Experiencias internacionales sobre la concesión de licencias obligatorias por razones de salud pública
Por Catalina de la Puente, Gastón Palopoli, Constanza Silvestrini, Juan Correa
El presente estudio tiene como objetivo analizar los regímenes de licencias obligatorias (LOs) en países seleccionados, en particular los elementos económicos de la concesión de las LOs, la determinación y negociación de regalías al titular del derecho. Para ello se realizó un análisis descriptivo y exploratorio de experiencias de concesión de LO en países seleccionados, con foco en las experiencias de los países en vías de desarrollo por su proximidad al caso argentino.
En particular se discuten los ejemplos de experiencias de emisión de medidas de LOs o de UG en países en vías de desarrollo. Con especial foco en Latinoamérica, donde sólo dos países han hecho uso de dichas medidas por razones sanitarias (Ecuador y Brasil). Además se examina la eficacia del empleo de LO o de UG en la reducción de precios donde se evidencian ahorros significativos Como conclusión se propone elaborar una metodología en relación a las regalías para Argentina mediante un rango de pago que tome en consideración criterios de accesibilidad y asequibilidad poblacional a la tecnología licenciada, así como la sustentabilidad de los presupuestos de los agentes financiadores.
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).
Broadcasting treaty – South Centre statement at SCCR 43
“We note with concern that the proposed text expands beyond the agreed mandate, under the approach of expanding exclusive rights to broadcasters with narrow limitations and exceptions (L&Es)…”
The copyright system must be truly balanced. It means it should enable public interest purposes, particularly access to knowledge and education, a fair reward for creators, and real incentives – and not barriers – for creativity and research…
Understanding the Functioning of EU Geographical Indications
By 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.
The UPOV accession process: Preventing appropriate PVP laws for new members
By Nirmalya Syam, Shirin Syed, and Viviana Munoz-Tellez
The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization established by the International Convention for the Protection of New Varieties of Plants adopted in Paris in 1961. UPOV requires its contracting parties to establish an intellectual property system for plant varieties that favors the interests of commercial plant breeders but does not address the needs of farming systems in developing countries or the rights of smallholder farmers.
The accession process for new countries to UPOV as provided in the UPOV Convention is based on an examination of conformity of the plant variety protection (PVP) law of the acceding country with obligations under the UPOV Convention. Only if the UPOV Council gives a positive decision on the basis of such conformity examination, the acceding state can deposit its instrument of accession. This accession process does not allow new members any flexibility to adapt their national PVP law to their own needs and accommodate their traditional agricultural sector and related public policy issues such as the livelihoods of farmers, sustainable agriculture, and implications for food security. Prior UPOV members have greater flexibility than new members in enacting domestic legislation to implement the obligations under the 1991 Act by adopting their own interpretations of the obligations, which cannot be reviewed by the UPOV Council at the time of their accession to the 1991 Act.
The various acts of the convention were essentially negotiated between developed countries. The UPOV accession procedure is unique compared to intellectual property treaties administered by the World Intellectual Property Organization (WIPO) as well as the accession processes in the World Trade Organization (WTO), the Convention on Biological Diversity and its protocols, or the Food and Agricultural Organization (FAO) International Treaty on Plant Genetic Resources. None of these agreements have an obligatory conformity examination of national legislation before accession. In addition, the UPOV Council’s decisions regarding examination of conformity are not always consistent, and significant discretion is exercised by the UPOV Secretariat in interpreting the provisions of the convention as well as their implementation in national law. The UPOV Council’s guidance document for the preparation of laws in accordance with the 1991 Act also provides an extremely narrow interpretation of the provisions of the convention.
Therefore, developing countries should consider whether, instead of accession to UPOV, it would be better for them to adopt their own sui generis system of PVP which allows them to enact a law in accordance with their needs and circumstances. It would also be important for the UPOV Council to adopt a national deference principle in conformity examinations; limit the examinations to a review of adopted laws, as the convention does not mandate the council or the secretariat to intervene in the process of development of national PVP laws; and not undertake additional examinations after a positive decision is given.
South Centre Supports Debates on Developments in Copyright Law and Access to Knowledge in Africa
By 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.
El debate sobre la exención de los derechos de propiedad intelectual en tiempos de pandemia
Descripción:
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
South Centre Repository of Copyright Limitations and Exceptions
The South Centre is launching a repository of materials on copyright limitations and exceptions (L&Es) for the benefit of the diplomatic community in Geneva and capital-based delegates, with a focus on multilateral negotiations at the World Intellectual Property Organization (WIPO) on this matter, and to support regional and national laws and policies. The South Centre is committed to promoting a public interest-oriented copyright system which enables access to knowledge and is conducive to research, education, preservation, and other public goals. Please feel free to suggest further materials for this repository to Dr. Vitor Ido, Programme Officer of the South Centre (ido@southcentre.int).
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.
Descripción: