On April 15, 2022, the Beijing Intellectual Property Court ruled that Wenzhou Haihe Pharmaceutical Co., Ltd.’s application for marketing authorization for a generic form of “Aidecalcidol Soft Capsule” did not fall within scope of protection of the relevant patent in China’s first patent linkage court decision.   China’s patent linkage system prevents marketing authorization for a generic prior to the expiration of the patent term on the branded equivalent unless the Beijing IP Court or the China National Intellectual Property Administration (CNIPA) rules that the generic does not fall within the scope of the relevant patent rights or is invalid.

On November 10, 2021, the Beijing Intellectual Property Court announced that it accepted its first drug patent linkage litigation case. In contrast, an alternative patent linkage adjudication mechanism seems more popular with the China National Intellectual Property Administration (CNIPA) announcing that as of October 27, 2021 they had accepted 12 cases.  China implemented a patent linkage system in their amended patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic of China (2020)).  The Chinese patent linkage system prevents marketing approval of generic drugs until after the expiration of patents covering the drugs or uses.

Article 76 of the amended Patent Law, which was implemented on June 1, 2021, added a settlement mechanism for disputes arising from patent rights related to drugs applied for registration. In this regard, the NMPA and CNIPA jointly issued the “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial).” The Supreme People’s Court also promulgated the “Regulations of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Drugs Applied for Registration.” 

On November 10, 2021, the Beijing IP Court announced that the plaintiff of the case, Chugai Pharmaceutical Co., Ltd., a subsidiary of Roche, claimed that it was the patentee as well as the holder of the marketing license for the patented drug “Aidecalcidol Soft Capsule”, and the patent involved in the drug was CN 2005800098777.6 entitled “ED-71 preparation.” The plaintiff discovered that the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. had applied to the NMPA for a generic drug marketing license application named “Aidecalcidol Soft Capsule”. The public information on the Chinese listed drug patent information registration platform showed that the defendant had made a 4.2 category statement regarding the generic drug (the generic drugs do not fall into the scope of protection of the related patents). Therefore, the plaintiff filed a drug patent linkage lawsuit with the Beijing Intellectual Property Court in accordance with the provisions of Article 76 of the Amended Patent Law, requesting the court to confirm that the generic drug “Aidecalcidol Soft Capsule” that the defendant applied for registration fell into the scope the rights of Patent No. 2005800098777.6 enjoyed by the plaintiff. 

The Beijing IP Court held

The technical solution used by the generic drug involved is neither the same nor equivalent to the technical solution of claim 1 of the involved patent, so the technical solution does not fall within the protection scope of claim 1 of the involved patent. Since claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug involved does not fall within the protection scope of claim 1, it also does not fall within the protection scope of claims 2-6. Accordingly, the plaintiff’s claim that the involved generic drug falls within the protection scope of claims 1-6 of the involved patent cannot be established, and the court will not support it.

Of particular note, the Beijing IP Court was able to issue the decision within the 9-month moratorium on marketing authorization approval set by the National Medical Products Administration. In contrast, CNIPA, which provides an alternative route to challenge a generic marketing authorization application, has not publicly announced any decisions yet despite accepting 12 cases by late October 2021.

The full text of the announcement is available here (Chinese only). More information in English on China’s patent linkage system is available here.