[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2858-2859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Patent License Agreement: 
Treatment of Inflammatory Bowel Disease (IBD), Including Ulcerative 
Colitis and Crohn's Disease

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of a Start-Up Exclusive 
Patent License Agreement to Paris Therapeutics, a company having a 
place of business in Santee, CA, to practice the inventions embodied in 
the following patent applications:

1. U.S. Provisional Patent Application. No. 61/488,671, filed 20 May 
2011 HHS Ref. No.: E-073-2011/0-US-01 Titled: Blockade of TL1A-DR3 
Interactions to Ameliorate T Cell Mediated Disease Pathology and 
Antibodies Thereof Inventors: Richard Siegel (NIAMS), Francoise 
Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
2. PCT Application No. PCT/US2012/028926, filed 13 March 2012 HHS 
Ref. No.: E-073-2011/1-PCT-02 Titled: Blockade of TL1A-DR3 
Interactions to Ameliorate T Cell Mediated Disease Pathology and 
Antibodies Thereof Inventors: Richard Siegel (NIAMS), Francoise 
Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
3. U.S. Patent Application No. 13/419,203, filed 13 March 2012 HHS 
Ref. No.: E-073-2011/1-US-01 Titled: Blockade of TL1A-DR3 
Interactions to Ameliorate T Cell Mediated Disease Pathology and 
Antibodies Thereof Inventors: Richard Siegel (NIAMS), Francoise 
Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
4. Australian Patent Application claiming priority to PCT/US2012/
028926, application number not available at this time, filed 26 
November 2013 HHS Ref. No.: E-073-2011/1-AU-03 Titled: Blockade of 
TL1A-DR3 Interactions to Ameliorate T Cell Mediated Disease 
Pathology and Antibodies Thereof Inventors: Richard Siegel (NIAMS), 
Francoise Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
5. Canadian Patent Application claiming priority to PCT/US2012/
028926, application number not available at this time, filed 19 
November 2013 HHS Ref. No.: E-073-2011/1-CA-04 Titled: Blockade of 
TL1A-DR3 Interactions to Ameliorate T Cell Mediated Disease 
Pathology and Antibodies Thereof Inventors: Richard Siegel (NIAMS), 
Francoise Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
6. European Patent Application No. 12790157.7, filed 14 November 
2013 HHS Ref. No.: E-073-2011/1-EP-05 Titled: Blockade of TL1A-DR3 
Interactions to Ameliorate T Cell Mediated Disease Pathology and 
Antibodies Thereof Inventors: Richard Siegel (NIAMS), Francoise 
Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
7. Japanese Patent Application claiming priority to PCT/US2012/
028926, application number not available at this time, filed 20 
November 2013 HHS Ref. No.: E-073-2011/1-JP-06 Titled: Blockade of 
TL1A-DR3 Interactions to Ameliorate T Cell Mediated Disease 
Pathology and Antibodies Thereof Inventors: Richard Siegel (NIAMS), 
Francoise Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
8. Korean Patent Application claiming priority to PCT/US2012/028926, 
application number not available at this time, filed 18 December 
2013 HHS Ref. No.: E-073-2011/1-KR-07 Titled: Blockade of TL1A-DR3 
Interactions to Ameliorate T Cell Mediated Disease Pathology and 
Antibodies Thereof Inventors: Richard Siegel (NIAMS), Francoise 
Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
9. Mexican Patent Application No. MX/a/2013/ 013329, filed 14 
November 2013 HHS Ref. No.: E-073-2011/1-MX-08 Titled: Blockade of 
TL1A-DR3 Interactions to Ameliorate T Cell Mediated Disease 
Pathology and Antibodies Thereof Inventors: Richard Siegel (NIAMS), 
Francoise Meylan (NIAMS), and Yun-Jeong Song (NIAMS)
10. U.S. Provisional Patent Application No. 60/879,668, filed 10 
January 2007, now expired, HHS Ref. No.: E-011-2007/0-US-01 Titled: 
Blockade of TL1A-DR3 Interactions to Ameliorate T Cell Mediated 
Disease Pathology Inventors: Richard Siegel (NIAMS) and Francoise 
Meylan (NIAMS)
11. U.S. Patent Application No. 11/972,395, filed 10 January 2008, 
now abandoned, HHS Ref. No.: E-011-2007/0-US-02 Titled: Blockade of 
TL1A-DR3 Interactions to Ameliorate T Cell Mediated Disease 
Pathology Inventors: Richard Siegel (NIAMS) and Francoise Meylan 
(NIAMS)

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The territory of the 
prospective Start-Up Exclusive Patent License Agreement may be 
worldwide, and the field of use may be limited to ``Antibodies against 
TL1A for the Treatment of Inflammatory Bowel Disease (IBD), including 
Ulcerative Colitis and Crohn's Disease.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
January 31, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application(s), inquiries, 
comments, and other materials relating to the contemplated Start-Up 
Exclusive Patent License Agreement should be directed to: Jaime M. 
Greene, M.S., Licensing and Patenting Manager, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5559; 
Facsimile: (301) 402-0220; Email: [email protected]. A signed 
confidentiality nondisclosure agreement will be required to receive 
copies of any patent applications that have not been published or 
issued by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This technology concerns anti-mouse TNF 
family ligand Tumor Necrosis Factor (ligand) Superfamily, Member 15 
(TL1A) and anti-human TL1A monoclonal antibodies and the hybridoma cell 
lines generating these antibodies, as well as methods of treating 
autoimmune inflammatory diseases by blocking the interaction between 
TL1A and Tumor Necrosis Factor Receptor superfamily, Member 25 (DR3). 
This technology may be useful for the development of diagnostics and 
therapeutics for autoimmune inflammatory disease.
    The prospective Start-Up Exclusive Patent License Agreement is 
being considered under the small business initiative launched on 
October 1, 2011 and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR part 404. The prospective Start-Up Exclusive 
Patent License Agreement may be granted unless the NIH receives written 
evidence and argument, within fifteen (15) days from the date of this 
published notice, that establishes that the grant of the contemplated 
Start-Up Exclusive Patent License Agreement would not be consistent 
with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Start-Up Exclusive Patent License 
Agreement. 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

[[Page 2859]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: January 9, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-00674 Filed 1-15-14; 8:45 am]
BILLING CODE 4140-01-P