OBJECTIVE  Based on the retrieval and analysis of cases related to the invalidation of drug patents in recent years in China, this paper puts forward relevant suggestions on the operation and management of pharmaceutical enterprises in China.

METHODS  According to analyzes a total of 503 invalidation request cases filed with the National Intellectual Property Administration from January 1, 2005 to July 12, 2020, analyzed them from the dimensions of the number of cases, involved parties, legal basis, related litigation, etc., which aimed to systematically and comprehensively understand the general situation of patent invalidation cases in the field of medicine in China.

RESULTS  The number of cases was increasing rapidly year by year, gradually forming a complete closed loop of patent challenges with litigation; the average closing period of administrative litigation after an invalidation case declared was 31.1 months. Judging from the judgment results, the success of patent invalidation rate over 50%.

CONCLUSION  Pharmaceutical enterprises should pay attention to patent evaluation, analysis and management in the whole process of drug R&D and marketing, improve their independent R&D capabilities and patent management quality.