Gilead faces fresh Sovaldi challenge

Gilead Sciences is facing a challenge to its attempt to obtain a patent for its hepatitis C drug Sovaldi (sofosbuvir) in certain Asian, Latin American and European countries.

The Initiative for Medicines, Access & Knowledge (I-Mak) announced today (May 20) that it has challenged an application filed by Gilead to patent Sovaldi in Argentina, Brazil, China, Russia and Ukraine.

“Pharmaceutical company Gilead Sciences is seeking illegitimate patents for the hepatitis C medicine sofosbuvir, blocking millions of people around the world from getting the treatment they need to get well,” the group said in a statement published on its website.

The group is working with local non-profit groups to challenge the validity of the patent.

In Argentina it is working with the Fundación Grupo Efecto Positivo (Positive Effect Foundation Group) and in Brazil it is working with the Grupo de Trabalho sobre Propriedade Intelectual (Working Group on Intellectual Property).

I-Mak has argued that the patent lacks an inventive step. “The drug is not new. The base compound has been disclosed in various earlier patents, which already disclose the base compound that is used in the sofosbuvir drug.

“The patent application is for old science, and patents should not be granted to products that are based on well-known techniques that are obvious to try,” it added.

I-Mak is concerned that if the patent is approved in the five countries then the drug will collectively cost the countries “an extra $270 billion” to treat people suffering from hepatitis C.

According to the organisation, 59 million people have hepatitis C in the five countries it has made the challenge.

It is not the first time I-Mak has challenged the validity of a patent application filed by Gilead to protect Sovaldi.

Last year, Gilead filed a patent application in India, which I-Mak opposed.

Gilead had not responded to a request for comment at the time of writing.