[Federal Register Volume 86, Number 173 (Friday, September 10, 2021)]
[Notices]
[Pages 50722-50723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Chimeric Live-
Attenuated Vaccine for West Nile Virus (WNV)

AGENCY: National Institutes of Health, Health and Human Services (HHS).

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 Blue Water Vaccines, Inc. (BWV), having a 
place of business in Cincinnati, Ohio, 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 September 27, 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 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 (now U.S. Patent Number 
10,058,602), U.S. Patent Application Number 16/025,624, filed July 2, 
2018 (now U.S. Patent Number 10,456,461), U.S. Patent Application 
Number 16/596,175, filed October 8, 2019 (now U.S. Patent Number 
10,869,920), U.S. Patent Application Number 16/952,864, filed November 
19, 2020, Israeli Patent Application Number 162949, filed January 9, 
2003 (now Israeli Patent Number 162949), Israeli Patent Application 
Number 209342, filed January 9, 2003 (now Israeli Patent Number 
209342), Canadian Patent Application Number 2472468, filed January 9, 
2003 (now Canadian Patent Number 2472468), Canadian Patent Application 
Number 2903126, filed August 27, 2015 (now Canadian Patent Number 
2903126), Australian Patent Application Number 2003216046, filed 
January 9, 2003 (now Australian Patent Number 2003216046), Australian 
Patent Application Number 2008203442 filed July 31, 2008 (now 
Australian Patent Number 2008203442), Australian Patent Application 
Number 2011250694, filed November 10, 2011 (now Australian Patent 
Number 2011250694), Australian Patent Application Number 2017203108, 
filed May 10, 2017 (now Australian Patent Number 2017203018), 
Australian Patent Application Number 2019203166, filed May 6, 2019 (now 
Australian Patent Number 2019203166), Australian Patent Application 
Number 2021203089, filed May 17, 2021, Japanese Patent Application 
Number 2003-559545, filed January 9, 2003 (now Japanese Patent Number 
4580650), 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), 
entitled ``Construction of West Nile Virus and Dengue Virus Chimeras 
for use in a Live Virus Vaccine to Prevent Disease Cause by West Nile 
Virus,'' [HHS Reference No. E-357-2001-0,1]; 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: ``Chimeric Live-Attenuated Vaccines 
for West Nile Virus (WNV) for use in animals or humans.''
    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. In 2012, 286 people in the United States 
died of WNV, according to the U.S. Centers for Disease Control and 
Prevention (CDC). Preliminary data for 2013 indicate over 1,200 cases 
of neuroinvasive disease

[[Page 50723]]

and 114 deaths due to WNV. During 2009-2018, a total of 21,869 
confirmed or probable cases of WNV disease, including 12,835 (59%) WNV 
neuroinvasive disease cases, were reported to CDC from all 50 states, 
the District of Columbia, and Puerto Rico.
    WNV 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. The virus can be found throughout Africa, regions 
of Europe and the Middle East, West Asia, Australia, Canada, Venezuela, 
and the United States. Outbreak areas are typically found along major 
bird migratory routes, with the largest outbreaks having occurred in 
Greece, Israel, Russia, Romania, and the United States. 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 in humans. 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 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: September 7, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-19566 Filed 9-9-21; 8:45 am]
BILLING CODE 4140-01-P