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

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

奥希替尼在美国获得多种特殊审评模式激励,新药注册审批与专利审查的时间周期高度重合。本文通过回溯奥希替尼的研发历程及其专利策略的特点,分析了药品加速审评审批的全球大趋势下首创型新药和跟进型新药研发过程中的机遇与挑战,在此基础上,提出探索建立创新药专利专项审查管理工作机制,针对进入临床阶段的创新药开辟专利审查快速通道,为创制安全有效的新药保驾护航。

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.