[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