[Federal Register Volume 63, Number 229 (Monday, November 30, 1998)]
[Notices]
[Page 65804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31732]


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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 Ovarian Cancer and Mesotheliomas

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. Patent Applications 08/776,271 entitled: 
``Mesothelium Antigen and Methods and Kits for Targeting it'' and 60/
067,175 entitled: ``Antibodies, Including Fv Molecules and 
Immunoconjugates having High Binding Affinity for Mesothelin and 
Methods for their Use'' and corresponding foreign patent applications 
to NeoPharm, Inc. having a place of business in Bannockburn, Illinois. 
The patent rights in these inventions have been assigned to the United 
States of America and the contemplated license may be limited to the 
use of the SS(dsFv)-PE38 immunotoxin and relevant patent applications 
for the therapeutic treatment of ovarian cancer and mesotheliomas.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before March 1, 1999, will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
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. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications.

SUPPLEMENTARY INFORMATION: The technology disclosed in USPA 08/776,271 
relates to the discovery of a differentiation antigen termed mesothelin 
which is associated with mesotheliomas and ovarian cancers. The 08/
776,271 technology includes uses for the amino acid and nucleic acid 
sequences for mesothelin, recombinantly expressed mesothelin antigen, 
methods for targeting and/or detecting the antigen and its expression 
level as an indication of the presence of tumor cells, and kits for 
such detection. In normal tissue, mesothelin is limited in its 
expression to mesothelial cells and basal cells of the trachea (low 
expression).
    The provisional 60/067,175 patent application is directed to anti-
mesothelin antibodies, including Fv molecules, with particularly high 
affinity for mesothelin, and immunoconjugates employing them. Also 
described in the provisional and application are diagnostic and 
therapeutic methods using the antibodies.

    Note: Mesothelin is a differentiation antigen present on the 
surface of ovarian cancers and mesotheliomas. Because in normal 
tissues, mesothelin is only present on mesothelial cells, it represents 
a good target for antibody mediated delivery of cytotoxic agents.

    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 ninety 
(90) days from the date of this published notice, NIH receives written 
evidence and argument that establishes that the grant of the license 
would be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 
404.7.
    The field of use may be limited to the use of the SS(dsFv)-PE38 
immunotoxin under the relevant patent applications for the therapeutic 
treatment of ovarian cancer and mesotheliomas.
    Applications for a license [i.e., completed ``Applications for 
License to Public Health Service Inventions] in the field of use of the 
SS(dsFv)-PE38 immunotoxin and the relevant Patent Applications for the 
therapeutic treatment of ovarian cancer and mesotheliomas filed in 
response to this notice will be treated as objections to the grant of 
the contemplated licenses. 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: November 16, 1998.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 98-31732 Filed 11-27-98; 8:45 am]
BILLING CODE 4140-01-M