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

Baker, Brook b.baker at northeastern.edu
Thu Sep 8 09:53:38 PDT 2016


This is the text of section 24 of the German Patent Act:

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.
(2) Where a licence seeker cannot exploit an invention for which he holds
protection under a patent with a later filing or priority date without
infringing a patent with an earlier filing or priority date, he shall be
entitled, in respect of the proprietor of the patent with the earlier
filing or priority date, to the grant of a compulsory licence from the
proprietor of the patent if
1.  the condition under subsection (1) no. 1 is fulfilled, and
2.  his own invention demonstrates an important technological advance of
substantial economic significance compared to that of the patent with the
earlier filing or priority date.
The proprietor of the patent can require the licence seeker to grant him a
cross-licence on reasonable terms and conditions for the use of the
patented invention with the later filing or priority date.
(3) Subsection (2) shall apply mutatis mutandis where a plant breeder
cannot obtain or exploit a plant variety right without infringing an
earlier patent.
(4) A compulsory licence under subsection (1) may be granted for a
patented invention in the field of semiconductor technology only where
this is necessary to eliminate those anti-competitive practices pursued by
the proprietor of the patent which have been established in court or
administrative proceedings.
(5) Where the proprietor of the patent does not apply the patented
invention in Germany or does not do so predominantly, compulsory licences
in accordance with subsection (1) may be granted to ensure an adequate
supply of the patented product on the German market. Import shall thus be
equivalent to the use of the patent in Germany.
(6) The grant of a compulsory licence in respect of a patent shall be
admissible only after the patent has been granted. The compulsory licence
may be granted subject to limitations and made dependent on conditions.
The extent and the duration of use shall be limited to the purpose for
which the compulsory licence was granted. The proprietor of the patent
shall be entitled to remuneration from the proprietor of the compulsory
licence, such remuneration being equitable in the circumstances of the
case and taking into account the economic value of the compulsory licence.
Where, in relation to recurrent remuneration payments due in the future,
there is a substantial change in the circumstances which governed the
fixing of the amount of remuneration, each party shall be entitled to
require a corresponding adjustment. Where the circumstances upon which the
grant of a compulsory licence was based no longer apply and if their
recurrence is improbable, the proprietor of the patent can require
withdrawal of the compulsory licence.
(7) A compulsory licence in respect of a patent may be transferred only
together with the business which is involved in exploiting the invention.
A compulsory licence in respect of an invention which is the
subject-matter of a patent with an earlier filing or priority date may be
transferred only together with the patent with a later filing or priority
date.



On 9/8/16, 12:07 PM, "Ip-health on behalf of Jamie Love"
<ip-health-bounces at lists.keionline.org on behalf of
james.love at keionline.org> wrote:

>https://www.bundespatentgericht.de/cms/index.php?option=com_content&view=a
>rticle&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=a
>rticle&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=a
>rticle&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
>_______________________________________________
>Ip-health mailing list
>Ip-health at lists.keionline.org
>http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org





More information about the Ip-health mailing list