In recent years, pharmaceutical formulation patents have become the focus of patent disputes between innovator drug companies and generic companies, and the determination of inventiveness is the core dispute in invalidation proceedings. Based on typical patent invalidation cases in the formulation field and following the "three-step approach" logic, this paper systematically analyzes the key steps in determining the inventiveness of pharmaceutical preparation inventions. This paper focuses on the selection of the closest prior art, the identification of technical problems, the judgment of prior art teachings, and the proof of unexpected technical effects. This paper provides practical references for patent application and invalidation response of pharmaceutical preparations.

1. 宋波, 郑啸, 石娟, 等. 我国复杂制剂开发难点及应对策略探讨[J]. 中国药房, 2022, 33(13): 1537-1540, 1544.SongB, ZhengX, ShiJ, et al. Discussion on development difficulties and countermeasures of complex preparations in China[J]. China Pharmacy, 2022, 33(13): 1537-1540, 1544. DOI: 10.6039/j.issn.1001-0408.2022.13.01.

2. 国家知识产权局. 专利审查指南(2023)[M]. 北京: 知识产权出版社, 2024: 187-190, 197-199.

3. 张立得, 牛继梅. 创造性评价中技术问题的理解与应用[J]. 专利代理, 2025, (2): 95-101.ZhangLD, NiuJM. Understanding and application of technical problem in evaluating inventiveness[J]. Patent Agency, 2025, (2): 95-101. DOI: 10.3969/j.issn.2096-0549.2025.02.014.

4. 李星. 发明构思在准确认定创造性评判过程中的作用及案例分析[J]. 天津科技, 2025, 52(9): 33-35, 39.LiX. Role of inventive concept in accurate determination of inventiveness and case analysis[J]. Tianjin Science & Technology, 2025, 52(9): 33-35, 39. DOI: 10.3969/j.issn.1006-8945.2025.09.008.

5. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第587077号)[EB/OL]. (2025-07-09)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=AV3diA0EEbC2bqvYY8.

6. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第57139号)[EB/OL]. (2022-07-08)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=KHiN%252Bt5DohbycSs46NRU9A%253D%253D&anjianbh=4uSG333CL6momOqCJM3r0g%253D%253D&searchType=8.

7. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第52581号)[EB/OL]. (2021-11-01)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=OXXgaBv1Lqs4HyNX8h2E0Q%253D%253D&anjianbh=%252FFaciXcVHeeu7z%252F%252BlmjwLg%253D%253D&searchType=8.

8. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第41032号)[EB/OL]. (2019-07-11)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=nXW9XHY3IXDxSKj3AdCUJg%253D%253D&anjianbh=LciLM2InsVzgXhj8837vxg%253D%253D&searchType=8.

9. 最高人民法院. (2022)最高法知行终286号:某药物内分泌股份有限公司与中华人民共和国国家知识产权局其他二审判决书[EB/OL]. (2024-08-15)[2026-06-30]. https://wenshu.court.gov.cn/website/wenshu/181107ANFZ0BXSK4/index.html?docId=nQaEQdsLTgtAMedo+DwWX+FW0kKnNNwXzN676QIx4SKbqwkNnORtz5O3qNaLMqsJhA67CCStCMDb9em0TbSvRF+PNheQpqvFcmTXZtPih6pCWyVY1x6dJB93LJzR0F7S.

10. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第561492号)[EB/OL]. (2023-05-11)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=bDfCXr9%252FcNNyRB6a%252BI%252FIRQ%253D%253D&anjianbh=yOvVuETmwtSifRbvBsEUog%253D%253D&searchType=8.

11. 最高人民法院. 最高法知行终6号,瑞泽某公司、中华人民共和国国家知识产权局行政二审行政判决书[EB/OL]. (2024-1-30)[2026-06-30]. https://wenshu.court.gov.cn/website/wenshu/181107ANFZ0BXSK4/index.html?docId=KdfagSZnUF97sLjfufZqXuPUP7702PYYOrDVDEuhrXBLuIVChnGlRpO3qNaLMqsJhA67CCStCMDb9em0TbSvRF+PNheQpqvFM0smPnGSjWS1nqMOrC8kCqhvHG5h13Ai.

12. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第561196号)[EB/OL]. (2023-05-04)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=%252BkHK2tVXEHiffqaz5KSKJg%253D%253D&anjianbh=atHC0Y7l9%252B3caaB9v2d0Zw%253D%253D&searchType=8.

13. 牛培利, 李文静, 刘艳. 浅谈化学领域关于“预料不到的技术效果”的判断[J]. 中国发明与专利, 2016, (1): 116-119.NiuPL, LiWJ, LiuY. Discussion on the determination of "unexpected technical effects" in the chemistry field[J]. China Invention & Patent, 2016, (1): 116-119. DOI: 10.3969/j.issn.1672-6081.2016.01.026.

14. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第35363号)[EB/OL]. (2018-04-17)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=BjFosMxgeshHVR1Rq%252Bk7HA%253D%253D&anjianbh=%252F0rVk6VE6%252FnSDAXNukga1A%253D%253D&searchType=8.

15. 国家知识产权局. 国家知识产权局无效宣告请求审查决定(第585493号)[EB/OL]. (2025-05-20)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=1qkRy8BXbrfjYVUuWUf8Iw%253D%253D&anjianbh=6MMKpdTgWQ7b84GGCjEN%252Fg%253D%253D&searchType=8.

16. 国家知识产权局,国家知识产权局无效宣告请求审查决定(第48315号)[EB/OL]. (2021-02-04)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=2vyNQ6zqeu5kyztoInBH2w%253D%253D&anjianbh=iMYDojEEmu7Cxg%252FegB4j9A%253D%253D&searchType=8.

17. 国家知识产权局,国家知识产权局无效宣告请求审查决定(第588094号)[EB/OL]. (2025-07-25)[2026-06-30]. https://cpquery.cponline.cnipa.gov.cn/detail/index?zhuanlisqh=rhZ5w0%252Buhrk2RkY0d9pYSQ%253D%253D&anjianbh=rewKEuCIoG45Fvxsr3DfnA%253D%253D&searchType=8.

18. European Patent Office. Guidelines for Examination in the European Patent Office, G-VII, 5: Problem-solution approach[EB/OL]. (2026-04) [2026-06-30]. https://www.epo.org/en/legal/guidelines-epc/2026/g_vii_5.html. doi：10.65216/20260401-0010

19. European Patent Office. T 0056/22, Rapid dissolution formulation comprising cinacalcet HCl[EB/OL]. (2024-08-06)[2026-06-30]. https://www.epo.org/boards-of-appeal/decisions/pdf/t220056eu1.pdf. doi：10.48736/gd1glh73w/cwyjfd

20. Supreme Court of the United States. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)[EB/OL]. (1966-02-21) [2026-06-30]. https://www.govinfo.gov/content/pkg/USREPORTS-383/pdf/USREPORTS-383-1.pdf. doi：10.1111/j.1755-6988.1966.tb00347.x

21. Almirall, LLC v. Amneal Pharmaceuticals LLC, 28 F.4th 265 (Fed. Cir. 2022)[EB/OL]. (2022-03-14)[2026-06-30]. https://www.cafc.uscourts.gov/opinions-orders/20-2331.OPINION.3-14-2022_1920940.pdf.

22. 指导性案例276号:诺某股份有限公司诉国家知识产权局、第三人戴某良发明专利权无效行政纠纷案[EB/OL].(2026-02-28)[2026-06-30]. https://www.court.gov.cn/fabu/xiangqing/490491.html.

23. 包姝晴. 从“实际解决的技术问题”看创造性答复策略[J]. 河南科技, 2026, 53(1): 132-137.BaoSQ. Reply Strategies for the Inventive Step from the Perspective of "Technical Problems Actually Solved"[J]. Henan Science and Technology, 2026, 53(1): 132-137. DOI: 10.19968/j.cnki.hnkj.1003-5168.2026.01.026.