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百济神州打赢了关键一战
经济观察报· 2025-10-11 08:31
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].
百济神州打赢了关键一战
Jing Ji Guan Cha Wang· 2025-10-11 05:45
Core Viewpoint - The patent dispute between BeiGene and AbbVie has concluded, allowing BeiGene to maintain its market position for the drug Zebrutinib in the U.S. market, marking a significant victory for Chinese innovative pharmaceutical companies in the U.S. intellectual property landscape [2][3][10]. Summary by Sections Patent Dispute Resolution - On October 8, BeiGene announced that AbbVie would not appeal the final decision from the U.S. Patent and Trademark Office, leading to the removal of patent barriers for Zebrutinib in the U.S. market [2]. - The patent battle began in June 2023 when AbbVie accused BeiGene of infringing its patent rights related to Ibrutinib [2][4]. - Zebrutinib is the first innovative drug approved in the U.S. from China, contributing over $6.4 billion in revenue since its launch [2][8]. Strategic Victory - The turning point in the patent battle was BeiGene's proactive approach in filing for a Post Grant Review (PGR) to challenge the validity of AbbVie's patent, which ultimately led to the patent being declared invalid [4][6]. - AbbVie had been preparing for this legal action since obtaining a new patent just days before filing the lawsuit against BeiGene [5][6]. Market Impact - Zebrutinib has become a leading product for BeiGene, accounting for over 70% of its sales, and has established a strong market presence in the U.S. and globally [8][9]. - In 2024, Zebrutinib achieved $2.6 billion in annual sales, ranking among the top 20 global oncology drugs [9]. Industry Implications - The resolution of this patent dispute is seen as a landmark victory for Chinese innovative pharmaceutical companies, shifting their role from defensive to proactive in international markets [10][12]. - The case serves as a reference for other Chinese pharmaceutical companies on how to navigate complex patent disputes in the U.S. [12]. Future Considerations - Despite the victory, the competitive landscape remains challenging, and Chinese pharmaceutical companies must continue to innovate and adapt to international regulations [9][11]. - Establishing robust global intellectual property strategies is essential for Chinese companies to effectively compete and protect their innovations [12].