[Federal Register Volume 69, Number 34 (Friday, February 20, 2004)]
[Notices]
[Pages 7976-7977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3709]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: (301) 435-5560; Facsimile: (301) 402-0220; E-
mail: [email protected].

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

[[Page 7977]]

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.
[FR Doc. 04-3709 Filed 2-19-04; 8:45 am]
BILLING CODE 4140-01-P