Analoge Anwendung der Verordnung über das ergänzende Schutzzertifikat für Arzneimittel auf Medizinprodukte?

The European legislator addressed the erosion of pharmaceutical patent protection resulting from complex clinical trials and approval procedures by creating the supplementary protection certificate by Regulation (EC) No. 469/2009. Except for plant protection products, however, no other products are eligible for SPC protection so far. This is particularly problematic regarding medical devices. They have the same intention as medicinal products and may have – at least auxiliary – medicinal action.
This thesis investigates whether medical devices can obtain SPC protection by analogous application of Regulation (EC) No. 469/2009. Especially, it compares the medicinal marketing authorization with the conformity assessment procedure (and consultation procedure, where applicable) for medical devices.
It also aims a critical analysis of the treatment of SPCs by the European legislator and the Court of Justice of the EU.