China Rejects Gilead Patent on Hepatitis C Drug Sofosbuvir

Doctors Without Borders/Médecins Sans Frontières (MSF) has learned that the Chinese patent office has just denied Gilead Science’s request for a key patent on the hepatitis C drug sofosbuvir. This drug, together with other antivirals, is the backbone of several newer, more effective curative treatments for hepatitis C, yet is exorbitantly priced in many countries, restricting access for people who need it. Hepatitis C is a global public health crisis, with at least 150 million people living with the disease, and 350,000-500,000 people die each year from complications of it.

The patent application was rejected following a pre-grant challenge filed by the Initiative for Medicines, Access & Knowledge (I-MAK). A number of additional challenges have been filed on patent applications for sofosbuvir, including in India, Argentina, Ukraine, Russia, Brazil, and at the European Patent Office by different parties. Key patents on sofosbuvir have already been rejected in both Egypt and India.

China is the world’s single largest source of active pharmaceutical ingredients (raw materials) for all medicines. There have been limitations on the use of the raw material for sofosbuvir because of patent barriers. There is increasing capacity for China to produce finished products for drugs and vaccines, and with decision to reject the secondary patent on sofosbuvir, there is greater potential for generic sofosbuvir to enter the Chinese market earlier. 

MSF is in the process of starting to scale-up treatment of hepatitis C, with plans to expand treatment in nine countries. MSF is currently treating people with sofosbuvir in Pakistan.

MSF Response:

“China’s rejection of a key patent on sofosbuvir goes to show that there are serious questions about whether this drug merits patenting, and sends a strong signal to other countries that are currently reviewing patent applications for the drug. China could prove to be an important supplier for the raw materials as well as the finished product of sofosbuvir. Increased competition from manufacturers in China could help push the price of sofosbuvir down, so that more people can access it. We hope that other countries where Gilead is seeking patents for sofosbuvir are watching closely.”

Rohit Malpani, Director of Policy & Analysis, MSF Access Campaign

“This is good news for people with hepatitis C, and will hopefully lead to more people in developing countries being able to access low-cost versions of sofosbuvir. Gilead’s exorbitant pricing is preventing people from getting the treatment they need in both rich and poor countries. A cure for hepatitis C does nobody any good if nobody can afford it.”

—Dr. Jennifer Cohn, Medical Director, MSF Access Campaign