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Contingencies and commitments | 3 Months Ended
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Mar. 31, 2023
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, 2022, 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022. 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022, 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022, 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: ANDA Patent Litigation Otezla ANDA Patent Litigation Amgen Inc. v. Sandoz Inc., et al. On April 19, 2023, the U.S. Court of Appeals for the Federal Circuit affirmed the permanent injunction entered by the U.S. District Court for the District of New Jersey prohibiting Sandoz and Zydus Pharmaceuticals (USA) Inc. from making, using, selling, offering to sell, or importing each of the generic versions of Otezla until February 2028. Repatha Patent Litigation Amgen Inc., et al. v. Sanofi, et al. Oral argument before the U.S. Supreme Court took place on March 27, 2023. Patent Disputes in the International Region In Amgen’s counterclaim litigation alleging that PRALUENT® infringes Amgen’s European Patent No. 2,641,917 (the ’917 Patent), on February 27, 2023, Amgen filed a notice of appeal of the European Patent Office’s Opposition Division order invalidating the claims of the ’917 Patent. On March 13, 2023, Amgen appealed to the Japanese Supreme Court the High Court’s decision that Amgen’s Japanese patent claims relating to PCSK9 were invalid for lacking adequate support. On April 24, 2023, Amgen filed its Grounds for Acceptance of Appeal and Grounds for Appeal with the Japanese Supreme Court. ABP 654 (ustekinumab) Patent Litigation Janssen Biotech, Inc. v. Amgen Inc. On February 21, 2023, Janssen filed a first amended complaint adding, among other things, a request for declaratory judgment that four additional patents, together with the two patents it previously asserted, would be infringed by Amgen’s submission of an application for FDA licensure of ABP 654, Amgen’s biosimilar version of Janssen’s STELARA® (ustekinumab). On March 5, 2023, Janssen filed a motion for preliminary injunction based on the alleged infringement of the two patents it had originally asserted, specifically U.S. Patent Nos. 9,217,168 and 9,475,858, seeking to enjoin Amgen from manufacturing or using in commercial quantities, offering to sell, or selling within the United States, or importing for commercial purposes into the United States, ABP 654. On March 23, 2023, the District Court Judge issued a scheduling order for this preliminary injunction proceedings, setting such hearing for August 4, 2023. Janssen Biotech Inc. v. Amgen Technology (Ireland) Unlimited Company On March 22, 2023, Janssen initiated an action in the Irish High Court alleging infringement of Irish Supplementary Protection Certificate No. 2009/015, indicating intent to seek an interlocutory injunction restraining ABP 654 manufacturing activities in Ireland. The trial date for preliminary Supplementary Protection Certificate issues, potentially followed by a hearing with respect to interlocutory injunction, has been set to begin on July 4, 2023. Antitrust Actions Sensipar Antitrust Class Actions On February 16, 2023, the U.S. District Court for the District of Delaware (the Delaware District Court) denied Amgen’s motion for interlocutory appeal. On March 2, 2023, Amgen filed a motion for reargument, which the Delaware District Court denied while also certifying a question regarding whether the current judge has the authority to certify a question decided by a predecessor judge. On April 17, 2023, Amgen filed a petition with the U.S. Court of Appeals for the Third Circuit, seeking a grant of our request for interlocutory appeal of the certified question as well as the Delaware District Court’s denial of our motion to dismiss the reverse payment claim. Amgen’s response to the class action complaints are due 30 days after resolution or denial of the interlocutory appeal. Regeneron Pharmaceuticals, Inc. Antitrust Action On February 10, 2023, the Delaware District Court denied Amgen’s motion to stay this action but left open the possibility of Amgen re-raising the motion if the U.S. Supreme Court rules in Amgen’s favor in its patent infringement cases against Sanofi and Regeneron Pharmaceuticals, Inc. On March 21, 2023, the Delaware District Court denied Amgen’s motion to dismiss the complaint. U.S. Tax Litigation Amgen Inc. & Subsidiaries v. Commissioner of Internal Revenue See Note 5, Income taxes, for discussion of the IRS tax dispute and the Company’s petitions in the U.S. Tax Court. Securities Class Action Litigation On March 13, 2023, Roofers Local No. 149 Pension Fund filed a purported class action against Amgen, Robert Bradway and Peter Griffith. The action was brought on behalf of an alleged class of Amgen shareholders who owned stock between July 29, 2020 and April 27, 2022 (the alleged class period). Plaintiffs allege that the defendants made a series of materially false and misleading statements and omissions during the alleged class period regarding the failure to timely disclose the potential tax liability claimed by the IRS. Plaintiffs further allege that they and other purported class members suffered losses and damages resulting from declines in the market value of Amgen’s common stock after the potential tax liability claimed by the IRS was disclosed. On April 4, 2023, the U.S. District Court for the Southern District of New York entered an order setting May 12, 2023 as the deadline for filing motions for appointment of lead counsel. ChemoCentryx, Inc. Securities Class Action Litigation In May 2022, ChemoCentryx, which was acquired by Amgen in October 2022 and is now a subsidiary of Amgen, filed a motion to dismiss the shareholder class action claims. On February 23, 2023, the U.S. District Court for the Northern District of California (Northern District Court of California) substantially denied ChemoCentryx’s motion to dismiss the matter in its entirety, while granting the motion to dismiss with respect to certain allegations of the plaintiffs. On April 4, 2023, the parties submitted a case management statement to the Northern District Court of California

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