Patent Rights

Document de Recherche 214, 20 mars 2025

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.

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Research Paper 214, 15 January 2025

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.

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SouthViews No. 260, 20 March 2024

Patent rights and misappropriation of traditional knowledge: the case of the Amazonian Mirantã

By Marcos Vinício Chein Feres

This article aims to understand whether there are any signs of misappropriation enabled by the international patent system in the case of associated traditional knowledge to Mirantã, a plant (genetic resource – GR) found in the Amazon Basin. There is clear correspondence between the traditional uses of Mirantã and patent claims found, which are, or may at least hint at, evidence of the misappropriation of traditional knowledge. More generally, this confirms the perspective of the existence of a coloniality of knowledge as in many jurisdictions, due to the lack of measures to protect traditional knowledge against misappropriation (e.g., via a disclosure requirement in patent applications), these patents are for now deemed valid.

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