China, Legal

Gilead loses key patent claims for Sovaldi in China, opening door to earlier generic entry

A partial patent invalidation by Chinese authorities has shaken the case Gilead has been building for its hep C star Sovaldi by removing a key barrier to generic entry.

The decision means knockoffs of the highly effective hep C treatment can arrive as early as next year — rather than 2024, when the patent was originally set to expire — according to the Initiative for Medicines, Access, and Knowledge, or I-MAK. I-MAK filed one of the two requests for patent invalidation cited in the ruling, together with Chinese drugmaker Fujian Cosunter Pharma.

Tahir Amin

Because the patent concerns sofosbuvir, a crucial base compound that’s also used to make combo drugs like Harvoni and Epclusa, this decision could affect not just one product but Gilead’s whole hep C franchise in the country.

In response to my question as to whether Gilead will appeal the ruling (they have three months to do so), a spokesperson says the Foster City, CA-based company has not withdrawn their claims to the sofosbuvir compound patent application in China. Here’s the rest of the response:

This patent application is currently being reviewed by the Patent Review Board (PRB). Last week China’s PRB confirmed the validity of claims covering the SOF metabolites. This decision has no impact on our SOF compound patent application. Gilead is confident in the intellectual property covering the sofosbuvir compound and all its hepatitis C medicines, which bring the potential of a cure to the vast majority of patients suffering from chronic hepatitis C virus (HCV) infection. In the meantime, we will continue to work with the Chinese government to facilitate broad access to Gilead’s hepatitis C medicines.

While Sovaldi was launched in China at one-fifth the contemporary price in the US — almost $9,000 for a 12-week regime — its price still frequently comes under attack, as it has in many other countries around the world. In fact, Gilead has drawn criticism ever since it began selling the drug at $84,000 in the US. And whereas Gilead designed licensing deals with generic companies in countries like Ukraine, Belarus, Thailand and Malaysia in response to complaints, no such agreement was struck in China.

Back in 2015, two years before Sovaldi would be approved in China, the authorities had rejected Gilead’s application for an inactive prodrug that is metabolized once in the body.

I-MAK, which also played a role in that decision, has been bringing legal challenges against Gilead in a number of other countries, including the US. Its co-founder Tahir Amin told STAT that even though Gilead still holds four remaining patent claims on Sovaldi and data exclusivity in China, they shouldn’t hinder generic makers as much as this patent had.

Cosunter, which marketed China’s first hep B generic, is said to be developing a copycat version of Sovaldi.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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