03-31326. Prospective Grant of Exclusive License: Zenapax (Humanized Antibody Against the IL-2 Receptor Alpha Chain) as a Novel Treatment for Multiple Sclerosis

AGENCY:

National Institutes of Health, Public Health Services, 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 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. provisional patent application 60/393,021 (DHHS ref. no. E-143-2002/0-US-01) filed June 28, 2002, international PCT application PCT/US02/38290 (DHHS ref. no. E-143-2002/0-PCT-02), international PCT application PCT/US03/20428 (DHHS ref. no. E-143-2002/0-PCT-04), and United States Patent Application Serial No. 10/607,598 (DHHS ref. no. E-143-2002/0-US-03), all entitled, “Zenapax (Humanized Antibody Against the IL-2 Receptor Alpha Chain) As A Novel Treatment for Multiple Sclerosis,” and all corresponding foreign patent applications to Protein Design Laboratories, of Fremont, California. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide. The field of use may be limited to the treatment of multiple sclerosis using monoclonal antibodies against the interleukin-2 receptor.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before February 17, 2004 will be considered.

ADDRESSES:

Requests for copies of the patent(s)/patent application(s), inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Catherine M. Joyce, Intellectual Property Management Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile 301-402-0220; email [e-mail].

Technology Brief: The above-referenced patent(s)/patent application(s) relate to the discovery that a humanized antibody to the interleukin-2 receptor alpha chain (IL-2Rα) (humanized anti-Tac antibody), dacluzimab, is effective in treating multiple sclerosis (MS). In particular, it has been discovered that patients who failed to respond to therapy with interferon-beta showed dramatic improvement when treated with dacluzimab, with patients showing both a reduction in the total number of lesions and cessation of appearance of new lesions during the treatment period.

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: December 10, 2003.

Steven M. Ferguson,

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