[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Notices]
[Pages 38850-38851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prospective Grant of Exclusive License: Mouse Monoclonal
Antibodies Specific for Normal Primate Tissue, Malignant Human Cultured
Cell Lines and Human Tumors
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
an exclusive world-wide license to practice the inventions embodied in
U.S. Patent 5,242,813, U.S. Patent Applications 08/051,133 and 08/
363,203 and corresponding foreign patent applications entitled ``Mouse
Monoclonal Antibodies Specific For Normal Primate Tissue, Malignant
Human Cultured Cell Lines and Human Tumors'' to Pharmacia, S.P.A. of
Milano, Itlay. 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 sixty
(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 present invention includes three murine monoclonal antibodies
(MAb), B1, B3 and B5. These antibodies react strongly with the Lewis Y
blood group antigen on many human solid tumors but weakly with normal
human tissues. MAb B3 reacts strongly with 10% of transitional cell
carcinomas of the bladder, 75% of adenocarcinomas of the colon, 70% of
adenocarcinomas of the lung, 65% with adenocarcinomas of the prostrate,
40% of squamous cell carcinomas of the lung and 25% of large cell
carcinomas. MAb B3 reacts heterogeneously with 70% of breast
carcinomas. Several important characteristics of this antibody make it
an ideal candidate for further development: (1) Its strong and uniform
reactivity with many human solid carcinomas; (2) its limited reactivity
with normal tissues; (3) its expression on both human and monkey
tissues will allow for predictive preclinical toxicology studies in
monkeys. Additionally, these antibodies, when incorporated as the
targeting element of an immunotoxin, have been shown to allow efficient
entry of toxin agents into cells. These antibodies should be useful in
the diagnosis and treatment of some forms of cancer.
ADDRESSES: Requests for copies of the patent applications, inquiries,
comments and other materials relating to the contemplated licenses
should be directed to: Raphe Kantor, Ph.D., Technology Licensing
Specialist, Office of Technology Transfer, National Institutes of
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804. Telephone: (301)
[[Page 38851]]
496-7735 ext. 247; Facsimile: (301) 402-0220. A signed Confidentiality
Agreement will be required to receive copies of the patent
applications. Applications for a license in the any field of use filed
in response to this notice will be treated as objections to the grant
to the contemplated licenses. Only written comments and/or applications
for a license which are received by NIH on or before September 26, 1995
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: July 17, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-18528 Filed 7-27-95; 8:45 am]
BILLING CODE 4140-01-M
