Prospective Grant of Exclusive Patent License: Improved Live-Attenuated Vaccine for Respiratory Syncytial Virus, 41855 [2021-16462]
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Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Improved Live-Attenuated
Vaccine for Respiratory Syncytial Virus
National Institutes of Health.
Notice.
AGENCY:
ACTION:
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
Codagenix, Inc. (Codagenix), having a
place of business in Farmingdale, New
York, U.S.A.
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 August 18,
2021 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;
Email: ps193c@nih.gov; Telephone:
(301) 496–2644; Facsimile: (240) 627–
3117.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Intellectual Property
U.S. Provisional Patent Application
Number 63/023,949, filed May 13, 2020
and PCT Patent Application Number
PCT/US2021/32305, filed May 13, 2021,
entitled ‘‘Improved Live-Attenuated
Vaccine for Respiratory Syncytial Virus
(RSV) Bearing Codon-Pair Deoptimized
NS1, NS2, N, P, M and SH Genes and
Additional Point Mutations in the P
Gene,’’ [HHS Reference No. E–104–
2020–0]; 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 worldwide, and the
field of use may be limited to: ‘‘Liveattenuated codon-deoptimized human
respiratory syncytial virus vaccine.’’
VerDate Sep<11>2014
17:21 Aug 02, 2021
Jkt 253001
RSV is the most important viral agent
of severe respiratory disease in infants
and young children worldwide and also
causes substantial morbidity and
mortality in older adults. RSV is
estimated to cause more than 33 million
lower respiratory tract illnesses, three
million hospitalizations, and nearly
200,000 childhood deaths worldwide
annually, with many deaths occurring
in developing countries. However,
despite the prevalence of RSV and the
dangers associated with infection, no
RSV vaccine has been successfully
developed to date. Accordingly, there is
a public health need for RSV vaccines.
This vaccine candidate comprises live
RSV that was attenuated by subjecting
the protein-coding sequences of the
viral NS1, NS2, N, P, M, and SH genes
to codon-pair deoptimization, which
resulted in many nucleotide
substitutions that were silent at the
amino acid level but conferred
attenuation. In addition, specific amino
acid substitutions were identified and
introduced into the P protein that
improved attenuation and genetic
stability. Genetic stability was
confirmed in vitro, and attenuation was
confirmed in experimental animals.
This live-attenuated RSV vaccine is
designed to be administered intranasally
by drops or spray to infants and young
children. Based on experience with
other live-attenuated RSV vaccine
candidates, the present candidates are
anticipated to be well tolerated in
humans and are available for clinical
evaluation. The National Institute of
Allergy and Infectious Diseases has
extensive experience and capability in
evaluating live-attenuated RSV vaccine
candidates in pediatric clinical studies.
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
Institute of Allergy and Infectious
Diseases 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 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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
41855
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.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–16462 Filed 8–2–21; 8:45 am]
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or before September 2, 2021.
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 86, Number 146 (Tuesday, August 3, 2021)]
[Notices]
[Page 41855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16462]
[[Page 41855]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Improved Live-
Attenuated Vaccine for Respiratory Syncytial Virus
AGENCY: National Institutes of Health.
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 Codagenix, Inc. (Codagenix), having a place
of business in Farmingdale, New York, U.S.A.
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 August 18, 2021 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; Email: [email protected]; Telephone: (301) 496-2644;
Facsimile: (240) 627-3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application Number 63/023,949, filed May
13, 2020 and PCT Patent Application Number PCT/US2021/32305, filed May
13, 2021, entitled ``Improved Live-Attenuated Vaccine for Respiratory
Syncytial Virus (RSV) Bearing Codon-Pair Deoptimized NS1, NS2, N, P, M
and SH Genes and Additional Point Mutations in the P Gene,'' [HHS
Reference No. E-104-2020-0]; 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 worldwide, and
the field of use may be limited to: ``Live-attenuated codon-deoptimized
human respiratory syncytial virus vaccine.''
RSV is the most important viral agent of severe respiratory disease
in infants and young children worldwide and also causes substantial
morbidity and mortality in older adults. RSV is estimated to cause more
than 33 million lower respiratory tract illnesses, three million
hospitalizations, and nearly 200,000 childhood deaths worldwide
annually, with many deaths occurring in developing countries. However,
despite the prevalence of RSV and the dangers associated with
infection, no RSV vaccine has been successfully developed to date.
Accordingly, there is a public health need for RSV vaccines. This
vaccine candidate comprises live RSV that was attenuated by subjecting
the protein-coding sequences of the viral NS1, NS2, N, P, M, and SH
genes to codon-pair deoptimization, which resulted in many nucleotide
substitutions that were silent at the amino acid level but conferred
attenuation. In addition, specific amino acid substitutions were
identified and introduced into the P protein that improved attenuation
and genetic stability. Genetic stability was confirmed in vitro, and
attenuation was confirmed in experimental animals.
This live-attenuated RSV vaccine is designed to be administered
intranasally by drops or spray to infants and young children. Based on
experience with other live-attenuated RSV vaccine candidates, the
present candidates are anticipated to be well tolerated in humans and
are available for clinical evaluation. The National Institute of
Allergy and Infectious Diseases has extensive experience and capability
in evaluating live-attenuated RSV vaccine candidates in pediatric
clinical studies.
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
Institute of Allergy and Infectious Diseases 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 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.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-16462 Filed 8-2-21; 8:45 am]
BILLING CODE 4140-01-P
