At Long Last: China's New Drug Data Exclusivity Regime

Within the spectrum of pharmaceutical intellectual property protections, four special mechanisms stand out: the Bolar exemption, patent linkage, patent term extension, and data exclusivity. The Bolar exemption allows generic manufacturers to conduct necessary research before patent expiry; patent linkage front-loads patent dispute resolution into the drug approval process; and patent term extension compensates for time lost to regulatory review. All three have already been implemented in China—the Bolar exemption was codified in Article 69 of the Patent Law in 2008 (now Article 75(1)(5) of the current Patent Law), the patent linkage system and patent term extension were both formally established by the fourth amendment to the Patent Law in 2021.