Actavis v. Sanofi
European Union Court of Justice
Case C-443/12 (2013)
- Written by Eric Miller, JD
Facts
Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC (collectively, Sanofi) (defendant) held a European patent, effective until 2011, on a drug used to treat hypertension. Sanofi obtained European market authorization for two products pertaining to the patent. The first product consisted of the drug’s active ingredient, irbesartan. The second combined irbesartan with hydrochlorothiazide (HCT), a common diuretic that was not protected by the patent. To make up for the time lag between the patent application and the marketing authorizations, Sanofi also secured two supplemental protection certificates (SPCs)—one for each product. After the irbesartan-only SPC had expired—but before the expiration of the combination SPC—Actavis Group PTC EHF and Actavis UK Limited (collectively, Actavis) (plaintiff) sought to market generic versions of both products. Actavis brought an action in the United Kingdom patent court, challenging the combination SPC’s validity. The UK judge expressed the opinion that the presence of inventive advance should be the most relevant factor, but the proceedings were stayed so that the European Union Court of Justice could issue a preliminary ruling on the matter.
Rule of Law
Issue
Holding and Reasoning (Per curiam)
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