[Federal Register Volume 68, Number 47 (Tuesday, March 11, 2003)]
[Notices]
[Pages 11573-11574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5690]


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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 HIV 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 60/329,709 filed October 16, 2001 and its 
foreign equivalents, entitled ``Novel Broadly Reactive HIV-Neutralizing 
Human Antibody Against Receptor-Induced Epitope on gp120,'' 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 12, 
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: Sally Hu, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: (301) 435-
5606; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: This invention provides a novel anti human 
antibody named X5. The X5 antibody demonstrates promise over other 
conventional anti-HIV antibodies because this antibody presents a 
unique binding activity different than its counterparts. It has been 
established that the very initial stage of HIV-1 entry into cells is 
mediated by a complex between the virus envelope glycoprotein (Env) 
such as gp120-gp41, a receptor CD4 and a co-receptor CCR5. This X5

[[Page 11574]]

antibody binds to an epitope on gp120 that is induced by interaction 
between gp120 and the receptor CD4. The X5 antibody also shows strong 
activity at very low levels ([mu]g/ml concentration). Because it is a 
human antibody, it can be administered directly into patients so that 
it is an ideal candidate for clinical trials. Finally, since it has 
neutralized all virus envelope glycoproteins that were tested against 
it, the epitope is very conserved and resistance is unlikely to 
develop. Therefore, this antibody and/or its derivatives are a good 
candidate for clinical development.
    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 HIV 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 27, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-5690 Filed 3-10-03; 8:45 am]
BILLING CODE 4140-01-P