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European Stakeholders Appeal EPO Ruling to Uphold Gilead's Sofosbuvir Patent

Samantha DiGrande
Recently, 6 European organizations appealed a European Patent Office (EPO) decision to uphold Gilead Science’s patent on the hepatitis C drug sofosbuvir, sold as Sovaldi.
Recently, 6 European organizations appealed a European Patent Office (EPO) decision to uphold Gilead Science’s patent on the hepatitis C drug sofosbuvir, sold as Sovaldi.

In March 2017, organizations from 17 European countries filed a challenge against Gilead’s patent that covers the base compound found in sofosbuvir, alleging that it lacked inventiveness. Despite the accusations, the EPO decided to uphold Gilead’s patent in September 2018, maintaining its exclusivity in the marketplace.

“The EPO is being too lenient with pharmaceutical corporations, giving them a free pass. There needs to be much greater scrutiny in Europe when it comes to determining whether pharmaceutical corporations deserve patents or not; otherwise, unmerited monopolies will continue to result in out-of-control drug prices,” said Olivier Maguet of Médecins du Monde.

Médicins du Monde, Medicines Sans Frontiéres (Doctors Without Borders), AIDES, Access to Medicines Ireland, Praksis, and Salud por Derecho appealed based on the claim that the EPO should revoke Gilead’s patent because it “does not meet the requirements to be a patentable invention from a legal or scientific perspective.”

To date, Gilead has maintained a monopoly on the hepatitis C drug market in Europe, which has, in turn, enabled the company to charge “excessive” prices for the drug.

“In some European countries, Gilead charges as much as 43,000 euros for a 12-week treatment course, when generic versions of the same course can be purchased for less than 75 euros outside of Europe,” read the press release.

In the United States, the drug launched in 2013 at $1000 per pill, or $84,000 for a 12-week standard treatment course. In the last 5 years, Gilead has made more than $58 billion from sales of sofosbuvir alone; however, earnings have been declining as of late due to increased competition in the US market.

“The excessive prices Gilead is charging for sofosbuvir have kept this breakthrough medicine away from millions of people with hepatitis C in Europe and around the world. What is the point of medical innovation if people and health systems cannot afford the products coming out of it?” said Gaelle Krikorian, head of policy at Medicines Sans Frontiéres Access Campaign, in a statement.

 
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