Partial Revocation Of EPO Patent On Sofosbuvir, Key For Hepatitis C

By Alexandra Nightingale for Intellectual Property Watch

Following a public hearing at its headquarters in Munich, the European Patent Office (EPO) decided to reject in part the arguments made by Gilead Sciences to uphold their patent on sofosbuvir, according to a non-profit group.

Sofosbuvir is used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection.

In February 2015, Médecins du Monde (MdM), an independent international movement to promote universal access to healthcare, filed an opposition to the patent on sofosbuvir granted to Gilead Sciences. A legal procedure, known as a patent opposition can be made and the validity of a patent challenged when a drug patented does not fulfil the patentability criteria as defined by the European Patent Convention (EPC).

The EPO decided today that Gilead’s patent extended beyond the content of the patent application and thereupon patent protection would no longer apply to sofosbuvir, according to MdM’s statement. [Update: EPO has issued a contrary statement to journalists, more reporting to come] China, Ukraine and Egypt have already fully rejected Gilead’s patent.

“This is a flawed patent that has been used by the pharmaceutical company to impose a huge pressure on States, that have accepted exorbitant prices leading to treatment restrictions for patients in many European countries!” Françoise Sivignon, president of MdM, said in a statement.

“Today’s decision highlights the growing global movement of rejecting unjustified patents. This decision significantly weakens Gilead’s protection on Sovaldi,” said Tahir Amin, co-founder and director of intellectual property of the initiative for Medicines, Access & Knowledge (iMAK).

“Patent oppositions are critical to improving the quality of examination and we applaud the EPO for revoking key claims that were not in compliance with the law. What is really needed is more rigorous patent examination before patents are granted in order to improve patent quality – this will stop companies from blocking people living with hepatitis C from getting the medicine they need to get healthy.”

Alexandra Nightingale is a researcher at Intellectual Property Watch. She completed her Bachelors in Law at the University of Sussex and holds an LLM degree in International Law from the School of Oriental and African Studies in London. During her Masters, she developed a strong interest in Intellectual Property, particularly patents and the aspects relating to global health. Her research interests now also include geographical indications and trademarks.