藥物晶型發明無效宣告請求案創造性判斷的探討  

Discussion on Inventive Step Assessment in Cases Involving Invalidation of Pharmaceutical Crystal Inventions

作　　者：胡楊 王軼 任曉蘭 Hu Yang;Wang Yi;Ren Xiaolan(The Reexamination and Invalidation Department of the Patent Office,China National Intellectual Property Administration(CNIPA))

机构地区：[1]國家知識産權局專利局複審和無效審理部

出　　处：《中国专利与商标》2022年第2期3-20,共18页China Patents & Trademarks

摘　　要：隨着我國醫藥産業的發展和對藥品安全與質量控制要求的提高,涉藥物晶型的無效宣告請求案備受業界關注。本文結合近期審結的部分案例,對涉藥物晶型無效宣告請求案中創造性的判斷及雙方當事人的舉证責任分配問題進行探討。同一種藥物,因結晶條件、工藝的不同,可能會得到具有不同空間結構和分子排列方式的晶型。Due to the developme nt of the China,s pharmaceutical industry and the in creased re-quirement for pharmaceutical safety and quality control,invalidation cases involving crystalline forms of drugs have attracted much attention from the industry.Based on some re-cently concluded cases,this article intends to delve into issues concerning the assessment of inventive step and the allocation of the burden of proof on both parties in the in-validation cases related to crystalline forms of drugs.

关 键 词：分子排列 晶型 品安全 宣告 

分 类 号：F42[经济管理—产业经济]