[Federal Register Volume 62, Number 26 (Friday, February 7, 1997)]
[Notices]
[Page 5836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3080]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Particle-Medicated Gene 
Delivery DNA Vaccines Against Dengue and Other Flavivirus Infections

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice in accordance with 15 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 limited field of use exclusive world-wide license to practice the 
invention embodied in U.S. Patent No. 5,494,671, issued February 27, 
1996 (U.S. Patent Application Serial No. 07/747,785, filed August 20, 
1991), entitled ``C-Terminally Truncated Dengue and Japanese 
Encephalitis Virus Envelope Proteins''; U.S. Patent Application Serial 
No. 08/250,802, filed May 27, 1994, entitled ``Chimeric and/or Growth 
Restricted Flaviviruses'' and related foreign patent applications to 
Auragen, Inc./Geniva, Inc. of Middleton, WI. The patent rights in these 
inventions have been assigned to the United States of America.

SUPPLEMENTARY INFORMATION: 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. It is anticipated that this license may be 
limited to particle-mediated gene delivery DNA vaccines against Dengue 
and other flavivirus infections. This license will not include live 
virus, killed virus, or protein-based vaccines. This 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 patent describes the use of C-terminally truncated flavivirus 
envelope proteins in vaccines against flavivirus infections and also 
relates to recombinant viruses which encode the truncated protein. The 
patent applications are directed to recombinant, modified or viable 
chimeric flaviviruses for use in vaccine preparations against 
flavivirus infections. This technology further provides for a 
baculovirus having a recombinant dengue cDNA sequence which encodes 
dengue proteins and for a baculovirus having a recombinant Japanese B 
encephalitis virus cDNA sequence which encodes Japanese B encephalitis 
proteins. The applications also relate to vaccines produced from 
recombinant DNA.

ADDRESSES: Requests for a copy of the issued patent, patent 
application, inquiries, comments, and other materials relating to the 
contemplated license should be directed to: Gloria H. Richmond, Patent 
Advisor, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 496-7057 ext 268; Facsimile: (301) 402-0220; E-mail: 
Gloria [email protected]. A signed Confidential Disclosure Agreement 
will be required to receive a copy of the patent application. 
Applications for a non-exclusive or exclusive license filed in response 
to this notice will be treated as objections to the grant of the 
contemplated license. Only written comments and/or applications for a 
license which are received by NIH on or before April 8, 1997 will be 
considered. 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: January 28, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-3080 Filed 2-6-97; 8:45 am]
BILLING CODE 4140-01-M