[Federal Register Volume 69, Number 46 (Tuesday, March 9, 2004)]
[Notices]
[Pages 11030-11031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Immunoconjugate for the 
Treatment of Mesothelin-Expressing Cancers

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

ACTION: Notice.

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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 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-002-
1996/0: Nucleic Acid Encoding Mesothelin, a Differentiation Antigen 
Present on Mesothelium, Mesotheliomas and Ovarian Cancers (issued as 
U.S. patent 6,153,430); E-002-1996/1: Mesothelium Antigen and Methods 
and Kits for Targeting It (issued as U.S. patent 6,083,502); E-021-
1998/0: Antibodies, Including Fv Molecules, and Immunoconjugates Having 
High Binding Affinity for Mesothelin and Methods for Their Use (filed 
as PCT/US98/25270 on November 25, 1998); and E-216-2000/1 (PCT 
application PCT/US01/18503, combining 60/211,331 and 60/213,804): 
Pegylation of Linkers Improves Antitumor Activity and Reduces Toxicity 
of Immunoconjugates, to Enzon Pharmaceuticals, Inc., which is located 
in Needham, MA. 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 use of the SS1P immunoconjugate 
for the treatment of mesothelin-expressing cancers.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before May 10, 
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; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: This technology is an immunocongugate, 
consisting of an anti-mesothelin antibody coupled to a killing moiety, 
specifically pseudomonas exotoxin (PE38). This immunotoxin is targeted 
towards mesothelin, and might be useful as a therapeutic for the 
treatment of mesothelin-expressing cancers such as mesotheliomas, 
ovarian cancers and pancreatic cancers.
    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

[[Page 11031]]

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: March 2, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-5222 Filed 3-8-04; 8:45 am]
BILLING CODE 4140-01-P