SPC for ezetimibe/simvastatin considered invalid in preliminary relief proceedings
February 2019
On 23 October 2018 the Court of Appeal of The Hague dismissed a request for a preliminary injunction based on the Dutch supplementary protection certificate ("SPC") on ezetimibe and simvastatin because it considered the SPC to be invalid. This is the first case in the Netherlands where a court applies the rules of law from the decision CJEU Teva/Gilead (C-121/17) of 25 July 2018.
Facts
MSD was the holder of patent EP 0 720 599 B1 ("EP 599"), which expired on 14 September 2014. Based on EP 599 MSD obtained:
- A SPC on the mono-product ezetimibe ("SPC I"), which expired on 16 April 2018.
- A SPC on the combination product ezetimibe and simvastatin ("SPC II"), which is in force until 1 April 2019.
After expiration of the SPC I Teva tried to enter the market with a generic combination product containing ezetimibe and simvastatin. Consequently, MSD requested for a preliminary injunction against Teva based on the SPC II. Teva argued that the SPC II is to be considered invalid based on Article 3(c) of Regulation (EC) No 469/2009 ("SPC Regulation") because MSD already had obtained the earlier SPC I.
Article 3 SPC Regulation states that a SPC shall be granted if the conditions of this provision are fulfilled. Article 3(c) SPC Regulation requires that the product has not already been the subject of a SPC.
Assessment of the court
The court holds, in view of the CJEU decisions Actavis/Sanofi (C-443/12), Actavis/Georgetown (C-484/12) and Actavis/Boehringer (C-577/13), that in principle for both a mono-product; and for a combination product (where that mono-product forms part) a SPC may be granted on the basis of the same patent. This is possible under the condition that:
- the combination product covers a totally separate invention than that embodied in the mono-product, or in other words that
- the combination product, independent of the invention embodied in the monoproduct, does constitute the subject-matter of the invention covered by the basic patent.
The court then applies the recent CJEU decision Teva/Gilead (C-121/17) and holds that a SPC on a combination product covers a totally separate invention (and therefore is valid) if the average person skilled in the art would, on the basis of the patent claims, the description and drawings of the basic patent and his/her common general knowledge on the priority date of the basic patent, identify the combination product as a separate invention (independent from and in addition to the invention embodied in the mono-product).
The court holds in the case at hand that the average person skilled in the art will qualify the combination of an azetidinone and a cholesterol biosynthesis inhibitor, mentioned in the description of EP 599, as an 'aspect' of the invention and not as a separate invention. This is even more the case for the combination of ezetimibe and simvastatin, which is mentioned nowhere explicitly in the description of EP 599. Neither does EP 599 mention that the combination of ezetimibe and simvastatin solves problems or has any benefits. Neither would lead the common general knowledge of the average person skilled in the art at the time of the priority date of EP 599, him/her to identify the combination of ezetimibe and simvastatin as a separate invention.
The court concludes that the condition of Article 3(c) SPC Regulation is not met because for ezetimibe an earlier SPC was granted and the combination of ezetimibe and simvastatin is not subject-matter of the invention covered by EP 599. For this reason the SPC II should not have been granted and there is a serious chance that SPC II will be invalidated in proceedings on the merits.
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"This is the first case in the Netherlands where a court applies the CJEU ruling in Teva/Gilead."