[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Notices]
[Pages 71079-71080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Treatment of 
Hermansky-Pudlak Syndrome and Idiopathic Pulmonary Fibrosis

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI) and the 
National Human Genome Research Institute (NHGRI), both of the National 
Institutes of Health, Department of Health and Human Services, are 
contemplating the grant of an exclusive patent license to Inversago 
Pharma Inc., located in Montreal, Quebec, Canada, to practice the 
inventions embodied in the patent applications listed in the 
SUPPLEMENTARY INFORMATION section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the National Human Genome Research Institute's 
Technology Transfer Office on or before November 23, 2020 will be 
considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Anna Solowiej, Ph.D., J.D., Senior Licensing and 
Patenting Manager, NHGRI Technology Transfer Office; Telephone (301) 
435-7791; Email: [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to Inversago 
Pharma Inc.:

----------------------------------------------------------------------------------------------------------------
                                   Patent No. or
          NIH ref No.             application No.       Issue date        Filing date              Title
----------------------------------------------------------------------------------------------------------------
E-282-2012-0-US-01.............  61/725,949.......  .................  November 13, 2012  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-PCT-02............  PCT/US2013/069686  .................  November 12, 2013  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-US-03.............  9,765,031........  September 19,      November 12, 2013  Cannabinoid Receptor
                                                     2017.                                 Mediating Compounds.
E-282-2012-0-CA-04.............  2889697..........  .................  April 27, 2015...  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-EP-05.............  13802153.0.......  TBD..............  June 01, 2015....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-CH-12.............  13802153.0.......  TBD..............  November 12, 2013  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-DE-13.............  13802153.0.......  TBD..............  November 12, 2013  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-FR-14.............  13802153.0.......  TBD..............  November 12, 2013  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-GB-15.............  13802153.0.......  TBD..............  November 12, 2013  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-IE-16.............  13802153.0.......  TBD..............  November 12, 2013  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-IN-06.............  3733/DELNP/2015..  .................  May 1, 2015......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-JP-07.............  6272626..........  January 12, 2018.  May 11, 2015.....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-CN-08.............  ZL201380069389.9.  August 20, 2019..  July 3, 2015.....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-US-09.............  10,683,270.......  June 16, 2020....  August 10, 2017..  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-0-US-10.............  15/674,333.......  TBD (application   August 10, 2017..  Cannabinoid Receptor
                                                     allowed).                             Mediating Compounds.
E-282-2012-0-US-11.............  16/870,093.......  .................  May 8, 2020......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-1-US-01.............  62/171,179.......  .................  June 4, 2015.....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-1-PCT-02............  PCT/US2016/035291  .................  June 1, 2016.....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-1-EP-05.............  16728547.7.......  .................  June 1, 2016.....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-1-US-08.............  15/579,123.......  .................  December 1, 2017.  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-1-US-09.............  16/438,850.......  .................  June 12, 2019....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-2-US-01.............  15/061,829.......  .................  March 4, 2016....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-2-PCT-02............  PCT/US2017/020250  .................  March 1, 2017....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-2-CN-03.............  2017800118698....  .................  March 1, 2017....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-282-2012-2-EP-04.............  17711443.6.......  .................  March 1, 2017....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-US-01.............  61/991,333.......  .................  May 9, 2014......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-PCT-02............  PCT/US2015/029946  .................  May 8, 2015......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-AU-03.............  2015255765.......  .................  November 7, 2016.  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-CA-04.............  2948349..........  .................  May 8, 2015......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-CN-05.............  201580028788.X...  February 7, 2020.  May 8, 2015......  Cannabinoid Receptor
                                                                                           Mediating Compounds.

[[Page 71080]]

 
E-140-2014-0-EP-06.............  15728668.3.......  .................  May 8, 2015......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-IN-07.............  201637038171.....  .................  November 8, 2016.  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-JP-08.............  2017-511558......  TBD (application   May 8, 2015......  Cannabinoid Receptor
                                                     allowed).                             Mediating Compounds.
E-140-2014-0-US-09.............  10,329,259.......  June 25, 2019....  November 8, 2016.  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-HK-10.............  17105705.6.......  .................  June 9, 2017.....  Cannabinoid Receptor
                                                                                           Mediating Compounds.
E-140-2014-0-AU-11.............  2019227889.......  .................  May 8, 2015......  Cannabinoid Receptor
                                                                                           Mediating Compounds.
----------------------------------------------------------------------------------------------------------------

    The patent rights in these inventions have been assigned to the 
Government of the United States of America.
    The prospective exclusive patent license territory may be worldwide 
and a field of use limited to human therapeutics for Hermansky-Pudlak 
syndrome and idiopathic pulmonary fibrosis.The invention covered by the 
patents and patent applications pertaining to HHS Ref. No. E-282-2012 
relates to cannabinoid receptor 1 (CB1R) inverse agonists. 
CB1R activation plays a key role in appetitive behavior, 
metabolism, and tissue fibrosis. Of importance as a therapeutic target 
here is that the receptor is expressed in both peripheral tissue as 
well as the central nervous system. The invention is a class of 
pyrazole compounds that act as CB1 receptor inverse agonists and have 
been shown effective at reducing obesity and its associated metabolic 
consequences while having no experimentally discernable 
neuropsychotropic side effects that are considered adverse, unlike the 
earlier antagonists rimonabant. These CB1R receptor 
compounds were developed with the goals of limiting their brain 
penetrance without losing their metabolic efficacy due to CB1 inverse 
agonism, and having a primary metabolite directly targeting enzymes 
involved in inflammatory and fibrotic processes associated with 
metabolic and other disorders. The patents are both compositions of 
matter and methods of use.
    The inventions covered by HHS Ref. E-140-2014-0 also pertain to 
pyrazole CB1R receptor inverse agonists. In addition, some 
of these compounds also have a direct inhibitory effect on inducible 
nitric oxide synthase (iNOS), whereas another group of the compounds 
directly activates AMP kinase. There is evidence that the metabolic 
effects of endocannabinoids are mediated by CB1 receptors in peripheral 
tissues. These dual-target compounds may be useful for treating 
metabolic disease and related conditions such as obesity and diabetes 
and their complications, including various forms of tissue fibrosis, 
without the dangerous side effects. This notice is made in accordance 
with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive 
patent license will be royalty bearing and may be granted unless within 
fifteen (15) days from the date of this published notice, NHGRI 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent license.
    Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: November 2, 2020
Claire T. Driscoll,
Director, Technology Transfer Office, National Human Genome Research 
Institute.
[FR Doc. 2020-24616 Filed 11-5-20; 8:45 am]
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