Gilead faces Sovaldi patent challenge in Europe

A medical aid non-profit organisation has opposed a European patent held by pharmaceutical company Gilead that covers its anti-hepatitis C drug Sovaldi (sofosbuvir).

In its challenge, France-based Médecins du Monde (MdM) argued that Gilead is charging too much for the drug.

MdM said the cost of the medicine in France—€41, 000 ($46, 400) for a 12-week treatment—and in other countries in Europe was “exorbitant” and hindered many people's access to the drug.

In a statement published yesterday (February 10), MdM said it had filed an opposition against the patent at the European Patent Office.

The organisation added that if its challenge is successful, it could spark competition from cheaper generic versions of the drug.

“If the use of sofosbuvir to treat hepatitis C is a major therapeutic advance, the molecule itself—the result of the work of many public and private researchers—is not innovative enough to deserve a patent,” MdM said in its statement.

MdM added that the challenge marks the first time in Europe that a medical non-governmental organisation “had used this path to [try to] improve patient access to drugs”.

Jean-François Corty, director of operations for MdM France, said in a statement: “We defend the universality of access to health care; the fight against health inequalities requires the maintenance of a supportive health system.

“Even in ‘rich’ countries like France … it is difficult to cope. Already we are seeing an arbitrary rationing approach that excludes patients from care.”

This is not the first time that that an organisation has challenged a patent protecting Sovaldi.

In India, three non-profit groups and generic drug maker Natco Pharma teamed up to challenge a patent application by Gilead on the grounds that its claimed matter was not patentable.

The Indian Patent Office initially rejected the application in January but, after an appeal against the decision by Gilead, the Delhi High Court remanded the ruling for a re-hearing after finding that the office had relied too much on evidence provided by the opposing parties.

Gilead did not respond to a request for comment.