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美国专利法药品试验免责制度研究

Study on exemption system of drug trials in U.S. patent law

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【作者】 施玮

【Author】 SHI Wei;Chaohu University;

【机构】 巢湖学院

【摘要】 多数国家规定,符合特定事由的未经专利权人同意的专利权使用不构成侵害专利权,基于试验目的的药品使用便为其一。药品试验免责是专利权人行使排他性权利的例外,但过于扩大试验免责的适用,将会使专利权人的排他性权利丧失意义。试验免责制度最早在美国确立,本文通过梳理药品试验免责的起源与发展,展现美国药品试验免责的积极内涵,希望对我国药品试验免责制度的建立提供借鉴。

【Abstract】 Most countries require that the use of patent right without the consent of the patent owner but in accordance with specific reasons do not constitute an infringement of the patent right, and the use of drugs based on the purpose of trial is one of the cases. Drug trail exemption is an exception to the exercise of the exclusive rights of patentee, but it will make the exclusive right of patentee loss its meaning with over expanding the scope of exemption. Drug trail exemption was established in the United States. This paper showed the positive connotation of the U.S. drug trail exemption through introducing the origin and development, hoping to provide reference for the establishment of the exemption system of drug trails in our country.

  • 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2016年05期
  • 【分类号】D971.2
  • 【被引频次】2
  • 【下载频次】117
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