[Federal Register Volume 82, Number 106 (Monday, June 5, 2017)]
[Notices]
[Pages 25804-25805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11491]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Production of
Attenuated West Nile Virus Vaccines
AGENCY: National Institutes of Health, Department of Health and Human
Services.
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 the International Medica Foundation located
in Shoreview, Minnesota, 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 June 20, 2017 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: [email protected]; Telephone: (301) 594-8730; Facsimile:
(240) 627-3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-357-2001/0,1, Pletnev et al., ``Construction of West Nile Virus
and Dengue Virus Chimeras for use in a Live Virus Vaccine to Prevent
Disease Cause by West Nile Virus,'' U.S. Provisional Patent Application
Number 60/347,281, filed January 10, 2002, PCT Patent Application
Number PCT/US2003/00594, filed January 9, 2003, U.S. Patent Application
Number 10/871,775 filed June 18, 2004 (now U.S. Patent Number
8,778,671), U.S. Patent Application Number 14/305,572, filed June 16,
2014, European Patent Application Number 03729602.7, filed January 9,
2003, Israeli Patent Application Number 162949, filed January 9, 2003
(now Israeli Patent Number 162949), Canadian Patent Application Number
2472468, filed January 9, 2003 (now Canadian Patent Number 2472468),
Australian Patent Application Number 2003216046, filed January 9, 2003
(now Australian Patent Number 2003216046), Japanese Patent Application
Number 2003-559545, filed January 9, 2003 (now Japanese Patent Number
4580650), Australian Patent Application Number 2008203442 filed July
31, 2008 (now Australian Patent Number 2008203442), Israeli Patent
Application Number 209342, filed January 9, 2003 (now Israeli Patent
Number 209342), European Patent Application Number 11000126.0, filed
January 9, 2003 (now European Patent Number 2339011, validated in
Belgium, Great Britain, the Netherlands, Norway, Germany, Denmark and
France), Australian Patent Application Number 2011250694, filed
November 10, 2011 (now Australian Patent Number 2011250694), Australian
Patent Application Number 2013213749, filed August 9, 2013, European
Patent Application Number 15163537.2, filed April 14, 2015, and
Canadian Patent Application Number 2903126, filed August 27, 2015, and
U.S. and foreign patent applications
[[Page 25805]]
claiming priority to the aforementioned applications.
E-006-2007/0, Pletnev et al., ``Synergistic Internal Ribosome Entry
Site/MicroRNA Based Approach for Attenuation of Flaviviruses and Live
Vaccine Development,'' U.S. Provisional Patent Application Number 62/
443,214, filed January 6, 2017, 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.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to live attenuated West Nile Virus
vaccines for use in humans or animals.
West Nile virus (WNV) is a positive-strand RNA virus of the family
Flaviviridae, part of the Japanese encephalitis virus serocomplex that
includes important human pathogens such as Murray Valley encephalitis,
Japanese encephalitis, and St. Louis encephalitis viruses. WNV has been
present in Africa and Asia for decades and has usually been associated
with mild illness that includes symptoms of low-grade fever, headache,
rash, myalgia, and arthralgia. Recently, WNV has spread rapidly across
the Western hemisphere and is now the major vector-borne cause of viral
encephalitis in the United States. By 2010, 3 million adults were
estimated to have been infected with WNV in the United States, with
nearly 13,000 cases of neuroinvasive disease, almost half of which
occurred in adults greater than 60 years of age. In this age group, WNV
infection can cause hepatitis, meningitis, and encephalitis, leading to
paralysis, coma, and death. WNV is considered an emerging infection in
the United States and presents a significant public health threat. This
epidemiological trend of WNV suggests that the United States can expect
periodic WNV outbreaks, underscoring the need for a safe and effective
vaccine to protect at-risk populations, especially older adults.
WNV is also a significant worldwide public health threat. Starting
in the mid-1990s, the frequency, severity, and geographic range of WNV
outbreaks increased, and outbreaks of WNV meningitis and encephalitis
affecting primarily adults struck Bucharest, Romania, in 1996,
Volgograd, Russia, in 1999, and Israel, in 2000. WNV crossed the
Atlantic and reached the Western hemisphere in the summer of 1999 when
a cluster of patients with encephalitis was reported in the
metropolitan area of New York City, New York, in the United States, and
within 3 years the virus had spread to most of the contiguous U.S. and
the neighboring countries of Canada and Mexico. In addition, although
few human cases have been reported, WNV has also been found in Central
and South America through surveillance studies in field specimens,
suggesting a potential risk for an outbreak in humans. In the
approximately eighty (80) years since its discovery, the virus has
propagated to a vast region of the globe and is now considered the most
important causative agent of viral encephalitis worldwide.
No vaccine exists today to prevent WNV. The methods and
compositions of this invention provide a means for prevention of WNV
infection by immunization with live attenuated, immunogenic viral
vaccines against WNV.
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 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 24, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-11491 Filed 6-2-17; 8:45 am]
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