Appeal filed against EPO sofosbuvir patent decision
Six organisations have appealed against the European Patent Office’s (EPO) decision to uphold a patent for a key hepatitis C drug.
The appeal, which concerns Gilead Sciences’ patent for sofosbuvir, was filed on Wednesday, December 5, by Médecins du Monde (MdM), Médecins Sans Frontières (MSF), AIDES (France), Access to Medicines Ireland, Praksis (Greece) and Salud por Derecho (Spain).
According to a statement released by MSF, the EPO should revoke Gilead’s patent (EU number 2,604,620) for sofosbuvir because “it does not meet the requirements to be a patentable invention from a legal or scientific perspective”.
Hepatitis C, an infectious virus that primarily affects the liver, can be spread through blood-to-blood contact.
According to the health groups, in some European countries, Gilead charges as much as €43,000 ($49,100) for a 12-week course. In comparison, generic versions of the same course can be purchased for less than €75 outside of Europe.
As a result of these prices, healthcare systems ration sofosbuvir, leaving thousands of people who suffer from hepatitis C without treatment, the organisations added.
In March 2017, MSF and other healthcare organisations filed an opposition against the ‘620 patent, which was granted in 2016. The organisations asked the EPO to revoke the patent.
Gilead’s ‘620 patent relates to sofosbuvir, which is included in several hepatitis C treatments including Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), and Epclusa (sofosbuvir and velpatasvir).
The opposition claimed that the ‘620 patent does not involve an inventive step; is not new; does not disclose the invention in a clear and complete matter; and contains subject matter which is beyond the scope of the application.
The filing said that more than 700,000 people die each year as a result of the hepatitis C virus, and at least 80 million people worldwide are living with the disease.
However, on September 14, the EPO upheld the ‘620 patent, with amendments. MSF told LSIPR that the amendments are the “cancellation, and not additions, of claims covering the existence of pharmaceutical compositions”.
Olivier Maguet, from MdM’s drug pricing campaign, said there needs to be “much greater scrutiny in Europe when it comes to determining whether pharmaceutical corporations deserve patents”.
The MSF statement said that the appeal aims to put an end to the “abuse of medicine patenting systems”, including in countries outside of Europe, where patent offices often follow the EPO’s decisions when deciding whether to grant a patent.
It said that there is an “urgent need” to reform patent systems “so that people have access to medicines they need to stay alive and healthy”.
The appeal comes five years after sofosbuvir was first approved for use in the US. Gilead launched the drug at $1,000 per pill, or $84,000 for a 12-week course. The organisations claimed that the company has made more than $58 billion from sales of the drug and its combinations since its approval.
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