[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9581-9582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Development and 
Commercialization of Therapeutic Products for Breast Cancer

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

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
Part 404.7(a)(1)(i), announces that the Department of Health and Human 
Services is contemplating the grant of an exclusive license to practice 
the inventions embodied in U.S. Patent Application No. 09/693,600 filed 
October 20, 2000 entitled ``Method and Composition for Enhancing Immune 
Response'' [E-037-2001/1-US-01]; Japanese Patent Application No. 2002-
555834 filed October 22, 2001 entitled ``Method and Composition for 
Enhancing Immune Response'' [E-037-2001/1-JP-03]; and European Patent 
Application No. 01989341.1 filed October 22, 2001 entitled ``Method and 
Composition for Enhancing Immune Response'' [E-037-2001/1-EP-04]; to 
ODC Therapy, Inc.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to therapeutic applications for breast 
cancer patients expressing high levels of serum or plasma IgE.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before April 21, 
2008 will be considered.

ADDRESSES: Requests for copies of the patent and/or patent 
applications, inquiries, comments and other materials relating to the 
contemplated exclusive license should be directed to: Mojdeh Bahar, 
J.D., M.A., Technology Licensing Specialist, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD. 20852-3804. Telephone: (301) 435-2950; 
Facsimile: (301) 402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: The invention relates to a method of 
inhibiting tumor growth which comprises the administration of an IL-13 
inhibitor. Additionally, the invention relates to a method and 
composition for enhancing an immune response in a subject by 
administering to a subject an inhibitor of IL-13 or an inhibitor of an 
NK-T cell. The method can be used to prevent growth of a tumor in a 
subject, e.g., to inhibit tumor recurrence or metastasis. The method 
can also be used to enhance a response to a vaccine in a subject. IL-13 
is an interleukin which has potent immunomodulatory effects. It is 
primarily secreted by TH2 lymphocytes. This invention relates to the 
discovery of a role for IL-13 in the down-regulation of tumor 
immunosurveillance. Using a mouse model in which tumors show a growth-
regression-recurrence pattern, the mechanisms for down-regulation of 
cytotoxic T lymphocyte-mediated tumor immunosurveillance was 
investigated. It was discovered that interleukin 4 receptor (IL-4R) 
knockout mice, and downstream signal transducer and activator of 
transcription 6 (STAT6) knockout mice, but not IL-4 knockout mice, 
resisted tumor recurrence. Thus, IL-13, the only other cytokine that 
uses the IL-4R-STAT6 pathway, was discovered to have a role in the 
down-regulation of tumor immunosurveillance.
    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 sixty 
(60) days from the date of this published notice, the NIH receives 
written evidence and argument that establish that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.

[[Page 9582]]

    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.

    Dated: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-3165 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P