French court refuses MSD injunction request in SPC clash

The Paris Court of Appeal has refused to grant Merck Sharp & Dohme (MSD) a preliminary injunction based on a supplementary protection certificate (SPC) against French pharmaceutical company Biogaran.

In the decision, which was handed down on June 26 and reported on by  The SPC Blog on Friday, July 6, the appeal court upheld an interim order by the Paris Court of First Instance which dismissed the application for a preliminary injunction.

The blog post was written by Gérard Dossmann and Marianne Gabriel of Cassalonga, who acted for Biogaran.

At the centre of the dispute is European patent number EP 0,720,599, which has now expired and covered “hydroxy-substituted azetidinone compounds effective as hypocholesterolemic agents”. In claim 8, the patent referred to ezetimibe, and in claim 17, it mentioned the combination of ezetimibe with simvastatin.

The ‘599 patent is the basic patent for a first SPC (number 03C0028), which covered ezetimibe and expired in April this year. This SPC relates to the marketing authorisation (MA) for Ezetrol, a cholesterol absorption inhibitor.

The patent is also the basis for a second SPC (number 05C0040), covering “ezetimibe optionally in the form of its pharmaceutically acceptable salts in combination with simvastatin”, and expires in April next year. It relates to the MA for Inegy, used for lowering levels of total cholesterol.

In December last year, Biogaran sought the invalidation of the second SPC (‘040) before the Paris Court of First Instance.

MSD then accused Biogaran of imminent infringement and sought interim measures.

But in April, the Court of First Instance dismissed the application for a preliminary injunction. It found that although claim 17 specifically targets simvastatin in combination with ezetimibe, in order to get a second SPC on the same patent, the combination must “not only be specified as such in a claim, it must still be in itself the centre of the invention”.

It found that the proposed combination doesn’t correspond to the core of the invention, so the SPC is invalid.

In late June, the Court of Appeal affirmed the lower court’s order in summary proceedings.

“It follows from the foregoing analysis that the combination product of ezetimibe with simvastatin has already been the subject of a first marketing authorisation on June 11, 2003, and that the second authorisation obtained on July 28, 2005 did not allow the grant of a[n] SPC under article 3(d) of [Regulation 469/2009],” said the court.

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

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