[Federal Register Volume 69, Number 203 (Thursday, October 21, 2004)]
[Notices]
[Page 61855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Human Parvovirus B19 
Vaccine

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 
a worldwide exclusive license to practice the inventions embodied in 
PCT/US89/04948 filed November 14, 1989, and National Stage filed in 
Australia (patent no. 631159), Canada (patent no. 1284268), Israel 
(patent no. 92298) and Japan (patent no. 2755817), entitled 
``Parvovirus Capsids''; U.S. patent no. 5,508,186, U.S. patent no. 
6,132,732, U.S. patent no. 6,001,371, U.S. patent no. 5,827,647, 
entitled ``B19 Parvovirus Capsids'' ; U.S. patent no. 5,916,563, U.S. 
patent no. 6,558,676 entitled ``Parvovirus Capsids''; and PCT/NL90/
00130 filed September 11, 1990, and National Stage filed in Europe 
(patent no. 0491824), Austria (patent no. 122395), Denmark (patent no. 
0491824), Germany (patent no. 69019359), Netherlands (patent no. 
8902301), Spain (patent no. 2073036) and United States (patent nos. 
6,204,044, 6,287,815 and 6,379,885), entitled ``Human Parvovirus B19 
Proteins and Virus-like Particles, Their Production and Their Use in 
Diagnostic Assays and Vaccines'' to Viral Antigens, Inc., having a 
place of business in Memphis, Tennessee. The patent rights in these 
inventions have been assigned or exclusively licensed 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 January 
19, 2005, 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 technology describes a method of 
producing non-infectious recombinant human parvovirus B-19 capsids 
composed of viral proteins VP1 and VP2 or VP2. The technology further 
relates to diagnostic assays utilizing the recombinantly produced 
parvovirus capsid proteins, or antibodies to such proteins. The 
technology also describes a vaccine effective against parvovirus B19 
infection, consisting of the recombinant capsid proteins. Data from the 
inventors show that the configuration of the vaccine optimal for 
eliciting neutralizing antibodies comprises approximately twenty five 
percent (25%) VP1 and seventy five percent (75%) VP2. In another 
embodiment, the technology describes the use of parvovirus B19 viral 
capsids as a gene delivery system for proteins.
    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 90 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 vaccines for 
parvovirus B19.
    The licensed territory will be worldwide exclusive.
    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: October 14, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-23561 Filed 10-20-04; 8:45 am]
BILLING CODE 4140-01-P