Licencias obligatorias para exportación: operacionalización en el orden jurídico argentino
Por Valentina Delich
En el año 2017, entró en vigor la enmienda del Acuerdo sobre los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC), por la cual se incluyó el artículo 31 bis en su texto. Esta disposición permite las licencias obligatorias para exportación a terceros países sin o con insuficiente capacidad de producción local. El objetivo es paliar las dificultades de los países sin infraestructura de producción de medicamentos para que puedan hacer un uso efectivo de las licencias obligatorias y así fortalecer el acceso a los medicamentos a un menor precio. Argentina es un país que tiene infraestructura de producción de medicamentos y potencialmente podría devenir en un exportador eficiente. Este documento explora la posible instrumentación del art. 31 bis en la legislación de Argentina, proponiendo incorporar en la ley de patentes nacional el instituto de la licencia obligatoria humanitaria.
Unlocking the Potential of Copyright Limitations and Exceptions (L&Es)
by Faith O. Majekolagbe
Copyright limitations and exceptions (L&Es) are vital tools for creativity, innovation, access to knowledge and education, and human capital formation. All of these are crucial to the development of societies and achieving the United Nations’ Sustainable Development Goals (SDGs). A strong system of well-defined copyright L&Es guarantees the public adequate access and use of the cultural goods and knowledge that are critical to achieving development goals. This paper identifies and discusses specific clusters of L&Es that are essential for achieving the SDGs. These clusters should be recognized and implemented in copyright laws at national, regional, and international levels to strengthen development objectives. Instead of applying specific L&Es to all countries, regardless of their unique developmental needs, recognizing these clusters of L&Es could help design an approach to international copyright law that is centred around development. Ultimately, this approach would provide greater flexibility in designing development programs that align with the SDGs and recognize copyright law’s inherent development rationale.
South Centre Statement at the 9th session of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response
March 2024
The South Centre underscores the imperative for an international binding pandemic treaty to prevent the recurrence of past failures like those witnessed during the COVID-19 crisis.
Patent rights and misappropriation of traditional knowledge: the case of the Amazonian Mirantã
By Marcos Vinício Chein Feres
This article aims to understand whether there are any signs of misappropriation enabled by the international patent system in the case of associated traditional knowledge to Mirantã, a plant (genetic resource – GR) found in the Amazon Basin. There is clear correspondence between the traditional uses of Mirantã and patent claims found, which are, or may at least hint at, evidence of the misappropriation of traditional knowledge. More generally, this confirms the perspective of the existence of a coloniality of knowledge as in many jurisdictions, due to the lack of measures to protect traditional knowledge against misappropriation (e.g., via a disclosure requirement in patent applications), these patents are for now deemed valid.
The South Centre carries out multiple activities to support developing countries with policy-oriented research, inputs and advice for negotiations and capacity building. See a summary of the South Centre’s activities in the Annual Report 2023.
New US Policy on Exercise of March-In Rights to Curb High Drug Prices: Lessons for the Global South
By Nirmalya Syam
In response to soaring prescription drug costs, the United States government recently announced proposed changes to the exercise of march-in rights under the Bayh-Dole Act, allowing federal agencies to license taxpayer-funded inventions to other parties based on factors such as accessibility and affordability. This article explores the implications of the US policy shift on global pharmaceutical pricing and access, particularly for developing countries. Drawing parallels between the US approach and flexibilities under intellectual property laws such as compulsory licensing and government use authorizations that are allowed under the WTO TRIPS Agreement, the article suggests that similar strategies could be employed by developing nations to address public health needs and economic considerations.
Régimen de licencias obligatorias y uso público no comercial en Argentina
Por Juan Ignacio Correa
Con la adopción del Acuerdo sobre los Aspectos de Propiedad Intelectual relacionados con el Comercio (ADPIC), la Argentina debió adaptarse a las nuevas reglas internacionales en materia de derecho de patentes. Uno de los puntos centrales del Acuerdo es la posibilidad de establecer diferentes formas de licencias obligatorias y uso gubernamental no comercial. Este documento analiza las condiciones previstas en el artículo 31 del ADPIC con ese fin y examina en detalle las diferentes causales de licencias obligatorias contempladas en la legislación argentina y las condiciones aplicables a cada una de ellas, así como para el uso de patentes por parte del gobierno con fines no comerciales. Finalmente, con base en el margen normativo del ADPIC y la legislación vigente, el documento discute el posible contenido de una reglamentación de licencias obligatorias y uso público no comercial que permita a la Argentina utilizar de manera efectiva esas herramientas cuando se presente alguna de las circunstancias previstas en la actual regulación.
How Should the WHO Pandemic Treaty Negotiations Tackle Intellectual Property?
By Viviana Muñoz Tellez
The WHO pandemic instrument should commit the Parties to limit the exclusionary effects that government-granted patents and other IPRs may have during pandemics in support of rapid diffusion of new vaccines, diagnostics, medicines and other tools and facilitate collaboration and freedom to operate. The current draft text of Article 11 would not make any change to the status quo.
Implementation of TRIPS Flexibilities and Injunctions: A Case Study of India
by Shirin Syed
The proponents of intellectual property (IP) have increasingly utilized injunctions with indiscriminate propensity as a strategic tool for IP enforcement, resulting in adverse socio-economic implications, including the enjoyment of human rights. This trend has eclipsed the flexibilities provided in the Doha Declaration on the TRIPS Agreement and Public Health. Although a substantial volume of the literature focuses on the flexibilities of compulsory license or scope of patentability, little attention has been given to the flexibilities related to IP enforcement. Discussing the implications of IP enforcement on public interest, the paper examines the gaps in the articulation of flexibilities of intellectual property rights (IPRs) enforcement, with special reference to injunctions in India. It examines how far the courts consider the implications on the enjoyment of fundamental rights while granting injunctions on patents. This paper argues that the Indian courts have deviated from the cautious approach provisioned under the TRIPS flexibilities that allows the courts to consider the public interest aspect and human rights implications while granting injunctions in patent litigation. Moreover, it asserts that the courts should exercise prudence in granting injunctive relief in cases involving patent infringement, and take into account the potential impact of such relief on the exercise of human rights. This suggests a need for a careful examination of the potential implications of injunctive remedies in such cases.
This Policy Brief discusses issues concerning trade, intellectual property, and technology transfer that are most relevant for consideration at the 13th World Trade Organization (WTO) Ministerial Conference (MC13) in February 2024 and inclusion in its outcomes.
The following recommendations are proposed:
TRIPS non-violation and situation complaints: MC13 Decision on the scope and modalities of non-violation and situation complaints under the Agreement on Trade related Aspects of Intellectual Property Rights (TRIPS). A second option is to extend the moratorium.
TRIPS, diagnostics and therapeutics for COVID-19: MC13 Decision that extends the MC12 TRIPS waiver Decision (only applicable to vaccines) to diagnostics and therapeutics
Relationship between TRIPS and the Convention on Biological Diversity: to be addressed in the MC13 Outcome Document
Follow up to the MC12 Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics: to be addressed in the MC13 Outcome Document
Relationship of trade and technology transfer: include in the MC13 Outcome Document to reinvigorate and give direction to the Working Group on Trade and Technology Transfer (WGTTT) and increase attention in all relevant bodies on how the WTO can promote technology transfer
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.
