The HIV medicine Isentress from Merck may be further distributed. On 11 July 2017, the German Federal Court of Justice confirmed a decision by the Federal Patent Court (reference X ZB 2/17). This had determined that the Japanese pharmaceutical company Shionogi must grant the competitor Merck a compulsory license to its European patent (EP 1 422 218) on the HIV active substance Raltegravir.
In its decision of 11 July 2017, the German Federal Court of Justice (BGH) confirmed the decision of the Federal Patent Court (Bundespatentgericht), by which, for the first time in the history of Germany, a patent-compulsory license was provisionally granted. At least as far as a decision in the main proceedings, which also determines the amount of the appropriate license fee for the compulsory license, the medicines concerned can now be further distributed in Germany.
The judges at the Federal Court of Justice followed with their decision the Federal Patent Court in the two essential prerequisites of §§ 24 I, 85 Patent Act (PatG): Merck had made ample effort in the preliminary stage to come to an agreement with Shionogi for the patent use. In view of the fact that the enforceability of the European patent is not definitively clarified, the offer of a single payment for patent use is justified in the specific case. In addition, the public interest in granting a compulsory license had been demonstrated. With regard to particularly vulnerable groups of patients, for whom no equivalent medicine is available, there is a strong public interest, which places the compulsory license in the interest of public healthcare.
The next step will depend on the Board of Appeal of the European Patent Office. It decides on the validity of the patent in October. If it is valid, the suspended infringement proceedings at the District Court in Düsseldorf are likely to continue. The Federal Patent Court will probably negotiate the main proceedings for the compulsory license in November.