Patent Rights

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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