Prospective Grant of Exclusive License: Drug and Method for the Therapeutic Treatment of Head and Neck Cancer

AGENCY:

National Institutes of Health, Public Health Services, DHHS.

ACTION:

None.

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. provisional patent application 06/911,227 (DHHS ref. no. E-385-86/0) filed September 24, 1986 and issued on January 01, 1990 as USPSN 4,892,827 (no foreign rights available from DHHS) and entitled “Recombinant pseudomonas exotoxins: Construction of an active immunotoxin with low side effects,” U.S. patent application 07/341,361 (DHHS ref. no. E-135-89/0) filed April 21, 1989 and entitled “Recombinant antibody—Toxin fusion protein,” now abandoned in favor of USPASN 07/865,722, U.S. patent application 07/865,722 (DHHS ref. no. E-135-89/1), a file-wrapper-continuation of USPASN 07/341,361, filed April 08, 1992 and issued as USPSN 6,051,405 on April 18, 2000 and entitled, “Constructs encoding recombinant antibody-toxin fusion proteins,” U.S. patent application 08/461,825 (DHHS ref. no. E-135-89/2), a divisional of 07/865,722, filed June 05, 1995 and issued as USPSN 5,863,745 on January 26, 1999 and entitled, “Recombinant antibody—Toxin fusion protein, “ and U.S. patent application 08/463,163 (DHHS ref. no. E-135-89/3), a divisional of 07/865,722, filed June 05, 1995 and issued as USPSN 5,696,237 on December 09, 1997 and entitled, “Recombinant antibody—Toxin fusion protein,” to Viventia Biotech, Inc., of Toronto Canada. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide. The field of use may be limited to use of VB4-845-PE immunotoxin targeting the Ep-CAM antigen in head and neck cancer.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before November 25, 2002, will be considered.

ADDRESSES:

Requests for copies of the patent(s)/patent application(s), inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Jonathan V. Dixon, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301.496.7056, x270; Facsimile 301.402.0220; e-mail dixonj@od.nih.gov.

Technology Brief: The above-referenced patent(s)/patent application(s) relate to various immunotoxins, specifically to Pseudomonas exotoxin. The patent(s) relate to the synthesis of recombinant antibody-toxin fusion proteins, which are capable of effectively and selectively killing cells bearing appropriate antigens or receptors.

SUPPLEMENTARY INFORMATION:

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 in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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.