On December 31, 2025, the Supreme People’s Court of China issued a final judgment in the administrative dispute case regarding the invalidity of the patent for Novo Nordisk’s Semaglutide core compound (CN200680006674.6, with a protection period until March 20, 2026), confirming the validity of the patent; This means that the previous judgment of the Beijing Intellectual Property Court upholding the validity of the Semaglutide compound patent is supported ((2023) Jing 73 Xing Chu No. 1324).

On June 10, 2021, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhongmei Huadong”), a subsidiary of Huadong Medicine, submitted an application for the invalidation of the patent for Semaglutide compounds, requesting the China National Intellectual Property Administration to declare the compound patent completely invalid. The reason given was that the patent specification did not sufficiently disclose experimental data for the general formula compounds, and could not prove its claimed technical effects such as “long-acting”, which did not meet the requirements of the Patent Law regarding sufficient disclosure. On September 5, 2022, the China National Intellectual Property Administration accepted Zhongmei Huadong’s request, determining that Novo Nordisk did not disclose sufficient experimental data in the original patent document to support its inventiveness, and that the supplementary experimental data submitted later were not accepted. Therefore, the patent was declared completely invalid (case number: 4W112521; see Examination Decision on Request for Invalidation No. 57950 for details).

At the end of 2022, Novo Nordisk filed an administrative lawsuit with the Beijing Intellectual Property Court, requesting the revocation of the ruling made by the China National Intellectual Property Administration and maintaining the validity of the patent. After nearly two years of waiting, on October 25, 2024, the first-instance judgment revoked the invalidation decision made by the China National Intellectual Property Administration and maintained the validity of the patent. The court held that “the technical effects can be derived from the original specification”, and the supplementary experimental data submitted by Novo Nordisk should be considered. These data demonstrated that Semaglutide had unexpected technical effects compared to existing technologies. Zhongmei Huadong (Zhongmei Huadong was the appellant in the case, and domestic generic drug companies such as Jiuyuan Gene, Livzon Group, Qilu Pharmaceutical, United Laboratories, CSPC Zhongqi , and Beijing ZhiTai Biological participated in the litigation as “third parties” in the second-instance stage) appealed to the Supreme People’s Court. On December 31, 2025, the Intellectual Property Tribunal of the Supreme Court made a final judgment: the appeal was rejected and the patent was maintained as valid. The core of the judgment still revolved around the two major points of contention: “whether the specification is fully disclosed” and “inventiveness”. The court ultimately determined that the original specification had disclosed sufficient information to enable those skilled in the art to anticipate the effects of the compound; the supplementary data were only further verification of the disclosed scheme and were acceptable; the structural differences and half-life advantages were not obvious and possessed inventiveness.

In addition to the two specifications of Semaglutide injection (1.34mg/ml, 3ml/ (prefilled syringe pen); 1.34mg/ml, 1.5ml/ (prefilled syringe pen)) linked to the aforementioned compound patent and biological pharmaceutical use patent (CN201780026303.2, protection period until April 28, 2037), Novo Nordisk’s other five specifications of Semaglutide injection (0.68mg/ml, 1.5ml; 1.34mg/ml, 1.5ml; 1.34mg/ml, 3ml; 2.27mg/ml, 3ml; 3.2mg/ml, 3ml) and three specifications of Semaglutide tablets (14mg: 10 tablets/box; 7mg: 10 tablets/box; 3mg: 10 tablets/box) are only linked to the aforementioned compound patent. Although Novo Nordisk won the patent litigation case for Semaglutide, due to the expiration of the aforementioned compound patent on March 20, 2026 (with approximately three months remaining), it will not be able to prevent the launch of a large number of generic drugs.

Since 2024, several enterprises, including Hangzhou Jiuyuan Gene Engineering Co., Ltd. (hereinafter referred to as “Jiuyuan Gene”), Livzon Group Xinbeijiang Pharmaceutical Manufacturing Inc. (hereinafter referred to as “Livzon Group”), Zhuhai Federal Biomedical Co., Ltd. (hereinafter referred to as “Zhuhai Federal Biomedical”), Zhongmei Huadong, Huisheng Biopharmaceutical Co., Ltd. (hereinafter referred to as “Huisheng Biopharmaceutical”), Chengdu Beite Biopharmaceutical Co., Ltd. (hereinafter referred to as “Beite Biopharmaceutical”), Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Wanbang Pharmaceutical”), and Lianyungang Runzhong Pharmaceutical Co., Ltd. (hereinafter referred to as “Runzhong Pharmaceutical”), have successively applied for the listing of their generic Semaglutide drugs.

As Jiuyuan Gene is involved in the application for the generic version of six specifications of Semaglutide injection (1.34mg/ml, 3ml (prefilled syringe pen); 2.68mg/ml, 3ml (prefilled syringe pen); 1.34mg/ml, 1.5ml (0.25/0.5mg prefilled syringe pen); 1.34mg/ml, 1.5ml (1mg prefilled syringe pen); 1.34mg/ml, 3ml (refill cartridge); 2.68mg/ml, 3ml (refill cartridge)), and its declaration regarding the aforementioned patent for the pharmaceutical use of biological products (CN201780026303.2) is a Type 4.2 declaration (Type 4.2: generic drugs do not fall within the scope of protection of the relevant patent rights of the original drugs listed on the China Marketed Drugs Patent Information Registration Platform), Jiuyuan Gene can market the product upon the expiration of the aforementioned compound patent.

As Livzon Group has applied for the generic production of three specifications of Semaglutide injection (1.34mg/ml, 3ml (cartridge); 1.34mg/ml, 1.5ml (prefilled syringe pen); 1.34mg/ml, 3ml (prefilled syringe pen)). However, its declaration regarding the aforementioned patent for the pharmaceutical use of biological products (CN201780026303.2) is a Type 3 declaration (Type 3: The China Marketed Drug Patent Information Registration Platform includes patents related to the generic drug being imitated, and the generic drug applicant promises that the generic drug applied for will not be marketed until the expiration of the corresponding patent right). Therefore, Livzon Group cannot market the drug after the expiration of the aforementioned compound patent.

As Zhuhai Federal Biomedical is involved in the application for generic versions of two specifications of Semaglutide injection (3ml:4mg; 1.5ml:2mg), but its declaration regarding the aforementioned patent for the pharmaceutical use of biological products (CN201780026303.2) is a Type 3 declaration (Type 3: The China Marketed Drug Patent Information Registration Platform includes relevant patents for the generic drug, and the generic drug applicant promises that the generic drug applied for will not be marketed until the expiration of the corresponding patent term); therefore, Zhuhai Federal Biomedical cannot market the drug after the expiration of the aforementioned compound patent.

Since Zhongmei Huadong, Beite Biopharmaceutical, and Wanbang Pharmaceutical are all involved in the application for generic versions of four specifications of Semaglutide injection (1.34mg/ml, 1.5ml (cartridge); 1.34mg/ml, 3ml (cartridge); 1.34mg/ml, 3ml (prefilled syringe); 1.34mg/ml, 1.5ml (prefilled syringe)), and their declarations regarding the aforementioned patent for the pharmaceutical use of biological products (CN201780026303.2) are Type 4.2 declarations (Type 4.2: generic drugs do not fall within the scope of protection of the relevant patent rights of the imitated drugs listed on the China Marketed Drugs Patent Information Registration Platform), Zhongmei Huadong, Beite Biopharmaceutical, and Wanbang Pharmaceutical can all market their products after the expiration of the aforementioned compound patent.

Since both Huisheng Biopharmaceutical and Runzhong Pharmaceutical are involved in the application for generic versions of two specifications of Semaglutide injection (1.34mg/ml, 1.5ml (pre-filled syringe); 1.34mg/ml, 3ml (pre-filled syringe)), but their declaration regarding the aforementioned patent for the pharmaceutical use of biological products (CN201780026303.2) is a Type 4.2 declaration (Type 4.2: The generic drug does not fall within the scope of protection of the relevant patent rights of the original drug listed on the China Marketed Drugs Patent Information Registration Platform), Huisheng Biopharmaceutical and Runzhong Pharmaceutical can market the product after the expiration of the aforementioned compound patent.

References:

1. https://ipr.mofcom.gov.cn/caselib/exDetail.shtml?caseId=53d8a6049801af80019b923228993a53

2. https://news.qq.com/rain/a/20260105A04KJK00