China’s Supreme People’s Court has delivered its verdict in the nation’s first patent linkage dispute, ruling against Japan’s Chugai Pharmaceutical Co., Ltd and in favor of generic drugmaker Wenzhou Haihe Pharmaceutical Co., Ltd. The case, involving osteoporosis drug eldecalcitol, marks a milestone under China’s Drug Patent Early Dispute Resolution Mechanism, implemented in July 2021.
Case Background
Chugai, the originator and patent holder of eldecalcitol (marketed as Edirol in China since 2020), appealed after the Beijing Intellectual Property Court (BJIPC) ruled in April 2022 that Haihe’s generic version did not infringe the patent. Haihe had filed for marketing approval in August 2021, declaring its product non-infringing under Category 4.2. The Supreme Court upheld the BJIPC’s decision on August 8, 2022, stating the generic’s technical solution fell outside the patent’s scope.
Significance
The ruling underscores the operational framework of China’s new patent dispute system, which aims to resolve conflicts between innovators and generics before drug approval. The case took eight months from Chugai’s initial filing in November 2021 to the final decision, highlighting the system’s efficiency.-Fineline Info & Tech
