[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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