German Federal Court Of Justice Denies Compulsory License On Anti-Cholesterol Drug Patent

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...