[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Pages 26413-26414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8889]


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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 Rheumatoid Arthritis (RA)

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. Sec.  209(c)(1) and 
37 CFR Part 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 PCT Application No. PCT/US01/04125, 
filed February 9, 2001, entitled ``Identification of a Novel Domain in 
the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand 
Receptor Assembly and Function'' [E-095-2000/0-PCT-02]; U.S. Patent No. 
7,148,061, issued December 12, 2006, 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. 11/637,272, filed December 12, 2006, 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-08]; PCT Application No. PCT/US06/24909, filed June 26, 
2006, entitled ``A Potential Novel Therapeutic Protein Molecule of 
Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) 
of Tumor Necrosis Factor Receptor Type 1'' [E-095-2000/4-PCT-01]; 
European Patent Application No. 01910476.9, filed February 9, 2001, 
entitled ``Identification of Novel Domain in the Tumor Necrosis Factor 
Receptor Family that Mediates Pre-ligand Receptor Assembly and 
Function'' [E-095-2000/0-EP-06]; Australian Patent Application No. 
2001238076, filed on February 9, 2001, entitled ``Identification of 
Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates 
Pre-

[[Page 26414]]

ligand Receptor Assembly and Function'' [E-095-2000/0-AU-04]; 
Australian Patent Application No. 2006203490, filed on August 11, 2006, 
entitled ``Identification of Novel Domain in the Tumor Necrosis Factor 
Receptor Family that Mediates Pre-ligand Receptor Assembly and 
Function'' [E-095-2000/0-AU-07]; and Canadian Patent Application No. 
2399388, filed February 9, 2001, entitled ``Identification of Novel 
Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-
ligand Receptor Assembly and Function'' [E-095-2000/0-CA-05] to Welson 
Pharmaceuticals, Inc.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to therapeutic applications for 
rheumatoid arthritis (RA) using Welson's proprietary platform.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before July 9, 2007 
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: <a href="/cdn-cgi/l/email-protection#fb999a939a8996bb949fd5959293d59c948d"><span class="__cf_email__" data-cfemail="1577747d746778557a713b7b7c7d3b727a63">[email protected]</span></a>.

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 part 
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 part 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: April 30, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer,Office of 
Technology Transfer,National Institutes of Health.
 [FR Doc. E7-8889 Filed 5-8-07; 8:45 am]
BILLING CODE 4140-01-P


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