Xin Lang Cai Jing·2025-04-30 07:20Core Viewpoint - The patent dispute between BeiGene and AbbVie regarding BTK inhibitors has reached a significant milestone, with the U.S. Patent and Trademark Office declaring AbbVie's Pharmacyclics' patent invalid, although an appeal is possible [1][3]. Group 1: Patent Dispute Details - The dispute began on June 13, 2023, when Pharmacyclics claimed that BeiGene's drug, Zebutinib, infringed on its patent for Ibrutinib [3]. - The U.S. Patent and Trademark Office's final decision on April 30, 2024, invalidated the entire rights of the '803 patent, which was under scrutiny [1][3]. - AbbVie has not yet responded regarding whether it will appeal the decision [1]. Group 2: Market Context - The global market for BTK inhibitors is projected to exceed 10 billion by 2024, with the U.S. being the largest market [7]. - As of 2024, Ibrutinib remains the top-selling BTK inhibitor, but its market share is being eroded by Zebutinib, which has shown significant growth [7]. - Ibrutinib's revenue is expected to decline by 6.9% in 2024, with U.S. sales dropping by 8.1% [7]. Group 3: Company Performance - BeiGene's Zebutinib is projected to achieve global sales of 2.6 billion in 2024, with U.S. sales reaching 2 billion, a 106.3% increase from the previous year [10]. - AstraZeneca's Acalabrutinib generated 3.129 billion in revenue in 2024, marking a 24% increase [13]. - The competitive landscape is intensifying, with multiple companies, including AbbVie, BeiGene, and Eli Lilly, having launched BTK inhibitors in the U.S. market [7]. Group 4: Ongoing Legal Issues - AbbVie has also filed a lawsuit against BeiGene for alleged theft of trade secrets related to BTK degraders, involving the compounds ABBV-101 and BGB-16673 [13]. - BeiGene asserts that its development of BGB-16673 predates AbbVie's patent application and is confident in its compliance with ethical standards [13].