[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]


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

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: [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