On April 15, Beijing Intellectual Property Court ruled on China's first litigation case on drug patent linkage since the revised Patent Law came into effect in July last year.
The Case's Details
The case's plaintiff was Chugai Pharmaceutical Co., Ltd, a Japanese drug manufacturer which owns the No. 200580009877.6 patent entitled "ED-71 preparation" and is the marketing authorization holder of the patent-related Eldecalcitol Soft Capsules, a drug for osteoporosis.
The company has registered the patent and the related drug on the Patent Information Registration Platform for Drugs Marketed in China (hereafter referred to as the platform).
The defendant was Wenzhou Haihe Pharmaceutical Co., Ltd, which submitted an application to the National Medical Products Administration for the marketing authorization of generic Eldecalcitol Soft Capsules. The defendant has made a Type 4.2 statement on the platform that the generic drug does not fall into the scope of the patent claim.
However, Chugai Pharma disagrees with the defendant's Type 4.2 statement. Therefore, the company exercised its right to file a lawsuit according to Article 76 of the Patent Law, requesting the Beijing Intellectual Property Court to rule on if the generic drug has fallen into the protection scope of the No. 200580009877.6 patent.
The Court's Ruling
The Beijing IP Court dismissed the request from Chugai Pharma. The court holds the view that Wenzhou Haihe Pharma's generic drug uses a technical solution different and nonequivalent to that in Chugai Pharma's Patent Claim 1 for the brand-name version of Eldecalcitol Soft Capsules. Therefore, the generic drug is ruled as not within the patent protection scope.
The defendant Whenzhou Haihe Pharma accepted the ruling, but the plaintiff Chugai Pharma said it would appeal.
China's Drug Patent Linkage System
The case above is a practice of the Measures for Implementing Early Resolution Mechanism for Drug Patent Disputes (Trial), which took effect in July 2021. The Measures lays the foundation of China's drug patent linkage system, which links the marketing approval of generics and patent protection of brand-name drugs.
The system asks marketing authorization holders of brand-name drugs to register the drug patents on the platform. If a company wants to market a generic version of a registered brand-name drug, the company has to make a patent statement and notify the patent owner. (Learn more about statement types: part 3 of the article "How Does China's Drug Patent Linkage System Work?")
If the patent owner objects to the statement, it can file a lawsuit or administrative request to China National Intellectual Property Administration (CNIPA). If the ruling supports the patent owner, the generic drug will not be approved for marketing authorization until 20 workdays before the patent expires.
If the ruling does not support the patent owner, the generic drug can continue with its review and approval procedures. The first generic drug getting the marketing authorization in China will enjoy 12-month market exclusivity.
In general, China's drug patent linkage system tries to balance patent protection and encouraging the development of high-quality generics. Know more about the system by reading the related articles: