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Notice

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

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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. Start Printed Page 403860871492, 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: kindraj@mail.nih.gov.

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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.

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Dated: July 1, 2005.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 05-13804 Filed 7-12-05; 8:45 am]

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