from Federal Register: April 11, 1996 (Volume 61, Number 71, Page 16103-16104
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of a Partial Exclusive License: Recombinant
Heregulin PE-40 Toxin Cancer Therapeutics Which Bind to the Ligand
Binding Site of the erbB3 and/or erbB4 Proteins

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

ACTION: Notice.

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SUMMARY: This is notice in accordance with 35 U.S.C. 203(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 partial exclusive license in the United States to practice the
invention embodied in U.S. Patent Application Number 06/911,227 (issued

[[Page 16104]]

on January 9, 1990 as U.S. Patent No. 4,892,827) entitled ``Recombinant
Pseudomonas Exotoxins: Construction of an Active Immunotoxin with Low
Side Effects'', to The Cooperative Research Centre for
Biopharmaceutical Research Pty., Ltd., having a place of business in
Darlinghurst Australia. 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 recombinant heregulin PE-40
toxin cancer therapeutics which bind to the ligand binding site of the
erbB3 and/or erbB4 proteins.
The present invention relates to modifications of recombinant
Pseudomonas exotoxin with insertion of various targeting molecules
specific for a given target site. The modified exotoxin of this
invention may prove to be a valuable cancer therapeutic when fused to
various target-specific cell recognition proteins. The modifications
result in reduced non-specific cytotoxicity while increasing target
specific cytotoxicity.

ADDRESSES: Requests for a copy of the subject issued patent, 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; Facsimile:
(301) 402-0220. 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. 96-9001 Filed 4-10-96; 8:45 am]
BILLING CODE 4140-01-M