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历时两年多,百济神州打赢泽布替尼美国专利侵权诉讼
Xin Jing Bao· 2025-10-10 02:06
Core Viewpoint - BeiGene has successfully resolved a two-year patent infringement lawsuit regarding its BTK inhibitor, Zebutinib, in the U.S. market, which clears the way for its global expansion [1][5]. Group 1: Product Performance - Zebutinib is BeiGene's best-selling BTK inhibitor, achieving sales of $1.297 billion (approximately 9.138 billion RMB) in 2023, marking its entry into the "billion-dollar molecule" category [2]. - In the first half of 2023, Zebutinib's global sales exceeded 12.527 billion RMB, a year-on-year increase of 56.2%, with the U.S. market contributing 8.958 billion RMB, up 51.7% [2]. - Zebutinib has gained significant market share in the U.S. due to its superior efficacy compared to AbbVie's ibrutinib in head-to-head studies for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [2]. Group 2: Legal Developments - The lawsuit initiated by Pharmacyclics, a subsidiary of AbbVie, claimed that BeiGene's Zebutinib infringed on its "803 patent," but the U.S. Patent and Trademark Office declared the patent invalid [4]. - On September 30, 2023, both parties reached a settlement and voluntarily withdrew the lawsuit, concluding the legal dispute [4][5]. - Despite the resolution of this case, AbbVie has ongoing litigation against BeiGene regarding its drug BGB-16673, alleging theft of trade secrets [5]. Group 3: Industry Context - The pharmaceutical industry often faces patent challenges, with companies like BeiGene needing to defend their intellectual property against generic competitors [6][7]. - Patent invalidation is a common strategy used by competitors to challenge the market position of successful drugs, which can significantly impact a company's operations [7][8]. - Companies are encouraged to expand their research pipelines to mitigate risks associated with patent litigation and ensure future growth [8].