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

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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 eg46t@nih.gov.

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.