[Federal Register Volume 73, Number 44 (Wednesday, March 5, 2008)]
[Notices]
[Pages 11935-11936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Human 
Therapeutics for the Treatment of Cancer

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

ACTION: Notice.

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[[Page 11936]]

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 U.S. 
Patent 5,167,956 entitled ``Immunotoxin with in-vivo T-Cell suppressant 
activity and Methods of Use'' [HHS Ref. E-012-1991/0-US-01], U.S. 
Patent Application 60/037,196 entitled ``Novel Vectors and Expression 
Methods for Producing Mutant Proteins'' [HHS Ref. E-043-1997/0-US-01], 
U.S. Patent Application 60/039,987 entitled ``Novel Immunotoxins and 
Methods of Inducing Immune Tolerance'' [HHS Ref. E-044-1997/0-US-01], 
U.S. Patent Application 09/064,413 entitled ``Use of Immunotoxins to 
Induce Immune Tolerance to Pancreatic Islet Transplantation'' [HHS Ref. 
E-059-1998/0-US-01], U.S. Patent Application 09/291,712 entitled 
``Methods Related to the Combined Use of Immunotoxins and Agents that 
Inhibit Dendritic Cell Maturation'' [HHS Ref. E-168-1999/0-US-01], and 
all continuing applications and foreign counterparts, to CK Life 
Sciences International, Inc., which has offices in Hong Kong. The 
patent rights in these inventions have been assigned to and/or 
exclusively licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to: The production and use of the 
immunotoxins covered by the licensed patent rights for the treatment of 
T-cell mediated diseases, including but not limited to T-cell lymphoma 
and autoimmune diseases.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before May 
5, 2008 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: David A. Lambertson, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The invention concerns immunotoxins and 
methods of using the immunotoxins for the treatment of autoimmune 
diseases and T cell malignancies. A specific immunotoxin covered by 
this technology is A-dmDT390-bisFV (UCHT1). The immunotoxins are 
targeted via an antibody that is specific to T cells, allowing the 
specific ablation of both malignant T cells and resting T cells. The 
transient ablation of resting T cells can ``reset'' the immune system 
by accentuating tolerating responses to autoimmune diseases like Lupus. 
Additionally, the immunotoxins can be used to treat T cell related 
cancers such as non-Hodgkins' lymphomas, including cutaneous T cell 
lymphoma (CTCL).
    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 establishes 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 27, 2008.
Bonny Harbinger,
Deputy Director, Office of Technology Transfer, National Institutes of 
Health.
 [FR Doc. E8-4198 Filed 3-4-08; 8:45 am]
BILLING CODE 4140-01-P