01-8088. Prospective Grant of Exclusive License: Identification of TRP-2 as a New Human Tumor Antigen Recognized by Cytotoxic T Lymphocytes

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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 license to practice the inventions embodied in U.S. Patent Applications S/N 08/725,736, filed on October 4, 1996, and now U.S. Patent 5,831,016 which issued on November 3, 1998; S/N 09/161,877 (DIV of 08/725,736), filed on September 28, 1998, and now U.S. Patent 6,132,980 which issued on October 17, 2000; S/N 09/162,368 (DIV of 08/725,736), filed on September 28, 1998, and now U.S. Patent 6,083,703 which issued on July 4, 2000; and S/N 09/651,210 (DIV of 08/725,736), filed on August 30, 2000, all entitled “Identification of TRP-2 as a New Human Tumor Antigen Recognized by Cytotoxic T Lymphocytes'; and PCT Patent Application PCT/US97/02186 (based upon U.S. Patent Applications S/N 08/599,602 and 08/725,736) filed on February 6, 1997, entitled “Human Cancer Antigen of Tyrosinase-Related Protein 1 and 2 and Genes Encoding Same”, to ImClone Systems Incorporated of New York, New York. 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 protein vaccines consisting of the full-length TRP-2 protein or the lumenal portion thereof. Fragments or peptides of TRP-2 can be used together with gp75 and/or Tyrosinase or fragments or peptides thereof for use as human anti-melanoma therapeutics but only when used in multimeric form, that is when multiple different epitopes are expressed contiguously in the said vaccine. Specifically excluded from the field of use are TRP-2 fragments or peptides (other than the afore-mentioned lumenal portion) used in a monomeric form, to be used either alone or in combination with other peptides, proteins, or other recombinant vector, DNA or RNA vaccines or vaccination protocols. Also excluded are the use of nucleic acid sequences encoding the TRP-2 antigen in any form including those used in any viral, bacterial, DNA and RNA vaccine or vaccination protocol.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before June 4, 2001 will be considered.

ADDRESSES:

Requests for copies of the patent/patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Elaine White, M.B.A., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD. 20852-3804. Telephone: [phone], X282; Facsimile [phone]; E-mail [e-mail].

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 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 23, 2001.

Jack Spiegel,

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