[Federal Register Volume 70, Number 68 (Monday, April 11, 2005)]
[Notices]
[Page 18419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Methods for Using 
Extracellular Adenosine Inhibitors and Adenosine Receptor Inhibitors as 
Applied to the Treatment of Human Cancer and Tumors

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

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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the invention embodied in Patent 
Applications U.S. 60/340,772, filed on 12/12/2001, U.S. 60/342,582, 
filed on 12/19/2001, PCT/US2002/036829, filed on 11/14/2002, and 
corresponding EP, CA, AU, and JP filings, as well as U.S. 10/498,416, 
filed on 06/10/2004; entitled ``Methods for using extracellular 
adenosine inhibitors and adenosine receptor inhibitors to enhance 
immune response and inflammation'', all by Michail V. Sitkovsky and 
Akio Ohta, to Adenosine Therapeutics, LLC, having a place of business 
in Charlottesville, VA. The patent rights in this invention have been 
assigned to the United States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before June 10, 
2005 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: Cristina Thalhammer-Reyero, Ph.D., M.B.A., 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; E-mail: 
[email protected]; Telephone: 301-435-4507; Facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: The technology described and claimed in the 
subject invention relates to methods to enhance and prolong the body's 
immune response as well as to promote targeted tissue damage, such as 
for tumor destruction, by inhibiting signaling through the adenosine 
receptor. The inventors have shown that adenosine A2a and A3a receptors 
play a critical and non-redundant role in down-regulation of 
inflammation in vivo by acting as the physiological termination 
mechanism that can limit the immune response. The methods described 
involve administering either an adenosine-degrading drug or an 
adenosine receptor antagonist to exert a more effective and durable 
immune response and inflammation, and more specifically to the subject 
exclusive license application, to reduce the size of tumors. 
Furthermore, using the claimed method in combination with conventional 
anti tumor agent can be an effective treatment against cancer.
    The invention has potential applications in the many markets in 
which therapeutic and preventive uses of manipulating the adenosine 
pathway are involved, including the regulation of hypoxia, tissue 
damage, tumor destruction, inflammation, increasing the efficacy of 
vaccines, and other immune responses.
    This invention is further described in Ohta A et al., ``Role of G-
protein-coupled adenosine receptors in downregulation of inflammation 
and protection from tissue damage,'' Nature 2001 Dec 20-27; 
414(6866):916-20.
    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 60 days 
from the date of this published Notice, 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.
    The field of use may be limited to ``Treatment of human cancer and 
tumors''.
    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: April 4, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-7248 Filed 4-8-05; 8:45 am]
BILLING CODE 4140-01-P