抗血栓药赛道华东医药成狙击手，六家药企陷专利战接连“中枪”

Core Viewpoint - The patent battle over the antithrombotic drug Indobufen tablets is intensifying, with multiple companies facing procurement qualification suspensions due to patent disputes [1][2][3]. Patent Dispute Overview - The Zhejiang Provincial Hangzhou Intermediate People's Court has suspended the procurement qualifications of several companies producing Indobufen tablets, including Hunan Shangzhonghe Biological Pharmaceutical Co., Ltd. and Zhejiang Saime Pharmaceutical Co., Ltd. [1][2] - A total of five companies have had their sales of Indobufen tablets suspended, indicating a significant impact on the market [1][8]. Market Potential - Indobufen tablets are becoming a "billion-level" product in the cardiovascular medication sector, with sales in hospitals increasing from 745 million yuan in 2021 to 1.408 billion yuan in 2023, reflecting a compound annual growth rate of 37.4% [3]. - Retail sales also exceeded 100 million yuan in 2023, showcasing strong market demand [3]. Patent Strategy and Challenges - The core of the patent dispute revolves around crystal form patents, which are often used by original drug companies to extend their market exclusivity after the expiration of the basic compound patent [4][5]. - Companies like Huadong Medicine have filed administrative decisions or lawsuits against 15 enterprises for alleged patent infringements, indicating a proactive approach to protect their intellectual property [2][5]. Regulatory Environment - The introduction of the "drug patent linkage system" in 2021 has changed the landscape of pharmaceutical patent protection in China, balancing the needs of original drug innovation and market access for generic drugs [9]. - Companies must ensure they do not infringe on patents to participate in drug procurement, as seen with Guangdong Dongyangguang's suspension due to patent issues [7]. Competitive Landscape - The competition among generic drug companies has shifted from breaking through barriers to building their own barriers through secondary patents, resembling the strategies of original drug companies [9][11]. - The ongoing patent disputes are not limited to Indobufen; other drugs like Benazepril have also faced similar challenges, indicating a broader trend in the industry [10]. Implications for Innovation - The focus on patent strategies may lead to increased investment in research and development among generic drug companies, pushing for innovation in crystal forms and formulation processes [10][11]. - However, the reliance on patent battles could hinder overall industry innovation and delay the reduction of drug prices, contradicting the goals of drug procurement policies aimed at improving accessibility [11].