[Federal Register Volume 68, Number 44 (Thursday, March 6, 2003)]
[Notices]
[Page 10744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5209]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Human Monoclonal Antibody 
Biotherapeutics for the Treatment of Hepatitis C (HCV) Infections

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 United 
States Patent Application 60/250,561 filed December 1, 2000 and its 
foreign equivalents, entitled ``Monoclonal Antibodies Specific for the 
E2 Glycoprotein of Hepatitis C Virus and Their Use in the Diagnosis, 
Treatment, and Prevention of HCV,'' to Virosys Pharmaceuticals, Inc., 
having a place of business in Redwood Shores, CA. 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 which are 
received by the NIH Office of Technology Transfer on or before May 5, 
2003 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 Ano, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: (301) 
435-5515; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: This invention relates to human monoclonal 
antibodies that exhibit immunological binding affinity for the 
hepatitis C virus E2 glycoprotein and are cross-reactive against 
different hepatitis C virus (HCV) strains. These antibodies may be used 
in passive immunoprophylaxis for the prevention of hepatitis C virus 
infection and/or in passive immunotherapy for the treatment of 
hepatitis C.
    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 development of human monoclonal 
antibody biotherapeutics for the treatment of HCV infections.
    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: February 24, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-5209 Filed 3-5-03; 8:45 am]
BILLING CODE 4140-01-P