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The 'Bolar' Exemption and the Supply of Patented Active Pharmaceutical Ingredients to Generic Drug Producers - An Attempt to Interpret Article 10(6) of Directive 2004/27/EC

Straus, JosephThe 'Bolar' Exemption and the Supply of Patented Active Pharmaceutical Ingredients to Generic Drug Producers - An Attempt to Interpret Article 10(6) of Directive 2004/27/EC Journal of intellectual property law & practice 9, 11 (2014), 895 - 908.

Under the EU 'Bolar' exemption studies and trials necessary to gain regulatory approval for generic medicinal products do not constitute patent infringement. In this article the author examines the coverage of the ‘Bolar’-rule in the broader context of the Community law in which it is embedded. He also addresses the compliance of this Community rule with the TRIPS Agreement. More specifically the author discusses the issue of third parties supply of patented active ingredients to generic drug companies for regulatory authorization and makes suggestions how it sould be solved under the ‘Bolar’-rule.

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