The international medical humanitarian organisation Médecins Sans Frontières (MSF) has, on March 27th, 2017, filed a patent challenge on the hepatitis C drug sofosbuvir with the European Patient Office (EPO) in an effort to increase access to affordable hepatitis C treatment. MSF has joined 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.
"The price of sofosbuvir is keeping treatment out of reach for 71 millions of people who need it, and treatment is being rationed or is just unavailable across the globe, including Europe", explains Dr Vic Arendt, President of the MSF Foundation for the Humanitarian Research. "Sofosbuvir is today unreachable for thoudands of patients because of its price, and the treatment is not available, or restricted because of its price, 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."
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.
Gilead’s patent monopolies on sofosbuvir are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe.
“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 Paul Delaunois, General Director of MSF Luxembourg. “Or this patent is attackable because the scientific knowledge that allowed the development of sofosbuvir are not new. This is only the gathering of two famous molecules, which is not very original ". The criteria for patentability must be more restrictive and punish a real innovation in order to avoid practices that conduct to excessive patenting of medicines; this would allow generic manufactures to work on hepatitis C treatment at an affordable price for people who need to be treated.
Access to affordable medicines has become a global challenge. Countries where Gilead retains monopoly control over sofosbuvir cannot import or produce generic versions. In a few countries, such as India, which has a very strict policy to grant a patent, Gilead has not been able to protect sofosbuvir. As a result, the pharmaceutical company was forced to negotiate voluntary licensing agreements allowing the production and distribution of the drug in generic form. In these countries, it costs less than 300€ to cure a patient living with hepatitis C.
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,” says Paul Delaunois. “MSF has filed or supported patent challenges in many countries.”
MSF has filed or supported patent challenges in many countries.
The opposition to the patent filed by civil society also encourages states to take measures, such as price renegotiation with Gilead, as France has successfully done and has obtained a significant rebate on the price of sofosbuvir. Or to adopt measures that would allow the importation of generic versions of sofosbuvir, such as the granting of compulsory licenses.
Note: Copies of these patent oppositions will be available on the Patent Oppositions Database (an online resource for groups and individuals wanting to challenge patents on medicines)