Actavis Group PTC EHF, Actavis UK Limited v. Sanofi

Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC (collectively, Sanofi) (defendant) held a European patent on a drug used to treat high blood pressure. The patent, which was effective from 1998 through 2011, covered the drug’s active ingredient, irbesartan. To make up for the time lag between application for the patent and European market authorization, Sanofi also obtained two supplementary protection certificates (SPCs), effectively extending the length of time that patent protection was in effect. The first SPC, effective from 1999 through 2012, applied to irbesartan alone. The second SPC, effective from 1999 through 2013, applied to irbesartan in combination with hydrochlorothiazide (HCT), a common diuretic that was not directly named in the patent. Sanofi marketed an irbesartan-only drug under the trademark Aprovel and the irbesartan-plus-HCT drug under the trademark CoAprovel. Actavis Group PTC EHF and Actavis UK Limited (collectively, Actavis) (plaintiff) sought to market generic versions of Aprovel and CoAprovel. Because the combination SPC was still in effect at the time, Actavis challenged its validity in the United Kingdom’s patent court. Litigation between Sanofi and Actavis had already occurred in other European countries, but with inconsistent results. For example, the German patent court granted an injunction on the basis of the combination SPC, but the French patent court did not. Expert testimony in the UK case suggested that the idea of combining irbesartan with a diuretic would have been obvious to a person of ordinary skill in the relevant field.