Article 76 of the new Patent Law, which was implemented on June 1, 2021, added a mechanism for dispute settlement arising from patent rights related to drugs applied for registration. In this regard, the National Medical Products Administration and the National Intellectual Property Administration issued the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes (for Trial Implementation). The Supreme People’s Court also promulgated the Provisions of the Supreme People's Court on Several Issues concerning the Application of Law in the Trial of Civil Cases involving Patent Disputes Related to Drugs of Which Applications for Registration, stipulating the specific content of the dispute settlement mechanism, and determining that the Beijing Intellectual Property Court has centralized jurisdiction over such cases. The civil cases of patent rights disputes related to the drugs applied for registration are commonly referred to as "drug patent linkage" cases in the industry.

Recently, the Beijing Intellectual Property Court accepted the first case of this type after the implementation of the new Patent Law.

The plaintiff of the case, Chugai Pharamceutical Co., Ltd. claimed that it was the marketing authorization holder of the marketed patent drug "Eldecalcitol Soft Capsule", and is the patentee of the Chinese invention patent, of which the patent number involved in the drug was 2005800098777.6 and the name was ED-71 preparation. The plaintiff discovered that the defendant, Wenzhou Haihe Pharmaceutical Co., Ltd. had applied to the National Regulatory Authority for a marketing authorization to the generic drug named "Eldecalcitol Soft Capsule". The Patent Information Registration Platform for Drugs Marketed in China showed that the defendant had made a 4.2-category statement regarding the generic drug. Therefore, the plaintiff filed a drug patent linkage litigation with the Beijing Intellectual Property Court in accordance with the provisions of Article 76 of the new Patent Law, requesting the court to confirm that the generic drug "Eldecalcitol Soft Capsule" applied by the defendant for registration fell into the protection scope of the invention patent No. 2005800098777.6 enjoyed by the plaintiff. The Beijing Intellectual Property Court found that the plaintiff’s suit was in compliance with the requirements of drug patent linkage litigation and registered the case in accordance with the law.

At present, the case is under further trial.