Notice2023-15445
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Caspase Inhibitors
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 21, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Elgia Therapeutics Inc. ("Elgia"), headquartered in La Jolla, CA.
Full Text
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<title>Federal Register, Volume 88 Issue 139 (Friday, July 21, 2023)</title>
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[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47152-47153]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15445]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Caspase Inhibitors
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Center for Advancing Translational Sciences, an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the Patents and Patent
Applications listed in the SUPPLEMENTARY INFORMATION section of this
Notice to Elgia Therapeutics Inc. (``Elgia''), headquartered in La
Jolla, CA.
DATES: Only written comments and/or applications for a license which
are received by the National Center for Advancing Translational
Sciences' Office of Strategic Alliances on or before August 7, 2023
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: Sury Vepa, Ph.D., J.D., Senior Licensing and
Patenting Manager, Office of Strategic Alliances, Telephone: (301) 642-
0460; Email: <a href="/cdn-cgi/l/email-protection#9eedebece7b0e8fbeeffdef0f7f6b0f9f1e8"><span class="__cf_email__" data-cfemail="5f2c2a2d2671293a2f3e1f31363771383029">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. U.S. Provisional Application No. 61/299,790, filed January 29,
2010 which is entitled ``Caspase Inhibitors'' (HHS Ref. No. E-308-2009-
0-US-01);
2. International Patent Application No. PCT/US2011/02274 filed on
January 27, 2011 which is entitled ``Caspase Inhibitors'' (HHS Ref. No.
E-308-2009-0-PCT-02); and
3. US Patent Application No. 13/575,273 filed on July 25, 2012
which is entitled ``Caspase Inhibitors'' and issued as U.S. Patent No.
9,365,612 (HHS Ref. No. E-308-2009-0-US-03).
The patent rights in these inventions have been either assigned
and/or exclusively licensed to the government of the United States of
America.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the following:
``Development, manufacture, use and commercialization of Caspase
Inhibitors
[[Page 47153]]
disclosed and claimed in the prospective licensed patent rights, for
the treatment of inflammatory diseases, such as hidradenitis
suppurativa (HS) in humans and animals.''
The subject technology discloses potent and selective caspase 1
inhibitors that target the active site of the enzyme. Several
cyanopropanate containing small molecules were synthesized, including
one based upon the optimized peptidic scaffold of the prodrug VX-765. A
number of these compounds were potent inhibitors of caspase 1 (IC50s <=
1 nM). Examination of these small molecules versus a caspase panel
demonstrated an impressive degree of selectivity for caspase 1
inhibition. The small molecular probe ML132 (CID-4462093; NCGC-
00183434) is the most potent caspase 1 inhibitor reported to date. It
also possesses a unique selectivity pattern relative to other reported
caspase inhibitors. A number of these compounds were assessed for their
hydrolytic stability and selected absorption, distribution, metabolism
and elimination (ADME) properties. Some of the compounds of this
invention could be developed as effective therapeutics for diseases
such as inflammatory diseases such as hidradenitis suppurativa (HS),
ischemic disorders, Huntington's disease, amyotrophic lateral sclerosis
(ALS), rheumatoid arthritis, osteoarthritis, inflammatory bowel disease
and sepsis.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published Notice, the National
Center for Advancing Translational Sciences 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.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially and may be made
publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: July 16, 2023.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing
Translational Sciences.
[FR Doc. 2023-15445 Filed 7-20-23; 8:45 am]
BILLING CODE 4140-01-P
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