[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38707-38708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Treatment of Type 
I Diabetes and its Comorbidities

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

[[Page 38708]]

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 
August 22, 2018 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., Senior Licensing and 
Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479, phone number 301-435-5019, or [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.:

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                                          Patent No. or
         HHS Reference No.               application No.            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..............  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.................  13802153.0.............  June 01, 2015.........  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.................  2015-542015............  May 11, 2015..........  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-CN-08.................  201380069389.9.........  July 3, 2015..........  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-US-09.................  15/674,365.............  August 10, 2017.......  Cannabinoid Receptor Mediating Compounds.
E-282-2012-0-US-10.................  15/674,333.............  August 10, 2017.......  Cannabinoid Receptor Mediating Compounds.
E-140-2014-0-US-01.................  61/991,333.............  May 9, 2014...........  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-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-EP-06.................  15728668.3.............  May 8, 2015...........  Cannabinoid Receptor Mediating Compounds.
E-140-2014-0-CN-05.................  201580028788.X.........  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............  May 8, 2015...........  Cannabinoid Receptor Mediating Compounds.
E-140-2014-0-US-09.................  15/309,728.............  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 will be granted worldwide and in a field of 
use not broader than human therapeutics for type I diabetes and its 
comorbidities diabetic nephropathy, chronic kidney disease, diabetic 
retinopathy, and peripheral and autonomic neuropathy.
    The invention covered by the patents and patent applications 
pertaining to HHS Ref. No. E-282-2012-0 pertain to cannabinoid receptor 
1 (CN1R) inverse agonists. CN1R 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 central nervous system. The invention 
is a class of pyrazole compounds that act as CN1 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 
such as the earlier antagonists rimonabant. These CN1R 
receptor compounds were developed with the goals of limiting their 
brain penetrance without losing their metabolic efficacy due to CN1 
inverse agonism, and having a primary metabolite directly targeting 
enzymes involved in inflammatory and fibrotic processes associated with 
metabolic disorders. The patent rights cover both compositions of 
matter and methods of use.
    The inventions covered by HHS Ref. E-140-2014-0 also pertain to 
pyrazole CN1R 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 CN1 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 liver or kidney fibrosis, 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: July 25, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-16836 Filed 8-6-18; 8:45 am]
 BILLING CODE 4140-01-P