SPC on the basis of an MA for active implantable medical devices

Thanks to Matthias Kindler and Bianca-Lucia Vos (Hoffmann Eitle) for providing the following summary of a recent decision on SPCs for medical devices:

"The German FPC has issued a decision on SPC application 12 2005 000 052 in the name of the Curators of the University of Missouri. The SPC is for “yttrium-90 glass microspheres” and the application had been rejected by the GPTO because the application referred to EC Certificates CE 500 749 and CE 501 532 for the product “TheraSphere(R) yttrium-90 glass microspheres” as relevant MAs. The EC certificates were issued by BSI Product Services according to Council Directive 90/385/EEC relating to active implantable medical devices. The GPTO based the rejection on the ground that only medicinal products and not medical devices were authorized by the legislators as the basis for an SPC.

The German FPC overturned the decision of the GPTO. They found that under the specific circumstances of the present case the certificates CE 500 749 and CE 501 532 are to be considered as certificates granted analogously to Directive 65/65/EEC (now replaced by 2001/83/EC in the version of Directive 2004/27/EC). "

A copy of the German decision can be obtained here, and an english translation here.