[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65697-65698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Production of 
Monovalent Live Attenuated Zika Vaccines and Multivalent Live 
Attenuated Zika and Dengue Vaccines

AGENCY: National Institutes of Health, 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 Fundacao Butantan (Butantan), having a place 
of business in Sao Paulo, Brazil.

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 January 22, 2019 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) 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,'' [HHS 
Reference No. E-118-2016-0-US-01]; PCT Patent Application Number PCT/
US2017/0021989, filed March 11, 2017 and entitled ``Live Attenuated 
Zika Virus Vaccines,'' [HHS Reference No. E-118-2016-0-PCT-02]; U.S. 
Patent Application Number 16/083,652 filed September 10, 2018 and 
entitled ``Live Attenuated Zika Virus Vaccines,'' [HHS Reference No. E-
118-2016-0-US-14]; Canadian Patent Application Number 3016697 filed 
March 11, 2017 and entitled ``Live Attenuated Zika Virus Vaccines,'' 
[HHS Reference No. E-118-

[[Page 65698]]

2016-0-CA-05]; Mexican Patent Application Number MX/A/2018/010958 filed 
March 11, 2017 and entitled ``Live Attenuated Zika Virus Vaccines,'' 
[HHS Reference No. E-118-2016-0-MX-12]; Brazilian Patent Application 
Number 1120180683426 filed September 11, 2018 and entitled ``Live 
Attenuated Zika Virus Vaccines,'' [HHS Reference No. E-118-2016-0-BR-
04]; Colombian Patent Application Number NC2018/0010874 filed March 11, 
2017 and entitled ``Live Attenuated Zika Virus Vaccines,'' [HHS 
Reference No. E-118-2016-0-CO-07]; 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 limited to the 
United States of America, Canada, Mexico, Brazil and Colombia, and the 
field of use may be limited to: ``Monovalent live attenuated Zika 
vaccines and multivalent live attenuated flavivirus vaccines.''
    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. 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 licenses 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: December 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-27673 Filed 12-20-18; 8:45 am]
 BILLING CODE 4140-01-P