[Federal Register Volume 71, Number 194 (Friday, October 6, 2006)]
[Notices]
[Pages 59125-59126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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 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);

[[Page 59126]]

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: (301) 435-2950; 
Facsimile: (301) 402-0220; E-mail: [email protected].

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-[alpha].
    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.
 [FR Doc. E6-16526 Filed 10-5-06; 8:45 am]
BILLING CODE 4140-01-P