Prospective Grant of an Exclusive Patent License: Oligonucleotides Analogues Targeting Human LMNA “lamin A” Gene, 36563-36564 [2021-14702]
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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
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[FR Doc. 2021–14703 Filed 7–9–21; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Oligonucleotides
Analogues Targeting Human LMNA
‘‘lamin A’’ Gene
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Human Genome
Research Institute (NHGRI), an institute
of the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an Exclusive, Sublicensable Patent
License to consolidate co-owned rights
to the inventions and the Patents and
Patent Applications listed in the
Supplementary Information section of
this notice to The Progeria Research
Foundation (‘‘PRF’’), having a place of
business in 200 Lake Street, Unit 102,
Peabody, MA 01960.
SUMMARY:
Only written comments and/or
applications for a license that are
received by the NHGRI Office of
Technology Transfer Office on or before
July 27, 2021 will be considered.
DATES:
Requests for a copy of the
patent application(s), inquiries, and
comments relating to the contemplated
license should be directed to: Eggerton
Campbell, License and Patent Manager,
NHGRI Technology Transfer Office,
Telephone: 301–402–1648; email:
eggerton.campbell@nih.gov.
ADDRESSES:
The
following and all continuing U.S. and
foreign patents/patent applications
thereof are the intellectual properties to
be licensed under the prospective
agreement:
SUPPLEMENTARY INFORMATION:
Country
Title
United States .........
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–US–01.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–PCT–03.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–GB–12.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–US–02.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–US–06.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–US–07.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–EP–04.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–JP–15.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–FR–11.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–DE–10.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–IE–13.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–JP–05.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–JP–08.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–NL–14.
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–0–CH–09.
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–US–01 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–PCT–02 ....................................
WIPO .....................
United Kingdom .....
United States .........
United States .........
United States .........
Europe ...................
Japan .....................
France ....................
Germany ................
Ireland ....................
Japan .....................
khammond on DSKJM1Z7X2PROD with NOTICES
and should be pertinent to the meeting
discussion. Individuals are encouraged
to provide a written statement of any
public comment(s) for accurate minutetaking purposes. If you decide you
would like to provide public comment
but do not pre-register, you may submit
your written statement by emailing
COVID19HETF@hhs.gov no later than
close of business on Thursday, August
5, 2021. Individuals who plan to attend
and need special assistance, such as
sign language interpretation or other
reasonable accommodations, should
contact: COVID19HETF@hhs.gov and
reference this meeting. Requests for
special accommodations should be
made at least 10 business days prior to
the meeting.
Japan .....................
Netherlands ............
Switzerland ............
United States .........
WIPO .....................
VerDate Sep<11>2014
17:26 Jul 09, 2021
Jkt 253001
PO 00000
Frm 00042
Fmt 4703
Application No.
Sfmt 4703
36563
E:\FR\FM\12JYN1.SGM
12JYN1
Patent No.
61/568,590.
PCT/US12/068609
WO 2013/086444.
12806796.4 ..........
2788488
13/708,709 ...........
9,326,992
15/084,255 ...........
9,833,468
15/727,483 CON ..
10,398,721
12806796.4 ..........
2788488
2019–109410.
12806796.4 ..........
2788488
12806796.4 ..........
2788488
12806796.4 ..........
2788488
2014–546152 .......
6132849
2017–41744.
12806796.4 ..........
2788488
12806796.4 ..........
2788488
62/330,027.
PCT/US17/30174
WO 2017/190041.
36564
Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
Country
Title
Application No.
United States .........
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–US–16 ......................................
United States .........
Australia .................
Brazil ......................
Canada ..................
China ......................
Colombia ................
Eurasia ...................
Europe ...................
Hong Kong .............
Oligonucleotide Analogues Targeting Human LMNA ....................................................................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–AU–03 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–BR–04 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–CA–05 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–CN–06 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–CO–07 .....................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–EA–08 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–EP–09 ......................................
Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human
LMNA NIH E–044–2013–1–HK–17.
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–IN–10 .......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–JP–11 .......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–KR–12 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–MX–13 .....................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–NZ–14 ......................................
Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–SG–15 ......................................
16/096,524 (371national phase).
17/024,100.
2017258642.
BR1120180722790.
3,022,303.
201780040785.7.
NC2018/0012783.
201892467.
17735676.3.
19126894.5.
khammond on DSKJM1Z7X2PROD with NOTICES
India .......................
Japan .....................
Korea (South) ........
Mexico ....................
New Zealand ..........
Singapore ...............
The patent rights in these inventions
have been assigned to the Government
of the United States of America, the
University of Maryland, Sarepta
Therapeutics, Inc, and the Progeria
Research Foundation (PRF), co-owners
of said rights, for commercial
development and marketing. The rights
to be granted by NHGRI are controlled
by NHGRI by virtue of co-ownership
and a license received to the listed
intellectual property. The prospective
patent license will be for the purpose of
consolidating the patent rights to PRF.
Consolidation of these co-owned rights
is intended to expedite development of
the invention, consistent with the goals
of the Bayh-Dole Act codified as 35
U.S.C. 200–212. The prospective patent
license will be worldwide, exclusive,
may be limited to those fields of use
commensurate in scope with the patent
rights, and will be sublicensable.
The subject technology pertains to
modified oligonucleotides (called
phosphorodiamidate morpholino
oligonucleotides or PMOs) targeted to
pre-mRNA of human LMNA Lamin A
gene. These PMOs can be used to
correct aberrant splicing of LMNA gene
known to be involved in HutchinsonGilford Progeria Syndrome (HGPS), and
could be used in treating this ultra-rare
disease and related laminopathies.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective Exclusive Patent
License will be royalty bearing and may
be granted unless, within fifteen (15)
days from the date of this published
notice, the NHGRI Technology Transfer
Office receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
Complete applications for a license
that are timely filed in response to this
notice will be treated as objections to
VerDate Sep<11>2014
17:26 Jul 09, 2021
Jkt 253001
this to the grant of the contemplated
exclusive patent license.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: June 29, 2021.
Claire T. Driscoll,
Director, Technology Transfer Office,
National Human Genome Research Institute,
National Institutes of Health.
[FR Doc. 2021–14702 Filed 7–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Mental Health Council.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Patent No.
10,822,608
201847043433.
2019–508165.
10–2018–7034615.
MX/A/2018/013157.
747685.
11201809468X.
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: August 6, 2021.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Tracy Lynn Waldeck,
Ph.D., Director, Division of Extramural
Activities, National Institute of Mental
Health, Neuroscience Center, 6001 Executive
Boulevard, Room 4133, Rockville, MD 20892,
(301) 480–6833, waldeckt@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: July 7, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–14737 Filed 7–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Heart, Lung,
and Blood Advisory Council.
The meeting will be closed to the
public in accordance with the
E:\FR\FM\12JYN1.SGM
12JYN1
]]>Agencies
[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36563-36564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14702]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License:
Oligonucleotides Analogues Targeting Human LMNA ``lamin A'' Gene
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Human Genome Research Institute (NHGRI), an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive,
Sublicensable Patent License to consolidate co-owned rights to the
inventions and the Patents and Patent Applications listed in the
Supplementary Information section of this notice to The Progeria
Research Foundation (``PRF''), having a place of business in 200 Lake
Street, Unit 102, Peabody, MA 01960.
DATES: Only written comments and/or applications for a license that are
received by the NHGRI Office of Technology Transfer Office on or before
July 27, 2021 will be considered.
ADDRESSES: Requests for a copy of the patent application(s), inquiries,
and comments relating to the contemplated license should be directed
to: Eggerton Campbell, License and Patent Manager, NHGRI Technology
Transfer Office, Telephone: 301-402-1648; email:
[email protected].
SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and
foreign patents/patent applications thereof are the intellectual
properties to be licensed under the prospective agreement:
----------------------------------------------------------------------------------------------------------------
Country Title Application No. Patent No.
----------------------------------------------------------------------------------------------------------------
United States........... Methods For Treating Progeroid Laminopathies 61/568,590..............
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-US-01.
WIPO.................... Methods For Treating Progeroid Laminopathies PCT/US12/068609.........
Using Oligonucleotide Analogues Targeting WO 2013/086444..........
Human LMNA NIH E-044-2013-0-PCT-03.
United Kingdom.......... Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-GB-12.
United States........... Methods For Treating Progeroid Laminopathies 13/708,709.............. 9,326,992
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-US-02.
United States........... Methods For Treating Progeroid Laminopathies 15/084,255.............. 9,833,468
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-US-06.
United States........... Methods For Treating Progeroid Laminopathies 15/727,483 CON.......... 10,398,721
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-US-07.
Europe.................. Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-EP-04.
Japan................... Methods For Treating Progeroid Laminopathies 2019-109410.............
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-JP-15.
France.................. Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-FR-11.
Germany................. Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-DE-10.
Ireland................. Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-IE-13.
Japan................... Methods For Treating Progeroid Laminopathies 2014-546152............. 6132849
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-JP-05.
Japan................... Methods For Treating Progeroid Laminopathies 2017-41744..............
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-JP-08.
Netherlands............. Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-NL-14.
Switzerland............. Methods For Treating Progeroid Laminopathies 12806796.4.............. 2788488
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-0-CH-09.
United States........... Oligonucleotide Analogues Targeting Human 62/330,027..............
LMNA NIH E-044-2013-1-US-01.
WIPO.................... Oligonucleotide Analogues Targeting Human PCT/US17/30174..........
LMNA NIH E-044-2013-1-PCT-02. WO 2017/190041..........
[[Page 36564]]
United States........... Oligonucleotide Analogues Targeting Human 16/096,524 (371-national 10,822,608
LMNA NIH E-044-2013-1-US-16. phase).
United States........... Oligonucleotide Analogues Targeting Human 17/024,100..............
LMNA.
Australia............... Oligonucleotide Analogues Targeting Human 2017258642..............
LMNA NIH E-044-2013-1-AU-03.
Brazil.................. Oligonucleotide Analogues Targeting Human BR1120180722790.........
LMNA NIH E-044-2013-1-BR-04.
Canada.................. Oligonucleotide Analogues Targeting Human 3,022,303...............
LMNA NIH E-044-2013-1-CA-05.
China................... Oligonucleotide Analogues Targeting Human 201780040785.7..........
LMNA NIH E-044-2013-1-CN-06.
Colombia................ Oligonucleotide Analogues Targeting Human NC2018/0012783..........
LMNA NIH E-044-2013-1-CO-07.
Eurasia................. Oligonucleotide Analogues Targeting Human 201892467...............
LMNA NIH E-044-2013-1-EA-08.
Europe.................. Oligonucleotide Analogues Targeting Human 17735676.3..............
LMNA NIH E-044-2013-1-EP-09.
Hong Kong............... Methods For Treating Progeroid Laminopathies 19126894.5..............
Using Oligonucleotide Analogues Targeting
Human LMNA NIH E-044-2013-1-HK-17.
India................... Oligonucleotide Analogues Targeting Human 201847043433............
LMNA NIH E-044-2013-1-IN-10.
Japan................... Oligonucleotide Analogues Targeting Human 2019-508165.............
LMNA NIH E-044-2013-1-JP-11.
Korea (South)........... Oligonucleotide Analogues Targeting Human 10-2018-7034615.........
LMNA NIH E-044-2013-1-KR-12.
Mexico.................. Oligonucleotide Analogues Targeting Human MX/A/2018/013157........
LMNA NIH E-044-2013-1-MX-13.
New Zealand............. Oligonucleotide Analogues Targeting Human 747685..................
LMNA NIH E-044-2013-1-NZ-14.
Singapore............... Oligonucleotide Analogues Targeting Human 11201809468X............
LMNA NIH E-044-2013-1-SG-15.
----------------------------------------------------------------------------------------------------------------
The patent rights in these inventions have been assigned to the
Government of the United States of America, the University of Maryland,
Sarepta Therapeutics, Inc, and the Progeria Research Foundation (PRF),
co-owners of said rights, for commercial development and marketing. The
rights to be granted by NHGRI are controlled by NHGRI by virtue of co-
ownership and a license received to the listed intellectual property.
The prospective patent license will be for the purpose of consolidating
the patent rights to PRF. Consolidation of these co-owned rights is
intended to expedite development of the invention, consistent with the
goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212. The
prospective patent license will be worldwide, exclusive, may be limited
to those fields of use commensurate in scope with the patent rights,
and will be sublicensable.
The subject technology pertains to modified oligonucleotides
(called phosphorodiamidate morpholino oligonucleotides or PMOs)
targeted to pre-mRNA of human LMNA Lamin A gene. These PMOs can be used
to correct aberrant splicing of LMNA gene known to be involved in
Hutchinson-Gilford Progeria Syndrome (HGPS), and could be used in
treating this ultra-rare disease and related laminopathies.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective Exclusive Patent License will be royalty
bearing and may be granted unless, within fifteen (15) days from the
date of this published notice, the NHGRI Technology Transfer Office
receives written evidence and argument that establishes that the grant
of the license would not be consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
Complete applications for a license that are timely filed in
response to this notice will be treated as objections to this to the
grant of the contemplated exclusive patent license.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: June 29, 2021.
Claire T. Driscoll,
Director, Technology Transfer Office, National Human Genome Research
Institute, National Institutes of Health.
[FR Doc. 2021-14702 Filed 7-9-21; 8:45 am]
BILLING CODE 4140-01-P
