Medical group challenges Sovaldi's EU patent

A medical organisation is trying to overturn Gilead Sciences' European patent for hepatitis C drug Sovaldi so cut-price generics can be made available.

The Paris-based Médecins du Monde (MDM) group has launched a suit alleging that the active ingredient in Sovaldi (sofosbuvir) "is the result of work by many public and private researchers [and] is not sufficiently innovative to warrant a patent."

This is believed to be the first time that a medical organisation has launched such an initiative in Europe, although similar actions have been undertaken in other areas of the world, notably India.

An action by the Cancer Patient Aid Association was a factor in the rejection of Novartis' patent for cancer drug Glivec (imatinib), while earlier this year the Indian Patent Controller turned down one of Gilead's patent applications for sofosbuvir after a challenge by the Initiative for Medicines, Access and Knowledge (I-MAK) and Delhi Network of Positive People (DNP+).

Medical charity Médecins Sans Frontières (MSF) set up an online database in 2012 designed to help organisations challenge patents held by pharmaceutical companies.

MDM said the challenge in Europe has been launched because Sovaldi's "exorbitant price" - which in the UK is £33,000 for a 12-week course - is "hindering many people's access to the drug."

"We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity," commented MDM's French programmes director Dr Jean-François Corty.

"Even in a 'rich' country such as France, with an annual drugs budget of 27 billion euros, it's hard to meet this cost and already we're seeing an arbitrary rationing approach that excludes patients from care," he added.

France negotiated one of the lowest prices for Sovaldi in Europe at around €41,000 per 12-week course last November, and since Germany and the UK have also negotiated discounted rates for the drug, although in the latter case NHS patients are having to wait until the summer for access to the drug while funding is made available.

The high price of Sovaldi has made it the most lucrative pharmaceutical launch of all time, bringing in more than $10 billion in 2014, its first full year on the market, while dual therapy follow-up Harvoni (sofosbuvir and ledipasvir) added another $2.1 billion despite only being approved last October.

Market forces are already starting to take their toll on the franchise, however, with competition from AbbVie's recently-approved rival Viekira Pak already exerting downward pricing pressure as the two companies offer discounted rates in return for exclusive formulary positions at US health insurers.

Gilead said it had no comment on the MDM action. The company signed a deal with seven India-based pharma firms to manufacture cheaper generic copies of Sovaldi in 91 developing countries last year.

Oliver Maguet, MDM's board member delegate for hepatitis C, said: "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 version available.

"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."