[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Page 18039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive 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 an exclusive 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 H2Bio, Inc. 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 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, 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 exclusive start-up option 
license, H2Bio, Inc. will have the exclusive right to execute an 
exclusive commercialization license which will supersede and replace 
the exclusive start-up option license with no greater field of use and 
territory than granted in the 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 
April 15, 2014 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; 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 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 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 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: March 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-07022 Filed 3-28-14; 8:45 am]
BILLING CODE 4140-01-P