药品专利链接制度实施后我国仿制药申请态势分析

Trend analysis of ANDA after the implementation of the drug patent linkage system in China

目的为完善药品专利链接制度提供参考。方法通过中国上市药品专利信息登记平台的“专利声明”和“专利信息公示”模块获取药品名称、药品类型、仿制药申请(ANDA)受理号、注册分类、申请人名称等数据,数据收集时间为2021年7月4日至2023年9月30日。对最终纳入统计的ANDA品种的专利声明年度分布、不同注册分类占比、4类声明细化情况、3类声明对应专利剩余有效期以及同品种厂家数进行分析。结果在统计的ANDA品种中,以1类声明为主(占比为86.53%),2、3、4类声明占比均在4%~5%之间。在3项注册分类上,注册分类3中1类声明占比高达98.55%;注册分类4中1类声明占比为79.65%,而2、3、4类声明占比均在7%左右。在4类声明的细化类别上,4.2类声明占比(79.23%)较大,并呈小幅上升趋势,相对而言4.1类声明挑战较少。3类声明对应专利剩余有效期过长,中位数为18个月。同品种申报厂家数<5家的占比为36.44%,≥20家的占比为14.75%。结论我国ANDA在实践中已有序衔接药品专利链接制度;建议在专利声明登记与异议机制、3类声明类ANDA的批准生效日期、4.1类声明的激励措施等方面予以优化,从而进一步规范ANDA秩序,引导仿制药高质量发展。

OBJECTIVE To provide a reference for improving the drug patent linkage system.METHODS Data on drug names,drug types,abbreviated new drug application(ANDA)acceptance numbers,registration classifications,and applicant names were obtained from the patent certifications and patent information disclosure modules of China’s patent information registration platform for marketed drugs.The data collection period was from July 4,2021,to September 30,2023.The analysis focused on the annual distribution of patent certifications for the ANDA varieties included in the statistics,the proportion of different registration classifications,the details of the typeⅣcertifications,the remaining validity periods of the corresponding patents for the typeⅢcertifications,and the number of manufacturers for the same variety.RESULTS Among the ANDA varieties analyzed,typeⅠcertifications predominated(accounting for 86.53%),while typesⅡ,ⅢandⅣcertifications each accounted for approximately 4%to 5%.In the three registration classifications,typeⅠcertifications in registration classification 3 accounted for as high as 98.55%,and in registration classification 4,typeⅠcertifications accounted for 79.65%,while typesⅡ,ⅢandⅣcertifications each accounted for around 7%.In terms of the detailed type of theⅣcertifications,typeⅣof article 2 certifications had a large proportion(79.23%)and showed a slight upward trend,whereas the challenges of typeⅣof article 1 certifications were few.The remaining validity period of the patents corresponding to typeⅢcertifications was excessively long,with a median of 18 months.The proportion of the same variety with fewer than 5 manufacturers was 36.44%,while those with more than or equal to 20 manufacturers accounted for 14.75%.CONCLUSIONS The ANDA system in China has been orderly integrated with the drug patent linkage system in practice.It is recommended to optimize aspects such as patent certifications registration and objection mechanisms,the effective approval dates for ANDA with typeⅢcertifications,and incentive measures for typeⅣof article 1 certifications,thereby further standardizing the ANDA process and guiding the high-quality development of generic drugs.