[Ip-health] Army extends comment period on Zika vaccine patent license to Sanofi, to March 10.

Jamie Love james.love at keionline.org
Fri Jan 27 00:49:48 PST 2017

Thanks to all of the persons who have worked on this, the US Army has now
extended the comment period on the Sanofi license for the Zika vaccine
patents to March 10.  This is the second extension of time for comment.  To
put into perspective, we have never been able to get a comment extension by
the NIH on its exclusive licenses.

Members of Congress have been pressing the Army to provide information
about the proposed license, including the federal funding of the vaccine
development, and Sanofi's actual contributions to the R&D funding, which
appear to be net zero, given the grants Sanofi is receiving for this.

Dr. Diane Singhroy is researching the manufacturing issues relating to the
vaccine, which is based upon an earlier vaccine developed in 2009, using
the same platform.

A pretty interesting account of the extensive role of HHS and the Army in
the development and funding of the vaccine is available in this NIH press
release from November 7, 2016.


"The experimental ZPIV vaccine is based on the same technology WRAIR used
in 2009 to successfully develop a vaccine for another flavivirus called
Japanese encephalitis. . . .  WRAIR, NIAID and the Biomedical Advanced
Research and Development Authority (BARDA) part of the HHS Office of the
Assistant Secretary for Preparedness and Response (ASPR) have established a
joint Research Collaboration Agreement to support the development of this

.... and the press release details the various trials the US government is
funding, and that "BARDA is funding the advanced development of the ZPIV
vaccine candidate through a six-year contract with Sanofi Pasteur, which
established a collaborative research and development agreement with WRAIR
to accelerate further development of the vaccine."

People might want to reflect on the future price negotiations over this
vaccine, when what is stake is a vaccine to prevent a baby from being born
with a small head and brain damage.   What's that worth these days?  If
Army grants the exclusive license, and the vaccine works, we will find out
what Sanofi thinks people will pay.

What we also don't know yet is what rights the NIH or the Army are giving
in the test data to Sanofi, the French company, for the trials the US
taxpayer is funding.

Here  is the federal register notice.



The Federal Register

Notice: Intent To Grant an Exclusive License of U.S. Government-Owned
A Notice by the Army Department on 01/27/2017

Publication Date: 01/27/2017
Agencies: Department of the Army
Document Type: Notice
Document Citation: 82 FR 8611
Page: 8611 (1 page)
Document Number: 2017-01851

The comment period for the Intent to Grant an Exclusive License of U.S.
Government-Owned Patents published in the Federal Register on Friday,
December 9, 2016 (81 FR 89087), required comments be postmarked on or
before December 24, 2016 and again on January 23, 2017. The comment period
has been extended to March 10, 2017.

Mr. Barry Datlof, Office of Research & Technology Assessment, (301)
619-0033. For patent issues, Ms. Elizabeth Arwine, Patent Attorney, (301)
619-7808, both at telefax (301) 619-5034.

Brenda S. Bowen,

Army Federal Register Liaison Officer.

[FR Doc. 2017-01851 Filed 1-26-17; 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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