Prospective Grant of Co-Exclusive Patent License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Zika and Dengue Vaccines
| Published date | 21 December 2018 |
| Record Number | 2018-27672 |
| Court | National Institutes Of Health |
Federal Register, Volume 83 Issue 245 (Friday, December 21, 2018)
[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]
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