S公司在美对M公司专利发起挑战，中国创新药的“专利攻防成人礼”

Core Viewpoint - The article discusses a patent dispute between two Chinese innovative pharmaceutical companies, S Company and M Company, regarding a US patent related to EGFR-targeted antibody-drug conjugates (ADCs) [1][4]. Group 1: Patent Challenge - S Company filed an Inter Partes Review (IPR) request against M Company's US patent USXX,XXX,370 on March 3, 2025, indicating that the patent may hinder S Company's development and commercialization of its EGFR-ADC drug in the US [1]. - The challenged patent includes claims related to ADCs that utilize known EGFR antibodies linked to toxin molecules, which could potentially block S Company's market entry [1][4]. Group 2: Business Development Opportunities - On May 30, 2025, S Company's parent company announced negotiations with several independent third parties regarding potential transactions related to the development, production, and commercialization of various products, including EGFR-ADC, with potential payments totaling approximately $5 billion [2]. - Resolving the Freedom to Operate (FTO) issue is crucial for S Company, especially if it plans to license the EGFR-ADC to external parties [2][5]. Group 3: FTO Resolution Strategies - There are two primary methods to resolve FTO issues: challenging the patent or obtaining a license. IPR is a common route for patent challenges in the US, aimed at gaining FTO or enhancing negotiation leverage [3]. - If S Company can negotiate a licensing agreement with M Company, it could effectively address its FTO concerns while also protecting its products from competition [3][5]. Group 4: Patent Quality and Strategy - The quality of patent writing among Chinese pharmaceutical companies has improved, with the 370' patent employing a layered approach to protect core drug structures and their variants, creating a defensive network against biosimilars and me-too ADCs [4]. - The decision to challenge a patent is influenced by whether it obstructs others' products, making the 370' patent a significant barrier for S Company [4].