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Notice

Prospective Grant of Exclusive License: Protein/Peptide Biotherapeutics for the Treatment of HIV Infections

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Information about this document as published in the Federal Register.

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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 an exclusive license to practice the invention embodied in a United States Patent Application filed February 11, 2003 (DHHS Reference No. E-236-2002/0), entitled “Design of a Novel Peptide Inhibitor of HIV Fusion that Disrupts the Internal Trimeric Coiled-coil of gp41,” to Virosys Pharmaceuticals, Inc., having a place of business in Redwood Shores, CA. 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 June 9, 2003, 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: Sally Hu, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: hus@od.nih.gov; Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

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SUPPLEMENTARY INFORMATION:

This invention provides a peptide derived from the sequence of the N-terminal helix (residues 546-581) of the gp41ectodomain of HIV-1. The peptide, called N36Mut(e.g), contains nine substitutions and disrupts interactions with the C-terminal region of the gp41 ectodomain. N36Mut(e.g) inhibits HIV-envelope mediated cell fusion about 50-fold more effectively than the native sequence (residues 546-581 of HIV-1 envelope) from which it was derived. Thus, N36Mut(e.g.) and derivatives has potential as an anti-HIV therapeutic agent as a HIV fusion inhibitor.

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 90 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 development of protein/peptide biotherapeutics for the treatment of HIV infections.

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.

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Dated: February 27, 2003.

Steven M. Ferguson,

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

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[FR Doc. 03-5689 Filed 3-10-03; 8:45 am]

BILLING CODE 4140-01-U