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Ramesh Shankar, Mumbai March 31 , 2017
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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