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13 July 2017Big Pharma

Germany’s Supreme Court upholds HIV compulsory licence

The Federal Court of Justice, Germany’s Supreme Court, has upheld a lower court’s ruling that granted a preliminary compulsory licence to use a patent protecting an HIV treatment.

In the decision (in German), dated Tuesday, July 11, the court agreed with the Federal Patent Court’s ruling allowing three companies in the Merck & Co group to sell antiretroviral drug Isentress (raltegravir), despite a European patent owned by Japanese pharmaceutical company Shionogi protecting that compound.

The court has yet to decide the case in full, which is why the injunction is only preliminary.

Shionogi had sued Merck for infringing European patent number 1,422,218 , following which Merck requested a compulsory licence from the Federal Patent Court. The court’s decision was reportedly the first time in its history that such a licence had been granted in preliminary injunction proceedings.

The parties had been attempting to negotiate a licence for Merck to use the patent, and the lower court agreed that Merck’s attempts were reasonable before the case was filed. According to one report, Merck’s offer to pay $10 million for a global licence was considered unacceptable by Shionogi.

The Federal Patent Court added that a compulsory licence was in the public interest.

Isentress is the only HIV treatment in Germany comprising raltegravir.

On appeal from Shionogi, the Supreme Court agreed with the previous decision, stating that Merck’s efforts to obtain a reasonable deal were sufficient, particularly as the patent has been opposed at the European Patent Office and the final outcome is uncertain.

The Supreme Court also said that certain HIV patients do need raltegravir to immediately protect their health. These groups include infants, children under 12, pregnant women, people who need prophylactic treatment because of the risk of infection, and patients who are already treated with Isentress and who are threatened with significant side effects when switching to another drug.

Marc Holtorf, head of the IP and life sciences division at Pinsent Masons in Germany, wrote on a news website run by the firm that the granting of compulsory patent licences is extremely rare in Germany, and that in the only previous case of a licence being granted, it was subsequently overturned on appeal.

Shionogi also sued Merck for infringement over the same patented drug in the UK, but a court ruled in November last year that the patent was invalid.

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