Intellectual Property

SouthViews No. 268, 12 July 2024

A New World – Without Patents

By Calixto Salomão Filho

Patent law has a profound impact on the social, environmental, and economic dynamics of societies. This commentary is a critical academic perspective on the theoretical underpinnings of patent law.

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Research Paper 203, 11 July 2024

The Vaccine Industry After the COVID-19 Pandemic: An International Perspective

By Felix Lobo

The purpose of this report is to analyze the impact that the COVID-19 pandemic has had on the vaccine industry from an international perspective. The objective is to learn from the experience and contribute to the design of better tools for future vaccine development and manufacturing, as we must be prepared for future emerging infectious diseases with the potential for global expansion. This industry makes fundamental contributions to global social welfare, but from a business point of view it is complex and difficult to manage, and from an economic point of view it is an industry that does not fit the paradigm of competitive market efficiency with notorious market failures.

We examine the impact of the pandemic on innovation and the scientific, technological and industrial development of vaccines and find that certain elements of the industry’s structure have changed, while others have remained. We also summarize the lessons learned from the deployment of some public policies to boost supply and drive demand, paying particular attention to the inequity in the global distribution of vaccines and to the COVAX program. We conclude that some of the policies have been very effective, while others have not fully achieved their objectives. From the achievements and limitations, lessons can be drawn for the reformulation and expansion of global public policies that would stimulate R&D, manufacturing, distribution and access.

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South Centre Statement – 65th WIPO Assemblies, 10 July 2024

South Centre Statement to the Sixty-Fifth Series of Meetings of the Assemblies of the Member States of WIPO (2024)

 10 July 2024

At the WIPO Assemblies 2024, the South Centre calls for rapid adherence to  the WIPO Treaty on IP, Genetic Resources & Associated Traditional Knowledge, for the revision in this regard of the Patent Cooperation Treaty, for advancing the agenda on copyright L&Es and for upholding the WIPO Development Agenda.

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Research Paper 198, 31 May 2024

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.

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Research Paper 197, 28 May 2024

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.

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SC Statement – WIPO Diplomatic Conference on GRs & Associated TK, 13-24 May 2024

STATEMENT

Diplomatic Conference on Genetic Resources and Associated Traditional Knowledge

Geneva, May 13-24, 2024

The South Centre at WIPO Diplomatic Conference urges strong improvements in Basic Proposal for IP and genetic resources treaty: clear minimum standards for patent disclosure, digital sequence information inclusion & WIPO website for monitoring claims. Searching consensus must not impede this vital treaty to incorporate effective measures against misappropriation.

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Policy Brief 129, 7 May 2024

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.

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SouthViews No. 263, 1 May 2024

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.

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Statements on IPRs of BBNJ, April 2024

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:

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SouthViews No. 261, 23 April 2024

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.

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Documento de investigación 196, 19 de abril de 2024

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.

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