By: Markus Rieck <
For the first time, the German Federal Patent Court in
Munich granted a compulsory license in a preliminary injunction proceeding. The
license was awarded to the U.S. company Merck. After the filing of a lawsuit
against Merck for patent infringement in Dusseldorf, Merck responded by filing
its own lawsuit against the Japanese company Shionogi, demanding a license of
Shionogi's patent (EP 1 422 218). The patent protects the HIV drug raltegravir
sold by Merck under the name Isentress in Germany. Merck had offered Shionogi a
license fee of 10 million US dollars, which Shionogi rejected.
Compulsory licenses can be granted in Germany if the
claimant tries without success to obtain a license from the patentee and public
interest demands the grant of the license. In cases of emergency, the
compulsory license can be granted by way of a preliminary injunction. The
availability of an equivalent alternative drug is a factor in the decision to
grant a preliminary injunction. In the Merck case, an independent expert
advised the court that there was no equivalent alternative drug available for
treatment of patients who had previously been treated with Merck’s product
Isentress.
The German Federal Patent Court has always been reluctant to grant
compulsory licenses. This is only the second decision that granted a compulsory
license, and the first that granted the license in a preliminary injunction
proceeding.
The decision has not been published, but the German
Federal Patent Court has issued a press release
<https://www.
Intermediate use of
AIDS medication granted
1 September 2016
In the proceedings pending before the Federal Patent Court
for a provisional judicial order for a usage permit in European patent 1 422
218 (see also press releases of the Federal Patent Court of 27 June 2016 and 27
July 2016), the 3rd Senate of the Federal Patent Court issued judgment of 31
August 2016 Decided to temporarily allow the applicants to use the patent in
such a way that they can continue to offer the drug Isentress® with the active
substance raltegravir for an antiviral therapy against HIV / AIDS in the
Federal Republic of Germany within the scope of the already dispensed forms of
administration.
The Senate, after obtaining an expert opinion, has come to
the conclusion that the drug is needed by certain groups of HIV-infected and /
or AIDS-affected patients for medical reasons and cannot avoid these without
considerable health risks on other preparations. This applies in particular to
pregnant women, infants and children as well as patients treated for HIV for
many years. In doing so, the Senate has also taken into account that an
effective risk of infection for third parties is reduced by an effective
reduction in viral loads. This is a public interest in granting a compulsory
license.
In the opinion of the Senate, the applicants have also
substantiated the further prerequisites for granting a compulsory license
pursuant to section 24 (1) of the Patents Act. Moreover, the urgency required
for the adoption of an interim application pursuant to Section 85 of the
Patents Act (Zivilgesetz) is necessary because, in the oral hearing before the
District Court of Düsseldorf (court: 4c O 48/15) on 13 September 2016, the
sentencing to discontinue the sale of Isentress ® for infringement of the
abovementioned European patent.
A written verdict is still pending. The main charge (3 Li
1/16) remains pending.
Az .: 3 LiQ 1/16
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