16 August 2018 - China’s State Intellectual Property Office (SIPO) has cancelled key patent claims that had been previously granted to US pharmaceutical corporation Gilead Sciences for the oral hepatitis C drug sofosbuvir. Gilead was forced to withdraw the unmerited patent claims, opening up the possibility for companies in China to produce and export affordable generic versions of sofosbuvir.
Sofosbuvir is an oral, direct-acting antiviral (DAA) that is safer, more tolerable and more effective than older treatments for hepatitis C. Sofosbuvir forms the backbone of most hepatitis C treatment combinations, but sofosbuvir and its key companion drugs are priced out of reach for people who need them in many countries, including China.
Gilead has applied for multiple patents in China for its hepatitis C medicines. Last year the company announced that the price for sofosbuvir in China would be US$8,937 per 12-week treatment. In countries where patent barriers don’t exist, generic competition has driven the price of sofosbuvir to below $100 per 12-week treatment.
SIPO’s decision was prompted by a legal challenge of Gilead’s patent claims on the base compound for sofosbuvir filed by the public interest group I-MAK and a Chinese generic manufacturing company, Cosunter Pharmaceutical. SIPO rejected Gilead’s application for the pro drug of sofosbuvir in 2015, after I-MAK had challenged the application, and the crystalline form in 2017. Key patents on sofosbuvir have already been rejected in Egypt and Ukraine, and decisions are pending or being appealed in other countries, including India, Argentina, Brazil, Russia and Thailand. MSF has also filed patent challenges in China for velpatasvir and the sofosbuvir/velpatasvir combination.
Statement from Jessica Burry, Pharmacist, MSF Access Campaign:
”The decision by the Chinese patent office to cancel these patent claims for sofosbuvir effectively ends Gilead’s monopoly in China. This will not only open the door for generic competition to offer a more affordable cure to the 8.9 million people living with hepatitis C in China, but will potentially allow Chinese generic manufacturers to supply this crucial drug to people in need in other markets.
We expect to see far-reaching benefits from this encouraging decision by the Chinese patent office that can serve as a precedent for other patent offices in Brazil, Europe and India that are currently reviewing similar patent claims on sofosbuvir. It is high time that patent offices around the world recognize the negative impact that unmerited patents have on people and health systems.”