[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Pages 44274-44275]
From the Federal Register Online via the Government Publishing 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.
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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: [email protected].
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