MSF challenges Gilead’s unmerited patent in China for lifesaving hepatitis C medicine

Affordable generic versions from China could save millions of people’s lives
Médecins Sans Frontières (MSF) today filed a legal patent challenge at China’s State Intellectual Property Office (SIPO), requesting the invalidation of the patent granted to US pharmaceutical corporation Gilead Sciences for the oral hepatitis C medicine velpatasvir. The patent is being contested on the grounds that it involves well-known technologies, rendering it an unmerited patent under China’s patent law, which is consistent with the World Trade Organization rules.
Velpatasvir, a direct-acting antiviral (DAA), is one of the key medicines used in combination with another DAA – sofosbuvir, for the oral treatment of all six major genotypes of hepatitis C virus. Its effectiveness as a pan-genotypic medicine offering a well-tolerated cure makes it a crucial drug in the fight against hepatitis C.
“Without access to affordable DAAs, people with hepatitis C in China are still forced to take an older, injected drug called interferon, which has low cure rates and causes people severe side effects, such as psychosis,” said Gaëlle Krikorian, Head of Policy for MSF’s Access Campaign. “Unlocking unmerited patents on velpatasvir and sofosbuvir will open up access to affordable generic versions of this crucial treatment.” 
The fixed-dose combination treatment of velpatasvir and sofosbuvir should be an important treatment option in national hepatitis C programs, yet access to these medicines remains limited. While the prices charged for this combination are exorbitant in many countries where patent barriers exist, they are rapidly falling in countries where generic versions are available. For example, Gilead launched the sofosbuvir/velpatasvir combination at a price of US$51,000 for a 12-week treatment course in the United Kingdom, whereas the same treatment course is available for as low as $286 in India from generic manufacturers. In China, this combination was registered in May 2018, but Gilead has not yet announced its price.
China is widely known as being the world’s largest supplier of active pharmaceutical ingredients (API), or raw material, used to make many kinds of medicines; if patents were not a barrier, China could become an important supplier – both domestically and internationally – for both the raw materials and finished products of oral hepatitis C drugs. 
“Chinese manufacturers are global suppliers of pharmaceutical raw materials, yet are unable to manufacture key hepatitis C medicines for people in China or other countries around the world because of unmerited patents,” said Jessica Burry, HIV and hepatitis C pharmacist for MSF’s Access Campaign. “Leveraging China’s generic production capacity could significantly increase competition and make these breakthrough medicines more affordable and available globally.” 
Gilead has applied for multiple patents in China for its hepatitis C medicines, and some of these are being opposed by a generic pharmaceutical company and non-profit organisations, based on similar grounds of being unmerited under China’s Patents Law. In addition to the current filing for invalidation of the velpatasvir patent, MSF had also filed a patent challenge against Gilead’s patent application for the sofosbuvir/velpatasvir combination. 
“Ending unmerited patent monopolies for oral hepatitis C drugs in China would help nearly nine million people in the country with hepatitis C access desperately needed treatment, and another 59 million untreated people worldwide,” said Krikorian.  
Gilead’s patent applications and granted patent claims on sofosbuvir, velpatasvir and their combination with other DAAs have been challenged in many other countries including in India, United States, European Union, Brazil, Ukraine and Russia. These efforts have paved the way for increased competition among  generic producers, which has brought prices down and improved access to treatment or people. 
MSF treats people with hepatitis C in 11 countries (Belarus, Ukraine, Pakistan, Uzbekistan, India, Myanmar, Cambodia, Uganda, Kenya, Mozambique and South Africa). Since 2015, MSF has provided DAA treatment to over 6,000 people with hepatitis C. Of those who have completed treatment to date, the overall cure rate is 94.9 percent.
Worldwide, an estimated 71 million people have chronic hepatitis C virus (HCV) infection, and almost 40% live in countries, including China, which still cannot access generic direct-acting antiviral(DAA) treatments.  HCV is a blood-borne virus that can lead to cirrhosis, liver failure and liver cancer, as well as a range of systemic health problems. Estimates indicate that only three million people had been treated with newer sofosbuvir-based treatment regimens by the end of 2016, leaving 68million people waiting to access DAAs to cure their hepatitis C infection. 
Reading Material - Not Even Close: This issue brief provides information on currently available HCV diagnostics and treatments, including pricing and registration information from manufacturers of DAAs