Prospective Grant of Exclusive License: Drug and Method for the Therapeutic Treatment of Human Brain Tumors

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. Patents and Patent Applications USPA SN: 60/185,039, entitled: “Anti-EGFRvIII with Improved Cytotoxicity and Yield, Immunotoxins Based Thereon and Methods of Use Thereof”; USP SN: 4,892,827, entitled, “Recombinant Pseudomonas Exotoxin: Construction of an Active Immunotoxin with Low Side Effects”—excluding any foreign equivalents corresponding to 4,892,827 (= USSN 06/911,227 ); USP SN: 5,747,654, entitled, “Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity”; USPA SN: 09/002,753, entitled: “Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity”; USP SN: 6,051,435, entitled: “Recombinant Antibody-Toxin Fusion Protein”; USPN 5,863,745, entitled: Recombinant Antibody-Toxin Fusion Protein; USPN 5,696,237, entitled: “Recombinant Antibody-Toxin Fusion Protein” and corresponding foreign patent applications to IVAX Corporation having an address in Miami, Florida. The United States of America is an assignee of the patent rights in these inventions and the contemplated exclusive license may be limited to the use of TGF-Alpha-PE38 and MR-1-1(dsFv)-PE38KDEL [= Anti-EGFRvIII (dsFv)-PE38KDEL] based immunotoxins as an In vitro diagnostic and therapeutic modality for the treatment of human brain tumors.

DATES:

Only written comments and/or applications for a license which are received by NIH on or before November 6, 2000 will be considered.

ADDRESSES:

Requests for copies of the patent applications, inquiries, comments and other materials relating to this contemplated exclusive 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, E-Mail: DixonJ@OD.NIH.GOV. A signed Confidentiality Agreement will be required to receive copies of any patent applications.

SUPPLEMENTARY INFORMATION:

The technology is directed to the use of TGF-Alpha-PE38 and MR-1-1(dsFv)-PE38KDEL [= Anti-EGFRvIII(dsFv)-PE38KDEL] based immunotoxins as an in vitro diagnostic and therapeutic modality for the treatment of human brain tumors.

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 exclusive license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Applications for a license [i.e., completed “Application for License to Public Health Service Inventions”] in the field of use of TGF-Alpha-PE38 and MR-1-1(dsFv)-PE38KDEL [= Anti-EGFRvIII(dsFv)-PE38KDEL] based immunotoxins as an in vitro diagnostic and therapeutic modality for the treatment of human brain tumors filed in response to this notice will be treated as objections to the grant of the contemplated exclusive 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.