To conduct a systematic analysis of patent infringement litigation involving traditional Chinese medicine (TCM), summarize its common problems, explore the underlying causes, and propose targeted improvement strategies.

The research primarily adopted an empirical analysis approach, supplemented by case studies. By integrating statistical data and relevant legislation, TCM patent infringement cases were examined from multiple dimensions, including judicial levels, final judgment reversal rates, litigation parties, and litigation patterns.

Several characteristics of TCM patent infringement litigation were indicated: first, in terms of judicial hierarchy, cases tended to reach higher levels of adjudication, with most undergoing second-instance or retrial procedures; second, the reversal rate in final judgments was relatively high; third, regarding party structure, both plaintiffs and defendants were predominantly legal entities; and fourth, in terms of litigation patterns, TCM patent infringement cases were often accompanied by administrative litigation, showing an intertwined relationship between civil and administrative proceedings.

TCM patent infringement litigation faces several challenges, including incomplete legislation, prolonged judicial processes, and difficulties in determining infringement. To address these issues, efforts should be made to strengthen administrative-judicial coordination mechanisms, promote local legislation, establish platforms for innovation and transformation of TCM achievements, apply the drug patent linkage system flexibly, develop strategic patent layout planning for enterprises, and cultivate specialized legal professionals in the TCM field, thereby fostering the sustainable development of China's TCM industry.