[Ip-health] KEI and MSF release comments on the proposed license of Zika vaccine candidates to PaxVax
kim.treanor at keionline.org
Mon Nov 13 13:01:48 PST 2017
KEI and MSF release comments on the proposed license of Zika vaccine
candidates to PaxVax
The National Institutes of Health is proposing giving an exclusive license
to multiple Zika vaccine candidates to PaxVax, a company with close ties to
the federal government.
The NIH-owned vaccine technologies are different from the Zika vaccine
candidate the U.S. Army had proposed licensing to Sanofi. In the
Sanofi/Army case, when BARDA withdrew funding for the late stage clinical
trials, Sanofi withdrew from the license negotiations.
The MSF / KEI submission
In comments submitted today, Knowledge Ecology International (KEI) and
Doctors Without Borders/Médecins Sans Frontières (MSF) provided a joint
submission which opposes the use of an exclusive license to the patents on
a National Institute of Allergy and Infectious Diseases (NIAID) vaccine.
The KEI and MSF joint letter also proposes that if the NIH insists on
proceeding with an exclusive license to PaxVax, it include the following
measures on pricing and transparency:
1. That PaxVax agree to market the publicly-funded vaccine in the United
States at a price no higher than the median price charged in other
countries with large GDPs and at least half of US per capita income, and
2. That PaxVax disclose the steps it will take to make the vaccine
available at an affordable price in every country with a demonstrated need.
KEI and MSF are also requesting more information on what technology is
included in this licensing agreement. We believe that two vaccines are
being considered, one of which is already in phase 2 clinical trials. In
our comments, we ask what funds have been invested by the federal
government, and about plans for future funding prospects.
If approved, the vaccine will likely earn PaxVax a publicly-resourced
priority review voucher worth $100 to $200 million, twelve years of
exclusive rights to test data, seven years of exclusive rights under the
Orphan Drug Act, tax credits under the Orphan Drug Tax Credit currently
equal to 50 percent of the costs of conducting trials, and a period of
years during which no other company can realistically register a biosimilar
vaccine, regardless of the patent status. Given these benefits, and the
fact that one of the vaccines is already in advanced stage clinical trials,
an exclusive license does not appear to be legal, under the under the
standards set out in 35 U.S.C. § 209.
KEI also provided a separate letter that raises concerns about the
appearance of a conflict of interest. Cerberus Capital Management acquired
a majority interest in PaxVax in late 2015. The co-founder and CEO of
Cerberus is Steve Feinberg, who gave millions to the Trump Presidential
Campaign. The founder and former CEO of PaxVax, Ken Kelley, has been
working as a White House Presidential Executive Fellow since 2015, advising
NIAID, and working on the government’s response to the Zika outbreak. The
potential of a conflict of interest between interested parties in PaxVax
and parties within the federal government calls for a higher level of
transparency into the transfer of any publicly funded technology.
Knowledge Ecology International
kim.treanor at keionline.org
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