On the Acceptance Criteria of Drug Patent Supplementary Experimental Data
Due to the long research and development time of drug patents,a large amount of supplementary experimental data will be generated after the application.China's legislation and practice have made it clear that the supplementary experimental data should be reviewed.However,review does not mean acceptance,and the typical cases reflect that the acceptance criteria for supplementary experimental data are still highly controversial.The legislative models and judicial practices of the United States,Europe and Japan are also different from each other.To solve the problems existing in the acceptance standards of drug patent supplementary experimental data,it should be improved from the following aspects:Clarify the different acceptance standards of"technical scheme"and"predicted effect";clarify the relationship between supplementary experimental data and the purpose of proof;relax the acceptance criteria for predicted effect;extend the understanding of common knowledge and prior art in the field.