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Contingencies and commitments | 3 Months Ended
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Mar. 31, 2025
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, 2024, 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, 2024. 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, 2024, 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, 2024, 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 Unified Patent Court of the European Union (UPC) On February 25, 2025, a hearing on the validity and infringement of European Patent No. 3,536,712 (the EP’712 Patent), which Sanofi Biotechnology SAS licensed from Regeneron Pharmaceuticals, Inc. (Regeneron), was held before the Dusseldorf Local Division of the UPC. The parties await the decision of the court. On February 28, 2025, Sanofi and Regeneron filed the Statement of Case on European Patent No. 4,252,857. On April 17, 2025, the Court of Appeals of the UPC canceled the oral hearing scheduled for May 22, 2025 on the appeal of the decision by the Central Division of the UPC to revoke Amgen’s European Patent No. 3,666,797 (the EP’797 Patent). This hearing will be rescheduled, and the parties have been invited to comment on the written decision of the European Patent Office Opposition Division rejecting Sanofi-Aventis and Regeneron’s opposition and concluding that the claims of the EP’797 Patent are valid. European Patent Office On March 12, 2025, following a hearing on Amgen’s opposition to Regeneron’s EP’712 Patent, the Opposition Division determined that the claims of the EP’712 Patent are valid, and issued its written decision on April 24, 2025. On April 25, 2025, Amgen filed a Notice of Appeal and request for expedited appeal proceedings. A hearing was held beginning on March 31, 2025 on Sanofi-Aventis and Regeneron’s opposition against Amgen’s EP’797 Patent. On April 3, 2025, the Opposition Division determined the claims of the EP’797 Patent are valid. On April 16, 2025, Sanofi-Aventis and Regeneron filed Notices of Appeal and requested expedited appeal proceedings. Japan On April 15, 2025, the Intellectual Property High Court dismissed Amgen’s appeal in Amgen’s lawsuit against Sanofi K.K. seeking monetary compensation for past patent infringement. Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation Amgen Inc. et al. v. Samsung Bioepis Co. Ltd., et al. The U.S. District Court for the District of New Jersey (the New Jersey District Court) scheduled a trial to begin on May 4, 2026. Amgen Inc. et al. v. Fresenius Kabi USA, LLC et al. The parties entered into a confidential settlement that resolves patent disputes related to Fresenius’ denosumab biosimilar products, including this litigation. On March 3, 2025, the parties filed a joint stipulation, and on March 7, 2025, the New Jersey District court entered an order dismissing all claims and affirmative defenses asserted in this litigation without prejudice. The confidential settlement allows Fresenius to launch its denosumab biosimilar products in the United States as early as June 30, 2025, and in Europe in November 2025. In re: Denosumab Patent Litigation (Multidistrict Litigations) The New Jersey District Court scheduled a claim construction hearing for all actions subject to the multidistrict litigation for November 12, 2025. PAVBLU® (aflibercept-ayyh) Patent Litigation On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the denial by the U.S. District Court for the Northern District of West Virginia of Regeneron’s motion for a preliminary injunction. KYPROLIS® (carfilzomib) Abbreviated New Drug Application (ANDA) Patent Litigation Onyx Therapeutics, Inc. v. Somerset Therapeutics, LLC On April 24, 2025, Onyx Therapeutics, Inc. (Onyx Therapeutics, a wholly-owned subsidiary of Amgen), filed a lawsuit in the U.S. District Court for the District of Delaware (the Delaware District Court) against Somerset Therapeutics, LLC (Somerset) asserting infringement of U.S. Patent No. 7,737,112 (the ’112 Patent) based on Somerset’s submission of an ANDA seeking FDA approval to market a generic version of KYPROLIS. Onyx Therapeutics seeks an order from the Delaware District Court making any FDA approval of the defendant’s ANDA effective no earlier than the expiration of the ’112 Patent. Antitrust Actions Regeneron Pharmaceuticals, Inc. Antitrust Action On April 10, 2025, the Delaware District Court denied Amgen’s motion for summary judgment. Trial is scheduled to begin on May 5, 2025. Sandoz Inc. Antitrust Action On April 11, 2025, Sandoz Inc. (Sandoz) filed a complaint in the U.S. District Court for the Eastern District of Virginia against Amgen Inc., Amgen Manufacturing Limited LLC, and Immunex Corporation claiming violations of the antitrust laws and tortious interference related to Amgen’s patent rights to ENBREL, and seeking damages, injunctive relief and attorneys’ fees. The factual allegations that form the basis for the claims of Sandoz’s complaint are substantially similar to those asserted in the lawsuit filed against Amgen in the same court by CareFirst of Maryland, Inc., Group Hospitalization and Medical Services, Inc., and CareFirst BlueChoice, Inc. See Antitrust Class Action—CareFirst of Maryland Antitrust Class Action 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, 2024. 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) Pursuant to the Case Management Plan and Scheduling Order set by the U.S. District Court for the Southern District of New York, the last day to file summary judgment motions is August 12, 2026. Shareholder Derivative Action (Sieveking) On April 2, 2025, Carolyn Sieveking and James P. Tierney filed a derivative action (the Sieveking Derivative Action) in the Delaware District Court purportedly on behalf of Amgen, against nominal defendant Amgen, Robert Bradway, Peter Griffith, Linda Louie and Amgen’s Board members during the relevant time period (the Sieveking Derivative Action). The complaint alleges claims for violations of Section 10(b), Rule 10b5 and Section 20(a) of the Securities Exchange Act of 1934, and breach of fiduciary duty. The factual allegations that form the basis for the claims in the Sieveking Derivative Action is fundamentally the same as those asserted by the Roofers Local No. 149 Pension Fund. ChemoCentryx, Inc. Securities Matters Under the current schedule set by the U.S. District Court for the Northern District of California, the lead plaintiff’s summary judgment motion is due May 8, 2025. That motion and ChemoCentryx’s cross-motion for summary judgment will be fully briefed by July 3, 2025.

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