[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.:
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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, 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.
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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 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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