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Notice

Prospective Grant of Exclusive License: “Modulating IL-13 Activity Using Mutated IL-13 Molecules That Are Antagonists or Agonists of IL-13”, PCT Application PCT/US00/31044

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health and Food and Drug Administration, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 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 PCT application PCT/US00/31044, entitled “Modulating IL-13 Activity Using Mutated IL-13 Molecules that are Antagonists or Agonists of IL-13”, which was filed on November 10, 2000, to Lee's Pharmaceutical Holdings, Limited, which is incorporated in Hong Kong. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be China, Taiwan and Hong Kong and the field of use may be limited to therapy for asthma and other immunological disorders.

DATES:

Only written comments and/or license applications that are received by the National Institutes of Health on or before September 15, 2003 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; and E-mail: heftib@mail.nih.gov.

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SUPPLEMENTARY INFORMATION:

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 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.

The technology claimed in the issued patent relates to mutated forms of IL-13, either agonists or antagonists, which have higher binding affinity for the IL-13 receptor than does wild-type IL-13. The application also claims therapeutic uses of these mutated forms of IL-13, and their use as targeting moieties.

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 8, 2003.

Steven M. Ferguson,

Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer.

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[FR Doc. 03-17865 Filed 7-14-03; 8:45 am]

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