from Federal Register: April 11, 1996 (Volume 61, Number 71, Page 16104]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Gene Therapy for Cancer
and Restenosis Applications

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, is contemplating the grant of
a limited field of use exclusive license in the United States 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 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 U.S. Patent Serial No. 08/136,113 entitled ``Efficient
and Selective Adenoviral-Mediated Gene Transfer into Vascular
Neointima'' and its CIP filed via the PCT (No USSN has been assigned to
date) designating only the US for examination, and all related foreign
filings, to GenVec, Inc., having a place of business in Rockville, MD
(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.
The field of use would be limited to Gene Therapy for Cancer and
Restenosis applications.
The present inventions relate to a modified bacterial gene for
cytosine deaminase and a method of expressing DNA of choice in
neointimal cells to reduce their proliferation after vascular injury.
Specifically, the CD gene can be used as a negative selectable marker
to transfect a targeted cell and deaminate a prodrug, 5-flourocytosine
(``5FC''), into 5-flourouricil (``5FU'') which has cytotoxic effects on
the targeted cell. This gene is complementary to the other technology
contemplated in this notice by being able to be expressed in neointimal
cells through an adenoviral vector. Such expression and subsequent
administration of the prodrug results in the reduction in proliferation
of the neointimal cells, particularly after vascular injury.

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 June 10, 1996, 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 29, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-9002 Filed 4-10-96; 8:45 am]
BILLING CODE 4140-01-M