Patent on TDF, a key HIV and hepatitis B drug, invalidated in China

 

The recent invalidation by China’s State Intellectual Property Office (SIPO) of one of the patents on tenofovir disoproxil fumarate (TDF), an essential medicine to treat HIV and hepatitis B, is a welcome step to reduce barriers that prevent access to affordable generic versions in China, according to Médecins Sans Frontières (MSF). 

 

 “We are pleased that SIPO has invalidated a patent that did not deserve to be granted in the first place,” said Youding Chen, China Manager for MSF’s Access Campaign. “With this decision, SIPO has taken a step in the right direction by applying strict criteria about what deserves and what doesn’t deserve a patent.  SIPO should also look to at the patents covering other critical medicines to ensure pharmaceutical patents are proactively and routinely scrutinised.”

 

But unless the Government takes further steps, the ruling will not immediately improve access to affordable TDF in China, as Gilead has obtained many other patents on TDF in the country. Applying for multiple patents on a single medicine in a bid to extend a drug company’s monopoly is a form of patent abuse known as ‘evergreening’. 

 

 “If patent barriers were removed, affordable, generic, once daily, fixed-dose combinations containing TDF to treat HIV would immediately improve patient outcomes, and people with hepatitis B would be able to access life-saving treatment at a more affordable price,” said Dr. Lucia ALEIXO, MSF’s Medical Representative in China. 

 

After patent oppositions were filed by civil society groups, the Indian and Brazilian Patent Offices have rejected patent applications for TDF filed by Gilead, including the very patent now revoked by SIPO.  But unlike in India and Brazil, other patents on TDF remain valid in China.  In addition, China is deliberately excluded from the voluntary licence agreements, which allow for generic manufacture or import of TDF under licence from Gilead, that Gilead has signed with generic companies and the Medicines Patent Pool.  The company has demonstrated no willingness to expand its licence agreements to include China.

 

 “Access to affordable sources of TDF would immediately improve patient outcomes for people on HIV treatment, and be a lifeline for people living with hepatitis B,” said Chen. “The government should demand that Gilead include China in its existing voluntary licence agreements for TDF, or issue a compulsory licence to enable the production and importation of more affordable versions of the medicine.”