[Federal Register Volume 74, Number 96 (Wednesday, May 20, 2009)]
[Notices]
[Pages 23736-23737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Manufacture, Use, 
Distribution of and Sale of Fused Azepinone Cyclin Dependent Kinase 
Inhibitors as Therapeutics

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR Part 404.7(a)(1)(i), that 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 U.S. 
Patent No. 6,610,684 entitled, ``Fused Azepinone Cyclin Dependent 
Kinase Inhibitors'' and all foreign counterparts [HHS Ref. No. E-025-
1998/0] to ShanaRx Pharmaceuticals. The patent rights in this invention 
have been assigned to the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of the Cyclin Dependent 
Kinase Inhibitors and their methods of use in the Licensed Patent 
Rights for the treatment of: (i) Disorders caused by damage, injury, 
infection in or abnormal function of the peripheral or central nervous 
system including pain, neuropathy, retinal degeneration, glaucoma, 
Alzheimer's disease, Parkinson's disease, ALS, depression, 
schizophrenia, and anxiety; (ii) disorders caused by damage, injury, 
infection in or abnormal function of cerebral vasculature and cardiac 
vasculature including cardiac failure and myocardial infections; (iii) 
cancer and neoplastic disorders; (iv) inflammatory and autoimmune 
diseases including Multiple Sclerosis; and (v) endocrine and 
neuroendocrine disorders including Diabetes Mellitus.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 18, 2009 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated co-exclusive 
license should be directed to: Whitney A. Hastings, M.S., Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804. Telephone: (301) 451-7337; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The invention describes a class of cyclin 
dependent kinase (CDK) inhibitors that have anti-proliferative activity 
in human tumor cell lines. CDKs are important in the control of the 
cell cycle and alterations in CDK expression, function, or regulation 
are associated with diseases characterized by cellular proliferation. 
Increasing CDK activity has been reported in many cancers and observed 
in a wide variety of primary human tumors and human tumor-derived cell 
lines, including lung, breast, brain, bone, skin, bladder, kidney, 
ovary, liver, colon, pancreas as well as in leukemia. The compounds of 
this invention have also been found to potently inhibit GSK3beta 
activity. Some of compounds of this invention have been shown to be 
more potent towards the GSK3beta target than towards CDKs. The GSK3beta 
enzyme, a proline-directed serine-threonine kinase, has been linked to 
a variety of cellular processes and several disparate areas of biology. 
Thus, this technology could provide therapeutic opportunities for a 
variety of indications, including Alzheimer's, neurological disorders, 
and cardiac failure.
    The prospective 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 exclusive license may be granted unless within ninety 
(90) 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.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive 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.


[[Page 23737]]


    Dated: May 12, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-11681 Filed 5-19-09; 8:45 am]
BILLING CODE 4140-01-P