[Ip-health] NIH is also licensing patents on the Zika virus

Jamie Love james.love at keionline.org
Sat Dec 10 03:35:46 PST 2016

The notice published on Friday was from the Army, and it proposed an
exclusive license on several patents applied for but not published or
granted, on a Zika vaccine, to Sanofi Pasteur, which is described by the US
Army as a firm having its principal place of business as  Swiftwater,
​ (as opposed to Paris).​

​The NIH is also posting a notice of patents available for licensing, for
the Zika vaccine. ​

​KEI has asked the Army for information about the technologies and
licensing terms for the Sanofi license, but so far, not much information
has been forthcoming.   Agencies believe they can provide notice of an
exclusive license, but no details of the license terms, the maturity of the
development of a product, or in some cases, the people involved, making the
public comment exercise a bit of a sham.    Separately, we recently filed
comments in a NIST proceeding, to propose some reforms of the Bayh-Dole Act


Government-Owned Inventions; Availability for Licensing
A Notice by the National Institutes of Health on 12/12/2016

Publication Date:
Document Citation: 81 FR 89482
Document Number: 2016-29605
AGENCY: National Institutes of Health, HHS.


The invention listed below is owned by an agency of the U.S. Government and
is available for licensing to achieve expeditious commercialization of
results of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage for
companies and may also be available for licensing.


Licensing information and copies of the U.S. patent application listed
below may be obtained by communicating with the indicated licensing contact
at the Technology Transfer and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville,
MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement
will be required to receive copies of unpublished patent applications.

Technology description follows.

Zika Virus Vaccines
Description of Technology

Zika virus (ZIKV) is a flavivirus transmitted by mosquitos that is strongly
linked to neurological complications including Guillain-Barré syndrome,
meningoencephalitis, and microcephaly. The association between active ZIKV
infection during pregnancy and microcephaly and intrauterine growth
retardation in the fetus has been confirmed in murine models of ZIKV

Scientists at NIAID have developed nucleic acid-based vaccine candidates to
prevent ZIKV infection in humans. The current lead candidate vaccine is a
plasmid DNA vaccine demonstrated to accord protection in preclinical models
and is undergoing clinical trial evaluation. Nucleic acid-based vaccines
have been developed previously for West Nile virus, another flavivirus
similar to Zika (J.E. Ledgerwood, et al. J. Infect. Dis. (2011) 203 (10):
1396-1404). Immunization with the nucleic acid ZIKV vaccine candidate
results in production of noninfectious virus like particles (VLPs) made of
ZIKV proteins. These ZIKV VLPs elicit an immune response which includes
neutralizing antibodies to ZIKV.

Other preclinical ZIKV vaccine candidates include mRNA, protein, and
noninfectious VLPs.

NIAID is continuing development of these vaccine candidates. The DNA-based
ZIKV vaccine candidate is currently in clinical trials. Consequently, for
some fields of use, NIAID will evaluate a license applicant's capabilities
and experience in advancing similar technologies through the regulatory

This technology is available for licensing for commercial development in
accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further
development and evaluation under a research collaboration. This technology
is not eligible for NIH's start up license.

Potential Commercial Applications:
Prevention of Zika virus infection
Competitive Advantages:
There is currently no licensed Zika virus vaccine
Development Stage:
Currently, DNA-based vaccine candidate in Phase I clinical trial
Phase II clinical trial planned for early 2017 for DNA-based vaccine

Other candidates are in pre-clinical development

Inventors: Barney S. Graham (NIAID), Theodore C. Pierson (NIAID), Kimberly
A. Dowd (NIAID), John R. Mascola (NIAID), Wing-Pui Kong (NIAID), Sung-Youl
Ko (NIAID), Eun Sung Yang (NIAID), Wei Shi (NIAID), Lingshu Wang (NIAID),
Christina R. Demaso (NIAID), Rebecca S. Pelc (NIAID), Adrian Creanga
(NIAID), Julie Ledgerwood (NIAID), William Schief (The Scripps Research
Institute), Sebastian Ramisch (The Scripps Research Institute), Leda
Castilho (Federal University of Rio de Janeiro)

Publications: K.A. Dowd, et al., Science, 354, 237-240 (2016).

DOI: 10.1126/science.aai9137.

Intellectual Property: U.S. Patent Application No. 62/396,613 filed
September 19, 2016 (HHS Reference No. E-181-2016/0-US-01).

Licensing Contact: Dr. Amy Petrik, 240-627-3721; amy.petrik at nih.gov.

Collaborative Research Opportunity: The National Institute of Allergy and
Infectious Diseases is seeking statements of capability or interest from
parties interested in collaborative research to further develop, evaluate
or commercialize Zika virus vaccine technologies. For collaboration
opportunities, please contact Dr. Amy Petrik, 240-627-3721;
amy.petrik at nih.gov.

Dated: December 5, 2016.

Suzanne Frisbie,

Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.

[FR Doc. 2016-29605 Filed 12-9-16; 8:45 am]



James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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