药物共晶类专利申请及审查  

Patent application and examination in pharmaceutical cocrystal field

作　　者：解晓妮 赵霞[1] XIE Xiao-ni;ZHAO Xia(Chemistry Examination Department,National Intellectual Property Administration,Beijing100088,China)

机构地区：[1]国家知识产权局专利局化学发明审查部,北京100088

出　　处：《中国新药杂志》2022年第20期1979-1983,共5页Chinese Journal of New Drugs

摘　　要：药物共晶能够以较低的研发成本改善药物的理化性质,引起创新主体的广泛关注,该类专利的申请量也在不断增加。本文总结了药物共晶类专利的申请现状,结合案例对审查标准进行了梳理。首先,说明书应当至少满足对晶体发明充分公开的要求;其次,在权利要求具备新颖性的前提下,对创造性的审查需要分析发明与现有技术在技术特征上的区别,尤其是共晶形成物的不同,并重点关注说明书记载的理化性质等技术效果上与现有技术的差异;最后,在权利要求支持的审查中,除了共晶的表征参数特征,还要审查摩尔比的限定是否属于合理概括。本文同时对该类专利申请的撰写提出了建议。Cocrystals improve the physicochemical and biopharmaceutical properties of drugs at a lower R&D cost, which is widely attracting innovation subjects. The number of patent application in pharmaceutical cocrystal field is increasing recently. This article summarizes the current state of patent applications in this field and combs the examination standards focusing on controversy in several cases. First, the descriptions should at least meet the requirements for the disclosure of pharmaceutical crystal applications. Second, on the basis of novelty, the examination of inventive step should focus on the different technical features between the invention and the prior art, especially the new cocrystal formers, and emphasize the different technical effects in the description, such as better physicochemical and biopharmaceutical properties. Finally, for the support of the claims, the limitations of both characterization parameters and molar ratio should be reasonable. Besides, some suggestions on the writing of the patent applications are also put forward.

关 键 词：药物共晶 专利申请 创造性 审查标准 

分 类 号：R95[医药卫生—药学]