论药品数据专有权

On the Exclusive Rights of Drug Data

药品数据专有权利与其他现行知识产权制度不同,其设立的初衷在于促进药品上市审批中安全有效性数据合理披露,并通过专有性财产权利的规范引入保障制药企业的合法权益,实现药品创新与药品仿制之间的平衡,以及私人权益与公共健康之间的协调。从药品数据专有权利生成与继受的过程来看,药品数据专有权利与药品上市审批机制的发展直接相关,其由药品上市审批的数据提交要求而肇生,并随药品上市审批的数据公开诉求而革新。在此基础上,纵观药品知识产权保护的整体框架,可以发现药品数据专有权利与药品专利权是两项平行、并存的法律规范,且二者都是一种以公开为对价来换取权利独占的契约性制度构造,保护目标上的统一性与保护效果上的互补性也使得二者在药品知识产权制度实践中呈现出一定程度的内容交叉与重叠,推进药品数据专有权利与药品专利权之间的协同与衔接也因此显得格外关键。

The exclusive rights of drug data are different from other current intellectual property systems.The original intention of its establishment is to promote the reasonable disclosure of safety and effectiveness data in drug market approval,and to protect the legitimate rights and interests of pharmaceutical enterprises through the standardization of exclusive property rights,achieving a balance between drug innovation and drug imitation,as well as the coordination be⁃tween private rights and public health.From the process of generating and inheriting the exclu⁃sive rights of drug data,it can be seen that the exclusive rights of drug data are directly related to the development of the drug marketing approval mechanism.They arise from the data sub⁃mission requirements of drug marketing approval and are innovated with the demand for data disclosure in drug marketing approval.On this basis,throughout the overall framework of drug intellectual property protection,it can be found that the exclusive rights of drug data and drug patent rights are two parallel and coexisting legal norms,and both are contractual institutional structures that exchange disclosure for exclusive rights.The unity of protection objectives and the complementarity of protection effects have also led to a certain degree of overlap and overlap between the two in the practice of drug intellectual property system.Therefore,promoting the synergy and connection between drug data proprietary rights and drug patent rights is particular⁃ly crucial.