A Compulsory Licence For Raltegravir To Be Issued In Germany

The first time in the 55-year history of the Federal Patent Court ('Bundespatentgericht') that a compulsory licence has been granted in proceedings Bird & Bird says.

Shionogi, a patentee of the European Patent EP 1 422 218, which covers the antiviral compound Raltegravir (RAL), had brought a patent infringement lawsuit before the Regional Court of Düsseldorf against Merck. It hits defence against the allegation of patent violation, Merck initiated compulsory licence proceedings.

In the present case Merck, carrying the burden of proving that a compulsory licence was in the public interest, argued that because HIV infection is still considered to be both infectious and lethal, it is in the interest of public health to treat HIV infections as effectively as possible. Having argued this, Merck emphasised that patient compliance is an important aspect in treating HIV infections successfully and forcing patients who are being treated with Isentress to replace it with another drug could not be achieved without subjecting the patient to potentially life-long side-effects.

While Shionogi had argued that there were comparable alternatives to the Merck product, in particular, the active compound Dolutegravir (DTG), the court-appointed expert stated that, at least for some patients, there was no equal alternative treatment since greater side-effects and disadvantageous drug interactions were suffered with DTG than with RAL. Moreover, as was confirmed by the expert, Isentress was particularly important in post-exposition prophylaxis and the treatment of certain patient groups, such as babies and infants, pregnant women and long-term patients.