Notice: Prospective Grant of Exclusive License: Monoclonal Antibodies 
Against Smallpox/Orthopoxviruses

Federal Register: January 20, 2010 (Volume 75, Number 12)     
                  Page 3244

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 (HHS), is contemplating the 
grant of a an exclusive license to practice the following invention as 
embodied in the following patent applications: E-145-2004/0,1,2,3,4, 
Purcell et al., ``Monoclonal Antibodies Against Orthopoxviruses'', 
United States Patent Application 12/142,594, filed June 19, 2008 to 
BioFactura, Inc., having a place of business in Rockville, Maryland. 
The patent rights in this invention 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 February 
19, 2010 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; E-mail: ps193c@nih.gov; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: Concerns that variola (smallpox) virus might 
be used as a biological weapon have led to the recommendation of 
widespread vaccination with vaccinia virus. While vaccination is 
generally safe and effective for prevention of smallpox, it is well 
documented that various adverse reactions in individuals have been 
caused by vaccination with existing licensed vaccines. Vaccinia immune 
globulin (VIG) prepared from vaccinated humans has historically been 
used to treat adverse reactions arising from vaccinia immunization. 
However, VIG lots may have different potencies and carry the potential 
to transmit other viral agents.
    Chimpanzee Fabs against the B5 and A33 outer extracellular membrane 
proteins of vaccinia virus were isolated and converted into complete 
mAbs with human gamma1 heavy chain constant regions. The two mAbs 
displayed high binding affinities to B5 and A33. The mAbs inhibited the 
spread of vaccinia virus as well as variola virus (the causative agent 
of smallpox) in vitro, protected mice from subsequent intranasal 
challenge with virulent vaccinia virus, protected mice when 
administered two (2) days after challenge, and provided significantly 
greater protection than that afforded by VIG.
    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 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 404.7.
    The field of use may be limited to monoclonal antibodies against 
orthopoxviruses (smallpox) for use in humans.
    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: January 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-977 Filed 1-19-10; 8:45 am]
BILLING CODE 4140-01-P