[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]
 BILLING CODE 4140-01-P