The German Federal Patent Court has ordered for the first time a provisional compulsory license under Section 24 of the Patent Act, allowing Merck (US) to continue to market the HIV-drug raltegravir, which is sold as Isentress® in Germany. Prior to that the Japanese company Shionogi & Co. Ltd. had requested a preliminary injunction against Merck (US) in 2015 for use of its European Patent 1,422,218 (DE 602 42 459.3), which covers the drug raltegravir. After Shionogi rejected Merck's offer for a voluntary worldwide license on the said patent, Merck (US) responded by requesting the compulsory license, and then made an urgent request for such a license under Section 85 of the German Patent Act.
First provisional compulsory license issued in Germany on a European patent for an AIDS medicament
In the respective case 3 Li 1/16 before the 3rd Senate of the Federal Patent Court, various pharmaceutical companies of the U.S. consolidated group Merck & Co. sought a compulsory license for the AIDS drug balance between the monopoly rights conferred by the European Patent 1,422,218 of the patent holder Shionogi and the urgent public interest in health care.
In the judgment of 31 August 2016, the Federal Patent Court decided in favour of Merck (US) to temporarily allow the use of the European patent in such a way, so that the already previously distributed forms of raltegravir could continue to be offered as the pharmaceutical drug Isentress® for antiretroviral therapy against HIV and AIDS in the Federal Republic of Germany.
Under consideration of an independent expert opinion, the 3rd Senate came to the conclusion that the drug raltegravir was required, without any suitable alternative, by at least certain groups of HIV-infected and/or patients suffering from AIDS for medical reasons. These groups of patients actually cannot switch to other drug products without significant health risks. This is particularly true for pregnant women, newborns, newly infected patients, and also for patients that have already been treated against HIV for many years.
In their decision the 3rd Senate also considered that under the continuing use of raltegravir a possible risk of infection for others may decrease due to an effective reduction of the HI-virus load by that drug. Moreover, according to the Senate’s view, the applicants did also comply with the other conditions of a compulsory license under Section 24 (1) of the German Patent Act. In addition, the required urgency for the grant of such an interim usage order under Section 85 of the German Patent Act was given due to an oral hearing that was to be held on September 13, 2016 before the District Court of Duesseldorf (Ref.: 4c O 48/15). In these parallel proceedings the conviction was sought by the patent owner for prohibiting the marketing of Isentress® due to an alleged infringement of the European patent 1,422,218 through Merck (US).
In summary, the Court ruled that the aforementioned facts would allow the grant of a provisional compulsory license on the basis of urgent public interest. Such a decision is unusual for the Federal Patent Court of Germany, since traditionally, German courts have been reluctant to grant compulsory licences; especially under emergency proceedings such as in the present case. Typically, arising compulsory license proceedings are already settled by an agreement between the patent holder and the potential licensees before the matter is decided.
A written verdict with substantiated reasoning is still outstanding. The principal proceedings of 3 Li 1/16 remain pending and Shionogi can appeal the above summarised decision.