美国药品橙皮书框架下专利信息的介绍与启示

Pharmaceutical Patent Information under the Framework of American Orange Book

目的通过对《经治疗等效性评价批准的药品》(Approved Drug Products with Therapeutic Equivalence Evaluations,简称“美国药品橙皮书”)中的专利信息研究,为我国构建药品专利信息检索系统,完善我国药品专利链接制度提供参考依据。方法列举并分析美国药品橙皮书收录的专利信息及专利信息的提交、变更、删除等管理机制。结果药品专利信息是构建药品监管信息发布的重要组成部分,提高专利登记信息的真实性和准确性是一项长期存在并需要持续优化的工作。结论建议结合我国监管框架,不断完善药品专利信息的收载和公示,推动建立医药企业良好竞争秩序,从而提升医药企业开展药品研发创新的动力和信心。

Objective To provide reference for China's establishment of a drug patent information retrieval system and for the improvement of the drug patent linkage system in China through research on the patent information in the American Orange Book.Methods The patent information included in the American Orange Book and the management mechanisms for the submission,modification,and deletion of patent information were analyzed.Results Pharmaceutical patent information was an important part of drug regulatory information.Improving the authenticity and accuracy of patent registration information was a longterm undertaking that requires continuous optimization.Conclusion It is recommended that the collection and release of drug patent information continue to be improved in line with the actual situation in China,and that pharmaceutical companies compete on an equal footing so as to leave pharmaceutical companies more motivated for and confident about drug R&D and innovation.