Ezetimibe & Simvastatin – Germany

Ezetimibe & Simvastatin – Germany

On Oct 01, 2018 Düsseldorf court revoked preliminary injunction granted previously against ratiopharm based on combination SPC.
Plaintiff (Merck) sued Defendant (Ratiopharm) for an injunction due to alleged infringement of the supplementary protection certificate DE 12 2004 000 026. This SPC protects the product “ezetimibe or pharmaceutically acceptable salt thereof in combination with Simvastatin (INEGY®). Plaintiff was the holder of the European Patent EP 0720599 B1 (“Basic Patent”), which expired on 14 September 2014. The SPC has been effective in the Federal Republic of Germany since 15 September 2014 and will presumably expire on 2 April 2019. The Basic Patent concerns the hydroxy-substituted azetidinone compound ezetimibe, or pharmaceutically acceptable salts thereof, and the combination of ezetimibe with a cholesterol synthesis inhibitor. Previously, Plaintiff obtained first SPC on same basic patent for single ezetimibe product (EZETROL®) which expired on 17 April 2018.
At Plaintiff’s request, the chamber granted a preliminary injunction on 16 May 2018, which prohibited Defendant from offering drugs containing ezetimibe/simvastatin combination in Germany. With a pleading dated 2 July 2018, Defendant objected to the preliminary injunction.
With respect to Art. 3 a) of SPC Regulation, Court held that the active ingredient simvastatin can be understood not only as included in the umbrella term cholesterol biosynthesis inhibitor in claim 9, but beyond that is specifically named in claim 17. Moreover, the Basic Patent addresses the specific combination of active ingredients both in the claims and in the description. Therefore, the contested combination constitutes a specific part of the technical teaching of the Basic Patent, and therefore is a protected product for the purposes of Art. 3 a) SPC Regulation.
With respect to Art. 3 c) of SPC Regulation, Court held that conditions were not met because ezetimibe represents the sole subject matter of the protected invention & it had already got SPC for that. The combination of the active ingredients ezetimibe and simvastatin does not constitute the core of the Basic Patent’s technical teaching. The extension should be made only once, since a certificate may not have been granted for one and the same product (cf. Art. 3 c) SPC Regulation). So only one SPC should be granted per product, which is understood in a more narrow sense as an active ingredient (of combination of active ingredients). A purely additive effect from two combined active ingredients, in which the combination of active ingredients achieves the same therapeutic effect as the separate administering of both active ingredients, doesn’t satisfy the CJEU as the sole subject matter of the invention (cf. CJEU, GRUR 2014, 157 – Actavls/Sanofi). And the Federal Patent Court also seems to view delineation between additive and synergistic effects as a useful distinction criterion, even if it doesn’t focus on the core of the invention.
According to these principles, the combination of ezetimibe and simvastatin does not constitute a product as such which embodies the central advance protected by this Basic Patent. The invention’s core is only to provide the new active ingredient ezetimibe. But Certificate has already been granted for that single product. Thus, the prerequisite in accordance with Art. 3 c) SPC Regulation for granting second Certificate for combination product has not been met.

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