[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30348-30349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14242]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Drug and Method for the
Therapeutic Treatment of Lymphomas and Leukemias
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
404.7(a)(1)(I) that the National Institutes of Health, Department of
Health and Human Services, is contemplating the grant of an exclusive
world-wide license to U.S. Patents and Patent Applications USPA SN: 60/
041,437, entitled: ``Recombinant Antibodies and Immunoconjugates
Targeted to CD-22 Bearing Cells and Tumors''; USPN 4,892,827, entitled,
``Recombinant Pseudomonas Exotoxin: Construction of an Active
Immunotoxin with Low Side Effects''--excluding any foreign equivalents
corresponding to 4,892,927 (= USSN 06/911,227); USPN 5,747,654,
entitled, ``Recombinant Disulfide-Stabilized Polypeptide Fragments
Having Binding Specificity''; USPA SN: 09/002,753, entitled:
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding
Specificity''; USPA SN: 07/865,722; entitled: ``Recombinant Antibody-
Toxin Fusion Protein''; USPN 5,863,745, entitled: ``Recombinant
Antibody-Toxin Fusion Protein''; USPN 5,696,237, entitled:
``Recombinant Antibody-Toxin Fusion Protein''; and USPA SN: 06/005,388,
entitled: ``Immunotoxin Containing a Disulfide-Stabilized Antibody
Fragment Joined to a Pseudomonas Exotoxin that does not Require
Proteolytic Activation'' and corresponding foreign patent applications
to AlbaPharm, Inc. having an address in Ann Arbor, Michigan. The United
States of America is an assignee of the patent rights in these
inventions and the contemplated exclusive license may be limited to the
use of RFB4 (dsFv)--PE38 [also known as BL22] immunotoxin and relevant
patents and patent applications for the therapeutic treatment of
Lymphomas and Leukemias which express the CD22 surface antigen.
DATES: Only written comments and/or applications for a license which
are received by NIH on or before August 6, 1999 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
comments and other materials relating to this contemplated exclusive
license should be directed to: J.R. Dixon, Ph.D., Technology Licensing
Specialist, Office of Technology Transfer, National Institutes of
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804. Telephone: (301) 496-7735 ext. 206; Facsimile: (301) 402-0220, E-
Mail: [email protected] A signed Confidentiality Agreement will be
required to receive copies of any patent applications.
SUPPLEMENTARY INFORMATION: The technology is directed to a RFB4 (dsFv)-
PE38 (also known as: BL22) immunotoxin and to methods and DNA sequences
to produce disulfide-stabilized (ds) recombinant polypeptide fragments
to construct the aforementioned immunotoxin. RFB4 is a disulfide-linked
recombinant immunotoxin fused to PE38, a mutant form of Pseudomonas
Exotoxin, that binds to CD22--a 135kDa phosphoglycoprotein adhesion
molecule present on the surface of B-cells. RFB4 is a mouse monoclonal
antibody that recognizes an external epitope on the CD22 cell surface
antigen and has no detectable cross-reactivity with any other normal
cell types. CD22 is a lineage-restricted B-cell antigen that belongs to
the Ig superfamily and is displayed on chronic B-Lymphocytic Leukemia
cells and B-cell Non-Hodgkins Lymphoma cells. To kill CD22-positive
cells, the RFB4 antibody was used to make a recombinant immunotoxin. To
construct the recombinant PE immunotoxin, the variable portions of the
heavy and light chains of RFB4 were cloned and the Fv fragments linked
together by a disulfide bond to form a disulfide stabilized (ds)
construct. The construct was combined by gene fusion with PE38, a
truncated version of PE, to form RFB4 (dsFv)-PE38, or BL22.
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
[[Page 30349]]
exclusive license may be granted unless within sixty (60) days from the
date of this published notice, NIH receives written evidence and
argument that establishes that the grant of the exclusive license would
not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR
404.7.
Applications for a license [i.e., completed ``Application for
License to Public Health Service Inventions''] in the field of use of
the RFB4 (dsFv)-PE38 immunotoxin and the relevant Patents and Patent
Applications for the therapeutic treatment of Lymphomas and Leukemias
which express the CD22 surface antigen filed in response to this notice
will be treated as objections to the grant of the contemplated
exclusive license. Comments and objections will not be made available
for public inspection and, to the extent permitted by law, will not be
subject to disclosure under the Freedom of Information Act, 5 U.S.C.
552.
Dated: May 26, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer.
[FR Doc. 99-14242 Filed 6-4-99; 8:45 am]
BILLING CODE 4140-01-M
