On 4 June 2019, the German Federal Court of Justice upheld a ruling by the German Federal Patent Court in which the latter court denied an application for a compulsory license under a patent related to the treatment of cholesterol-related disorders (Case X ZB 2/19). This decision is in line with previous German jurisprudence that has, with a few exceptions, been restrictive to grant compulsory licenses.

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 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 four years now by the Applicants—group companies of a French pharmaceutical company—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 Applicants were 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 Applicants 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.

The Federal Patent Court Ruling

In its ruling on 6 September 2018, the Federal Patent Court denied the grant of a (preliminary) compulsory license mainly on two grounds (Case 3 LiQ 1/18):

First, the court held that the Applicants’ 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 Applicants 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 Applicants 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 Applicants have 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 Applicants in particular failed to demonstrate that other available drugs on the market were inferior to the therapeutic qualities of Praluent.

The Federal Court of Justice Ruling

The Federal Court of Justice has upheld the ruling of the Federal Patent Court. The Federal Court of Justice agreed with the Federal Patent Court that the Applicants did not make sufficient efforts to obtain a reasonable license from the Defendant. The Applicants had only expressed their interest in a license at a very late stage and even then had offered only a very low license rate.

As the Federal Patent Court did, the Federal Court of Justice also denied that it was in the public interest to grant a compulsory license. The decisive factor for the Court was that the Applicants failed to demonstrate that Praluent offers tangible therapeutic advantages over other available drugs. Inter alia, the mere possibility that Praluent could be administered in lower doses, as compared to other available drugs, was not considered sufficient to warrant the grant of a compulsory license.

 

This article was originally published on AllAboutIPMayer Brown’s blog on relevant developments in the fields of intellectual property and unfair competition law.

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