Beijing News (Reporter Wang Kala) SihuanPharm's subsidiary, Jilin Huisheng Biopharmaceutical Co., Ltd., has once again challenged the patent of Novo Nordisk's exclusive product, insulin degludec, by filing invalidation requests for two core patents of the drug. Recently, the China National Intellectual Property Administration issued the "Invalidation Request Examination Decision," declaring one patent completely invalid while upholding the validity of the other.
Insulin Degludec Injection belongs to a new generation of long-acting basal insulin analogs, with a unique long-acting mechanism and excellent blood sugar-lowering effects. It is characterized by stable blood glucose concentration, low risk of hypoglycemia, high safety, and long-lasting effects. Its half-life can be up to 25 hours, and its sustained action can last up to 42 hours. It is an exclusive product of Novo Nordisk.
In 2017, the original research drug insulin degludec was approved for marketing in China. Although its share in the Chinese insulin market is not high, its growth rate is very fast. According to IQVIA data, the sales of insulin degludec in China grew rapidly between 2018 and 2021, with an annual compound growth rate of 903.8%. Insulin degludec/insulin aspart, another original research drug developed by Novo Nordisk, is the world's first soluble insulin formulation, which was approved for marketing in China in May 2019. Insulin degludec/insulin aspart is a biphasic insulin premixed soluble formulation composed of insulin degludec and insulin aspart mixed in a ratio of 7:3. It effectively balances fasting blood glucose and postprandial blood glucose control, with low rates of confirmed hypoglycemia and nocturnal confirmed hypoglycemia. It does not require mixing before use, offers convenient administration, and effectively improves patient compliance.
Data from MiNe Network shows that in 2022, among the top 10 insulin and similar drugs in China's public medical institutions, Insulin Degludec Injection and Insulin Degludec/Insulin Aspart Injection were the two products that achieved sales growth, while the sales of the other eight products declined year-on-year. Among them, the sales of Insulin Degludec exceeded 1 billion yuan in 2022, entering the 1-billion-yuan tier for the first time, with a sales growth rate of 19.34%; the sales of Insulin Degludec/Insulin Aspart exceeded 600 million yuan, surging 231.73% year-on-year.
The patent information registration platform for marketed drugs in China shows that the two patents for insulin degludec are for a novel insulin derivative, a composition comprising acylated insulin and zinc, and a method for preparing said composition. The expiration dates of the patents are July 22, 2024, and December 21, 2026, respectively.
Why is Jilin Huisheng Biopharmaceutical Co., Ltd. so eager to challenge the patent of Degludec Insulin Aspart?
According to the announcement released by SihuanPharm in July 2022, the marketing application for insulin degludec submitted by Jilin Huisheng Biopharmaceutical Co., Ltd. was accepted by the National Medical Products Administration (NMPA). In May 2023, another marketing application for insulin degludec-insulin aspart was submitted. Based on the patent protection period of insulin degludec, even if Jilin Huisheng Biopharmaceutical Co., Ltd.'s product is approved for marketing, it can only be officially launched after the patent expires on December 21, 2026. If the patent challenge is successful, an earlier market launch could be achieved.
Reporters from The Beijing News found on the China Patent Examination Information Inquiry Platform of the National Intellectual Property Administration that in January and February 2022, Jilin Huisheng Biopharmaceutical Co., Ltd. had filed invalidation requests for the aforementioned two patents respectively. In March 2022, the patentee modified the claims of both patents. Based on the amended claims by the patentee, Jilin Huisheng Biopharmaceutical Co., Ltd. withdrew the invalidation requests, and ultimately, the National Intellectual Property Administration made a decision to "declare part of the patent rights invalid" for both patents.
In May 2023, Huisheng Biopharmaceutical Co., Ltd. filed another invalidation request with the China National Intellectual Property Administration (CNIPA) regarding the amended text that complied with the regulations for the patent holder. According to the "Invalidation Request Examination Decision" disclosed by the CNIPA on January 8, the patent right for "a composition comprising acylated insulin and zinc and a method for preparing the composition" was declared completely invalid, while the patent for "novel insulin derivatives" remained valid. The invalidated patent was set to expire on December 21, 2026. This means that Degludec Insulin and Degludec/Aspart Dual Insulin from Huisheng Biopharmaceutical Co., Ltd. could potentially be launched earlier upon approval.
SihuanPharm once mentioned that after the launch of Jilin Huisheng Biopharmaceutical's insulin degludec, it can form a combination with other products in the company’s pipeline, such as insulin degludec/insulin aspart dual insulin and insulin degludec/liraglutide compound preparations, which will help accelerate the expansion of the diabetes product market.
Reporters from The Beijing News queried the Insight database of Dingxiangyuan. Several Chinese companies, including Jilin Huisheng Biopharmaceutical (a subsidiary of SihuanPharm), Tonghua Dongbao, Wanbang Biochemical, Federal Biotechnology (Zhuhai Hengqin, a subsidiary of United Laboratories), Shuanglu Pharmaceutical, Chenan Biotechnology, Sinopharm East China Pharmaceutical, Sinono Biotechnology, and Zhuhai Jibaikang Biotechnology, are developing biosimilars of insulin degludec or combination therapies such as insulin degludec/insulin aspart and insulin degludec/liraglutide. Jilin Huisheng Biopharmaceutical is the only company that has submitted an application for product marketing approval, while related products from other companies remain in clinical trial stages.
Proofread by Baoqing Liu