[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Page 62521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25170]
[[Page 62521]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of
Therapeutic Agents for the Treatment of Metastatic Breast Cancer and T-
cell Lymphoma
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 to
Birich Technologies, Inc., of an exclusive evaluation option license to
practice the inventions embodied in the following U.S. Patent
Applications (and all continuing applications and foreign
counterparts): Serial No. 61/045,088 entitled, ``COMPOSITIONS AND
METHODS FOR DELIVERING INHIBITORY OLIGONUCLEOTIDES'' [HHS Ref. E-051-
2008/0-US-01]; Serial No. 61/333,512 entitled, ``Peptide Inhibitors of
Interferon Gamma and Interleukin 10 Signaling'' [HHS Ref. E-167-2010/0-
US-01]; and Serial No. 60/987,340 entitled, ``Diagnostic and
Therapeutic Applications of a p53 Isoform in Regenerative Medicine,
Aging and Cancer'' [HHS Ref. E-033-2008/0-US-01]. The patent rights in
these inventions have been assigned or exclusively licensed to the
Government of the United States of America.
The prospective exclusive evaluation option license territory may
be worldwide, and the field of use may be limited to:
The use in humans of the peptide-based antisense delivery
technology (ChemoArp) in conjunction with either (i) a peptide-based
interleukin-10 (IL-10) inhibitor as a dual-biologic therapy to treat
metastatic breast cancer, or ii) incorporating a p53 isoform
antisense oligonucleotide as a single biologic therapy to treat T-
cell lymphoma.
Upon the expiration or termination of the exclusive evaluation
option license, Birich Technologies, Inc. will have the exclusive right
to execute an exclusive commercialization license which will supersede
and replace the exclusive evaluation option license with no greater
field of use and territory than granted in the exclusive evaluation
option license.
DATES: Only written comments or applications for a license (or both)
which are received by the NIH Office of Technology Transfer on or
before October 30, 2012 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: Patrick McCue, 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) 435-5560; Facsimile: (301)
402-0220; Email: [email protected].
SUPPLEMENTARY INFORMATION: These inventions concern i) compositions and
methods for targeted delivery of inhibitory nucleic acids to cells
using a cell surface receptor ligand targeting domain and an inhibitory
oligonucleotide-binding domain to efficiently deliver the antisense
nucleic acid to cells that expresses the cell surface receptor that
binds the ligand, ii) compositions that potently and selectively
interfere with dimerization of interleukin-10 and binding of this
protein to its receptor, and iii) compositions that inhibit
delta133p53, a natural variant nucleic acid of tumor suppressor protein
53 (p53) that inhibits p53-dependent cell senescence.
The prospective exclusive evaluation option 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 Part 404.7. The prospective exclusive evaluation option
license, and a subsequent exclusive commercialization 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 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 evaluation 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: October 9, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-25170 Filed 10-12-12; 8:45 am]
BILLING CODE 4140-01-P