Compulsory patent license for protected active substances for individualized therapies


In a recent decision ("Raltegravir"), the German Federal Court of Justice (FCJ) has for the first time confirmed a compulsory patent license granted by the German Federal Patent Court (FPC) in first instance in a preliminary injunction proceeding. The compulsory license permits the preliminary manufacture and the (further) distribution of the antiretroviral HIV/AIDS medicament Isentress (active ingredient: Raltegravir), which has been distributed in German since 2007. Only once before, the FPC had granted a compulsory license for a patent-protected active substance (Interferon-gamma) for the treatment of a severe disease. However, this decision was later lifted by the FCJ in its Polyferon decision due to the lack of public interest in the grant of a compulsory license.

The recent decision rendered in a preliminary injunction proceeding offers interesting approaches, which may enhance the importance of compulsory patent licenses in the future. After the board of appeal of the European Patent Office (EPO) revoked the underlying compulsory license patent in mid-October, it is unlikely that  the FCJ will again deal with the request for compulsory license in main proceedings.