Temporary Compulsory License For Antiretroviral Drug Upheld By German Court

By Monika Ermert for Intellectual Property Watch

MUNICH — The German Federal Supreme Court in a decision drawing significant attention on 11 July upheld a temporary compulsory licence granted for the HIV drug Isentress (X ZB 2/17). The antiretroviral drug, based on raltegravir, has been the object of a prolonged court fight between Japanese drug company Shionogi and its US competitor Merck.

Merck since 2008 sells Isentress on the German market. It is used for treatments of HIV patients to reduce the amount the virus cells in the body, while increasing the number of CD4 (T) cells.

Shionogi tried to stop the sale of Isentress in Germany arguing that it violates its Japanese patent (2005/207/392). At the same time a patent granted by the European Patent Office granted in 2012 (applied for in 2002, 1/422/218) has been challenged by Merck.

That case is still pending as well as a final decision by the German Courts on a permanent compulsory licence which was requested by Merck and supported by other companies. While the text of the full ruling has not been published yet, in a press release, the Court stated it agreed with the lower court that the applicants for the compulsory license had made reasonable attempts to receive a licence from Shionogi based on usual market conditions, especially given that a decision on the challenge against the European patent was still pending.

The Court also agreed that there was obvious “public interest to grant a compulsory license.”

“While not every HIV or Aids patient does rely on an permanent access to Raltegravir, there are groups of patients that need it to secure their treatement and ensure its quality. Especially babies, children below 12, pregnant women that need prophylactic treatment,” the Court wrote. A change to potential substitutes could result in considerable side effects. Compulsory licences are granted very rarely by German courts.