E8-20650. 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.

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, 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: [e-mail]; Telephone: [phone]; Facsimile: [phone].

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:

• rcp248/404/1030ΔSH, including the stabilized version of this virus;
• ΔNS1;
• ΔM2-2.

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(Δ1724);
• 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

• ΔG, alone or in combination with ΔSH;
• ΔM2-2;
• 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.