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Contingencies and commitments | 9 Months Ended
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Sep. 30, 2018
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, 2017, 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 18, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2017; and in Notes 14 and 15, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2018 and June 30, 2018, respectively. 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 18, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2017, or in Notes 14 and 15, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2018 and June 30, 2018, respectively, plaintiffs 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 pending against us described in this filing, in Note 18, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2017, or in Notes 14 and 15, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2018 and June 30, 2018, respectively, 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: Sensipar® (cinacalcet) Litigation Sensipar® Abbreviated New Drug Application (ANDA) Patent Litigation On July 27, 2018, the U.S. District Court for the District of Delaware (the Delaware District Court) issued a trial order finding on the infringement claims and defenses in the Amgen Inc. v. Aurobindo Pharma Ltd. et al. consolidated lawsuit that Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively, Zydus) infringe our U.S. Patent No. 9,375,405 (the ’405 Patent) and that the following defendants do not infringe the ’405 Patent: Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (collectively, Amneal); Piramal Healthcare UK Limited (Piramal); and Watson Laboratories, Inc., Actavis, Inc. and Actavis Pharma, Inc. (collectively, Watson). On August 24, 2018, the Delaware District Court issued an order dismissing, without prejudice, the invalidity counterclaims of Amneal, Piramal, and Watson and entered judgment of non-infringement of the ’405 Patent in favor of Amneal, Piramal and Watson. On September 20, 2018, Amgen filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court). On October 9, 2018, the Delaware District Court dismissed, without prejudice, the invalidity counterclaims of Zydus and entered judgment of infringement of the ’405 Patent by Zydus in favor of Amgen, including an order that the effective date of the U.S. Food and Drug Administration (FDA) approval of Zydus’s generic version of Sensipar® shall be no earlier than the expiry date of our ’405 Patent. On October 11, 2018, Zydus filed a notice of appeal to the Federal Circuit Court and on October 24, 2018, the Federal Circuit Court consolidated the appeals of Zydus and Amgen. On September 7, 2018, Amgen filed a lawsuit in the Delaware District Court for infringement of the ’405 Patent against Emcure Pharmaceuticals Ltd., Heritage Pharmaceuticals Inc., and Heritage Pharma Labs Inc. As previously disclosed, Amgen filed lawsuits in the Delaware District Court and the U.S. District Court for the Middle District of North Carolina (the North Carolina District Court) each against Accord Healthcare, Inc. (Accord) and Intas Pharmaceuticals Ltd. (Intas) for infringement of the ’405 Patent. On September 18, 2018, Accord responded to our lawsuit in the Delaware District Court by denying infringement of the ’405 Patent and alleging that the patent is invalid. On September 20, 2018, Intas was dismissed from the Delaware District Court lawsuit without prejudice by joint stipulation of the parties, and Amgen filed a notice voluntarily terminating the lawsuit filed in the North Carolina District Court. Sensipar® Pediatric Exclusivity Litigation On October 2, 2018, by agreement between Amgen and the FDA, the U.S. Court of Appeals for the District of Columbia Circuit dismissed Amgen’s appeal of the final judgment that had been ordered by the U.S. District Court for the District of Columbia. NEUPOGEN® (filgrastim)/ Neulasta® (pegfilgrastim) Litigation Adello NEUPOGEN® Patent Litigation On October 3, 2018, Amgen filed an amended complaint in the U.S. District Court for the District of New Jersey (the New Jersey District Court) adding defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc., to this patent infringement litigation and reducing the number of patents-in-suit from 17 to 4—specifically, U.S. Patent Nos. 8,940,878; 8,952,138; 9,643,997 (the ’997 Patent); and 9,856,287 (the ’287 Patent). On October 17, 2018, Adello Biologics, LLC (Adello) responded to the amended complaint, seeking judgment that our patents-in-suit are not infringed by Adello’s biosimilar filgrastim product and that our patents are invalid. Apotex NEUPOGEN®/Neulasta® Patent Litigation On August 7, 2018, Amgen Inc. and Amgen Manufacturing, Ltd. (collectively, Amgen) filed a lawsuit in the U.S. District Court for the Southern District of Florida against Apotex Inc. and Apotex Corp. (collectively, Apotex) for infringement of the ’287 Patent in accordance with the patent provisions of the Biologics Price Competition and Innovation Act. This lawsuit stems from Apotex’s submissions of applications for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta® and a filgrastim product as biosimilar to Amgen’s NEUPOGEN®. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Apotex from infringing the ’287 Patent. On October 1, 2018, Apotex and Adello filed a petition in the United States Patent and Trademark Office requesting that the Patent Trial and Appeal Board institute post grant review proceedings on the ’287 Patent. Pfizer NEUPOGEN® Patent Litigation On August 9, 2018, defendant Pfizer answered Amgen’s complaint in this patent infringement litigation and included counterclaims seeking a declaratory judgment that Amgen’s ’997 Patent is not infringed by Pfizer’s biosimilar filgrastim product and that our patent is invalid. ENBREL (etanercept) Litigation Sandoz ENBREL Patent Litigation On September 10, 2018, the New Jersey District Court entered an order that the making, using, offering to sell or selling in the United States, or the importation into the United States by Sandoz Inc., Sandoz International GmbH, and Sandoz GmbH (collectively, Sandoz) of Sandoz’s biosimilar etanercept product infringes U.S. Patent Nos. 8,063,182 and 8,163,522. The New Jersey District Court held a bench trial from September 11, 2018 to September 25, 2018 focusing on Sandoz’s challenges to the validity of these patents. Closing arguments are scheduled for November 19, 2018. Hospira EPOGEN® (epoetin alfa) Patent Litigation Following a jury verdict finding our U.S. Patent No. 5,856,298 (the ’298 Patent) valid and infringed by Hospira Inc. (Hospira) and awarding Amgen $70 million in damages for such infringement, Hospira moved for judgment as a matter of law of noninfringement and invalidity of the ’298 Patent or, in the alternative, for reduction of the damage award or a new trial on the ’298 Patent. On August 27, 2018, the Delaware District Court denied Hospira’s motion and final judgment was entered on September 11, 2018. On October 3, 2018, Hospira filed a notice of appeal to the Federal Circuit Court and on October 15, 2018, Amgen filed a cross-appeal. MVASI™ (bevacizumab-awwb) Patent Litigation On August 31, 2018, plaintiffs Genentech and City of Hope reduced the number of asserted patents in this patent infringement litigation pending against Amgen from 26 to 8 in accordance with the scheduling order issued by the Delaware District Court. The jury trial has been rescheduled to begin on July 13, 2020. KANJINTI™ (trastuzumab) Patent Litigation On August 23, 2018, plaintiffs Genentech and City of Hope moved to dismiss Amgen’s unenforceability counterclaims and affirmative defense in this patent infringement litigation pending against Amgen.

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