E7-10334. Prospective Grant of Exclusive License: Development of Anti-HIV Therapeutics, Anti-HIV Topical Microbicides, and Anti-Breast Cancer Therapeutics

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/US99/13856 filed June 18, 1999, preceded by U.S. Provisional Patent Application Serial No. 60/089,842 (HHS Ref. E-136-1998/0-US-01), filed June 19, 1999, entered the national stage filing in June 1999 in Korea Patent Application No. 10-2000-7014479; in Mexico Patent Application No. 012525; in Australia Patent Application No. 46972/99; in Canada Patent Application No. 2335464; in Brazil Patent Application No. PI9911385-6; in U.S. Patent No. 6,706,729 and filed DIV in U.S. Patent Application No. 10/738,062 in December 2003; in EPO Patent Application No. 99930428.0 and validated in Germany, France, United Kingdom, Italy and Ireland in November 2006, entitled “Novel Thioesters and Uses Thereof”, Inventors: Drs. James A. Turpin (NCI), Yongsheng Song (NCI), John K. Inman (NIAID), Mingjun Huang (NCI), Anders Wallqvist (NCI), Andrew Maynard (NCI), David G. Covell (NCI), William G. Rice (NCI), and Ettore Appella (NCI);

PCT/US02/23924 filed July 25, 2002, preceded by U.S. Provisional Patent Application Serial No. 60/310,133 (E-329-2000/0-US-01), filed August 3, 2001, entered the national stage filing in February 2004 in EPO Patent Application No. 02756732.0; in Australia Patent Application No. 2003322721; in Canada Patent Application No. 2456083 and U.S. Patent Application No. 10/485,165, entitled “Acylthiols and Component Thiol Compositions as Anti-HIV and Anti-Retroviral Agents”, Inventors: Drs. John K. Inman (NIAID), Atul Goel (NCI), Ettore Appella (NCI), and Jim A. Turpin (NCI);

to ImQuest Pharmaceuticals Inc. (Hereafter ImQuest), having a place of business in Frederick, Maryland. 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 July 30, 2007 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 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.

E-136-1998/0-US-01 describes composition claims for a novel family of thiolesters and uses thereof. These thiolesters are capable of inactivating viruses by a variety of mechanisms, particularly by complexing with metal ion-complexing zinc fingers. The invention further provides for methods for inactivating a virus, particularly human immunodeficiency virus (HIV), using these compounds, and thereby also inhibiting transmission of the virus.

E-329-2000/0-US-01 provides a novel family of acylthiols, and polypeptides, pharmaceutical compositions, devices and other materials containing them, and uses thereof. More specifically, this invention provides covalent (irreversible) inhibitors of HIV that selectively target its highly conserved nucleocapsid protein (NCp7) by dissociating a metal ion from a zinc finger-containing protein. Because of the mutationally intolerant nature of NCp7, drug resistance is much less likely to occur with drugs attacking this target. In addition, these drugs should inactivate all types and strains of HIV and could also inactivate other retroviruses since most retroviruses share one or two highly conserved zinc fingers that have the Cys-Cys-His-Cys motif of the NCp7. Finally, this invention could be very useful for the large-scale practical synthesis of HIV inhibitors because these compounds can be prepared from inexpensive starting materials and facile reactions. Thus, it opens the possibility that an effective drug treatment for HIV could reach underdeveloped countries.

The field of use may be limited to the development of anti-HIV therapeutics, anti-HIV topical microbicides and anti-breast cancer therapeutics.

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.

Date: May 22, 2007.

Steven M. Ferguson,

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