[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3723-3724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Therapeutics for the 
Treatment of Autoimmune Disease

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
404.7(a)(1)(i), announces 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. Patent 
No. 6,083,503, entitled ``Interleukin-2 stimulated T lymphocyte cell 
death for the treatment of autoimmune diseases, allergic responses, and 
graft rejection'' (DHHS Reference E-137-1991/0-US-03); U.S. Patent No. 
5,989,546 entitled ``Interleukin-2 stimulated T lymphocyte cell death 
for the treatment of allergic responses'' (DHHS Reference E-137-1991/0-
US-04); U.S. Patent No. 5,935,575, entitled ``Interleukin-4 stimulated 
T lymphocyte cell death for the treatment of allergic disorders'' (DHHS 
Reference E-151-1992/0-US-11); U.S. Patent Application No. 08/431,644 
filed May 2, 1995 entitled ``Modified Myelin Basic Protein Molecules'' 
(DHHS Reference E-033-1996/0-US-01); and U.S. Patent Application No. 
08/482,114 filed June 7, 1995 entitled ``Modified Proteolipid Protein 
Molecules'' (DHHS Reference E-

[[Page 3724]]

128-1996/1-US-01); to Apogenix Biotechnology AG, having a place of 
business in Heidelberg, Germany. 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 therapeutics for the treatment of 
Multiple Sclerosis.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before March 28, 
2005, will be considered.

ADDRESSES: Requests for copies of the patent and/or patent 
applications, inquiries, comments and other materials relating to the 
contemplated exclusive license should be directed to: Mojdeh Bahar, 
J.D., Technology Licensing Specialist, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-2950; Facsimile: (301) 
402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: The technology claimed in the aforementioned 
patents is a method for the treatment or prevention of autoimmune 
diseases, allergic or atopic disorders, and graft rejections. The 
instant method comprises inducing the death by apoptosis of a 
subpopulation of T lymphocytes that is capable of causing such 
diseases, while leaving the majority of other T lymphocytes unaffected. 
Cell death is achieved by cycles comprising challenging via 
immunization these T cells with antigenic substance at short time 
intervals, or by immunization followed by administering interleukin-2 
(IL-2) when these T cells are expressing high levels of IL-2 receptor 
so as to cause these T cells to undergo apoptosis upon re-immunization 
with the antigenic peptide or protein.
    The technologies in the aforementioned patent applications are 
directed to compositions and methods for clinical assessment, diagnosis 
and treatment of Multiple Sclerosis (MS). The compositions are 
molecules related to the human proteolipid protein (PLP), and the 21.5 
kDA fetal isoform of human myelin basic protein (MBP), and include 
nucleic acids and polypeptides. The nucleic acids are useful in the 
efficient production of modified PLP polypeptides and modified and 
unmodified MBP polypeptides and the polypeptides are useful for 
assaying T cells for responsiveness to MBP and PLP epitopes. They are 
further useful as therapeutic agents that act by inducing T cell 
responses, including apoptosis, as a means of treating MS.
    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: January 19, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-1413 Filed 1-25-05; 8:45 am]
BILLING CODE 4140-01-P