生物医药领域补充实验数据的考量和标准构建——以创造性为视角

Consideration and Standard Construction of Supplementary Experimental Data in Biomedical Field——from the Perspective of Creativity

在审查生物医药专利的创造性时,补充实验数据能否得到采纳,往往直接关系到证明"预料不到的技术效果"。本文通过对补充实验数据问题的规范梳理,指出立法上的制度不足,包括针对性缺陷和明确度缺陷,并通过对典型案例的样本剖析,指出考虑补充实验数据的司法缺位,即法律适用不到位、判断标准不明确、分析论证不充分的情况。对于能否考虑补充实验数据,系社会公众与申请人的利益平衡博弈。本文通过考虑先申请制度的宗旨、以公开换保护的原则、生物医药领域的特殊性以及申请人的利益保护,分析和探讨了考虑补充实验数据的具体判断标准。

When examining the ＂creativity＂ of a patent in the field of biomedicine whether the supplementary experimental data can be accepted or not is directly related to the certification of ＂unexpected technical effects＂.This paper,through reviewing the regulations regarding supplementary experimental data,points out the shortages in law systems,including the lack of pertinence and clarity.Also,this paper,through analyzing samples of typical precedents,points out the current situation of absence of judicial consideration in supplementary experimental data,i.e.,the law application is not well performed,the criteria of judgment are ambiguous,and the analysis and demonstration are not sufficient.As to whether the supplementary experimental data should be considered,fundamentally speaking,this issue is about the balance between the public and the applicant＇s interests.This paper analyzes and discusses the specific criteria for considering the supplementary experimental data by examining the purpose of the system of ＂first come first served,＂ the principle of exchanging confidentiality for protection,the particularity of the biomedical field,and the interests of the applicant.