ECJ Clarifies Scope Of Supplementary Protection Certificate

On 9 February 2012, the Court of Justice of the European Union (the "ECJ") answered a preliminary question referred to it by the High Court of Justice of England and Wales (the "Referring Court") in Novartis AG ("Novartis") v. Actavis UK Ltd. ("Actavis") (Case C-442/11). The ECJ judgment offers guidance on the scope of supplementary protection certificates ("SPCs").

Novartis is a pharmaceutical company which obtained a patent for valsartan, an active ingredient that is mainly administered for the treatment of high blood pressure. Novartis markets Diovan®, a medicinal product with valsartan as its sole active ingredient, and Co-Diovan®, a medicinal product based on valsartan combined with the active ingredient hydrochlorothiazide. The patent for valsartan expired on 12 February 2011. However, Novartis was granted an SPC for valsartan on the basis of the patent for valsartan and the marketing authorisation obtained for Diovan®.

Despite the fact that Novartis had obtained this SPC, Actavis, a company involved in generic pharmaceuticals, announced that it would market a generic version of Co-Diovan® following the expiry of the patent for valsartan.

Novartis brought an action against Actavis before the Referring Court, arguing that if the generic of Co-Diovan® were to be marketed, this would infringe the rights granted by the SPC for valsartan. According to Novartis, the SPC for valsartan confers the same protection as the patent for valsartan pursuant to Article 5 of Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the "SPC Regulation"). This provision clarifies the effects of SPCs and provides that "subject to Article 4, the [SPC] is to confer the same rights as conferred by the basic patent and to be subject to the same limitations and the same obligations". Article 4 of the SPC Regulation provides that, within the limits of the protection granted by the basic patent, the protection conferred by an SPC only extends to the active ingredient or combination of active ingredients covered by the marketing authorisation for the...