradece al PNUD por la amable autorización para publicar esta versión no oficial. Traducido para el South Centre por el Sr. Natanael França.
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.
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.
Harnessing the Multilateral Patent and Plant Variety Protection Regimes to Advance Food Security:
Implications of the EU-ECOWAS Economic Partnership Agreement
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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. Critical analysis is made of a regional agreement signed between the Economic Community of West African States (ECOWAS) and the European Union (EU), the 2014 EU-ECOWAS Economic Partnership Agreement (EPA), to assess what implications the agreement may have for food security in West Africa. Interdisciplinary research is carried out to identify the characteristics needed to advance food security in the region of West Africa. Also, philosophical and doctrinal analysis of IP laws and legal theories is conducted to identify which legal principles are best suited for advancing food security in the region. Based on the findings, the thesis draws up a model framework for IP protection that is more suitable for enhancing food security in West Africa.
Author: Uchenna Felicia Ugwu is a lawyer and academic researcher with over ten years’ experience extensively investigating the relationship between Intellectual Property (IP) norms and socio-economic development in developing countries. She recently received a PhD in International IP Law and Development from the University of Ottawa.
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).
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.
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