[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Notices]
[Page 28722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Limited Exclusive License: 
Radioimmunotherapy Utilizing Bismuth 213 and Monoclonal Antibodies 
Having Binding Specificity to Tag-72 and Human Carcinomas

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, 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 
Applications SN 08/299,999 and corresponding foreign patent 
applications entitled, ``Production Of A Single-Gene Encoded 
Immunoglobulin''; ``Second Generation Monoclonal Antibodies Having 
Binding Specificity To Tag-72 And Human Carcinomas'' (07/073,685, 07/
547,336, now U.S. Patent 5,512,443, issued 4/30/96)'', and U.S. Patent 
Application PHS Ref. No. D-001-96/0 ``Humanized Monoclonal Antibodies 
Specific to TAG-72; Methods For Their Manufacture and Usage in The 
Treatment Or Diagnosis of Cancer'' to Bio-Nucleonics, Inc. of Miami, 
Florida. The patent rights in these inventions have been assigned to 
the United States of America, except for PHS Ref. No. D-001-96/0 in 
which the patent rights in this invention has been assigned to the 
United States of America and Dow Chemical, Inc.
    The prospective exclusive license field of use may be limited to: 
The use of CC49 monoclonal antibodies only in conjunction with Bismuth-
213 for human radioimmunotherapy (RIT) and the use of CC49 monoclonal 
antibodies only in conjunction with Bismuth-213 as research reagents.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before July 28, 1997 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Joseph G. Contrera, M.S., J.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; Telephone: (301) 496-7056 ext. 244; Facsimile: 
(301) 402-0220. A signed Confidentiality Agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: 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 invention relates to a monoclonal anti-tumor antibody, 
designated CC49 which is a second generation monoclonal antibody of the 
B72.3 antibody. CC49 recognizes the tumor associated glycoprotein, TAG-
72. The TAG-72 antigen is expressed on at least 75% of colorectal 
cancers; 85% of ovarian, endometrial, gastric, and pancreatic cancers; 
60% of prostate cancers; and approximately 50% of breast and lung 
cancers. Of particular importance is the fact that B72.3, the first 
generation monoclonal antibody specific for TAG-72, was the first 
monoclonal antibody to be approved by the Food and Drug Administration 
(FDA) for in-vivo use.
    For working with B72.3, a second generation antibody, designated 
CC49 was developed which is highly specific for the same TAG-72 
antigen. The CC49 monoclonal antibody specific for TAG-72 glycoprotein 
is currently in preclinical studies, and shows superior results over 
B72.3. The CC49 monoclonal antibody and the gene which encodes for it, 
is the subject technology of this exclusive license application.
    Applications for a license in the field of use filed in response of 
this notice will be treated as objections to the grant of the 
contemplated licenses. Comments and objections submitted to this notice 
will not be made available for public inspection and, to the extent 
permitted by law, will not be released under the Freedom of Information 
Act, 5 U.S.C. 552.

    Dated: May 19, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-13833 Filed 5-23-97; 8:45 am]
BILLING CODE 4140-01-M