[Federal Register: January 16, 2004 (Volume 69, Number 11)]
[Notices]
[Page 2607]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja04-81]
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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: pipiag@mail.nih.gov.
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