[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47537-47538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: DNA-Based Vaccine 
for Prevention of Zika Virus Infection

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases 
(NIAID), 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 PaxVax, Inc., located in 
Redwood City, California, to practice the inventions embodied in the 
patent applications listed in the Supplementary Information section of 
this notice.

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 November 13, 2017 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Dr. Amy Petrik, Technology 
Transfer and Patent Specialist, Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Suite 2G, MSC9804, Rockville, MD 20852-9804, phone 
number 301-496-2644, or [email protected].

[[Page 47538]]


SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property is to be licensed under the prospective agreement: HHS Ref. 
No. E-181-2016/0, including provisional patent applications 62/396,613 
filed September 19, 2016 entitled ``Zika Virus Vaccines'', and all 
continuing U.S. and foreign patents/patent applications for the 
technology family, to PaxVax Inc.
    All rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
and the field of use may be limited to: ``Development and use of DNA-
based vaccines expressing virus-like particle antigens comprising Zika 
virus membrane and/or envelope proteins for prevention of Zika virus 
infection in humans.''
    Since 2015, Zika virus (ZIKV) outbreaks have had a significant 
effect on global public health. The mosquito-borne disease, which 
causes several congenital abnormalities in the developing fetus, as 
well as other neurological disorders in infected individuals has no 
approved vaccine to treat or prevent infection. To address this 
critical need, several approaches are being explored for a vaccine 
against ZIKV infection in priority populations including women of 
child-bearing age and their partners.
    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.
    The subject invention relates to the use of nucleic acid molecules 
encoding Zika virus (ZIKV) proteins that when introduced in a cell 
produces noninfectious virus-like particles (VLPs) capable of eliciting 
a protective immune response against viral infection. More 
specifically, the subject vaccine is a DNA-based candidate encoding a 
polypeptide of a ZIKV membrane and envelope proteins that when 
expressed results in production of noninfectious VLPs that generate 
protective neutralizing antibodies against ZIKA infection. The vaccine, 
which is based on a similar vaccine developed for the related West Nile 
virus, is currently undergoing clinical trial evaluation. The subject 
invention has been advertised in the Federal Register and published on 
12 December 2016.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within thirty (30) days from the date 
of this published notice, the NIAID 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 License. 
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: October 5, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-21986 Filed 10-11-17; 8:45 am]
 BILLING CODE 4140-01-P