How China's Patent Linkage System Will be Implemented

Summary

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• 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

This system intends to resolve drug patent disputes between originators and generic drug applicants in the early stages through a judicial or an administrative proceeding before the relevant generic drugs are approved for marketing……

The newly launched Chinese drug patent linkage system, the so-called Drug Patent Dispute Early Resolution Mechanism, links Chinese drug marketing authorizations to the patent status of an originator's brand name drugs. This system intends to resolve drug patent disputes between originators and generic drug applicants in the early stages through a judicial or an administrative proceeding before the relevant generic drugs are approved for marketing with the aim of striking a balance between protecting originators' brand name drugs and promoting generic drugs of high quality.

In 2017, the Chinese Central Government announced that it would introduce a drug patent linkage system in China, and subsequently amended the PRC Patent Law (中华人民共和国专利法) in 2020 to codify the drug patent linkage system. In accordance with the PRC Patent Law, on July 4, 2021, the PRC National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) jointly issued the Implementing Measures for the Mechanism for the Early Resolution of Pharmaceutical Patent Disputes (Trial Implementation) (Patent Linkage Measures) (药品专利纠纷早期解决机制实施办法 (试行)), which came into force on the same day.