The Balance Of Pharmaceutical Data Exclusivity Protection Under The Patent System

Pharmaceutical data exclusivity has been a controversial system since the day it was created,and one of the important controversies is the competitive relationship between the practical function of the data exclusivity system and that of patent system.If we trace back to the history of pharmaceutical industry,it can be noticed that after“the abbreviated new drug application” system was introduced in this area,patent system started to exert its function of supplying inducement to encourage the research and development of pharmaceutical products.However,since we already have this powerful system to supply inducement,is it necessary for us to have the data exclusivity system?The main body of this paper is divided into four chapters.The first chapter is the basic understanding of exclusivity protection of drug test data and test data,and discovers the imbalance of drug test data through comparison with trade secrets,so as to draw out the value of exclusivity protection system of test data.The second chapter firstly introduces the test data protection system of exclusive incentive function and equilibrium theory,combined with the generic listing program to illustrate the influence of drug incentive is reduced;the second lead to drug test data for new drug research and development of the exclusive right of incentive effect,the final analysis,by changing the system of different perspectives to highlight the exclusive rights under patent system parallel test data of balancing of interests.The third chapter explores the interactive relationship between exclusivity of drug test data and patent system.The first is to compare the similarities and differences between the two systems,which leads to the important elements of patent protection.Secondly it analyzes the limitation brought by patent elements layer by layer.Thirdly,through the discussion of limitations,the paper analyzes the coordination of test data exclusivity to patent from three aspects:technology development,patent challenge and R&D inducement.Finally,in addition to analyzing the balance and coordination between the two,this paper discusses the deficiency of the exclusive right of experimental data and analyzes its performance in four aspects in order to obtain more comprehensive enlightenment and reference.The fourth chapter discusses the current situation of domestic institutions based on China’s current law and hot topics,analyzes the deficiencies from the aspects of substantive law and procedural law,and gives reference suggestions based on the above-mentioned American model.