[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9678-9679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Human 
Anti-CD22 Monoclonal Antibodies for the Treatment of Human Cancers and 
Autoimmune Disease

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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive evaluation option license to practice the inventions embodied 
in U.S. Patent Application 61/042,239 entitled ``Human Monoclonal 
Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT 
Application PCT/US2009/124109 entitled ``Human and Improved Murine 
Monoclonal Antibodies Against CD22'' [HHS Ref. E-080-2008/0-PCT-02], 
U.S. patent application 12/934,214 entitled ``Human Monoclonal 
Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-03], and all 
related continuing and foreign patents/patent applications for the 
technology family, to Sanomab, Ltd. The patent rights in these 
inventions have been assigned to and/or exclusively licensed to the 
Government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide, and the field of use may be limited to:

    The use of the m971 and m972 (SMB-002) monoclonal antibodies as 
therapies for the treatment of B cell cancers and autoimmune 
disease. The Licensed Field of Use includes the use of the 
antibodies in the form of an immunoconjugate, including 
immunotoxins.

    Upon the expiration or termination of the exclusive evaluation 
option license, Sanomab, Ltd. will have the exclusive right to execute 
an exclusive commercialization license which will supersede and replace 
the exclusive evaluation option license with no greater field of use 
and territory than granted in the exclusive evaluation option license.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
March 5, 2012 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the

[[Page 9679]]

contemplated exclusive evaluation option license should be directed to: 
David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 
(301) 435-4632; Facsimile: (301) 402-0220; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: This invention concerns monoclonal 
antibodies against CD22 and methods of using the antibodies for the 
treatment of CD22-expressing cancers, including hematological 
malignancies such as hairy cell leukemia, chronic lymphocytic leukemia 
and pediatric acute lymphoblastic leukemia, and autoimmune disease such 
as lupus and Sjogren's syndrome. The specific antibodies covered by 
this technology are designated m971 and m972 (SMB-002; applicant 
designation).
    CD22 is a cell surface antigen that is preferentially expressed on 
certain types of cancer cells, and is involved in the modulation of the 
immune system. The m971 and m972 antibodies can selectively bind to 
diseased cells and induce cell death while leaving healthy, essential 
cells unharmed. This can result in an effective therapeutic strategy 
with fewer side effects due to less non-specific killing of cells.
    The prospective exclusive evaluation option license is being 
considered under the small business initiative launched on 1 October 
2011, and will comply with the terms and conditions of 35 U.S.C. 209 
and 37 CFR 404.7. The prospective exclusive evaluation option license, 
and a subsequent exclusive commercialization license, may be granted 
unless the 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 within fifteen (15) days 
from the date of this published notice.
    Complete applications for a license in the field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive evaluation option license. Comments and 
objections submitted 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: February 13, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-3829 Filed 2-16-12; 8:45 am]
BILLING CODE 4140-01-P