艾伯维子公司自愿撤诉 首个国产“十亿美元”重磅药物专利案正式结案

Core Viewpoint - The patent dispute between BeiGene and Pharmacyclics LLC has concluded, marking a significant milestone for BeiGene's drug, Zebrutinib, which has achieved over $1 billion in global sales, making it the first Chinese innovative drug to reach this milestone [1][2][3]. Summary by Sections Patent Dispute Conclusion - On October 8, BeiGene announced that Pharmacyclics LLC decided not to appeal the final written decision from the USPTO, leading to the voluntary withdrawal of the lawsuit filed in 2023 [1][2]. - The lawsuit claimed that BeiGene's Zebrutinib infringed on Pharmacyclics' patent rights, specifically the "803 patent" granted in June 2023 [2][3]. Zebrutinib's Market Performance - Zebrutinib, a BTK inhibitor, was approved by the FDA in November 2019 and is used for treating mantle cell lymphoma (MCL) [2]. - In 2023, Zebrutinib generated $1.3 billion in global sales, establishing it as the first Chinese-developed drug to surpass $1 billion in annual sales [2][3]. Legal Background and Implications - The "803 patent" was submitted in June 2020, seven months after Zebrutinib's market entry, and was deemed overly broad and lacking inventiveness by the USPTO [2][3]. - The resolution of this patent dispute removes a significant barrier for BeiGene in the U.S. market, where over 51% of its revenue comes from [3]. Ongoing Patent Risks - Despite the resolution of the Zebrutinib case, BeiGene still faces patent litigation risks, including a lawsuit from Pharmacyclics regarding BeiGene's compound BGB-16673, which received PRIME designation from the EMA in July 2023 [3][4]. Broader Industry Context - The rise of Chinese pharmaceutical companies in international markets has led to an increase in patent disputes, with 4.1% of Chinese pharmaceutical firms facing intellectual property disputes abroad [4][5]. - In 2024, 29 new patent litigation cases involving Chinese biopharmaceutical companies were reported, with 22 cases where Chinese firms were defendants [4][5].