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Verdict: Compulsory license for AIDS drug raltegravir


Federal Patent Court: Numerous patients depend on medication

Munich (jur). The Federal Patent Court granted companies in the Merck Group a compulsory license for the AIDS active ingredient raltegravir in an urgent procedure. After the judgment of the previous day, announced on Thursday, September 1, 2016, the German Merck subsidiary MSD Sharp & Dohme GmbH can at least initially leave its drug Isentress® on the market (Az .: 3 LiQ 1/16). Numerous patients are dependent on it, the reasoned.

The Japanese company Shionogi has a European license for Raltegravir. The active ingredient belongs to the quite new group of active ingredients called Ingetrase inhibitors. These prevent the DNA of the virus from being incorporated into that of human cells.

With this active ingredient, the MSD drug Isentress is on the market in Germany. Shionogi sees his patent rights violated. The company has therefore filed an injunction with the Düsseldorf District Court.

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

According to the patent law, the prerequisite for this is that the other company has made serious but unsuccessful efforts to obtain a regular license and "the public interest requires the issuance of a compulsory license".

The Federal Patent Court had obtained an expert opinion and had already ruled on the dispute for two days in a rush. Disputes over a compulsory license are rare. The fact that the Federal Patent Court has already granted a compulsory license in urgent proceedings has so far been a comparable case in the history of the court founded in 1961.

As reasons for the urgency, the Munich judges referred to the injunction in Düsseldorf.

The Federal Patent Court based its content on the expert opinion. According to this, certain patient groups are dependent on raltegravir. In particular, pregnant women, infants and children, as well as patients who have been treated for AIDS for many years, could not switch to other drugs without considerable risks.

Shionogi had unsuccessfully referred to the other two common ingetrase inhibitors, Dolutegravir and Elvitegravir. According to the German Aids Aid, Elvitegravir has considerable disadvantages in its use, but Dolutegravir is quite comparable. Ultimately, however, there are always patients for whom one of the active ingredients is the better.

According to the expert opinion obtained from the Federal Patent Court, these patients cannot be neglected. Therefore, there is a public interest in a drug with the active ingredient 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. The amount of the license fee due is then decided there. mwo / fle

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