[Federal Register: July 30, 1999 (Volume 64, Number 146)]
[Notices]               
[Page 41452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy99-116]                         

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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 
an exclusive license worldwide to practice the invention embodied in: 
US Patent Application Serial Number 08/842,409, entitled ``Conjugate 
Vaccine for Nontypeable H. influenzae'', filed April 23, 1997 and US 
Provisional Patent Application Serial Number 60/071,483 (now PCT/US99/
00590), entitled ``Lipooligosaccharide-Based Vaccine for Prevention of 
Moraxella (Branhamella) catarrhalis Infections in Humans'', filed 
January 13, 1998, to Immune Complex Corporation, having a place of 
business in San Diego, CA. 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 
September 28, 1999 will be considered.

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; e-mail: rb20m@nih.gov.

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. 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 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 conjugate 
vaccines for the prevention or treatment of diseases in humans caused 
by infection with nontypeable H. influenzae and M. catarrhalis, wherein 
the carrier is composed of Hepatitis B Virus core protein-based 
particles. Publication of this notice should be considered a 
modification of an earlier notice on this subject published in Vol. 64, 
No. 43, page 10671, on March 5, 1999.
    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: July 22, 1999.

Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 99-19501 Filed 7-29-99; 8:45 am]
BILLING CODE 4140-01-P