Research on the review of experimental data in patent applications for traditional Chinese medicine
SUN Qing-shan
YAO Jia
LI Kai-nuo
Abstract：In China's patent applications for traditional Chinese medicine(TCM),the examination of experimental data constitutes a critical component in determining sufficient disclosure,innovation,and practical applicability.However,current challenges persist in the review process of TCM patent experimental data,including ambiguous regulatory standards,insufficient verification of data authenticity,and inadequate coordination with TCM registration requirements.When evaluating TCM experimental data,it is imperative to not only respect the unique characteristics of TCM research and development(particularly the evidentiary value of"human experience")but also incentivize the implementation of rigorous clinical trials to advance TCM modernization.Recommendations include establishing a clear"three-in-one"evaluation framework for TCM patent experimental data review,optimizing authenticity verification protocols,enhancing the role of clinical experimental data in patent challenges,and prioritizing clinical evidence during supplementary data evaluations.
Keywords：patent of traditional Chinese medicinepatent applicationexperimental dataclinical trialmodernization of traditional Chinese medicine
Publication Date：2025-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2372-2377 )