On 15 April, 2022, the Beijing Intellectual Property Court announced decision on the first instance in which the plaintiff CHUGAI Pharmaceutical Co., Ltd. requests confirmation on whether the generic drug manufactured by the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. falls into the protection scope of the patent owned by the plaintiff. The Court’s decision shows that the generic drug in question does not fall into the protection scope of the patent.

 

This case is the first litigation case relating to patent linkage system in China since the implementation of the new Chinese patent law.

 

Brief introduction of the case

 

The plaintiff, CHUGAI Pharmaceutical Co., Ltd. is the patentee of No. 200580009877.6, titled "ED-71 preparation" (referred to as “’776 patent”), and the holder of the marketing license of the patented drug "Eldecalcidol Soft Capsule" which is mainly used to treat osteoporosis. The plaintiff registered the above-mentioned drug and the ’776 patent on the Platform for Registering Patent Information of CN Marketed Drugs. The plaintiff found that the defendant, Wenzhou Haihe Pharmaceutical Co., Ltd., applied to the State Food and Drug Administration for the registration of a generic drug named "Eldecalcidol Soft Capsule" for a marketing license. The defendant also filed the “Type 4.2 Statement” on the Platform for Registering Patent Information of CN Marketed Drugs, indicating that the generic drug does not fall into the scope of protection of relevant patent rights.

 

Therefore, the plaintiff filed a dispute with the Beijing Intellectual Property Court in accordance with Article 76 of the new Patent Law to confirm whether the generic drug falls into the protection scope of the ’776 patent and requested to confirm that the generic drug "Eldecalcidol Soft Capsule" applied for registration by the defendant falls into the protection scope of the ’776 patent.

 

The Beijing Intellectual Property Court held that the technical solution used by the generic drug involved is neither the same nor equivalent to the technical solution of claim 1 of the ’776 patent and therefore the technical solution does not fall into the protection scope of claim 1 of the ’776 patent. Since claims 2-6 are dependent claims of claim 1, when the technical solution of the generic drug involved does not fall into the protection scope of claim 1, the technical solution also does not fall into the protection scope of claims 2-6. Accordingly, the plaintiff's claim that the generic drug involved falls into the protection scope of claims 1-6 of the ’776 patent cannot be established, and the court will not support it.

 

The plaintiff said in court that he would appeal, and the defendant expressed his obedience to the first instance decision.

 

The plaintiff filed the lawsuit in November 2021 and received a first instance decision in April 2022. It took about 5 months.