Prospective Grant of an Exclusive Patent License: Development and Commercialization of Certain Fusion Proteins and Their Use for the Treatment of Humans With Short Stature, 6892-6893 [2021-01488]
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6892
Federal Register / Vol. 86, No. 14 / Monday, January 25, 2021 / Notices
Licensing Contact: To license this
technology, please contact Carol A.
Salata at 240–627–3727; csalata@
niaid.nih.gov.
The prospective exclusive license
territory may be worldwide, and the
fields of use may be limited to the
following:
Dated: January 14, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
Dated: January 8, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
Fields of Use Applying to Intellectual
Property Group B
[FR Doc. 2021–01487 Filed 1–22–21; 8:45 am]
[FR Doc. 2021–01490 Filed 1–22–21; 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: Development and
Commercialization of Cell Therapies
for Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Ziopharm
Oncology, Inc. (‘‘Ziopharm’’),
headquartered in Boston, MA.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before February 9, 2021 will be
considered.
SUMMARY:
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240) 276–5484; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
jbell on DSKJLSW7X2PROD with NOTICES
Group B
E–173–2020: T Cell Receptors
Recognizing R273C or Y220C
Mutation in P53
1. U.S. Provisional Patent Application
63/074,747, filed September 4, 2020
(E–173–2020–0–US–01).
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
VerDate Sep<11>2014
18:31 Jan 22, 2021
Jkt 253001
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer to express T cell receptors
reactive to mutated P53, as claimed in
the Licensed Patent Rights, for the
treatment of human cancers.
Specifically excluded from this field of
use are CRISPR-engineered peripheral
blood T cell therapy products for the
treatment of human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Intellectual Property Group B is
primarily directed to isolated TCRs
reactive to mutated tumor protein 53
(TP53 or P53), within the context of
several HLAs. P53 is the archetypal
tumor suppressor gene and the most
frequently mutated gene in cancer.
Contemporary estimates suggest that
>50% of all tumors carry mutations in
P53. Because of its prevalence in cancer
and its restricted expression to
precancerous and cancerous cells, this
antigen may be targeted on mutant P53expressing tumors with minimal normal
tissue toxicity.
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, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published Notice, the National
Cancer 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 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.
PO 00000
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Fmt 4703
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Certain Fusion
Proteins and Their Use for the
Treatment of Humans With Short
Stature
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Cancer Institute, both institutes of the
National Institutes of Health,
Department of Health and Human
Services, are contemplating the grant of
an Exclusive Patent License to practice
the inventions embodied in the Patents
and Patent Applications listed in the
Supplementary Information section of
this Notice to EpifiZa Inc. of Montreal,
QC (Canada).
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before February 9, 2021 will be
considered.
SUMMARY:
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Richard T. Girards, Jr., Esq.,
MBA, Senior Technology Transfer
Manager, National Institutes of Health,
NCI Technology Transfer Center by
email (richard.girards@nih.gov) or
phone (240–276–6825).
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
E–003–2014: Agents That Specifically
Bind Matrilin–3 and Their Use/Cartilage
Targeting Agents and Their Use
1. United States Provisional Patent
Application No. 61/927,904, filed 15
January 2014 (HHS Reference No. E–
003–2014–0–US–01);
2. United States Patent No.
10,323,083, issued 18 June 2019 (HHS
Reference No. E–003–2014–0–US–06);
3. United States Patent Application
No. 16/391,101, filed 22 April 2019
E:\FR\FM\25JAN1.SGM
25JAN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 14 / Monday, January 25, 2021 / Notices
(HHS Reference No. E–003–2014–0–US–
07);
4. International Patent Application
No. PCT/US2015/011433, filed 14
January 2015 (HHS Reference No. E–
003–2014–0–PCT–02);
5. Australia Patent No. 2015206515,
issued 26 March 2020 (HHS Reference
No. E–003–2014–0–AU–03);
6. Canada Patent Application No.
2931005, filed 14 January 2015 (HHS
Reference No. E–003–2014–0–CA–04);
7. European Patent No. 3 094 350 B1,
issued 04 March 2020 (HHS Reference
No. E–003–2014–0–EP–05) and all of its
national validations;
8. European Patent Application No.
19219282.1, filed 14 January 2015 (HHS
Reference No. E–003–2014–0–EP–11);
and
9. any and all other U.S. and ex-U.S.
patents and patent applications
claiming priority to any one of the
foregoing, now or in the future.
The patent and patent application
rights in these inventions have been
assigned and/or exclusively licensed to
the government of the United States of
America.
The prospective exclusive license
territory may be worldwide and the
fields of use may be limited to the
following: The development,
manufacture, distribution, sale and use
of one or more fusion proteins for the
treatment of humans with short stature
associated with one or more genetic
conditions.
These technologies disclose, e.g.,
monoclonal antibodies and antibody
fragments that specifically bind to
matrilin-3, conjugates including these
molecules, and nucleic acid molecules
encoding the antibodies, antigen
binding fragments and conjugates. Also
disclosed are compositions including
the disclosed antibodies, antigen
binding fragments, conjugates, and
nucleic acid molecules. Methods of
treating or inhibiting a cartilage disorder
in a subject, as well as methods of
increasing chondrogenesis in cartilage
tissue are further provided. The
methods can be used, for example, for
treating or inhibiting a growth plate
disorder in a subject, such as a skeletal
dysplasia or short stature.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR 404. The
prospective exclusive license will be
royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published Notice, the National
Cancer 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 404.
VerDate Sep<11>2014
18:31 Jan 22, 2021
Jkt 253001
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: January 11, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2021–01488 Filed 1–22–21; 8:45 am]
6893
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: January 15, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–01443 Filed 1–22–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 Institute of
Environmental Health Sciences Special
Emphasis Panel: R21 Mechanism for TimeSensitive Research Opportunities in
Environmental Health Sciences.
Date: February 19, 2021.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Durham, NC 27709 (Virtual
Meeting).
Contact Person: Laura A. Thomas, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Science, Research Triangle Park, NC
27709, 984–287–3328, laura.thomas@
nih.gov.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NST–2 Conflict SEP
Additional Applications.
Date: February 18, 2021.
Time: 9:00 a.m. to 10:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Delany Torres, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS, Neuroscience Center Building (NSC),
6001 Executive Blvd., Suite 3208, Rockville,
MD 20852, delany.torressalazar@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NST–1 Additional
Applications.
Date: March 2, 2021.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 86, Number 14 (Monday, January 25, 2021)]
[Notices]
[Pages 6892-6893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01488]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Certain Fusion Proteins and Their Use for the
Treatment of Humans With Short Stature
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health
and Human Development and the National Cancer Institute, both
institutes of the National Institutes of Health, Department of Health
and Human Services, are contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the Patents and Patent
Applications listed in the Supplementary Information section of this
Notice to EpifiZa Inc. of Montreal, QC (Canada).
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center on or before February 9, 2021 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior
Technology Transfer Manager, National Institutes of Health, NCI
Technology Transfer Center by email ([email protected]) or phone
(240-276-6825).
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-003-2014: Agents That Specifically Bind Matrilin-3 and Their Use/
Cartilage Targeting Agents and Their Use
1. United States Provisional Patent Application No. 61/927,904,
filed 15 January 2014 (HHS Reference No. E-003-2014-0-US-01);
2. United States Patent No. 10,323,083, issued 18 June 2019 (HHS
Reference No. E-003-2014-0-US-06);
3. United States Patent Application No. 16/391,101, filed 22 April
2019
[[Page 6893]]
(HHS Reference No. E-003-2014-0-US-07);
4. International Patent Application No. PCT/US2015/011433, filed 14
January 2015 (HHS Reference No. E-003-2014-0-PCT-02);
5. Australia Patent No. 2015206515, issued 26 March 2020 (HHS
Reference No. E-003-2014-0-AU-03);
6. Canada Patent Application No. 2931005, filed 14 January 2015
(HHS Reference No. E-003-2014-0-CA-04);
7. European Patent No. 3 094 350 B1, issued 04 March 2020 (HHS
Reference No. E-003-2014-0-EP-05) and all of its national validations;
8. European Patent Application No. 19219282.1, filed 14 January
2015 (HHS Reference No. E-003-2014-0-EP-11); and
9. any and all other U.S. and ex-U.S. patents and patent
applications claiming priority to any one of the foregoing, now or in
the future.
The patent and patent application rights in these inventions have
been assigned and/or exclusively licensed to the government of the
United States of America.
The prospective exclusive license territory may be worldwide and
the fields of use may be limited to the following: The development,
manufacture, distribution, sale and use of one or more fusion proteins
for the treatment of humans with short stature associated with one or
more genetic conditions.
These technologies disclose, e.g., monoclonal antibodies and
antibody fragments that specifically bind to matrilin-3, conjugates
including these molecules, and nucleic acid molecules encoding the
antibodies, antigen binding fragments and conjugates. Also disclosed
are compositions including the disclosed antibodies, antigen binding
fragments, conjugates, and nucleic acid molecules. Methods of treating
or inhibiting a cartilage disorder in a subject, as well as methods of
increasing chondrogenesis in cartilage tissue are further provided. The
methods can be used, for example, for treating or inhibiting a growth
plate disorder in a subject, such as a skeletal dysplasia or short
stature.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
404. The prospective exclusive license will be royalty bearing, and the
prospective exclusive license may be granted unless within fifteen (15)
days from the date of this published Notice, the National Cancer
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 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 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: January 11, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-01488 Filed 1-22-21; 8:45 am]
BILLING CODE 4140-01-P
