[Ip-health] German Federal Patent Court issues compulsory license on patents for HIV drug Raltegravir

Jamie Love james.love at keionline.org
Thu Sep 8 09:07:51 PDT 2016


https://www.bundespatentgericht.de/cms/index.php?option=com_content&view=article&id=137%3A2016-06-27-13-41-51&catid=9%3Apressemitteilungen&Itemid=79&lang=en

June 27, 2016

3 Li 1/16 - compulsory license proceedings before the Federal Patent Court

3 LiQ 1/16 - Application for provisional use permit from the Federal Patent
Court

Pharmaceutical Companies covet compulsory license for AIDS drug
Balance between monopoly rights of the patent holder
and public interest in health care

At the 3rd Division of the Federal Patent Court an action is pending, with
the grant of a compulsory license to the European Patent 1,422,218 (DE 602
42 459.3) of the Japanese pharmaceutical company Shionogi & Co. Ltd. is
sought (Az .: 3 Li 1/16) ,

Applicant of the compulsory license proceedings before the Federal Patent
Court are various companies in the US consolidated group Merck & Co., an
HIV / AIDS drug with the active ingredient raltegravir, an integrase
inhibitor marketed in the Federal Republic of Germany. Integrase inhibitors
are used for the treatment of HIV infection. They prevent the incorporation
of the viral DNA into the DNA of human cells.

The patentee believes that the drug distribution infringes their patent and
therefore the Landgericht Dusseldorf (Az .: 4c O 48/15) sued inter alia for
an injunction. The applicants then the Federal Patent Court proceedings
(Ref .: 3 Li 1/16) according to §§ 24, where 81 patent law in order to
obtain a compulsory license to the patent, their use of the HIV / AIDS drug
in the Federal Republic against payment would allow a reasonable royalty.
Priti Radhakrishnan from I-Mak spotted this.   The German Federal Patent
Court has issued a compulsory license for a patent on the HIV drug
raltegravir.   Below are the Google translations of the press releases from
the court.


https://www.bundespatentgericht.de/cms/index.php?option=com_content&view=article&id=138%3Azwangslizenz-aids-medikament2&catid=9%3Apressemitteilungen&Itemid=79&lang=en

July 27, 2016

3 Li 1/16 - compulsory license proceedings before the Federal Patent Court

3 LiQ 1/16 - Application for provisional use permit from the Federal Patent
Court

Compulsory license and provisional use permit for AIDS drug
In the case before the 3rd Division of the Federal Patent Court procedures
on preliminary injunction a use authorized in the European Patent 1,422,218
(see also press release of the Federal Patent Court of 27 June 2016) of the
3rd Senate has mandated a medical expert with the establishment of opinion
and an additional day of the trial scheduled.

While the applicants contend that the requirements for an injunction in
accordance with § 85 Patent Act and for the issuance of a compulsory
license pursuant to § 24 Patent Act that would affect the patentee is the
opposed and has argued that the applicants in advance of the trial already
insufficient to a have endeavored license on reasonable terms.

The parties also argue about whether the health care of affected HIV
patients would actually be jeopardized if the AIDS drug with the active
ingredient raltegravir in the Federal Republic would no longer be marketed.
The Delegate from the 3rd Division of the Federal Patent Court experts
should therefore be clarified include whether - how forward by the
defendant - other equivalent drugs, such as those available with the drug
Dolutegravir and elvitegravir, all infected with the HIV virus patient
groups to treat.

In that procedure (3 LiQ 1/16) to the hearing before the 3rd Division of
the Federal Patent Court on 30th and August 31, 2016 respectively at 9.30
held.


https://www.bundespatentgericht.de/cms/index.php?option=com_content&view=article&id=139%3A2016-09-01-13-36-42&catid=9%3Apressemitteilungen&Itemid=79&lang=en

September 1, 2016

In the proceedings before the Federal Patent Court proceedings on
preliminary injunction a use authorized in the European Patent 1,422,218
(see also press releases of the Federal Patent Court of 27 June 2016 and 27
July 2016), the 3rd Division of the Federal Patent Court in a judgment of
31 August 2016 decided the applicants temporarily to allow the use of the
patent in such a way that as part of the already previously distributed
forms can continue to offer the drug ISENTRESS with the drug raltegravir
for antiviral therapy against HIV and AIDS in the Federal Republic of
Germany.

The Senate has come to an expert opinion to the conclusion that the drug of
certain groups of HIV-infected and / or suffering from AIDS patients is
required for medical reasons and they can not switch to other products with
no significant health risks. This is particularly true for pregnant women,
infants and children and many years against HIV treated patients. Here, the
Senate has also considered that a possible risk of infection for others is
reduced by an effective reduction of the viral load. This is where a public
interest in the grant of a compulsory license.

In this Court's view, the applicants have also the other conditions of a
compulsory license pursuant to § 24 para. 1 of the Patent Law credible. In
addition, for the grant of interim usage order pursuant to § 85 of the
Patent Law lie before required urgency as in the present at the September
13, 2016 hearing before the Landgericht Dusseldorf (Az .: 4c O 48/15) the
conviction for prohibiting the marketing of Isentress ® threatening for
breach of the aforementioned European patent.

A written verdict is still pending. The main claim, (3 Li 1/16) is still
pending.

Az .: 3 LiQ 1/16

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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