Merck Sharp & Dohme Corp. vs. the Dutch Patent Office, District Court of The Hague, 10 April 2018, ECLI: NL:RBDHA:2018:4081

The issue at hand is whether the Dutch Patent Office (“DPO”) has rightfully refused the application for a Dutch supplementary protection certificate (“SPC”) for a combination product of ezetimib and rosuvastatin on the basis of Art. 3 of Regulation No 469/2009 (“SPC Regulation”).

Facts

On September 8, 2014, Merck Sharp & Dohme Corp. (“Merck”) submitted an application to grant an SPC for a cholesterol inhibiting combination product comprising of ezetimibe and rosuvastatin. The basic patent for Merck’s Dutch SPC is EP (NL) 0 720 599 B1 (“EP 599”), which expired on 14 September 2014. Merck has previously obtained an SPC on the monoproduct ezetimibe, which has meanwhile expired on 16 April 2018. The DPO had refused Merck’s applications, in essence arguing that since Merck has already obtained an SPC for the monoproduct based on EP 599, it cannot obtain an SPC for the combination of ezetimibe and rosuvastatin based on the same patent. In the present proceedings, Merck appeals the DPO’s refusal.

Assessment

The court establishes that EP 599 covers a novel class of azetidinon compounds that can be used in the prevention of arteriosclerosis and/or as cholesterol inhibiting medicinal products. One of these compounds is ezetimibe and is the “innovative active ingredient” (as formulated in CJEU 12 December 2013, C-443/12, ECLI:EU:C:2013:833 (Actavis/Sanofi)). Cholesterol biosynthesis inhibitors are, in the context of EP 599, not considered as “innovative active ingredients” and as such as not the subject matter of EP 599. Also, rosuvastatin is not explicitly mentioned in EP 599 as such cholesterol biosynthesis inhibitor.

Applying the CJEU case law Actavis/Sanofi and Actavis/Boehringer (CJEU 12 March 2015, C-577/13, ECLI:EU:C:2015:165), the court holds that in a situation like the present, in which the combination product consists of on the one hand an active substance that is as such protected by the basic patent and, on the other hand an active ingredient which is not protected by that same basic patent (and as such not the subject matter of the invention), there is no room for granting an SPC for the combination product, since for the first active substance (ezetimibe) on the basis of an earlier marketing authorization and the same basic patent an earlier SPC has already been granted.

In this respect, the court takes into account that during the validity of the first SPC (based on ezetimibe only), Merck was entitled to oppose the use of medicinal products consisting of a combination of ezetimibe with a biosynthesis inhibitor (such as rosuvastatin) for the same therapeutic application. Thus after the expiry of EP 599, Merck had already enjoyed an additional period of effective protection for its rights based on its basic patent, also concerning the combination product.

Merck assertions regarding the alleged inventive step involved with combining ezetimibe and rosuvastatin are held to be irrelevant, since the issue at hand is whether Merck can have multiple SPCs by way of the sequential marketing of the patented ezetimibe and combinations of ezetimibe with varying biosynthesis inhibitors (which are not covered by the basic patent) based on different marketing authorisations. In view of the CJEU case law, this is held to be contrary to the SPC Regulation, and Merck’s appeal is therefore dismissed.

A copy of the judgment can be read here.

Headnote: Jeroen Boelens, NautaDutilh