What Can Cambodia Learn from Thailand and India as It Prepares to Graduate from Least Developed Country Status?
By Brigitte Tenni, Deborah Gleeson, Joel Lexchin, Phin Sovath, and Chalermsak Kittitrakul
Cambodia is expected to graduate from Least Developed Country status soon, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia’s intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations’ Sustainable Development Goals. This paper examines Cambodia’s IP laws and regulations to identify provisions that could reduce access to affordable generic medicines when it starts granting patents for pharmaceuticals. It systematically compares Cambodia’s IP laws and regulations with those of Thailand and India – two developing countries that have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS-plus provisions in its patent legislation and avoid membership in bilateral or plurilateral trade agreements that include TRIPS-plus provisions as well as signing patent treaties and memorandums of understanding that may facilitate the granting of unwarranted patents.
Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines
By Behrang Kianzad
The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly in a situation of “national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Some legislations, such as European competition law, offer a toolbox for curbing the exercise of IPRs if they would be found in conflict with certain competition rules, such as rules prohibiting excessive pricing by dominant undertakings. The paper analyses the interface between intellectual property law and competition law in general, moving on to the settled case law of the Court of Justice of the European Union (CJEU) on this matter. It provides a general overview of legal and economics arguments related to excessive pricing prohibition and the main case law of European competition law on the matter and discusses whether compulsory licensing as a remedy against excessive pricing of patented life-saving pharmaceutical products can be a viable and appropriate remedy. Finally, the paper offers policy recommendations relating to compulsory licensing based on excessive pricing.
The WIPO Diplomatic Conference for a Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
By Viviana Muñoz Tellez
A new international legal instrument is set to be concluded under the auspices of the World Intellectual Property Organization (WIPO) in May 2024. Its legal nature should be that of an international treaty, given that a Diplomatic Conference, the last treaty making stage, will be held for its conclusion. The purpose of the instrument (hereinafter “the Treaty”) is to create an international minimum standard for patent applicants to provide information concerning the origin or source of the genetic resources or traditional knowledge associated with genetic resources as part of the patent application process. This Policy Brief provides an overview of the rationale for the Treaty and of the process and substantive issues to be negotiated, and advances recommendations towards ensuring a successful conclusion of the Diplomatic Conference.
The Protection of Traditional Knowledge, Traditional Cultural Expressions, Expressions of Folklore and Genetic Resources Within the African Continental Free Trade Area – Alignment with International and Regional Developments
By Caroline B. Ncube
The adoption of the Protocol on Intellectual Property Rights under the Agreement on the African Continental Free Trade Area presents an opportune moment to consider a continental framework for the protection of Traditional Knowledge, Traditional Cultural Expressions, Expressions of Folklore and Genetic Resources. This SouthViews considers lessons which can be drawn from national laws, using South Africa as an example, for the relevant Annex to be negotiated under the protocol.
Statements on Understanding on Intellectual Property Rights at time of Signature or Ratification of the BBNJ Treaty
South Centre
The Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable use of Marine Biological Diversity of Areas Beyond National Jurisdiction (BBNJ) negotiations did not fully address issues of intellectual property rights (IPRs), but countries can make statements on IPRs at the time of signature and/or on ratification of the BBNJ. Read our recommendations:
Proposal for a new Article 11bis in the WHO Pandemic Accord: a Pandemic Technology Transfer Mechanism
by Olga Gurgula and Luke McDonagh
The COVID-19 pandemic demonstrates the failure of voluntary mechanisms during global emergencies and exemplifies the need for effective involuntary technology transfer tools. The WHO Pandemic Accord offers an opportunity to provide an effective mechanism to build upon existing TRIPS flexibilities in the specific pandemic context. We propose a new provision (Article 11bis) that outlines a mechanism on cross-border procedure of non-voluntary technology transfer during a pandemic. This procedure could be invoked in a pandemic scenario in which voluntary technology transfer mechanisms have failed to provide sufficient supplies of a needed pandemic product.
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.
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.
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.
