01-7226. Prospective Grant of Exclusive License: The Use of Recombinant Cholera Toxin B Subunit to Treat Autoimmune and/or Inflammatory Diseases

AGENCY:

National Institutes of Health, Public Health Service, and HHS.

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 National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in PCT Patent Application, S/N PCT/US00/30837, entitled, “Methods of Treating Inflammatory Bowel Disease Using Cholera Toxin B Subunit” which was filed on November 9, 2000 and claims priority to U.S. Patent Application, S/N 60/165,111, entitled, “Methods of Treating Inflammatory Bowel Disease Using Cholera Toxin B Subunit,” which was filed on November 12, 1999, and corresponding foreign patent applications, to Active Biotech Research AB which is located in Lund, Sweden. 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 human therapeutics for the treatment of inflammatory bowel disease and/or other human autoimmune or inflammatory diseases.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before May 22, 2001 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: Richard U. Rodriguez, 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], X287; Facsimile: [phone]; and E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology claimed in the PCT application relates to methods for treating inflammatory and/or autoimmune diseases through the administration of recombinant cholera toxin B subunit (rCTB). This treatment appears to suppress the production of interferon-gamma and interleukin-12 thus causing apoptosis, or cell death, in a select pool of T-cells. The administration of rCTB may be particularly useful for the treatment of inflammatory bowel disease which would include, but not necessarily be limited to, Crohn's disease and ulcerative colitis.

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 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 16, 2001.

Jack Spiegel,

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