Context:
- China introduced its pharmaceutical patent-linkage regime in 2021 under the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial) (July 4, 2021 NMPA Implementing Measures), requiring chemical generic applicants to address listed originator patents through one of four declarations. Category III—the closest analogue to a U.S. Paragraph III certification—requires the applicant not to market before patent expiry. Yet approval works differently: the U.S. Food and Drug Administration (FDA) may only tentatively approve an otherwise approvable Paragraph III application, whereas China’s National Medical Products Administration (NMPA) may formally approve a Category III generic after technical review but continue to bar its launch.
- This split surfaced in China in the Nefecon dispute. Everest Medicines holds the China rights to the IgA nephropathy drug, developed by Swedish biotech Calliditas, now part of Japan’s Asahi Kasei; Hainan Herui makes the Chinese generic. Despite its Category III commitment not to launch before May 2029, Herui obtained formal approval in December 2025 and then promptly sought provincial procurement listings and promoted the product, prompting the Guangzhou Intellectual Property Court to grant a preliminary injunction (PI) on February 26, 2026 (February 27, 2026 Yicai report).
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