30 non-governmental and civil society organizations from 17 European countries have submitted a new opposition this week to the patent of Sofosvbir, the drug that cures Hepatitis C. The resource is based on compound used to produce the medicine. This important patent protecting Sofosbuvir was granted to Gilead in June 2016. Organizations, including Doctors of the World, Rights to Health—promoters of It’s not Healthy—and Doctors without Borders understand, however, that it does not meet the requirements defined by the 1973 European Patent Convention.
This action continues the path initiated by Doctors of the World in 2015, when it first filed an opposition to a Sofosbuvir patent at the European Patent Office (EPO). At the end of the procedure, in October 2016, the EPO continued to recognize the patent, but forced it to make amendments to the patent application documentation.
The new opposition, filed on another one of the drug’s patents, is based on the assumption that the base compound is not an invention and therefore the pharmaceutical company does not meet the requirements defined by the European Patent Convention.
“Yes, medicines are market products and are subject to a patent system. But there are some rules. However, the patent criteria are not always respected by pharmaceutical companies nor are the market rules applied by all governments,” says Oliver Maguet, whose responsible for the campaign on drug price for Doctors of the World. The organizations are trying to remove the barriers that limit millions of people’s access to a necessary drug.
“About 80 million people worldwide live with Hepatitis C and this drug has the ability to cure them. However, Gilead’s excessively high price is preventing their access to treatment and the future eradication of the disease,” says Vanessa López, Director of Rights to Health. “Recently patient associations have made the drug available to all those who need it in Spain, although the prices paid by the State remain extremely high. Rights to Health, together with the rest of the Spanish civil society and the rest of the world, will continue to work to get a fair and affordable price for this drug.”
If successfully resolved, the opposition could accelerate the entry of generic drugs into the European market and generate legal arguments to help states empower themselves in negotiations with Gilead.