Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Vector-Mediated Gene Delivery of Human Aquaporin-1 To Prevent Radiation-Induced Salivary Hypofunction, 60906-60907 [2024-16594]
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60906
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 24, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–16614 Filed 7–26–24; 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: Adeno-Associated
Virus Vector-Mediated Gene Delivery
of Human Aquaporin-1 To Prevent
Radiation-Induced Salivary
Hypofunction
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Diabetes and Digestive and Kidney
Disease and National Institute of Dental
and Craniofacial Research, 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
Australian, Brazilian, Canadian,
Chinese, European, Hong Kong, Israeli,
Japanese, South Korean, Mexican,
Malaysian, New Zealand, Philippines,
Singapore, United States, and South
African Applications listed in the
Supplementary Information section of
this notice to MeiraGTx, LLC, located in
New York City, New York, USA.
DATES: Only written comments and/or
applications for a license that are
received by the National Institute of
Diabetes and Digestive and Kidney
Disease’s Technology Advancement
Office on or before August 13, 2024 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: Vladimir Knezevic, MD,
(Senior) Advisor for Commercial
Evaluation, Technology Advancement
Office, Building 12A, Room 3011,
Bethesda, MD 20817–5632 (for business
mail), Telephone: (301) 435–5560;
Email: vlado.knezevic@nih.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
Intellectual Property
I. ARIPO Patent Application AP/P/
2024/015557 filed on February 28, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–AP–01).
II. Australian Patent Application
2022325158 filed on February 26, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–AU–01).
III. Brazilian Patent Application
BR112024002194–7 filed on February 7,
2024, entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–BR–01).
IV. Canadian Patent Application
3227584 filed on January 31, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–CA–01).
V. Chinese Patent Application
202280058429.9 filed on February 27,
2024, entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–CN–01).
VI. Eurasian Patent Application
202490372 filed on March 1, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–EA–01).
VII. European Patent Application
22786210.9 filed March 1, 2024, entitled
‘‘AQP1 Gene Therapy To Prevent
Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–EP–01).
VIII. Hong Kong Patent Application
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–HK–01) with the priority
filing date of August 4, 2021.
IX. Israeli Patent Application 310485
filed on January 29, 2024, entitled
‘‘AQP1 Gene Therapy To Prevent
Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–IL–01).
X. Japanese Patent Application 2024–
506727 filed on February 2, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–JP–01).
XI. South Korean Patent Application
10–2024–7007179 filed on February 29,
2024, published as 10–2024–0049295 on
April 16, 2024, entitled ‘‘AQP1 Gene
Therapy To Prevent Radiation-Induced
Salivary Hypofunction’’ (HHS Reference
Number E–129–2021–0–KR–01).
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
XII. Mexican Patent Application MX/
a/2024/001577 filed on February 1,
2024, entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–MX–01).
XIII. Malaysian Patent Application
PI2024000751 filed on February 2, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–MY–01).
XIV. New Zealand Patent Application
808619 filed on February 26, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–NZ–01).
XV. Philippines Patent Application 1–
2024–550312 filed on February 2, 2024,
entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–PH–01).
XVI. Singapore Patent Application
11202400787X filed on February 2,
2024, entitled ‘‘AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–SG–01).
XVII. United States Patent
Application 18/294,048 filed on January
31, 2024, entitled ‘‘AQP1 Gene Therapy
To Prevent Radiation-Induced Salivary
Hypofunction’’ (HHS Reference Number
E–129–2021–0–US–02).
XVIII. South African Patent
Application 2024/01677, filed on
February 27, 2024, entitled ‘‘AQP1 Gene
Therapy To Prevent Radiation-Induced
Salivary Hypofunction’’ (HHS Reference
Number E–129–2021–0–ZA–01).
The patent rights for these inventions
have been assigned 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 use of adenoassociated virus 2 vector-mediated gene
delivery of human aquaporin-1 for the
prevention of radiation-induced
xerostomia (‘dry mouth’ syndrome).
The above-listed patent portfolio
covers inventions directed to gene
therapy and specifically, expression
vector and therapeutic method of using
such vector in the prevention of
radiation-induced xerostomia.
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 receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
E:\FR\FM\29JYN1.SGM
29JYN1
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
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 23, 2024.
Vladimir Knezevic,
Senior Advisor for Commercial Evaluation,
Technology Advancement Office, National
Institute of Diabetes and Digestive and Kidney
Disease.
[FR Doc. 2024–16594 Filed 7–26–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI) on
Recommendations on Re-Envisioning
U.S. Postdoctoral Research Training
and Career Progression Within the
Biomedical Research Enterprise
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Request for information.
The National Institutes of
Health (NIH) is issuing a follow-up
Request for Information (RFI) as part of
its effort to gauge feedback from the
biomedical research community to
inform the implementation of
recommendations from the Advisory
Committee to the Director Working
Group on Re-envisioning NIHSupported Postdoctoral Training.
DATES: The RFI is open for public
comment for a period of 90 days and
will close at 11:59 p.m. (EST) on
October 23, 2024. Please ensure prompt
response to this RFI to ensure
consideration.
ADDRESSES: Submissions can be sent
electronically to: (https://
rfi.grants.nih.gov/?s=6660cc1aa1264
f88920cf122). Responses to this RFI are
voluntary and may be submitted
anonymously. You may voluntarily
include your name and contact
information with your response. If you
choose to provide NIH with this
information, NIH will not share your
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
name and contact information outside of
NIH unless required by law. Responses
must be received by October 23, 2024,
11:59 p.m. to ensure consideration.
FOR FURTHER INFORMATION CONTACT:
Questions about this request for
information should be directed to:
Ericka M. Boone, Director, Division of
Biomedical Research Workforce, at (301)
496–0180 or reenvisionpostdoc@
nih.gov.
SUPPLEMENTARY INFORMATION: The
National Institutes of Health (NIH) is
seeking feedback from the biomedical
research community on the
implementation of specific
recommendations proposed by the
Advisory Committee to the Director
(ACD) in accordance with 42 U.S.C.
217a, section 222 of the Public Health
Service Act, for Re-envisioning NIHsupported Postdoctoral Training. This
Request for Information (RFI) aims to
gather insights and suggestions to
inform the effective implementation of
recommendations across NIH-funded
research institutions.
Background Information
NIH established an Advisory
Committee to the Director Working
Group on Re-Envisioning NIHSupported Postdoctoral Training
(https://acd.od.nih.gov/working-groups/
postdocs.html) (ACD Postdoctoral WG)
to explore the status of the postdoctoral
training system, identify and
understand critical factors and issues
relating to the perceived decline in the
number of postdoctoral scholars, and to
provide recommendations to address
these factors. As part of this ACD-led
effort, community input on the status of
the postdoctoral training system was
encouraged through four listening
sessions and through a February 2023
RFI: Re-envisioning U.S. Postdoctoral
Research Training and Career
Progression within the Biomedical
Research Enterprise (https://
grants.nih.gov/grants/guide/notice-files/
NOT-OD-23-084.html). Input was
received from various members of the
biomedical research community,
including early-stage investigators,
biomedical faculty, training directors,
postdoctoral and graduate student office
leaders, biotech/biopharma industry
scientists, and research education
program advocates. Results from the
public listening sessions (https://
acd.od.nih.gov/documents/IMOD_
Postdoc_Listening_Sessions_
summary.pdf) and the previously
published RFI on Re-envisioning U.S.
Postdoctoral Research Training and
Career Progression within the
Biomedical Research Enterprise released
PO 00000
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60907
on February 14, 2023, and the follow-up
report (https://acd.od.nih.gov/
documents/RFI_Postdocs_Report_
2023.pdf) captured a wide range of
topics related to postdoctoral scholar
issues and challenges, including lack of
adequate salary and standard benefits,
poor job satisfaction, lack of
opportunities in academic careers,
negative work culture and the need for
high-quality mentorship. Additionally,
respondents provided diverse
suggestions for changes to existing NIH
policies, resources, and programs,
including those expansion of NIH
funding opportunities that can address
postdoctoral scholar research and career
development goals. Based on feedback,
the ACD Postdoctoral WG issued six (6)
high-level recommendations:
• Recommendation 1: Increase pay
and benefits for all NIH-supported
postdoctoral scholars.
• Recommendation 2: Create and
expand mechanisms to support the full
talent pool of postdoctoral scholars.
• Recommendation 3: Facilitate the
transition of postdoctoral scholars into
the next career stage, including roles
beyond academic faculty.
• Recommendation 4: Promote
training and professional development
of postdoctoral scholars and their
mentors.
• Recommendation 5: Support safe
and diverse perspectives and research
environments within institutional
research programs.
• Recommendation 6: Improve means
to measure and share postdoctoral
scholars’ career progression.
Please see the full ACD Postdoctoral
Scholar WG report at—https://
acd.od.nih.gov/documents/
presentations/12152023_Postdoc_
Working_Group_Report.pdf.
Information Requested
As a part of NIH’s ongoing efforts to
better support the postdoctoral scholar
workforce, the purpose of this RFI is to
solicit public input on how NIH might
most effectively implement certain
recommendations developed by the
ACD WG to address current challenges
affecting the postdoctoral trainee
community. NIH is particularly
interested in receiving input from
trainees (e.g., graduate students,
postdocs), as well as early-stage
investigators, biomedical faculty,
training directors, postdoctoral and
graduate student office leaders, biotech/
biopharma industry scientists, and
research education program advocates.
NIH encourages organizations (e.g.,
patient advocacy groups, professional
societies) to submit a single response
reflective of the views of the
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60906-60907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16594]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Adeno-
Associated Virus Vector-Mediated Gene Delivery of Human Aquaporin-1 To
Prevent Radiation-Induced Salivary Hypofunction
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Diabetes and Digestive and Kidney
Disease and National Institute of Dental and Craniofacial Research,
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 Australian,
Brazilian, Canadian, Chinese, European, Hong Kong, Israeli, Japanese,
South Korean, Mexican, Malaysian, New Zealand, Philippines, Singapore,
United States, and South African Applications listed in the
Supplementary Information section of this notice to MeiraGTx, LLC,
located in New York City, New York, USA.
DATES: Only written comments and/or applications for a license that are
received by the National Institute of Diabetes and Digestive and Kidney
Disease's Technology Advancement Office on or before August 13, 2024
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: Vladimir Knezevic, MD, (Senior) Advisor for
Commercial Evaluation, Technology Advancement Office, Building 12A,
Room 3011, Bethesda, MD 20817-5632 (for business mail), Telephone:
(301) 435-5560; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
I. ARIPO Patent Application AP/P/2024/015557 filed on February 28,
2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-AP-01).
II. Australian Patent Application 2022325158 filed on February 26,
2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-AU-01).
III. Brazilian Patent Application BR112024002194-7 filed on
February 7, 2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-
Induced Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-BR-
01).
IV. Canadian Patent Application 3227584 filed on January 31, 2024,
entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced Salivary
Hypofunction'' (HHS Reference Number E-129-2021-0-CA-01).
V. Chinese Patent Application 202280058429.9 filed on February 27,
2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-CN-01).
VI. Eurasian Patent Application 202490372 filed on March 1, 2024,
entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced Salivary
Hypofunction'' (HHS Reference Number E-129-2021-0-EA-01).
VII. European Patent Application 22786210.9 filed March 1, 2024,
entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced Salivary
Hypofunction'' (HHS Reference Number E-129-2021-0-EP-01).
VIII. Hong Kong Patent Application entitled ``AQP1 Gene Therapy To
Prevent Radiation-Induced Salivary Hypofunction'' (HHS Reference Number
E-129-2021-0-HK-01) with the priority filing date of August 4, 2021.
IX. Israeli Patent Application 310485 filed on January 29, 2024,
entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced Salivary
Hypofunction'' (HHS Reference Number E-129-2021-0-IL-01).
X. Japanese Patent Application 2024-506727 filed on February 2,
2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-JP-01).
XI. South Korean Patent Application 10-2024-7007179 filed on
February 29, 2024, published as 10-2024-0049295 on April 16, 2024,
entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced Salivary
Hypofunction'' (HHS Reference Number E-129-2021-0-KR-01).
XII. Mexican Patent Application MX/a/2024/001577 filed on February
1, 2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-MX-01).
XIII. Malaysian Patent Application PI2024000751 filed on February
2, 2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-MY-01).
XIV. New Zealand Patent Application 808619 filed on February 26,
2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-NZ-01).
XV. Philippines Patent Application 1-2024-550312 filed on February
2, 2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-PH-01).
XVI. Singapore Patent Application 11202400787X filed on February 2,
2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-SG-01).
XVII. United States Patent Application 18/294,048 filed on January
31, 2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-Induced
Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-US-02).
XVIII. South African Patent Application 2024/01677, filed on
February 27, 2024, entitled ``AQP1 Gene Therapy To Prevent Radiation-
Induced Salivary Hypofunction'' (HHS Reference Number E-129-2021-0-ZA-
01).
The patent rights for these inventions have been assigned 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 use of adeno-associated virus 2 vector-mediated gene
delivery of human aquaporin-1 for the prevention of radiation-induced
xerostomia (`dry mouth' syndrome).
The above-listed patent portfolio covers inventions directed to
gene therapy and specifically, expression vector and therapeutic method
of using such vector in the prevention of radiation-induced xerostomia.
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 receives written
evidence and argument that establishes that the grant of the license
would not be consistent with the
[[Page 60907]]
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 23, 2024.
Vladimir Knezevic,
Senior Advisor for Commercial Evaluation, Technology Advancement
Office, National Institute of Diabetes and Digestive and Kidney
Disease.
[FR Doc. 2024-16594 Filed 7-26-24; 8:45 am]
BILLING CODE 4140-01-P
