The China National Intellectual Property Administration (CNIPA) has declared invalid the patent No. 201510572124.1 held by Denmark-based Novo Nordisk (NYSE: NVO) related to Victoza (liraglutide) and its stable preparation of proinsulin peptide. This patent was challenged by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a subsidiary of China’s Huadong Medicine Co., Ltd. (SHE: 000963).
Liraglutide, an analog of human glucagon-like peptide 1 (GLP-1), plays a crucial role in diabetes management. Zhongmei Huadong received approval for its biosimilar version of liraglutide in March 2023, aimed at blood sugar control in type 2 diabetes, followed by approval for obesity treatment in July 2023. Additionally, Tonghua Dongbao Pharmaceutical Co., Ltd.’s biosimilar version was approved in November 2023.
In a related matter, Hangzhou Jiuyuan Gene Engineering Co., Ltd., another affiliate of Huadong Medicine, filed a patent invalidation request for liraglutide formulation patent ZL004800341528 in 2015. The CNIPA declared this patent invalid, prompting Novo Nordisk to file an administrative lawsuit against the decision. The Beijing Intellectual Property Court’s first-instance judgment rejected Novo Nordisk’s lawsuit, and the company subsequently appealed. The final ruling upheld the initial judgment, reinforcing the patent invalidation.- Flcube.com
