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

Céline Grillon celine.grillon at medecinsdumonde.net
Tue Sep 13 07:42:25 PDT 2016


The patent has also been opposed by Merck & co at the EPO : https://register.epo.org/application?lng=en&number=EP02749384 
The decision in first instance was to maintain the patent in a modified form. It is in appeal now.

Regards,

Celine 



-----Message d'origine-----
De : Ip-health [mailto:ip-health-bounces at lists.keionline.org] De la part de Baker, Brook
Envoyé : jeudi 8 septembre 2016 18:54
À : Jamie Love <james.love at keionline.org>; Priti Radhakrishnan <priti at i-mak.org>; Ip-health <ip-health at lists.keionline.org>
Objet : Re: [Ip-health] German Federal Patent Court issues compulsory license on patents for HIV drug Raltegravir

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&vie
>w=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&vie
>w=a 
>rticle&id=138%3Azwangslizenz-aids-medikament2&catid=9%3Apressemitteilun
>gen
>&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&vie
>w=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.o
>rg


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