[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Page 63317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26342]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 patent 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.
    The prospective exclusive 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.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 14, 2011 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated 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 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 license will be 
royalty bearing and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR part 404.7. The prospective 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 part 404.7 within thirty 
(30) 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 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: October 4, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-26342 Filed 10-11-11; 8:45 am]
BILLING CODE 4140-01-P