Ezetimibe & Rosuvastatin – Netherlands

On Apr. 10, 2018, District Court The Hague handed down its decision in combo SPC case & denied appeal filed by Merck against patent office’s decision that rejected the SPC application.

By decision of May 03, 2016, the Dutch patent office (Respondent) rejected the Merck’s (Plaintiff) application for a supplementary protection certificate for ezetimibe & rosuvastatin. By a decision of Apr 28, 2017, the respondent declared the plaintiff's objection to the primary decision unfounded. Merck (Plaintiff) appealed against the contested decision.

On Sep 08, 2014, the plaintiff filed an application for the issue of an SPC for a product described as ezetimibe, optionally in the form of a pharmaceutically acceptable salt, and rosuvastatin. Plaintiff based its application on European Patent 0720599 B1 entitled Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents (Hydroxysubstituted azetidinone compounds, useful as hypocholesterolemic agents). This patent expired on Sep 14, 2014. Ezetimibe satisfies the Markush formula of claim 1 of EP 599 patent and, more specifically, corresponds to the compound in claim 8. Combinations of ezetimibe with a cholesterol biosynthesis inhibitors were claimed in claim 17, where a number of biosynthesis inhibitors were specifically mentioned. Based on the basic patent, plaintiff has previously obtained an SPC for the monoproduct 'ezetimibe, if desired in the form of a pharmaceutically acceptable salt'. This SPC expires on 16 April 2018.

The dispute was whether Article 3 (a and / or c) of the Regulation precludes Plaintiff from obtaining an SPC for the combination product ezetimibe and rosuvastatin, in addition to an SPC for the monoproduct ezetimibe. The basic patent in this case refers to a new group of azetidinone compounds that can be used for the prevention of arteriosclerosis and / or as cholesterol-lowering agents. This matter can be regarded in the terminology of Actavis / Sanofi as the 'core inventive advance' of the patent. Ezetimibe is one of those new compounds and thus as an innovative active ingredient ('innovative active ingredient'), which is protected as such ('as such') by EP 599. Cholesterol biosynthesis inhibitors are not protected as such in EP 599. Cholesterol biosynthesis inhibitors are therefore not an 'innovative active ingredient' in the context of EP 599 and as such are not the object (matter) of EP 599. A number of biosynthesis inhibitors have been specified in claim 17 but rosuvastatin is not mentioned.

Court thus held that from the explanation given by the CJEU to article 3 in Actavis / Sanofi and Actavis / Boeringer, it follows that in this situation, where the combination product consists of an active substance that is protected as such ('as such') by the basic patent and the object (subject matter) of the patented invention and on the other hand of an active substance - forming part of a non-limited group of biosynthesis inhibitors - which is not protected as such by the same basic patent and is not the object of the invention, no place for granting of SPC for the combination product, now that SPC based on the same basic patent has already been granted for the first active substance on the basis of a previous marketing authorization.