The Origin and Value of Biologics Test Data Protection System:A Comparative Perspective with Patent Protection
The biologics test data protection system,as a TRIPS-plus provision,has become a focal point in international multilateral or bilateral trade agreements and domestic industrial policy formulation in recent years.This paper examines the origin and value of this system through a retrospective analysis and comparative evaluation.It finds that the test data of innovative biologics generate positive externalities for biosimilars by allowing them to rely on the former's data,thereby only needing to prove similarity for market approve.This is the root cause of the system.From a comparative perspective,test data protection complements patent protection,especially in the biologics field,in terms of protection object,intensity,substantive protection period,etc.Based on these findings,this paper suggests that China needs to balance the original proposition of intellectual property protection between"innovation incentive"and"drug accessibility"in future system construction,tailored to China's national conditions.At the same time,it is necessary to pay attention to the coordination and connection with the registration,classification,approval systems and patent protection of biologics in order to construct a biologics test data protection system with Chinese characteristics.
biologicstest data protectionsystem originsystem valuepatent protection
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