Regulatory Focus™ > News Articles > Sovaldi Patent Rejected in China Following Third-Party Challenge

Sovaldi Patent Rejected in China Following Third-Party Challenge

Posted 19 June 2015 | By Michael Mezher 

Sovaldi Patent Rejected in China Following Third-Party Challenge

China's patent office has rejected a patent related to Gilead Science's blockbuster hepatitis C (HCV) drug Sovaldi.


The rejection comes one month after the Initiative for Medicines, Access & Knowledge (I-MAK) filed several patent challenges against Gilead in China.

I-MAK has also filed similar challenges in Argentina, Brazil, Russia and Ukraine, all citing Sovaldi's high price as a barrier to access in many middle-income countries where licensed generic versions of Sovaldi are not sold.

Even licensing schemes instituted by Gilead to promote access to Sovaldi have not been immune from criticism by I-MAK. In 2014, Gilead entered into licensing agreements with seven Indian generic manufacturers, allowing them to manufacture generic copies of Sovaldi and sell them in 91 low- and middle-income countries. Both I-MAK and the humanitarian aid group Médecins Sans Frontières have criticized the terms of the licensing agreements for leaving out countries such as China, Brazil and Thailand where HCV is prevalent.

Rejection and Impact in China

The rejected patent is for a "prodrug" of Sovaldi, an inactive form of the drug which is converted by the body to a chemically active form.

At this time it remains unclear why Gilead's patent application was rejected. However, I-MAK's third-party patent challenge against the patent (CN 200880018024.2) alleges that claims made in the patent application lack an inventive step, claim non-patentable subject matters and do not sufficiently disclose technical aspects of the invention.

Earlier this year, India's patent office rejected a similar patent for Sovaldi, which I-MAK also challenged. The rejection was ultimately overturned after Gilead appealed to the Delhi High Court, which sent the application back to the patent office for reevaluation.

The decision by China's patent office is unlikely to affect Gilead's intellectual property protections for Sovaldi in China, as the company holds multiple other patents for the drug, including one for its base compound. However, the rejections in China and India could signal a trend by intellectual property officials in low- and middle-income countries to take a stricter approach to pharmaceuticals patents.


Reuters, I-MAK Patent Challenge

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.