China's First Litigation Case of Pharmaceutical Patent Linkage —— Chugai Pharmaceutical Co., Ltd. vs. Wenzhou Haihe Pharmaceutical Co., Ltd., Case of Dispute over Identifying Whether to Fall into Protection Scope of Patent Rights

May 6, 2023

Case Brief

In light of Article 76.1 of the Chinese Patent Law, Chugai Pharmaceutical Co., Ltd. filed a lawsuit on pharmaceutical patent linkage with the Beijing Intellectual Property Court, requesting to identify that the technical solution of the generic drug "Eldecalcitol Soft Capsules" of Wenzhou Haihe falls into the protection scope of patent claims involved. The court of first instance ordered to reject the litigation claims filed by Chugai Co., Ltd. Chugai Pharmaceutical Co., Ltd. was dissatisfied and filed an appeal. The Supreme People's Court held in the second instance that, Wenzhou Haihe failed to make any statement on the claim with the maximum protection scope and to notify Chugai Pharmaceutical Co., Ltd., the marketing authorization holder, of the statement and the statement basis in a timely manner, and such failure was inappropriate and should be criticized; as for the determination of whether the technical solution of generic drug would fall into the protection scope of patent claims, in principle, comparison and evaluation should be conducted based on the application files submitted by the generic drug applicant; upon comparison, the technical solution of generic drug involved did not fall into the protection scope of patent claims. It was therefore ordered to reject the appeal and uphold the original sentence.

Typical Significance

The present case is China's first litigation case of pharmaceutical patent linkage. China's pharmaceutical patent linkage system is preliminarily established and is still in the exploration phase. The judgment of the present case embodies legislative-purpose-compliant exploratory legal application regarding new issues incurred in the initial practice phase of pharmaceutical patent linkage system and receives considerable attention and widespread praise from the Chinese and foreign media and pharmaceutical communities. CMG has promptly reported the present case, which is selected as one of the "Top Ten Nomination Cases for Promoting the Process of Rule of Law in the New Era in 2022".

(Source of case: Supreme People's Court of the People's Republic of China)