速递｜司美格鲁肽专利松动进入关键月：组合物专利被部分无效，3月到期节点把竞争拉到台前

Core Viewpoint - The article discusses the transition of the patent landscape for semaglutide from a focus on core compound patents to the implications of expiring peripheral formulation/device patents, indicating an impending competitive market environment [5][9]. Patent Status and Implications - A composition patent related to semaglutide was partially invalidated, leading to a narrower scope of protection, specifically reducing the concentration range from "0.5–10 mg/mL" to "0.5–5 mg/mL" and specifying the administration route as "subcutaneous" [6][8]. - The narrowing of the patent scope suggests that competitors will have clearer paths to market entry, shifting the focus from whether they can produce a product to how they can navigate around existing patents [8][10]. Competitive Landscape - March 2026 is highlighted as a critical turning point, where the expiration of core compound patents will lead to increased competition, with companies needing to quickly adapt their products and supply chains within the constraints of remaining peripheral patents [9][10]. - The competition will not be a simple win-lose scenario but will involve multiple dimensions such as pricing strategies, channel management, and brand positioning, which will determine market share distribution [10]. Regulatory and Compliance Challenges - In international markets, as supply shortages ease, original manufacturers are tightening compliance and legal boundaries around alternative supply options, indicating that even with patent windows, risks remain due to regulatory challenges [11]. - The article emphasizes the need for follow-up companies to design their products to avoid infringing on narrowed patent claims while meeting registration and commercialization requirements [11].