By: Markus Rieck <http://www.fuchs-ip.eu/team/>
For the first time, the German Federal Patent Court in Munich granted a compulsory license in a preliminary injunction proceeding. The license was awarded to the U.S. company Merck. After the filing of a lawsuit against Merck for patent infringement in Dusseldorf, Merck responded by filing its own lawsuit against the Japanese company Shionogi, demanding a license of Shionogi's patent (EP 1 422 218). The patent protects the HIV drug raltegravir sold by Merck under the name Isentress in Germany. Merck had offered Shionogi a license fee of 10 million US dollars, which Shionogi rejected.
Compulsory licenses can be granted in Germany if the claimant tries without success to obtain a license from the patentee and public interest demands the grant of the license. In cases of emergency, the compulsory license can be granted by way of a preliminary injunction. The availability of an equivalent alternative drug is a factor in the decision to grant a preliminary injunction. In the Merck case, an independent expert advised the court that there was no equivalent alternative drug available for treatment of patients who had previously been treated with Merck’s product Isentress.
The German Federal Patent Court has always been reluctant to grant compulsory licenses. This is only the second decision that granted a compulsory license, and the first that granted the license in a preliminary injunction proceeding.
The decision has not been published, but the German Federal Patent Court has issued a press release <https://www.
bundespatentgericht.de/cms/ index.php?option=com_content& view=article&id=139:2016-09- 01-13-36-42&catid=9: pressemitteilungen&Itemid=79& lang=en>,
which states (machine translated) the following:
Intermediate use of AIDS medication granted
1 September 2016
In the proceedings pending before the Federal Patent Court for a provisional judicial order for a usage permit in European patent 1 422 218 (see also press releases of the Federal Patent Court of 27 June 2016 and 27 July 2016), the 3rd Senate of the Federal Patent Court issued judgment of 31 August 2016 Decided to temporarily allow the applicants to use the patent in such a way that they can continue to offer the drug Isentress® with the active substance raltegravir for an antiviral therapy against HIV / AIDS in the Federal Republic of Germany within the scope of the already dispensed forms of administration.
The Senate, after obtaining an expert opinion, has come to the conclusion that the drug is needed by certain groups of HIV-infected and / or AIDS-affected patients for medical reasons and cannot avoid these without considerable health risks on other preparations. This applies in particular to pregnant women, infants and children as well as patients treated for HIV for many years. In doing so, the Senate has also taken into account that an effective risk of infection for third parties is reduced by an effective reduction in viral loads. This is a public interest in granting a compulsory license.
In the opinion of the Senate, the applicants have also substantiated the further prerequisites for granting a compulsory license pursuant to section 24 (1) of the Patents Act. Moreover, the urgency required for the adoption of an interim application pursuant to Section 85 of the Patents Act (Zivilgesetz) is necessary because, in the oral hearing before the District Court of Düsseldorf (court: 4c O 48/15) on 13 September 2016, the sentencing to discontinue the sale of Isentress ® for infringement of the abovementioned European patent.
A written verdict is still pending. The main charge (3 Li 1/16) remains pending.
Az .: 3 LiQ 1/16