Charity challenges Gilead's European patent on hepatitis C therapy Sovaldi

Doctors of the World - Médecins du Monde (MdM) filed an opposition before the European Patent Office against Gilead Sciences' hepatitis C therapy Sovaldi (sofosbuvir), arguing that "the molecule itself is not sufficiently innovative."

Since 2014 Sovaldi is on the market and is a blockbuster for Gilead. Due to the circumstance that a Sovaldi treatment lead to a total recovery in a high number of hepatitis C patients, it seems like a magic pill. However the price for this magic pill seems to be a miracle either. The costs for a single pill of Sovaldi in Germany is about 700 EUR (according to Spiegel Online). For a therapy of 24 weeks the costs run up to 100.000 EUR. In addition Sovaldi treatment needs a combination with other drugs such that the total costs for a 24 week therapy will reach 200.000 EUR. The cost for Solvaldi for a 12 week course of treatment in the UK are about 44 000 pounds ($67 079) (according to Reuters). Therefore the price policy of Gilead is critizised by MdM claiming that the drug maker is “abusing” its patent and charging an “exorbitant” price that hinders access for many patients.

MdM is arguing that Gilead is "abusing" its patent on Sovaldi, known generically as sofosbuvir, MdM said its challenge marked the first time in Europe a medical charity has used this method to try and improve patients' access to medicines.

"As Gilead is abusing its patent to impose prices which are unsustainable for healthcare systems, (MdM) has decided to contest it."

 According to World Health Organization data, as many as 150 million people worldwide live with chronic hepatitis C infection, most of them in low and middle-income countries. In the European Union, between 7.3 and 8.8 million people are believed to be infected with hepatitis C.

MdM decided to contest the patent of Gilead as it seems on the arguments of lack of inventive step (Art. 56 EPC) and  added subject matter (Art. 123 (2) EPC). According to MdM the actual breakthrough was previously achieved by researchers at Cardiff University.

If the patent is revoked by the EPO the price for Sovaldi will be reduced dramatically leading to an acess for many patients.


It is noteworth that last month the Indian Patent Office rejected the patent application in India stating that only minor changes in the molecule did not improve its efficacy. Gilead has filed an appeal.