Mei Ri Jing Ji Xin Wen·2025-10-12 14:20Core Viewpoint - The patent dispute between BeiGene and Pharmacyclics LLC has concluded, with Pharmacyclics deciding not to appeal the final decision from the USPTO, marking a significant resolution for BeiGene's flagship product, Zebrutinib, which has achieved over $1 billion in global sales in 2023 [2][4][5]. Group 1: Patent Dispute Resolution - Pharmacyclics LLC, a subsidiary of AbbVie, has opted not to appeal the USPTO's decision regarding the patent dispute with BeiGene, allowing both parties to voluntarily withdraw the lawsuit filed in 2023 [2][3]. - The lawsuit claimed that BeiGene's Zebrutinib infringed upon Pharmacyclics' patent rights, specifically the "803 patent," which was granted in June 2023, just seven months after Zebrutinib's market approval [4][5]. - The USPTO ruled that the claims of the "803 patent" were overly broad and lacked inventiveness, leading to its invalidation, which has now been finalized with the withdrawal of the lawsuit [5]. Group 2: Financial Impact and Market Position - Zebrutinib, a BTK inhibitor developed by BeiGene, was the first innovative drug from China to be approved in the U.S. based on Chinese clinical data, achieving sales of $1.3 billion in 2023 [4][5]. - The resolution of the patent dispute is crucial as over 51.86% of BeiGene's revenue in the first half of 2023 came from the U.S. market, making it the company's largest revenue source [5]. Group 3: Ongoing Patent Risks - Despite the resolution of the Zebrutinib patent case, BeiGene still faces ongoing patent litigation from AbbVie regarding another compound, BGB-16673, which has received priority drug designation from the EMA [3][6]. - The company has stated its intention to vigorously defend against these allegations and has filed a motion to dismiss the lawsuit set for December 2024 [6]. Group 4: Industry Context - The patent dispute highlights the increasing patent risks faced by Chinese pharmaceutical companies as they expand internationally, with 4.1% of the pharmaceutical manufacturing sector encountering intellectual property disputes abroad [7][9]. - Recent reports indicate that 22 out of 29 new patent litigation cases involving Chinese biopharmaceutical companies were filed in the U.S., underscoring the challenges in navigating international patent laws [7][8].