Prospective Grant of Exclusive License: Use of Leptin and Leptin Analogs for the Treatment of Lipodystrophy, 44274-44275 [2010-18492]

Download as PDF 44274 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices Dated: July 22, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–18508 Filed 7–27–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, October 21, 2010, 8 a.m. to October 21, 2010, 5 p.m., Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD, 20814 which was published in the Federal Register on July 9, 2010, 75 FR 39547. This FRN amendment has been processed to change the location of this meeting from the Doubletree Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda MD 20814 to the Legacy Hotel and Meeting Center, 1775 Rockville Pike, Rockville MD 20852. The meeting is closed to the public. Dated: July 22, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–18503 Filed 7–27–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health sroberts on DSKD5P82C1PROD with NOTICES 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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. VerDate Mar<15>2010 19:05 Jul 27, 2010 Jkt 220001 Name of Committee: National Cancer Institute Special Emphasis Panel, Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer. Date: August 31, 2010. Time: 12 p.m. to 1:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6116 Executive Boulevard, Room 210, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Kenneth L. Bielat, PhD, Scientific Review Officer, Special Review Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 7147, Bethesda, MD 20892–8329, 301–496–7576, bielatk@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, Basic, Translational and Clinical Oncology. Date: September 28–29, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel & Executive Meeting Ctr. Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: David G. Ransom, PhD, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd, Rm 8133, Bethesda, MD 20892–8328, 301–451–4757, david.ransom@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, Drug Discovery, Biomarkers, Therapeutics. Date: September 28–29, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Peter J. Wirth, PhD, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8129, Bethesda, MD 20892–8328, 301–496–7565, pw2q@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: July 22, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–18498 Filed 7–27–10; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Use of Leptin and Leptin Analogs for the Treatment of Lipodystrophy National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent Application No. 60/336,394, filed on October 22, 2001 (HHS Ref. No. E–064–2004/0–US– 01); PCT Application No. PCT/US02/ 033875, filed on October 22, 2002 (HHS Ref. No. E–064–2004/0–PCT–02); U.S. Patent Application No. 10/279,129, filed on October 22, 2002 (HHS Ref. No. E– 064–2004/0–US–03); Japanese Patent Application No. 2003–537565, filed on October 22, 2002 (HHS Ref. No. E–064– 2004/0–JP–04); Mexican Patent No. 250445, filed on October 22, 2002 and granted on October 16, 2007 (HHS Ref. No. E–064–2004/0–MX–05); Polish Patent Application No. P–374301, filed on October 22, 2002 (HHS Ref. No. E– 064–2004/0–PL–6); Canadian Patent Application No. 2464277, filed on October 22, 2002 (HHS Ref. No. E–064– 2004/0–CA–07); European Patent Application No. 02793811.7, filed on October 22, 2002 (HHS Ref. No. E–064– 2004/0–EP–08); U.S. Patent No. 7,183,254, filed on July 18, 2003 and granted on 2/27/2007 (HHS Ref. No. E– 064–2004/0–US–09); U.S. Patent Application No. 11/606,805, filed on October 29, 2006 (HHS Ref. No. E–064– 2004/0–US–10); Mexican Patent Application No. 2007/006095, filed on May 14, 2007 (HHS Ref. No. E–064– 2004/0–MX–11); Australian Patent Application No. 2002359288, filed on October 22, 2002 (HHS Ref. No. E–064– 2004/0–AU–12); Hong Kong Patent Application No. 4106574.7, filed on September 1, 2004 (HHS Ref. No. E– 064–2004/0–HK–13); European Patent Application No. 10165256.8, filed on June 8, 2010 (HHS Ref. No. E–064–2004/ 0–EP–14); and Japanese Patent Application No. 2010–137501, filed on June 16, 2010 (HHS Ref. No. E–064– 2004/0–JP–15), all entitled ‘‘Use of Leptin for Treating Human Lipoatrophy and Method of Determining Predisposition to Said Treatment’’, to SUMMARY: E:\FR\FM\28JYN1.SGM 28JYN1 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices Amylin Pharmaceuticals, Inc., having a place of business in San Diego, California, U.S.A. The patent rights in this invention have been assigned to the United States of America, the University of Texas Southwestern Medical Center at Dallas, and Amgen, Inc. The contemplated exclusive license territory may be worldwide, and the field of use may be limited to ‘‘use of leptin and leptin analogs for the treatment of lipodystrophy or a metabolic condition associated with lipodystrophy in humans, including lipodystrophy associated with or secondary to HIV infection’’. DATES: Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before August 27, 2010 will be considered. ADDRESSES: Requests for copies of the patents, inquiries, comments, and other materials relating to the contemplated license should be directed to: Tara L. Kirby, PhD, 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: 301–402–0220; E-mail: tarak@mail.nih.gov. This technology relates to leptin, a protein hormone that plays a key role in regulating energy intake and expenditure. This hormone is released from adipose tissue and inhibits appetite in the brain by counteracting peptide hormones responsible for stimulating hunger, and also stimulates the synthesis of another peptide hormone, a-MSH, which acts as an appetite suppressant. Lipodystrophy, a disorder characterized by pathological deposition of adipose tissue (fat), is caused by a deficiency or complete absence of leptin. Patients with severe lipodystrophy have abnormalities in adipose tissue distribution with loss of subcutaneous fat, and suffer from multiple metabolic disorders—extreme insulin resistance, very high triglyceride levels, diabetes and steatosis (fat accumulation in tissues like liver and muscle)—that are associated with increased risk of severe pancreatitis, early diabetes complications, cirrhosis and early cardiovascular death. Leptin replacement therapy in such patients leads to clear and dramatic metabolic benefits, including a reduction in insulin resistance and triglyceride levels, which are refractory to other treatment. sroberts on DSKD5P82C1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 19:05 Jul 27, 2010 Jkt 220001 This technology relates to the use of leptin, a leptin analog, or a leptin derivative to treat lipoatrophy, as well as methods and kits for determining a predisposition of a lipoatrophic patient to respond to treatment with leptin, a leptin analog, or a leptin derivative. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 30 days from the date of this published Notice, 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 404.7. Applications for a license in the prospective field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted in response 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: July 22, 2010. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–18492 Filed 7–27–10; 8:45 am] BILLING CODE 4140–01–P 44275 You may submit comments, identified by Docket ID FEMA–2010– 0037, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Search for Docket ID FEMA–2010–0037 and follow the instructions for submitting comments. • Fax: 703–483–2999. • Mail/Hand Delivery/Courier: Office of Chief Counsel, Federal Emergency Management Agency, 500 C Street, SW., Room 835, Washington, DC 20472– 3100. Instructions: All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at https:// www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy Act notice that is available via a link in the footer of https:// www.regulations.gov. Docket: For access to the docket for this notice or comments submitted by the public on this notice, go to the Federal eRulemaking Portal at https:// www.regulations.gov search for docket ID FEMA–2010–0037. These documents may also be inspected at FEMA, Office of Chief Counsel, Room 835, 500 C Street, SW., Washington, DC 20472– 3100. ADDRESSES: FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Alessandro Amaglio, Regional Environmental Officer, Region IX, FEMA, 111 Broadway, Suite 1200, Oakland, CA 94607–4052 and phone number at (510) 627–7027. On June 10, 2010, (75 FR 32960), FEMA published a notice of intent to prepare an EIS and request for comments for four hazard mitigation applications for fuel reduction projects in the East Bay Hills area in California pursuant to Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA), the Council on Environmental Quality (CEQ) regulations implementing NEPA, and FEMA’s Environmental Considerations regulations. FEMA is extending the public comment period on the notice of intent to prepare an EIS to accommodate comments that the Federal, State, Tribal, and local government agencies and interested members of the public may have after the public scoping meetings. SUPPLEMENTARY INFORMATION: [Docket ID FEMA–2010–0037] Hazardous Fire Risk Reduction, East Bay Hills, CA Federal Emergency Management Agency, DHS. ACTION: Notice of extension of comment period. AGENCY: The Federal Emergency Management Agency (FEMA) is extending the comment period on its notice of intent to prepare an Environmental Impact Statement (EIS) evaluating the environmental impacts of funding a combination of hazardous fuel reduction projects within the East Bay Hills area in Alameda and Contra Costa Counties, California. DATES: Comments must be submitted by October 1, 2010. SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Authority: 42 U.S.C. 4331 et seq.; 40 CFR part 1500; 44 CFR part 10. E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Pages 44274-44275]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Leptin and Leptin 
Analogs for the Treatment of Lipodystrophy

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 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the invention embodied in U.S. 
Patent Application No. 60/336,394, filed on October 22, 2001 (HHS Ref. 
No. E-064-2004/0-US-01); PCT Application No. PCT/US02/033875, filed on 
October 22, 2002 (HHS Ref. No. E-064-2004/0-PCT-02); U.S. Patent 
Application No. 10/279,129, filed on October 22, 2002 (HHS Ref. No. E-
064-2004/0-US-03); Japanese Patent Application No. 2003-537565, filed 
on October 22, 2002 (HHS Ref. No. E-064-2004/0-JP-04); Mexican Patent 
No. 250445, filed on October 22, 2002 and granted on October 16, 2007 
(HHS Ref. No. E-064-2004/0-MX-05); Polish Patent Application No. P-
374301, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-PL-6); 
Canadian Patent Application No. 2464277, filed on October 22, 2002 (HHS 
Ref. No. E-064-2004/0-CA-07); European Patent Application No. 
02793811.7, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-EP-
08); U.S. Patent No. 7,183,254, filed on July 18, 2003 and granted on 
2/27/2007 (HHS Ref. No. E-064-2004/0-US-09); U.S. Patent Application 
No. 11/606,805, filed on October 29, 2006 (HHS Ref. No. E-064-2004/0-
US-10); Mexican Patent Application No. 2007/006095, filed on May 14, 
2007 (HHS Ref. No. E-064-2004/0-MX-11); Australian Patent Application 
No. 2002359288, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-
AU-12); Hong Kong Patent Application No. 4106574.7, filed on September 
1, 2004 (HHS Ref. No. E-064-2004/0-HK-13); European Patent Application 
No. 10165256.8, filed on June 8, 2010 (HHS Ref. No. E-064-2004/0-EP-
14); and Japanese Patent Application No. 2010-137501, filed on June 16, 
2010 (HHS Ref. No. E-064-2004/0-JP-15), all entitled ``Use of Leptin 
for Treating Human Lipoatrophy and Method of Determining Predisposition 
to Said Treatment'', to

[[Page 44275]]

Amylin Pharmaceuticals, Inc., having a place of business in San Diego, 
California, U.S.A. The patent rights in this invention have been 
assigned to the United States of America, the University of Texas 
Southwestern Medical Center at Dallas, and Amgen, Inc.
    The contemplated exclusive license territory may be worldwide, and 
the field of use may be limited to ``use of leptin and leptin analogs 
for the treatment of lipodystrophy or a metabolic condition associated 
with lipodystrophy in humans, including lipodystrophy associated with 
or secondary to HIV infection''.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before August 
27, 2010 will be considered.

ADDRESSES: Requests for copies of the patents, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Tara L. Kirby, PhD, 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: 301-402-0220; E-mail: tarak@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This technology relates to leptin, a protein 
hormone that plays a key role in regulating energy intake and 
expenditure. This hormone is released from adipose tissue and inhibits 
appetite in the brain by counteracting peptide hormones responsible for 
stimulating hunger, and also stimulates the synthesis of another 
peptide hormone, [alpha]-MSH, which acts as an appetite suppressant.
    Lipodystrophy, a disorder characterized by pathological deposition 
of adipose tissue (fat), is caused by a deficiency or complete absence 
of leptin. Patients with severe lipodystrophy have abnormalities in 
adipose tissue distribution with loss of subcutaneous fat, and suffer 
from multiple metabolic disorders--extreme insulin resistance, very 
high triglyceride levels, diabetes and steatosis (fat accumulation in 
tissues like liver and muscle)--that are associated with increased risk 
of severe pancreatitis, early diabetes complications, cirrhosis and 
early cardiovascular death. Leptin replacement therapy in such patients 
leads to clear and dramatic metabolic benefits, including a reduction 
in insulin resistance and triglyceride levels, which are refractory to 
other treatment.
    This technology relates to the use of leptin, a leptin analog, or a 
leptin derivative to treat lipoatrophy, as well as methods and kits for 
determining a predisposition of a lipoatrophic patient to respond to 
treatment with leptin, a leptin analog, or a leptin derivative.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 30 days 
from the date of this published Notice, 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 404.7.
    Applications for a license in the prospective field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive license. Comments and objections submitted 
in response 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: July 22, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-18492 Filed 7-27-10; 8:45 am]
BILLING CODE 4140-01-P
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