Verdict compulsory license for AIDS drug raltegravir

Federal Patent Court: Numerous patients rely on medication

Munich (jur). In an urgent procedure, the Federal Patent Court has awarded companies of the Merck Group a compulsory license for the AIDS drug raltegravir. According to the judgment of the previous day, announced on Thursday, September 1, 2016, the German Merck subsidiary MSD Sharp & Dohme GmbH can at least for the time being leave their drug Isentress® on the market (Ref .: 3 LiQ 1/16). Numerous patients are dependent on it, so the reasoning.

For Raltegravir, the Japanese company Shionogi has a European license. The active ingredient belongs to the quite new active ingredient group of ingetrase inhibitors. These prevent the incorporation of the virus's DNA into that of human cells.

With this active substance in Germany the MSD drug Isentress is on the market. Shionogi sees this as violating his patent rights. The company has therefore submitted an injunction to the Düsseldorf Regional Court.

The district court wanted to negotiate on 13 September. In order to prevent a sales ban for Isentress, MSD and other companies of the Merck Group applied to the Federal Patent Court for a compulsory license and requested a corresponding injunction.

Prerequisite for this is, according to patent law, that the other company has seriously but unsuccessfully sought a regular license and "the public interest requires the granting of a compulsory license".

The Federal Patent Court had obtained an opinion and had already negotiated the dispute for two days in an emergency proceeding. Disputes about a compulsory license are rare. That the Federal Patent Court has now been awarded a compulsory license in an express procedure, there is in the history of the court founded in 1961 so far at best a comparable case.

As a reason for the urgency, the Munich judges referred to the injunction lawsuit in Dusseldorf.

In terms of content, the Federal Patent Court relied on the report. According to this, certain patient groups are dependent on raltegravir. Especially pregnant women, infants and children as well as patients who have been treated for many years against AIDS could not switch to other drugs without significant risks.

Without success, Shionogi had referred to the other two common ingested inhibitors Dolutegravir and Elvitegravir. According to the German Aids-Hilfe Elvitegravir has considerable disadvantages in the application, but Dolutegravir is quite comparable. Ultimately, however, there are always patients for whom one of the active substances is the better one.

According to the expert's report obtained by the Federal Patent Court, these patients can not be neglected. Therefore, there is a public interest in a drug containing raltegravir. In addition, the drug reduces the "viral load" of these patients. This also reduces the risk of infection for third parties.

The main proceedings are still pending before the Federal Patent Court. There is then decided on the amount of the due license fee. mwo / fle