10 September 2018
The Dutch legal journal JGR (journal on medicines law) recently published an article titled ‘Geneesmiddelenonderzoek en de Bolar-exceptie; harmonisatie tot de voordeur’ (Drug research and the Bolar-exemption; harmonization up to the front door) written by Arvid van Oorschot. The article covers the lack of European harmonization of the exemption for drug research in patent law; the so-called Bolar-exemption. The scope of this exemption differs per member state. This could mean that the same (cross border) clinical trial qualifies as patent infringement in one member state yet is exempted in another. In the Netherlands the Bolar-exemption is interpreted narrowly whereas a broad interpretation is applied by the majority of the European member states. This results in an unequal level playing field which is incompatible with the European harmonization objective and the Dutch national ambition to stimulate drug research. Therefore both Europe and the Netherlands would benefit from a uniform interpretation of the Bolar-exemption.
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