Compulsory license allows further distribution of AIDS drug Isentress

BGH sees provisional distribution as "public interest"

The Federal Court of Justice (BGH) in Karlsruhe has continued to allow further distribution of the HIV and AIDS drug Isentress despite existing patent disputes. Although not every HIV or AIDS patient is dependent on treatment with Isentress and the active substance raltegravir contained therein, but individual patient groups very well, judged on Tuesday, July 11, 2017, the X.-BGH civil division (Az .: X Eg 2/17). There is therefore a public interest that the German Merck subsidiary MSD Sharp & Dohme GmbH and other Merck companies receive a compulsory license for the preliminary sale of the drug.

Raltegravir is one of the integrase inhibitors. These prevent the incorporation of the virus's DNA into that of human cells. The active ingredient was developed by the US pharmaceutical company Merck and also patented in Europe. With the active ingredient raltegravir, the MSD drug Isentress is on the market in Germany.

The Japanese company Shionogi, on the other hand, considers a broader European patent to be a theoretical variety of antiviral agents, one of which is raltegravir.

Shionogi believes that MSD violates this patent with Isentress. The company has therefore submitted an injunction to the Düsseldorf Regional Court. It suspended the dispute pending the decision on the appeal before the European Patent Office.

However, in order to reliably prevent a sales ban for Isentress, MSD and the other Merck subsidiaries applied to the Federal Patent Court for a compulsory license and a corresponding preliminary injunction.

In an urgent procedure, the Federal Patent Court granted the Merck subsidiaries this compulsory license by order of 31 August 2016 for the time being, so that the drug may continue to be distributed (Ref .: 3 LiQ 1/16, JurAgentur report dated 2 September 2016). Numerous HIV and AIDS patients are dependent on it, so the reasoning. Under the patent law, a compulsory license is possible if required by the public interest.

This decision was confirmed by the BGH. The distribution of Isentrees is temporary, until the decision of the patent litigation allowed. The public interest in granting a compulsory license was credible.

"There are ... patient groups that need raltegravir to maintain treatment safety and quality," said the BGH. These included, in particular, infants, children under the age of twelve, pregnant women, persons in need of prophylactic treatment because of the risk of infection, and patients previously treated with Isentress who are at risk of serious side effects and interactions when switching to another drug. fle