On the 10th of February 2015, Doctors of the World – Médecins du Monde (MdM) filed[1] its opposition to the patent granted for sofosbuvir with the European Patent Office (EPO).  

 

sofosbuvir leaflet coverFor several months, MdM, along with other organisations, has been warning of the problems posed by the cost of new treatments for hepatitis C and of sofosbuvir[2] in particular. The Gilead pharmaceutical lab holds a monopoly for sofosbuvir and is marketing a 12-week treatment at an exorbitant price – 41 000 euros in France and 44 000 euros in the United Kingdom – thereby hindering many people’s access to the drug.

Opposition to a patent is a legal recourse by which the validity of a patent may be challenged and which, if successful, will in this instance encourage competition from generic versions of sofosbuvir[3] costing just 101 dollars. While using sofosbuvir to treat hepatitis C represents a major therapeutic advance, the molecule itself, which is the result of work by many public and private researchers, is not sufficiently innovative to warrant a patent. As Gilead is abusing its patent to impose prices which are unsustainable for healthcare systems, Doctors of the World – Médecins du Monde has decided to contest it; this is the first time in Europe that a medical NGO has employed this route to improve patient access to drugs.

“We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,” explains Dr Jean-François Corty, MdM’s French Programmes Director. He goes on to add that: “Even in a ‘rich’ country like France, with an annual drugs budget of 27 billion euros, it’s hard to meet this cost and already we’re seeing an arbitrary rationing approach that excludes patients from care.”

According to the World Health Organisation (WHO), an estimated 130 to 150 million individuals are chronic carriers of hepatitis C. Within the EU, between 7.3 and 8.8 million people are believed to be infected with hepatitis C. In France, 230 000 people are reportedly chronic carriers of hepatitis C.

“Opposition to a patent has already been used by civil society in India and Brazil to get improperly granted patents for drugs revoked and to make generic versions available,” explains Olivier Maguet, MdM board member delegate for hepatitis C. He concludes by saying that: “This has led to a discernible drop in the cost of treatments and to patients being treated who would otherwise not have had the chance.”

 

Doctors of the World – Médecins du Monde is taking up the fight to promote universal access to treatment for hepatitis C in Europe and the rest of the world. We are also launching a public debate in France on drug-price fixing and its impact on the healthcare system.

[1] With the legal and technical advice of I-Mak and Lionel Vial.

[2] Sofosbuvir is a direct-acting antiviral (DAA) used in the treatment of hepatitis C.

[3] Hill A, van de Ven N, Simmons B, et al. Minimum target prices for production of treatment and associated diagnostics for Hepatitis C in developing countries (Abstract LBPE12). Poster presented at: 20th International AIDS Conference; 2014 July 20–25; Melbourne, Australia.

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Download the full press briefing here.

Download the Technical file (with facts, evidence and arguments in support of the grounds of opposition).

Visit www.oppositionaubrevet.medecinsdumonde.org for information in French.

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In response to the March 4 article by Richard Bergström (Director General of EFPIA) entitled “Attacking the Patent System for Pricing Issues Is a Non-Starter,” Doctors of the World seeked to address several factual errors and misrepresentations, here.

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