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Contingencies and commitments
 9 Months Ended
Sep. 30, 2020
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, 2019, 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; 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, 2019; and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2020 and June 30, 2020.
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 Note 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2019; or in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2020 and June 30, 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; 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, 2019; or in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2020 and June 30, 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
Otezla® ANDA Patent Litigation
Amgen Inc. v. Sandoz Inc., et al.
On August 6, 2020, based on a joint request by Amgen and Mankind Pharma Ltd. (Mankind), 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 Mankind’s apremilast product during the term of U.S. Patent Nos. 6,962,940 (the ’940 Patent); 7,659,302 (the ’302 Patent); 8,455,536 (the ’536 Patent); 9,018,243 (the ’243 Patent); 9,724,330 (the ’330 Patent); 7,427,638 (the ’638 Patent); 7,893,101 (the ’101 Patent); and 10,092,541 (the ’541 Patent), unless authorized pursuant to a confidential settlement agreement. On August 14, 2020, based on a joint request by Amgen and Macleods Pharmaceuticals Ltd. (Macleods), the New Jersey District Court entered a consent judgment and injunction prohibiting the making, using, selling, offering to sell, or importing of Macleods’s apremilast product during the term of the ’638 Patent and the ’541 Patent, unless authorized pursuant to a confidential settlement agreement. On October 7, 2020, based on a joint request by Amgen and Amneal Pharmaceuticals LLC (Amneal), the New Jersey District Court entered a consent judgment and injunction prohibiting the making, using, selling, offering to sell, or importing of Amneal’s apremilast product during the term of the ’101 Patent, the ’940 Patent, the ’638 Patent, the ’302 Patent, the ’536 Patent, the ’243 Patent, the ’330 Patent and the ’541 Patent, unless authorized pursuant to a confidential settlement agreement.
Trial in the consolidated action against the remaining defendants is scheduled to commence on June 14, 2021.
Sensipar® (cinacalcet) ANDA Patent Litigation
On September 8, 2020, the U.S. District Court for the District of Delaware (the Delaware District Court) entered judgment of validity and infringement of our U.S. Patent No. 9,375,405 (the ’405 Patent) in the lawsuit filed against Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (collectively, Amneal) and, except to the extent specifically authorized in a confidential settlement agreement, enjoined Amneal from infringing the ’405 Patent by making, using, selling, offering to sell or importing Amneal’s cinacalcet product during the term of the patent.
A hearing before the Delaware District Court on the request of Piramal Healthcare UK Limited (Piramal) to recover damages for being enjoined during the pendency of Amgen’s appeal has been rescheduled for February 21, 2021. On October 14, 2020, the Delaware District Court issued an order permitting Slate Run Pharmaceuticals, LLC, Piramal’s business partner, to intervene in the pending action.
ENBREL Patent Litigation
Immunex Corporation, et al. v. Sandoz Inc., et al.
On September 29, 2020, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) denied the petition for rehearing of Sandoz Inc., Sandoz International GmbH and Sandoz GmbH filed on July 31, 2020.
Repatha Patent Litigation
Amgen Inc., et al. v. Sanofi, et al.
On October 21, 2020, the Federal Circuit Court set the hearing on Amgen’s appeal for December 9, 2020.
NEUPOGEN® (filgrastim)/Neulasta® Patent Litigation
Apotex Patent Trial and Appeal Board (PTAB) Challenge
On July 14, 2020, Amgen and Apotex Inc. and Apotex Corp. (Apotex) filed a joint motion to terminate the inter partes review proceedings stating that there is no current dispute between the parties with respect to U.S. Patent No. 8,952,138 (the ’138 Patent). On July 29, 2020, the United States government filed a petition for writ of certiorari with respect to the cases that the Federal Circuit Court remanded to the PTAB of the U.S. Patent and Trademark Office, including the case regarding the ’138 Patent, for proceedings consistent with its decision in Arthrex Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019), requesting that such remanded cases be held pending the U.S. Supreme Court’s disposition of the petition for writ of certiorari in United States v. Arthrex, Inc., No. 19-1434. On August 25, 2020, Amgen filed its response to the United States government’s petition for writ of certiorari indicating that Amgen did not intend to respond unless requested by the U.S. Supreme Court.
Amgen Inc., et al. v. Pfizer Inc. et al.
On July 10, 2020, Pfizer Inc. and Hospira Inc. (collectively, Pfizer) requested that the Delaware District Court stay the patent infringement lawsuit Amgen filed against Pfizer on U.S. Patent No. 10,577,392 (the ’392 Patent) until the co-pending patent infringement lawsuit on U.S. Patent No. 9,643,997 is resolved. Amgen has opposed Pfizer’s motion for a stay and seeks to avoid delay in the Delaware District Court’s resolution of the ’392 Patent dispute.
Breach of Contract Action
Novartis Pharma AG v. Amgen Inc.
On September 14, 2020, Amgen’s motion for clarification and/or reconsideration of the U.S. District Court for the Southern District of New York’s June 9, 2020 order was denied.
Antitrust Class Action
Sensipar® Antitrust Class Actions
On August 5, 2020, the plaintiffs filed objections to the U.S. Magistrate Judge for the District of Delaware’s report and recommendation issued on July 22, 2020. On August 19, 2020, Amgen filed a response to the plaintiffs’ objections.
Humira® Biosimilar Antitrust Class Actions
On July 28, 2020, the plaintiffs in the antitrust class action lawsuit filed a notice of appeal. On October 5, 2020, the plaintiffs filed their opening brief to the U.S. Court of Appeals for the Seventh Circuit. Amicus briefs were filed on behalf of the plaintiffs, including one by the Federal Trade Commission and one on behalf of 20 states, both filed on October 13, 2020.