China has proposes to strengthen the protection of new drugs through not only patent linkage but also patent compensation. The guidance was released in the latest draft of China’s revised Patent Law issued by the National People’s Congress. It reinforces the idea of extension of a patent to compensate for commercial delays caused by regulatory reviews in China.
In Pink Sheet and Generic Bulletin articles, life sciences regulatory & compliance partner Katherine Wang (Shanghai) explains that the significant changes in the new legislative draft are a result of a bilateral agreement signed in January as part of the "Phase One" of the US-China Economic Trade Agreement. "The changes in the patent term extension and patent linkage reflect China’s commitment in the ETA," said Katherine.
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