Keywords: Compulsory License, German Federal Patent Court, HIV Drug
On 31 August 2016, the German Federal Patent Court issued a compulsory license under a patent that protects an HIV drug to affiliates of Merck & Co. (case number 3 LiQ 1/16). It was only the second time in the history of the court that a compulsory license has been granted and the first time that such license was granted in an emergency procedure. The Federal Patent Court's first decision to grant a compulsory license dates back to 1991 (case number 3 Li 1/90) and did not survive appeal to the Federal Court of Justice (case number X ZR 26/92).
The Facts of the Case
The European patent EP 1 422 218, which is owned by Japanese company Shionogi & Company Ltd., protects an integrase inhibitor that is used in the treatment of HIV infections. A medicinal product that arguably makes use of the patented invention has been marketed for a couple of years now by Merck & Co. in the United States and Europe under the trade name of Isentress. The active substance in Isentress, Raltegravir, prevents the integration of the HIV genome into the host DNA and, thus, prevents the HI-Virus from multiplying. Raltegravir has shown a relatively high tolerability among patients and has proven effective against multidrug-resistant viruses.
In 2015, the German Merck & Co. subsidiary MSD Sharp & Dohme GmbH was sued for an injunction for patent infringement by Shionogi in the Regional Court of Düsseldorf (case number 4c O 48/15). In response, Merck & Co. tried to obtain a worldwide license under the patent. Shionogi rejected the offer and MSD 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 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.
On the basis of an expert opinion, the Federal Patent Court reached the conclusion that there was a significant medical need among certain HIV-infected and/or AIDS patients for Isentress, and that these patients could not resort to other currently available integrase inhibitors without severe health risks. This was in particular true for pregnant women, infants and long-time HIV patients. With an effective reduction of the viral load, the risk of infection of third persons could also be reduced. A public interest for the grant of a compulsory license was, therefore, present. The court did not follow Shionogi's argument that Merck & Co. had not made a serious effort to obtain a license.
However, the ruling is only provisional. The main proceeding is still pending before the Federal Patent Court. Shionogi might also be able to appeal the court's main decision to the Federal Court of Justice.
Originally published November 9, 2016
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