Novartis v. Actavis, French Cour de cassation, Paris, France, 15 January 2013, Case number A 11-26.632, with thanks to Pierre Véron and Nicolas Bouche, Véron & Associés, for providing the judgment, a translation in English and a summary
The French Cour de cassation follows the Court of Justice of the European Union’s ruling of 9 February 2012 in the parallel UK case and decides that the proprietor of an SPC for product A may prevent third parties from marketing a drug combining A + B.
Novartis was the proprietor of a basic patent (expired on 12 February 2011) covering valsartan and of an SPC for the product valsartan, a drug against hypertension.
Actavis marketed in France a drug containing valsartan and another active ingredient, HCTZ, a diuretic.
Novartis sought a preliminary injunction against Actavis, which was granted by the tribunal de grande instance on 28 January 2011, but the cour d’appel de Paris reversed it on 16 September 2011 on the grounds that “although the medicinal product valsartan + HCTZ contains the active ingredient valsartan, it is not the "product" valsartan within the meaning of the Regulation but another "product" comprising a combination of active ingredients”.
Novartis brought the case before the Cour de cassation, the highest French court for civil matters.
The legal question (the interpretation of Articles 4 and 5 of Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products) was whether the SPC covering the product valsartan was infringed.
In other words, whether the owner of an SPC for product A can prevent the marketing of an A + B product where B is also an active ingredient.