[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Notices]
[Page 7438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of Human
Monoclonal Antibodies Against DR4
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 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 PCT Patent Application No. PCT/US2011/040750 and foreign equivalents
thereof entitled ``Agonistic Human Monoclonal Antibodies Against DR4''
(HHS Ref. No. E-158-2010/0) to Customized Biosciences, Inc., which is
located in Pasadena, CA. The patent rights in these inventions have
been assigned to the United States of America.
The prospective start-up exclusive commercial license territory may
be worldwide and the field of use may be limited to ``use of the
Licensed Patent Rights to develop therapeutic agents for the treatment
of lymphomas, leukemias, hepatocellular cancer, colorectal cancer,
ovarian cancer, lung cancer, rheumatoid arthritis, systemic lupus
erythematosus, multiple sclerosis, amyotrophic lateral sclerosis, and
Alzheimer's disease''.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
February 19, 2013 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: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301)
402-0220; Email: [email protected].
SUPPLEMENTARY INFORMATION: The tumor necrosis factor (TNF)-related
apoptosis-inducing ligand (TRAIL) and its functional receptors, DR4 and
DR5, have been recognized as promising targets for cancer treatment.
Therapeutics targeting TRAIL and its receptors are not only effective
in killing many types of tumors but they also synergize with
traditional therapies, and show efficacy against tumors that are
otherwise resistant to conventional treatments.
The above identified patent application relates to the development
of two human monoclonal antibodies (mAbs) that bind to death receptor 4
(``DR4''). The two mAbs were selected from a human phage displayed Fab
library by panning against a recombinant DR4 extracellular domain.
Therefore the two mAbs are fully human. These antibodies could have
considerable potential as cancer therapeutics alone or in combination
with other drugs. Further, these antibodies could be used as a research
tool for the study of DR4.
The prospective start-up exclusive commercial 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 404.7. The prospective start-up exclusive commercial
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 404.7
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 start-up exclusive commercial 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, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-02152 Filed 1-31-13; 8:45 am]
BILLING CODE 4140-01-P