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Contingencies and commitments | 3 Months Ended
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Mar. 31, 2024
Commitments and Contingencies Disclosure [Abstract] |
Contingencies and commitments | Contingencies and commitments Contingencies In the ordinary course of business, we are involved in various legal proceedings, government investigations and other matters that are complex in nature and have outcomes that are difficult to predict. See our Annual Report on Form 10-K for the year ended December 31, 2023, Part I, Item 1A. Risk Factors—Our business may be affected by litigation and government investigations. We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote; and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023. We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We evaluate, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously. Our legal proceedings involve various aspects of our business and a variety of claims, some of which present novel factual allegations and/or unique legal theories. In each of the matters described in this filing; and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023, in which we could incur a liability, our opponents seek an award of a not-yet-quantified amount of damages or an amount that is not material. In addition, a number of the matters pending against us are at very early stages of the legal process, which in complex proceedings of the sort we face often extend for several years. As a result, none of the matters described in this filing; and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023, in which we could incur a liability, have progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are not material. While it is not possible to accurately predict or determine the eventual outcomes of these matters, an adverse determination in one or more of these matters currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows. Certain recent developments concerning our legal proceedings and other matters are discussed below. Repatha Patent Litigation Patent Disputes in the International Region Germany On February 29, 2024, in Amgen’s Nullity Action before the German Federal Patent Court seeking invalidation of Regeneron Pharmaceuticals, Inc.’s (Regeneron) European Patent No. 2,756,004 (the EP’004 Patent), the Federal Patent Court issued a preliminary opinion that the EP’004 Patent is likely to be invalid and scheduled the main hearing for November 25, 2025. European Patent Office On November 16, 2023 and February 29, 2024, Sanofi-Aventis and Regeneron each filed a notice of opposition against Amgen’s European Patent No. 3,666,797 before the European Patent Office’s Opposition Division. On February 29, 2024, Amgen filed a Notice of Opposition and Grounds of Opposition before the European Patent Office against Regeneron’s European Patent No. 3,536,712. Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation Amgen Inc. et al. v. Sandoz Inc., et al. On April 29, 2024, the U.S. District Court for the District of New Jersey (the New Jersey District Court) entered judgment in the lawsuit pending against Sandoz Inc. based on Sandoz’s submission to the FDA of a Biologics License Application seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products (“Sandoz’s biosimilar denosumab products”). The complaint asserted infringement of patents listed in the FDA’s Purple Book for Amgen’s Prolia and XGEVA products. A preliminary injunction hearing, held between October 30 and December 21, 2023, focused on a composition of matter patent U.S. Patent No. 7,364,736 (the ‘736 Patent) and two manufacturing patents. The judgment entered by the New Jersey District Court found the asserted claims of Amgen’s ‘736 Patent valid, enforceable and infringed by Sandoz’s biosimilar denosumab products and included an injunction prohibiting Sandoz and third parties acting on behalf of or in active concert with Sandoz from making, using, selling, or offering to sell in the United States or importing into the United States Sandoz’s biosimilar denosumab products before the expiry of the ’736 Patent on February 19, 2025, except as specifically authorized by a confidential settlement agreement. As a result of the settlement, the parties’ remaining claims and counterclaims related to the other asserted patents were dismissed with prejudice and Sandoz is permitted to launch the Sandoz biosimilar denosumab products in the United States on May 31, 2025, unless accelerated pursuant to the terms of a confidential settlement agreement, and subject to confidential financial terms stated therein. ABP 938 (aflibercept) Patent Litigation On April 11, 2024, the Judicial Panel on Multidistrict Litigation granted Regeneron’s motion to transfer Regeneron’s patent infringement lawsuit pending against Amgen in the U.S. District Court for the Central District of California to the U.S. District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings. Antitrust Class Action Sensipar Antitrust Class Actions On February 17, 2024, Amgen and the indirect purchasers filed a stipulation in the U.S. District Court for the District of Delaware (the Delaware District Court) to dismiss the indirect purchasers’ claims. On February 22, 2024, Amgen and the indirect purchasers filed a stipulation in the U.S. Court of Appeals for the Third Circuit (the Third Circuit Court) dismissing the portion of the Third Circuit Court’s appeal relating to the claims of the indirect purchasers. Amgen and the direct purchasers filed a stipulation on April 12, 2024 in the Delaware District Court, dismissing with prejudice the direct purchasers’ claims that were at issue in the appeal and seeking entry of final judgment in Amgen’s favor. On April 15, 2024, the Delaware District Court entered an order pursuant to the stipulation and closed the case. The direct purchasers retain a right to appeal the claims that were dismissed by the Delaware District Court on March 11, 2022. U.S. Tax Litigation and Related Matters Amgen Inc. & Subsidiaries v. Commissioner of Internal Revenue See Note 4, Income taxes, for discussion of the IRS tax dispute and the Company’s petitions in the U.S. Tax Court. ChemoCentryx, Inc. Securities Matters On March 6, 2024, the U.S. District Court for the Northern District of California certified a class of all persons who purchased or otherwise acquired the common stock of ChemoCentryx between November 26, 2019 and May 6, 2021. Trial is scheduled to begin on September 22, 2025. On March 20, 2024, ChemoCentryx filed a petition with the U.S. Court of Appeals for the Ninth Circuit, seeking permission to have the district court’s order on class certification heard on appeal. The lead plaintiff’s response to ChemoCentryx’s petition was submitted on April 2, 2024.

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