试论生物医药领域专利授权确权纠纷中补充实验数据问题

Issues on Supplementing Experimental Data within Patent Authorization and Affirmation Disputes in the Biomedical Field

在涉及生物医药领域的专利授权确权纠纷中,补充实验数据是一个很受关注的问题。一段时间以来,部分医药企业持有一种观点,认为目前在行政及司法审查中对于补充实验数据的采信条件过于严苛,甚至有打击企业创新积极性之虞。本文试图通过梳理近年来的一些案例,厘清目前行政机关、司法机关对于申请日之后补充提交的实验数据的现实态度,然后对采信标准的合理性进行探讨。

In the disputes concerning the patent authorization and affirmation in the biomedical field, supplementing experimental data is a highly concerned issue. For some time, some pharmaceutical enterprises have held the view that the admissible standard of the supplementary experimental data in the current administrative and judicial review proceedings is too strict, and may even discourage the enthusiasm of enterprises for innovation. This paper attempts to clarify the current attitudes of the administrative authorities and the courts towards the supplementary experimental data submitted after the application date by sorting out some cases in recent years, and then explores the rationality of the admissible standard.