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MSF to oppose patent for Pfizer's pneumococcal conjugate vaccine PCV-13
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Ramesh Shankar, Mumbai
July 30 , 2016
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The international medical humanitarian organisation Médecins Sans
Frontières (MSF) will defend the rights of millions of children around
the world to be protected against pneumonia at a patent hearing on July
29 at India’s Patent Office on US pharmaceutical company Pfizer's
pneumococcal conjugate vaccine (PCV13). In March, the organisation had
filed a ‘patent opposition’ to prevent Pfizer from getting a patent on
this vaccine, so that more affordable versions can become available to
developing countries and humanitarian organisations.
MSF’s
challenge to Pfizer’s patent—a ‘pre-grant opposition,’ which is a form
of citizen review at the patent examination stage—shows that Pfizer’s
patent application lacks technical merit. Simply adding 6 serotypes to a
widely-used carrier protein (CRM197), in order to conjugate 13
serotypes of streptococcus pneumonia into a single carrier represents a
step that is considered ‘obvious’ to skilled vaccine developers.
Additionally, Pfizer’s response to the patent office does not provide
sufficient evidence to support its claims.
“The pneumonia vaccine
clearly does not merit patenting under India’s Patents Act and would
only result in artificially prolonging Pfizer’s market monopoly, which
keeps millions of children at risk of contracting this deadly killer,”
said Leena Menghaney, head of MSF’s Access Campaign in South Asia.
“India must rebuff demands from pharmaceutical companies, and tackle
low-quality patent applications which only add trivial technical changes
and often deprive millions of people from accessing more affordable
treatment and vaccines. Pfizer’s unmerited patent application on the
pneumonia vaccine should be rejected, opening the door to more
affordable versions of the vaccines being produced.”
One vaccine
producer in India has already announced that it could supply the
pneumonia vaccine for $6 dollars per child (for all three doses) to
public health programmes and humanitarian organisations like MSF. This
is almost half the current lowest global price of $10 dollars per child,
which is only available to a limited number of developing countries via
donor funding through Gavi, the Vaccine Alliance.
Pfizer has
priced the pneumonia vaccine, which it markets as Prevenar-13 out of
reach of many developing countries and humanitarian organisations. At
the lowest global price, it is now 68 times more expensive to fully
vaccinate a child than in 2001, according to a 2015 MSF report, 'The
Right Shot: Bringing down Barriers to Affordable and Adapted Vaccines',
with the pneumonia vaccine accounting for almost half of the price of
vaccinating a child in the poorest countries.
“The pneumonia
vaccine is the world’s best-selling vaccine, and last year alone, Pfizer
brought in more than US$6 billion dollars in sales just for this
product—meanwhile many developing countries, where millions of children
risk getting pneumonia, simply can’t afford it,” said Dr Greg Elder,
medical coordinator for MSF’s Access Campaign. “To make sure children
everywhere can be protected from deadly pneumonia, other companies need
to be allowed to enter the market so they can supply this vaccine for a
much lower price than what Pfizer charges.”
Pneumonia is the
leading cause of childhood death, killing almost one million children
each year. Currently, pharmaceutical companies Pfizer and
GlaxoSmithKline (GSK) are the only two manufacturers of the vaccine,
which could prevent a large number of these deaths. Broad use of the
vaccine could also reduce antibiotic use in children by 47 per cent each
year in an analysis conducted in 75 countries, helping to stem the
global rise of antibiotic resistance.
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