Analysis

3 Takeaways As China Rolls Out Its Version Of ANDA Disputes

By Ryan Davis (May 12, 2022, 8:35 PM EDT) -- A year after China launched a system for generic-drug patent disputes modeled on the U.S. Hatch-Waxman Act, the first decisions have come down. Here are the key things to know about the outcomes, including the rapid pace and early wins for generics makers against Roche and Purdue.

China's system, established last year, allows for owners of drug patents to file infringement litigation, either in court or the patent office, over planned generic versions during the regulatory approval process, akin to suits over abbreviated new drug applications in the U.S.

Before the so-called patent linkage system, generic versions could launch in China without...

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