Posted: September 10th, 2020
Joined cases: Biogen B.V. and Samsung Bioepis UK Limited v. Richter Gedeon NYRT and Richter Gedeon NYRT v. Biogen Netherlands B.V. and Samsung Bioepis B.V., District Court The Hague, 29 July 2020, ECLI:NL:RBDHA:2020:7089
Richter is the holder of EP 3 212 667 B1 (“EP 667”) which claims a pharmaceutical formulation which is free of a phosphate buffer and which comprises a therapeutically effective amount of Adalimumab in a buffered solution comprising L-Histidine and citrate.
Biogen and Samsung Bioepis claim that the Dutch part of EP 667 is invalid amongst others for lack of novelty over WO 2014/039903 of Manning and over an article of Bender titled “Alternative buffers for pharmaceutical anti-TNFα monoclonal antibody formulations”. Richter counterclaims for infringement arguing that Samsung Bioepis and Biogen’s Adalimumab biosimilar Imraldi infringes EP 667.
During the proceedings Richter files various auxiliary requests and only at the hearing announces that it no longer relies on the claims as granted. The Court therefore, as a starting point for the assessment of the validity of the auxiliary requests, considers that granted claim 1 of EP 667 is not novel over formulations disclosed in Bender and Manning.
One of the auxiliary requests claims a prefilled syringe or injection pen which comprises the formulation of granted claim 1. As Manning discloses to subcutaneous administer formulations disclosed in Manning, for example with a syringe, the Court finds that the auxiliary request lacks novelty over Manning.
In a further auxiliary request Richter had carved out the specific formulation disclosed in Manning that was covered by the granted claim. The Court does not assess whether the carve out meets the requirements of the EPC as it finds this auxiliary request to lack novelty over Bender, which discloses formulations that are covered by the claims of the auxiliary request which have not been (fully) carved out. The Court therefore invalidates the Dutch part of EP 667 and dismisses Richter’s infringement claim insofar as the Dutch part of EP 667 is concerned. As is common in Dutch main proceedings, Richter’s cross-border infringement claims are stayed as the Court in main proceedings has no jurisdiction to rule on the validity of the foreign parts of EP 667.
Headnote: Daisy Termeulen, Simmons & Simmons (who represented Samsung Bioepis in the proceedings)