A French Court has upheld the validity of a Supplementary Protection Certificate ("SPC") protecting the ezetimibe+simvastatin combination under Article 3(a) of the SPC Regulation.
Merck Sharp & Dohme ("MSD") is the owner of a basic patent covering the compound ezetimibe. The basic patent also covers ezetimibe's combinations with statin compounds, such as simvastatin, in its dependent claim, and simvastatin was already known as at the priority date. On the basis of this basic patent, MSD was granted an SPC for ezetimibe that expired on 17 April 2018, and an SPC for the combination ezetimibe+simvastatin expiring on 2 April 2019. Facing generic entry for the combination product when the ezetimibe SPC expired, MSD initiated preliminary injunction proceedings against a generic company, and a main revocation action was initiated by another generic company against the combination SPC.
In the PI case, the President of the Paris First Instance Court and the Paris Court of Appeal refused to grant the injunction on 5 April 2018 and 26 June 2018 respectively, relying primarily on the CJEU referrals in Georgetown and Sanofi to rule that since ezetimibe is the only "core of the invention" in the basic patent, the combination SPC could not be granted for ezetimibe+simvastatin.
Nevertheless, on the merits, the Paris First Instance Court upheld the validity of the combination SPC in a decision issued on 25 October 2018. The Court ruled on the basis of Georgetown and Sanofi as well as the decision in Gilead on 25 July 2018, that for the purposes of Article 3(a) of the SPC Regulation, "if the product, which is a combination of active ingredients according to Article 1 of EC Regulation No. 469/2009, necessarily belongs to the invention covered by the patent and if each active ingredient is specially identifiable, the grant of an SPC for the combination of active ingredients is possible", as in the present case. Although the SmPC of the ezetimibe product mentioned the possibility of combining ezetimibe with statin compounds even before the combination was authorised as a medicinal product, the Court disagreed with the generic and also ruled that the marketing authorisation for the ezetimibe product could not be considered the first marketing authorisation in respect of the combination product for the purposes of Article 3(d) of the SPC Regulation.
In addition to the SPC argument, the decision rules on other issues, such as the statute of limitation of a revocation action (not time barred in the present case), and the sufficiency of disclosure of the combination ezetimibe+simvastatin in the basic patent (upheld on the basis of the test set in the finasteride decision of the French Supreme Court).
Please see here for the court's decision in French.
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