Contingencies and commitments |
6 Months Ended |
|---|---|
Jun. 30, 2026 | |
| 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, 2025, 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, 2025; and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. 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. The outcomes of these proceedings are inherently uncertain and depend on a variety of factors, including the development of the factual record, judicial or administrative rulings, and, in certain cases, the outcome of appellate review. Further, certain of the matters pending against us are at earlier stages of the legal process, which in complex proceedings of the sort we face often extend for several years, and have not progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate. Accordingly, except for amounts accrued, in each of the matters described in this filing in which we could incur a liability, our opponents seek an award of a not-yet-estimable amount of damages or an amount that is 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. Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation Amgen Inc. et al. v. Amneal Pharmaceuticals, Inc. et al.; Amgen Inc. et al. v. Dr. Reddy’s Laboratories Ltd., et al.; and Amgen Inc. et al. v Alkem Laboratories Ltd., et al. A claim construction hearing will be scheduled after October 21, 2027, and the joint pretrial order is due August 28, 2028. A trial date has not yet been set. PAVBLU® (aflibercept-ayyh) Patent Litigation United States Regeneron Pharmaceuticals, Inc. v. Amgen Inc. (action filed January 10, 2024) (the 2024 Action) A hearing on Amgen’s motion for a suggestion of remand was held on May 27, 2026. On May 26, 2026, Amgen filed its opposition brief to Regeneron Pharmaceuticals, Inc.’s (Regeneron) motion to strike certain of Amgen’s affirmative defenses and to dismiss certain of Amgen’s counterclaims pleaded in response to Regeneron’s complaint that was filed in January 2024 (the 2024 Complaint), and on June 24, 2026, Regeneron filed its reply brief. Regeneron Pharmaceuticals, Inc. v. Amgen Inc. (action filed June 17, 2025) (the 2025 Action) On July 7, 2026, the U.S. District Court for the Northern District of West Virginia granted in part and denied in part Regeneron’s motion to strike certain of Amgen’s affirmative defenses and to dismiss certain of Amgen’s counterclaims. The court’s ruling (1) dismissed with prejudice the following Amgen defenses and counterclaims: the inequitable conduct defense, the counterclaim seeking a declaratory judgment that U.S. Patent No. 12,331,099 (the ’099 Patent) is unenforceable, the counterclaims for Sherman Act monopolization and attempted monopolization as to the allegations relating to the ’099 Patent, the counterclaim for unlawful and unfair practices under the California Unfair Competition Law as to the allegations relating to the ’099 Patent, the patent misuse defense and counterclaim, and the unclean hands defense; (2) dismissed without prejudice Amgen’s counterclaims for Sherman Act monopolization and attempted monopolization as to the allegations relating to certain patents asserted in the 2024 Action and its counterclaim for unlawful and unfair practices under the California Unfair Competition Law as to the allegations relating to certain patents asserted in the 2024 Action; and (3) denied Regeneron’s motion with respect to Amgen’s prosecution laches defense and counterclaim. KYPROLIS® (carfilzomib) Abbreviated New Drug Application (ANDA) Patent Litigation Onyx Therapeutics, Inc. v. Hetero USA Inc. et al. On May 4, 2026, Onyx and Hetero entered a joint stipulation in which Hetero agreed that the asserted claims of U.S. Patent No. 7,737,112 (the ’112 Patent) are valid and enforceable, and that the filing of its ANDA infringed and the making, using, offering to sell, selling, or importing of its proposed ANDA product will infringe the asserted claims. On the same day, pursuant to the parties’ joint stipulation, the U.S. District Court for the District of Delaware entered an order enjoining Hetero from infringing the asserted claims until the expiration, or delisting from the Orange Book, of the ’112 Patent, except as, and to the extent, specifically authorized by Onyx in writing, and dismissed the action. TAVNEOS® (avacopan) Abbreviated New Drug Application (ANDA) Patent Litigation ChemoCentryx, Inc. v. Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Global FZE, and Zydus Lifesciences Limited (collectively, Zydus); ChemoCentryx, Inc. v. Annora Pharma Private Limited, Hetero USA Inc., and Hetero Labs Limited (collectively, Annora) On May 18, 2026, ChemoCentryx responded to Zydus’ counterclaims and asserted its affirmative defenses. On May 21, 2026, the U.S. District Court for the District of New Jersey entered an order consolidating the cases against Zydus and Annora for all purposes, including discovery, case management, and trial. Antitrust Class Actions CareFirst of Maryland Antitrust Class Action On June 8, 2026, Amgen filed its opening brief with the U.S. Court of Appeals for the Fourth Circuit. On June 10, 2026, the U.S. District Court for the Eastern District of Virginia granted Amgen’s motion to stay the case pending the outcome of the appeal. 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. Securities Class Action Litigation (Roofers Local No. 149 Pension Fund) The parties have reached an agreement to settle this matter, subject to approval by the U.S. District Court for the Southern District of New York (Southern District Court of New York). On July 20, 2026, the plaintiffs filed a motion for preliminary class settlement approval with the Southern District Court of New York. ChemoCentryx, Inc. Securities Matters On May 15, 2026 the lead plaintiff filed a revised stipulation of settlement. On June 12, 2026, the U.S. District Court for the Northern District of California entered an order granting preliminary approval of the settlement, setting September 21, 2026 as the deadline for objections to the settlement and to opt into the class. A hearing for final approval of the settlement is scheduled for October 29, 2026.
|