The Bolar exemption: the question of third parties


Bernd Allekotte

The Bolar exemption: the question of third parties

A new referral to the CJEU should shed light on the extent of the so-called Bolar exemption in Europe, says Bernd Allekotte.

By order dated December 5, 2013, the Court of Appeals in Düsseldorf (docket no. I-2 U 68/12) referred various questions to the Court of Justice of the European Union (CJEU). The court asks for guidance on whether (and under what conditions) the supply of patented compounds by a third party to a (domestic) generic company, which intends to use the compounds for obtaining a marketing authorisation for a generic drug, is covered by the Bolar exemption.

Legal background

Generic companies are allowed to use a patented compound/substance in the studies and trials that are required for obtaining a marketing authorisation. European pharma legislation (Directives 2004/27/EC and 2004/24/EC) provides for respective EU-wide provisions that shield the generic company from being held liable for patent infringement when using the compounds/substances for these purposes (so-called “Bolar exemption”).

Bolar exemption, CJEU, German Patent Act, District Court in Düsseldorf, Court of Appeals in Düsseldorf