药品专利创造性认定探析  

On creativity identification of drug patent

作　　者：王春蕾 杨凡 WANG Chun-lei;YANG Fan(Law School,Nankai University,Tianjin 300350,China;Marxism School,Tianjin University of Technology,Tianjin 300384,China)

机构地区：[1]南开大学法学院,天津300350 [2]天津理工大学马克思主义学院,天津300384

出　　处：《沈阳工业大学学报（社会科学版）》2022年第2期110-115,共6页Journal of Shenyang University of Technology(Social Sciences)

基　　金：国家医疗保障局项目(2021037)。

摘　　要：创造性是专利授权的关键要件,也是认定最为复杂的要件。药品研发投入巨大、成功率低,对专利保护的依赖程度远高于其他行业。当前,我国奉行“仿创结合”的药品研发政策,世界范围内的药品创新速度也有所放缓,新发明大多立足于现有技术。我国创造性认定体系客观性不足,导致实践中专利授权的随意性和不必要专利诉讼频发,破坏了专利制度平衡创新者和仿制者利益的美好愿望,亦导致消费者权利受到侵害,危及公众健康权。借鉴域外经验,应针对药品专利发布专门司法解释,规范专利申请人的申请行为,完善案例指导制度,以形成良好的专利审查与授权秩序,营造良好的药品创新环境。Creativity is the key factor of patent authorization,and also the most complicated one of identification.The research and development of drug require huge investment,and the rate of success is low,hence its dependence on patent protection is far higher than other industries.At present,China pursues the policy of drug research and development of “combination of imitation and innovation”.And the innovation speed of drug around the world also slows down,and the most new inventions are based on existing technologies.The system of creativity identification is lack of objectivity in China,which leads to the arbitrariness of patent authorization and frequent unnecessary patent litigation in practice.It destructs the good wish of balancing the interests of innovators and imitators by patent system,and also leads to the infringement of consumer rights and endangers the right to public health.Referencing foreign experience,the special judicial interpretations should be issued,the applicating behavior of patent applicant should be standardized,and the case guidance system should be improved,so as to form a good order of patent examination and authorization,and create a good environment for drug innovation.

关 键 词：药品专利 药品研发 专利授权 专利审查 创造性 公共健康权 

分 类 号：D923.42[政治法律—民商法学]