Patenting of Plants and Exceptions to Exclusive Rights: Lessons from European Law
Biotechnology has increased the use of patent law to protect the outcomes of plant breeding. While the TRIPS Agreement allows countries to exclude the patentability of plants and essentially biological processes to obtain them, many developing countries are granting patents on plants and plant components, such as seeds, cells, and genes. These patents can limit access to plant materials for further research and breeding and prevent farmers from saving and re-using seeds that incorporate patented materials. This study shows how European legislation has sought to strike a balance between the protection of plant-related inventions and the rights of breeders and farmers through the introduction of specific exceptions to patent rights and discusses what lessons can be drawn for developing countries.
Guidelines for the examination of patent applications relating to pharmaceuticals
By Carlos M. Correa
This document represents a follow-up to an earlier document, Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, which was published in 2007 as a working paper by the International Centre for Trade and Sustainable Development (ICTSD), the United Nations Conference on Trade and Development (UNCTAD) and the World Health Organization (WHO).
The present document takes into account developments since the publication of the ICTSD-UNCTAD-WHO working paper in 2007. It includes new examples of patent applications and/or grants, and analysis of and references to the initiatives of a number of countries that have adopted laws and/or policies that seek to factor in public health considerations in the examination of patent applications.
With this document, the aim is to provide guidance for the development or revision of guidelines on patent examination processes in developing countries in response to concerns about the rise of patent numbers in the pharmaceutical sector. For this purpose, a number of recommendations are made with regard to the examination of the patentability of applications relating to pharmaceutical products and processes.
South Centre Submission to the 18th Session of the CGRFA
The South Centre presents its compliments to the Commission on Genetic Resources for Food and Agriculture (CGRFA) and is pleased to send to the Commission the following information on its programmes and activities relevant to the prioritized themes for the 18th session of the CGRFA.
EU Proposals regarding Article 31bis of the TRIPS Agreement in the Context of the COVID-19 Pandemic
By Nirmalya Syam
This Policy Brief presents an analysis of the proposal by the European Union (EU) with regards to Article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as part of a Declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic. It discusses the EU’s proposed clarifications, why Article31bis does not provide an effective solution to promote access to pharmaceutical products and possible options.
COVID-19 y la necesidad de una organización internacional
Velásquez, Germán: Vacunas, medicamentos y patentes. COVID-19 y la necesidad de una organización internacional. Vacunas covid-19: entre la ética, la salud y la economía. Desarrollo de la vacuna COVID-19; la inmunidad y el contagio; el nacionalismo de las vacunas; el mecanismo COVAX; licencias obligatorias; Acceso a medicamentos y vacunas: un nuevo actor. Medicamentos y propiedad intelectual: diez años de la estrategia mundial de la oms. Repensando la fabricación mundial y local de productos médicos tras el covid-19. Repensando la i+d para productos farmacéuticos después del covid-19. Propiedad intelectual y acceso a medicamentos y vacunas. Las reformas de la organización mundial de la salud en la época de covid-19. 2021. 244 pp. ISBN 978-9915-650-31-9.
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra
The WTO TRIPS Waiver Should Help Build Vaccine Manufacturing Capacity in Africa
By Faizel Ismail
The current global health crisis created by the COVID-19 pandemic has re-focused our attention on the inadequacy of the TRIPS agreement and the patent system to address global public health crises. This time, developing countries must ensure that the TRIPS waiver succeeds in creating the impetus for the building of manufacturing capacity in the poorest countries, especially in Africa, for vaccines, pharmaceuticals and other health technologies. This is the only effective way in which African countries can reduce their dependence on imports of essential medicines and build their health security, contributing to the achievement of the sustainable development goals, for the poorest countries.
Interpreting the Flexibilities Under the TRIPS Agreement
By Carlos M. Correa
While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.
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.
The Role of Courts in Implementing TRIPS Flexibilities: Brazilian Supreme Court Rules Automatic Patent Term Extensions Unconstitutional
By Vitor Henrique Pinto Ido
This policy brief provides a background, summary and analysis of the Brazilian Federal Supreme Court decision of 6 May 2021 that ruled automatic patent term extensions unconstitutional, striking down Article 40, Sole Paragraph, of the Brazilian Industrial Property Code of 1996. It concludes that this is a landmark ruling that contributes to the implementation of a more balanced patent regime in Brazil, with a positive impact on access to medicines in the country. It is an important precedent in relation to the role that courts may play in defining the contours of intellectual property protection and the TRIPS flexibilities.
Propiedad intelectual y acceso a medicamentos: una introducción a cuestiones clave – algunos términos y conceptos básicos
Por Germán Velásquez
La propiedad intelectual y las patentes en particular se han convertido en uno de los temas más debatidos sobre el acceso a los medicamentos, desde la creación de la Organización Mundial del Comercio (OMC) y la entrada en vigor del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC). Las patentes no son de ninguna manera las únicas barreras para el acceso a medicamentos que salvan vidas, pero pueden desempeñar un papel significativo, o incluso determinante. Durante el período de protección de la patente, la capacidad del titular de la patente para determinar los precios, en ausencia de competencia, puede hacer que el medicamento resulte inalcanzable para la mayoría de las personas que viven en los países en desarrollo. Este primer número de los “Materiales de capacitación del South Centre” pretende, en su primera parte, ofrecer una introducción a cuestiones clave en el ámbito del acceso a los medicamentos y la propiedad intelectual. La segunda parte describe y define algunos términos y conceptos básicos de esta área relativamente nueva de las políticas farmacéuticas, que son los aspectos comerciales de los derechos de propiedad intelectual que regulan la investigación, el desarrollo y el suministro de medicamentos y las tecnologías sanitarias en general.
Expanding the production of COVID-19 vaccines to reach developing countries
Lift the barriers to fight the pandemic in the Global South
By Carlos M. Correa
The unfolding of COVID-19 has shown that the international system has been unable to ensure equal access to the vaccines and other products necessary to fight the pandemic. While the need for a strong response remains obvious, proposals for scaling up the production of COVID-19 vaccines across the globe are still blocked in the World Trade Organization.
La covid-19 et l’impératif d’une organisation internationale
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À partir de début 2020, le monde a dû faire face à un considérable défi sanitaire, économique et social avec l’épidémie de la COVID-19. La crise s’est poursuivie et aggravée dans la plupart des pays du monde. Beaucoup ont voulu explorer des réponses sans prendre réellement en compte les avis des principaux organismes internationaux dans le domaine de la santé, au premier rang desquels l’Organisation mondiale de la santé (OMS). L’OMS fait l’objet de critiques. Il est néanmoins fondamental qu’une agence multilatérale comme elle puisse exercer une véritable autorité et jouer un rôle de chef de le indépendant et en défense de l’ensemble des pays de la planète. Alors, comment faire pour qu’elle puisse jouer ce rôle ? Ce livre contribue à apporter des réponses à cette question, en s’appuyant sur les réflexions développées par le Centre Sud, un organisme intergouvernemental qui défend les perspectives des pays du Sud. Il aborde notamment l’avancement des réflexions et débats concernant l’accès aux médicaments et vaccins pour répondre à cette pandémie ou à d’éventuelles crises ultérieures.
Auteur: Germán Velásquez est conseiller spécial en matière de politique et de santé au South Centre à Genève.
Velásquez, Germán: Vacunas, medicamentos y patentes. COVID-19 y la necesidad de una organización internacional. Vacunas covid-19: entre la ética, la salud y la economía. Desarrollo de la vacuna COVID-19; la inmunidad y el contagio; el nacionalismo de las vacunas; el mecanismo COVAX; licencias obligatorias; Acceso a medicamentos y vacunas: un nuevo actor. Medicamentos y propiedad intelectual: diez años de la estrategia mundial de la oms. Repensando la fabricación mundial y local de productos médicos tras el covid-19. Repensando la i+d para productos farmacéuticos después del covid-19. Propiedad intelectual y acceso a medicamentos y vacunas. Las reformas de la organización mundial de la salud en la época de covid-19. 2021. 244 pp. ISBN 978-9915-650-31-9.
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