我国药品试验数据保护制度探讨——以埃克替尼药品保护为例
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昆明理工大学

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Analysis of China's drug trial data protection system - take Alectinib protection as an example
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    摘要:

    在TRIPS协定框架下,药品试验数据保护制度的本土化建构亟需重新审视制度的功能与体系定位。文章以创新药埃克替尼为实证样本,结合法理分析,论证药品试验数据的知识产权属性及其保护的制度逻辑。研究表明,化合物专利存在稳定性不足、市场独占期折损的固有缺陷,叠加数据保护制度的缺位,严重削弱创新回报预期。数据保护制度并非仅为专利法的附属工具,需突破“专利补充论”认知,在权利配置中嵌入公益性约束。我国应构建兼顾制度独立性与体系协调性的数据保护规则,以平衡创新激励与国民健康保障的双重目标。

    Abstract:

    Under the framework of the TRIPS Agreement, the localisation of the drug test data protection system urgently needs to re-examine the function and system positioning of the system. The article takes the innovative drug Alectinib as an empirical sample, and combines legal analysis to argue the intellectual property attributes of drug test data and the institutional logic of its protection. Research shows that compound patents have inherent defects such as insufficient stability and loss of market monopoly period, superimposed on the lack of data protection system, which seriously weakens the expectation of innovation returns. The data protection system is not only a subsidiary tool of patent law. It needs to break through the understanding of "patent supplement theory" and embed public welfare constraints in the allocation of rights. China should build data protection rules that take into account institutional independence and system coordination, so as to balance the dual goals of innovation incentives and national health security.

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  • 收稿日期:2025-03-18
  • 最后修改日期:2025-04-22
  • 录用日期:2025-04-23
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