[Federal Register Volume 69, Number 165 (Thursday, August 26, 2004)]
[Notices]
[Page 52514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: ``BL22, an Immunotoxin 
That Shows Efficacy in Clinical Trials in Treating Patients With 
Chemotherapy-Resistant Hairy Cell Leukemia, and HA22, a Newly 
Engineered Immunotoxin, Which Shows Improved Cytotoxic Activity Over 
BL22''

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 Food and Drug Administration and the 
Department of Health and Human Services is contemplating the grant of 
an exclusive license to practice the inventions embodied in: E-146-
1999/0, entitled Reduction of Nonspecific Animal Toxicity of 
Immunotoxin by Mutating Framework Regions of Fv To Lower Isoelectric 
Point, which includes: Pending U.S. Patent Application 10/416,129, 
based on PCT application PCT/US01/43602; E-216-2000/2, entitled 
Pegylation of Linkers Improves Antitumor Activity and Reduces Toxicity 
of Immunoconjugates, which includes: Pending U.S. Patent Application 
10/297,337, based on PCT application PCT/US01/18503; E-129-2001/0, 
entitled Mutated Anti-CD22 Antibodies With Increased Affinity to CD22 
Expressing Leukemia Cells, which includes: PCT application PCT/US02/
30316; and E-046-2004/0, entitled Mutated Anti-CD22 Antibodies and 
Immunoconjugates, which includes: U.S. Patent Application number 60/
525,371; to Genencor International, Inc., which is located in Palo 
Alto, 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 the to use of the BL22 and HA22 
immunoconjugates for the treatment of hematologic malignancies.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before October 25, 
2004 will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: Brenda J. Hefti, 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; and E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: This technology is a family of two 
immunoconjugates, each consisting of an anti-CD22 antibody coupled to a 
killing moiety, specifically pseudomonas exotoxin (PE38). The 
immunotoxins are both targeted towards CD22, and might be useful as 
therapeutics for the treatment of leukemias, lymphomas, and autoimmune 
diseases. The BL22 immunoconjugate has shown success in early clinical 
trials, and it is believed by the investigators that the HA22 
immunoconjugate will be superior to the BL22 because of its increased 
affinity for CD22.
    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.
    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: August 18, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 04-19537 Filed 8-25-04; 8:45 am]
BILLING CODE 4140-01-P