13 August 2013Asia

SIPO pulls Viread patent – victory for pharma innovators?

The Chinese State Intellectual Property Office (SIPO) has revoked a patent covering biopharmaceutical company Gilead Science’s HIV drug Viread, Reuters subsidiary news site BioWorld reported.

Viread (tenofovir) is used in combination with other antiretroviral agents to treat HIV, and may also be used in the treatment of hepatitis B. It was approved by the US Food and Drug Administration in 2001.

Some had speculated that China would issue a compulsory licence for the drug.

Viread was one of the first medicines included in the Medicines Patent Pool, an initiative aimed at driving down the price of HIV drugs for patients in developing countries.

According to BioWorld, Gilead’s patent covering the drug was challenged by domestic pharmaceutical company Aurisco.

While exact details about the patent’s revocation are thin on the ground, a spokesperson for Gilead told WIPR: “We are currently reviewing the notice from the Chinese Patent Review Board (PRB) and evaluating our options.

“The notice from the PRB refers to one of the patents covering TDF (tenofovir disoproxil fumarate). There is an additional patent covering the compound that is not affected by this ruling.”

The ruling comes one year after the compulsory licence was introduced to Chinese patent law.

George Chan, a consultant at Rouse in Beijing, told WIPR that compulsory licences for patented medicines allow innovator drug companies to make their patented medicines available in times of national emergency, where an extraordinary state of affairs occurs, or where the public interest requires – for example if the cost of a patented medicine makes the medicine inaccessible to the vast majority of persons in need.

He said that SIPO’s decision may be construed in some ways as a victory for the pharmaceutical industry innovators as a whole – more so than for the generics.

With some earlier reports suggesting that the authorities were considering issuing compulsory licenses for Gilead’s patented Viread medicine to allow the manufacture of more affordable generic versions of the patented drug, the invalidation of Gilead’s patent, rather than the authorities issuing a compulsory license for Gilead’s patent, leaves the status quo intact, and this would favour pharmaceutical innovators, Chan explained.

To date, SIPO has not issued one compulsory licence, he said. If a compulsory licence had been issued, it would have set a precedent that would have had a significant impact on the pharmaceutical industry, he added.

Chan said that the affordability of Viread is especially relevant for China, which is estimated to have at least 30 million people with chronic infections for hepatitis B, and Viread is a first-line drug for chronic hepatitis B infections.

He added that the accessibility of patented medicines for age-related diseases is also taking on greater importance as the median age of China’s population continues to rise.

Some commentary has suggested that the invalidation of the Viread patent is a power play by the Chinese government to establish a position from which it can negotiate lower prices for other drugs, Chan added.

SIPO did not respond to a request for comment.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at