01-13887. 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)

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: [phone], ext. 240; Facsimile: [phone]; E-mail: [e-mail]. 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.