[Ip-health] German Federal Supreme Court Affirms Compulsory License on HIV Drug

Andrew S. Goldman andrew.goldman at keionline.org
Thu Jul 13 11:40:53 PDT 2017


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.

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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