03-27503. Prospective Grant of Exclusive License: Synthetic, Anti-Complement Protein and the Gene Encoding Same

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 world-wide exclusive license to practice the invention embodied in: United States Patent Numbers 5,157,110 and 5,187,268, entitled “Synthetic Anti-Complement Protein and Gene Encoding Same”, issued October 20, 1992 and February 26, 1993, respectively, to K-Biotech, PTY, having a place of business in Cape Town, South Africa. 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 January 2, 2004 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: Susan Ano, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; e-mail: [e-mail]; Telephone: [phone]; Facsimile: [phone].

SUPPLEMENTARY INFORMATION:

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 technology described in USPN 5,157,110 relates to the discovery of a protein, vaccinia complement protein (VCP), that inhibits the complement cascade. VCP is the smallest complement controlling protein, is soluble (complement inhibitors produced by humans are typically membrane-bound), does not have glycosylation sites, and acts via a different component of the complement compared to most other (inhibiting at C3 level rather than C5). The technology described in USPN 5,187,268 describes the cloned gene encoding this protein. Complement inhibitors may be used for combating inflammatory responses.

The field of use may be limited to development of anti-inflammatory therapeutics based on VCP.

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: October 24, 2003.

Steven M. Ferguson,

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