[Federal Register Volume 66, Number 107 (Monday, June 4, 2001)]
[Notices]
[Pages 29979-29980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13887]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Live, 
Attenuated Vaccines for Human Use Against Respiratory Syncytial Viruses 
Types A and B, and Parainfluenza Viruses Types 1, 2 and 3

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

ACTION: Notice.

-----------------------------------------------------------------------

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 inventions embodied in 
the patent applications referenced below 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 United States of America is an assignee to the patent rights 
of these inventions.

USPA 09/291,894, filed 4/13/99, entitled ``Production of attenuated 
Chimeric RSV vaccines from cloned nucleotide sequences'' (now PCT/US00/
08802, filed 3/31/00)
USPA 09/350,821, filed 7/9/99, entitled ``Recombinant PIV vaccines 
attenuated by deletion or ablation of non-essential gene'' (now PCT/
US00/18523, filed 7/6/00)
USPA 60/143,132, filed 7/9/99, entitled ``Production of attenuated, 
human-bovine chimeric RSV vaccines'' (now USPA 09/602,212 and PCT/US00/
17755, both filed 6/23/00)
USPA 60/143,425, filed 7/13/99, entitled ``Production of recombinant 
RSV expressing immune modulatory molecules'' (now USPA 09/614,285 and 
PCT/US00/19042, both filed 7/12/00)
USPA 60/143,097, filed 7/7/99, entitled ``Production of attenuated RSV 
vaccines involving modification of M2 open reading frame (ORF) 2'' (now 
USPA 09/611,829 and PCT/US00/18534, both filed 7/7/00)

[[Page 29980]]

USPA 60/143,134, filed 7/9/99, entitled ``Attenuated human-bovine 
chimeric PIV vaccines'' (now USPA 09/586,479 and PCT/US00/17066, both 
filed 6/15/00)
USPA 60/129,006, filed 4/13/99, entitled ``Production of attenuated 
negative stranded RNA virus vaccines from cloned nucleotides'' (now 
PCT/US00/09695, filed 4/12/00)
USPA 60/170,195, filed 12/10/99, entitled ``Use of recombinant PIVs as 
vectors to protect against infectious Diseases caused by PIV and other 
human Pathogens'' (now USPA 09/733,692 and PCT/US00/33293, both filed 
12/8/00)
USPA 60/213,708, filed 6/23/00, entitled ``RSV vaccines expressing 
protective antigens from promoter-proximal genes''
USPA 60/215,809, filed 7/5/00, entitled ``Attenuated human-bovine 
chimeric PIV vaccines''
USPA 60/007,083, filed 9/27/95, entitled ``Production of infectious 
Respiratory Syncytial Virus from cloned nucleotide sequences'' (now 
USPA 08/720,132 and PCT/US96/15524, both filed 9/27/96)

    The contemplated exclusive license may be limited to the 
development of live, attenuated vaccines for human use against 
Respiratory Syncytial Viruses Types A and B, and Parainfluenza Viruses 
Types 1, 2 and 3.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 3, 2001 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 Uri Reichman, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 496-7056, ext. 240; Facsimile: (301) 402-0220; E-mail: 
[email protected]. A signed Confidential Disclosure Agreement will be 
required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION: The Patent Applications cover a wide range 
of methods to produce live attenuated vaccines for PIV and RSV. This 
includes, for example, deletion or ablation of non-essential genes 
(PIV, USPA 09/350,821), insertion of genes expressing immune modulatory 
molecules (RSV, USPA 60/143,425), modification of the second 
translational open reading frame of the M2 gene (RSV, USPA 60/143,097), 
and shifts in gene positions that modulate expression of selected genes 
(RSV, USPA 60/213,708). It also includes human-bovine chimeric 
constructs (PIV, USPA 60/215,809, USPA 60/143,134; RSV, USPA 60/
143,132) or RSV-PIV chimeric constructs (USPA 60/170,195 for PIV1,2,3 
and USPA 09/291,894 for RSVA/B). US Provisional Application 60/129,006 
relates to a new attenuation strategy applicable for the development of 
RSV and PIV vaccine candidates. It generally describes the finding that 
attenuating mutations identified in certain negative stranded RNA 
viruses are transferable to other viruses of the Mononegavirale order. 
US Provisional Application 60/007,083 describes an expression system 
for recovery of RSV viruses from the corresponding cDNA sequences.
    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.
    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: May 25, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-13887 Filed 6-1-01; 8:45 am]
BILLING CODE 4140-01-P