药物晶型类专利申请及其创造性审查

Patent application in pharmaceutical crystal field and the examination of its inventive step

针对国内药物晶型类专利申请数量快速增长,本文基于领域特点对其创造性审查标准进行了梳理。首先,新晶型不必然具备创造性,且评判创造性时不能将药物晶型微观特性的不可预期性等同于晶型产品的非显而易见性;其次,创造性评判应遵循创造性审查的一般原则和方法;第三,适用指南第二部分第十章的相关审查规定时,要正确理解"结构接近"并把握好"预料不到的技术效果"的判断;第四,适用公知常识时,不能仅仅基于存在"获得优势药物晶型的普遍动机"以及晶体的获得和检测均是常规方法就否定发明的创造性。文章还对该类专利申请的撰写提出了建议。

The number of patent application in pharmaceutical crystal field is growing rapidly in China.The examination standards of inventive step are summarized based on the characteristics of the field.First,an inventive step is not necessarily involved in a new crystal,and the unpredictability of microscopic characteristics of pharmaceutical crystal is not equal to the non-obviousness of crystal product.Second,the general principles and methods concerning the examination of inventive step should be followed.Third,"similar in structure"and"unexpected technical effect"should be understood and seized correctly while the relevant provisions involved in part II,chapter10 of Guidelines for Patent Examination are applied.Fourth,while common knowledge is applicable,the inventive step of the invention should not be denied based only on the existence of general motivation for obtaining dominant pharmaceutical crystal and the fact that the preparation and detection methods are both conventional.Besides,some suggestions on the writing of the patent applications are also put forward.