[Federal Register Volume 87, Number 4 (Thursday, January 6, 2022)]
[Notices]
[Pages 782-783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Human Therapeutics 
for Fibrotic Disease

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
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 NHLBI Office of Technology Transfer and Development 
January 21, 2022 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: Michael Shmilovich, Esq., CLP Senior Licensing 
and Patenting Manager, phone number 301-435-5019 or <a href="/cdn-cgi/l/email-protection#f4879c999d989b8299b49a9d9cda939b82"><span class="__cf_email__" data-cfemail="4a3922272326253c270a242322642d253c">[email protected]</span></a>.

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 license to Inversago 
Pharma, Inc.:

[[Page 783]]



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                                      Patent No. or
           NIH ref No.               application No.         Issue date          Filing date                               Title
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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, 2017.  November 12, 2013..  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-CA-04...............  2889697............  ...................  April 27, 2015.....  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-EP-05...............  2919779............  January 6, 2021....  June 01, 2015......  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-CH-12...............  2919779............  January 6, 2021....  November 12, 2013..  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-DE-13...............  2919779............  January 6, 2021....  November 12, 2013..  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-FR-14...............  2919779............  January 6, 2021....  November 12, 2013..  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-GB-15...............  2919779............  January 6, 2021....  November 12, 2013..  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-IE-16...............  2919779............  January 6, 2021....  November 12, 2013..  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-IN-06...............  354301.............  December 23, 2020..  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...............  10,787,419.........  September 29, 2020.  August 10, 2017....  Cannabinoid Receptor 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-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-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.
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...............  6762930............  September 11, 2020.  May 8, 2015........  Cannabinoid Receptor 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.
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    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 in a field of use limited 
to human therapeutics for fibrotic disease.
    The invention covered by the patents and patent applications 
pertaining to NIH Ref. No. E-282-2012-0 and -1 pertain to cannabinoid 
receptor 1 (CB<INF>1</INF>R) inverse agonists. CB<INF>1</INF>R 
activation plays a key role in appetitive behavior and metabolism. Of 
importance as a therapeutic target here is that the receptor is 
expressed in both peripheral tissue as well as the CNS. 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, and for fibrotic disease, while 
having no experimentally discernable neuropsychotropic side effects 
that are considered adverse such as the earlier antagonists rimonabant. 
These CB<INF>1</INF>R 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 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 CB<INF>1</INF>R 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, and includes various fibrotic disorders, 
without the dangerous the 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, the NHLBI 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: January 3, 2022.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2022-00022 Filed 1-5-22; 8:45 am]
BILLING CODE 4140-01-P


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