February 23 will mark the oral hearing phase for the patent challenge case brought by Huadong Medicine Co., Ltd (SHE: 000963) against Novo Nordisk (NYSE: NVO) in relation to Ozempic (semaglutide), according to the China National Intellectual Property Administration (CNIPA). This legal proceeding is a significant development in the ongoing dispute over the intellectual property rights of this widely used diabetes and obesity treatment.
Semaglutide: Market and Therapeutic Impact
Semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) analog, is already available in the US, Europe, Canada, and Japan, among other locations. The drug obtained market approval in China in April 2021. Known for its ability to significantly reduce blood sugar and promote weight loss by stimulating insulin secretion, semaglutide also offers notable cardiovascular benefits. In addition to its approval for type 2 diabetes, it has been approved abroad for the treatment of obese or overweight patients. The drug generated close to USD 6 billion in sales in 2021, highlighting its commercial success and market importance.
Patent Challenge and Legal Proceedings
Huadong filed the patent invalidation request in June 2021, a time when there was no patent linkage system in China. The company partnered with Peg-Bio Biopharma Co., Ltd in October 2020, under which Peg-Bio would handle the global development, regulatory filing, and commercialization of the drug. CNIPA declared the core patent CN200680006674.6 to be fully invalid in September 2022. Novo Nordisk appealed to the Beijing Intellectual Property Court, arguing that the patent should expire on March 20, 2026.
Additional Patent Filings and Challenges
Novo Nordisk has filed multiple formulation patents for its product in China, including a solid composition containing GLP-1 agonist and N-(8-(2-hydroxybenzoyl)amino)octanoate (patent No.: 20161042028X), valid until 2031, and a GLP-1 peptide composition and its preparation (patent No.: 2017111568426), with an expiry date of 2033. Huadong and Sihuan Pharma filed for invalidation of these patents in September and April 2022, respectively.
Market Context and Implications
China’s GLP-1 market was valued at RMB 5.8 billion (USD 841.4 million) in 2022, marking a 132% year-on-year increase. Novo Nordisk’s GLP-1 products generated RMB 3.7 billion (USD 536.76 million) in sales, accounting for two-thirds of the market share, with liraglutide and semaglutide contributing RMB 1.5 billion (USD 217.6 million) and RMB 2.2 billion (USD 319.15 million), respectively. Currently, there is no generic semaglutide filed for marketing in China, where the originator was included in the National Reimbursement Drug List (NRDL) in December 2021.
Strategic Implications
The upcoming oral hearing for Huadong’s patent challenge against Novo Nordisk’s Ozempic is a critical juncture in the battle for market share in the GLP-1 segment. The outcome of this legal challenge could have significant implications for the competitive landscape, potentially opening the door for generic entries and altering the dynamics of the diabetes and obesity treatment market in China.-Fineline Info & Tech
