The European Public Health Alliance (EPHA) is one of 30 civil society organizations from 17 European countries to file a coordinated patent opposition on sofosbuvir with the European Patent Office (EPO). Sofosbuvir is a hepatitis C therapy sold under the brand name Sovaldi among others.
The development of effective new therapies for hepatitis C virus (HCV) has been accompanied frequently by outcries from patients and governments regarding the exorbitant prices that pharmaceutical companies charge for the treatments.
Sofosbuvir is the basis of HCV therapies like Sovaldi and Harvoni (sofosbuvir plus ledipasvir). The patent for sofosbuvir is held by Gilead, a U.S. pharmaceutical company.
The problem is that patents feed monopolies, which subsequently encourages extreme prices. Gilead, for instance, has charged an average of €55,000 per patient in Europe for a 12-week regimen of sofosbuvir, while production costs are estimated at less than €1 per pill.
Most European governments are against these price-setting practices, which either force them to quit on a particular drug entirely, or force them to rationalize the drug’s supply to a very limited number of critical-stage patients. Both scenarios are against European universal healthcare models.
“With this filing, we are questioning the grounds on which the patent was granted and we emphasize the possible non-compliance with the current patentability criteria. It is no longer off-limits to discuss these matters in Europe, particularly given the gravity of the access to medicines problems Europeans face today,” Yannis Natsis, leader of EPHA’s access to affordable medicines campaign, said in a press release.
Patent opposition is a mechanism provided according to EPO rules. It allows for the shortening of the duration or total removal of a patent, if validated. This can pave the way to restrict the monopolistic price setting to enable competition, including from generics.
“EPHA respects today’s medicine patents system and with this filing aims to ensure that drug-makers play by the rules. The successful first patent opposition launched by our member Médecins du Monde in 2015, vindicated their concerns that this is not always the case. (This) filing builds on this important precedent and is another step toward better access to medicines,” said Archie Turnbull, EPHA’s president.
Besides EPHA, supporting organizations for this action include 11 European Médecins du Monde (MdM) chapters, 13 European Médecins Sans Frontières (MSF) sections, Access to Medicines Ireland (Ireland), AIDES (France), Just Treatment (United Kingdom), PRAKSIS (Greece), and Salud por Derecho (Spain).