中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 817-820.
DOI: 10.19803/j.1672-8629.2021.09.05

• 中国药品橙皮书专栏 • 上一篇    下一篇

美国药品橙皮书框架下专利信息的介绍与启示

沙明泉, 李逸云, 温宝书*   

  1. 国家药品监督管理局药品审评中心,北京 100022
  • 收稿日期:2021-05-31 出版日期:2021-09-15 发布日期:2021-09-18
  • 通讯作者: *温宝书,男,硕士,高级工程师,药品审评管理。E-mail：wenbsh@cde.org.cn
  • 作者简介:沙明泉,女,硕士,主管药师,药品审评管理。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-002）

Pharmaceutical Patent Information under the Framework of American Orange Book

SHA Mingquan, Li Yiyun, WEN Baoshu*   

  1. Center for Drug Evaluation, NMPA, Beijing 100022, China
  • Received:2021-05-31 Online:2021-09-15 Published:2021-09-18

PDF (PC)

149

摘要： 目的 通过对《经治疗等效性评价批准的药品》（Approved Drug Products with Therapeutic Equivalence Evaluations,简称“美国药品橙皮书”）中的专利信息研究,为我国构建药品专利信息检索系统,完善我国药品专利链接制度提供参考依据。方法 列举并分析美国药品橙皮书收录的专利信息及专利信息的提交、变更、删除等管理机制。结果 药品专利信息是构建药品监管信息发布的重要组成部分,提高专利登记信息的真实性和准确性是一项长期存在并需要持续优化的工作。结论 建议结合我国监管框架,不断完善药品专利信息的收载和公示,推动建立医药企业良好竞争秩序,从而提升医药企业开展药品研发创新的动力和信心。

关键词: 药品注册, 药品橙皮书, 药品专利信息, 专利链接制度

Abstract: Objective To provide reference for China's establishment of a drug patent information retrieval system and for the improvement of the drug patent linkage system in China through research on the patent information in the American Orange Book. Methods The patent information included in the American Orange Book and the management mechanisms for the submission, modification, and deletion of patent information were analyzed. Results Pharmaceutical patent information was an important part of drug regulatory information. Improving the authenticity and accuracy of patent registration information was a long-term undertaking that requires continuous optimization. Conclusion It is recommended that the collection and release of drug patent information continue to be improved in line with the actual situation in China, and that pharmaceutical companies compete on an equal footing so as to leave pharmaceutical companies more motivated for and confident about drug R&D and innovation.

Key words: drug registration, Orange Book, patent information, patent linkage

中图分类号: