[Federal Register: August 26, 2004 (Volume 69, Number 165)]
[Notices]
[Page 52514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au04-61]
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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:
heftib@od.nih.gov.
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