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China: A Patent Linkage Update
July 1, 2022
China committed to a patent linkage (Hatch-Waxman) regime linking pharmaceutical regulatory approval and patent infringement determinations in the Phase 1 Trade Agreement concluded with the United States in January 2020. The linkage regime is part of a series of pharmaceutical IP related reforms set forth in that Agreement.
With the enactment of China’s revised patent law, as well as the adoption of new rules on patent linkage on July 4, 2021 and a new Judicial Interpretation on July 5, 2021, the basic legislative framework for China’s new patent linkage regime is now in place. But how will these new rules work in practice?