Germany’s Federal Court of Justice this week upheld a Federal Patent Court decision to grant an injunction ordering the issuance of a compulsory licence to the European patent protecting the underlying compound in Isentress, an anti-viral that treats HIV.
Japanese pharmaceutical company Shionogi owns a family of patents to the raltegravir compound in Isentress.
Merck manufactures and sells Isentress in Europe, but has been unable to agree a worldwide licence with Shionogi for its raltegravir patents, prompting the litigation.
The Federal Court of Justice backed the Federal Patent Court’s decision to force through a compulsory licence, as Merck had made sufficient attempts to negotiate a licence.
There was also significant public interest in keeping access to Isentress open in Germany, where it is the only anti-viral containing raltegravir available and is required to meet the needs of certain patients, including infants, pregnant women, and people who have already been prescribed with Isentress.
Compulsory licences are not granted often, in Europe or globally.
Rwanda and Thailand have issued compulsory licences in the past. In 2012, the Indian government granted a compulsory licence to Natco Pharma to manufacture and distribute Nexavar for 3 percent of the cost of the original drug patented by Bayer, although the licence was eventually revoked.