China’s Patent Linkage System

Founders Legal retained foreign counsel Foundin IP, has reported that the Beijing Intellectual Property Court issued a ruling in Chugai Pharmaceutical Co., Ltd. v.s. Wenzhou Haihe Pharmaceutical Co., Ltd. This case is China’s first patent linkability case since the implementation of the new Chinese Patent Law.Patent linkability refers to a newly implemented system of Article 76 of the Patent Law of the People’s Republic of China. The system establishes a drug marketing review and approval process for marketing license applicants  who have been found to infringe on a previously granted patent.

According to the complaint, CHUGAI Pharmaceutical Co., Ltd. (the “Plaintiff”) is a Japanese pharmaceutical company that holds the patent for “ED-71 Preparation” and markets the drug under the brand name “Eldecalcidol Soft Capsule.” The Defendant, Wenzhou Haihe Pharmaceutical Co., Ltd., applied to the State Food and Drug Administration for a generic drug registration and a marketing license as well as a “Type 4.2 Statement,” which indicates that the medicine does not infringe on any of the Plaintiff’s valid patents.

According to Foundin IP, The Beijing Intellectual Property Court agreed that the technical solution utilized by the generic drug is neither equivalent nor similar to the technical solution of claim 1 of the patent, therefore falling outside of protection scope. Furthermore, because claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug does not fall within the scope of claim 1, then neither does the technical solution. The court finds that the plaintiff’s assertion that the generic drug falls within the scope of claims 1-6 of the patent cannot be sustained.

According to Foundin IP, the plaintiff plans to appeal the decision, which took about 5 months.