Compulsory Licence for AIDS medicine in Germany
The German Federal Patent Court has awarded the US Merck company a licence to a patent held by the Japanese company Shionogi covering the antiretroviral drug raltegravir. It’s only the second time that such a licence has been granted under Section 24 of the German Patent Act and the first time that the licence was granted in an emergency procedure. Merck had previously offered Shionogi a licence fee of 10 million US dollar, but the sum was rejected.
Shionogi is currently suing Merck in the Düsseldorf district court for infringement of the European patent No 1 422 218 and Merck requested the licence on the grounds of public interest because of the need to supply the German marketplace with its Isenstress product to treat AIDS. Shionogi argued that Merck had not tried seriously to obtain a licence to the patent and also that it would be possible to use other drugs. The Federal Patent Court was advised by an independent expert that, at least for certain groups of patients, it would not be possible to use another treatment. As a result, the Patent Court granted Merck the requested licence, as reported in its own press release.
Shionogi can appeal the decision. The infringement proceedings continue with a hearing set in mid-September.
The case is highly unusual. German courts have traditionally been reluctant to grant compulsory licences. Requests are made from time to time, but are normally settled by an agreement between the patent holder and potential licensees before the matter is ever decided.
The decision is restricted to the German marketplace. However, other European Union countries have similar provisions in their laws and thus it is likely that should a court in another country be asked to make a similar decision, then it is likely that the German decision will be at least considered, even if it is not binding on the other court. Currently there is no mechanism to obtain a Europe-wide compulsory licence. The proposed unitary European patent system does have such a provision, but the agreements have not yet entered into force.