05-1413. Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Autoimmune Disease

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 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-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: [phone]; Facsimile: [phone]; E-mail: [e-mail].

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.