Prospective Grant of an Exclusive Patent License: Gene Therapy for Ocular Disease, 43246-43247 [2020-15340]
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43246
Federal Register / Vol. 85, No. 137 / Thursday, July 16, 2020 / Notices
HISTORY:
V. European Application 16717228.7
filed November 8, 2017, issued as EP
3280451, validated in Italy, Spain,
France, UK, and Germany (HHS
Reference No.: E–185–2014–0–EP–06).
None.
[FR Doc. 2020–15380 Filed 7–15–20; 8:45 am]
BILLING CODE 4150–28–P
Group B, HHS Reference No.: E–100–
2017–0: ‘‘Codon-Optimized Human
NPC1 Genes for the Treatment of
Niemann-Pick Type C1 Deficiency and
Related Conditions’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Gene Therapy for
Treatment or Prevention of NiemannPick Disease Type C1, Subject to
Existing Three Non-Exclusive Licenses
National Institutes of Health,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The National Human Genome
Research Institute is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
United States, European and Canadian
Applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice to AveXis, Inc., located in
Bannockburn, Illinois, USA.
DATES: Only written comments and/or
applications for a license which are
received by the National Human
Genome Research Institute’s Technology
Transfer Office on or before July 31,
2020 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Anna Solowiej, Ph.D., J.D.,
Senior Licensing and Patenting
Manager, NHGRI Technology Transfer
Office, 6700B Rockledge Drive, Suite
3100, Bethesda, MD 20817 (for business
mail); Telephone (301) 435–7791; Email:
anna.solowiej@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
Group A, HHS Reference No.: E–185–
2014–0: ‘‘Viral Gene Therapy as
Treatment for Cholesterol Storage
Disease or Disorder’’
I. U.S. Provisional Application 62/
144,702, filed April 8, 2015, expired
(HHS Reference No.: E–185–2014–0–
US–01).
II. PCT Application PCT/US2016/
026524, filed April 7, 2016, expired
(HHS Reference No.: E–185–2014–0–
PCT–02).
III. U.S. Application 15/565,065, filed
October 6, 2017 (HHS Reference No.: E–
185–2014–0–US–04).
IV. Canadian Application 2,982,129,
filed October 6, 2017 (HHS Reference
No.: E–185–2014–0–CA–05).
VerDate Sep<11>2014
17:43 Jul 15, 2020
Jkt 250001
I. U.S. Provisional Application U.S.
62/522,677, filed June 20, 2017, expired
(HHS Reference No.: E–100–2017–0–
US–01).
II. PCT Application PCT/US2018/
038584, filed June 20, 2018, expired
(HHS Reference No.: E–100–2017–0–
PCT–02).
III. U.S. Application U.S. 16/623,863
filed December 19, 2019 (HHS Reference
No.: E–100–2017–0–US–05).
IV. Canadian Application 3,068,010,
filed December 19, 2019 (E–100–2017–
0–CA–03).
V. European Application 18740403.3
filed January 20, 2020 (HHS Reference
No.: E–100–2017–0–EP–04).
The patent rights in these inventions
have been assigned or exclusively
licensed to the Government of the
United States of America.
The prospective exclusive license
territory may be worldwide and in fields
of use that may be limited to
manufacture and commercialization of
pharmaceutical products for the
treatment and/or prevention of Niemann
Pick disease, Type C1 (NPC1) using
gene therapy in humans that incorporate
the Licensed Product(s), in combination
with AAV9, subject to three existing
non-exclusive licenses for this
technology.
Above listed patent portfolio cover
inventions directed to gene therapy and
specifically, expression vectors and
therapeutic methods of using such
vectors in the treatment of NiemannPick Disease Type C1.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing. The prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Human Genome Research Institute
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.
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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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 in 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: July 7, 2020
Claire T. Driscoll,
Director, Technology Transfer Office,
National Human Genome Research Institute.
[FR Doc. 2020–15342 Filed 7–15–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Gene Therapy for
Ocular Disease
National Institutes of Health,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The National Eye Institute,
the National Institute on Deafness and
Other Communication Disorders, and
the National Heart, Lung, and Blood
Institute, institutes of the National
Institutes of Health, Department of
Health and Human Services, are
contemplating the grant of an exclusive
patent license to VegaVect, Inc., a startup company spun-off from the
University of Pittsburgh Medical Center
Enterprises and incorporated as a C
corporation under the laws of the state
of Delaware, to practice the inventions
covered by the patent estate listed in the
SUPPLEMENTARY INFORMATION section of
this notice. This is a second notice
intended to apprise the public of a
change in prospective licensee of the
subject intellectual property rights in
the stated field of use from a first notice:
Prospective Grant of An Exclusive
Patent License: Gene Therapy for Ocular
Disease, published in the Federal
Register on November 26, 2019.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
(representing the National Eye Institute
and the National Heart, Lung, and Blood
Institute (representing the National
Institute on Deafness and Other
Communication Disorders) on or before
July 31, 2020 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
SUMMARY:
E:\FR\FM\16JYN1.SGM
16JYN1
43247
Federal Register / Vol. 85, No. 137 / Thursday, July 16, 2020 / Notices
comments relating to the contemplated
an exclusive patent license should be
directed to: Michael Shmilovich, Esq.,
Senior Licensing and Patent Manager,
31 Center Drive Room 4A29, MSC2479,
Bethesda, MD 20892–2479, phone
number 301–435–5019, or shmilovm@
mail.nih.gov.
SUPPLEMENTARY INFORMATION:
INTELLECTUAL PROPERTY
NIH ref No.
E–284–2012–0–US–01 .....
E–284–2012–1–US–01 .....
E–284–2012–2–PCT–01 ...
E–284–2012–2–AU–02 .....
E–284–2012–2–CA–03 .....
E–284–2012–2–JP–04 ......
E–284–2012–2–US–05 .....
E–284–2012–2–US–07 .....
E–284–2012–2–EP–06 .....
E–284–2012–2–PCT–08 ...
E–164–2018–0–US–01 .....
E–164–2018–1–US–01 .....
E–164–2018–2–US–01 .....
E–164–2018–3–PCT–01 ...
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
AAV8 retinoschisin expression vector for
treating X-linked retinoschisis.
AAV8 retinoschisin expression vector for
treating X-linked retinoschisis.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Methods And Compositions For Treating
Genetically Linked Diseases Of The Eye.
Intraocular Delivery Of Gene Therapy Expression Vectors.
Intraocular Delivery Of Gene Therapy Expression Vectors.
Intraocular Delivery Of Gene Therapy Expression Vectors.
Intraocular Delivery Of Gene Therapy Expression Vectors.
All U.S. and foreign patents and
applications claiming priority to any
member of the above.
The patent rights in these inventions
have been assigned or exclusively
licensed to the Government of the
United States of America.
The prospective exclusive license
territory may be worldwide and in fields
of use that may be limited to human
therapeutics for (1) X-linked juvenile
retinoschisis and (2) schisis cavity
associated ocular disease or injury.
The aforementioned patent estates
cover inventions directed to gene
therapy and specifically, expression
vectors and therapeutic methods of
using such vectors in the treatment of
ocular diseases resulting from failure to
produce or the defective production of
an ocular protein. This invention is also
directed to methods of administering
expression vectors capable of
modulating a target gene or gene
product for the treatment of ocular
disease.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing. The prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Heart, Lung, and Blood Institute
receives written evidence and argument
that establishes that the grant of the
VerDate Sep<11>2014
Patent application
No.
Title
17:43 Jul 15, 2020
Jkt 250001
February 15, 2013.
61/815,636 .................
April 24, 2013.
PCT/US2014/16389 ..
February 14, 2014.
2014216160 ...............
February 14, 2014 .....
2014216160
July 13, 2017.
2900231 .....................
February 14, 2014 .....
2900231
July 30, 2019.
2015–558144 .............
February 14, 2014 .....
6449175
December 14, 2018.
14/766,842 .................
February 14, 2014 .....
9,873,893
15/876,821 .................
February 14, 2014 .....
10,350,306
14708176.4 ................
February 14, 2014.
PCT/US2019/14418 ..
January 21, 2019.
62/701,267 .................
July 20, 2018.
62/724,480 .................
August 29, 2018.
62/768,590 .................
November 16, 2019.
PCT/US2019/042365
July 18, 2019.
Dated: July 2, 2020.
Michael Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute.
[FR Doc. 2020–15340 Filed 7–15–20; 8:45 am]
BILLING CODE 4140–01–P
Frm 00043
Issue date
61/765,654 .................
license would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
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 in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
PO 00000
Issued patent
No.
Filing date
Fmt 4703
Sfmt 4703
January 23, 2018.
July 16, 2019.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; NTU Bench Testing.
Date: August 12, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1078, Bethesda, MD 20892 (Virtual Meeting).
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 85, Number 137 (Thursday, July 16, 2020)]
[Notices]
[Pages 43246-43247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15340]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Gene Therapy
for Ocular Disease
AGENCY: National Institutes of Health, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Eye Institute, the National Institute on Deafness
and Other Communication Disorders, and the National Heart, Lung, and
Blood Institute, institutes of the National Institutes of Health,
Department of Health and Human Services, are contemplating the grant of
an exclusive patent license to VegaVect, Inc., a start-up company spun-
off from the University of Pittsburgh Medical Center Enterprises and
incorporated as a C corporation under the laws of the state of
Delaware, to practice the inventions covered by the patent estate
listed in the SUPPLEMENTARY INFORMATION section of this notice. This is
a second notice intended to apprise the public of a change in
prospective licensee of the subject intellectual property rights in the
stated field of use from a first notice: Prospective Grant of An
Exclusive Patent License: Gene Therapy for Ocular Disease, published in
the Federal Register on November 26, 2019.
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center (representing the National Eye Institute and the National Heart,
Lung, and Blood Institute (representing the National Institute on
Deafness and Other Communication Disorders) on or before July 31, 2020
will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and
[[Page 43247]]
comments relating to the contemplated an exclusive patent license
should be directed to: Michael Shmilovich, Esq., Senior Licensing and
Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479, phone number 301-435-5019, or [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
----------------------------------------------------------------------------------------------------------------
Patent Issued patent
NIH ref No. Title application No. Filing date No. Issue date
----------------------------------------------------------------------------------------------------------------
E-284-2012-0-US-01.......... Methods And 61/765,654..... February 15,
Compositions 2013.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-1-US-01.......... Methods And 61/815,636..... April 24, 2013.
Compositions
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-2-PCT-01......... Methods And PCT/US2014/ February 14,
Compositions 16389. 2014.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-2-AU-02.......... AAV8 2014216160..... February 14, 2014216160 July 13, 2017.
retinoschisin 2014.
expression
vector for
treating X-
linked
retinoschisis.
E-284-2012-2-CA-03.......... AAV8 2900231........ February 14, 2900231 July 30, 2019.
retinoschisin 2014.
expression
vector for
treating X-
linked
retinoschisis.
E-284-2012-2-JP-04.......... Methods And 2015-558144.... February 14, 6449175 December 14,
Compositions 2014. 2018.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-2-US-05.......... Methods And 14/766,842..... February 14, 9,873,893 January 23,
Compositions 2014. 2018.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-2-US-07.......... Methods And 15/876,821..... February 14, 10,350,306 July 16, 2019.
Compositions 2014.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-2-EP-06.......... Methods And 14708176.4..... February 14,
Compositions 2014.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-284-2012-2-PCT-08......... Methods And PCT/US2019/ January 21,
Compositions 14418. 2019.
For Treating
Genetically
Linked
Diseases Of
The Eye.
E-164-2018-0-US-01.......... Intraocular 62/701,267..... July 20, 2018..
Delivery Of
Gene Therapy
Expression
Vectors.
E-164-2018-1-US-01.......... Intraocular 62/724,480..... August 29, 2018
Delivery Of
Gene Therapy
Expression
Vectors.
E-164-2018-2-US-01.......... Intraocular 62/768,590..... November 16,
Delivery Of 2019.
Gene Therapy
Expression
Vectors.
E-164-2018-3-PCT-01......... Intraocular PCT/US2019/ July 18, 2019..
Delivery Of 042365.
Gene Therapy
Expression
Vectors.
----------------------------------------------------------------------------------------------------------------
All U.S. and foreign patents and applications claiming priority to
any member of the above.
The patent rights in these inventions have been assigned or
exclusively licensed to the Government of the United States of America.
The prospective exclusive license territory may be worldwide and in
fields of use that may be limited to human therapeutics for (1) X-
linked juvenile retinoschisis and (2) schisis cavity associated ocular
disease or injury.
The aforementioned patent estates cover inventions directed to gene
therapy and specifically, expression vectors and therapeutic methods of
using such vectors in the treatment of ocular diseases resulting from
failure to produce or the defective production of an ocular protein.
This invention is also directed to methods of administering expression
vectors capable of modulating a target gene or gene product for the
treatment of ocular disease.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing.
The prospective exclusive license may be granted unless within fifteen
(15) days from the date of this published notice, the National Heart,
Lung, and Blood Institute 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.
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 in 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: July 2, 2020.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute.
[FR Doc. 2020-15340 Filed 7-15-20; 8:45 am]
BILLING CODE 4140-01-P
