Analysis of the judgement and consideration application of rules for supplementary experimental data in pharmaceutical field from administrative and judicial perspectives
GENG Sheng-yan
Abstract：With the advancement of Sino-US trade negotiations and the revision of relevant chapters on supplementary experimental data in the Patent Examination Guidelines,the number of administrative and judicial cases in which supplementary experimental data are the focus of dispute has shown a significant upward trend in recent years.At the same time,however,the trial processes of individual cases have also revealed certain controversial characteristics.This article comprehensively reviews the relevant provisions of the Patent Examination Guidelines and typical adjudication rules in the judicial field,and summarizes the approaches and methods for judging the"three facts"and the"three pairs of relationships"in the trial of supplementary experimental data.It then provides an in-depth analysis of representative administrative decisions and judicial judgments in recent years.On this basis and taking into account the characteristics of the trial practice,suggestions are put forward for the key steps in the trial of supplementary experimental data,so as to objectively and reasonably evaluate the issues related to supplementary experimental data under China's institutional framework for supplementary experimental data,continuously enhance the consistency and predictability of trials involving supplementary experimental data,and thereby help promote the innovative and high-quality development of China's pharmaceutical industry.
Keywords：pharmaceutical fieldpatentsupplementary experimental datacan be obtainedacceptance criteria
Publication Date：2026-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1121-1127 )