Contingencies and commitments	3 Months Ended
Contingencies and commitments	Mar. 31, 2021
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, 2020, Part I, Item 1A. Risk Factors—Our business may be affected by litigation and government investigations. We describe in this footnote our legal proceedings and other matters that are significant or that we believe could become significant. 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, or 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, 2020, 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, or 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, 2020, 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: Abbreviated New Drug Application (ANDA) Patent Litigation KYPROLIS® ANDA Patent Litigation Onyx Therapeutics, Inc. v. Cipla Limited, et al. On March 8, 2021, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) affirmed the May 2020 judgment of the U.S. District Court for the District of Delaware (the Delaware District Court), which judgment had found in favor of Onyx Therapeutics, Inc. (Onyx), and against Cipla Limited and Cipla USA, Inc. (collectively, Cipla), on infringement, validity and enforceability of claims 23 and 24 of Onyx’s U.S. Patent No. 7,417,042 (the ’042 Patent), claim 1 of U.S. Patent No. 8,207,125 (the ’125 Patent), and claim 31 of U.S. Patent No. 7,737,112 (the ’112 Patent). The May 2020 judgment also includes an injunction prohibiting Cipla from making, using, offering to sell, selling or importing into the United States Cipla’s carfilzomib product during the term of the three asserted patents (the ’042, ’125 and ’112 Patents). On April 7, 2021, Cipla filed a petition in the Federal Circuit Court requesting panel rehearing of the Federal Circuit Court’s decision on Cipla’s appeal, which was denied on April 23, 2021. Otezla® ANDA Patent Litigation Amgen Inc. v. Sandoz Inc., et al. On March 24, 2021, based on a joint request by Amgen and Prinston Pharmaceutical Inc. (Prinston), the U.S. District Court for the District of New Jersey (the New Jersey District Court) entered a consent judgment and injunction prohibiting the making, using, selling, offering to sell, or importing of Prinston’s apremilast product during the term of U.S. Patent Nos. 7,427,638 and 10,092,541, unless authorized pursuant to a confidential settlement agreement. On April 6, 2021, based on a joint request by Amgen together with Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. (collectively, Aurobindo), the New Jersey District Court entered a consent judgment and injunction prohibiting the making, using, selling, offering to sell, or importing of Aurobindo’s apremilast product during the term of U.S. Patent Nos. 6,962,940; 7,208,516; 7,427,638; 7,659,302; 7,893,101; 8,455,536; 8,802,717; 9,018,243; 9,724,330; 9,872,854; and 10,092,541 unless authorized pursuant to a confidential settlement agreement. Sensipar® (cinacalcet) ANDA Patent Litigation Amgen Inc. v. Amneal Pharmaceuticals LLC, et al. (formerly, Amgen Inc. v. Aurobindo Pharma Ltd. et al.) On March 24, 2021, the Delaware District Court commenced an evidentiary hearing on the request by Piramal Healthcare UK Limited and Slate Run Pharmaceuticals LLC for damages caused by the injunction during the pendency of Amgen’s appeal. Repatha® Patent Litigation Amgen Inc., et al. v. Sanofi, et al. On February 11, 2021, the Federal Circuit Court issued a decision affirming the Delaware District Court’s ruling that claims 19 and 29 of our U.S. Patent No. 8,829,165 and claim 7 of our U.S. Patent No. 8,859,741 are invalid for failing to meet the enablement requirement. Amgen filed a petition for rehearing en banc on April 14, 2021. On April 15, 2021, the Federal Circuit Court invited Sanofi and Regeneron to respond to Amgen’s petition. Sanofi and Regeneron’s response is due May 28, 2021. NEUPOGEN® (filgrastim)/Neulasta® Patent Litigation Amgen Inc. et al. v. Pfizer Inc. et al. On March 16, 2021, the Delaware District Court issued an order rescheduling the trial between Amgen Inc. and its wholly owned subsidiary, Amgen Manufacturing, Limited (collectively, Amgen) and Pfizer Inc. and Hospira Inc. (collectively, Pfizer) to begin on September 20, 2021. Amgen Inc., et al. v. Hospira Inc. et al. On March 23, 2021, the Delaware District Court denied Pfizer’s motion to dismiss the complaint by Amgen, which alleges Pfizer’s infringement of U.S. Patent No. 8,273,707. On April 6, 2021, the Delaware District Court stayed further proceedings in the matter pending claim construction of the patent claims. A claim construction hearing is scheduled for June 11, 2021. Patent Trial and Appeal Board (PTAB) Challenge Lupin PTAB Challenge On December 15, 2020, Lupin Limited filed a petition to institute inter parties review (IPR) proceeding at the U.S. Patent and Trademark Office (USPTO) of U.S. Patent No. 9,856,287 (the ’287 Patent) challenging claims of the ’287 Patent as unpatentable. Amgen’s preliminary response was filed on April 14, 2021, and the PTAB has no more than three months to decide whether to institute a proceeding. Antitrust Class Action Sensipar® Antitrust Class Actions On February 16, 2021, the plaintiffs in the antitrust class action lawsuit brought on behalf of putative classes of direct or indirect purchasers of Sensipar® filed their amended complaints. On March 4, 2021, a stipulation and order regarding the filing of a second amended complaint were filed to add another plaintiff: Teamsters Western Region & Local 177 Health Care Fund. On March 17, 2021, a defendant, MSP Recovery Claims, Series LLC, filed its notice of voluntary dismissal. On March 30, 2021, the remaining defendants, including Amgen, filed their motions to dismiss the second amended complaint. Humira® Biosimilar Antitrust Class Actions On February 25, 2021, oral argument was held by the U.S. Court of Appeals for the Seventh Circuit on the appeal by plaintiffs-appellants of the lower court’s dismissal of the consolidated complaint with prejudice.