Doctors Without Borders Among 30 Groups to Challenge HCV Drug Patent in Europe

On March 27, 2017, Doctors Without Borders released a statement saying that, in order to increase access to treatment, it was among 30 organizations from 17 countries to file a challenge with the European Patent Office (EPO) against Gilead Sciences Inc's patent for the hepatitis C (HCV) drug, sofosbuvir (Sovaldi).

Sofosbuvir is one of several direct-acting antivirals (DAAs) that have come to market in the past few years. Recently, the US Food and Drug Administration approved an indication for Sovaldi as well as ledipasvir/sofosbuvir (Harvoni), to treat HCV infection in children ages 12 years and over. These are the first two DAAs to be approved to treat HCV in children or adolescents in the United States. The safety and efficacy of Sovaldi in combination with ribavirin was examined in an open-label clinical trial that included 50 patients within that age group. The combination successfully treated 100% of patients with HCV genotype 2, and 97% of patients with HCV genotype 3, after 12 weeks of the final dose. The researchers observed that success rates in children were “comparable to those observed in adults.” However, reports of reactivation of hepatitis B in coinfected patients have come to light.

Sovaldi has lifted HCV cure rates above 90% in adults, shortened treatment times, and reduced the debilitating side effects that patients suffered with the previous therapies that relied on interferon injections. Gilead says its HCV drugs have treated more than 1.3 million people worldwide and have cured more patients in the past two and a half years than in the previous 20 years combined. The patent in question has been granted in 19 other countries, including in the United States and Canada, according to the California-based company.

High prices, though, have kept the drugs out of reach for many of the 80 million people worldwide living with HCV. Although it costs only around $1 to produce a Sovaldi pill, Gilead charges 55,000 euros ($59,000) for a 12-week regimen of the drug in Europe, the Brussels-based alliance said. This leaves many infected with HCV unable to afford treatment.

“Patent-based monopolies and exclusivities encourage price-setting at extreme levels,” according to the European Public Health Alliance (EPHA), whose members include patient advocates and health care professionals. However, Members of the public can challenge a European patent granted by the EPO. After a review, the patent may be upheld for use in Europe, but it might also be revoked or its duration shortened on the continent. Doctors Without Borders, a Geneva-based non-profit that delivers medical aid worldwide, contends that Sovaldi doesn’t deserve a patent at all because the base compound isn’t new. The group, known internationally as Médecins Sans Frontières (MSF), says a successful challenge could make generic Sovaldi more available across Europe. Key patents on Sovaldi have already been revoked in China and Ukraine, and decisions are pending in Argentina, India, Brazil, Russia, and Thailand, it said.

“Gilead’s patent monopolies on Sovaldi are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe,” said Aliénor Devalière, EU policy adviser for MSF’s Access Campaign.

The EPO filings have no immediate impact on the patents or on Gilead’s exclusive right to sell Sovaldi, Harvoni and velpatasvir/sofosbuvir (Epclusa) in the European Union, Gilead spokesperson Sarah Swift said. “Gilead is committed to delivering our innovative medicines in a way that is economically sustainable and respects healthcare budgets while also respecting our patents,” she said.

“Treatment should be available to everyone who needs it, no matter where they live—including in Europe,” said Isaac Chikwanha, hepatitis C medical adviser for MSF’s Access Campaign.