[Federal Register Volume 69, Number 11 (Friday, January 16, 2004)]
[Notices]
[Page 2607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1021]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Method of Treating Cancer 
in Humans Using IL-21

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This 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 
U.S. Patent Application 60/368,438 (re-filed), PCT Patent Application 
No. PCT/US03/09707, filed March 27, 2003 (DHHS ref. E-137-2002/0-PCT-
02), entitled ``Method of Treating Cancer in Humans,'' to Actis 
Biologics, Inc., which is located in Livermore, California. 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 IL-21 with the company's proprietary Viral Vector 
delivery system.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
March 16, 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 primary technology describes the use of 
IL-21 for cancer therapy and/or cancer prevention. When compared to 
similar cytokines, IL-21 has shown substantial anticancer activity and 
reduced toxicity in murine models.
    IL-21 belongs to the class I family of cytokines and is closely 
related to IL-2 and IL-15. Some cancer patients have shown significant 
response to administration of IL-2. However, IL-2 has also been 
associated with severe toxicity leading to a variety of undesirable 
side effects. This invention attempts to resolve the toxicity concerns 
and presents a new therapy for cancer prevention and treatment.
    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 establishes 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.
    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: January 12, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-1021 Filed 1-15-04; 8:45 am]
BILLING CODE 4140-01-P