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MSF files patent challenge on hepatitis C drug sofosbuvir with European Patent Office
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Ramesh Shankar, Mumbai
March 31 , 2017
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Even as four cases challenging patent on hepatitis C drugs sofosbuvir,
velpatasvir and daclatasvir are pending in Indian Patent Office, the
international medical humanitarian organisation Médecins Sans Frontières
(MSF) has filed a patent challenge on sofosbuvir with the European
Patent Office (EPO) in an effort to increase access to affordable
hepatitis C treatment. It has now joined Médecins du Monde (MdM) and
other civil society organisations from 17 countries in simultaneously
filing patent challenges on the pharmaceutical corporation Gilead’s
monopoly on sofosbuvir, in a bid to remove the barriers that prevent
millions of people receiving treatment.
In India in February this
year, a group of NGOs including the Initiative for Medicines, Access
& Knowledge (I-MAK), Delhi Network of Positive People (DNP+) and MSF
had filed four patent challenge cases in India, two patent challenges
on daclatasvir, one on velpatasvir and a further challenge on
sofosbuvir. Sofosbuvir, velpatasvir and daclatasvir are all crucial to
the first line treatment options that cure people of hepatitis C and
stop the progression of liver disease.
Sofosbuvir forms the
backbone of most hepatitis C combination treatments for people, one of a
range of oral ‘direct-acting antivirals’ to come to market within the
last four years that has caused cure rates to skyrocket. In Europe,
Gilead charges as much as US$ 59,000 per 12-week sofosbuvir treatment
(€55,000) – in the United States, Gilead initially set the price at
$84,000, or a staggering $1,000 per pill. Meanwhile, studies have shown
that it costs less than $1 per pill to produce the drug, the MSF stated.
“With
an estimated 80 million people worldwide living with hepatitis C,
treatment should be available to everyone who needs it, no matter where
they live – including in Europe”, said Dr Isaac Chikwanha, Hepatitis C
Medical Advisor for MSF’s Access Campaign. “The price of sofosbuvir is
keeping treatment out of reach for millions of people who need it, and
treatment is being rationed or is just unavailable across the globe,
including in many of the countries where MSF works, such as Russia, and
many other middle-income countries including Thailand and Brazil. A drug
that cures doesn’t do any good if the people who need it can’t afford
it.”
“Gilead’s patent monopolies on sofosbuvir are blocking
access to affordable hepatitis C treatment, including generic versions,
in many countries including those in Europe”, said Aliénor Devalière, EU
Policy Advisor for MSF’s Access Campaign. “This patent can – and should
– be challenged; the science behind sofosbuvir isn’t new.”
Access
to affordable medicines has become a global challenge. Countries where
Gilead retains monopoly control over sofosbuvir cannot import or produce
generic versions; for many people living in some middle-income
countries, Gilead’s restrictive voluntary licensing agreements still
keep sofosbuvir out of reach for people and their governments. Patent
challenges – or patent oppositions – can remove or shorten the length of
a patent and enable the robust generic competition needed to
dramatically reduce prices. Key patents on sofosbuvir have already been
revoked in China and Ukraine, and decisions are pending in other
countries, including Argentina, India, Brazil, Russia and Thailand.
“Successful
patent oppositions have created access to life-saving drugs for
millions of people in the past, and are now being employed as a legal
measure to improve access to hepatitis C treatment,” said Yuanquiong Hu,
Legal Advisor for MSF’s Access Campaign. “MSF has filed or supported
patent challenges in many countries. People all over the world, and in
the projects where MSF works, need affordable access to life-saving
medicines.”
If the patent challenge is successful, it could
accelerate the availability of affordable generic versions of sofosbuvir
in Europe. It would also encourage all countries to take measures to
open up access to affordable generic versions of sofosbuvir by either
negotiating better deals with Gilead right now, and/or taking actions
including issuing compulsory licences to import or manufacture more
affordable generics.
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