04-3709. Prospective Grant of Exclusive License: Combined Growth Factor-Deleted and Thymidine Kinase-Deleted Vaccinia Virus Vector

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 part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services is contemplating the grant of an exclusive patent license to practice the inventions embodied in the PCT Patent Application No. PCT/US00/14679, filed May 26, 2000 [DHHS ref. E-181-1999/0-PCT-02], entitled “Combined Growth Factor-Deleted and Thymidine Kinase-Deleted Vaccinia Virus Vector,” and all related foreign patents/patent applications, to PNP Therapeutics, Inc., which is located in Birmingham, Alabama. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide and the field of use may be limited to human therapeutics for the treatment of cancer via use of vaccinia virus vector in combination with the company's proprietary technology. This notice should be considered a modification of an earlier Federal Register notice (68 FR 6930-6931; February 11, 2003).

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 20, 2004, will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: George G. Pipia, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

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 part 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 part 404.7.

The present technology describes the use of “Growth Factor-Deleted and Thymidine Kinase-Deleted Vaccinia Virus Vector” for cancer therapy. Tumor-selective, replicating viruses may infect and kill cancer cells and efficiently express therapeutic genes in cancer cells. The current invention embodies mutant vaccinia virus expression vectors. These vectors, which are vaccinia virus growth factor-deleted and thymidine-kinase deleted, are substantially incapable of replicating in non-dividing cells, while maintaining specificity for cancer cells. It is therefore believed that the vectors will be of value for cancer therapy either by directly killing cancer cells or by expressing therapeutic agents in cancer cells while sparing normal, non-dividing cells.

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 13, 2004.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.