On 6 September 2018, the German Federal Patent Court denied an application for a (preliminary) compulsory license under a patent related to the treatment of cholesterol-related disorders to the Applicant, group companies of a French pharmaceutical company (Case 3 LiQ 1/18). This decision is in line with previous jurisprudence of the court that has, with very few exceptions, been restrictive to grant compulsory licenses, in particular in emergency procedures.

The Facts of the Case

The European patent EP 2 215 124 (DE 60 2008 042 526), which is owned by the Defendant in the preliminary proceedings, a US pharmaceutical company, protects antigen-binding proteins (antibodies) that are used in the treatment of conditions associated with elevated serum cholesterol levels (e.g., coronary heart diseases). A drug that arguably makes use of the patented invention has been marketed for about three years now by the Applicant in Europe and the United States under the trade name of Praluent. The active substance in Praluent, alirocumab, functions as an inhibitor of the enzyme PCSK9 (proprotein convertase subtilisin/kexin type 9), resulting in lowered bad (LDL) cholesterol levels in the blood.

In 2016, the Applicant was sued for an injunction for patent infringement by the Defendant in the Regional Court of Düsseldorf (Case 4c O 39/16). In the course of the pending lawsuit, the Applicant engaged in licensing negotiations with the Defendant and, following their failure, brought an action for issuance of a compulsory license before the Federal Patent Court and, at the same time, requested a provisional allowance order under section 85 of the German Patent Act.

Pursuant to section 24 para. 1 of the German Patent Act, a compulsory license shall only be granted by the Federal Patent Court when a license seeker has, within a reasonable period of time, unsuccessfully attempted to obtain an economically reasonable license from the patent owner and when the public interest calls for the grant of a compulsory license.

The Ruling

The Federal Patent Court based its decision to deny the grant of a preliminary compulsory license on two grounds:

First, the court held that the Applicant’s licensing offer was not made within a reasonable period of time prior to the application for a compulsory license. According to the factual findings of the court, an offer to conclude a license agreement was only made three weeks before the Applicant applied for a compulsory license on 12 July 2018. After the patent infringement proceeding, which had temporarily been suspended to verify the patent-in-suit’s validity, had resumed in December 2017, the Applicant could have started its licensing attempts much earlier. The court supported its conclusion with the fact that a study that was used by the Applicant to show public interest in a compulsory license was already issued in March 2018. The license offer from 20 June 2018 was therefore a “last minute request.”

Second, the court concluded that the Applicant has not shown prima facie evidence (Glaubhaftmachung) that a public interest in the availability of Praluent exists. A public interest in the availability of a drug was not to be assumed if drugs with substantially equivalent qualities were available to the relevant patient groups. In the eyes of the court, the Applicant in particular failed to demonstrate that other available drugs on the market were inferior to the therapeutic qualities of Praluent.

However, the ruling is only provisional. The main proceeding is still pending before the court. The Applicant might also be able to appeal the court’s main decision to the Federal Court of Justice.