Prospective Grant of Co-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 a co-exclusive license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/393,021, filed June 28, 2002, “Method of Treating Autoimmune Diseases with Interferon-Beta and IL-2R Antagonist” (DHHS ref. no. E-143-2002/0-US-01), International Patent Application No. PCT/US2002/038290, filed November 27, 2002, International Publication No. WO 2004/002500 A1, published January 8, 2004, “Method of Treating Autoimmune Diseases with Interferon-Beta and IL-2R Antagonist” (DHHS ref. no. E-143-2002/0-PCT-02), International Application No. PCT/US2003/020428, filed June 27, 2003, International Publication No. WO 2004/002421 A2, published January 8, 2004, “Method For the Treatment of Multiple Sclerosis” (DHHS ref. no. E-143-2002/0-PCT-04), and U.S. Patent Application No. 10/607,598, filed June 27, 2003, Publication No. US 2004/0109859 A1, published June 10, 2004, “Method For the Treatment of Multiple Sclerosis” (DHHS ref. no. E-143-2002/0-US-03), and all corresponding foreign patent applications to Serono S.A., of Geneva, Switzerland. The patent rights in these inventions have been assigned to the United States of America. This notice is a modification of a notice published in the Federal Register in 68 FR 70826-70827, Dec. 19, 2003.

The prospective co-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. Two co-exclusive licenses may be granted.

DATES:

Only license applications which are received by the National Institutes of Health on or before October 25, 2004 will be considered.

ADDRESSES:

Requests for information, inquiries, comments, and other materials relating to the contemplated co-exclusive license should be directed to: Thomas P. Clouse, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-4076; Facsimile: 301-402-0220; E-mail: clouset@mail.nih.gov. Copies of the international publications can be obtained from http://ep.espacenet.com. Copies of the U.S. publication can be obtained from http://www.uspto.gov.

SUPPLEMENTARY INFORMATION:

The above-identified patent applications relate to the discovery that administration of an interleukin-2 receptor antagonist to a patient is effective in the treatment of autoimmune disorders. Examples in the patent applications show that a humanized antibody to the interleukin-2 receptor alpha chain (IL-2Rα) (humanized anti-Tac antibody), daclizumab, is effective in treating MS. In particular, it has been discovered that patients who failed to respond to therapy with interferon-beta showed dramatic improvement when treated with daclizumab, with patients showing both a reduction in the total number of lesions and cessation of appearance of new lesions during the treatment period. Pending claims in the above-referenced patent applications are directed to methods of treating a patient with multiple sclerosis (MS) by administering a therapeutically effective amount of an IL-2 receptor antagonist. IL-2 receptor antagonists can be antibodies, peptides, chemical compounds, and small molecules.

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 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 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 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.