Decision Released for the First Case regarding Chinese Patent Linkage System

China’s Patent Linkage System

Founders Legal retained foreign counsel Foundin IP, has reported that the Beijing Intellectual Property Court issued a ruling in Chugai Pharmaceutical Co., Ltd. v.s. Wenzhou Haihe Pharmaceutical Co., Ltd. This case is China’s first patent linkability case since the implementation of the new Chinese Patent Law.

China Patent Linkage

Patent linkability refers to a newly implemented system of Article 76 of the Patent Law of the People’s Republic of China. The system establishes a drug marketing review and approval process for marketing license applicants  who have been found to infringe on a previously granted patent.

According to the complaint, CHUGAI Pharmaceutical Co., Ltd. (the “Plaintiff”) is a Japanese pharmaceutical company that holds the patent for “ED-71 Preparation” and markets the drug under the brand name “Eldecalcidol Soft Capsule.” The Defendant, Wenzhou Haihe Pharmaceutical Co., Ltd., applied to the State Food and Drug Administration for a generic drug registration and a marketing license as well as a “Type 4.2 Statement,” which indicates that the medicine does not infringe on any of the Plaintiff’s valid patents.

According to Foundin IP, The Beijing Intellectual Property Court agreed that the technical solution utilized by the generic drug is neither equivalent nor similar to the technical solution of claim 1 of the patent, therefore falling outside of protection scope. Furthermore, because claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug does not fall within the scope of claim 1, then neither does the technical solution. The court finds that the plaintiff’s assertion that the generic drug falls within the scope of claims 1-6 of the patent cannot be sustained.

According to Foundin IP, the plaintiff plans to appeal the decision, which took about 5 months.

Seeking assistance with your foreign patent application? Learn more about our patent services or schedule an initial consultation here.

Yuri L. Eliezer, Managing Partner

Yuri L. Eliezer, Esq.
Patent Attorney
Managing Partner
[email protected]

Lauren Hawksworth
Marketing Administrator

Yuri heads the Intellectual Property practice group at Founders Legal. A practice he co-founded at the Atlanta Tech Village – the nation’s fourth largest incubator. Yuri was one of the few attorneys invited by the USPTO to provide technical training and industry insight at the Patent Examiner Technical Training Program (PETTP), where he shared insight into technology company decision points and challenges within the US Patent System. By the nominations of colleagues that have worked with him over the past several years, Yuri was selected to the 2021 and 2020 Super “Patent” Lawyer Lists, an award that is given to just 2.5% of attorneys. His recognition relates to his work in securing multi-million dollar patents for his clients – patents that have been tested through USPTO examination, re-examination and litigation. Yuri also strives to use his first-hand knowledge of the legal industry to develop innovative methods to improve the practice of law, and has been recognized as a player in the law practice technology field.
When you visit our website, it may store information through your browser from specific services, usually in form of cookies.