收藏切换
Reflections on patent management under the situation of accelerated approval of new drugs based on an analysis of the research and development process of osimertinib
收藏切换
Qian YANG, Chun-peng JIN, Ru ZHENG, Qiu-juan MA
Chinese Journal of New Drugs | 2021, 30(24) : 2234 - 2241
Less
收藏切换
Chinese Journal of New Drugs | 2021, 30(24): 2234-2241
Reflections on patent management under the situation of accelerated approval of new drugs based on an analysis of the research and development process of osimertinib
Full
Qian YANG, Chun-peng JIN, Ru ZHENG, Qiu-juan MA
Affiliations
  • Patent Examination Corporation Center of Beijing, China National Intellectual Property Administration, Beijing 100160, China
Published: 2021-12-30
Outline
收藏切换

The research and development process of osimertinib was prompted by new drug expedited programs in the US, which resulted in the highly coincident time periods of drug registration and patent examination. Based on the review of the research and development process and patent strategy of osimertinib, the opportunities and challenges of pioneering new drugs and follow-on drugs under the global trend of accelerating approval process were analyzed. The exploration of special patent examination management such as creating a fast-track for drugs undergoing clinical trials was proposed to strengthen the protection of innovations.

new drug expedited programs  /  patent strategy  /  patent management  /  osimertinib
杨倩, 靳春鹏, 郑茹, 马秋娟. 新药加速审批形势下对专利管理工作的思考——基于奥希替尼研发历程的分析. 中国新药杂志, 2021 , 30 (24) : 2234 -2241 .
Qian YANG, Chun-peng JIN, Ru ZHENG, Qiu-juan MA. Reflections on patent management under the situation of accelerated approval of new drugs based on an analysis of the research and development process of osimertinib[J]. Chinese Journal of New Drugs, 2021 , 30 (24) : 2234 -2241 .
Year 2021 volume 30 Issue 24
41
3
Cite this Article
BibTeX
Article Info
  • Online Date:2026-10-28
  • Published:2021-12-30
Article Data
Affiliations
History
  • Accepted:2021-06-24
Affiliations
    Patent Examination Corporation Center of Beijing, China National Intellectual Property Administration, Beijing 100160, China
References
Share
https://castjournals.cast.org.cn/joweb/zgxyzz/EN/
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT