03-3302. Prospective Grant of Exclusive License: Novel Vaccinia Virus Vector for the Treatment of Human Cancers

AGENCY:

National Institutes of Health, Public Health Services, HHS.

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 60/137,126 (DHHS ref. no. E-181-1999/0-US-01) filed May 28, 1999 and entitled, “Combined growth factor-deleted and thymidine kinase-deleted vaccinia virus,” international PCT application PCT/US00/14679 (DHHS ref. no. E-181-1999/0-PCT-02) and entitled, “Combined growth factor-deleted and thymidine kinase-deleted vaccinia virus,” and all corresponding foreign patent applications to JENNEREX Pharmaceuticals, of Mill Valley, California. 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 the development of an oncolytic vaccinia virus vector for the treatment of recurrent squamous cell carcinoma of the head and neck (“SCCHN”).

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before April 14, 2003, 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: [phone]; Facsimile: 301.402.0220; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The above-referenced patent(s)/patent application(s) relate to mutant vaccinia virus expression vectors. The vaccinia vector claimed in this application is useful in that it is substantially non-replicating in non-dividing cells. The new vaccinia virus is deleted of both the growth factor gene and the thymidine kinase gene, which provides for its selective replication properties, and may be useful as a vector for cancer gene therapy or vaccination.

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.

Dated: February 4, 2003.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.