[Ip-health] MSF & I-MAK: Gilead attempt to secure patent on hepatitis C drug opposed in India

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Fri Nov 22 09:32:02 PST 2013

Gilead attempt to secure patent on hepatitis C drug opposed in India

‘Patent opposition’ seeks to ensure production of affordable generics


New Delhi/New York, 22 November 2013—Médecins Sans Frontières (MSF)
supports the ‘patent opposition’ just filed at India’s Patent Office by the
Initiative for Medicines, Access & Knowledge (I-MAK), which aims to prevent
US pharmaceutical company Gilead/Pharmasset from gaining a patent in India
on sofosbuvir, a drug for hepatitis C that is coming to market soon with an
anticipated exorbitant price.

Gilead is expected to charge around $80,000 for one treatment course of
sofosbuvir in the US. Even if offered at a fraction of this price in
developing countries, this drug will be priced out of reach. The patent
opposition—a form of citizen review allowed in many countries—offers
technical grounds to show a drug does not merit patenting under India's
Patents Act. This opposition was filed to ensure that affordable generic
versions of sofosbuvir can be produced to help the millions of people
infected with chronic hepatitis C in developing countries access the drug.

“Old science, known compound,” said Tahir Amin, lawyer and director of
I-MAK.org. “India’s patent law doesn’t give monopolies for old science or
for compounds that are already in the public domain. We believe this patent
on sofosbuvir does not deserve to be granted in India and have the legal
grounds to prove it.”

Sofosbuvir is the first of several oral hepatitis C drugs expected to come
to market in the coming year. It cures hepatitis C in a much shorter time
period than today’s available treatment, and for some forms of hepatitis C,
eliminates the need to use the injectable drug pegylated interferon, which
can be difficult to administer and causes many serious side effects. Gilead
is anticipated to receive marketing approval for sofosbuvir in the US on 8

MSF has started providing hepatitis C treatment for a small number of
people co-infected with HIV in its clinic in Mumbai, but cost (as high as
$5,000 per patient) and complexity of today’s available treatment means
that patient numbers remain extremely low despite considerable needs.

“In our projects, we need access to medicines like sofosbuvir that are
easier for patients to take so we can expand treatment to more people. If
the drug is unaffordable, the majority of the most vulnerable groups will
remain untreated,” said Dr. Simon Janes, medical coordinator with MSF in
India. “We know from our experience providing HIV treatment over more than
a decade in dozens of developing countries that treatment needs to be
simple and affordable—preferably less than $500 to start with. An
unaffordable price for this drug will have a chilling effect on funders and
governments who need to start financing and providing treatment.”

The World Health Organization estimates there are 184 million people
infected with hepatitis C worldwide, with the disease causing half a
million deaths each year. The vast majority of these people live in
developing countries where—with the exception of Brazil and Egypt—there is
no provision for universal access to hepatitis C treatment in public
healthcare programmes.

“The world is waking up to a new crisis with hepatitis C,” said Olga
Stefanishina of the Ukrainian Community Advisory Board. “More and more
people are being diagnosed with chronic hepatitis C but are left to die
because there’s no affordable treatment. With this patent opposition in
India, we are starting the fight for better treatment that people can
afford and governments can provide. We have no time to wait for charity or
country-by-country negotiations—low cost generic drugs must be made
available to all high-burden countries without discrimination.”

India has been called the ‘pharmacy of the developing world,’ because it
produces many affordable generic versions of drugs patented elsewhere. More
than 80% of the HIV medicines used in developing countries come from India,
which is able to produce these medicines because its patent law sets the
bar high for which medicines do and do not merit patenting, allowing
generic manufacturers to compete for the market and drive prices down.

“The hepatitis C drugs coming out of the drug pipeline, including
sofosbuvir, are compounds that are relatively simple and cheap to make,”
said Dr. Andrew Hill, a pharmacologist at Liverpool University who has
published a study showing that sofosbuvir could be produced for as little
as US $62-$134 for a 12-week treatment course. “The profit projections for
the oral hepatitis C drugs are staggering, and stand in no relation to what
it costs to make these drugs.”

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: twitter.com/joanna_keenan


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