[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13660-13661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Replicating Tumoricidal 
Viral Therapy for Cancer Applications

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This 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 a limited 
field of use exclusive license worldwide to practice the invention 
embodied in U.S. Patent Application Number 07/725,076 (issued on 
October 25, 1994 as U.S. Patent No. 5,358,866) entitled ``Cytosine 
Deaminase Negative Selection System for Gene Transfer Techniques and 
Therapies'' and its divisional applications 08/271,874, 08/447,580, 08/
447,393, 08/445,203, 08/447,487, 08/449,627, 08/448,867, 08/449,636, 
and all related foreign filings, to ONYX, Inc., having a place of 
business in Richmond, CA (USA). The patent rights in these inventions 
have been assigned to the United States of America.
    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. 
This notice modifies a previous notice of April 11, 1996 found in 
Volume 61, Number 71 of the Federal Register.
    The field of use would be limited to Replicating Tumoricidal Viral 
Therapy for Cancer applications.
    The present inventions relate to a modified bacterial gene for 
cytosine deaminase. Specifically, the CD gene can be used as a negative 
selectable

[[Page 13661]]

marker to transfect a targeted cell and deaminase a prodrug, 5-
flourocytosine (``5FC''), into 5-flourouricil (``5FU'') which has 
cytotoxic effects on the targeted cell.

ADDRESSES: Requests for copies of the subject issued patent and pending 
patent applications, inquiries, comments and other materials relating 
to the contemplated license should be directed to: Mr. Larry M. 
Tiffany, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852; Telephone: 
(301) 496-7056, ext. 206; Facsimile: (301) 402-0220. A signed 
Confidentiality Agreement will be required to receive copies of the 
pending patent applications. Applications for a license to the field of 
use described in this Notice will be treated as objections to the 
contemplated license. Only written comments and/or applications for a 
license which are received by the NIH Office of Technology Transfer on 
or before May 20, 1997 will be considered. Comments and objections will 
not be made available for public inspection and, to the extent 
permitted by law, will not be subject to disclosure under the Freedom 
of Information Act, 5 U.S.C. 552.

    Dated: March 11, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-7127 Filed 3-20-97; 8:45 am]
BILLING CODE 4140-01-M