[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42025-42026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16853]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive Option License: The Development
of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the
Treatment of Human Cancers
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
Part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of a co-exclusive (or
exclusive, if the other party declines to move forward with an
agreement) start-up option license to practice the inventions embodied
in U.S. Patent Application 61/706,396 entitled ``Mesothelin Antibodies
And Methods For Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-
2012/0-US-01], PCT Application PCT/US2013/059883 entitled ``Mesothelin
Antibodies And Methods For Eliciting Potent Antitumor Activity'' [HHS
Ref. E-236-2012/0-PCT-02], and all related continuing and foreign
patents/patent applications for the technology family, to MesoPharm
Therapeutics, Inc. The
[[Page 42026]]
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 (or exclusive) start-up option
licensed territory may be worldwide, and the field of use may be
limited to:
The use of the monoclonal antibody SD1 (and glycoengineered
variants thereof) as an antibody therapy for the treatment of
mesothelioma, pancreatic cancer, breast cancer, ovarian cancer and
lung adenocarcinoma. 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 co-exclusive start-up
option license, MesoPharm Therapeutics, Inc. will have the co-exclusive
right to execute a co-exclusive (or exclusive, if the other party
declines their option) commercialization license which will supersede
and replace the co-exclusive start-up option license with no greater
field of use and territory than granted in the co-exclusive start-up
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
August 4, 2014 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated co-exclusive
start-up 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,
ovarian cancer and pancreatic cancer. The specific antibody covered by
this technology is designated SD1, which is a single domain, fully
human monoclonal antibody against mesothelin.
Mesothelin is a cell surface antigen that is preferentially
expressed on certain types of cancer cells. The SD1 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 co-exclusive start-up option license will be
royalty bearing and will comply with the terms and conditions of 35
U.S.C. 209 and 37 CFR Part 404. The prospective co-exclusive start-up
option 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 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 start-up 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: July 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16853 Filed 7-17-14; 8:45 am]
BILLING CODE 4140-01-P