Claims the US company's patent protection is allowing it to charge prices that are far too high
Gilead Sciences' patent for the hepatitis C drug Sovaldi (sofosbuvir) is being challenged by medical aid charity Medecins du Monde (Doctors of the World), which claims the US company's patent protection is allowing it to charge 'unsustainable' prices.
The legal action has been filed with the European Patent Office (EPO) in Munich, Germany.
According to the charity, Gilead is charging £33,000 for a 12-week treatment of sofosbivir in the UK, which is hindering many people's access to the drug.
Opposition to the patent could encourage competition from generic versions of the drug, which can be produced for only £66, the charity said.
'We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,' said Dr Jean-François Corty, Doctors of the World's French Programmes Director.
'Even in a ‘rich’ country such as France, with an annual drugs budget of €27bn, it’s hard to meet this cost and already we’re seeing an arbitrary rationing approach that excludes patients from care.'
According to the World Health Organization, an estimated 130 to 150 million people are chronic carriers of hepatitis C globally. Within the EU, between 7.3 and 8.8 million people are believed to be infected. In the UK, 215,000 people are estimated to have chronic hepatitis C, which can lead to liver cancer, liver cirrhosis and liver failure, the charity said.
While the use of sofosbuvir to treat hepatitis C represents a major therapeutic advance, Doctors of the World says the molecule itself, which is the result of work by many public and private researchers, is not sufficiently innovative to warrant a patent.
'Opposition to a patent has already been used by civil society in India and Brazil to get improperly granted patents for drugs revoked and to make generic versions available,' added Olivier Maguet, Doctors of the World spokesperson for hepatitis C. 'This has led to a discernible drop in the cost of treatments and to patients being treated who would otherwise not have had the chance.'
Gilead Sciences did not respond to a request for further information from Manufacturing Chemist.