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 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, α-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.