[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Pages 26414-26415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of Inflammatory 
Bowel Disease (IBD) Using IL-13 Modulators and Inhibitors

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 (HHS), is contemplating the 
grant of an exclusive license to practice the invention embodied in:

    PCT patent application PCT/US2002/018790 filed 14 June 2002, 
entitled: ``Methods of Treating and Preventing Colitis involving IL-
13 and NK-T Cells'' [HHS Reference Number: E-131-2002/0-PCT-01], to

Wyeth Pharmaceuticals, based in Madison, New Jersey. The field of use 
may be limited to the use of IL-13 modulators or NK-T cell modulators 
(such as antibodies) for the treatment or prevention of Inflammatory 
Bowel Disease, including ulcerative colitis and Crohn's disease. The 
United States of America is an assignee of the patent rights in these 
inventions.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before July 
9, 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: 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: Ulcerative colitis (UC) is a chronic 
inflammatory disease of the colorectum and affects approximately 
400,000 people in the United States. The cause of UC is not known, 
although an abnormal immunological response by the mucosal T cells 
responsive to bacterial antigens in the gut microflora, is thought to 
be involved. Present treatments for UC include anti-inflammatory 
therapy using aminosalicylates or corticosteroids, as well as 
immunomodulators and diet. However, 25-40% of ulcerative colitis 
patients must eventually have their colons removed due to massive 
bleeding, severe illness, rupture of the colon, risk of cancer or due 
to side effects of corticosteroids and novel treatments are still 
actively being sought. NIH scientists and their collaborators have used 
a mouse model of experimental colitis (oxazolone colitis, OC) to show 
that IL-13, a Th2 cytokine, is a significant pathologic factor in OC 
and that neutralizing IL-13 in these animals effectively prevents 
colitis (Immunity (2002) 17, 629-638).
    OC is a colitis induced by intrarectal administration of a 
relatively low dose of the haptenating agent oxazolone subsequent to 
skin sensitization with oxazolone. A highly reproducible and chronic 
colonic inflammation is obtained that is histologically similar to 
human ulcerative colitis. Studies show that NKT cells rather than 
conventional CD4+T cells mediate oxazolone colitis and that NKT cells 
are the source of IL-13, and are activated by CD1 expressing intestinal 
epithelial cells. Tissue removed from UC patients was also shown to 
contain increased numbers of nonclassical NKT cells that produce 
markedly increased amounts of IL-13 and that in keeping with epithelial 
damage being a key factor in UC, these NKT cells are cytotoxic for 
epithelial cells (J Clin. Investigation (2004) 113,

[[Page 26415]]

1490-1497). Methods of use claims are directed to treatments preventing 
the inflammatory response of colitis by modulating IL-13 and NKT cell 
activity and to methods for screening for therapeutic compounds 
effective for colitis.
    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.
    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 30, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-8892 Filed 5-8-07; 8:45 am]
BILLING CODE 4140-01-P