German Federal Supreme Court Affirms Compulsory License on HIV Drug

On July 11, 2017, the German Federal Supreme Court announced that it had affirmed the decision of the Federal Patent Court last year to issue a compulsory license allowing Merck to continue selling its HIV drug, raltegravir (marketed as Isentress).

The compulsory license was requested by Merck amidst preliminary patent infringement proceedings in response to Shinogi’s request for an injunction to bar Merck from selling the allegedly infringing drug. The request fell under both section 24(1) of the German Patent Law, which provides for compulsory licenses and section 85, which provides for compulsory licenses in scenarios of urgent need and public interest. The Federal Supreme Court agreed with the Patent Court’s determination that the public interest warranted the compulsory license, given the threat that an injunction creates for certain HIV patients. The Court’s release states:

“The Federal Court also shares the assessment of the Federal Patent Court that a public interest in the granting of a compulsory license is credible. It is true that not every HIV or AIDS patient is required to be treated with raltegravir at any time. There are, however, patient groups that needed raltegravir to maintain the safety and quality of treatment. These include, in particular, 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 and interactions when switching to another drug.”[Translated from German by Google.]

These are four observations on the decision:

  1. This is a court in Germany, a country known for robust enforcement of patent rights.
  2. The decision focused on the interests and protection of the patients, who faced risks if forced to switch to other drugs.
  3. Shinogi, the holder of the infringed patents, was a non-practicing entity, which may have been important.
  4. The decision will be seen as a precedent for other cases where the public interest and concerns about health are present.

The relevant provisions of the German law are as follows:

Section 24

(1) The non-exclusive authorisation to commercially use an invention shall be granted by the Federal Patent Court in an individual case in accordance with the following provisions (compulsory licence) where

1. a licence seeker has, within a reasonable period of time, unsuccessfully attempted to obtain permission from the proprietor of the patent to use the invention on reasonable commercial terms and conditions, and

2. the public interest calls for the grant of a compulsory licence.

Section 85

(1) In proceedings for the grant of a compulsory licence the claimant may, at his request, be permitted to use the invention on the basis of an injunction if he substantiates that the requirements under section 24 (1) to (6) are fulfilled and that there is an urgent need, in the public interest, for the immediate grant of the permission.

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Andrew Goldman