Ezetimibe & Simvastatin - Netherlands

On Oct 23, 2018, The Court of Appeal in interlocutory proceedings ruled that SPC for the combination product of ezetimibe and simvastatin is likely to be found invalid.

The Hague Court confirms in its preliminary opinion that the combination SPC for ezetimibe + simvastatin has been granted in violation of article 3 (c) of the SPC-Regulation as the combination is not the object of the invention protected by the basic patent. Also as interpreted by the CJEU, condition has not been met in this case, because SPC had already been granted for ezetimibe single product and the combination with simvastatin is not inventive concept of the Basic Patent.

The ruling of the Court of Appeal is in line with the earlier ruling of the District Court of Dusseldorf delivered on Oct 01, 2018 where Dusseldorf court revoked preliminary injunction granted based on same combination SPC.