| 引用本文: | 蒋蓉,沈洁,邵蓉.美国生物类似药注册申请中专利纠纷解决程序的研究[J].中国现代应用药学,2021,38(18):2283-2287. |
| JIANG Rong,SHEN Jie,SHAO Rong.Research on the Patent Dispute Resolution Procedure During the Registration Application of Biosimilars in the United States[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(18):2283-2287. |
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| 摘要: |
| 目的 为完善我国生物类似药专利纠纷解决程序提出相应建议。方法 深入研究美国生物类似药专利纠纷解决程序的法律基础、实施方式，并选取典型案例针对焦点问题进行分析。结果 美国的专利舞蹈制度有助于早期介入并解决生物类似药专利纠纷问题，并且配备了完善的配套措施。结论 建议建立我国生物类似药专利纠纷解决程序，引入拟制侵权制度，建立我国生物制品上市产品目录集，从而完善我国生物类似药专利纠纷的解决。 |
| 关键词: 生物类似药 专利纠纷 专利舞蹈 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.18.015 |
| 分类号:R951 |
| 基金项目:江苏省教育厅高校哲学社会科学研究项目（2019SJA0059）；中国药科大学“双一流”学科创新团队建设项目（CPU2018GY39） |
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| Research on the Patent Dispute Resolution Procedure During the Registration Application of Biosimilars in the United States |
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JIANG Rong, SHEN Jie, SHAO Rong
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The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing 211198, China
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| Abstract: |
| OBJECTIVE To propose suggestions for improving the patent dispute settlement procedure of biosimilars in China. METHODS Intensive studied the legal basis and implementation way of the patent dispute resolution procedure for biosimilars in the United States. And the typical case was selected to analyze the focus issues. RESULTS The patent dance system in the United States was helpful for early intervention and settlement of patent disputes of biosimilars, and was equipped with complete supporting measures. CONCLUSION To improve the patent dispute resolution of biosimilars in China, it is suggested to establish the procedure of patent dispute resolution of biosimilars, introduce the system of artificial infringement, and establish the catalogue of listed products of biological products in China. |
| Key words: biosimilars patent dispute patent dance |
