Core Viewpoint - Shenzhen MicuRx Biopharma Co., Ltd. received a decision from the National Intellectual Property Administration declaring the invalidation of its patent related to a specific compound and its medical applications, which may impact its product pipeline but does not significantly affect its overall patent protection strategy [1][3]. Group 1: Patent Invalidation Details - The invalidation request was filed by Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. on December 30, 2024, concerning the patent for "an E-configured benzamide compound and its medical formulations and applications" (Patent No. ZL201410136761.X) [1]. - The National Intellectual Property Administration concluded that the patent rights are entirely invalid based on Article 46, Clause 1 of the Patent Law [2]. Group 2: Impact on Company Products - The invalidated patent pertains to the indication patent for the product Sidabamine, which has a comprehensive patent protection system that includes multiple patents covering compounds, crystal forms, key processes, formulations, and indications, extending the protection period until August 30, 2042 [3]. - Sidabamine has received approvals for three indications in China: Peripheral T-cell Lymphoma (PTCL), Breast Cancer (BC), and Diffuse Large B-cell Lymphoma (DLBCL), with PTCL and DLBCL being conditionally approved [4]. - Even if the patent system is breached, generic drugs cannot obtain approval for the conditionally approved indications (PTCL and DLBCL) due to existing regulations, ensuring continued market exclusivity for the company [5]. Group 3: Current Status of the Invalidation Decision - As of the announcement date, the invalidation decision has not yet taken effect and will only become effective if neither party appeals to the Beijing Intellectual Property Court within three months of receiving the notification [6][5].
深圳微芯生物科技股份有限公司关于收到国家知识产权局《无效宣告请求审查决定书》的公告