Drug Patent Linkage System in China
A first litigation case has been handled 23 May 2022
After years of discussion, a patent linkage system has been implemented for the first time in China which became effective with the amended patent law, last June 1, 2021.
The Chinese patent linkage system prevents marketing approval of generic drugs until after the expiration of patents covering the drugs or uses, providing a settlement mechanism for disputes arising from patent rights related to drugs applied for registration.
A first drug patent linkage litigation case has been accepted by the Beijing IP Court, which involves patent CN 200580009877.6 protecting “Aidecalcidol Soft Capsule”, for treating osteoporosis, and a generic drug marketing license application having the same name. The Court held that the generic drug does not fall within the scope of protection of the patent.
