On October 8, BeiGene (688235) issued an announcement about the progress of litigation related to company. Pharmacyclics LLC (as the complainant, hereinafter referred to as "Pharmacyclics") has decided not to appeal the final written decision of the United States Patent and Trademark Office (hereinafter referred to as "USPTO"). On September 30, BeiGene and Pharmacyclics jointly submitted an agreement to the U.S. District Court for the District of Delaware to voluntarily withdraw the litigation case, bringing the matter to a final resolution. 

On June 13, 2023, Pharmacyclics filed a complaint against BeiGene and its wholly-owned subsidiary, BeOne Medicines USA, Inc. (formerly known as BeiGene USA, Inc.) (as respondents) in the U.S. District Court for the District of Delaware, alleging that BeiGene’s product, Brukinsa® (Zanubrutinib Capsules), infringed upon its U.S. Patent No. 11,672,803, which was granted on June 13, 2023 (hereinafter referred to as the "‘803 Patent"). Pharmacyclics requested the court to judge and determine that the activities related to Brukinsa® conducted by BeiGene and BeOne Medicines USA, Inc. had caused and would cause others to infringe its patent. Pharmacyclics also sought appropriate compensation (no specific amount was specified) and other relief measures as deemed fit by the court. 

On October 12, 2023, the court approved the joint stipulation submitted by BeiGene and Pharmacyclics, agreeing to suspend the infringement proceedings until the outcome of the Patent 803 Post-Grant Review (hereinafter referred to as "PGR") application filed by BeiGene with the USPTO before November 1, 2023. On April 29, 2025, the USPTO issued a final written decision, declaring all claims of the patent 803 questioned by BeiGene in the PGR proceedings invalid. Pharmacyclics could appeal the USPTO’s decision. 

On May 29, 2025, Pharmacyclics submitted a request for Review of the final written decision to the USPTO, and it was rejected on July 17, 2025. 

According to BeiGene, this litigation has no negative impact on the research, development, and sales of Brukinsa® in the United States, nor has it significantly affected the company’s production and operations.

From IPRdaily

October 9th, 2025