SAN CARLOS, CALIF. -- BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced that the U.S. Patent and Trademark Office (USPTO) rendered a Final Written Decision invalidating all claims of Pharmacyclics LLC’s (Pharmacyclics) U.S. Patent No. 11,672,803 (the ‘803 patent) that were challenged by BeiGene in a post-grant review (PGR) proceeding.

On November 1, 2023, BeiGene filed a PGR petition with the USPTO challenging the validity of certain claims of the ‘803 patent, in response to a patent infringement lawsuit Pharmacyclics brought against BeiGene concerning BRUKINSA® (zanubrutinib). On May 1, 2024, the USPTO granted BeiGene’s petition to institute the PGR. The USPTO’s Final Written Decision is appealable by Pharmacyclics.

Commenting on the ruling, BeiGene General Counsel Chan Lee said: “We are pleased that the USPTO invalidated all challenged claims of the ‘803 patent. Today’s decision reinforces our belief that Pharmacyclics’ ‘803 patent is overly broad and invalid. BeiGene is confident in the strength of our intellectual property supporting BRUKINSA, a clearly differentiated and independently developed medicine. With approvals in more than 70 countries and regions for the treatment of multiple B-cell malignancies, BRUKINSA continues to set a new standard of care for patients worldwide.”