The first revocation decision from the Unified Patent Court (UPC) has seen a win for Sanofi and Regeneron in a dispute with Amgen over cholesterol lowering drugs. The Central Division of the UPC found a key patent owned by Amgen to be invalid, in a ruling effective over all UPC member states.
Praluent and Repatha are cholesterol-lowering antibody drugs which are PCSK9 protein inhibitors. Praluent is marketed by Sanofi in partnership with Regeneron, while Repatha is marketed by Amgen.
Both sides have been locked in patent disputes over the two drugs for the past decade. Until recently, the disputes in Europe have been battled out in multiple national courts. However, just over a year ago the UPC opened its doors for business offering the opportunity for parties to obtain a binding decision in all the European countries that have agreed to participate in the UPC system.
On the very first day of the UPC going live, Sanofi brought a revocation action against European patent no. 3666797 (EP’797), owned by Amgen. EP’767 claimed PCSK9-inhibiting antibodies for use in the treatment of conditions involving high cholesterol levels. On the same day, and only minutes after Sanofi’s revocation action was filed, Amgen filed an infringement action against both Sanofi and Regeneron in relation to the same patent. Regeneron later brought its own counterclaim for revocation. The UPC combined the two revocation actions into one. Now, the UPC has issued its decision on this revocation action.
The UPC decided to revoke EP’797 entirely, with the judge’s ruling that the claims did not involve an inventive step. The document relied on by the Court as a “realistic” starting point of the assessment of inventive step taught that PCSK9 activity correlated with cholesterol levels in the blood. It also suggested that antibodies to block the activity of PCSK9 could be developed for the treatment of high cholesterol levels. The judges held that it was therefore obvious to develop the claimed antibodies for the treatment of conditions involving high cholesterol, stating that “the skilled person would arrive at the claimed subject matter without inventive skill”.
As to the parallel infringement action, a hearing before the UPC’s Munich Local Division is scheduled for later this year, to consider whether the proceedings should be stayed.
The decision is clearly a blow to Amgen, and it is likely that they will appeal the decision. If an appeal is filed, it will be interesting to see if the original decision is upheld or overturned, in what will probably be one the first decisions on a revocation action from the UPC’s Court of Appeal. It will also be interesting to see whether future decisions from the UPC follow a similar line of reasoning, particularly when it comes to the assessment of inventive step.
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