Posted: June 6th, 2019
In its decision of 4 June 2019, the tenth senate of the Federal Court of Justice (FCJ) confirmed a rejection of an application for a preliminary compulsory license for a cholesterol-lowering drug. It is just the second time that the FCJ had to deal with the questions of a compulsory licence. The first case concerning an HIV Drug dates from July 2017. In that decision from 2017 the FCJ granted a compulsory licence. Now the FCJ has rejected such a compulsory licence as the facts of the cases differ.
In the new decision of 4 June 2019 the applicants distribute the medical product Praluent containing the active substance alirocumab in Germany. This substance is directed against a protein (PCSK9) and reduces LDL cholesterol levels in the blood. The defendant is the holder of the patent in dispute, concerning antigen-binding proteins against the protein PCSK9, and distributes a drug called Repatha containing the antibody Evolocumab, which is also directed against the protein PCSK9.
While the defendant filed a claim against the applicants for infringement of their patent, the applicants filed an action at the Federal Patent Court for the grant of a compulsory license under Sec. 24 Patent Act (PatG) and also applied for a preliminary permission to use the invention by the drug Praluent in four specific forms by preliminary injunction under Sec. 85 Patent Act.
The Federal Patent Court dismissed the application, the tenth division of the German Federal Supreme Court confirmed this decision.
It agreed with the Federal Patent Court that the applicants did not make sufficient efforts during a reasonable period of time to grant a contractual licence to the patent. The applicants expressed their interest in a licence at a very late stage, offered only a very low licence rate, did not react to the reply of the defendant and they only sent letters to the defendant again in the course of the appeal proceedings (patent was maintained in the opposition proceedings in an amended version).
Like the Federal Patent Court, the German Federal Supreme Court denied a public interest requiring the grant of a compulsory license. It did not see that Praluent offers the respondent noticeable therapeutic advantages over the drug Repatha. Both drugs are based on the same mechanism of action and achieve the same pharmacological effect. Furthermore, the Federal Supreme Court was not convinced that the administration of Praluent reduces the mortality rate of hypercholesterolemia patients treated with this substance. Although the applicants submitted a study to prove this, the results – according to established biostatistical principles – can also be based on randomness.
Particularly in the latter point, the underlying facts differ from those in the decision X ZB 2/17 (Judgment of 11 July 2017), in which the FCJ confirmed a compulsory licence. There the court had to decide on the further distribution of an HIV drug. Although not every HIV or AIDS patient relies on being treated with the disputed drug at all times, there are patient groups who need this drug to maintain treatment safety and quality.
These groups include in particular infants, children under 12 years of age, pregnant women, persons who need prophylactic treatment because of the risk of infection, and patients who are already being treated with the disputed drug and who would face significant side effects and interactions when switching to another medication. Therefore in this previous case there was a public interest in granting a compulsory licence, which was missing in the newly decided case.
There also seems a difference in the behaviour of the applicants as they didn’t pursue the licence request in a timely manner. However – at least in the press release – the FCJ does not particulary stress this point.
It will be interesting to see whether the FCJ further clarifies the requirements of granting a compulsory licence. The full text of the decision is not yet available. The press release of the FCJ can be found here (in German). Once the full text is out we will update text.
Reported by Alexander Haertel and Martin Koszycki, Kather Augenstein Rechtsanwälte, Düsseldorf