E7-23191. Prospective Grant of Exclusive License: Development of FDA Approved HIV Resistance Diagnosis Kit

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 U.S. Patent No. 5,714,313, issued February 03, 1998, entitled “Simple Method For Detecting Inhibitors Of Retroviral Replication” (HHS Ref. E-054-1991/1-US-01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), having a place of business in France. 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 January 29, 2008 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:

The subject technology discloses a DNA vector comprised of a selectable marker gene inserted into a retrotransposon for use in identifying and selecting cells in which retrotransposition has occurred. This novel method uses a retrotransposon comprised of a retroviral reverse transcriptase/RNAse H gene domain, which creates a unique restriction enzyme site wherever reverse transcription occurs. This novel system offers a means of identifying compounds or agents that can inhibit retrotransposition or retroviral replication. Previous methods developed to detect retrotransposition have not been able to accurately identify DNA in which reverse transcription has occurred. Certain types of retrotransposition are similar to retroviral replication. Thus, this method is applicable to identifying antiretroviral compounds as well as inhibitors of retrotransposition.

The field of use may be limited to the development of FDA approved HIV resistance diagnosis kit through the combination of the subject technology and AmiKana's proprietary yeast based HIV protease phenotyping procedure (Patent Publication No. WO2006000693).

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: November 19, 2007.

Steven M. Ferguson,

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