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
