2 unchanged sentences
Most of the issues raised by such claims are highly complex and subject to substantial uncertainties.
−Removed: For a description of risks relating to these legal proceedings, see “Part I—Item 1A—Risk Factors” of this Quarterly Report, including the discussion under the headings entitled “Risks Related to Our Intellectual Property.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain;
+Added: For a description of risks relating to these legal proceedings, see “Part II—Item 1A—Risk Factors” of this Quarterly Report, including the discussion under the headings entitled “Risks Related to Our Intellectual Property.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain;
therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.
8 unchanged sentences
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 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: The suit against MSN is currently stayed until November 14, 2024.
+Added: On April 29, 2025, the USPTO issued a Final Written Decision that invalidated all claims of the ‘803 patent challenged by BeiGene.
AbbVie Litigation
3 unchanged sentences
The complaint seeks an unspecified amount of monetary damages, declaratory judgment, restitution and other equitable remedies.
−Removed: The Company will vigorously defend against the claims and file its response to AbbVie’s complaint by December 19, 2024.
+Added: The Company is vigorously defending against the claims and filed a motion to dismiss the complaint in its entirety on December 19, 2024.
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.