China has recently seen the first decision in a case initiated
under its patent linkage system. Under this system, when a generic
drug company files an application for marketing authorisation, it
can make one of four declarations, including that there is a
registered patent relating to the product but it will be declared
invalid or non-infringed. If such a declaration is provided, the
patent owner is notified of the application for marketing approval,
and must commence proceedings within 45 days with the Beijing IP
Court or before CNIPA. There is then a 9-month moratorium on
marketing authorisation approval.
In this case, the plaintiff, Chugai
Pharmaceutical Co., Ltd (Chugai), is the patentee
of Chinese Patent No. 200580009877.6 (US family member No.
10/588,609) protecting the ED-71 preparation, and also the
marketing authorization holder of the relevant patented drug,
Eldecalcitol Soft Capsules. The defendant,
Wenzhou Haihe Pharmaceutical Co., Ltd (Haihe), is
a
