[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18039-18040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Multivalent Vaccines for 
Rabies Virus and Ebola and Marburg (Filoviruses)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404, that the National Institutes of Health (NIH), Department of Health 
and Human Services (HHS), is contemplating the grant of a an exclusive 
license to practice the following invention as embodied in the 
following patent applications: E-032-2011/0, Blaney et al., 
``Multivalent Vaccines for Rabies Virus and Filoviruses,'' U.S. Patent 
Application Number 61/439,046, filed

[[Page 18040]]

on February 3, 2011, PCT Application Number PCT/US2012/23575, filed on 
February 2, 2012, U.S. Patent Application Number 13/983,545, filed on 
August 2, 2013, European Patent Application Number 12702953.6, filed on 
February 2, 2012, and Canadian Patent Application Number 2826594, filed 
on February 2, 2012, to Exxell BIO, Inc., having a place of business in 
Shoreview, Minnesota, United States of America. The patent rights in 
these inventions have been assigned to the United States of America and 
Thomas Jefferson University.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before April 
30, 2014 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: Peter Soukas, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: No vaccine candidates against Ebola virus 
(EBOV) or Marburg virus (MARV) are nearing licensure, and the need to 
develop a safe and efficacious vaccine against filoviruses continues. 
Whereas several preclinical and clinical vaccine candidates against 
EBOV or MARV exist (please see below for further elaboration), their 
further development is a major challenge based on safety concerns, pre-
existing vector immunity, issues such as manufacturing, dosage, and 
marketability, and funding for development. The inventors have 
developed a new platform based on live or chemically inactivated 
(killed) rabies virus (RABV) virions containing EBOV glycoprotein (GP) 
in their envelope. In preclinical trials, immunization with such 
recombinant RABV virions provided excellent protection in mice against 
lethal challenge with the mouse adapted EBOV and RABV. More 
specifically, the inventors have developed a trivalent filovirus 
vaccine based on killed rabies virus virions for use in humans to 
confer protection from all medically relevant filoviruses and RABV. Two 
additional vectors containing EBOV Sudan GP or MARV GP are planned to 
be constructed in addition to the previously developed EBOV Zaire GP 
containing vaccine. Live attenuated vaccines have been developed for 
use in at risk nonhuman primate populations in Africa and inactivated 
vaccines have been developed for use in humans.
    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. 
The prospective exclusive license may be granted unless, within thirty 
(30) 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.
    The fields of use may be limited to (1) inactivated vaccines 
against rabies virus and filoviruses for use in humans and (2) live 
attenuated vaccines against rabies virus and filoviruses for use in 
non-human animals.
    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: March 26, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-07023 Filed 3-28-14; 8:45 am]
BILLING CODE 4140-01-P