Prospective Grant of Exclusive License: “Anti-Notch Antibodies and Pharmaceutical Compositions for the Therapeutic Treatment of Tumors Which Over Express Notch Protein”

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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 U.S. Patent Applications 60/124,119, entitled: “Anti-Notch-1 Monoclonal Antibodies for Inducing Cellular Differentiation and Apoptosis” and 60/102,816, entitled: “Apoptosis Inducing Agents and Methods” plus, if available, corresponding foreign patent applications to Viragen, Inc. having a place of business in Plantation, Florida. The patent rights in these inventions have been assigned to the United States of America.

DATES:

Only written comments and/or applications for a license which are received by NIH on or before July 31, 2000 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: J.R. Dixon, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804. Telephone: (301) 496-7735 ext. 206; Facsimile: (301) 402-0220. A signed Confidentiality Agreement will be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION:

The technology disclosed in USPA SN: 60/124,119 and 60/102,816 relates to a method, pharmaceutical composition, and antibodies to treat tumors by causing apoptosis in tumor cells that over express Notch protein.

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 field of use may be limited to the use of anti-Notch antibodies and pharmaceutical composition for the diagnosis and therapeutic treatment of tumors which over express Notch protein.

Applications for a license [i.e., completed “Application for License to Public Health Service Inventions] in the field of use of anti-Notch antibodies and pharmaceutical composition for the therapeutic treatment of tumors which over express Notch protein filed in response to this notice will be treated as objections to the grant of the contemplated license. 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.