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美国药品专利链接制度中专利登记规则研究
美国药品专利链接制度中专利登记规则研究
陈 敬1,2,史录文1,2

1 北京大学药学院药事管理与临床药学系,北京 100191; 2 北京大学医药管理国际研究中心,北京 100191
Research on pharmaceutical patents listing rules as a part of patent linkage system in United States
(Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Peking University, Beijing 100191,China)

摘要参考文献相关文章

起始页:1484

摘要:[摘要] 本文回顾美国专利登记制度及实践运行状况,分析制度优劣,为我国药品专利链接中专利登记制度的构建提供参考。我国如拟引入专利链接制度,应借鉴美国经验教训,科学设计符合我国国情的专利登记制度。

关键词:[关键词] 专利链接;专利登记;橘皮书

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Abstract:[Abstract] This paper attempts to look back to the legislation and practice of Orange Book Patent Listing in U.S. and tries to explore the issues arising from the process. It provides a useful reference for the policy-making to establish the pharmaceutical patent listing rules as a part of the patent linkage system in China. We should properly design the mechanism of patent listing rules suitable for China and draw lessons from U.S., if China intends to introduce the patent linkage system.

Key words:[Key words] patent linkage; patent listing; Orange Book

    [1] 朱淑尹.美国专利连结制度中专利登录的介绍与探讨[J]. 知识产权月刊,2015,196:1-8.


    [2] 陈敬, 史录文. 美国药品专利链接制度研究[J]. 中国新药杂志, 2012, 21(22): 2591-2594.


    [3] 张清奎. 浅析药品注册过程中的专利链接[J]. 中国新药杂志, 2007, 16(8): 577-579.


    [4] Federal Trade Commission. Generic drug entry prior to patent expiration: An FTC study

    [R]. Washington (DC): Federal Trade Commission, 2002.


    [5] Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, 132 S.Ct. 1670 (2012).


    [6] KARKI L. Review of FDA law related to pharmaceuticals: the Hatch-Waxman Act, regulatory amendments and implications for drug patent enforcement[J]. J Pat Trademark Off Soc, 2005, 87: 602.


    [7] MARENBERG BJ. FDA issues final rule on patent listing requirements and 30-month stays of approval following submission of abbreviated new drug applications[J]. Biotech Law Report, 2004, 23(1): 48-51.


    [8] REIN FH, CRYSTAL JB. CARACO V. Novo Nordisk: breathing life into the MMA's counterclaim provision[J]. J Gene Med, 2012, 9(3): 154-166.


    [9] 张晓东. 药品专利链接制度研究[J]. 华东理工大学学报: 社会科学版, 2012, 27(3): 87-93.


    [10] 刘晶晶, 武志昂. 建立我国药品专利链接制度的专家调查研究[J]. 中国新药杂志, 2016, 25(11): 1206-1211.