[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]



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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