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专利链接制度对我国仿制药申报的激励效果分析及对策建议
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| 篇名： | 专利链接制度对我国仿制药申报的激励效果分析及对策建议 |
| TITLE： | Analysis of the incentive effect of the patent linkage system on the application of generic drugs in China and suggestions for countermeasures |
| 摘要： | 目的 为优化专利链接制度体系，鼓励仿制药申报上市提供参考。方法在文献研究的基础上，结合笔者工作经验比较分析专利链接制度在我国实行后仿制药申报及专利挑战的情况，根据专利链接制度对我国仿制药专利挑战激励不足的原因进行分析，并提出相应的对策建议。结果与结论我国专利链接制度于2021年落地，但由于制度施行仍在起步阶段，实践指导的相关文件尚不完善，配套的激励机制尚不健全，导致仿制药企业发起专利挑战的意愿不强。建议我国可以从丰富仿制药信息登记平台功能、培育专业的药品专利代理机构、建立首仿药共同挑战平台等方面，进一步完善专利链接配套制度，进而激励我国仿制药企业提高创新动力，挑战原研药专利并申报上市，通过充分竞争达到平抑药价、造福百姓的效果。 |
| ABSTRACT： | OBJECTIVE To optimize the system of patent linkage system and provide a reference for encouraging generic drugs to apply for listing. METHODS On the basis of literature research， combined with the author’s work experience， the situation of generic drug application and patent challenge were analyzed comparatively after the implementation of the patent linkage system in China. Based on the patent linkage system， the reasons for the insufficient incentive for the challenge of generic drug patents in China were analyzed； corresponding countermeasures and suggestions were proposed. RESULTS & CONCLUSIONS The patent linkage system in China was implemented in 2021， but due to the implementation of the system being still in its initial stage， the relevant documents for practical guidance are not yet complete， and the supporting incentive mechanism is not yet sound， resulting in a weak willingness of generic pharmaceutical enterprises to initiate patent challenges. It is suggested that China can further improve the patent linkage system by improving the patent information registration platform of generic drugs， developing professional drug patent agencies， and establishing the patent common challenges platform of the first generic drug， in order to incentivize Chinese generic drug enterprises to increase innovation motivation， challenge original research drug patents， and apply for listing， achieving the effect of suppressing drug prices and benefiting the people through full competition. |
| 期刊： | 2023年第34卷第19期 |
| 作者： | 曹嘉成；樊嘉训；王闻珠 |
| AUTHORS： | CAO Jiacheng，FAN Jiaxun，WANG Wenzhu |
| 关键字： | 专利链接制度；专利挑战；仿制药；药品注册 |
| KEYWORDS： | patent linkage system； patent challenges； generic drug； drug registration |
| 阅读数： | 49 次 |
| 本月下载数： | 5 次 |
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