BeiGene to Vigorously Defend Patent Infringement Allegations by Pharmacyclics

16 June 2023 | Friday | News

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, is aware that Pharmacyclics LLC has filed a complaint against BeiGene, Ltd. and BeiGene USA, Inc., alleging that BeiGene’s BRUKINSA® infringes a Pharmacyclics patent issued on June 13, 2023. BeiGene’s work is original, and we will vigorously defend against all allegations of patent infringement.

It is an unfortunate but rather regular occurrence that companies make allegations that a competitive product potentially infringes their intellectual property rights, even more so in response to a clearly differentiated medicine for cancer patients as BRUKINSA.

BeiGene has developed original and novel intellectual properties around BRUKINSA to demonstrate its differentiated profile. BRUKINSA’s broad global development and registration program includes more than 4,900 patients in 35 trials across 29 markets. BRUKINSA is now approved in more than 65 markets around the world and is approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL) in the United States.

Most recently, the ALPINE study, a head-to-head comparison between BRUKINSA and IMBRUVICA® in R/R CLL/SLL, demonstrated BRUKINSA’s superior efficacy (PFS and ORR) and safety (atrial fibrillation) over IMBRUVICA. The study also reported zero sudden cardiac death events for BRUKINSA versus a 1.9% rate for IMBRUVICA. Those results were published in the New England Journal of Medicine and presented as a simultaneous late breaker presentation at the American Society of Hematology meeting in December 2022.

As a science-based, global biotech company with over 9,400 people and operations on five continents, BeiGene highly values and respects valid and enforceable intellectual property rights. BeiGene remains confident in BRUKINSA’s intellectual property and will continue its mission to discover and develop innovative oncology treatments that are more efficacious and safer. BeiGene also remains committed to making medicines that are more affordable and accessible to cancer patients worldwide.

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