摘要
药物晶型的专利保护是能够跨越药物的化学结构、增加药物专利有效期限的重要手段,其在国内外的专利保护中的比重正逐年上升,制药企业之间关于晶型专利的纷争也随之不断增多。该文从药物的药效作用角度出发,将近些年的关于药物晶型专利纷争案例分为抗肿瘤类、抗病毒类、心脑血管类、抗菌药物类、抗糖尿病类以及其他晶型药物等类型,对其中典型案例的创造性和新颖性进行分析解读,为药物晶型专利的审查、撰写和申请提供可行性建议。
The patent protection of polymorph drugs is an important mean to cross the chemical structure of drugs and increase the effective period of drug patents.The number of polymorph drug patents at home and abroad is increasing year by year,but the disputes between patent companies on polymorph drug patents are also keep growing.According to the classification of pharmacodynamic effects,the polymorph drugs were divided into anti-tumor,anti-viral,cardiovascular and cerebrovascular,antibiotics,antidiabetics and other crystalline drugs in this paper.The typical cases were analyzed and feasible suggestions were provided for the application or investigation of the pharmaceutical crystal form patent.
作者
王雪
张宝喜
靳桂民
龚宁波
吕扬
WANG Xue;ZHANG Baoxi;JIN Guimin;GONG Ningbo;LYU Yang(Beijing Key Laboratory of Polymorphs Drugs Research,Institute of Materia Medica,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100050,China)
出处
《医药导报》
CAS
北大核心
2020年第5期715-722,共8页
Herald of Medicine
基金
国家重点研发计划(2016YFC1000900,2016YFC1000901)
药品医疗器械审评审批制度改革专项课题(ZG2017-4-02)
中国医学科学院医学与健康科技创新工程项目(2017-I2M-1-010)。
关键词
药物晶型
专利无效
药效作用
创造性
新颖性
Polymorph drugs
Patent invalidity
Pharmacodynamic effect
Creativity
Novelty