2024年罗氏双特异性抗体药物Emicizumab专利调研实务指南

Investment Rating - The report does not explicitly provide an investment rating for the industry or the specific company involved in the development of Emicizumab. Core Insights - Emicizumab is a bispecific monoclonal antibody developed by Roche, targeting coagulation factors IXa and X, primarily used for treating hemophilia A patients with inhibitors to factor VIII. It mimics the function of factor VIII to promote coagulation and reduce bleeding risks. The drug was approved in the US in November 2017 and subsequently in various regions globally, including China in November 2018 [8][15][29]. - The report emphasizes the importance of high-quality patent research for companies in areas such as infringement analysis, biosimilar drug development, investment, and drug research and development, which enhances core competitiveness [8][29]. Summary by Sections Section 1: Patent Research Process - The report outlines a systematic approach to patent research for bispecific monoclonal antibodies, detailing the steps from basic information retrieval to the creation of patent layout maps for Emicizumab in the US and China [6][11][29]. Section 2: Emicizumab Patent Research Practices - Initial searches in the Synapse New Drug Intelligence Database help identify relevant patents and core patents related to Emicizumab, with a total of 19 simple family patents identified [16][17]. - The core patent family for Emicizumab is identified as WO2012067176A1, which protects the sequences of the drug [17][18]. Section 3: Related Patent Searches - The report describes methods for searching related patents, including heavy and light chain sequence searches and keyword searches, to ensure comprehensive coverage of relevant patents [22][23]. Section 4: Analysis of Emicizumab Patents - A detailed analysis of all related patents is conducted, resulting in the creation of patent layout maps for Emicizumab in both the US and China, highlighting the number and status of patents [24][28]. Section 5: Patent Layout in the US - Roche has filed 35 related patent applications in the US, with 6 currently active, 7 under examination, and 22 expired. The foundational patent protecting Emicizumab's sequence and preparation process is US9334331B2, filed in 2011 [26][27]. Section 6: Patent Layout in China - In China, Roche has filed 19 related patent applications, with 9 active and 9 under examination. The foundational patent CN103298937B, filed in 2011, protects Emicizumab's sequence and preparation process [28][29].