[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Page 62521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25170]



[[Page 62521]]

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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.

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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: mccuepat@mail.nih.gov.

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