Beijing Intellectual Property Court accepted the first lawsuit case of ＂drug patent link＂

WeChat official account, Nov. 10, 2021: The new Patent Law, which came into effect on June 1, 2021, added a dispute resolution mechanism for patents related to drugs applied for registration. In this regard, National Medical Products Administration and China National Intellectual Property Administration issued the Measures for the Implementation of the Early Resolution Mechanism of Drug Patent Disputes (Trial). The Supreme People’s Court also issued the Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Laws in the Trial of Civil Cases of Patent Disputes Related to Drugs Applying for Registration, which stipulated the specific contents of the dispute settlement mechanism and determined that the Beijing Intellectual Property Court had centralized jurisdiction over such cases. The civil cases of patent disputes related to drugs applied for registration are commonly referred to as "drug patent link" cases in the industry.

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

The plaintiff of the case, Sino-foreign Pharmaceutical Co., Ltd., claimed that it was the holder of the marketing license of the patented drug "Aidit calcitol soft capsule" and the patentee of the China invention patent with the patent number of 2005800098777.6 and the name of "ED-71 preparation" involved in this drug. The plaintiff found that Wenzhou Haihe Pharmaceutical Co., Ltd., the defendant, applied to the State Drug Administration for the listing license of generic drugs named "Aidit Calcineol Soft Capsule". The public information of China listed drug patent information registration platform shows that the defendant made a Class 4.2 statement about the generic drug. Therefore, the plaintiff filed a drug patent linking lawsuit with the Beijing Intellectual Property Court in accordance with Article 76 of the new Patent Law, requesting the court to confirm that the generic drug "Aidit calcitol soft capsule" applied for registration by the defendant falls within the patent protection scope of the invention patent No.2005800098777.6 enjoyed by the plaintiff. The Beijing Intellectual Property Court considered that the plaintiff’s lawsuit met the requirements of the prosecution conditions of drug patent link litigation and registered it according to law.

At present, the case is under further investigation.