Prospective Grant of Exclusive License: Treatment of Retroviral Infections With a Phorbol Ester Derivative

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 (DHHS), is contemplating the grant of an exclusive license worldwide to practice the inventions embodies in patents under Supplementary Information to AIDS Research Alliance of America, having a place of business in West Hollywood, California. The Government of the United States of America is an assignee of the patent rights in these inventions.

DATE:

Only written comments and/or license applications which are received by the NIH Office of Technology Transfer on or before February 20, 2001 will be considered.

ADDRESSES:

Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the contemplated license should be directed to: Sally Hu, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; Telephone: (301) 496-7056, ext. 265; Facsimile: (301) 402-0220. A signed Confidential Disclosure Agreement (CDA) may be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

The patents and patent applications to be licensed are:

“Antiviral Composition”, U.S. Patent Application Serial No. 07/530,562 filed May 30, 1990;

“Antiviral Composition”, U.S. Patent Application Serial No. 08/424,558 filed April 17, 1995, issued as U.S. Patent No. 5,599,839 on February 4, 1997; and

Their foreign cognates including: Australian Patent No. 639343 issued November 12, 1993; Canadian Patent No. 2,083,945 issued February 7, 1995; European Patent No. 0531413 issued August 28, 1998 (designating Austria, Belgium, Switzerland, Germany, Denmark, Spain, France, Greece, Italy, Netherlands, Sweden, Luxembourg and the United Kingdom); and Japanese Patent No. 2020302 issued February 19, 1996.

The subject inventors have identified a method of treating viral infections comprising the 12-deoxyphorbol ester derivative known as prostratin. The patent specifically discusses an anti-viral composition and methods of treating patients with viral infections using such composition. The anti-viral composition of the present invention comprises prostratin and a pharmaceutically acceptable carrier. While purportedly having anti-viral activity, this composition reportedly does not have substantial tumor promoting activity and does not have other substantial toxicological properties that would preclude its use in treating viral infections.

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 a method of treating retroviral infections (e.g., HIV/AIDS) comprising the use of prostratin (a phorbol ester derivative).

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Since prostratin was originally isolated from flora primarily located in Western Samoa, the NIH is concerned that the collection and utilization of the natural material comport with all applicable Federal and Western Samoan policies related to biodiversity. In order to comport with such policies, the successful applicant will also be required to negotiate and enter into agreements with the appropriate Western Samoan Government agencies. 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 (FOIA), 5 U.S.C. 552.