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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 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;
+Added: 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;
therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.
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: On June 26, 2020, following the suspension and recall of ABRAXANE in China supplied to us by Celgene Logistics Sàrl, a Bristol-Myers Squibb Company (referred to elsewhere in this report as BMS, but for this paragraph only, “BMS-Celgene”), we initiated an arbitration proceeding at the International Chamber of Commerce against BMS-Celgene (the “Arbitration”) asserting that it had breached and continued to breach the terms and conditions of the License and Supply Agreement entered into by BeiGene and BMS-Celgene in July 2017 (the “LSA”) and the Amended and Restated Quality Agreement (the “QA” and collectively with the LSA, the “BMS-Celgene License”).
−Removed: Under the BMS-Celgene License, we alleged that BMS-Celgene was obligated, among other things, to ensure the continuity and adequacy of its supply of ABRAXANE to us.
−Removed: In the Arbitration, we sought (i) a declaration that BMS-Celgene was and continued to be in breach of the BMS-Celgene License, (ii) a declaration that BMS-Celgene acted with gross negligence and/or willful misconduct, (iii) an award of damages, and (iv) such other relief as the arbitrators deemed appropriate.
−Removed: BMS-Celgene responded in part by submitting a counterclaim against us seeking to recover approximately $30 million in costs that it contends it incurred as part of the ABRAXANE recall.
−Removed: In October 2021, BMS-Celgene delivered a notice to us purporting to terminate the BMS-Celgene License with respect to ABRAXANE ® and providing 180-days' notice that it was withdrawing ABRAXANE from the range of products for sale or distribution in China pursuant to Section 2.6 of the BMS-Celgene License.
−Removed: Thereafter, we amended our claims to add a claim for wrongful termination of the BMS-Celgene License with respect to ABRAXANE.
−Removed: A hearing was held in the Arbitration in June 2022.
−Removed: Prior to a decision being issued in the Arbitration, on August 1, 2023, we entered into a Settlement and Termination Agreement (the “Settlement Agreement”) with BMS-Celgene and certain of its affiliates relating to the termination of the parties’ ongoing contractual relationship, the Arbitration, the LSA, the QA, and the Share Subscription Agreement (the “SSA”), entered into by the parties in 2017 and 2018.
−Removed: Pursuant to the Settlement Agreement, the parties agreed to mutually dismiss the Arbitration and BMS-Celgene and its affiliates agreed to transfer 23,273,108 of our ordinary shares originally purchased in 2017, in each case subject to and in accordance with the terms and conditions of the Settlement Agreement.
−Removed: We have no payment obligation in exchange for the transferred shares pursuant to the Settlement Agreement.
−Removed: Furthermore, the parties agreed to terminate the LSA and QA on December 31, 2023, subject to our right to continue selling all inventory of REVLIMID ® and VIDAZA ® until sold out or December 31, 2024, whichever is earlier.
−Removed: The Settlement Agreement provides for a settlement and release by each party of claims arising from or relating to the Arbitration, the LSA, the QA and the SSA, as well as other disputes and potential disputes between the parties, in each case subject to and in accordance with the terms and conditions of the Agreement.
−Removed: The settlement closed on August 15, 2023, and the matter is concluded.
+Added: Pharmacyclics Litigation
On June 13, 2023, Pharmacyclics LLC (“Pharmacyclics”) filed a complaint in the U.S.
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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”) to be filed by the Company by November 3, 2023.
−Removed: On November 1, 2023, the Company filed a PGR petition against the ‘803 Patent with the USPTO.
+Added: Patent and Trademark Office (“USPTO”) that was later filed by BeiGene on November 1, 2023.
+Added: 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.
+Added: ANDA Litigation
+Added: On March 8, 2024, the Company filed patent infringement suits under Hatch-Waxman Act against Sandoz Inc.
+Added: (“Sandoz”) and separately against MSN Pharmaceuticals, Inc.
+Added: and MSN Laboratories Private Ltd.
+Added: (collectively “MSN”) in the United States District Court for the District of New Jersey.
+Added: 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.
+Added: 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.
+Added: 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.
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.