[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Pages 41792-41793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17218]



National Institutes of Health

Prospective Grant of Co-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.


SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR Part 404.7(a)(1)(i), that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
a co-exclusive 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], US 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 
Customized Therapeutics. 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 co-exclusive licensed 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 

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
31, 2012 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated co-exclusive 
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; E-mail: [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 
    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 co-exclusive 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 co-exclusive 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

[[Page 41793]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: July 11, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-17218 Filed 7-13-12; 8:45 am]