01-22792. Prospective Grant of Exclusive License: Veterinary Vaccine Against Escherichia Coli O157 Infection Composed of Detoxified LPS Conjugated to Proteins

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 to practice the invention embodied in: United States Patent Application 09/744,289 and its foreign equivalents entitled “Vaccine Against Escherichia Coli O157 Infection Composed of Detoxified LPS Conjugated to Proteins” filed January 22, 2001, with priority back to PCT/US98/14976, filed July 20, 1998 to Fort Dodge Animal Health, a Division of American Home Products, having a place of business in Overland Park, Kansas. The patent rights in this invention have been assigned to the United States of America.

DATES:

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before November 13, 2001 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: Peter Soukas, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: [e-mail]; Telephone: [phone], ext. 268; Facsimile: [phone].

SUPPLEMENTARY INFORMATION:

This invention comprises the O-specific polysaccharide of Shiga toxin-producing bacteria, particularly E. coli O157, conjugated to a carrier protein such as Pseudomonas aeruginosa recombinant exoprotein A or hepatitis B surface or core antigen. This vaccine is suitable for use in humans and animals. Cattle are carriers of E. coli O157, and are the primary reservoir of E. coli O157 by shedding the bacteria into the environment. Fifty percent (50%) of cattle are estimated to be carriers of E. coli O157. Use of this vaccine in cattle could eliminate E. coli O157 and prevent contamination of meat in slaughterhouses.

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.

The field of use may be limited to E. coli conjugate vaccines for veterinary use.

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: September 4, 2001.

Jack Spiegel, Ph.D.,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.