马库什化合物专利申请的常见问题及应对策略-中国药房.PDF

马库什化合物专利申请的常见问题及应对策略 ＊ # 高 彬 ，许亚玲，周韶红，李勤耕（重庆医科大学药学院，重庆 400016） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2015）13-1739-04 DOI 10.6039/j.issn. 1001-0408.2015.13.03 摘 要 目的：提出适合我国国情的马库什化合物专利申请策略。方法：分析并总结马库什化合物在专利申请中的常见问题及应 对策略。结果与结论：马库什化合物专利申请十分复杂，专利申请时常出现不具备实用性、新颖性、创造性和说明书公开不充分、 权利要求书得不到说明书支持、权利要求不清楚、修改超范围等缺陷。通过分析发现，申请前充分检索、合理安排实施例种类与数 量、申请过程中合理控制公开时间与审查周期，可在一定程度上提高马库什化合物专利申请的授权率与权利稳定性。 关键词 马库什化合物；药品；专利 Common Problems of Patent Application of Markush Compound and Countermeasures GAO Bin ，XU Ya-ling ，ZHOU Shao-hong ，LI Qin-geng （School of Pharmacy ，Chongqing Medical University ， Chongqing 400016，China ） ABSTRACT OBJECTIVE ：To propose strategies for the patent application of Markush compound ，which is suitable for Chinese situations. METHODS ：Common problems of the patent application of Markush compound and countermeasures were analyzed and summarized. RESULTS CONCLUSIONS ：The patent application of Markush compound is quite complicated and there were of- ten some problems ，such as the absence of practicability ，novelty and originality of the patent ，the insufficient disclosure of instruc- tions ，no supporting from instructions ，unclear claims ，modification beyond the range ，etc. According to the analysis ，it was found that the probability of granting the patent of Markush compound and the stability of patent rights may be improved to some degree by full retrieval and rational arrangement for the types and number of cases and rational control of time and review cycle during the application. KEYWORDS Markush compound ；Drug ；Patent 制措施。在对系统进行定期审查时，风险与控制也需要进行 [ 2] ISPE. GAMP 5：a risk-based approach to compliant GXP 审查，包括是否存在之前未被识别的危险、之前已识别的危险 computerized systems[S]. 2008. 是否不再适用、原始评估是否有效等。同时，证实控制措施有