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Contingencies and commitments | 6 Months Ended
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Jun. 30, 2019
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, 2018, 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 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2018; 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, 2019. 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 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2018, 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, 2019, 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 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2018, 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, 2019, 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: Novartis Breach of Contract Action On July 16, 2019, Novartis Pharma AG (Novartis) filed an amended complaint in the U.S. District Court for the Southern District of New York adding a claim for breach of contract alleging Novartis is owed amounts associated with 2018 budget overruns and Amgen responded with a counterclaim alleging additional breaches by Novartis of the collaboration agreements between the parties. Repatha® (evolocumab) Patent Litigation On June 6, 13 and 21, 2019, the U.S. District Court for the District of Delaware (the Delaware District Court) held evidentiary hearings on Amgen’s motion for a permanent injunction against PRALUENT®. The Delaware District Court has scheduled an August 8, 2019 hearing on the post-trial motion for a judgment notwithstanding the jury verdict filed by Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc., and Regeneron Pharmaceuticals, Inc. Sensipar® (cinacalcet) Litigation Cipla Ltd. v. Amgen Inc. On May 2, 2019, the Delaware District Court denied Amgen’s motion for preliminary injunction in the lawsuit by Cipla Limited and Cipla USA, Inc. (collectively, Cipla) seeking a declaration that provisions of its settlement agreement with Amgen have been triggered by the at-risk launch of a generic cinacalcet product by Teva Pharmaceutical Industries Ltd. (Teva). On the same day, Amgen filed its notice of appeal of the Delaware District Court’s denial of Amgen’s motion for preliminary injunction in the United States Court of Appeals for the Third Circuit (the Third Circuit Court of Appeals). On May 3, 2019, Amgen filed a motion for injunction pending appeal in the Delaware District Court, which was denied on May 9, 2019. On May 13, 2019, Amgen filed a motion for injunction pending appeal and expedited briefing in the Third Circuit Court of Appeals. On May 23, 2019, the Third Circuit Court of Appeals denied the motion for injunction pending appeal and granted the request for expedited briefing. On July 16, 2019, the Third Circuit Court of Appeals affirmed the Delaware District Court’s decision denying Amgen’s motion for a preliminary injunction. With respect to Cipla’s pending claims, the Delaware District Court has given Cipla until July 31, 2019 to amend its complaint. Amgen Inc. v. Amneal Pharmaceuticals LLC, et al. Abbreviated New Drug Application (ANDA) Patent Litigation On June 13, 2019, the Delaware District Court held a hearing on the motion filed by Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) to enforce the settlement agreement entered between Amgen and Sun. By its complaint, Sun is contending that its generic cinacalcet product should not be held off the U.S. market. On July 17, 2019, Amgen filed a motion requesting the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) to vacate the Delaware District Court’s noninfringement judgment in favor of Watson Laboratories, Inc. and Actavis Pharma, Inc. and direct entry of the parties’ proposed consent judgment. KYPROLIS® (carfilzomib) ANDA Patent Litigation On May 6, 2019, the Delaware District Court commenced trial in the Onyx Therapeutics, Inc. v. Cipla Limited., et al. consolidated case. On May 7, 2019, the Delaware District Court signed consent judgments filed prior to trial by Onyx Therapeutics, Inc. (Onyx Therapeutics) and each of Aurobindo Pharma USA, Inc. (Aurobindo); InnoPharma Inc. (InnoPharma); Sagent Pharmaceuticals, Inc. (Sagent); Apotex Inc. and Apotex Corp. (collectively, Apotex); Fresenius Kabi USA, Inc. and Fresenius Kabi USA, LLC (collectively, Fresenius) and signed a consent judgment filed that same day by Onyx Therapeutics and MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, MSN). On May 14, 2019, the Delaware District Court signed consent judgments filed during trial by Onyx Therapeutics and each of Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, DRL) and Breckenridge Pharmaceutical, Inc. (Breckenridge). In the consent judgments between Onyx Therapeutics and each of Aurobindo, InnoPharma, Sagent, Apotex, Fresenius, DRL, and Breckenridge, the parties stipulated to entry of: (1) judgment dismissing with prejudice all of the parties’ claims, counterclaims, affirmative defenses and demands; and (2) an injunction prohibiting infringement of U.S. Patent Nos. 7,417,042; 7,737,112 (the ’112 Patent); and 8,207,125 by the manufacture, use, sale, offer to sell, or importation into the United States of the applicable defendant’s carfilzomib product unless specifically authorized pursuant to the applicable confidential settlement agreement. In the consent judgment between Onyx Therapeutics and MSN, the parties stipulated to entry of: (1) judgment dismissing with prejudice all of the parties’ claims, counterclaims, affirmative defenses and demands; and (2) an injunction prohibiting infringement of the ’112 Patent by the manufacture, use, sale, offer to sell, or importation into the United States of MSN’s carfilzomib product unless specifically authorized pursuant to the confidential settlement agreement. On May 16, 2019, trial concluded between Onyx Therapeutics and the lone remaining defendant, Cipla. The parties await the judgment of the Delaware District Court. NEUPOGEN® (filgrastim) / Neulasta® (pegfilgrastim) Patent Litigation Coherus Neulasta® Patent Litigation On July 29, 2019, the Federal Circuit Court affirmed the Delaware District Court’s final judgment dismissing Amgen’s lawsuit against Coherus BioSciences, Inc. (Coherus) for infringement of U.S. Patent No. 8,273,707. Sandoz NEUPOGEN® / Neulasta® Patent Litigation On May 8, 2019, the Federal Circuit Court affirmed the U.S. District Court for the Northern District of California’s grant of summary judgment of noninfringement of U.S. Patent Nos. 8,940,878 and 6,162,427 by Sandoz Inc., Sandoz International GmbH and Sandoz GmbH. On June 7, 2019, Amgen and Amgen Manufacturing, Limited (AML) filed a petition for rehearing en banc in the Federal Circuit Court. On May 13, 2019, Sandoz Inc. voluntarily dismissed, without prejudice, the separate lawsuit it had filed in the U.S. District Court for the Northern District of California against Amgen and AML seeking a judgment of noninfringement and invalidity of the U.S. Patent No. 9,643,997 (the ’997 Patent). Mylan Neulasta® Patent Litigation On June 13, 2019, the District Court for the Western District of Pennsylvania granted the request by Mylan Inc., Mylan Pharmaceuticals Inc., Mylan GmbH, and Mylan N.V. (collectively, Mylan) for a temporary stay pending the outcome of Amgen’s Federal Circuit Court appeal in the Coherus Neulasta® Patent Litigation, and Amgen’s petition for en banc review of the Federal Circuit Court’s May 8, 2019 decision in the Sandoz NEUPOGEN® / Neulasta® Patent Litigation (each case discussed above). Tanvex NEUPOGEN® Patent Litigation On July 23, 2019, Amgen filed a lawsuit in the U.S. District Court for the Southern District of California against Tanvex BioPharma USA, Inc., Tanvex BioPharma, Inc., and Tanvex Biologics Corp. (collectively, Tanvex) for infringement of U.S. Patent No. 9,856,287 (the ’287 Patent) in accordance with the patent provisions of the Biologics Price Competition and Innovation Act (BPCIA). This lawsuit stems from Tanvex’s submissions of an application for U.S. Food and Drug Administration (FDA) licensure of a filgrastim product as biosimilar to Amgen’s NEUPOGEN®. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Tanvex from infringing the ’287 Patent. Coherus Neulasta® Trade Secret Litigation Following a May 1, 2019 settlement between Amgen and Coherus, on May 2, 2019, pursuant to a joint request regarding settlement, the Ventura County Superior Court dismissed Amgen’s claims against Coherus with prejudice. Patent Trial and Appeal Board Patent Challenges On May 20, 2019, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) issued a decision denying Apotex’s request for rehearing on the PTAB’s finding and sua sponte amending the final decision with a finding the one remaining claim in Amgen’s U.S. Patent No. 8,952,138 is unpatentable. On July 22, 2019, Amgen filed a notice of appeal to the Federal Circuit Court with respect to all claims held to be unpatentable. On June 8, 2019, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH filed a petition seeking to institute inter partes review (IPR) proceedings before the PTAB to challenge the patentability of the ’997 Patent. The ’997 Patent is also among the patents at issue in the Mylan Neulasta® Patent Litigation, the previously-disclosed litigation between Amgen and Kashiv Biosciences, LLC (formerly known as Adello Biologics, LLC), Amneal Pharmaceuticals LLC, and Amneal Pharmaceuticals, Inc., and the previously-disclosed litigation between Amgen and Pfizer Inc. and Hospira Inc. Amgen’s patent owner preliminary response to this IPR petition is due September 11, 2019, after which the PTAB will have three months to render a decision regarding whether to institute PTAB trial proceedings on the ’997 Patent. Patent Litigation Relating to our Biosimilar Products AMJEVITA TM (adalimumab-atto) / AMGEVITA TM Patent Litigation As previously disclosed, Amgen has been sued in a number of European countries by Fresenius Kabi Deutschland GmbH (Fresenius), alleging that AMGEVITA TM infringes various patents of Fresenius and seeking, among other remedies, injunctive relief prohibiting patent infringement. In May 2019, the parties acted jointly, to the extent necessary, to withdraw from and/or seek dismissal of the lawsuits. KANJINTI TM (trastuzumab) Patent Litigation On July 10, 2019, Genentech, Inc. (Genentech) filed a motion asking the Delaware District Court for a temporary restraining order and preliminarily injunction prohibiting Amgen from commercially launching, marketing or selling KANJINTI TM until the Delaware District Court renders a decision on the merits of Genentech’s asserted U.S. Patent Nos. 6,627,196; 7,371,379; and 10,160,811. Following Amgen’s opposition, on July 18, 2019, the Delaware District Court denied Genentech’s motion. On July 19, 2019, Genentech filed a notice of appeal and a motion requesting the Federal Circuit Court to enter an injunction prohibiting Amgen from continuing with its launch of KANJINTI TM until final resolution of Genentech’s appeal. On July 24, 2019, the Delaware District Court entered an order dismissing City of Hope as a party to the lawsuit and dismissing with prejudice Genentech’s claims for infringement of a number of expired patents, leaving eight patents asserted by Genentech in the litigation. MVASI TM (bevacizumab-awwb) Patent Litigation On July 10, 2019, Genentech, alleging that Amgen’s notice of commercial marketing pursuant to the BPCIA is insufficient, filed motions asking the Delaware District Court for a temporary restraining order and enforcement of the BPCIA to prohibit Amgen from commercially marketing MVASI TM until Amgen has provided new notice and waited until the expiry of the notice period. Following Amgen’s opposition, on July 18, 2019, the Delaware District Court denied Genentech’s motions. On July 19, 2019, Genentech filed a notice of appeal and a motion requesting the Federal Circuit Court to enter an injunction prohibiting Amgen from marketing MVASI TM until final resolution of Genentech’s appeal. Antitrust Class Actions Humira® Biosimilar Antitrust Class Actions As previously disclosed, in March and April 2019, ten purported class actions against Amgen, along with AbbVie Inc. and AbbVie Biotechnology Ltd. (collectively, AbbVie), were filed in U.S. District Court for the Northern District of Illinois (the Illinois Northern District Court). In April and May 2019, two additional purported class actions against Amgen and AbbVie were filed in the Illinois Northern District Court. The additional cases are captioned: Louisiana Health Service & Indemnity Co., d/b/a Blue Cross and Blue Shield of Louisiana, and HMO Louisiana, Inc. v. AbbVie Inc., et al. (April 30, 2019) (Louisiana Health); and Cleveland Bakers and Teamsters Health and Welfare Fund v. AbbVie Inc., et al. (May 10, 2019) (Cleveland Bakers, and together with Louisiana Health, the New Humira® Antitrust Class Actions). In each of the New Humira® Antitrust Class Actions, the plaintiffs bring federal antitrust claims along with various state law claims under common law and antitrust, consumer protection, and unfair competition statutes. The plaintiffs in the New Humira® Antitrust Class Actions specifically allege that AbbVie has unlawfully monopolized the alleged market for Humira® and biosimilars of Humira®, including by creating an allegedly unlawful so-called patent thicket around Humira®. The plaintiffs in the New Humira® Antitrust Class Actions allege that AbbVie and Amgen entered into an allegedly unlawful settlement agreement under which Amgen allegedly agreed to delay its entry into the U.S. market with AMGEVITA TM, its Humira® biosimilar, in exchange for an alleged promise of exclusivity as the sole Humira® biosimilar in that market for five months, beginning in January 2023. In each of the New Humira® Antitrust Class Actions, plaintiffs seek injunctive relief, treble damages and attorney’s fees on behalf of a putative class of third-party payers and/or consumers that have indirectly purchased, paid for or provided reimbursement for Humira® in the United States. On June 4, 2019, the Illinois Northern District Court entered an order consolidating the twelve purported class action cases for pre-trial purposes. On June 13, 2019, the Illinois Northern District Court entered an order requiring the plaintiffs to file a consolidated complaint by August 12, 2019. Sensipar® Antitrust Class Actions As previously disclosed, a plaintiff in one of the class action lawsuits against Amgen and various entities affiliated with Teva filed a motion seeking to have the four class action lawsuits consolidated and designated as a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania, and a different plaintiff in another of the class action lawsuits filed a motion seeking to have the four class action lawsuits, along with Cipla Ltd. v. Amgen Inc., consolidated and designated as a MDL in the Delaware District Court. On July 25, 2019, the MDL panel held a hearing on the motions to consolidate.

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