[Federal Register Volume 69, Number 165 (Thursday, August 26, 2004)]
[Notices]
[Pages 52515-52516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19536]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: [email protected]. 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-
2R[alpha]) (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.


[[Page 52516]]


    Dated: August 18, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-19536 Filed 8-25-04; 8:45 am]
BILLING CODE 4140-01-P