[Federal Register Volume 65, Number 79 (Monday, April 24, 2000)]
[Notices]
[Page 21779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10166]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Second Generation 
Monoclonal Antibodies, and Humanized Carcinomas

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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive license to practice the inventions embodied in U.S. Patent 
Applications S/N 07/073,685, filed on July 15, 1987, and S/N 07/547,336 
(FWC of 07/07,3,685), filed on July 20, 1990, both entitled ``Second 
Generation Monoclonal Antibodies Having Binding Specificity to TAG-72 
and Human Carcinomas and Methods for Employing the Same'' and now U.S. 
Patent 5,512,443 which issued on April 30, 1996; and U.S. Provisional 
Patent Applications S/N 60/106,534, filed on October 31, 1998, and S/N 
60/106,757, filed on November 2, 1998, both entitled ``Variants of 
Humanized Anti-Carcinoma MAb CC49'', and PCT Patent Application PCT/
US99/25552 (based upon S/N 60/106,534 and 60/106,757) filed on October 
29, 1999, entitled ``Variants of Humanized Anti-Carcinoma Monoclonal 
Antibody CC49'' to IDEC Pharmaceutical Corporation of San Diego, 
California. The patent rights in these inventions have been assigned to 
the United States of America.
    The prospective exclusive license territory will be worldwide and 
the field of use may be limited to anti-TAG-72 monoclonal antibodies, 
including fragments, components, constituents and/or humanized variants 
thereof, and excluding bispecific monoclonal antibodies, which are 
directly conjugated to a radioactive isotope, for use as human anti-
cancer therapeutics.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before June 23, 
2000 will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: Elaine F. Gese, M.B.A., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804. 
Telephone: (301) 496-7056, X282; Facsimile (301) 402-0220; E-mail 
[email protected].

SUPPLEMENTARY INFORMATION: U.S. Patent 5,512,443 claims various 
``second generation'' monoclonal antibodies, including CC49, which have 
binding specificity to Tumor Associated Glycoprotein (TAG-72). PCT 
Patent Application PCT/US99/25552 claims humanized variants of CC49, as 
well as methods of generating such variants.
    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, the NIH receives 
written evidence and argument that establish that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.
    Applications for a license filed in response to this notice for the 
noted field of use will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted in 
response 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: April 17, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-10166 Filed 4-21-00; 8:45 am]
BILLING CODE 4140-01-M