[Federal Register Volume 70, Number 133 (Wednesday, July 13, 2005)]
[Notices]
[Pages 40385-40386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Mesothelin, a 
Differentiation Antigen Present on Mesothelium, Mesotheliomas and 
Ovarian Cancers and Methods and Kits for Targeting

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

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 National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in U.S. 
Patent Application No. 60/010,166, filed January 5, 1996, entitled 
``Mesothelin, A Differentiation Antigen Present On Mesothelium, 
Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting'' 
[E-002-1996/0-US-01]; United States Patent No. 6,153,430, issued on 
November 28, 2000, entitled ``Nucleic Acid Encoding Mesothelin, A 
Differentiation Antigen Present On Mesothelium, Mesotheliomas And 
Ovarian Cancers'' [E-002-1996/0-US-02]; United States Patent 
Application No. 09/684,599, filed October 5, 2000, entitled 
``Mesothelin, A Differentiation Antigen Present On Mesothelium, 
Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting'' 
(E-002-1996/0-US-03); United States Patent No. 6,083,502, issued on 
July 4, 2000, entitled ``Mesothelium Antigen And Methods And Kits For 
Targeting It'' [E-002-1996/1-US-02]; PCT Application No. PCT/US97/
00224, filed January 3, 1997, entitled ``Mesothelium Antigen And 
Methods And Kits For Targeting It'' [E-002-1996/1-PCT-01]; Australian 
Patent No. 703769, filed January 3, 1997, entitled ``Mesothelium 
Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-AU-03]; 
Canadian Patent No. 2241604, filed January 3, 1997, entitled 
``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-
1996/1-CA-04]; Japanese Patent Application No. 9-525355, filed January 
3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For 
Targeting It'' [E-002-1996/1-JP-06]; European Patent No. 0871492, filed 
January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits 
For Targeting It'' [E-002-1996/1-EP-05]; Switzerland Patent Application 
No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And 
Methods And Kits For Targeting It'' [E-002-1996/1-CH-07]; German Patent 
No. 69726404.1, filed January 3, 1997, entitled ``Mesothelium Antigen 
And Methods And Kits For Targeting It'' (E-002-1996/1-DE-08); French 
Patent Application No. 0871492, filed January 3, 1997, entitled 
``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-
1996/1-FR-09]; Italian Patent No. 05503/BE/2004, January 3, 1997, 
entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' 
[E-002-1996/1--T-10]; Spanish Patent No. 0871492, filed January 3, 
1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting 
It'' [E-002-1996/1-ES-11]; United Kingdom Patent No.

[[Page 40386]]

0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And 
Methods And Kits For Targeting It'' [E-002-1996/1-GB-12]; United States 
Patent No. 5,320,956, issued June 14, 1996, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-US-20]; United States Patent No. 5,525,337, 
issued June 11, 1996, entitled ``Monoclonal Antibody Binding Cell 
Surface Antigen For Diagnosing Cancer'' [E-195-1990/0-US-21]; United 
States Patent No. 5,817,313, issued October 6, 1998, entitled 
``Monoclonal Antibodies And Conjugates Thereof Useful For The Treatment 
Of Cancer'' [E-195-1990/0-US-22]; PCT Patent Application No. PCT/US91/
07227, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-
1990/0-PCT-02]; Denmark Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-DK-03]; United Kingdom 
Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-GB-04]; Austrian Patent No. 0554356, filed 
October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-AT-05]; 
Belgium Patent No. 0554356, filed October 9, 1991, entitled 
``Monoclonal Antibody'' [E-195-1990/0-BE-06]; European Patent No. 
0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-
195-1990/0-EP-09]; French Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-FR-11]; German Patent 
No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' 
[E-195-1990/0-DE-08]; Greece Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-GR-12]; Netherlands 
Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-NL-15]; Italian Patent No. 0554356, filed 
October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-IT-13]; 
Luxembourg Patent No. 0554356, filed October 9, 1991, entitled 
``Monoclonal Antibody'' [E-195-1990/0-LU-14]; Spanish Patent No. 
0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-
195-1990/0-ES-10]; Sweden Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-SE-16]; Switzerland 
Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-CH-07]; Australian Patent No. 648363, filed 
October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-AU-17]; 
Canadian Patent No. 2093928, filed October 9, 1991, entitled 
``Monoclonal Antibody'' [E-195-1990/0-CA-18]; and Japanese Patent No. 
2660241, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-
195-1990/0-JP-19] to Morphotek, Inc., which has offices in Exton, 
Pennsylvania. The patent rights in these inventions have been assigned 
to the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the use of licensee's MORAb-009 
antibody for the treatment of mesothelin-expressing cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 12, 2005 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Jesse S. Kindra, J.D., M.S., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-5559; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The technology relates to CAK1, or 
``mesothelin'', which is an antigen present on the cell surface in 
mesothelium and on many mesotheliomas and ovarian cancers. While the 
role of this differentiation antigen has not yet been determined, it is 
postulated that it may be implicated in adhesion and in the 
dissemination of mesotheliomas and of ovarian cancers. CAK1, therefore, 
is a potential target for monoclonal antibodies to be used in the 
diagnosis and treatment of these cancers. The gene for CAK1 has been 
cloned and sequenced, as embodied in the current technology. This 
technology, therefore, should provide a valuable research tool for use 
in the development of diagnostics and/or therapeutic agents toward 
mesotheliomas and ovarian 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 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 establishes that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 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: July 1, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-13804 Filed 7-12-05; 8:45 am]
BILLING CODE 4140-01-P