On July 4, 2021, the National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) released the Measures for Implementing Early Resolution Mechanism for Drug Patent Disputes (Trial) (hereinafter referred to as the Measures) with immediate effect.1
Before issuing the Measures, China has already been implementing some drug patent regulations and policies, including the Patent Law and the Opinions on Deepening the Reform of the Review and Approval Systems and Encouraging Innovation in Drugs and Medical Devices.
For the chronology of drug patent protection in China and the Measure's impact, please refer to BaiPharm's previous report: China Rolls Out Measures to Establish Drug Patent Linkage System.
Along with other relevant regulations and policies, the Measures constitutes the framework of China's Drug Patent Linkage System. The system aims to bridge the marketing approval of generics and the patent protection of brand-name drugs. The system also asks NMPA (the drug administration), CNIPA (the patent administration), and the court to make efforts collaboratively to resolve patent disputes at an early stage preceding NMPA's approval of the generic drug.
Main Contents: Drug Patent-Related Systems
The Measures' main contents are as follows:
System for Platform Development and Information Publication;
System for Patent Registration;
Patent Statement System for Generic Drugs;
System of Jurisdiction Linkage and Administration Linkage;
System of Stay Period for Approval;
Classification System for Dealing with Drug Reviews and Approvals;
System of Marketing Exclusivity Period for First Generics (Note that the first generic in China refers to the first drug products manufactured and marketed domestically. The exclusivity is only applicable to the first generics that successfully challenge the valid patents, not to the first generics that get marketing approval after the corresponding patents expire);
Patent Registration of Licensed Brand-Name Drugs
The Patent Registration Platform
The "Patent Information Registration Platform for Drugs Marketed in China (hereinafter referred to as the platform)" launched by NMPA has come into use.
The platform has two main functions:
Serving brand-name drug's marketing authorization holders (MAHs) in registering patent information;
Disclosing the registered patent to the public.
Patents to be Registered on the Platform:
(1) For chemical drugs (except drug substances):
Patents for active substance compounds, drug recombinants with active substances, and medical uses.
(2) For traditional Chinese medicines (TCMs):
Patents for recombinants, extracts, and medical uses.
(3) For biological products:
Patents for sequential structures of active ingredients, and medical uses.
Patents NOT Admitted for Registration on the Platform:
products of metabolism;
methods of preparing and manufacturing the drugs;
When and What Information to Register
Within 30 days upon receiving the drug registration certificate, a brand-name drug MAH shall register the following information on the platform: