浅议无效程序中相同药物晶型的认定——兼评江苏恒瑞vs.上海宣创之阿帕替尼甲磺酸盐晶型无效案

The Study on the Judgment of the Same Crystal Form in the Invalidation Proceedings for Drug——On an Invalid Case Involving with the Crystal of Apatinib Mesylate

药物晶型的实质是药物分子在微观上的有序排列。不同的空间排列也意味着药物分子的不同晶型。X-RPD、DSC、TGA等图谱数据仅是对晶型的性质表征,这些表征数据并不能改变药物分子的空间排列,因而对晶型不能起到限定作用。如果两个晶型在空间分布上没有区别,则应当认定为同一晶型。而且在证明是否为相同药物晶型时,应当适用高度盖然性的证明标准。

The essence of drug crystal is the ordered arrangement of drug molecules. And different type of arrangement means the different crystal form for the same drug molecular. Although X-RPD, DSC, TGA and so on are always used as the characterization, they don＇t belong to the technical features. And they could not change the ordered arrangement of drug molecules. If there are no differences in the arrangement between two crystals, it should be identified as the same. And in the process of the proving the same drug crystal type, the high probability should be applied as the standard of proof.