[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Notices]
[Page 43205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Vaccine to Treat and 
Prevent Disease Caused by Human Papillomaviruses, Particularly Cervical 
Cancer

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

ACTION: Notice.

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SUMMARY: This 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 exclusive license worldwide to practice the invention embodied in: 
PCT Patent Application Number PCT/US97/12115 (NIH Reference Number E-
032-96/1), entitled ``Infectious Papillomavirus Pseudoviral 
Particles'', filed July 14, 1997, to American Home Products Corporation 
through its Wyeth-Ayerst Laboratories Division, Wyeth-Lederle Vaccines 
business unit, having a place of business in Madison, N.J. The patent 
right in this invention has 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 October 
8, 1999 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: Robert Benson, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 496-7056, ext. 267; 
Facsimile: (301) 402-0220, e mail: [email protected]..

SUPPLEMENTARY INFORMATION: The patent application describes pseudoviral 
particles of papillomavirus capsids encapsidating DNA useful for gene 
therapy and as vaccines. The pseudoviral particles are made by co-
expressing the papillomavirus L1, L2 and E2 genes in a cell line along 
with a vector comprising the useful DNA and DNA containing E2 protein 
binding sites (E2BS). The presence of the E2BS containing DNA results 
in the encapsidation of the DNA. The encapsidated DNA can be a gene to 
replace a defective gene, or can encode an antigen, for gene therapy or 
immunization respectively. Since papillomaviruses selectively multiply 
in epithelial cells, the capsids may be particularly useful for mucosal 
vaccines, and for delivering genes to epithelial tissues. The existence 
of many non-crossreacting serotypes of human and other animal 
papillomaviruses can be taken advantage of to eliminate the problem of 
immune rejection upon the second injection of a pseudoviral particle. 
The same gene or antigen encoding DNA can be incorporated in 
pseudoviral particles of different serotypes for multiple dosing.
    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 the development of vaccines for 
the prevention or treatment of diseases in humans caused by infection 
with human papillomaviruses.
    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.

    Date: August 3, 1999
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-20457 Filed 8-6-99; 8:45 am]
BILLING CODE 4140-01-P