Gilead's Hepatitis C Drug Patent Challenged by 30 Groups Across Europe

A 12-week hepatitis C regimen costs $59,000 in Europe.

Doctors Without Borders and humanitarian groups across Europe are coordinating their opposition to Gilead Sciences Inc.’s patent for hepatitis C treatment sofosbuvir, the basis for the biopharmaceutical giant’s Sovaldi, Harvoni, and Epclusa drugs. Thirty organizations from 17 countries filed the challenge with the European Patent Office (EPO) on March 27 to increase access to the treatments.

“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.

Gilead charges 55,000 euros ($59,000) for a 12-week regimen in Europe, while a pill costs only about $1 to produce, the Brussels-based alliance said. “The asking prices are either entirely unaffordable or force rationing to a very limited number of patients,” it said.

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 sofosbuvir 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 sofosbuvir more available across Europe. Key patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in Argentina, India, Brazil, Russia, and Thailand, it said.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 sofosbuvir are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe,” said Aliénor Devalière (photo), EU policy adviser for MSF’s Access Campaign.

Gilead says its hepatitis C drugs have treated more than 1.3 million people worldwide and have cured more patients in the past 2 ½ years than in the previous 20 years combined. The patent in question has been granted in 19 other countries, including the United States and Canada, according to the Foster City, California-based company.

The EPO filings have no immediate impact on the patents or on Gilead’s exclusive right to sell sofosbuvir (Sovaldi), ledipasvir/sofosbuvir (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 health care budgets while also respecting our patents,” she said.

Sofosbuvir is one of several direct-acting antivirals (DAAs) that have come to market in the past few years. These pills have lifted hepatitis C cure rates above 90%, shortened treatment times, and reduced the debilitating side effects that patients suffered with the previous therapies that relied on interferon injections.

High prices, though, have kept the drugs out of reach for many of the 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 Isaac Chikwanha, hepatitis C medical adviser for MSF’s Access Campaign.

The news release and photo were provided by Doctors Without Borders and the Patent Opposition Database can be found here.

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