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 article searched the 2015 FDA approved the rare disease new chemical entity drug patents, the patent profile and important compounds and related subject patents were analyzed, and the focus of comparative study of China and the United States patent layout strategy. The results show that foreign pharmaceutical companies should promote drug research and development and marketization through the merger and patent licensing, and timely deploy different types of patents and actively expand the scope of patent protection by continuing to apply. Its flexible strategy, it is worth learning from domestic pharmaceutical companies.