2015年FDA批准罕见病新化学实体药物及专利信息分析

Analysis of patent information of NCE drugs approved by FDA for rare diseases in 2015

本文检索了2015年FDA批准罕见病新化学实体药物专利,对其专利概况及重要化合物及相关主题专利进行了分析,并重点对比研究了中国和美国专利布局策略。结果表明,外国制药企业通过合并与专利许可,推进药物研发与上市,且适时布局不同类型专利,通过继续申请等方法积极扩大专利保护范围。其策略灵活,值得国内医药企业借鉴。

This paper retrieves the patents of NCE drugs approved by FDA for rare diseases in 2015,and the patent situation,important compounds,and related topics were analyzed,with a focus on comparison of the patent layout strategies of China and the United States. It was found that foreign companies promote drug development and launch through mergers and patent license,lay different types of patents at the right time,and timely expand the scope of patent protection through such means as continuation application. Their flexible strategy is worthy of reference by domestic pharmaceutical enterprises.