[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Notices]
[Pages 75573-75574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29572]


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

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.

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

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 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 January 
20, 2015 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: 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. One recent use contemplated by the inventors is use of 
the vaccine candidates to generate polyclonal sera against Filoviruses 
(i.e. Ebola and Marburg).
    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.
    These patent rights are the subject of a previous Federal Register 
notice (see 79 FR 18039, Monday, March 31, 2014).
    The fields of use may be limited to production of polyclonal 
antibodies for prevention/treatment of Filoviruses in humans and non-
human animals.

[[Page 75574]]

    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: December 11, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2014-29572 Filed 12-17-14; 8:45 am]
BILLING CODE 4140-01-P