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”).
Start a subscription today to access the LSIPR website.
To access the full archive, digital magazines and special reports you will need to take out a paid subscription.
If you have already subscribed please login.
If you have any technical issues please email tech support.
For access to the complete website, archive, and to receive print publications, choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial with full access, select ‘TWO WEEK FREE TRIAL’.
Bolar exemption, CJEU, German Patent Act, District Court in Düsseldorf, Court of Appeals in Düsseldorf
