SC Statement – WIPO DLT Diplomatic Conference, November 2024
South Centre Statement to the WIPO Diplomatic Conference to Conclude and Adopt a Design Law Treaty
11-22 November 2024, Riyadh, Saudi Arabia
South Centre Statement to the WIPO Diplomatic Conference to Conclude and Adopt a Design Law Treaty
11-22 November 2024, Riyadh, Saudi Arabia
Towards a Balanced WIPO Design Law Treaty (DLT) for Developing Countries
By Nirmalya Syam
The WIPO Design Law Treaty (DLT) aims to harmonize and simplify global industrial design registration procedures, encourage digital applications and reduce costs. While the reforms required by the DLT could boost efficiency, they will mainly benefit enterprises from developed countries with resources to secure global design rights. This policy brief highlights the key concerns for developing countries, particularly the treaty’s potential impacts on small and medium-sized enterprises (SMEs) and indigenous communities. It advocates for critical adjustments in the DLT negotiation texts to allow for policy space in the DLT – binding technical assistance, flexible grace periods, enabling disclosure of the origin and source of traditional knowledge and traditional cultural expressions used in designs that are sought to be registered, and optional divisional and electronic filing provisions.
Can international law promote innovation from genetic resources and benefit sharing while recognizing the rights of traditional knowledge holders?
By Henry de Novion
Indigenous peoples and local communities have been innovating for millennia and contributing to the development of new products and processes. For international law to promote innovation, it is indispensable to promote indigenous peoples and local communities’ rights to prior informed consent, to benefit sharing, and to guaranteeing their territories, culture, and existence.
A Fair Solution for Access and Sharing of Benefits of Digital Sequence Information? Decision for the CBD COP in November 2024
By Viviana Munoz Tellez
A decision is expected from the Conference of the Parties of the Convention on Biological Diversity (CBD) by 1 November 2024 on a solution to the fair and equitable sharing of benefits from the use of digital sequence information (DSI) on genetic resources. There are different forms of non-monetary and monetary benefits from the use of DSI that are being considered. This paper argues that for monetary benefit sharing, the focus should be on when DSI is used commercially, as part of products or services. Calculations should be based on revenue that includes sales and intellectual property licencing.
Decision 15/9 and the Nagoya Protocol: Who should get what in the Multilateral Benefit-Sharing Mechanism?
By Joseph Henry Vogel, Natasha C. Jiménez-Revelles, Xavier A. Maldonado-Ramírez de Arellano
Article 10 of the Nagoya Protocol (NP), “Global Multilateral Benefit-Sharing Mechanism” (GMBSM), asks Parties to consider the distribution of benefits derived from the utilization of genetic resources in transboundary situations. A literature exists which applies the economics of information to genetic resources, when interpreted as “natural information”. The policy implication would incentivize reduction in the drivers of mass extinction, through economic rents in royalty obligations. Fifteen cases become thought experiments on how to share royalty income. A sixteenth case addresses the TP53 gene in elephants, which may revolutionize oncology. In parallel to Article 10 of the NP is Decision 15/9 of the fifteenth Conference of the Parties to the Convention on Biological Diversity. That Decision establishes a “multilateral benefit-sharing mechanism from the use of digital sequence information on genetic resources”. Redundancy with the GMBSM is only apparent. The Decision omits rents and thus renders its mechanism inefficient, unfair and inequitable.
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.
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.
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.