[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]
BILLING CODE 4140-01-P