E7-15621. Prospective Grant of Exclusive License: Method for Treating Strokes by Inducing Tolerance to E-Selectin

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 license worldwide to practice the inventions embodied in: U.S. Patent Application Numbers 60/206,693 filed May 24, 2000, 10/296,423 filed November 22, 2002 and corresponding foreign applications entitled “Method for Preventing Strokes by Inducing Tolerance to E-Selectin” and U.S. Patent Application Numbers 60/828,732 filed October 9, 2006 and 60/905,741 filed March 8, 2007 entitled “Treatment and Prevention of Inflammation” to Novavax, Inc., having a place of business in Rockville, Maryland. The patent rights in these inventions have been assigned to the United States of America.

The contemplated exclusive license may be limited to the use of E-selectin for the prevention or treatment of stroke.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 9, 2007 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Norbert J. Pontzer, J.D., PhD, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone], E-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application if not yet published.

SUPPLEMENTARY INFORMATION:

This invention provides methods of treating or preventing brain damage in stroke through administration of E-selectin, an inducible adhesion molecule on endothelial cells. The expression of E-selectin is induced on human endothelium in response to activation by cytokines IL-1 and TNF. E-selectin mediates the adhesion of various leukocytes, including neutrophils, monocytes, eosinophils, natural killer cells, and a subset of T cells to activated endothelium. Activation of vascular endothelial cells by proinflammatory cytokines is believed to be involved in conversion of the luminal surface of endothelium from anticoagulant and anti-inflammatory to procoagulant and pro-inflammatory leading to thrombosis. Segmental vascular activation and thrombosis are involved in the development of strokes.

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 60 days from the date of this published Notice, 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.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated 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: August 3, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.