[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24760-24761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09900]
[[Page 24760]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive License: The Development of
Diazeniumdiolate Derivatives for Cancer Treatment and Prevention in
Humans
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of a start-up
exclusive patent license to practice the inventions embodied in U.S.
Provisional Patent Application No. 60/026,816, entitled ``O\2\-Aryl
Substituted Diazeniumdiolates'', filed September 27, 1996, now
abandoned (HHS Ref. No. E-093-1996/0-US-01); U.S. Provisional Patent
Application No. 60/045,917, entitled ``O\2\-Aryl Substituted
Diazeniumdiolates and Use Thereof'', filed May 7, 1997, now abandoned
(HHS Ref. No. E-093-1996/1-US-01); U.S. Provisional Patent Application
No. 60/051,696, entitled ``O\2\-Glycosylated 1-Substituted Diazen-l-
IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-
YL] Diazen-1-IUM-l,2-Diolates'', filed July 3, 1997, now abandoned (HHS
Ref. No. E-093-1996/2-US-01); PCT Patent Application No. PCT/US1997/
017267, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted
Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato)
Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates'', filed September 26, 1997,
now abandoned (HHS Ref. No. E-093-1996/3-PCT-01); European Patent No.
0929538, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted
Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato)
Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates'', issued on November 24,
2004 [HHS Ref. No. E-093-1996/3-EP-02], which is validated in Great
Britain [E-093-1996/3-GB-09], Germany [E-093-1996/3-DE-10], France [E-
093-1996/3-FR-11], Ireland [E-093-1996/3-IE-12], Italy [E-093-1996/3-
IT-13], Switzerland [E-093-1996/3-CH-14] and Belgium [E-093-1996/3-BE-
15]; Australian Patent No. 733590, entitled ``O\2\-Arylated or O\2\-
Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-
Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-
Diolates'', issued on August 30, 2001 [HHS Ref. No. E-093-1996/3-AU-
03]; Canadian Patent No. 2266908, ``O\2\-Arylated or O\2\-Glycosylated
1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-
Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates,'' issued on
July 20, 2010 [HHS Ref. No. E-093-1996/3-CA-04]; Japanese Patent No.
4285775, ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-
IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-
YL] Diazen-1-IUM-l,2-Diolates,'' issued on April 3, 1999 [HHS Ref. No.
E-093-1996/3-JP-05]; U.S. Patent No. 6,610,660, entitled ``O\2\-
Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates
and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-
l,2-Diolates,'' issued on August 26, 2003 [HHS Ref. No. E-093-1996/3-
US-06]; U.S. Patent No. 6,911,433, entitled ``O\2\-Glycosylated 1-
Substituted Diazen-l-IUM-1,2-Diolates,'' issued on June 28, 2005 [HHS
Ref. No. E-093-1996/3-US-07]; European Patent Application No.
04009529.1, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted
Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato)
Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates,'' filed on April 22, 2004
[E-093-1996/3-EP-08]; U.S. Patent No. 7,081,524, entitled ``O\2\-
Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2-
Diolates,'' issued on July 25, 2006 [HHS Ref. No. E-093-1996/3-US-16];
Japanese Patent No. 5015903, entitled ``O\2\-Substituted 1-[(2-
Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates and Compositions
Thereof,'' issued on June 15, 2012 [HHS Ref. No. E-093-1996/3-JP-17];
Canadian Patent Application No. 2,705,474, entitled ``O\2\-Glycosylated
1-Substituted Diazen-1-IUM-l,2-Diolates,'' filed on May 28, 2010 [E-
093-1996/3-CA-18]; and European Patent Application No. 10010885.1,
entitled ``O\2\-Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen-
1-IUM-l,2-Diolates,'' filed on September 24, 2012 [E-093-1996/3-EP-19],
developed by Dr. Larry K. Keefer, Dr. Joseph E. Saavedra, et al. The
prospective exclusive license territory may be ``worldwide'', and the
field of use may be limited to: ``use of O\2\-Arylated, O\2\-
Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates, and O\2\-
Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-
Diolates for cancer treatment and prevention in humans.'' to JSK
Therapeutics, Inc. (``JSKT''), a company incorporated under the laws of
the State of Delaware having an office in at least Salt Lake City,
Utah, U.S.A. The patent rights in these inventions have been assigned
to the United States of America.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before May
13, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application, patents,
inquiries, comments, and other materials relating to the contemplated
start-up exclusive license should be directed to: Charlene A. Sydnor,
Ph.D., Office of Technology Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804;
Telephone: (301) 435-4689; Facsimile: (301) 402-0220; Email:
[email protected]. A signed confidentiality nondisclosure agreement
will be required to receive copies of any patent applications or
patents that have not been published or issued by the United States
Patent and Trademark Office or the World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION: This technology concerns a new series of
diazeniumdiolate derivatives that are stable in neutral to acidic
environments and generate nitric oxide in basic or nucleophilic
environments. These synthesized derivatives are potentially suited to
the delivery of nitric oxide to basic or nucleophilic compartments
within the body. They may be useful for inactivating proteins to
prevent detoxification of chemotherapeutic agents or disruption of
proteins active in tumor formation, infection, or regulatory
activities. The compounds are stable in an aqueous environment but can
be activated by enzymatic action to release nitric oxide that is
believed to be useful in treating fulminant liver failure, respiratory
problems, impotence, and a variety of cardiovascular/hematologic
disorders. The diazeniumdiolates have also been derivatized by their
incorporation into polymers. These compounds may allow for site
specific delivery of nitric oxide. Overall, these compounds appear to
be applicable toward the wide variety of processes involving nitric
oxide.
The patents and patent applications for this technology contain
claims that cover a family of diazeniumdiolate compounds, including:
(1) O\2\-substituted diazeniumdiolates; (2) O\2\-glycosylated
diazeniumdiolates; and (3) O\2\-substituted 1-[(2-
carboxylato)pyrrolidin-1-yl] diazeniumdiolates. Also covered are uses
of these compounds as: (1) A treatment for a biological disorder,
including angina, acute myocardial infarction, congestive heart
failure,
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hypertension, and metastasis; (2) A treatment for cancer; and (3) A
treatment for an infectious agent, including a virus or parasite.
The prospective start-up exclusive license will be royalty bearing
and will comply with the terms and conditions of 35 U.S.C. 209 and 37
CFR 404.7. The prospective start-up exclusive license may be granted
unless within fifteen (15) days from the date of this published notice,
the NIH 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 404.7.
Properly filed competing applications for a license in response to
this notice will be treated as objections to the contemplated license.
Comments and objections submitted in response 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: April 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-09900 Filed 4-25-13; 8:45 am]
BILLING CODE 4140-01-P