[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24318-24319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11257]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Production of Monovalent
Live Attenuated Zika Vaccines and Multivalent Live Attenuated
Flavivirus Vaccines
AGENCY: National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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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 to Fundacao Butantan, having a place of
business in Sao Paulo, Brazil.
DATES: Only written comments and/or application for a license which are
received by the NIAID Technology Transfer and Intellectual Property
Office on or before June 25, 2018 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials 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: [email protected]; 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,''
Whitehead et al., and PCT Patent Application Number PCT/US2017/0021989,
filed March 11, 2017 and entitled ``Live Attenuated Zika Virus
Vaccines,'' Whitehead et al. [HHS Reference E-118-2016/0]; and U.S. and
foreign patent applications claiming priority to the aforementioned
applications.
The patent rights in these inventions have been assigned to the
government of the United States of America.
[[Page 24319]]
The field of use may be limited to monovalent live attenuated Zika
vaccines and multivalent live attenuated flavivirus vaccines. The
Licensed Territory may be limited to the United States of America,
Canada, Mexico, Brazil and Argentina.
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. While important, current measures
for mosquito control are insufficient in most settings to prevent the
spread of the 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 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 filed in response to this notice will be treated as objections
to the grant of the contemplated Exclusive Commercialization Patent
License Agreement. Comments and objections submitted to this notice
will not be made available for public inspection and, to the extent
permitted by law, will not be released under the Freedom of Information
Act, 5 U.S.C. 552.
Dated: May 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-11257 Filed 5-24-18; 8:45 am]
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