[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Pages 53480-53481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21771]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Conjugate Vaccines
Against B. anthracis (Anthrax) and Monoclonal Antibodies Against
Anthrax
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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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 an exclusive license to practice the following invention as
embodied in the following patent applications: (1) E-146-2004/0,
Purcell et al., ``Monoclonal Antibodies That Neutralize Anthrax
Protective Antigen (PA) Toxin'', U.S. Patent Application Number 60/
639,074, filed on December 22, 2004, PCT Application Number PCT/US2005/
046/790, filed on December 21, 2005, and U.S. Patent Application Number
11/793,735, filed on December 8, 2009, (2) E-123-2007/0, Purcell et
al., ``Monoclonal Antibodies that Neutralize B. anthracis Protective
Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)'', U.S. Patent
Application Number 60/903,022, filed on February 23, 2007, PCT
Application Number PCT/US2008/054609, filed on February 21, 2008, and
U.S. Patent Application Number 12/528,427, filed on August 24, 2009,
and European Patent Application Number 08730415.0, filed on September
23, 2009, (3) E-125-2008/0, Purcell et al., ``Monoclonal Antibodies
That React With the Capsule of Bacillus anthracis'', U.S. Patent
Application Number 61/116,222, filed on November 19, 2008, PCT
Application Number PCT/US2009/065198, filed on November 19, 2009, and
U.S. Patent Application Number 13/130,044, filed on May 18, 2011, (4)
E-343-2002/0, Schneerson et al., ``gammaPGA Conjugates for Eliciting
Immune Responses Directed Against Bacillus anthracis and Other
Bacilli'', U.S. Patent Application Number 60/476,598, filed on June 5,
2003, PCT Application Number PCT/US2004/17736, filed on June 4, 2004,
U.S. Patent Application Number 10/559,825, filed December 2, 2005, now
U.S. Patent Number 7,803,386, European Patent Application Number
04754360.8, filed June 4, 2004, Canadian Patent Application Number
2,528,067, filed June 4, 2004, and Australian Patent Application Number
2004252091, filed June 4, 2004, now Australian Patent Number
2004252091, and (5) E-040-2005/0, Schneerson et al., ``Methods for
Preparing Immunogenic Conjugates'', U.S. Patent Application Number 11/
005,851, filed on December 6, 2004, now U.S. Patent Number 7,625,736,
PCT Application Number PCT/US2005/19678, filed June 3, 2005, European
Patent Application Number 05758048.2, filed June 3, 2005, now European
Patent Number 1765394 (rights were validated in Germany (Patent Number
602005015855), France (Patent Number 1765394), Great Britain (Patent
Number 1765394), and Ireland (Patent Number 1765394)), Indian Patent
Application Number 7703/DELNP/2006, filed June 3, 2005, Chinese Patent
Application Number 200580018108.2, filed June 3, 2005, Australian
Patent Application Number 2005249571, filed June 3, 2005, now
Australian Patent Number 2005249571, Canadian Patent Application Number
2,568,364, filed June 3, 2005, and U.S. Patent Application Number 12/
582,420, filed October 20, 2009, to Biologics Resources LLC, having a
place of business in Boyds, Maryland, United States of America. 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
September 26, 2011 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: [email protected]; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: Anthrax, whether resulting from natural or
bioterrorist-associated exposure, is a constant threat to human health.
The lethality of anthrax is primarily the result of the effects of
anthrax toxin, which has 3 components: a receptor-binding protein known
as ``protective antigen'' (PA) and 2 catalytic proteins known as
``lethal factor'' (LF) and ``edema factor'' (EF). Although production
of an efficient anthrax vaccine is an ultimate goal, the benefits of
vaccination can be expected only if a large proportion of the
population at risk is immunized. In contrast, passive administration of
neutralizing human or chimpanzee monoclonal antibody to a subject at
risk for anthrax or exposed to anthrax could provide immediate efficacy
for emergency prophylaxis against or treatment of anthrax.
The methods and compositions of these inventions provide a means
for prevention and/or therapy of B. anthracis (anthrax) infection by
immunization with conjugate vaccines against anthrax and/or passive
immunization with monoclonal antibodies against B. anthracis.
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 fields of use may be limited to (1) monoclonal antibodies
against B. anthracis (anthrax) for use in humans and (2) B. anthracis
conjugate vaccines 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
[[Page 53481]]
under the Freedom of Information Act, 5 U.S.C. 552.
Dated: August 19, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-21771 Filed 8-25-11; 8:45 am]
BILLING CODE 4140-01-P