目的 为我国药品专利期限补偿制度的组织实施工作提供建议和参考。方法 通过梳理国际药品知识产权保护制度,对国际通行药品专利期限补偿制度中的美国模式和欧盟模式进行比较研究。结果 通过分析域外不同药品专利期限补偿制度模式下的补偿原则、实施流程和经验,总结了药品专利期限补偿制度的理论体系。结论 从我国建立药品专利期限补偿制度的意义、影响、后续的实施方式,以及实施过程中需要重点关注的问题等方面提供了具体建议。
Abstract
OBJECTIVE To provide suggestions and references for the organization and implementation of drug patent term restoration in China. METHODS A comparative study of the U.S. model and the EU model of the international prevailing drug patent term restoration was conducted by combing the international pharmaceutical intellectual property protection. RESULTS By analyzing the restoration principles, implementation processes and experiences under different models of drug patent term restoration systems in foreign countries, the theory of the drug patent term restoration was summarized. CONCLUSION Suggestions are provided in terms of the significance and impact of establishing the drug patent term restoration in China, as well as the way of follow-up implementation and the issues to focus on during implementation.
关键词
药品 /
专利补偿 /
比较研究
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Key words
drug /
patent term restoration /
comparative study
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中图分类号：
R95
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脚注
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基金
国家药品监督管理局高级研修学院研究项目资助(NMPAIED2019Q05)
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