Court of Justice rules on material scope of supplementary protection certificate regime

Abstract

The Court of Justice of the European Union (ECJ) has clarified that a product placed on the Community market as a medicinal product for human use before obtaining a marketing authorization in accordance with Directive 65/65 and, in particular, without undergoing safety and efficacy testing is not within the scope of Regulation 1768/92 and may not therefore be the subject of a supplementary protection certificate (SPC); such SPC, if granted, must be regarded as invalid.