[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65696-65697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-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 a Co-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 Medigen Vaccines Biologics Corp. (Medigen), 
having a place of business in Zhubei, Taiwan, and Panacea Biotec Ltd., 
having a place of business in New Delhi, India.

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 Co-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:

[[Page 65697]]

ps193c@nih.gov; 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]; Indian 
Patent Application Number 201817036778 filed September 28, 2018 and 
entitled ``Live Attenuated Zika Virus Vaccines,'' [HHS Reference No. E-
118-2016-0-IN-09]; 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 co-exclusive licensed territory may be limited to 
India, 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 co-exclusive license will be royalty bearing, 
and the prospective co-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 co-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. 2018-27672 Filed 12-20-18; 8:45 am]
 BILLING CODE 4140-01-P