Prospective Grant of Start-Up Exclusive Patent License Agreement: Treatment of Inflammatory Bowel Disease (IBD), Including Ulcerative Colitis and Crohn's Disease, 2858-2859 [2014-00674]
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Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Notices
Dated: January 10, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–00672 Filed 1–15–14; 8:45 am]
BILLING CODE 4140–01–P
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.
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:
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
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 YunJeong 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 YunJeong Song (NIAMS)
5. Canadian Patent Application claiming
priority to PCT/US2012/028926,
application number not available at this
VerDate Mar<15>2010
14:55 Jan 15, 2014
Jkt 232001
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 YunJeong 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 YunJeong 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 YunJeong 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.’’
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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:
greenejaime@mail.nih.gov. 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
DATES:
E:\FR\FM\16JAN1.SGM
16JAN1
Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Notices
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
DEPARTMENT OF THE INTERIOR
Bureau of Safety and Environmental
Enforcement (BSEE)
[Docket ID BSEE–2013–0013; OMB Control
Number 1014–0011; 134E1700D2
EEEE500000 ET1SF0000.DAQ000]
Information Collection Activities:
Platforms and Structures; Proposed
Collection; Comment Request
ACTION:
60-day notice.
To comply with the
Paperwork Reduction Act of 1995
(PRA), BSEE is inviting comments on a
collection of information that we will
submit to the Office of Management and
Budget (OMB) for review and approval.
The information collection request (ICR)
concerns a renewal to the paperwork
requirements in the regulations under
Subpart I, Platforms and Structures.
DATES: You must submit comments by
March 17, 2014.
ADDRESSES: You may submit comments
by either of the following methods listed
below:
• Electronically: go to https://
www.regulations.gov. In the entry titled
Enter Keyword or ID, enter BSEE–2013–
0013 then click search. Follow the
instructions to submit public comments
and view all related materials. We will
post all comments.
• Email nicole.mason@bsee.gov. Mail
or hand-carry comments to the
Department of the Interior; Bureau of
Safety and Environmental Enforcement;
Regulations and Standards Branch;
ATTN: Nicole Mason; 381 Elden Street,
HE3313; Herndon, Virginia 20170–4817.
Please reference ICR 1014–0011 in your
comment and include your name and
return address.
FOR FURTHER INFORMATION CONTACT:
Nicole Mason, Regulations and
Standards Branch at (703) 787–1605 to
request additional information about
this ICR.
SUPPLEMENTARY INFORMATION:
Title: 30 CFR part 250, Subpart I,
Platforms and Structures.
OMB Control Number: 1014–0011.
Abstract: The Outer Continental Shelf
(OCS) Lands Act, as amended (43 U.S.C.
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:55 Jan 15, 2014
Jkt 232001
1331 et seq. and 43 U.S.C. 1801 et seq.),
authorizes the Secretary of the Interior
to prescribe rules and regulations
necessary for the administration of the
leasing provisions of the Act related to
the mineral resources on the OCS. Such
rules and regulations will apply to all
operations conducted under a lease,
right-of-way, or a right-of-use and
easement. Operations on the OCS must
preserve, protect, and develop oil and
natural gas resources in a manner that
is consistent with the need to make such
resources available to meet the Nation’s
energy needs as rapidly as possible; to
balance orderly energy resource
development with protection of human,
marine, and coastal environments; to
ensure the public a fair and equitable
return on the resources of the OCS; and
to preserve and maintain free enterprise
competition.
In addition to the general rulemaking
authority of the OCSLA at 43 U.S.C.
1334, section 301(a) of the Federal Oil
and Gas Royalty Management Act
(FOGRMA), 30 U.S.C. 1751(a), grants
authority to the Secretary to prescribe
such rules and regulations as are
reasonably necessary to carry out
FOGRMA’s provisions. While the
majority of FOGRMA is directed to
royalty collection and enforcement,
some provisions apply to offshore
operations. For example, section 108 of
FOGRMA, 30 U.S.C. 1718, grants the
Secretary broad authority to inspect
lease sites for the purpose of
determining whether there is
compliance with the mineral leasing
laws. Section 109(c)(2) and (d)(1), 30
U.S.C. 1719(c)(2) and (d)(1), impose
substantial civil penalties for failure to
permit lawful inspections and for
knowing or willful preparation or
submission of false, inaccurate, or
misleading reports, records, or other
information. Because the Secretary has
delegated some of the authority under
FOGRMA to BSEE, 30 U.S.C. 1751 is
included as additional authority for
these requirements.
The Independent Offices
Appropriations Act (31 U.S.C. 9701), the
Omnibus Appropriations Bill (Pub. L.
104–133, 110 Stat. 1321, April 26,
1996), and OMB Circular A–25,
authorize Federal agencies to recover
the full cost of services that confer
special benefits. Under the Department
of the Interior’s implementing policy,
BSEE is required to charge the full cost
for services that provide special benefits
or privileges to an identifiable nonFederal recipient above and beyond
those that accrue to the public at large.
Several requests for approval required
in Subpart I are subject to cost recovery,
PO 00000
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2859
and BSEE regulations specify service
fees for these requests.
Regulations implementing these
responsibilities are among those
delegated to BSEE to ensure that
operations in the OCS will meet
statutory requirements; provide for
safety and protection of the
environment; and result in diligent
exploration, development, and
production of OCS leases. This ICR
addresses the regulations at 30 CFR part
250, Subpart I, and the associated
supplementary notices to lessees and
operators (NTLs) intended to provide
clarification, description, or explanation
of these regulations.
We use the information to determine
the structural integrity of all OCS
platforms and floating production
facilities and to ensure that such
integrity will be maintained throughout
the useful life of these structures. We
use the information to ascertain, on a
case-by-case basis, that the fixed and
floating platforms and structures are
structurally sound and safe for their
intended use to ensure safety of
personnel and prevent pollution. More
specifically, we use the information to:
• Review data concerning damage to
a platform to assess the adequacy of
proposed repairs.
• Review applications for platform
construction (construction is divided
into three phases—design, fabrication,
and installation) to ensure the structural
integrity of the platform.
• Review verification plans and thirdparty reports for unique platforms to
ensure that all nonstandard situations
are given proper consideration during
the platform design, fabrication, and
installation.
• Review platform design, fabrication,
and installation records to ensure that
the platform is constructed according to
approved applications.
• Review inspection reports to ensure
that platform integrity is maintained for
the life of the platform.
We protect proprietary information
according to the Freedom of Information
Act (5 U.S.C. 552) and its implementing
regulations (43 CFR 2), and under
regulations at 30 CFR 250.197 and 30
CFR 252, which addresses disclosure of
data and information to be made
available to the public. No items of a
sensitive nature are collected.
Responses are mandatory or are
required to obtain a benefit.
Frequency: On occasion, weekly,
monthly, semi-annually, annually, and
as a result of situations encountered
depending upon the requirements.
Description of Respondents: Potential
respondents comprise Federal oil, gas,
or sulphur lessees and/or operators.
E:\FR\FM\16JAN1.SGM
16JAN1
]]>Agencies
[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2858-2859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00674]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: greenejaime@mail.nih.gov. 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
