微芯生物专利遇挑战 西达本胺相关专利被申请无效

Core Viewpoint - Shenzhen MicuRx Biotech Co., Ltd. (referred to as "MicuRx") has received a notification from the National Intellectual Property Administration regarding a request for the invalidation of one of its patents, which is currently in the acceptance stage but has not yet been formally reviewed [1][4]. Patent Invalidation Request - The patent in question is for "a TRKA (G667C) and FLT3 target inhibitor and its composition with Sidabamine" (Patent No.: ZL202211051615.8), which is part of a series of patents related to the Sidabamine product. The application was submitted on August 30, 2022, and granted on March 17, 2023. The invalidation request was filed by Jiangsu Hengrui Medicine Co., Ltd. on January 23, 2025, and the acceptance notification was issued on February 5, 2025 [1][4]. Product and Clinical Trials - Sidabamine, classified as a national Class 1 innovative drug, is a novel molecular entity discovered exclusively by MicuRx. It has been approved for three indications in China: peripheral T-cell lymphoma, breast cancer, and diffuse large B-cell lymphoma. Additionally, it has received approvals in Japan and Taiwan for other indications. MicuRx is also advancing multiple clinical trials for combination therapies involving Sidabamine [2][5]. Regulatory Approval - Despite the patent challenge, MicuRx has received a Clinical Trial Approval Notification from the National Medical Products Administration, allowing the initiation of a Phase III clinical trial for Sidabamine in combination with CHOP for newly diagnosed peripheral T-cell lymphoma [2][5]. Patent Strategy - MicuRx emphasizes that it has developed multiple invention patents surrounding Sidabamine technology and applications, with the longest patent protection extended to 2042. Therefore, even if the current patent is ultimately invalidated, the company will still have other patents to protect the Sidabamine product, ensuring that its production, sales, and usage will not be significantly adversely affected [3][6].