就近期美国联邦最高法院Mayo v.Prometheus案的判决,对美国《专利法》第101条“专利适格标的”产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指出美国专利标的物范围一直缺乏清晰、明确的界定;专利适格标的检测方法虽历经多次变革,但始终无法形成一个统一、清晰的检测标准。从法律功能、专利效力、产业发展等角度,分析了Mayo案件判决产生的影响,并就企业创新成果的保护、专利中请提出了建议。
This article provides analysis and insight on the U.S. Supreme Court's recent ruling in Mayo v. Prometheus involving patent eligibility of methods in the area of personalized medicine. A review of the recent doctrinal development is conducted after the Mayo case's introduction. The study shows that the standard of patentable subject matter under 35 U.S.C 101 suffers from a lack of clarity. Then, the article analyzes how Mayo v. Prometheus may affect the existing patents, the examination and decision implemented by the USPTO, and the developing of the life science area. Finally, some strategies and practices are provided to help the inventors to protect innovation in light of the Mayo's decision.