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Contingencies and commitments | 3 Months Ended
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Mar. 31, 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. 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 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2018, 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 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2018, 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 April 4, 2019, Amgen filed a lawsuit in the U.S. District Court for the Southern District of New York against Novartis Pharma AG (Novartis) seeking a declaratory judgment that Novartis materially breached two collaboration agreements related to the development and commercialization of Aimovig® (erenumab-aooe) due to Novartis’ affiliate Sandoz Gmbh (Sandoz) entering into a contract manufacturing agreement with Alder BioPharmaceuticals, Inc. (Alder) related to eptinezumab, an expected direct competitor to Aimovig® and entrant in the calcitonin gene-related peptide (CGRP)-related migraine therapy market. Amgen seeks to terminate its collaboration agreements with Novartis and also seeks damages from Novartis for breach of contract and negligent misrepresentation. Also on April 4, 2019, Novartis initiated a separate lawsuit against Amgen in the same court seeking declaratory judgment that Novartis, alternatively, did not materially breach the collaboration agreements or, even if it did breach the collaboration agreements, such breach was not material and has been cured, and that Amgen may not terminate the collaboration agreements. On April 8, 2019, Amgen answered Novartis’ complaint and filed counterclaims seeking a declaratory judgment that Novartis materially breached the collaboration agreements due to its affiliate Sandoz entering into the contract manufacturing agreement with Alder. In its counterclaim, Amgen seeks to terminate its collaboration agreements with Novartis and also seeks damages from Novartis for breach of contract and negligent misrepresentation. Sensipar® (cinacalcet) Litigation Amgen Inc. v. Amneal Pharmaceuticals LLC, et al. (formerly, Amgen Inc. v. Aurobindo Pharma Ltd. et al.) ANDA Patent Litigation On March 19, 2019, Amgen filed an emergency motion for an injunction pending appeal, seeking an order from the U.S. District Court for the District of Delaware (the Delaware District Court) enjoining defendant Piramal Healthcare UK Limited (Piramal) from making, using, selling, offering for sale or importing its generic cinacalcet product. Amgen’s motion follows an announcement that Slate Run Pharmaceuticals LLC (Slate Run), in partnership with Piramal, had begun selling Piramal’s generic cinacalcet product at risk notwithstanding the appeals pending at the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court). On April 15, 2019, the Delaware District Court signed an order enjoining Piramal and Slate Run from selling their generic cinacalcet product until certain events occur related to a decision by the Federal Circuit Court on the parties’ appeal. The order has no effect on the product that Piramal and Slate Run have already sold to third parties. On March 21, 2019, defendants Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) filed a motion to enforce the settlement agreement entered between Amgen and Sun, contending that Sun’s generic cinacalcet product should not be held off the U.S. market. On March 26, 2019, the Delaware District Court denied the joint motion for indicative ruling of Watson Laboratories, Inc. and Actavis Pharma, Inc. (collectively, Watson) and Amgen, which had asked the court to vacate its final judgment of noninfringement as to Watson and to enter a proposed consent judgment of infringement and validity of Amgen’s U.S. Patent No. 9,375,405 and an injunction prohibiting the making, having made, using, selling, offering to sell or distributing Watson’s generic cinacalcet product in the United States, or importing Watson’s generic cinacalcet product into the United States, consistent with a confidential settlement agreement entered into by the parties. On April 10, 2019, Amgen filed an appeal to the Federal Circuit Court. On April 29, 2019, the Federal Circuit Court lifted the stay of Amgen’s appeal of the judgment of noninfringement as to Watson and consolidated it with Amgen’s appeal of the Delaware District Court’s denial of the joint motion for indicative ruling. Cipla Ltd. v. Amgen Inc. On March 11, 2019, following an announcement by Cipla Limited and Cipla USA, Inc. (collectively, Cipla) that it had begun selling its generic cinacalcet product in the United States, Amgen filed in the Delaware District Court a counterclaim and related motion for preliminary injunction in Cipla’s lawsuit seeking a declaration that provisions of its February 2018 settlement agreement with Amgen have been triggered by the at-risk launch of a generic cinacalcet product by Teva Pharmaceutical Industries Ltd. (Teva), an affiliate of Watson. Amgen’s motion seeks to prohibit Cipla from making, having made, using, selling, offering to sell or distributing its generic cinacalcet product in breach of such settlement agreement. On April 2, 2019, the Delaware District Court held a hearing on Amgen’s motion for preliminary injunction. Sensipar® Antitrust Class Actions From February 21, 2019, to April 10, 2019, four plaintiffs filed putative class action lawsuits against Amgen and various entities affiliated with Teva alleging anticompetitive conduct in connection with settlements between Amgen and manufacturers of generic cinacalcet product. Two of those actions were brought in the Delaware District Court, captioned UFCW Local 1500 Welfare Fund v. Amgen Inc., et al. (February 21, 2019) (Local 1500) and Cesar Castillo, Inc. v. Amgen Inc., et al. (February 26, 2019) (Castillo). The third action was brought in the U.S. District Court for the District of New Jersey (the New Jersey District Court), captioned Teamsters Local 237 Welfare Fund, et al. v. Amgen Inc., et al. (March 14, 2019) (Local 237) and the fourth action was brought in the U.S. District Court for the Eastern District of Pennsylvania (the Eastern Pennsylvania District Court), captioned KPH Healthcare Services, Inc. a/k/a Kinney Drugs, Inc. v. Amgen Inc., et al (April 10, 2019) (KPH). Each of the lawsuits is brought on behalf of a putative class of direct or indirect purchasers of Sensipar® and alleges that the plaintiffs have overpaid for Sensipar® as a result of Amgen’s conduct that allegedly improperly delayed market entry by manufacturers of generic cinacalcet products. The lawsuits focus predominantly on the settlement among Amgen, Watson and Teva of the parties’ patent infringement litigation. Each of the lawsuits seeks, among other things, treble damages, equitable relief and attorneys’ fees and costs. On April 10, 2019, the plaintiff in the KPH lawsuit filed a motion seeking to have the four lawsuits consolidated and designated as a multidistrict litigation (MDL) in the Eastern Pennsylvania District Court, and the plaintiff in the Local 1500 lawsuit filed a motion seeking to have the four lawsuits, along with Cipla Ltd. v. Amgen Inc., consolidated and designated as a MDL in the Delaware District Court. Sanofi / Regeneron Repatha® (evolocumab) Patent Litigation On February 25, 2019, a jury of the Delaware District Court unanimously upheld the validity of claims 7 and 15 of U.S. Patent No. 8,829,165 (the ’165 Patent) and claim 7 of U.S. Patent No. 8,859,741 (the ’741 Patent) in our infringement action against Sanofi, Sanofi-Aventis U.S. LLC and Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc. (collectively, Sanofi) and Regeneron Pharmaceuticals, Inc. (Regeneron). The jury also found that claims 19 and 29 of the ’165 Patent meet the enablement requirement, but are invalid for failure to meet the written description requirement. On March 18, 2019, Sanofi and Regeneron filed post-trial motions seeking to reverse judgment as a matter of law or for a new trial with respect to claims 7 and 15 of the ’165 Patent and claim 7 of the ’741 Patent, and Amgen filed a motion for a permanent injunction. The Delaware District Court has scheduled hearing dates on Amgen’s motion for a permanent injunction for June 6, 13 and 21, 2019. KYPROLIS® (carfilzomib) ANDA Patent Litigation On March 4, 2019, the Delaware District Court entered an order on a stipulation between Onyx Therapeutics, Inc. and Breckenridge Pharmaceutical, Inc. (Breckenridge), providing that Breckenridge infringes the asserted claims of U.S. Patent Nos. 7,417,042; 7,737,112 and 8,207,125, and consolidated this lawsuit against Breckenridge into the existing consolidated case, Onyx Therapeutics, Inc. v. Cipla Limited, et al., for all purposes. Trial in the consolidated case is scheduled to commence on May 6, 2019. Bioepis ENBREL (etanercept) Patent Litigation On April 30, 2019, Immunex Corporation and Amgen Manufacturing, Limited (collectively, Amgen), along with Hoffmann-La Roche Inc. (Roche), filed a lawsuit in the New Jersey District Court against Samsung Bioepis Co., Ltd. (Bioepis). This lawsuit stems from Bioepis’s submission of an application for U.S. Food and Drug Administration (FDA) licensure of an etanercept product as biosimilar to Amgen’s ENBREL. Amgen and Roche have asserted infringement of five patents: U.S. Patent Nos. 8,063,182 (the ’182 Patent); 8,163,522 (the ’522 Patent); 7,915,225 (the ’225 Patent); 8,119,605 (the ’605 Patent); and 8,722,631 (the ’631 Patent). By their complaint, Amgen and Roche seek an injunction to prohibit Bioepis from commercializing its biosimilar etanercept product in the United States prior to the expiry of such patents. NEUPOGEN® (filgrastim) / Neulasta® (pegfilgrastim) Patent Litigation Apotex NEUPOGEN® / Neulasta® Patent Litigation On April 5, 2019, the U.S. District Court for the Southern District of Florida (the Florida District Court) denied the motion of Apotex Inc. and Apotex Corporation (collectively, Apotex) to dismiss Amgen’s complaint for failure to state a claim. On April 18, 2019, Apotex answered the complaint including counterclaims seeking declaratory judgments of noninfringement and invalidity. Coherus Neulasta® Patent Litigation A hearing on Amgen’s Federal Circuit Court appeal of the final judgment dismissing Amgen’s lawsuit against Coherus BioSciences, Inc. (Coherus) for infringement of Amgen’s U.S. Patent No. 8,273,707 is scheduled for May 8, 2019. As previously disclosed, we are also engaged in a separate lawsuit in the Ventura County Superior Court in which we have alleged that Coherus and others misappropriated our confidential information and trade secrets through the hiring of former Amgen employees and that the defendants have used such information to develop and market UDENYCA TM, as biosimilar to Amgen’s Neulasta®. On March 27, 2019, the Ventura County Superior Court ordered Howard Weiser dismissed from the lawsuit based on a joint request regarding settlement filed on behalf of Amgen and Mr. Weiser. Trial in the misappropriation and trade secret litigation began on April 22, 2019. Pfizer NEUPOGEN® Patent Litigation On March 22, 2019, Amgen filed an amended complaint against Pfizer Inc. and Hospira Inc. (collectively, Pfizer) in the Delaware District Court narrowing the patent claims at issue in the infringement dispute and adding a request for damages. On April 11, 2019, Pfizer answered Amgen’s amended complaint including counterclaims seeking declaratory judgments of noninfringement and invalidity. Sandoz NEUPOGEN® / Neulasta® Patent Litigation On February 21, 2019, Sandoz Inc. (Sandoz) filed a new lawsuit in the U.S. District Court for the Northern District of California (the California Northern District Court) against Amgen Inc. and Amgen Manufacturing, Limited seeking a judgment of noninfringement and invalidity of the ’997 Patent. The lawsuit stems from Sandoz filing applications under the Biologics Price Competition and Innovation Act for the FDA licensure of filgrastim and pegfilgrastim products as biosimilar to NEUPOGEN® and Neulasta®, respectively. On April 24, 2019, Amgen filed a motion to dismiss the lawsuit for failure to state a claim. Patent Trial and Appeal Board Patent Challenges On March 7, 2019, Kashiv Biosciences, LLC, formerly known as Adello Biologics, LLC (Kashiv), filed petitions seeking to institute inter partes review (IPR) proceedings before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) to challenge the patentability of each claim of U.S. Patent Nos. 8,940,878 (the ’878 Patent) and 9,643,997 (the ’997 Patent). The ’878 Patent is also among the patents at issue in the previously-disclosed litigation between Amgen Inc. and Amgen Manufacturing, Limited (collectively, Amgen) and Kashiv, Amneal Pharmaceuticals LLC, and Amneal Pharmaceuticals, Inc. (the Kashiv NEUPOGEN® litigation) and in the previously-disclosed litigations between Amgen and Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (the Sandoz NEUPOGEN® litigation) and between Amgen and Sandoz Inc., Sandoz International GmbH, Sandoz GmbH and Lek Pharmaceuticals d.d. (the Sandoz Neulasta® litigation). The ’997 Patent is also among the patents at issue in the Kashiv NEUPOGEN® litigation, the Pfizer NEUPOGEN® Patent Litigation, the new Sandoz NEUPOGEN® / Neulasta® Patent Litigation and the previously-disclosed litigation between Amgen and Mylan Inc., Mylan Pharmaceuticals Inc., Mylan GmbH, and Mylan N.V. The deadline for Amgen to file a preliminary response to these IPR petitions is June 14, 2019, after which the PTAB will have three months to render a decision regarding whether to institute PTAB trial proceedings on the ’878 and ’997 Patents. In a separate challenge, on April 14, 2019, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBiosim GmbH filed a petition seeking to institute IPR proceedings before the PTAB to challenge the patentability of U.S. Patent No. 9,856,287 (the ’287 Patent). The ’287 Patent is also the subject of the Apotex NEUPOGEN® / Neulasta® Patent Litigation and is among the patents at issue in the Kashiv NEUPOGEN® litigation. The patent owner preliminary response to the IPR petition is due July 17, 2019, after which the PTAB will have three months to render a decision regarding whether to institute PTAB trial proceedings on the ’287 Patent. In a separate challenge, on April 19, 2019, the PTAB granted Apotex and Kashiv’s previously-disclosed petition to institute post grant review proceedings on the ’287 Patent, challenging claims of the ’287 Patent as unpatentable. Amgen’s response to the petition is due July 11, 2019. AMJEVITA TM (adalimumab-atto) / AMGEVITA TM Patent Litigation On April 18, 2019, Amgen responded to the lawsuit filed by Coherus, denying patent infringement and seeking judgment that the patents-in-suit are invalid, unenforceable and/or not infringed by Amgen. MVASI TM (bevacizumab-awwb) Patent Litigation On March 29, 2019, Genentech, Inc. (Genentech) and City of Hope filed a third lawsuit against Amgen in the Delaware District Court alleging infringement of 14 patents. All but 2 of the 14 patents asserted in this lawsuit have already been the subject of litigation pending among these parties in this court relating to Amgen’s submission of the application that led to the FDA licensure of MVASI TM as biosimilar to Genentech’s Avastin® (bevacizumab). Among other remedies, Genentech and City of Hope are seeking injunctive relief. Humira® Biosimilar Antitrust Class Actions From March 18, 2019, to April 19, 2019, ten purported class actions against Amgen, along with AbbVie Inc. and AbbVie Biotechnology Ltd. (collectively, AbbVie), were filed in the U.S. District Court for the Northern District of Illinois. The cases are captioned: UFCW Local 1500 Welfare Fund v. AbbVie Inc., et al. (March 18, 2019) (Local 1500); Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. AbbVie Inc., et al. (March 20, 2019); Mayor and City Council of Baltimore v. AbbVie Inc., et al. (March 22, 2019); Pipe Trades Services MN Welfare Fund v. AbbVie Inc., et al. (March 29, 2019); St. Paul Electrical Workers’ Health Plan v. AbbVie Inc., et al. (March 29, 2019); Welfare Plan of the International Union of Operating Engineers Locals 137, 137A, 137B, 137C, and 137R v. AbbVie Inc., et al. (April 1, 2019); Law Enforcement Health Benefits, Inc. v. AbbVie, Inc., et al. (April 9, 2019) (Law Enforcement); Kentucky Laborers District Council Health and Welfare Fund v. AbbVie, Inc., et al. (April 16, 2019); Sheet Metal Workers’ Local Union No. 28 Welfare Fund v. AbbVie, Inc., et al. (April 19, 2019) (Sheet Metal Workers’); and Locals 302 & 612 of The International Union of Operating Engineers-Employers Construction Industry Health And Security Trust Fund v. AbbVie Inc., et al. (April 25, 2019) (Construction Industry) (collectively, Humira® Antitrust Class Actions). In each of the Humira® Antitrust Class Actions, the plaintiffs bring federal antitrust claims along with various state law claims under state common law and state antitrust, consumer protection, and unfair competition statutes. In each case, the plaintiffs 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®. In the Local 1500, Sheet Metal Workers’ and Construction Industry cases, the plaintiffs further allege that AbbVie entered into allegedly unlawful market division agreements with Amgen and other companies that had developed Humira® biosimilars, including Samsung Bioepis Co., Ltd., Mylan Inc., Mylan Pharmaceuticals, Inc., Sandoz, Inc., Fresenius Kabi USA, LLC, Pfizer Inc. and Momenta Pharmaceuticals, Inc., in connection with the settlement of patent litigation relating to Humira®, whereby Amgen and the other defendants that have developed Humira® biosimilars were permitted to market those products in Europe as early as October 2018, while remaining off the market in the United States until 2023. In each of the Humira® Antitrust Class Actions other than the Local 1500 and Construction Industry cases, the plaintiffs 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 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. Defendants’ responses to the first six complaints were stayed by the court and a status hearing is set for May 2, 2019. U.S. Attorney’s Office for the District of Massachusetts-Patient Assistance Investigation On April 25, 2019, Amgen, the U.S. Department of Justice and the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services entered into a settlement agreement. Under that agreement, Amgen agreed to pay $24.75 million to resolve the government’s allegations relating to Amgen’s support of independent charitable organizations that provide patients with financial assistance to access their medicines. Additionally, Amgen and OIG entered into a Corporate Integrity Agreement that requires Amgen to maintain its corporate compliance program and to undertake a set of defined corporate integrity obligations for a period of five years.

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