Analysis of the drug patent term extension provisions in the context of the new Detailed Rules for the Implementation of the Patent Law of the People's Republic of China and Patent Examination Guidelines
SUN Ming-ming
Abstract：The new Patent Law of the People's Republic of China establishes for the first time the provisions of patent term extension for an invention patent relating to a drug.The new Detailed Rules for the Implementation of the Patent Law of the People's Republic of China and Patent Examination Guidelines revised in 2023 provided detailed provisions and explanations.This paper analyzed the applicable objects,request conditions,calculation method of patent term extension,subject and process of request stipulated in the new Detailed Rules and Guidelines and compared them with the relevant provisions in the United States and Japan.The current situation of drugs in the application stage and the situation of recently approved drugs was also analyzed.Based on the provisions of the new Detailed Rules and Guidelines,the length of time for which the recently approved drugs can be extended for the patent term was calculated,and suggestions for enterprises to request for extension for the patent term of drugs were put forward.
Keywords：Detailed Rules for the Implementation of the Patent Law of the People's Republic of ChinaPatent Examination Guidelinespatent term extensionnew drug
Publication Date：2025-02-27
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 346-351 )