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”).
To continue reading this article and to access our full archive, digital magazines and special reports you will need a subscription.
Start a subscription today to access the LSIPR website
If you have already subscribed please login.
For multi-user price options, or to check if your company has an existing subscription we can add you into, please email Atif at achoudhury@newtonmedia.co.uk
If you have any technical issues please email tech support.
For access to the complete website and archive choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial select ‘TWO WEEK FREE TRIAL’.
Bolar exemption, CJEU, German Patent Act, District Court in Düsseldorf, Court of Appeals in Düsseldorf
