SPCs: A Preliminary Ruling From The CJEU In Actavis v Sanofi

On 12 December 2013, the Court of Justice of the European Union (CJEU) handed down its preliminary ruling in the case of Actavis Group PTC EHF, Actavis UK Ltd v Sanofi, Sanofi Pharma Bristol-Myers Squibb SNC (C-443/12).

Summary of Facts

Sanofi obtained a first SPC, which covered the active ingredient ibersartan for treating primary hypertension. The SPC was based on the basic patent EP 0454511 and the marketing authorisation (MA) granted on 27 August 1997 in respect of the medicinal product Aprovel (which contained ibersartan as the single active ingredient). Claims 1 to 7 of the basic patent were solely related to ibersartan. The SPC expired on 14 August 2012.

Sanofi subsequently obtained a second SPC, which covered the combination of ibersartan and hydrochlorothiazide. This SPC was based on the same basic patent as the first SPC but on an MA granted on 15 October 1998 in respect of the medicinal product CoAprovel. Claim 20 of the basic patent related to a pharmaceutical composition containing ibersartan in association with a diuretic (in general). The SPC expired on 14 October 2013.

Actavis brought proceedings before the High Court challenging the validity of the second SPC since the generic version of CoAprovel that they intended to market would infringe the second SPC. Actavis argued that the SPC was not protected by the basic patent within the meaning of Article 3(a) of Regulation No. 469/2009, since the combination of ibersartan and hydrochlorothiazide was not expressly identified in any of the claims of the basic patent. Further to this, Actavis argued that the SPC was invalid in light of Article 3(c) of the same Regulation since the 'product', within the meaning of the provision, had already been the subject of an SPC.

Regulation No. 469/2009 can be found using the following link:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:152:0001:0010:en:PDF

Questions Referred

The High Court could not resolve the dispute based on earlier rulings and thus, referred the following questions to the CJEU:

1. What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of Regulation No. 469/2009? 2. In a situation in which multiple products are protected by a basic patent in force...