[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53153-53154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20945]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Use of Exenatide
for the Treatment of Neurodegenerative Diseases
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 Patent
License to Peptron, Inc., a company having a place of business in
Daejeon, South Korea, to practice the inventions embodied in U.S.
Provisional Patent Application No. 60/309,076, filed July 31, 2001,
entitled ``Long-Acting Insulinotropic Peptides and Uses Thereof'' (HHS
Ref. No. E-049-2001/0-US-01); U.S. Patent No. 7,576,050, issued August
18, 2009, entitled ``GLP-1 Exendin-4 Peptide Analogs and Uses Thereof''
(HHS Ref. No. E-049-2001/0-US-03); U.S. Patent No. 8,278,272, issued
October 2, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses
Thereof'' (HHS Ref. No. E-049-2001/0-US-14); U.S. Patent Application
No. 13/594,313, filed August 24, 2012, entitled ``GLP-1, Exendin-4,
Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-21);
PCT Patent Application No. PCT/US2002/024141, filed July 30, 2002,
entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS
Ref. No. E-049-2001/0-PCT-02); Australian Patent No. 2002317599, issued
July 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses
Thereof'' (HHS Ref. No. E-049-2001/0-AU-04); Australian Patent No.
2008202893, issued April 26, 2012, entitled ``GLP-1, Exendin-4, Peptide
Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-10);
Australian Patent Application No. 2012202081, filed April 11, 2012,
entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS
Ref. No. E-049-2001/0-AU-20); Canadian Patent Application No. 2455963,
filed January 29, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs
and Uses Thereof'' (HHS Ref. No. E-049-2001/0-CA-05); European Patent
No. 1411968, issued September 17, 2008, entitled ``GLP-1, Exendin-4,
Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-06)
and validated in Germany (HHS Ref. No. E-049-2001/0-DE-11), France (HHS
Ref. No. E-049-2001/0-FR-12), and Great Britain (HHS Ref. No. E-049-
2001/0-GB-13); European Patent No. 2022505, issued December 14, 2011,
entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS
Ref. No. E-049-2001/0-EP-09) and validated in Germany (HHS Ref. No. E-
049-2001/0-DE-17), France (HHS Ref. No. E-049-2001/0-FR-18), and Great
Britain (HHS Ref. No. E-049-2001/0-GB-19); European Patent Application
No. 10177860.3, filed September 21, 2010, entitled ``GLP-1, Exendin-4,
Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-16);
Indian Patent Application No. 0488/DELNP/2004, filed February 27, 2004,
entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS
Ref. No. E-049-2001/0-IN-07); Japanese Patent Application No. 2003-
517083, filed February 2, 2004, entitled ``GLP-1, Exendin-4, Peptide
Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-08); Japanese
Patent Application No. 2009-262568, filed November 18, 2009, entitled
``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-
049-2001/0-JP-15; and Japanese Patent Application No. 2013-007743,
filed January 18, 2013, entitled ``GLP-1, Exendin-4, Peptide Analogs
and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-22). The patent rights
in these inventions have been assigned to the Government of the United
States of America. The territory of the prospective Exclusive Patent
License may be worldwide, and the field of use may be limited to
``Methods of using exenatide for the treatment of neurodegenerative
disease in humans.''
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
September 27, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application(s), inquiries,
comments, and other materials relating to the contemplated Exclusive
Patent License should be directed to: Tara L. Kirby, 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) 435-4426; Facsimile:
[[Page 53154]]
(301) 402-0220; Email: [email protected]. A signed confidentiality
nondisclosure agreement will be required to receive copies of any
patent applications that have not been published or issued by the
United States Patent and Trademark Office or the World Intellectual
Property Organization.
SUPPLEMENTARY INFORMATION: This technology relates to the use of
glucagon-like peptide-1 (GLP-1), exendin-4, and analogs for the
treatment of neurodegenerative diseases. These peptides are GLP-1
receptor agonists and incretin mimetics, and enhance glucose-dependent
insulin secretion and regulate glucagon secretion. As such, they have
been used in the treatment of type 2 diabetes. The inventors have shown
that these peptides also exert neurotrophic and neuroprotective effects
in a variety of predictive models of neurodegeneration, and thus may
represent potential therapeutics for neurodegenerative diseases,
including Alzheimer's disease, Parkinson's disease, Huntington's
disease, amyotrophic lateral sclerosis (ALS), peripheral neuropathy
(associated or unassociated with diabetes) and stroke.
The prospective Exclusive Patent License may be granted unless the
NIH receives written evidence and argument, within thirty (30) days
from the date of this published notice, that establishes that the grant
of the contemplated license would not be consistent with the
requirements of 35 U.S.C. 209 and 37 CFR Part 404.
Complete applications for a license in the prospective field of use
that are filed in response to this notice will be treated as objections
to the grant of the Exclusive Patent 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: August 22, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-20945 Filed 8-27-13; 8:45 am]
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