Pautas para el examen de patentes sobre anticuerpos monoclonales
Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini
La investigación tiene como objetivo conocer el estado de las solicitudes de patente en materia de anticuerpos monoclonales (mAbs). El documento analiza las distintas estrategias en materia de reivindicaciones que utilizan los solicitantes con el fin de obtener protección por derecho de patentes. Se utilizó como fuente de información la base de datos construida y descrita en el Documento de Investigación No. 186 de South Centre. Se indaga sobre las principales reivindicaciones utilizadas en el campo de los mAbs, el tipo de clasificación CIP y el tipo de invención (producto o proceso) más frecuente en las patentes concedidas vigentes o caducas en Argentina. Finalmente, se analiza la utilización de las directrices de patentamiento argentinas en el caso de mAbs y se hacen recomendaciones respecto de posibles reformas a dichas directrices.
TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics
By Nirmalya Syam and Muhammad Zaheer Abbas, PhD
The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
Implementing the Doha Declaration in OAPI Legislation: Do Transition Periods Matter?
By Patrick Juvet Lowé Gnintedem
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provided for a number of transition periods allowing countries to engage in a phased implementation of their TRIPS obligations. More specifically, transition periods targeted the patenting of pharmaceutical products. The original deadlines for transition periods have expired for developed and developing country WTO members. However, based on the Doha Declaration on the TRIPS Agreement and Public Health and subsequent TRIPS Council decisions, least developed countries (LDCs) continue to benefit from extended transition periods. In the African Intellectual Property Organization (OAPI), after an amendment in 1999, the legal framework has evolved with the amendment of the Bangui Agreement, i.e., the Act of Bamako of 14 December 2015. As for the previous text, the newly amended Bangui Agreement consecrates the unification on industrial property amongst its seventeen Member States. The main objective of such an amendment remains to adapt its legal framework to the international environment and to the economic and social development needs of Member States. Yet only five OAPI Member States are developing countries; the twelve others are LDCs. Then the question arises: do transition periods consecrated pursuant to the Doha Declaration still matter for LDCs who have agreed to be subjected to the OAPI legislation? This paper points out that transition periods remain relevant in OAPI countries by application of the more favorable rule between the Bangui Agreement and the WTO TRIPS Council decisions. It is however noted that the OAPI current legal framework is still problematic, while its LDCs members are underutilizing this flexibility.
Identifying Legal Challenges for Farmers’ Innovation
By Saurav Ghimire
On 9 October 2023, an expert workshop on “Identifying Legal Challenges for Farmers’ Innovation” was organised at the Centre for Private and Economic Law, Vrije Universiteit Brussel, in collaboration with the South Centre and Université Catholique de Louvain. The hybrid event gathered experts to discuss the challenges for farmers’ innovation, particularly those emerging from regulatory regimes. The workshop brainstormed policy and regulatory hindrances to farmers’ involvement in plant breeding, namely, in access to breeding materials, access to the market and reward/protection for the innovation.
The expert workshop was organised as a part of a joint research project, “Farmers as Plant Breeders: Legal Mechanisms to Foster Farmers’ Innovation”, led by Prof. Christine Frison (Université Catholique de Louvain), Prof. Kim Van der Borght (Vrije Universiteit Brussel), and Prof. Carlos Correa (South Centre). The research project is funded by the Research Foundation Flanders (FWO).
Patentamiento de anticuerpos monoclonales. El caso de Argentina
Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini
Este documento de investigación tiene como objeto identificar, describir y analizar las patentes concedidas por el Instituto Nacional de la Propiedad Industrial (INPI) de Argentina, en materia de anticuerpos monoclonales desde el año 2010 al 2020 inclusive. La investigación incluye la materia protegida y el universo de solicitantes, entre otros aspectos. Para ello, se procedió a construir una base de datos de patentes y solicitudes, donde se examinan las características de las patentes solicitadas y concedidas, titularidad y nacionalidad de los solicitantes, estado de las solicitudes, tiempo que demora la resolución de una patente solicitada y patentes divisionales. El documento presenta también recomendaciones de política pública aplicables a las patentes sobre anticuerpos monoclonales.
Colombia declara de interés público el uso de patente sobre Dolutegravir para incrementar el acceso a tratamiento a personas que viven con HIV
3 de octubre de 2023
El South Centre, el organismo intergubernamental de 55 países en desarrollo, celebra la decisión del Gobierno de Colombia de hacer uso gubernamental no comercial de una patente con el objetivo de garantizar que las personas que viven con VIH reciban tratamientos basados en Dolutegravir (DTG). Estos tratamientos son financiadas con recursos públicos asignados a la salud.
Neglected Dimension of the Inventive Step as Applied to Pharmaceutical and Biotechnological Products: The case of Sri Lanka’s patent law
By Ruwan Fernando
Apart from the basic statutory definition in section 65 of the Intellectual Property Act of Sri Lanka, there do not appear to be any detailed statutory guidelines or judicial decisions to provide any framework for the assessment of inventive step in Sri Lanka. The current statutory definition is highly insufficient to evaluate the standard of obviousness in relation to biotechnological and pharmaceutical claims based on a combination or modification of a prior art reference.
The Courts in both developed and developing countries have adopted a variety of tests to evaluate the obviousness standard of a claimed invention based on a combination or modification of a prior art reference. Sri Lanka, as a developing country, should look at the development that has taken place in other jurisdictions and adapt the patent law to local conditions when developing tests or guidelines in a manner that is compatible with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its biotechnology/pharmaceutical policy guidelines.
This approach that is appropriate to Sri Lanka is twofold. First, it is most likely to prevent the issuance of patents on trivial or incremental inventions that do not provide any technical advance to the existing prior art and are a mere extension of what is already known in the prior art. Second, it is most likely to protect genuine technical advances to the existing prior art while at the same time enhancing competition and promoting local innovations so that the local researchers will be able to draw on the existing knowledge for the purpose of follow-on innovations.
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).
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
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: