How China's Patent Linkage System Will be Implemented

August 13, 2021 | BY

Susan Mok

Ting Wu of Haiwen & Partners raises some questions to highlight how China's newly implemented drug patent linkage system attempts to resolve drug patent disputes in the early stages, which will have a sweeping impact on market entry strategies for chemical drugs in China

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Summary


  • The patent linkage system intends to resolve drug patent disputes between originators and generic drug applicants in the early stages
  • The Chinese drug patent linkage system does not apply to drug patents that are not recorded in the Chinese Orange Book
  • The regulatory approval stay only applies to a patent protection scope dispute claim under a Category 4 Statement