生物序列类专利侵权诉讼问题探讨

Discussion on Lawsuits for Infringement of Biological Sequence Patents

通过分析涉及生物序列类的判决案例,探讨了生物序列类专利侵权诉讼中的等同侵权判定、生物序列同源性限定时的侵权分析和生物序列作为分子标记在鉴定微生物时的相关问题。生物序列类专利侵权诉讼中,关于等同特征,需立足于被诉侵权行为发生时本领域普通技术人员的知识,综合考虑技术手段、功能、效果,具体来说,需综合考虑一级序列结构、空间构象、实现功能、效果的核心序列区域等。关于序列同源性的专利诉讼,确权阶段采用“同源性+功能+来源”等限定方式,在确权时有可能被允许;在专利侵权诉讼中,这种保护方式往往更有利。而在微生物相关的专利侵权诉讼中,权利要求保护范围与说明书及其附图的解释功能需要厘清。

By analyzing the cases involving biological sequences,this paper discusses the determination of equivalent infringement in biological sequence patent infringement litigation,the infringement analysis of biological sequence homology limitation,and the related issues of biological sequences as molecular markers in the identification of microorganisms.In the infringement litigation of biological sequence patents,regarding equivalent features,it is necessary to base on the knowledge of ordinary technical personnel in the field at the time of the sued infringement,and comprehensively consider the technical means,functions,and effects;Specifically,it is necessary to comprehensively consider the primary sequence structure,spatial conformation,and core sequence regions that achieve functionality and effectiveness.With regard to the patent litigation of sequence homology,in the right confirmation stage,the use of “homology+function+source” and other limited methods may be allowed in the right confirmation;In patent infringement litigation,this protection method is often more advantageous.In patent infringement lawsuits related to microorganisms,the scope of claim protection and the explanatory function of the specification and its accompanying drawings need to be clarified.