[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 30022-30023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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[[Page 30023]]

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: [email protected]; Telephone: 
(301) 435-5606; Facsimile: (301) 402-0220.

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.
 [FR Doc. E7-10334 Filed 5-29-07; 8:45 am]
BILLING CODE 4140-01-P