[Ip-health] MSF launches challenge to Pfizer’s patent on the pneumonia vaccine in India, to increase access to more affordable versions

Joanna Keenan joanna.l.keenan at gmail.com
Fri Mar 11 02:51:16 PST 2016

Médecins Sans Frontières has today filed a challenge on the patent
application in India by Pfizer on its blockbuster pneumonia vaccine.

*MSF launches challenge to Pfizer’s patent on the pneumonia vaccine in
India, to increase access to more affordable versions *


*New Delhi/ New York, March 11, 2016* – Médecins Sans Frontières/Doctors
Without Borders (MSF) has filed a ‘patent opposition’ in India to prevent
US pharmaceutical company Pfizer from getting a patent on the pneumococcal
conjugate vaccine (PCV13), so more affordable versions can become available
to developing countries and humanitarian organisations. This is the first
time a vaccine (biosimilar) patent has been challenged in India by a
medical organisation, with the goal of millions more children being
protected against deadly pneumonia.

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. Pfizer has priced PCV13
(marketed as Prevenar) out of reach of many developing countries and
humanitarian organisations. It is now 68 times more expensive to vaccinate
a child than in 2001, according to a 2015 MSF report, *The Right Shot:
Bringing down Barriers to Affordable and Adapted Vaccines.* The pneumonia
vaccine accounts for almost half 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. Manica
Balasegaram, Executive Director of MSF’s Access Campaign. “To make sure
children everywhere can be protected from deadly pneumonia, other companies
need to enter the market to supply this vaccine for a much lower price than
what Pfizer charges.”

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.

In 2015, all 193 countries at the World Health Assembly passed a landmark
resolution demanding more affordable vaccines and increased transparency
around vaccine prices. “Last year, more than 50 countries spoke out against
high vaccine prices and about the difficulties of introducing new vaccines,
including Indonesia, Jordan and Tunisia. We can’t wait any longer for all
countries to be able to afford this vaccine,” said Balasegaram.

The pre-grant opposition—a form of citizen review at the patent examination
stage—submits technical grounds before the patent office to show that
claims that cover a certain aspect of a drug or vaccine do not merit
patenting under India’s Patents Act. An equivalent patent to the one
opposed today in India was already revoked by the European Patent Office
(EPO) and is currently being challenged in South Korea. Pfizer’s patent
application involves the methods of conjugating 13 serotypes of
streptococcus pneumonia into a single carrier.

“Our pre-grant opposition shows that the method Pfizer is trying to patent
is too obvious to deserve a patent under Indian law, and is just a way to
guarantee a market monopoly for Pfizer for many years to come,” said Leena
Menghaney, Head of MSF’s Access Campaign in South Asia. “India must rebuff
demands from pharmaceutical companies, which are backed by diplomatic
pressure tactics of the U.S. and other governments, that India change its
patentability standards to restrict generic competition. Pfizer’s unmerited
patent application on the pneumonia vaccine should be rejected, opening the
door to more affordable versions of the vaccines being produced.”

After years of fruitless negotiations with Pfizer to lower the vaccine’s
price for use in its projects, MSF is challenging this patent application
in India to ensure that manufacturers who are planning to produce the
pneumonia vaccine do not face key patent barriers at the time of launching
a more affordable version.

“Pneumonia kills a child every 35 seconds,” said Balasegaram. “As doctors
who have watched far too many children die of pneumonia, we’re not going to
back down until we know that all countries can afford this vaccine.”



To view Pfizer’s patent claims and patent opposition filed by MSF, access
this link:
This week, MSF’s Access Campaign launched an upgraded version of the Patent
Opposition Database <http://www.patentoppositions.org>, an online resource
for civil society and patient groups in developing countries that enables
sharing of technical information related to legal challenges of unwarranted
medical patents. The web-based searchable database, which already contains
technical documentation for more than 100 patent oppositions relating to
key medicines, now offers improved collaboration tools and easier
searching. Visit patentoppositions.org <http://www.patentoppositions.org/>.

Each year, MSF teams vaccinate millions of people, both as outbreak
response to diseases such as measles, meningitis, yellow fever and cholera,
as well as routine immunisation activities in projects where it provides
health care to mothers and children. In 2014 alone, MSF delivered more than
3.9 million doses of vaccines and immunological products. MSF has purchased
the pneumococcal conjugate vaccine (PCV), used to protect against
pneumonia, in the past for use in its emergency operations. MSF is scaling
up its use of PCV and other vaccines with a particular focus on improving
its work in routine immunisation, as well as extending the package of
vaccines used in humanitarian emergencies. MSF has vaccinated children
caught in emergencies with PCV in Central African Republic, Ethiopia, South
Sudan, and Uganda, among others.

In 2015, MSF launched its ‘A FAIR SHOT’ campaign to push for pharmaceutical
companies Pfizer and GSK to reduce the price of the pneumonia vaccine to $5
per child for all three doses. Visit afairshot.org.

Kind regards


*Joanna Keenan*
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan


More information about the Ip-health mailing list