05-20242. Prospective Grant of Exclusive License: North-2'-Deoxy-Methanocarbathmydines as Antiviral Agents Against Poxvirus

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 (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications: HHS Ref. No. E-047-2005; U.S. Provisional Patent Application Number 60/684,811, filed on May 25, 2005 to N&N Scientific, having a place of business in Maryland but incorporated in Illinois. 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 December 6, 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: Robert M. Joynes, 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. The field of use may be limited to the treatment of poxviruses.

The subject invention relates to a method for the prevention or treatment of poxvirus infection by administering an effective amount of an antiviral agent comprising a carbocyclic 2'-deoxynucleoside analog (as described in U.S. Patent Nos. 5,629,454 and 5,869,666) to an individual in need thereof. North-methanocarbathymidine (N-MCT), a thymidine analog with a pseudosugar moiety locked in the northern conformation, which was previously shown to exert strong activity against herpes simplex virus types 1 and 2, has been identified as exhibiting potent activity against poxviruses. N-MCT effectively blocks poxvirus synthesis through its phosphorylated metabolite, which is more efficiently produced in poxvirus-infected cells. This compound is approximately seven times more potent than cidofovir against vaccinia and cowpox in cell culture. The higher potency and target specificity of N-MCT against poxvirus, as well as its high margin of safety, makes it a highly desirable agent against the poxviridae family. In addition, the mechanism of N-MCT may be different from that of cidofovir, making it even more desirable due to the scarcity of the potential available efficacious anti-pox agents currently under development.

The licensed territory will be exclusive worldwide.

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: September 27, 2005.

Steven M. Ferguson,

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