German Federal Patent Court denies request for preliminary grant of a compulsory license – Where do we go from here?
As recently as 2016 the German Federal Patent Court handed down the landmark decision on Isentress® (raltegravir) where a compulsory license was granted to MSD in preliminary proceedings, affirmed both on appeal and in main proceedings (reported on Bird & Bird. The court was recently faced with another request to grant a compulsory license. Sanofi sought a compulsory licence for the distribution of its high cholesterol drug Praluent® but this was dismissed in preliminary proceedings (docket no: 3 LiQ 1/18).
Background of the case
The most recent compulsory license request concerned Sanofi’s monoclonal antibody alirocumab which is an inhibitor of pro-protein convertase subtilisin/kexin type 9 (PSCK9). Alirocumab has been shown to reduce the levels of low-density lipoprotein cholesterol (LDL-C). Sanofi’s product Praluent®, which contains the active ingredient alirocumab, is approved for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia.
After Amgen filed an infringement suit at the Regional Court Düsseldorf (docket no.: 4c O 39/16) alleging that Sanofi’s product infringes Amgen’s European Patent EP 2 215 124 B1 relating to an antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PSCK9) Sanofi responded by filing a request for the grant of a compulsory license by way of a preliminary injunction request as well as main proceedings in the Federal Patent Court.
Not only is Amgen the proprietor of the EP at issue here, but it also markets an own product containing the inhibitor of pro-protein convertase subtilisin/kexin type 9 (LDL-C) evolocumab which is marketed under the name Repatha®.
Reasoning of the Court
At the oral hearing on 6 September 2018, the judicial panel found that neither requirement for the grant of a compulsory license was fulfilled. In order for a compulsory license to be granted the license seeker must show that (1) it has, within a reasonable period of time, unsuccessfully attempted to obtain permission from the proprietor to use the invention on reasonable commercial terms and conditions as well as that (2) the grant of such compulsory license lies within the public interest (Section 24 para. 1 of the German Patent Act).
Timing of the compulsory license request
In accordance with its finding that ‘last minute offers’ by the license seeker should not be sufficient to show an earnest and reasonable interest in obtaining a license in the Isentress case, the Court held here that Sanofi had not given Amgen sufficient time to consider the offer.
Sanofi had only waited about 3 weeks after sending an offer to the patentee to file the request for a compulsory license. Amgen had not dismissed the offer entirely but had asked for further time to consider it (also in light of a public holiday in between). However, due to the approaching oral hearing in the infringement proceedings, Sanofi had felt the pressure to go ahead with the compulsory license request. Even though Sanofi was relying on earlier (failed) attempts in 2015 and 2016 to obtain a license, the Court expressed the opinion that the offer was not sufficient to show an earnest effort in obtaining a license. In particular, the Court did not consider the negotiations to have finally failed yet.
As regards the contents of the offer, the Court did not object to Sanofi offering a rather low royalty rate of 2%, in particular because this rate had not been indicated to constitute an upper limit.
Direct comparison of Praluent® and Repatha®
Additionally, the Federal Patent Court held it had not been shown that there would indeed be negative effects for patients, should Praluent® no longer be available on the German…
