05-14502. Prospective Grant of Exclusive License: Use of HIV-Dependent Expression Constructs and Uses Therefor for the Development of FDA-Approvable HIV Diagnostic Kits

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 PCT/US04/31967 filed September 28, 2004 from U.S. provisional application 60/507,034 (E-276-2003/0-US-01), entitled “HIV-Dependent Expression Constructs and Uses Therefor” (E-276-2003/0-PCT-02), (Inventors: Yuntao Wu and Jon Marsh), to Revix Technology LLC (hereafter Revix), having a place of business in Manassas, Virginia. The patent rights in these inventions 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 September 20, 2005 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, Ph.D., M.B.A., 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:

E-276-2003/0-PCT-02 provides nucleic acid molecules comprising expressible sequences, which could be reporter or therapeutic genes, whose expression depends on the presence of HIV Tat and Rev proteins. This invention could be used for detection of HIV infection, in screening assays to identify compounds that inhibit HIV infection, and potentially as a therapeutic to kill HIV-infected cells and treat HIV-infected subjects.

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 the development of FDA-approvable HIV clinical diagnostic kit.

It has to be noted that the non-exclusive license opportunities in the field(s) of use of the development of HIV detection kit/reagent for research use and/or cellular screening method for research use, as well as the exclusive license opportunity in the field of use of the development of a novel therapeutic against HIV infections are still available for subject invention.

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: July 12, 2005.

Steven M. Ferguson,

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