The CJEU has this week handed down its answer to a question referred by the German Bundespatentgericht, and has emphatically shut the door on the possibility of obtaining an SPC for a medical device. 

Here the Bundespatentgericht had requested confirmation of whether authorisation of a medical device containing an active ingredient could be considered to have been authorised under Directive [2001/83] as required by Article 2 of the SPC Regulation since authorisation of the medical device would require a complete assessment of safety and efficacy of an associated active ingredient. In answering this question in the negative the CJEU has retained the bar on SPCs for medical devices, effectively shutting down any possibility for extending patent term in this manner.