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Contingencies and commitments | 9 Months Ended
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Sep. 30, 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; and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025. 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, 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, 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 Unified Patent Court (UPC) of the European Union On August 6, 2025, the Dusseldorf Local Division of the UPC stayed Sanofi’s lawsuit against Amgen alleging infringement of the European Patent No. 4,252,857 until the UPC Court of Appeals reaches a decision on the appeal from Sanofi’s lawsuit against Amgen involving European Patent No. 3,536,712 (the EP’712 Patent). On August 12, 2025, the Court of Appeals of the UPC heard oral argument on Amgen’s appeal seeking to set aside the Central Division of the UPC’s decision to revoke Amgen’s European Patent No. 3,666,797. On September 15, 2025, Amgen and Sanofi Biotechnologies SAS and Regeneron Pharmaceuticals, Inc. (Regeneron) filed respective Statements of Grounds of Appeal from the Dusseldorf Local Division of the UPC’s decision that the EP’712 Patent is valid but not infringed by Amgen. Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation Amgen Inc. et al. v. Samsung Bioepis Co. Ltd. et al. The parties entered into a confidential settlement agreement that resolves the patent litigation related to Samsung Bioepis Co Ltd.’s and Samsung Biologics Co., Ltd’s (collectively, Samsung) denosumab biosimilar products in the United States. Accordingly, the U.S. District Court for the District of New Jersey (New Jersey District Court) entered a Consent Order and Judgment on September 5, 2025, finding the claims of Amgen’s U.S. patents asserted against Samsung are valid, enforceable and infringed by Samsung’s denosumab biosimilars in the United States. In addition, Amgen and Samsung have reached a confidential settlement that allows Samsung to launch its biosimilar products in the United States. Amgen Inc. et al. v. Shanghai Henlius Biotech Inc. et al. On September 5, 2025, Shanghai Henlius Biotech Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC and Organon & Co. responded to Amgen’s complaint, asserting counterclaims and affirmative defenses. On October 10, 2025, Amgen responded to those counterclaims and asserted its affirmative defenses. Amgen Inc. et al. v. Hikma Pharmaceuticals USA Inc. et al. On September 5, 2025, Hikma Pharmaceuticals USA Inc., Gedeon Richter Plc., and Gedeon Richter USA, Inc. responded to Amgen’s complaint, asserting counterclaims and affirmative defenses on September 5, 2025. On October 10, 2025, Amgen responded to those counterclaims and asserted its affirmative defenses. Amgen Inc. et al. v. Biocon Biologics, Inc. et al. On September 5, 2025, Biocon Biologics, Inc., Biocon Biologics UK Limited, and Biocon Biologics Limited (collectively, Biocon) responded to Amgen’s complaint, asserting counterclaims and affirmative defenses. Pursuant to a consent order providing leave to amend, Amgen filed an Amended Complaint on September 23, 2025, adding Biosimilars Newco Limited (BNCL) as a defendant to the litigation. The parties entered into a confidential settlement agreement that resolves the patent litigation related to Biocon’s denosumab biosimilar products in the United States. Accordingly, the New Jersey District Court entered a Consent Judgment and Injunction on September 30, 2025, finding the claims of Amgen’s U.S. patents asserted against Biocon valid, enforceable and infringed by Biocon's denosumab biosimilars in the United States. In addition, Amgen and Biocon have reached a confidential settlement that allowed Biocon to launch its biosimilar products in the United States as early as October 1, 2025. In re: Denosumab Patent Litigation (Multidistrict Litigations) The claim construction hearing previously set by the New Jersey District Court was cancelled and on September 8, 2025, a new case schedule was issued for all matters pending in the multidistrict litigation. Neither a claim construction hearing nor a trial date have been set. PAVBLU™ (aflibercept-ayyh) Patent Litigation On September 12, 2025, Amgen responded to Regeneron’s complaint asserting infringement of U.S. Patent No. 12,331,099 (the ’099 Patent), denying infringement and asserting counterclaims seeking a declaratory judgment that the ’099 Patent is not infringed, invalid, and/or unenforceable, and counterclaims for Sherman Act (15 U.S.C. § 2) monopolization through Walker Process fraud, Sherman Act (15 U.S.C. § 2) attempted monopolization through Walker Process fraud, and unlawful and unfair practices under the California Unfair Competition Law. By its counterclaims, Amgen seeks, among other remedies, damages and an injunction against conduct by Regeneron. On September 29, 2025, the U.S. District Court for the Northern District of West Virginia entered a scheduling order for the matters pending in the multidistrict litigation including a claim construction hearing for November 23, 2026. KYPROLIS® (carfilzomib) Abbreviated New Drug Application (ANDA) Patent Litigation Onyx Therapeutics, Inc. v. Somerset Therapeutics, LLC On October 3, 2025, based on a joint request by Onyx Therapeutics, Inc. (Onyx Therapeutics, a wholly-owned subsidiary of Amgen) and Somerset Therapeutics, LLC (Somerset), the U.S. District Court for the District of Delaware (Delaware District Court) entered a Stipulation and Order that the filing of Somerset’s ANDA infringed, and the making, using, offering to sell, selling or importing of its proposed ANDA product will infringe, U.S. Patent No. 7,737,112 (the ’112 Patent), which Somerset admits is valid and enforceable. The Stipulation and Order enjoins Somerset and its affiliates from engaging in infringing conduct during the term of the ’112 Patent, subject to the terms of a confidential settlement agreement. Onyx Therapeutics, Inc. v. Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited. On September 4, 2025, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited (collectively, Amneal), asserting infringement of the ’112 Patent based on Amneal’s submission of an application pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act 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 application effective no earlier than the expiration of the ’112 Patent. Antitrust Actions CareFirst of Maryland Antitrust Class Action On September 30, 2025, the U.S. District Court for the Eastern District of Virginia issued an order granting in part and denying in part Amgen’s motion to dismiss. The court dismissed the plaintiffs’ antitrust claim under Puerto Rico law, and their unjust enrichment claims under the laws of seven states and Puerto Rico, but otherwise permitted the plaintiffs’ claims to proceed. Sandoz Inc. Antitrust Action On August 21, 2025, Amgen filed its reply to Sandoz Inc.’s opposition to Amgen’s motion to dismiss. Other Similar Antitrust Actions In August and September 2025, the Company received service of process of seven cases that were filed in the California Superior Court for the County of Ventura that raise allegations substantially similar to those in the CareFirst of Maryland antitrust class action. The cases were filed by: Centene Corporation on July 29, 2025; Humana, Inc. on July 29, 2025; Molina Healthcare, Inc. on July 29, 2025; Blue Cross and Blue Shield of Florida, Inc. (BCBSFL) on July 29, 2025; Blue Cross and Blue Shield of Kansas City (BCBSKC) on July 29, 2025; Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (BCBSMA) on August 8, 2025; and Health Care Services Corp. (HCSC) on August 21, 2025. Amgen subsequently removed the cases filed by BCBSFL, BCBSKC, BCBSMA, and HCSC to the U.S. District Court for the Central District of California. On September 29, 2025, HCSC voluntarily dismissed its case without prejudice. BCBSFL, BCBSKC, and BCBSMA voluntarily dismissed their cases without prejudice on October 1, 2025. 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) On September 11, 2025, the U.S. District Court for the Southern District of New York issued an order that extended deadlines. Pursuant to the order, the class certification briefing will be completed by April 24, 2026. The last day to file summary judgment motions is December 21, 2026, but no briefing schedule has been set. ChemoCentryx, Inc. Securities Matters On August 15, 2025, the U.S. District Court for the Northern District of California granted defendants’, including ChemoCentryx’s, motion for summary judgment in its entirety and denied lead plaintiff’s motion for partial summary judgment. On September 12, 2025, the lead plaintiff filed a notice of appeal to the Ninth Circuit Court of Appeals; its opening brief is due December 5, 2025.

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