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Contingencies and commitments
 6 Months Ended
Jun. 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 Report on Form 10-Q for the period ended March 31, 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 Report on Form 10-Q for the period ended March 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; 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 Report on Form 10-Q for the period ended March 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® (carfilzomib) ANDA Patent Litigation
Onyx Therapeutics, Inc. v. Cipla Limited, et al.
On May 8, 2020, consistent with its May 4, 2020 decision and order, the U.S. District Court for the District of Delaware (the Delaware District Court) entered final judgment in favor of Onyx Therapeutics, Inc. (Onyx, a wholly-owned subsidiary of Amgen) and against Cipla Limited and Cipla USA, Inc. (collectively, Cipla) on infringement, validity and enforceability of claims 23 and 24 of U.S. Patent No. 7,417,042; claim 1 of U.S. Patent No. 8,207,125; and claim 31 of U.S. Patent No. 7,737,112 (the ’112 Patent). The Delaware District Court entered judgment in favor of Cipla and against Onyx on Cipla’s counterclaim for invalidity of claim 32 of the ’112 Patent and ordered that the effective date of any final approval by the U.S. Food and Drug Administration (FDA) of Cipla’s ANDA must be after expiration of the three asserted patents and any regulatory exclusivity to which Onyx may become entitled. The final judgment 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.
On May 29, 2020, Cipla filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court).
Otezla® (apremilast) ANDA Patent Litigation
Amgen Inc. v. Sandoz Inc., et al.
On May 28, 2020, based on a joint request by Amgen and Emcure Pharmaceuticals Ltd. and Heritage Pharmaceuticals Inc. (collectively, Emcure), 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 Emcure’s apremilast product during the term of U.S. Patent Nos. 7,427,638 (the ’638 Patent); 7,893,101 (the ’101 Patent); 9,872,854 (the ’854 Patent); and 10,092,541 (the ’541 Patent) unless authorized pursuant to a confidential settlement agreement.
On July 7, 2020, the New Jersey District Court ordered a stipulated dismissal without prejudice of all claims, counterclaims, and affirmative defenses between Amgen and Sandoz Inc. (Sandoz) with respect to U.S. Patent Nos. 8,802,717; 7,208,516; and the ’854 Patent, leaving U.S. Patent Nos. 6,962,940; 7,659,302; 8,455,536; 9,018,243; and 9,724,330; the ’638 Patent; the ’101 Patent; and the ’541 Patent asserted by Amgen against Sandoz in the litigation.
Sensipar® (cinacalcet) ANDA Patent Litigation
Amgen Inc. v. Amneal Pharmaceuticals LLC, et al. (formerly, Amgen Inc. v. Aurobindo Pharma Ltd. et al.) Consolidated Case
On July 9, 2020, the Federal Circuit Court granted a motion filed by Watson Laboratories, Inc. and Actavis Pharma, Inc. (collectively, Watson) and Amgen to dismiss Amgen’s appeals of the Delaware District Court’s judgment of noninfringement as to Watson and denial of the joint motion for indicative ruling.
A hearing on the request by Piramal Healthcare UK Limited to recover damages for being enjoined during the pendency of Amgen’s appeal will be held by the Delaware District Court during the week of December 14, 2020. No trial date has been set for the patent infringement and validity issues to be tried in the remanded case against Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC.
ENBREL (etanercept) Patent Litigation
Immunex Corporation, et al. v. Sandoz Inc., et al.
On July 1, 2020, the Federal Circuit Court affirmed the judgment of the New Jersey District Court upholding the validity of U.S. Patent Nos. 8,063,182 and 8,163,522.
Repatha® (evolocumab) Patent Litigation
Patent Disputes in the International Region
As previously disclosed, we are involved in and expect future involvement in additional disputes regarding our proprotein convertase subtilisin/kexin type 9 (PCSK9) patents in other jurisdictions and regions. This includes matters filed against us and that we have filed in the United Kingdom, Germany, France, the Netherlands, Italy, Spain and Japan.
On June 24, 2020, Amgen filed written answers to the invalidity trials initiated by Regeneron on February 12, 2020 before the Japan Patent Office seeking to invalidate Amgen’s Japanese patents that were previously held infringed by PRALUENT® and valid over challenges filed by Sanofi K.K.
NEUPOGEN® (filgrastim)/Neulasta® (pegfilgrastim) Patent Litigation
Fresenius Patent Trial and Appeal Board (PTAB) Challenge
On June 23, 2020, the PTAB of the U.S. Patent and Trademark Office terminated two proceedings filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH (collectively, Fresenius) challenging the patentability of Amgen’s U.S. Patent Nos. 9,643,997 and 9,856,287 due to a settlement between Amgen and Fresenius.
Litigation relating to our Biosimilar Products
KANJINTI® (trastuzumab-anns) Patent Litigation
Genentech, Inc. v. Amgen Inc.
On July 7, 2020, pursuant to a settlement and license agreement, Amgen and Genentech, Inc. stipulated to dismissal of the lawsuit. On July 9, 2020, the Delaware District Court closed the matter.
MVASI® (bevacizumab-awwb) Patent Litigation
Genentech, Inc. and City of Hope v. Amgen Inc.
On July 7, 2020, pursuant to a settlement and license agreement, Genentech, Inc. and City of Hope (collectively, Genentech) and Amgen stipulated to dismissal of the lawsuit. On July 9, 2020, the Delaware District Court closed the matter.
Genentech, Inc. and City of Hope v. Immunex Rhode Island Corp. and Amgen Inc.
On July 6, 2020, the Federal Circuit Court affirmed the Delaware District Court’s denial of Genentech’s request for injunction. On July 7, 2020, pursuant to a settlement and license agreement, the parties stipulated to dismissal of the lawsuit. On July 9, 2020, the Delaware District Court closed the matter.
Breach of Contract Action
Cipla Ltd. et al. v. Amgen Inc.
On July 16, 2020, Amgen and Cipla filed a stipulation of dismissal. On July 21, 2020, the Delaware District Court issued an order dismissing all pending claims between Amgen and Cipla.
Novartis Pharma AG v. Amgen Inc.
On June 9, 2020, the U.S. District Court for the Southern District of New York (the New York Southern District Court) entered an order granting Novartis Pharma AG’s (Novartis) motion for judgment on the pleadings as to count II of Novartis’s amended complaint and denying Amgen’s motions for judgment on the pleadings as to counts I, II and IV of Novartis’s amended complaint. On June 23, 2020, Amgen filed a motion for clarification and/or reconsideration of the New York Southern District Court’s June 9, 2020 order. On July 7, and July 14, 2020, respectively, Novartis and Amgen each filed its response. No trial date has been set.
Antitrust Class Action
Sensipar® Antitrust Class Actions
On July 22, 2020, the U.S. Magistrate Judge for the District of Delaware issued a recommendation to the Delaware District Court that the claims against Amgen be dismissed but recommended that leave be given to plaintiffs to amend their complaints.
Humira® Biosimilar Antitrust Class Actions
On June 8, 2020, the U.S. District Court for the Northern District of Illinois (the Illinois Northern District Court) issued an order granting the motion by the defendants Amgen, along with AbbVie Inc. and AbbVie Biotechnology Ltd., Samsung Bioepis Co., Ltd., Sandoz and Fresenius Kabi USA LLC., to dismiss the consolidated class action complaint. On June 29, 2020, the plaintiffs in the antitrust class action lawsuit filed a status report asking the Illinois Northern District Court to convert the dismissal to one with prejudice. On June 30, 2020, the Illinois Northern District Court granted the motion and the plaintiffs have 30 days therefrom to file their notice of appeal.