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Contingencies and commitments | 6 Months Ended
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Jun. 30, 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; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 Amgen Inc., et al. v. Sanofi, et al. On May 18, 2023, the U.S. Supreme Court entered final judgment affirming the lower court’s decision invalidating claims 19 and 29 of U.S. Patent No. 8,829,165 and claim 7 of the U.S. Patent No. 8,859,741 as lacking an enabling disclosure of the invention claimed. Patent Disputes in the International Region On June 1, 2023, Amgen filed an action before the Unitary Patent Court against Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A. (collectively, Sanofi) and Regeneron Pharmaceuticals, Inc. alleging that the importation, marketing, sale and use of PRALUENT® infringes European Patent 3,666,797 (the EP’797 Patent) seeking an injunction and damages for past infringement. On June 29, 2023, the Unitary Patent Court served us with an action filed by Sanofi before the Unitary Patent Court seeking revocation of Amgen’s EP’797 Patent. On July 20, 2023, Amgen filed objections to the admissibility of Sanofi’s revocation action before the Unitary Patent Court’s Central Division and Local Divisions on the grounds that Amgen’s infringement action was filed prior to Sanofi’s revocation action. On November 14, 2023, the Regional Court of Dusseldorf is scheduled to hear argument on Sanofi Biotechnology SAS’ lawsuit alleging that our marketing of Repatha infringes European Patent 2,756,004. The Munich Regional Court scheduled a hearing for February 28, 2024 on Sanofi’s action against Amgen in which Sanofi seeks damages arising from the provisional enforcement of an injunction against PRALUENT® that was lifted after an October 29, 2020 ruling by the Technical Board of Appeal that broader claims in Amgen’s European Patent 2,215,125 encompassing PRALUENT® were invalid. Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation Amgen Inc. et al. v. Sandoz Inc., et al. On May 1, 2023, Amgen Inc. and Amgen Manufacturing Limited filed a lawsuit in the U.S. District Court for the District of New Jersey (New Jersey District Court) against Sandoz Inc., Sandoz GmbH, Lek Pharmaceuticals d.d., Novartis Pharmaceutical Productions d.o.o., and Novartis AG (collectively, Defendants) based on the 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. The complaint asserts infringement of the following 21 patents, which are listed in the FDA’s Purple Book for Amgen’s Prolia and XGEVA products: U.S. Patent Nos. 7,364,736; 7,928,205; 8,058,418; 9,012,178; 9,133,493; 9,228,168; 9,320,816; 9,328,134; 9,359,435; 9,481,901; 10,167,492; 10,513,723; 10,583,397; 10,822,630; 10,894,972; 11,077,404; 11,098,079; 11,130,980; 11,254,963; 11,299,760; and 11,434,514 (collectively, the Asserted Patents). Amgen seeks a judgment from the New Jersey District Court that Defendants have infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Defendants’ proposed denosumab biosimilar before expiration of each of the Asserted Patents found to infringe. Amgen also seeks monetary remedies for any past acts of infringement. On June 16, 2023, Amgen filed an amended and supplemental complaint to include additional information regarding the completion of the BPCIA information exchange after the filing of the original complaint. Sandoz Inc. responded to the amended and supplemental complaint on July 7, 2023, denying infringement and asserting counterclaims seeking a declaratory judgment that asserted patents are invalid and/or unenforceable. On July 21, 2023, the New Jersey District Court granted Amgen’s request for a briefing schedule to present and hear a motion to be filed by Amgen on or before September 1, 2023 seeking a preliminary injunction to prohibit patent infringement by Sandoz’s denosumab product until the court is able to reach judgment on the merits of Amgen’s lawsuit. On August 2, 2023, the New Jersey District Court scheduled a preliminary injunction hearing that will commence on October 30, 2023. ABP 654 (ustekinumab) Patent Litigation Janssen Biotech, Inc. v. Amgen Inc. On May 22, 2023, pursuant to a confidential settlement agreement, the parties filed a joint stipulation of dismissal with prejudice of the U.S. litigation. On May 23, 2023, the U.S. District Court for the District of Delaware (Delaware District Court) issued an order dismissing the U.S. litigation with prejudice. Janssen Biotech Inc. v. Amgen Technology (Ireland) Unlimited Company On May 22, 2023, pursuant to a confidential settlement agreement, the parties requested that the Irish proceedings be struck out and on the same day the Irish High Court issued an order striking out the proceedings and vacating all previous orders in those proceedings. Antitrust Class Action Sensipar Antitrust Class Actions On June 26, 2023, the U.S. Court of Appeals for the Third Circuit entered an order granting defendants’ (including Amgen’s) petition for interlocutory appeal and denying plaintiffs’ cross-petition. The questions certified are whether (1) the statute for interlocutory decisions authorizes a district court judge to certify for interlocutory appeal an order issued in the same case by a predecessor district court judge; and (2) the settlement of a patent infringement claim that involves the forgiveness of damages associated with that patent’s alleged infringement, on its own or combined with an acceleration clause, constitutes a reverse payment. On July 3, 2023, Amgen and Teva Pharmaceuticals USA, Inc. filed a notice of appeal. Regeneron Pharmaceuticals, Inc. Antitrust Action The Delaware District Court scheduled the trial to begin on November 12, 2024. 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. Shareholder Derivative Litigation On August 2, 2023, Leon Martin filed a derivative action, purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent board members. The action was filed in the U.S. District Court for the Southern District of New York as related to the pending federal securities class action filed by Roofers Local No. 149 Pension Fund on March 13, 2023 (the Roofers securities class action). The complaint in this matter alleges claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment and waste of corporate assets. The factual allegations that form the basis for these claims are essentially the same as the allegations asserted in the Roofers securities class action regarding purportedly false and misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls. FTC Litigation re the Proposed Horizon Therapeutics plc Acquisition On May 16, 2023, the FTC filed a complaint and motion for preliminary injunction in the U.S. District Court for the Northern District of Illinois (Northern Illinois District Court) seeking to enjoin Amgen’s proposed acquisition of Horizon. The FTC alleges that the deal would allow Amgen to leverage its portfolio of blockbuster drugs someday to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout, if competitors eventually come to market. The preliminary injunction hearing in the case is set to begin on September 11, 2023. On June 1, 2023, Amgen, Horizon and the FTC submitted a stipulated proposed temporary restraining order (TRO) to the Northern Illinois District Court providing that Horizon and Amgen would not close the acquisition until the earlier of October 31, 2023 or the second business day after the Northern Illinois District Court rules on the FTC’s request for a preliminary injunction. On June 2, 2023, the Northern Illinois District Court issued an order granting the stipulated TRO. Amgen and Horizon filed their answer to the complaint on June 9, 2023. On June 22, 2023, an amended complaint was filed adding six states to the lawsuit, and on June 29, 2023, Amgen filed an answer and counterclaims to the amended complaint. On June 22, 2023, the FTC filed an administrative complaint before the FTC’s administrative judge, and on July 7, 2023 Amgen and Horizon filed an answer to the administrative complaint. The Transaction Agreement provides that Amgen will be required to pay Horizon a termination fee of $974.4 million if the Transaction Agreement is terminated under certain circumstances in which there was a failure to obtain regulatory approvals by December 12, 2023, as described in Amgen’s Form 8-K filed December 12, 2022, and in the Transaction Agreement filed therewith. One of those circumstances would likely arise if the above-described preliminary injunction hearing is not decided favorably to Amgen and Horizon.

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