[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5036-5037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Human 
Anti-Mesothelin Monoclonal Antibodies for the Treatment of Human 
Cancers

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 part 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 61/040,005 entitled ``Human 
Monoclonal Antibodies Specific for Mesothelin'' [HHS Ref. E-079-2008/0-
US-01], PCT Application PCT/US2009/038228 entitled ``Human Monoclonal 
Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-PCT-02], 
Australian patent application AU 2009228361 entitled ''Human Monoclonal 
Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-AU-03], Canadian 
patent application CA 2718321 entitled ``Human Anti-Mesothelin 
Monoclonal Antibodies'' [HHS Ref. E-079-2008/0-CA-04], European patent 
application EP 09726082.2 entitled ``Human Monoclonal Antibody Against 
Mesothelin'' [HHS Ref. E-079-2008/0-EP-05], U.S. patent application 12/
934,060 entitled ``Human Anti-Mesothelin Monoclonal Antibodies '' [HHS 
Ref. E-079-2008/0-US-06], 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.

[[Page 5037]]

    The prospective exclusive evaluation option license territory may 
be worldwide, and the field of use may be limited to:

    The use of the monoclonal antibody m912 (SM-101) as an antibody 
therapy for the treatment of pancreatic cancer, ovarian cancer, lung 
cancer, mesothelioma, and stomach/gastric cancer. The Licensed Field 
of Use explicitly excludes the use of the antibody in the form of an 
immunoconjugate, including, but not limited to, 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 
February 16, 2012 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the 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 a monoclonal 
antibody and methods of using the antibody for the treatment of 
mesothelin-expressing cancers, including mesothelioma, lung cancer, 
stomach/gastric cancer, ovarian cancer and pancreatic cancer. The 
specific antibody covered by this technology is designated m912 (SM-
101), which is a fully human monoclonal antibody against mesothelin.
    Mesothelin is a cell surface antigen that is preferentially 
expressed on certain types of cancer cells. The m912 antibody can 
selectively bind to these cancer 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 Part 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 Part 404.7 within fifteen 
(15) days from the date of this published notice. A previous notice for 
this license was published on 12 October 2011.
    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: January 24, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-2213 Filed 1-31-12; 8:45 am]
BILLING CODE 4140-01-P