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[Federal Register: March 23, 2001 (Volume 66, Number 57)]
[Notices]               
[Page 16277-16278]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr01-123]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

 
Prospective Grant of Exclusive License: The Use of Recombinant 
Cholera Toxin B Subunit to Treat Autoimmune and/or Inflammatory 
Diseases

AGENCY: National Institutes of Health, Public Health Service, and 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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive license to practice the inventions embodied in PCT Patent 
Application, S/N PCT/US00/30837, entitled, ``Methods of Treating 
Inflammatory Bowel Disease Using Cholera Toxin B Subunit'' which was 
filed on November 9, 2000 and claims priority to U.S. Patent 
Application, S/N 60/165,111, entitled, ``Methods of Treating 
Inflammatory Bowel Disease Using Cholera Toxin B

[[Page 16278]]

Subunit,'' which was filed on November 12, 1999, and corresponding 
foreign patent applications, to Active Biotech Research AB which is 
located in Lund, Sweden. The patent rights in these inventions have 
been assigned to the United States of America.
    The prospective exclusive license territory will be worldwide and 
the field of use may be limited to human therapeutics for the treatment 
of inflammatory bowel disease and/or other human autoimmune or 
inflammatory diseases.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before May 22, 2001 
will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: Richard U. Rodriguez, M.B.A., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804. 
Telephone: (301) 496-7056, X287; Facsimile: (301) 402-0220; and E-mail: 
<A HREF="mailto:RodriguR@od.nih.gov">RodriguR@od.nih.gov</A>.

SUPPLEMENTARY INFORMATION: The technology claimed in the PCT 
application relates to methods for treating inflammatory and/or 
autoimmune diseases through the administration of recombinant cholera 
toxin B subunit (rCTB). This treatment appears to suppress the 
production of interferon-gamma and interleukin-12 thus causing 
apoptosis, or cell death, in a select pool of T-cells. The 
administration of rCTB may be particularly useful for the treatment of 
inflammatory bowel disease which would include, but not necessarily be 
limited to, Crohn's disease and ulcerative 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 Part 
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.
    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: March 16, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-7226 Filed 3-22-01; 8:45 am]
BILLING CODE 4140-01-P

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