5 unchanged sentences
Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
−Removed: Pharmacyclics Litigation
−Removed: On June 13, 2023, Pharmacyclics LLC (“Pharmacyclics”) filed a complaint in the U.S.
−Removed: District Court for the District of Delaware (the “Court”) against the Company and its subsidiary, BeiGene USA, Inc., which subsequently changed its name to BeOne Medicines USA, Inc., alleging that BRUKINSA infringes Pharmacyclics’ U.S Patent No.
−Removed: 11,672,803 issued on June 13, 2023 (the “‘803 patent”).
−Removed: Pharmacyclics seeks a declaration of infringement, unspecified monetary damages and other relief.
−Removed: On October 12, 2023, the Court entered a joint stipulation filed by the parties to stay the infringement suit pending resolution of a petition for post-grant review (“PGR”) of the ‘803 Patent with the U.S.
−Removed: Patent and Trademark Office (the “USPTO”) that was later filed by the Company on November 1, 2023.
−Removed: On May 1, 2024, the USPTO granted the Company’s PGR petition.
−Removed: On April 29, 2025, the USPTO issued a Final Written Decision (“FWD”) that invalidated all challenged claims of the ‘803 patent.
−Removed: On May 29, 2025, Pharmacyclics filed a request for Director Review of the USPTO’s FWD.
−Removed: On July 17, 2025, the USPTO denied Pharmacyclics’ request.
−Removed: Pharmacyclics did not appeal the USPTO’s FWD and Director Review decision.
−Removed: On September 30, 2025, the parties filed a joint stipulation with the Court to dismiss the infringement suit.
AbbVie Litigation
1 unchanged sentence
filed a complaint in the U.S.
−Removed: District Court for the Northern District of Illinois against the Company, one of its wholly-owned subsidiaries and an individual scientist, alleging misappropriation of trade secrets concerning the Company’s Bruton’s tyrosine kinase (“BTK”) degrader program, including the lead compound, BGB-16673.
+Added: District Court for the Northern District of Illinois against the Company, one of its wholly-owned subsidiaries and an individual scientist, alleging misappropriation of trade secrets concerning the Company’s BTK degrader program, including the lead compound, BGB-16673.
The complaint seeks an unspecified amount of monetary damages, declaratory judgment, restitution and other equitable remedies.
The Company is vigorously defending against the claims and filed a motion to dismiss the complaint in its entirety on December 19, 2024.
+Added: ANDA Litigation
+Added: On February 25, 2026, our subsidiaries, BeOne Medicines USA Inc.
+Added: and BeOne Medicines I GmbH, filed a patent infringement suit under the Hatch-Waxman Act against Zydus Pharmaceuticals (USA) Inc.
+Added: and Zydus Lifesciences Limited (collectively, “Zydus”) in the United States District Court for the District of New Jersey.
+Added: The patent infringement suit is in response to Zydus’ notice to BeOne concerning the filing of an Abbreviated New Drug Application (“ANDA”) with the U.S.
+Added: Food and Drug Administration (“FDA”), seeking FDA approval to market a generic version of BRUKINSA ® (zanubrutinib) tablets along with “Paragraph IV certifications” challenging certain BRUKINSA ® Orange Book patents for invalidity and/or non-infringement.
+Added: According to the notice, Zydus has not challenged BRUKINSA’s composition of matter patent, which remains intact and protects BRUKINSA ® from generic competition until its expiration in 2034.
+Added: BeOne’s complaint alleges that by filing the ANDA, Zydus infringes certain of BRUKISNA’s Orange Book patents and seeks a permanent injunction to prevent Zydus from commercializing a generic version of BRUKINSA ® tablets until the expiration of the asserted patents.
+Added: ANDA litigation is common in the U.S.
+Added: pharmaceutical industry.
+Added: We may receive additional notices from other generic drug companies and may file additional ANDA lawsuits in the future.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.