[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]


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

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.

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

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