01-7225. Prospective Grant of Co-Exclusive License: Treating Inflammatory Bowel Disease Using Antibodies Against Interleukin-Twelve (IL-12)

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), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a co-exclusive license to practice the inventions embodied in U.S. Patent 5,853,697 entitled, “Methods of Treating Established Colitis Using Antibodies Against IL-12,” which was filed on October 25, 1995 and issued on December 29, 1998, and corresponding foreign patent applications, to Centocor, Inc. which is located in Malvern, PA. The patent rights in these inventions have been assigned to the United States of America.

The prospective co-exclusive license territory will be worldwide and the field of use will be therapeutics for the treatment of inflammatory bowel disease, including but not necessarily limited to colitis and Crohn=s disease.

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 and/or patent applications, inquiries, comments and other materials relating to the contemplated co-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]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology claimed in the aforementioned patent and patent applications relates to methods of treating inflammatory bowel diseases through the administration of antibodies against IL-12. A method for evaluating the effectiveness of the IL-12 antibodies in reducing the inflammatory response is also claimed.

The prospective co-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 co-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. This notice serves to modify the previous intent to grant notice published in the Federal Register, 62 FR 13162, March 19, 1997.

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 co-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.