Charity challenges Sovaldi patent
pharmafile | February 10, 2015 | News story | Sales and Marketing | Gilead, HCV, Médecins du Monde, sofosbuvir, sovaldi, world health organization
Doctors of the World (also known as Médecins du Monde) has filed an opposition to the patent for Gilead’s blockbuster hepatitis C drug Sovaldi.
The international non-profit organisation claims that the drug’s ‘exorbitant’ price and Gilead’s monopoly in the area is hindering many people’s access to the treatment, and is unsustainable for healthcare systems. In the UK Sovaldi (sofosbuvir) costs £33,000 for a 12-week course of treatment.
It has therefore decided to challenge Gilead’s patent in an attempt to encourage generic competition. Doctors of the World says that generic versions of the drug could be produced for as little as £66.
“We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,” explains 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 €27 billion, it’s hard to meet this cost.”
The challenge is based on the charity’s claim that although Solvaldi is a ‘major therapeutic advance’ the molecule itself is not sufficiently innovative to warrant a patent.
Sovaldi is the most commonly recommended direct-acting antiviral (DAA) – a new generation of hepatitis C drugs that are much more effective and safer than previous treatments. Sovaldi has been found to cure 90% of patients in just 12 weeks.
This, combined with its high price, led it becoming the most successful drug launch ever last year.
Gilead has contended that the drug’s cost is justified because it prevents even more expensive liver transplants. However, Doctors of the World has countered that “it is not acceptable that a pharmaceutical company set up the price of its product on the cost of the damage it could prevent”.
The charity also notes that the a large proportion of hepatitis C research is financed using public funds, and so basing high prices on R&D costs is also unjustified.
They are far from alone in criticising Sovaldi’s price. In the US a company is suing Gilead for the money it has spent on the drug, and the US Senate Finance Committee is investigating its pricing and whether the market for Sovaldi ‘is working efficiently and rationally’. In the UK the NHS called the medicine ‘unaffordable’ prior it getting the nod from NICE.
This is the first time in Europe that a medical charity has used a patent opposition to try and improve patient access to a drug.
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.
George Underwood
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