[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Pages 4284-4285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Prevention and 
Treatment of Human Cancer and Tumors by Inhibitors of Any or All of the 
Adenosine Receptor Subtypes Covered by the Licensed Patent Rights

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 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a co-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 Redox Therapies, Inc., having a place of business in 
Boston, MA. 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 April 2, 
2007 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,

[[Page 4285]]

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 prospective co-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 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 down-regulation of inflammation 
and protection from tissue damage,'' Nature 2001 Dec 20-27; 
414(6866):916-20.
    The field of use may be limited to ``Prevention and treatment of 
human cancer and tumors by inhibitors of any or all of the adenosine 
receptor subtypes covered by the Licensed Patent Rights''.
    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.
    This announcement is a supplement to the one published in the 
Federal Register on April 11, 2005 (70 FR 18419).

    Dated: January 18, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-1376 Filed 1-29-07; 8:45 am]
BILLING CODE 4140-01-P