German Court Issues Compulsory License on HIV Drug Patent

A German patent court has ordered a compulsory license under Section 24 of the Patent Act, allowing Merck (US) to continue to market the HIV drug raltegravir (marketed as Isentress).

The August 31, 2016 decision was made by the Federal Patent Court in proceedings between Merck and Japanese company Shionogi, which had requested a preliminary injunction against Merck in 2015 for use of its patent. After Shionogi rejected Merck’s offer for a voluntary worldwide license on the patent, Merck responded by requesting the compulsory license, and then making an urgent request for such a license under Section 85 of the Patent Act.

The patent court’s decision was grounded in urgent public interest and the fact that many HIV patients using raltegravir, including pregnant women, newborns, and newly infected patients, cannot switch off of Isentress without significant health risks.

The decision is subject to appeal.

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