[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