X射线图谱限定特征对晶型药物专利申请保护范围的影响

Effect of X-ray diffraction pattern features on scope of drug crystal form patent applications

本文从X射线衍射图谱与药物晶体晶型之间的对应关系出发,分别介绍了晶型和多晶型的含义以及通过X射线衍射图谱如何解析晶体的具体晶型的一般方法,从而归纳总结了药物晶型专利申请中常见的X射线衍射图谱限定权利要求的具体类型,并提出了判断该类权利要求的保护范围是否清楚的一般原则,从而为药物晶型专利申请的撰写提供了相关的建议。

From the corresponding relations between X-ray diffraction pattern and drug crystal form, the meanings of the terms ＂crystal form＂ and ＂polymorph＂ are introduced in this paper, and how to analyze the specific crystal form by means of X-ray diffraction is also described. In addition, the specific claim types defined by Xray diffraction pattern, which are common in drug crystal form patent applications, are summarized, and the general principle of judging the clarity of the scope in such claims is proposed, in order to give some advices on writing patent applications of drug crystal form.