[Federal Register Volume 64, Number 43 (Friday, March 5, 1999)]
[Notices]
[Page 10671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5421]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Conjugate Vaccines To 
Prevent Disease Caused by Nontypeable Haemophilus influenzae and 
Moraxella catarrahalis, Particularly Otitis Media

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 exclusive license worldwide to practice the invention embodied in: 
U.S. Patent Application Serial Number 08/842,409, entitled ``Conjugate 
Vaccine for Nontypeable H. influenzae'', filed April 23, 1997 and U.S. 
Provisional Patent Application Serial Number 60/071,483, entitled 
``Lipooligosaccharide-Based Vaccine for Prevention of Moraxella 
(Branhamella) catarrhalis Infections in Humans'', filed January 13, 
1998, to American Home Products Corporation through its Wyeth-Ayerst 
Laboratory Division, Wyeth-lederle Vaccines business unit, having a 
place of business in Madison, NJ. The patent rights in these inventions 
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 4, 
1999.

ADDRESSES: Requests for a copy of the patent applications, 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.

SUPPLEMENTARY INFORMATION: The two patent applications describe 
conjugates of detoxified lipooligosaccharide (dLOS), isolated from the 
cellular membrane of either nontypeable H. influenzae or M. 
catarrhalis, and a carrier protein, exemplified by tetanus toxoid. 
These conjugates have been shown to raise bactericidal antibodies 
against the bacterial strain from which the dLOS was isolated and are 
also cross-reactive with different strains.
    The prospective co-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 nontypeable H. influenzae and M. catarrhalis.
    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 22, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-5421 Filed 3-4-99; 8:45 am]
BILLING CODE 4140-01-M