E6-16526. Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Autoimmune Diseases Including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD) and Psoriasis

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 Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in United States Patent Application Number 60/181,909 entitled “Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function” filed February 11, 2000 (HHS Ref. No. E-095-2000/0-US-01); U.S. Patent Application No. PCT/US01/04125 entitled “Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function” filed February 9, 2001, 2000 (HHS Ref. No. E-095-2000/0-PCT-02); U.S. Patent Application No. 10/203,495, filed August 9, 2002, entitled “Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function” (E-095-2000/0-US-03); U.S. Patent Application No. 60/694,015 entitled “Amelioration of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors” filed June 24, 2005 [E-095-2000/2-US-01]; U.S. Patent Application No. 60/717,589 entitled “Amelioration of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors” filed September 16, 2005 [E-095-2000/3-US-01]; U.S. PCT Application entitled “A Potential Novel Therapeutic Protein Molecule of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptor Type 1” filed February 9, 2001 [E-095-2000/4-PCT-01]; European Patent Application No. 01910476.9 entitled “Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function” filed February 9, 2001 [E-095-2000/0-EP-06]; Australian Patent Application No. 2001238076 entitled “Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function” issued on February 9, 2001 [E-095-2000/0-AU-04]; and Canadian Patent Application No. 2399388 entitled “Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function” filed February 9, 2001, [E-095-2000/0-CA-05] to Domantis, Inc.

The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for autoimmune diseases including rheumatoid arthritis (RA) inflammatory bowel disease (IBD) and psoriasis as covered under the agreement and based upon the Patent Rights.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before December 5, 2006 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., M.A., 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 invention relates to methods and compositions that are useful for novel treatment of arthritis and other autoimmune diseases. This technology discloses the identification of a functional domain, Pre-ligand Assembly Domain (PLAD), an essential part in signaling involving receptors of the Tumor Necrosis Factor superfamily and its use in ameliorating rheumatoid arthritis (RA). PLAD is essential for signaling involving TFNR including TNFR-1 (p60), TNFR-2 (p80), Fas, TRAIL-R, LTR, CD40, CD30, CD27, HVEM, OX40 and DR4 and can be isolated as functional polypeptides which can be useful in inhibiting the first step in TNFR mediated signaling, ligand-independent assembly of members of the TNFR superfamily. The ability to inhibit TNFR signaling suggests that these PLAD polypeptides may be useful in development of new therapeutic molecules or as therapeutic molecules themselves used for modulation of immune responses, apoptosis, and inflammation. The inventors have discovered compounds that interfere with PLAD and can block the effects of TNF-α.

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: September 28, 2006.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.