Gilead faces challenge to European patent on pricey hep C drug

Last Updated: 2015-02-10

By Kate Kelland

LONDON (Reuters) - Global health charity Medecins du Monde (MdM) launched a legal challenge on Tuesday to a European patent held by U.S. drugmaker Gilead Sciences Inc which it accused of charging "exorbitant" prices for a hepatitis C drug.

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.

"While using sofosbuvir to treat hepatitis C represents a major therapeutic advance, the molecule itself, which is the result of work by many public and private researchers, is not sufficiently innovative to warrant a patent," MdM said in a statement.

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

A Gilead spokeswoman said the firm had no comment at this time.

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.

Sovaldi is a so-called nucleotide analog inhibitor which blocks a protein needed by the hepatitis C virus to replicate.

Gilead has previously argued Sovaldi's high price is justified by its near guarantee of a cure, far fewer side effects and its ability to help patients avoid expensive hospital treatment, including potential liver transplants.

But the sheer cost of the drug - which sold $5.8 billion in its first six months, making it the most successful new drug launch ever - has fueled controversy.

MdM said the cost of the medicine in Britain, some 33,000 pounds ($50,160) for a 12-week treatment, was an "exorbitant price" which hinders many people's access to the drug.

It said that if successful, its legal challenge could allow competition from generic versions of the drug which it said could be produced for as little as 66 pounds.

Jean-François Corty, MdM's French programs director said the charity was defending universal access to healthcare.

"The struggle against health inequality involves safeguarding a healthcare system based on solidarity," he said in a statement.

"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."