影响药品专利链接制度的重要因素和解决路径  

Important Factors Affecting the Pharmaceutical Patent Linkage System and the Solutions thereof

作　　者：耿文军 丁锦希[1] 

机构地区：[1]中国药科大学 [2]正大天晴药业集团股份有限公司

出　　处：《知识产权》2018年第7期87-91,共5页Intellectual Property

摘　　要：介绍了药品专利链接的两种规则,即声明规则和停摆期规则,比较了两个规则的成本和收益,并通过成本收益分析法剖析了两种规则的差异及其导致的成本和收益,认为药品注册申请中的审评审批速度、合理的等待期、专利确权和侵权裁判时间是停摆期规则得到最优收益的最重要的因素。因此加快审评审批速度,通过多元化的方式尽快解决侵权纠纷可以使得专利链接制度利益最大化。The paper introduces two rules concerning pharmaceutical patent linkage system,namely the declaration rule and the stay rule,and compares the cost and benefits between the two rules.By applying cost-benefit analysis,the paper analyzes the differences between the two rules as well as the cost and benefit generated by the differences.The paper concludes that the drug approval speed,reasonable waiting period,and the period for right confirming or infringement adjudication are the most important factors to obtain maximum benefit from the stay rule.It is therefore suggested to speed up the process of drug approval,and to solve the infringement disputes through fast and diversify ways can help to achieve the maximum benefits of pharmaceutical patent linkage system.

关 键 词：药品专利链接 仿制药 药品可及性 成本收益分析 声明规则 停摆期规则 

分 类 号：D923.42[政治法律—民商法学]