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”).
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
Cooley
European Patent Office
Finnegan LLP
GH Research
Gowling WLG
George Washington Law School
HGF Limited
IQVIA
Kirkland & Ellis International LLP
Marks & Clerk
Mintz Levin
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
Taylor Wessing
The United States Patent and Trademark Office (USPTO)
Valea AB
World Intellectual Property Office
For multi-user price options, or to check if your company has an existing subscription we can add you into for FREE, please contact Atif at achoudhury@newtonmedia.co.
If you have any technical issues please email tech support.
Bolar exemption, CJEU, German Patent Act, District Court in Düsseldorf, Court of Appeals in Düsseldorf
