[Federal Register Volume 65, Number 245 (Wednesday, December 20, 2000)]
[Notices]
[Page 79873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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.

    Dated: December 12, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-32365 Filed 12-19-00; 8:45 am]
BILLING CODE 4140-01-M