Page 7 - 《中国药房》2024年21期

·药事管理·

药品专利链接制度实施后我国仿制药申请态势分析
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姚雪芳 ，张 妍（南京中医药大学卫生经济管理学院，南京 210023）
＊

中图分类号 R95 文献标志码 A 文章编号 1001-0408（2024）21-2577-05
DOI 10.6039/j.issn.1001-0408.2024.21.01

摘 要 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。
关键词 药品专利链接制度；仿制药申请；专利声明；态势分析

Trend analysis of ANDA after the implementation of the drug patent linkage system in China
YAO Xuefang，ZHANG Yan（School of Health Economics and Management， Nanjing University of Chinese
Medicine， Nanjing 210023， China）

ABSTRACT 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 type Ⅳ certifications， the remaining validity periods of the corresponding
patents for the type Ⅲ certifications， and the number of manufacturers for the same variety. RESULTS Among the ANDA varieties
analyzed， type Ⅰ certifications predominated （accounting for 86.53%）， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for
approximately 4% to 5%. In the three registration classifications， type Ⅰ certifications in registration classification 3 accounted for
as high as 98.55%， and in registration classification 4， type Ⅰ certifications accounted for 79.65%， while types Ⅱ， Ⅲ and Ⅳ
certifications each accounted for around 7%. In terms of the detailed type of the Ⅳ certifications， type Ⅳ of article 2 certifications
had a large proportion （79.23%） and showed a slight upward trend， whereas the challenges of type Ⅳ of article 1 certifications
were few. The remaining validity period of the patents corresponding to type Ⅲ certifications 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 type Ⅲ certifications， and incentive measures for type Ⅳ of
article 1 certifications， thereby further standardizing the ANDA process and guiding the high-quality development of generic drugs.
KEYWORDS drug patent linkage system； ANDA； patent certifications； trend analysis

2020 年 10 月，我国第 4 次修正的《中华人民共和国
Δ 基金项目 江苏省 2024 年度高校哲学社会科学研究一般项目 专利法》首次从立法层面确立了药品专利链接制度。
（No.2024SJYB0240）；2023 年南京中医药大学大学生创新训练项目
2021年7月，国家知识产权局和国家药品监督管理局联
（No.103152023018）
合发布《药品专利纠纷早期解决机制实施办法（试行）》
＊第一作者 讲师，博士。研究方向：医药市场准入政策与知识产
权。E-mail：sarina_yao@126.com （以下简称《实施办法》），标志着药品专利链接制度正式

中国药房 2024年第35卷第21期 China Pharmacy 2024 Vol. 35 No. 21 · 2577 ·