European Medical Groups Mount Legal Bid to Break Gilead’s Hold on HCV Drug

New patent battle focuses on Sovaldi, which costs thousands of dollars for a course

Sovaldi (sofosbuvir) cures 90% of hepatitis C virus (HCV) infections, bringing hope for millions of patients infected with the dangerous liver disease. But critics say the manufacturer, Gilead Sciences, has priced it out of the reach of many patients and public health systems. A single Sovaldi pill can cost up to $1,000.

Seeking to clear the way for a low-cost generic version of the drug, 30 groups from 17 European nations, including Doctors Without Borders (MSF) and Doctors of the World (MDM), filed a legal challenge with the European Patent Office in Munich on March 27. The new suit takes aim at the base compound used to make the drug.

In a previous challenge last October, MDM notched a partial victory when the European Patent Office upheld Gilead's patent but "in an amended form." The ruling protected sofosbuvir's component parts, but not the base compound itself.

In its previous legal filing, MDM had argued Gilead did not deserve the patent because the science behind the drug was not sufficiently innovative and relied on advances made by other private and public researchers.

According to the World Health Organization (WHO), between 130 million and 150 million people are chronically infected with the virus—a condition that leads to cirrhosis of the liver in 15–30% of cases within 20 years. The annual death toll from HCV-related liver diseases is around 700,000 according to the WHO website.

Gilead has not yet commented on the suit.

Source: Medical Xpress; March 27, 2017.