On 15 Apr. 2022, the Beijing Intellectual Property Court announced the first-instance judgment of the case Chugai Pharmaceutical Co., Ltd. v. Wenzhou Haihe Pharmaceutical Co., Ltd., addressing whether the generic drug in question falls within the protection scope of relevant patent rights.
The case is reported to be the first pharmaceutical patent linkage lawsuit in China since the implementation of the amended Patent Law.
The generic drug involved is mainly for osteoporosis treatment.
After trial, the court held that the technical solution used by the generic drug at issue was neither the same nor equivalent to the technical solution of the involved patent, and therefore the technical solution did not fall within the protection scope of the involved patent.
According to Article 76 of the fourth amendment to the Patent Law passed in October 2020, during the marketing review and approval of new drugs, the applicant for the drug marketing authorization and the concerned patentee or interested party may request a judgment through judicial or administrative proceedings on whether the technical solution of the drug applying for registration falls within the scope of protection of another party’s drug patent rights. This provision laid the foundation for China’s pharmaceutical patent linkage system.
Later, China’s Supreme People’s Court promulgated the “Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration” (最高人民法院关于审理申请注册的药品相关的专利权纠纷民事案件适用法律若干问题的规定), authorizing the Beijing Intellectual Property Court to have exclusive jurisdiction over pharmaceutical patent linkage lawsuits.
Cover Photo by Lavinia Occeña on Unsplash
Contributors: CJO Staff Contributors Team
