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.
Article 2 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a prior authorisation procedure, under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, for a device incorporating as an integral part a substance, within the meaning of Article 1(4) of that directive as amended, cannot be treated in the same way, for the purposes of applying that regulation, as a marketing authorisation procedure for that substance under Directive 2001/83/EC of the European Parliament
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