BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today 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.”
About BRUKINSA® (zanubrutinib)
BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 70 markets, and more than 180,000 patients have been treated globally.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the strength of BeiGene’s intellectual property supporting BRUKINSA; BRUKINSA’s ability to set a new standard of care for patients worldwide; and BeiGene’s plans, commitments, aspirations and goals under the caption “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. BeiGene’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.
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