China's First Judicial Decision on Patent Linkage

Summary 

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• China has recently introduced a patent linkage regime which aims to resolve patent disputes more quickly.
• This regime was tested recently in a dispute between a brand-name and a generic drug company which was decided on by the Beijing IP Court.
• Patent linkage lawsuits can be started with declarations being filed at either the Beijing IP Court or the CNIPA – each forum has certain advantages.
• It will take some time for details of the regime to be ironed out, and guidance is expected to be issued in due course. This is likely to result in a rise in the number of patent linkage cases.

In August 2021, a case was filed at the Beijing Intellectual Property Court by Chugai Pharmaceutical Co., Ltd. (中外制药株式会社, "Chugai"), a Japanese drug company that registered a patent on the Patent Information Registration Platform for Marketed Drugs (Registration Platform) for Eldecalcitol (艾地骨化醇), a drug for treatment of osteoporosis. The defendant named in the lawsuit was Wenzhou Haihe Pharmaceutical Co., Ltd. (温州海鹤药业有限公司, "Haihe"), a Chinese company that had applied for market approval of a generic version of Eldecalcitol. The lawsuit led to the court issuing China's first-ever decision in a dispute between a brand-name and a generic drug company under the country's newly-created patent linkage regime.

THE PATENT AND THE LAWSUIT