美国生物制品注册早期相关知识产权制度研究

齐云, 杨悦, 邢花

中国药学杂志 ›› 2022, Vol. 57 ›› Issue (3) : 242-248.

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中国药学杂志 ›› 2022, Vol. 57 ›› Issue (3) : 242-248. DOI: 10.11669/cpj.2022.03.013
论著

美国生物制品注册早期相关知识产权制度研究

  • 齐云1, 杨悦2, 邢花1*
作者信息 +

Intellectual Property System Related to Biologics Early Registration in the United States

  • QI Yun1, YANG Yue2, XING Hua1*
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文章历史 +

摘要

目的 探索并分析美国生物制品注册早期相关知识产权制度。方法 通过查阅国内外文献,回顾美国《生物制品价格竞争与创新法案》颁布的背景,梳理美国利用专利舞蹈制度解决各种专利纠纷问题。结果 数据保护制度与专利并行,在12年保护期内提交生物类似药申请,美国食品药品监督管理局(FDA)还未批准的状态下,专利舞蹈制度通过生物类似药企业与原研企业之间进行的信息交换过程,识别相关专利并诚信协商确定专利诉讼范围,尽量减小专利诉讼压力,力争在生物类似药上市销售前解决专利纠纷,加快生物类似药上市,从而提高公众用药可及性。结论 生物制品的特殊性造成专利问题早期解决机制比化学药品更为复杂,不宜采用与化学药品相同的模式解决纠纷。

Abstract

OBJECTIVE To explore and analyze the intellectual property protection system related to the registration of biological products in the United States. METHODS Domestic and foreign documents were consulted, the background of the US "Biologics Price Competition and Innovation Act" was reviewed, the use of the patent dance system in the United States was sorted to resolve various patent disputes. RESULTS The data protection system is parallel to patents. The application for biosimilar drugs is submitted within the 12-year protection period. Before the FDA has not approved it, the patent dance system uses the information exchange process between the biosimilar drug company and the original research company to identify relevant patents and the scope of patent litigation shall be determined through good faith negotiation, minimize the pressure of patent litigation, strive to resolve patent disputes before biosimilars are marketed, and accelerate the listing of biosimilars, so as to improve the availability of medicines to the public. CONCLUSION The particularity of biological products causes the early resolution of patent issues to be more complicated than chemical drugs, and it is not appropriate to use the same model as chemical drugs to resolve disputes.

关键词

生物制品 / 生物类似药 / 独占权 / 专利诉讼 / 专利舞蹈

Key words

biologics / biosimilar / exclusivity / patent litigation / patent dance

引用本文

导出引用
齐云, 杨悦, 邢花. 美国生物制品注册早期相关知识产权制度研究[J]. 中国药学杂志, 2022, 57(3): 242-248 https://doi.org/10.11669/cpj.2022.03.013
QI Yun, YANG Yue, XING Hua. Intellectual Property System Related to Biologics Early Registration in the United States[J]. Chinese Pharmaceutical Journal, 2022, 57(3): 242-248 https://doi.org/10.11669/cpj.2022.03.013
中图分类号: R95   

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