Doctors of the World is today filing a patent challenge on a hepatitis C drug with the European Patent Office (EPO) in an attempt to bring down the price and increase access to treatment that can cure the disease. The drug, sofosbuvir (brand name Sovaldi), is made by the pharmaceutical company Gilead.

We have joined MSF, Just Treat and 30 other organisations in 17 countries in jointly filing a patent challenge on Gilead’s monopoly on the life-saving medicine.

Sofosbuvir is an oral ‘direct-acting antiviral’. It is part of most hepatitis C combination treatments and has led to a dramatic increase in cure rates.

The price, however, is also dramatic. In the UK the list price is £34,983 for a standard course. While the final price paid by NHS England is confidential it’s thought to be at least £20,000. Studies show that it costs 80p to make each pill.

Even at a price per person of £20,000 it would cost a staggering £4.3 billion to cure everyone in the UK of the disease.

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 keep sofosbuvir out of reach for people and their governments.

In the UK, 215,000 people are living with hepatitis C. The NHS has capped treatment at 10,000 people per year. Around the world, 80 million people are infected.

Nick Harvey, head of communications at DOTW, said: “Nobody is saying that pharmaceutical companies shouldn’t be making a profit, just not extortionate ones.

“We are in a situation where 350,000 people around the world are dying every year from hepatitis C completely unnecessarily because there is a cure.

“Life-saving medicine is taking a back seat to profits and that shouldn’t be the case.”

Patent challenges or 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Key patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in other countries, including Argentina, India, Brazil, Russia and Thailand.

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 now, and/or taking actions including issuing compulsory licences to import or manufacture more affordable generics.

For media enquiries contact Nick Harvey on nharvey@doctorsoftheworld.org.UK or 0207 167 5789.