Value Added SPCs - CJEU Clarifies Broad Scope Of Protection

Following hot on the heels of important SPC decisions issued in late 2011, the Court of Justice of the European Union (CJEU) has now issued a reasoned order in the Novartis v Actavis case (C-442/11).

SPCs

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation. The purpose of SPCs is to compensate patent holders for at least part of the delay in commercialising a patented active ingredient (or combination of active ingredients) caused by the need to conduct trials on safety and efficacy (and thereafter to obtain regulatory approval).

The CJEU Ruling

The CJEU held that an SPC granted for a product consisting of a single active ingredient should confer the same rights as those conferred by the basic patent for that product in the form of a medicinal product. In other words, an SPC proprietor should be able to oppose any regulatory approved use of that single active ingredient,