Prospective Grant of Exclusive Patent License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Zika and Dengue Vaccines, 65697-65698 [2018-27673]
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Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
ps193c@nih.gov; Telephone: (301) 496–
2644; Facsimile: (240) 627–3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application
Number 62/307,170, filed March 11,
2016 and entitled ‘‘Live Attenuated Zika
Virus Vaccines,’’ [HHS Reference No. E–
118–2016–0–US–01]; PCT Patent
Application Number PCT/US2017/
0021989, filed March 11, 2017 and
entitled ‘‘Live Attenuated Zika Virus
Vaccines,’’ [HHS Reference No. E–118–
2016–0–PCT–02]; Indian Patent
Application Number 201817036778
filed September 28, 2018 and entitled
‘‘Live Attenuated Zika Virus Vaccines,’’
[HHS Reference No. E–118–2016–0–IN–
09]; and U.S. and foreign patent
applications claiming priority to the
aforementioned applications.
The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective co-exclusive licensed
territory may be limited to India, and
the field of use may be limited to:
‘‘Monovalent live attenuated Zika
vaccines and multivalent live attenuated
flavivirus vaccines.’’
Zika virus (ZIKV) is an emerging
infectious disease that was first
identified in 1947, and that has more
recently become a major public health
threat around the world. ZIKV has
recently been shown to cause
devastating neurological damage in
infants and serious complications in
adults in some cases, and may have
other effects that have not yet been
identified or definitively linked to the
virus. There are no treatments or
vaccines for this insidious virus.
Recommendations that women who live
in or travel to endemic areas avoid
pregnancy for long periods of time are
unrealistic, particularly in contexts
where access to reproductive services is
limited, and threaten to leave those
most likely to suffer the devastating
consequences of Zika without effective
protection. There is therefore urgent
need to develop biomedical
interventions in parallel with ongoing
public health efforts against ZIKV.
No vaccine exists today to prevent
ZIKV infections. The methods and
compositions of this invention provide
a means for prevention of ZIKV
infection by immunization with live
attenuated, immunogenic viral vaccines
against ZIKV and/or Dengue virus.
Many entities, governmental,
academic, and commercial, are actively
pursuing development of ZIKV vaccines
each using a different approach to
address this public health need. The
U.S. Government is coordinating its
VerDate Sep<11>2014
00:00 Dec 21, 2018
Jkt 247001
vaccine development response to ZIKV
and has published this plan at https://
www.phe.gov/Preparedness/planning/
Pages/zika-white-paper.aspx.
Vaccine development approaches for
ZIKV include but are not limited to
inactivated virus (dead virus), live
attenuated virus (weakened virus),
recombinant viral vectors (weakened
virus with target genes added), and
subunit (portion of a virus) as well as
mRNA- and DNA-based (gene-targeted).
These various strategies provide
multiple redundancies, expanded
choice, and ensure short and long term
maximal benefits to the public.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective co-exclusive license
will be royalty bearing, and the
prospective co-exclusive license may be
granted unless within thirty (30) days
from the date of this published notice,
the National Institute of Allergy and
Infectious Diseases receives written
evidence and argument that establishes
that the grant of the licenses 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
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated co-exclusive patent
commercialization 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 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: December 11, 2018,
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–27672 Filed 12–20–18; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00076
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65697
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Production of Monovalent
Live Attenuated Zika Vaccines and
Multivalent Live Attenuated Zika and
Dengue Vaccines
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Commercialization
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the Summary
Information section of this notice to
Fundacao Butantan (Butantan), having a
place of business in Sao Paulo, Brazil.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before January 22,
2019 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Commercialization Patent
License should be directed to: Peter
Soukas, Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, National Institutes of Health,
5601 Fishers Lane, Suite 6D, Rockville,
MD 20852–9804; Email: ps193c@
nih.gov; Telephone: (301) 496–2644;
Facsimile: (240) 627–3117.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
U.S. Provisional Patent Application
Number 62/307,170, filed March 11,
2016 and entitled ‘‘Live Attenuated Zika
Virus Vaccines,’’ [HHS Reference No. E–
118–2016–0–US–01]; PCT Patent
Application Number PCT/US2017/
0021989, filed March 11, 2017 and
entitled ‘‘Live Attenuated Zika Virus
Vaccines,’’ [HHS Reference No. E–118–
2016–0–PCT–02]; U.S. Patent
Application Number 16/083,652 filed
September 10, 2018 and entitled ‘‘Live
Attenuated Zika Virus Vaccines,’’ [HHS
Reference No. E–118–2016–0–US–14];
Canadian Patent Application Number
3016697 filed March 11, 2017 and
entitled ‘‘Live Attenuated Zika Virus
Vaccines,’’ [HHS Reference No. E–118–
E:\FR\FM\21DEN1.SGM
21DEN1
amozie on DSK3GDR082PROD with NOTICES1
65698
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices
2016–0–CA–05]; Mexican Patent
Application Number MX/A/2018/
010958 filed March 11, 2017 and
entitled ‘‘Live Attenuated Zika Virus
Vaccines,’’ [HHS Reference No. E–118–
2016–0–MX–12]; Brazilian Patent
Application Number 1120180683426
filed September 11, 2018 and entitled
‘‘Live Attenuated Zika Virus Vaccines,’’
[HHS Reference No. E–118–2016–0–BR–
04]; Colombian Patent Application
Number NC2018/0010874 filed March
11, 2017 and entitled ‘‘Live Attenuated
Zika Virus Vaccines,’’ [HHS Reference
No. E–118–2016–0–CO–07]; and U.S.
and foreign patent applications claiming
priority to the aforementioned
applications.
The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective exclusive licensed
territory may be limited to the United
States of America, Canada, Mexico,
Brazil and Colombia, and the field of
use may be limited to: ‘‘Monovalent live
attenuated Zika vaccines and
multivalent live attenuated flavivirus
vaccines.’’
Zika virus (ZIKV) is an emerging
infectious disease that was first
identified in 1947, and that has more
recently become a major public health
threat around the world. ZIKV has
recently been shown to cause
devastating neurological damage in
infants and serious complications in
adults in some cases, and may have
other effects that have not yet been
identified or definitively linked to the
virus. There are no treatments or
vaccines for this insidious virus.
Recommendations that women who live
in or travel to endemic areas avoid
pregnancy for long periods of time are
unrealistic, particularly in contexts
where access to reproductive services is
limited, and threaten to leave those
most likely to suffer the devastating
consequences of Zika without effective
protection. There is therefore urgent
need to develop biomedical
interventions in parallel with ongoing
public health efforts against ZIKV.
No vaccine exists today to prevent
ZIKV infections. The methods and
compositions of this invention provide
a means for prevention of ZIKV
infection by immunization with live
attenuated, immunogenic viral vaccines
against ZIKV and/or Dengue virus.
Many entities, governmental,
academic, and commercial, are actively
pursuing development of ZIKV vaccines
each using a different approach to
address this public health need. The
U.S. Government is coordinating its
vaccine development response to ZIKV
and has published this plan at https://
VerDate Sep<11>2014
00:00 Dec 21, 2018
Jkt 247001
www.phe.gov/Preparedness/planning/
Pages/zika-white-paper.aspx.
Vaccine development approaches for
ZIKV include but are not limited to
inactivated virus (dead virus), live
attenuated virus (weakened virus),
recombinant viral vectors (weakened
virus with target genes added), and
subunit (portion of a virus) as well as
mRNA- and DNA-based (gene-targeted).
These various strategies provide
multiple redundancies, expanded
choice, and ensure short and long term
maximal benefits to the public.
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 thirty (30) days from the date of
this published notice, the National
Institute of Allergy and Infectious
Diseases receives written evidence and
argument that establishes that the grant
of the licenses 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
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization 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 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: December 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–27673 Filed 12–20–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Technology Transfer Centers
(TTC) Network Program Monitoring—
NEW
The Substance Abuse and Mental
Health Administration’s (SAMHSA) will
monitor program performance of its
Technology Transfer Centers (TTCs).
The TTCs disseminate current
behavioral health and HIV services
research from the National Institute on
Drug Abuse, National Institute on
Alcohol Abuse and Alcoholism,
National Institute of Mental Health,
Agency for Healthcare Research and
Quality National Institute of Justice, and
other sources, as well as other SAMHSA
programs. To accomplish this, the TTCs
develop and update state-of-the-art,
research-based curricula and
professional development training.
The TTCs hold a variety of events:
technical assistance events, meetings,
trainings, and learning collaboratives. A
TTC technical assistance event is
defined as a jointly planned
consultation generally involving a series
of contacts between the TTC and an
outside organization/institution during
which the TTC provides expertise and
gives direction toward resolving a
problem or improving conditions.
Technical assistance events can be
categorized into universal, targeted and
intensive. Other TTC events such as
meetings, training, strategic planning
and learning collaboratives are utilized
to support technical assistance. These
events are TTC-sponsored or cosponsored events in which a group of
people representing one or more
agencies other than the TTC work
cooperatively on a project, problem,
and/or policy.
SAMHSA intends to use five (5)
instruments for program monitoring of
TTC events as well as ongoing quality
improvement, which are described
below.
1. Event Description Form (EDF): The
EDF collects event information. This
instrument asks approximately 10
questions of TTC faculty/staff relating to
the event focus and format. It allows the
TTCs and SAMHSA to track the number
of events held (See Attachment 1).
2. TTC Post Event Form—Domestic:
The Post Event Form—Domestic will be
administered immediately following the
event. It asks approximately 11
questions of each individual that
participated in the event (Attachment
2). The instrument asks the participants
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65697-65698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27673]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Production of
Monovalent Live Attenuated Zika Vaccines and Multivalent Live
Attenuated Zika and Dengue Vaccines
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive
Commercialization Patent License to practice the inventions embodied in
the Patents and Patent Applications listed in the Summary Information
section of this notice to Fundacao Butantan (Butantan), having a place
of business in Sao Paulo, Brazil.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Allergy and Infectious
Diseases' Technology Transfer and Intellectual Property Office on or
before January 22, 2019 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated Exclusive Commercialization
Patent License should be directed to: Peter Soukas, Technology Transfer
and Patent Specialist, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, National
Institutes of Health, 5601 Fishers Lane, Suite 6D, Rockville, MD 20852-
9804; Email: ps193c@nih.gov; Telephone: (301) 496-2644; Facsimile:
(240) 627-3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application Number 62/307,170, filed March
11, 2016 and entitled ``Live Attenuated Zika Virus Vaccines,'' [HHS
Reference No. E-118-2016-0-US-01]; PCT Patent Application Number PCT/
US2017/0021989, filed March 11, 2017 and entitled ``Live Attenuated
Zika Virus Vaccines,'' [HHS Reference No. E-118-2016-0-PCT-02]; U.S.
Patent Application Number 16/083,652 filed September 10, 2018 and
entitled ``Live Attenuated Zika Virus Vaccines,'' [HHS Reference No. E-
118-2016-0-US-14]; Canadian Patent Application Number 3016697 filed
March 11, 2017 and entitled ``Live Attenuated Zika Virus Vaccines,''
[HHS Reference No. E-118-
[[Page 65698]]
2016-0-CA-05]; Mexican Patent Application Number MX/A/2018/010958 filed
March 11, 2017 and entitled ``Live Attenuated Zika Virus Vaccines,''
[HHS Reference No. E-118-2016-0-MX-12]; Brazilian Patent Application
Number 1120180683426 filed September 11, 2018 and entitled ``Live
Attenuated Zika Virus Vaccines,'' [HHS Reference No. E-118-2016-0-BR-
04]; Colombian Patent Application Number NC2018/0010874 filed March 11,
2017 and entitled ``Live Attenuated Zika Virus Vaccines,'' [HHS
Reference No. E-118-2016-0-CO-07]; and U.S. and foreign patent
applications claiming priority to the aforementioned applications.
The patent rights in this invention have been assigned to the
Government of the United States of America.
The prospective exclusive licensed territory may be limited to the
United States of America, Canada, Mexico, Brazil and Colombia, and the
field of use may be limited to: ``Monovalent live attenuated Zika
vaccines and multivalent live attenuated flavivirus vaccines.''
Zika virus (ZIKV) is an emerging infectious disease that was first
identified in 1947, and that has more recently become a major public
health threat around the world. ZIKV has recently been shown to cause
devastating neurological damage in infants and serious complications in
adults in some cases, and may have other effects that have not yet been
identified or definitively linked to the virus. There are no treatments
or vaccines for this insidious virus. Recommendations that women who
live in or travel to endemic areas avoid pregnancy for long periods of
time are unrealistic, particularly in contexts where access to
reproductive services is limited, and threaten to leave those most
likely to suffer the devastating consequences of Zika without effective
protection. There is therefore urgent need to develop biomedical
interventions in parallel with ongoing public health efforts against
ZIKV.
No vaccine exists today to prevent ZIKV infections. The methods and
compositions of this invention provide a means for prevention of ZIKV
infection by immunization with live attenuated, immunogenic viral
vaccines against ZIKV and/or Dengue virus.
Many entities, governmental, academic, and commercial, are actively
pursuing development of ZIKV vaccines each using a different approach
to address this public health need. The U.S. Government is coordinating
its vaccine development response to ZIKV and has published this plan at
https://www.phe.gov/Preparedness/planning/Pages/zika-white-paper.aspx.
Vaccine development approaches for ZIKV include but are not limited
to inactivated virus (dead virus), live attenuated virus (weakened
virus), recombinant viral vectors (weakened virus with target genes
added), and subunit (portion of a virus) as well as mRNA- and DNA-based
(gene-targeted). These various strategies provide multiple
redundancies, expanded choice, and ensure short and long term maximal
benefits to the public.
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
thirty (30) days from the date of this published notice, the National
Institute of Allergy and Infectious Diseases receives written evidence
and argument that establishes that the grant of the licenses 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 timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent
commercialization 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 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: December 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-27673 Filed 12-20-18; 8:45 am]
BILLING CODE 4140-01-P
