Prospective Grant of Exclusive License: Monoclonal Antibodies Against Smallpox/Orthopoxviruses, 3244 [2010-977]
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Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Notices
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Dated: January 11, 2010.
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Deputy Director, National Institutes of Health.
[FR Doc. 2010–858 Filed 1–19–10; 8:45 am]
BILLING CODE 4140–01–P
pwalker on DSK8KYBLC1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Monoclonal Antibodies
Against Smallpox/Orthopoxviruses
AGENCY: National Institutes of Health,
Public Health Service, DHHS.
VerDate Nov<24>2008
16:06 Jan 19, 2010
Jkt 220001
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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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]
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[Federal Register Volume 75, Number 12 (Wednesday, January 20, 2010)]
[Notices]
[Page 3244]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-977]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Monoclonal Antibodies
Against Smallpox/Orthopoxviruses
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
