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., 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: The Company intends to vigorously defend against the claims.
−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 (“USPTO”) that was later filed by BeiGene on November 1, 2023.
−Removed: On May 1, 2024, the USPTO granted BeiGene’s PGR petition and is expected to issue a final decision on the validity of the ‘803 patent within 12 months.
−Removed: ANDA Litigation
−Removed: On March 8, 2024, the Company’s two wholly-owned subsidiaries, BeiGene USA, Inc.
−Removed: and BeiGene Switzerland GmbH filed patent infringement suits under Hatch-Waxman Act against Sandoz Inc.
−Removed: (“Sandoz”) and separately against MSN Pharmaceuticals, Inc.
−Removed: and MSN Laboratories Private Ltd.
−Removed: (collectively “MSN”) in the U.S.
−Removed: District Court for the District of New Jersey.
−Removed: The patent infringement suits are in response to Sandoz’s and MSN’s notices to the Company concerning the filings of Abbreviated New Drug Applications (“ANDAs”) with the U.S.
−Removed: Food and Drug Administration (“FDA”), seeking FDA approval to market a generic version of BRUKINSA along with “Paragraph IV certifications” challenging certain BRUKINSA Orange Book patents for invalidity, unenforceability and/or non-infringement.
−Removed: According to the notices, neither Sandoz nor MSN have challenged BRUKINSA’s composition of matter patent, which remains intact in protecting BRUKINSA from generic competition until its expiration in 2034.
−Removed: On August 15, 2024, the court entered a joint stipulation and order dismissing the suit against Sandoz.
−Removed: On November 14, 2024, BeiGene entered into a settlement agreement with MSN wherein BeiGene granted MSN the right to sell a generic version of BRUKINSA in the U.S.
−Removed: no earlier than June 15, 2037, subject to potential acceleration or extension under circumstances customary for settlement of this type.
−Removed: On November 19, 2024, the court entered a joint stipulation and order dismissing the suit against MSN.
AbbVie Litigation
4 unchanged sentences
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.
Mine Safety Disclosures
1 unchanged sentence
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.