Lessons for the Global South from U.S. Legislation on Patent Thickets
By Nirmalya Syam
The US Senate’s passage of the Affordable Prescription for Patients Act (S-150) targets patent thickets, strategic barriers used by pharmaceutical companies to delay the entry of biosimilar drugs and maintain high prices. This US legislative act offers valuable lessons for the Global South, where similar reforms can strengthen patent review processes, encourage competition, and utilize TRIPS flexibilities to improve access to affordable medicines, fostering a more equitable healthcare system.
Negotiating Health and Autonomy: Data Exclusivity, Healthcare Policies and Access to Pharmaceutical Innovations
By Henrique Zeferino De Menezes, Julia Paranhos, Ricardo Lobato Torres, Luciana Correia Borges, Daniela De Santana Falcão and Gustavo Soares Felix Lima
This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research and development and greater profitability. However, this is a sensitive issue with economic and social repercussions for developing countries that adopt this protection regime. This paper highlights critical issues for the political economy of innovation and presents a review of empirical studies that show that data exclusivity delays the entry of generic drugs into the market, increasing prices and reducing access. At the same time, its adoption has no benefits because there are no positive effects on internal technological innovation, nor reduction of the “International drug lag”, nor the development of drugs for specific epidemiological demands.
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.
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.
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.
Understanding the New WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
By Nirmalya Syam and Carlos M. Correa
A new WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge was adopted on 24 May 2024. The treaty creates an international obligation for patent applicants to disclose the source or origin of genetic resources (GRs) and associated traditional knowledge (TK) in patent applications. This development marks a significant step towards mitigating the misappropriation of GRs and TK, particularly benefiting developing countries that have long advocated for such a framework. While the treaty establishes minimum standards for disclosure and sanctions, it permits contracting parties considerable flexibility in implementation and opens avenues for future expansion of its scope to address emerging technologies and derivative products.
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.
