Prospective Grant of Exclusive Patent License: Use of Exenatide for the Treatment of Neurodegenerative Diseases, 53153-53154 [2013-20945]

Download as PDF 53153 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Notices and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Palliative Care: Conversations Matter evaluation will assess the information and materials being disseminated as part of the official campaign. Survey findings will help (1) Determine if the campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand the information needs of health care providers to inform future campaign efforts; and (3) examine how effective the campaign materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 200. Estimated Annualized Burden Hours TABLE A–12–1—ESTIMATES OF ANNUAL BURDEN HOURS Number of respondents Type of respondents Average time per response (in hours ) Frequency of response Total burden hours Physicians ........................................................................................ Nurses .............................................................................................. 150 150 2 2 20/60 20/60 100 100 Total .......................................................................................... 300 ............................ ............................ 200 * The average time for completing one of the surveys is 20 minutes; this includes reading the consent form on page 1 of the survey. Dated: August 19, 2013. Amanda Greene, NINR PRA Liaison, Science Evaluation Officer, NINR, NIH. [FR Doc. 2013–21005 Filed 8–27–13; 8:45 am] BILLING CODE 4140–01–P 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. 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, wreier-aviles on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:21 Aug 27, 2013 Jkt 229001 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, PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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: E:\FR\FM\28AUN1.SGM 28AUN1 53154 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Notices (301) 402–0220; Email: tarak@ mail.nih.gov. 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. 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. wreier-aviles on DSK5TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: 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 VerDate Mar<15>2010 15:21 Aug 27, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel Detection of Pathogen Induced Cancer. Date: October 1, 2013. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W034, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Adriana Stoica, Ph.D., Scientific Review Officer, Special Review & Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W234, Rockville, MD 20850, 240–276–6368, Stoicaa2@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel Planning for a National Center for Particle Beam Radiation Therapy Research. Date: October 3, 2013. Time: 9:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 6W032, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Thomas A. Winters, Ph.D., Scientific Review Officer, Special Review & Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W412, Bethesda, MD 20892–9750, 240–276–6386, twinters@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel Informatics Technology for Cancer Research. Date: October 22, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites-Hotel, 6711 Democracy Blvd., Bethesda, MD 20817. Contact Person: Viatcheslav A Soldatenkov, MD, Ph.D., Scientific Review PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W254, Bethesda, MD 20892– 8329, 240–276–6378, soldatenkovv@ mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel NCI Omnibus Grants on Cancer Genetics and Etiology. Date: October 22–23, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites Alexandria—Old Town, 1900 Diagonal Road, Alexandria, VA 22314. Contact Person: Marvin L. Salin, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W236, Bethesda, MD 20892–8329, 240–276–6369, msalin@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group Subcommittee F–Institutional Training and Education. Date: October 28–29, 2013. Time: 7:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Arlington Capital View, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Timothy C. Meeker, Ph.D., MD, Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W624, Bethesda, MD 20850, 240– 276–6464, meekert@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel Research Answers to NCI’s Provocative QuestionsGroup A (R01). Date: October 31–November 1, 2013. Time: 7:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Clifford W Schweinfest, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W108, Bethesda, MD 20892–9750, 240–276–6378, schweinfestcw@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel Collaborative Human Tissue Network (CHTN) (UM1). Date: November 4–5, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room: Nov 4–6W030 & Nov 5–7W030, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Donald L Coppock, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53153-53154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20945]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: tarak@mail.nih.gov. 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

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