Ezetimibe + Simvastatin - France

On Jun 26, 2018, Paris Court of Appeal upheld the interim order of Paris Court of First Instance & dismissed the requests for preliminary injunction against Biogaran based on SPC.

As reported on “the SPC blog”, the basic patent EP 0720599 covers in particular ezetimibe in claim 8 and combination of ezetimibe with simvastatin in claim 17. EP’599 patent is the basic patent of a first SPC No. 03C0028 relating to ezetimibe (Ezetrol®) which expired on April 17, 2018 and of a second SPC no. 05C0040 relating to the "ezetimibe optionally in the form of its pharmaceutically acceptable salts in combination with simvastatin" expiring on April 2, 2019 (Inegy®).

In December 2017, Biogaran filed an action on the merits before the Paris Court of First Instance for the invalidation of SPC 0040. By an interim order issued on April 5, 2018, the Paris Court of First Instance dismissed the request for preliminary injunction filed by SPC holder. The Paris Court of Appeal has confirmed the lower court’s order. Specifically, court said that though both the active compounds are specifically mentioned in claims but inventive idea of patent lies in ezetimibe only. The second compound simvastatin was already known.

The case is currently pending on the merits before the Paris Court of First Instance.