Prospective Grant of Exclusive License: “Transcription Factor Decoy and Tumor Growth Inhibitor”

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 world-wide license to U.S. Patent Applications 08/977,643, entitled: “Transcription Factor Decoy and Tumor Growth Inhibitor” plus, if available, corresponding foreign patent applications, to Genta Incorporated having a place of business in Lexington, MA. The patent rights in these inventions have been assigned to the United States of America and the contemplated license may be limited for use in the development and commercialization of diagnostic and therapeutic modalities to treat various diseases and inhibit tumor growth based on the use of cAMP Response Element-palindrome Oligonucleotide as a transcription factor decoy to regulate gene expression (i.e., gene transcription and translation).

DATES:

Only written comments and/or applications for a license which are received by NIH on or before September 26, 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 application.

SUPPLEMENTARY INFORMATION:

The technology disclosed in USPA SN: 08/977,643 patent application provides compositions and methods for the use of cAMP Response Element-palindrome oligonucleotide as a transcription factor decoy and an inhibitor of tumor growth. Specifically, the 08/977,643 application provides nucleic acid molecules that compete with cAMP Response Elements (“CRE”) for binding to transcription factors and a method for regulating gene transcription in target cells comprising: Providing one or more cAMP response element enhancer DNAs and one or more transcription factors that associate with the cAMP response element enhancer DNA; and exposing the target cells to the cAMP response element decoys under condition such that the cAMP response element decoys will compete with the cAMP response element enhancer DNA for binding to the one or more transcription factors.

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 development and commercialization of diagnostic and therapeutics modalities to treat various diseases and inhibit tumor growth based on the use of cAMP Response Element-palindrome Oligonucleotide as a transcription factor decoy to regulate gene expression (i.e., gene transcription and translation).

Applications for a license [i.e., completed “Application for License to Public Health Service Inventions”] in the field of use in the development and commercialization of diagnostic and therapeutics modalities to treat various diseases and inhibit tumor growth based on the use of cAMP Response Element-palindrome Oligonucleotide as a transcription factor decoy to regulate gene expression (i.e., gene transcription and translation) 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.