By Fineline Cube 
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced today that it has terminated its patent litigation against AbbVie’s Pharmacyclics regarding their BTK inhibitors (BTKi). The settlement follows Pharmacyclics’ decision not to appeal the U.S. Patent and Trademark Office’s Final Written Decision that invalidated all contested claims of U.S. Patent No. 11,672,803 (the “803 patent”).
Background
- Patent Claim Dispute – The 803 patent, which underpinned Pharmacyclics’ 2023 infringement lawsuit, covered a method of use for a BTKi with a specific chemical structure to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Clinical Context – The lawsuit was filed shortly after BeOne’s BTKi, Brukinsa, defeated Pharmacyclics’ BTKi, Imbruvica, in a phase 3 head‑to‑head trial for second‑line CLL/SLL.
Resolution
- Joint Stipulation – On September 30, 2025 (U.S. Time), BeOne and Pharmacyclics signed a joint stipulation to voluntarily dismiss the related district court litigation with prejudice.
- Outcome – The case is now fully resolved, eliminating the legal uncertainty that had surrounded the 803 patent claims.
Implications
- Strategic Focus – BeOne can redirect resources toward expanding Brukinsa’s commercial launch and pipeline development.
- Market Dynamics – The dismissal removes a potential barrier to broader adoption of BTK inhibitors within the competitive CLL/SLL treatment landscape.
- Regulatory Landscape – The decision underscores the importance of robust post‑grant review proceedings in shaping the biotech patent ecosystem.-Fineline Info & Tech