[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Notices]
[Pages 49465-49466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of 
Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor

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 (a)(1)(i), that the National Institutes of Health (NIH), Department 
of Health and Human Services (HHS), is contemplating the grant of an 
exclusive license to practice the invention embodied in: PCT patent 
application PCT/US2004/041256 filed December 9, 2004, entitled: 
``Methods for Suppressing an Immune Response or Treating a 
Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], 
to Sahajanand Medical Technologies Pvt. Ltd., registered as a private 
limited company in accordance with the Companies Act of India, having a 
principle place of business in Surat, India and U.S. headquarters in 
Gaithersburg, Maryland. The field of use may be limited to the use of 
2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the 
treatment and prevention of stenosis and restenosis and/or other 
proliferative disorders. The United States of America is an assignee of 
the patent rights in these inventions.
    This notice replaces a notice published in 71 FR 46496, August 14, 
2006, to correct the heading ``Prospective Grant of Exclusive License: 
Treatment of Cardiovascular Conditions with Nitrite Therapy'' to read 
``Prospective Grant of Exclusive License: Treatment of Proliferative 
Disorders Using an Unexpected mTOR Kinase Inhibitor''.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
October 13, 2006 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Susan Carson, D.Phil., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; e-mail: [email protected]; 
telephone: (301) 435-5020; facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The search for specific kinase inhibitors is

[[Page 49466]]

an active area of drug development as there is a continued need for 
effective anti-proliferative therapeutics with acceptable toxicities. 
The core invention is a novel method of use of one of the 4H-1-
benzopyran-4-one derivatives (LY303511) which has been shown to target 
mTOR and casein kinase 2 (CK2) without affecting P13K activity (JPET, 
May 26, 2005, doi: 10.1124/ jpet.105.083550). Proof of concept data is 
available in an in vivo human zenograft PC-3 prostate tumor model, 
without observed toxicity. In vitro data suggests that 2-(4-
piperazinyl)-8-pheynl-4H-1-benzopyran-4-one and derivatives may be 
effective in treating inflammatory, autoimmune and other proliferative 
disorders including restenosis and a variety of cancers. Method of use 
claims are directed to derivatives of 2-(4-piperazinyl)-substituted 4H-
1-benzopyran-4-one compounds as anti-proliferative, immunosuppressive, 
anti-inflammatory, anti-restenosis and anti-neoplastic agents.
    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, by the date 
referenced above, 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 filed 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: August 15, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-13936 Filed 8-22-06; 8:45 am]
BILLING CODE 4140-01-P