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.
Statement by the South Centre to the WIPO Intergovernmental Committee on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
South Centre is participating in the textual based negotiations in WIPO on the protection of traditional knowledge and traditional cultural expressions this week at IGC50 chaired by DPR of Brazil, Erika Watanabe Patriota. International rules are needed to protect the interests of indigenous and local communities and prevent misappropriation.
This paper argues that the global capitalist economy has been and is built on the monopolization of advanced technological knowledge through trade secrets and intellectual property rights protection, controlled by companies and countries of the Global North. Companies and countries in the Global South use commoditized knowledge or knowledge in the commons. In the colonial period this was largely confined to the production of agricultural commodities and now to carry out the bulk of production functions. This division of knowledge and the difference in returns to monopolized knowledge and knowledge in the commons drives global inequality. The paper points out that countries of the Global South that moved out of the middle-income trap did so by advancing from just using knowledge to also creating knowledge. Finally, it argues that there is a need to reform the system of intellectual property rights in order to promote inclusion and not exclusion.
The Riyadh Design Law Treaty: Harmonizing Global Design Procedures with Mixed Implications
By Nirmalya Syam
The Riyadh Design Law Treaty (DLT), adopted on November 22, 2024, aims to harmonize and simplify the global registration procedures for industrial designs. By standardizing procedural requirements across jurisdictions, the treaty seeks to create a more predictable and accessible system for designers, particularly benefiting small-scale designers and small and medium-sized enterprises (SMEs). However, the DLT can have implications for developing countries, as many lack significant design-intensive industries. Key provisions in the DLT include a 12-month grace period, deferred publication, divisional applications, and the option to require disclosures regarding traditional knowledge and cultural expressions used in a design. While the treaty enhances global design protection, concerns persist regarding its impact on local designers, market competition, and procedural fairness. The immediate advantages of the DLT for developing countries are limited, highlighting the need for continued technical assistance and capacity-building efforts.
Statement in Support of Discussions on Counterfeiting in the Biotechnology Sector and the Prevention of Biopiracy WIPO Advisory Committee on Enforcement (ACE)
Today at the 17th Session of the World Intellectual Property Organization (WIPO) Advisory Committee on Enforcement (ACE), the South Centre delivered its statement, emphasizing the need to prevent biopiracy while addressing counterfeiting in the biotechnology sector. A balanced IP enforcement approach is key to protecting biodiversity & traditional knowledge.
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.
Las nuevas pandemias son inevitables. ¿Cómo podemos estar mejor preparados para ellas y, sobre todo, cómo podemos evitar los errores e injusticias cometidos durante la pandemia de COVID19? Actualmente se están llevando a cabo negociaciones para formular un tratado internacional vinculante sobre prevención y preparación que garantice respuestas más justas a futuras pandemias. Este libro pretende ser una contribución crítica a estos debates en curso.
¿Cómo garantizar un acceso equitativo a los medicamentos y diagnósticos cuando la mayoría de ellos se producen en un número reducido de países? ¿Cómo explicar que la financiación actual de la cooperación sanitaria esté en manos de un pequeño grupo de países y fundaciones del Norte? ¿Cómo reforzar el papel de la Organización Mundial de la Salud, que actualmente desempeña un papel secundario en la coordinación de las políticas de salud pública? ¿Por qué se ha sustituido el concepto de «medicamentos esenciales», gran avance de la política de salud pública, por el de «contramedidas médicas», término más acorde con el afán de lucro del sector privado?
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra