Core Viewpoint - The voluntary withdrawal of the lawsuit by both parties marks a significant victory for BeiGene and represents a shift for Chinese innovative pharmaceutical companies from "defensive outbound" to "rule-based outbound" strategies [1][16]. Summary by Sections Patent Dispute Conclusion - The two-year patent battle concluded with BeiGene successfully defending its position as AbbVie decided not to appeal the final decision of the U.S. Patent and Trademark Office [2][3]. - The resolution clears the patent obstacles for Zanubrutinib in the U.S. market, which is the first innovative drug approved in the U.S. from China and has generated over $6.4 billion in revenue for BeiGene [3][4]. Strategic Importance of Zanubrutinib - Zanubrutinib is crucial for BeiGene, contributing over 70% of its sales, and serves as a key product for entering the U.S. and global markets [12]. - The drug has achieved significant market share, surpassing its competitor Ibrutinib in the BTK inhibitor field by mid-2025 [3][13]. Legal Strategy and Tactics - A pivotal moment in the patent battle was BeiGene's proactive approach in initiating a Post Grant Review (PGR) process, leading to the invalidation of AbbVie's patent [6][8]. - This strategy shifted the focus from infringement to the validity of the patent itself, allowing BeiGene to take the initiative rather than merely defending against claims [9][10]. Implications for Chinese Pharmaceutical Companies - The outcome is viewed as a landmark victory for Chinese innovative pharmaceutical companies in navigating the U.S. intellectual property landscape [4][16]. - The case serves as a reference model for other Chinese companies facing complex patent disputes abroad, emphasizing the importance of understanding U.S. patent law and utilizing various procedural tools [17][18]. Future Considerations - Despite the victory, the competitive landscape remains challenging, and Chinese pharmaceutical companies must continue to innovate and comply with international regulations [14][16]. - Establishing a robust global intellectual property strategy is essential for both defensive and offensive maneuvers in future patent disputes [18].

一场持续两年多的专利保卫战告终了，百济神州（688235.SH/06160.HK/ONC.US）守住了城池。 10月8日，百济神州公告，艾伯维决定不对美国专利商标局最终决定提起上诉，双方已提交共同协议。 至此，泽布替尼在美国市场的专利障碍得以清除。 这场专利战始于2023年6月，当时，艾伯维子公司以泽布替尼侵犯其伊布替尼专利权益为由，起诉了百 济神州。 百济神州是中国创新药"一哥"，也是国际化成绩最好的药企。对百济神州来说，这是一场不能输的战 役。 泽布替尼是中国第一款在美获批的创新药，也是中国第一款国产重磅炸弹药物（年销售额超10亿美 元）。上市以来为百济神州贡献营收合计超64亿美元。近几年，泽布替尼在美国市场更是风生水起， 2025年上半年，在BTK抑制剂领域，泽布替尼市场占有率已超过对手伊布替尼，提升至全球第一。可以 说，百济神州造就了泽布替尼，泽布替尼也成就了百济神州。 专注生命科学领域业务的汉坤律师事务所合伙人顾泱告诉经济观察报，百济神州与艾伯维自愿撤回全部 诉讼，标志着双方在本次专利争议中取得了程序性和实质性进展，也为中国创新药出海解决专利纠纷提 供了思路。 这场诉讼的落幕，被业内视为中国创新药企 ...