China rejects Gilead’s Sovaldi patent
pharmafile | June 24, 2015 | News story | Research and Development, Sales and Marketing | China, Gilead, hep C, sofosbuvir, sovaldi
Manufacturer of the blockbuster hepatitis C treatment Sovaldi Gilead has seen its application for a patent in China rejected following a challenge by an access to medicines campaign group.
The decision opens the door for Chinese manufacturers to produce copycat versions of Sovaldi (sofosbuvir) for the Chinese market at a fraction of the price of Sovaldi – which costs more than £30,000 for a course of treatment.
Campaign groups say Sovaldi and its antiviral combinations are ‘exorbitantly priced’ in many countries, and that this restricts access for people who need it. Globally there are at least 150 million people living with hepatitis C, and 350,000 to 500,000 people die each year from arising complications.
Gilead’s application for a patent in China was rejected following a pre-grant challenge filed by the Initiative for Medicines, Access & Knowledge (I-MAK), a US-based not-for-profit organisation lead lawyers and scientists campaigning for wider access to affordable medicines through the patent system.
A number of additional challenges have been filed on patent applications for Sovaldi, including in India, Argentina, Ukraine, Russia, Brazil and at the European Patent Office by different parties. Key patents on Sovaldi have already been rejected in both Egypt and India.
But China could prove to be an important supplier for the raw materials as well as the finished product of Sovaldi. There have been limitations on the use of the raw material for Sovaldi because of patent barriers, and so the decision to reject the secondary patent on Sovaldi should mean more potential for generic Sovaldi to enter the Chinese market earlier. Increased competition from manufacturers in China could help push the price of Sovaldi down.
A spokesperson for Gilead declined to comment. However the medical aid charity Médecins Sans Frontières/Doctors Without Borders (MSF), which is also campaigning for wider access to Sovaldi and other medicines, welcomed the Chinese patent office’s decision.
Rohit Malpani, who is the director of policy and analysis for the MSF Access Campaign, says: “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. We hope that other countries where Gilead is seeking patents for sofosbuvir are watching closely.”
Dr Jennifer Cohn who is the medical director of the MSF Access Campaign, says: “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.”
Lilian Anekwe
Related Content
Gilead’s HIV treatment meets primary trial endpoint
Gilead has announced positive topline results from its phase 3 ARTISTRY-2 trial, which evaluated a …
Gilead announces first shipments of HIV prevention drug to Eswatini and Zambia
Gilead has announced the first shipments of its HIV prevention drug lenacapavir to Eswatini and …
CARBOGEN AMCIS manufacturing license advances services in China
Swiss pharma manufacturing company, CARBOGEN AMCIS, has announced that its facility in Shanghai, China, has …
