IP and Public Interest
Intellectual Property For Development Group – Side Event:
30 Years of Trips: Expectations and Concerns of Developing Countries
Date: 19th March 2025, 1 PM
Venue: Room SI, World Trade Organization
Hybrid event
Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
The WIPO Development Agenda: Progress and Challenges in 2025
By Nirmalya Syam
The World Intellectual Property Organization (WIPO) Development Agenda (DA), adopted in 2007, seeks to align intellectual property (IP) policies with the development priorities of member States. Enduring challenges persist despite some progress including the adoption of treaties to facilitate access to copyright protected works for visually impaired and print disabled persons, and the recent treaty on IP, genetic resources and associated traditional knowledge, and the adoption of several projects for implementing different DA recommendations. DA projects, however, have had limited impact on mainstreaming a development orientation in WIPO, there is limited promotion of use of IP flexibilities for development, and WIPO’s technical assistance continues to lack a development orientation. There is also a sustained absence of consideration and reporting of development related issues across WIPO bodies. Divergent interpretations of “development”, weak coordination and monitoring systems, and governance inequities have hindered the DA’s transformative potential. This brief examines these issues and advances recommendations to address the challenges to establish an effective DA.
Application of the Bolar Exception: Different Approaches in the EU
By Dmytro Doubinsky
This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar exception, a legal mechanism designed to allow generic drug manufacturers to seek regulatory approval before a patent expires, thus preventing the de facto extension of patent monopolies. The study examines the transformation of the Bolar exception from a specific legal case into a significant tool of intellectual property, commercial, and pharmaceutical law. The paper analyzes key international legal frameworks and European directives related to the Bolar exception and highlights divergent interpretations of the Exception in German and Polish case law. Through this comparative analysis, the paper argues for the broader implementation of Bolar exceptions to improve access to affordable medicines and reduce healthcare costs.
International Regulation of Industrial Designs: The TRIPS Agreement in the Light of European Union Law
By Adèle Sicot
This paper analyzes the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) on industrial designs, and the manner in which the narrow aspects dealt with by the Agreement have been addressed by European Union (EU) legislation. The paper highlights the absence of a definition of protectable subject matter, and the considerable flexibility left to the member countries of the World Trade Organization to determine the framework of protection, notably on the basis of copyright. The paper also notes certain areas in which European legislation is more elaborate, and others which could be considered incompatible with the TRIPS Agreement.
Navigating the WTO’s Working Group on Trade and Transfer of Technology: A Critical Analysis from the Perspective of Developing Countries
By Nirmalya Syam
This paper critically analyzes the operations and effectiveness of the World Trade Organization’s (WTO) Working Group on Trade and Transfer of Technology (WGTTT). Despite the establishment of the WGTTT in 2001 with a mandate to enhance technology flows to developing countries, the Group has struggled to produce meaningful outcomes due to divergent priorities between developed and developing countries. This paper finds that the WGTTT remains an exploratory discussion forum rather than a negotiation platform with the capacity to generate new initiatives that address the technology transfer needs of developing countries. Key reforms are proposed, including transitioning to a negotiation-oriented approach, improving the balance of member priorities, and focusing on actionable themes to enhance the WGTTT effectiveness in fostering technology transfer to developing countries.
Matrix of Key Issues in the WTO TRIPS Council
Health, Intellectual Property and Biodiversity Programme, November 2024
The following matrix provides a factual overview and analysis of the standing and non-standing agenda items of the regular session of the WTO TRIPS Council of 6-7 November. The matrix also discusses the TRIPS Implementation issues as part of the WTO Doha Development Round of negotiations.
Régulation internationale des dessins et modèles industriels : l’Accord sur les ADPIC à l’aune du droit de l’Union européenne
Par Adèle Sicot
Ce document analyse les dispositions de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (l’Accord sur les ADPIC) sur les dessins et modèles et la manière dont les aspects limités traités par l’Accord ont été abordés par la législation de l’Union Européenne (l’UE). Il note l’absence d’une définition de la matière susceptible de protection et une considérable flexibilité laissée aux pays membres de l’Organisation Mondiale du Commerce pour déterminer le cadre de protection, notamment sur la base du droit d’auteur. Le document note aussi certains aspects dans lesquels la législation européenne est plus élaborée et d’autres dans lesquels on pourrait observer une incompatibilité avec l’Accord sur les ADPIC.
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.
