经济观察报·2025-10-11 08:31Core 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].