[Federal Register Volume 73, Number 174 (Monday, September 8, 2008)]
[Notices]
[Pages 52058-52059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Live, Attenuated Virus 
Vaccines Against RSV, PIV, and hMPV

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

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 
worldwide exclusive license to practice the invention embodied in:

RSV Technologies

    (1) U.S. Patents 5,993,824 (issued November 30, 1999) and 
associated pending U.S. patent applications, serial numbers 10/934,003 
(filed September 2, 2004) and 10/722,000 (filed November 25, 2003) and 
associated foreign rights from PCT applications PCT/US97/12269 (filed 
July 15, 1997) and PCT/US00/08802 (filed March 31, 2000) (HHS 
references E-142-1996/0,3,4);
    (2) U.S. Patent 6,713,066 (issued March 30, 2004) and associated 
pending U.S. patent application, serial number 11/011,502 (filed 
December 13, 2004) and associated foreign rights from PCT application 
PCT/US00/18534 (HHS reference E-194-1999/0);
    (3) PCT application PCT/US00/09695 and associated foreign rights 
therefrom (HHS reference E-040-1999/0);
    (4) U.S. patent applications, serial numbers 11/054,343 (filed 
February 9, 2001) and 11/033,055 (filed January 10, 2005), and 
associated foreign rights from PCT application PCT/US01/20107 (HHS 
reference E-225-2000/0).

PIV Technologies

    (1) U.S. Patents 6,410,023 (issued June 25, 2002); 7,208,161 
(issued April 24, 2007); 7,314,631 (issued January 1, 2008); 7,250,171 
(issued July 31, 2007); and pending U.S. patent application, serial 
number 11/785,364 (filed April 17, 2007), and associated foreign rights 
through PCT applications PCT/US98/10551 (filed May 22, 1998) and PCT/
US00/18523 (filed July 6, 2000) (filed December 8, 2000) (HHS 
references E-089-1997/2,3,4,5,6,7);
    (2) U.S. patent application, serial number 10/667,141 (filed 
September 18, 2003) and associate foreign rights from PCT/US03/29685 
(filed September 18, 2003) (HHS reference E-092-2002/0);
    (3) U.S. patent application (serial number pending, filed January 
10, 2006) and associated foreign rights from PCT/US2006/000666 (filed 
January 10, 2006) (HHS reference E-295-2004/0);
    (4) U.S. patent application, serial number 10/302,547 (filed 
November 21, 2002) and associated foreign rights from PCT/US02/37688 
(filed November 21, 2002) (HHS reference E-280-2001/0).

hMPV Technology

    (1) U.S. patent application, serial number 10/789,400 (filed 
February 27,

[[Page 52059]]

2004) and associated foreign rights from PCT/US04/05881 (filed February 
27, 2004) (HHS references E-093-2003/0,1,2)

to MedImmune, LLC, having a place of business in Gaithersburg, 
Maryland, USA. 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 November 
7, 2008 will be considered.

ADDRESSES: Requests for a copy of the patents and patent applications, 
inquiries, comments and other materials relating to the contemplated 
license should be directed to: Michael Shmilovich, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; e-mail: [email protected]; 
Telephone: (301) 435-5019; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: 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 sixty (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 above referenced technologies describe development of live, 
attenuated virus vaccines for respiratory syncytial virus (RSV), 
subgroups A and B, human parainfluenza, types 1, 2,3 (HPIV1, HPIV2, and 
HPIV3), and human metapneumovirus (hMPV).
    The field of use in which NIH contemplates granting an exclusive 
license may be limited to the following and excludes fields employing 
any vectored vaccines and any human-bovine chimeras for RSV A, RSV B, 
HPIV3, HPIV2, HPIVI, and hMPV:
    Live attenuated virus vaccines for intranasal administration to 
humans against RSV subgroups A and B, HPIV1, HPIV2, HPIV3, and hMPV 
based on the following viruses (in bold) and their corresponding 
attenuating mutations (in bulleted italics):
    Human RSV subgroups A or B or A/B chimeras:
     rcp248/404/1030[Delta]SH, including the stabilized version 
of this virus;
     [Delta]NS1;
     [Delta]M2-2.

HPIV3

     rcp45

HPIV2

     Mutations in C and L imported from other viruses, e.g., 
HRSV, BPIV3, and HPIV3, with or without stabilization by codon 
substitution or deletion;
     L([Delta]1724);
     Viruses with P and V genes separated

HPIV1

     Mutations in C and L imported from other viruses, e.g., 
HRSV, BPIV3, and HPIV3, with or without stabilization by codon 
substitution or deletion;
     C(170);
     C(R84G) mutation;
     L(942stablized);
     Viruses with P and C genes separated.

hMPV

     [Delta]G, alone or in combination with [Delta]SH;
     [Delta]M2-2;
     Avian-human chimera with avian P ORF placed in hMPV 
backbone.
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: August 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-20650 Filed 9-5-08; 8:45 am]
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