“药王”司美格鲁肽专利案落槌,最高人民法院终审维持专利有效

Core Viewpoint - The patent for semaglutide, a key compound developed by Novo Nordisk, will expire on March 20, 2026, leading to increased competition from generic and biosimilar drugs, although a recent ruling by the Supreme People's Court of China upheld the validity of the patent, providing a temporary shield for the original drug [1][3]. Group 1: Patent and Legal Developments - The Supreme People's Court of China supported the Beijing Intellectual Property Court's decision to maintain the validity of the semaglutide compound patent, which is significant for the drug's market position and reflects the government's commitment to protecting pharmaceutical innovation [1][3]. - The core patent for semaglutide, "acylated GLP-1 compound," is set to expire on March 20, 2026, with over 20 domestic companies already in various stages of clinical approval for their biosimilar versions [2]. Group 2: Market Impact and Competition - Following the patent expiration, biosimilars are expected to aggressively compete with the original drug, similar to the decline in sales experienced by Humira (adalimumab) after its patent expiration [2]. - Novo Nordisk's semaglutide has gained significant clinical recognition, with approximately 38 million patient-years of usage reported since its launch, and is projected to become the top-selling drug by Q1 2025 [1][2]. Group 3: Ongoing Development and Adaptations - Novo Nordisk is actively developing new indications for semaglutide, including treatments for chronic kidney disease and cardiovascular risks associated with type 2 diabetes, which may help sustain its market position despite impending competition [4][5]. - The company anticipates a low single-digit negative impact on global sales growth in 2026 due to the patent expiration, indicating a cautious outlook on future revenue streams [4].

“药王”司美格鲁肽专利案落槌,最高人民法院终审维持专利有效 - Reportify