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German Federal Court: Permission granted – HIV/AIDS drug distribution continued

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug used for treatment of patients infected with HIV or suffering from AIDS (see press release in German). In August of 2016, the Federal Patent Court had granted a preliminarily compulsory license,  provisionally allowing the continued distribution of the drug. The respondent, Shionogi, who claimed infringement of its European Patent EP 1 422 218, had launched the appeal which was unsuccessful. The amount of the licence fee for the compulsory license will be determined in the main proceedings (scheduled for November).

Merck was represented by a Hogan Lovells team led by Düsseldorf partners Miriam Gundt and Andreas von Falck. Isentress®, a drug used in antiviral treatment against the immune deficiency illness, has been sold by Merck in Germany since 2008.

We are happy that the German Federal Court has rejected the appeal against the preliminary permission for the continued distribution of Isentress“, says Miriam Gundt. “This drug is essential to specific groups of HIV-infected patients for medicinal reasons, since they cannot be referred to other medications without significant risks to their health. This is especially the case for pregnant women, infants, children and patients with a long-term treatment history. The German Federal Court also considered the fact that effectively lowering the viral load will diminish the possible infection risk for the rest of the population.”

Background

The patent in suit was filed on 8 August 2002 and granted on 21 March 2012. In the opposition proceedings, the European Patent Office maintained the patent in suit in amended form. The appeal against this decision is still pending (the oral hearing is scheduled for October). On 3 June 2014, Shionogi claimed that Isentress was covered by the Japanese patent 5 207 392, belonging to the patent in suit’s patent family. Negotiations on a worldwide license agreement were unsuccessful. With its submission dated 17 August 2015, Shionogi sued Merck for patent infringement before the District Court Düsseldorf (No. 4c O 48/15). The District Court has stayed the proceedings awaiting a decision from the European Patent Office on the pending appeal. The respondent’s immediate appeal against the stay was unsuccessful.