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Contingencies and commitments | 9 Months Ended
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Sep. 30, 2017
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, 2016, 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 Note; 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, 2016; and in Notes 12 and 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2017 and June 30, 2017, 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 range from cases brought by a single plaintiff to a class action with thousands of putative class members. These legal proceedings, as well as other matters, involve various aspects of our business and a variety of claims—including but not limited to patent infringement, marketing, pricing and trade practices and securities law—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 our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2016, or in Notes 12 or 13, Contingencies and commitments, to our condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2017 and June 30, 2017, 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 faced by us 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 our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2016, or in Notes 12 or 13, Contingencies and commitments, to our condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2017 and June 30, 2017, respectively, have progressed sufficiently through discovery and/or 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: PCSK9 Antibody Patent Litigation U.S. Patent Litigation—Sanofi/Regeneron On October 5, 2017, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) reversed-in-part the judgment of the U.S. District Court for Delaware (the Delaware District Court) and remanded for a new trial two of defendants’ patent validity defenses (failure to meet the law’s requirements for patentability of written description and enablement of the claimed inventions) and affirmed the Delaware District Court’s judgment of infringement of claims 2, 7, 9, 15, 19 and 29 of U.S. Patent No. 8,829,165 and claim 7 of U.S. Patent No. 8,859,741 and patent validity on the defendants’ third patent validity defense (finding that the claimed inventions were not obvious to a person of ordinary skill in the field of the patents). The Federal Circuit Court also vacated and remanded for further consideration by the Delaware District Court the permanent injunction granted by the Delaware District Court prohibiting the infringing manufacture, use, sale, offer for sale or import of alirocumab in the United States. Sensipar® (cinacalcet) Litigation Sensipar® Abbreviated New Drug Application (ANDA) Patent Litigation As previously disclosed, Amgen has filed 18 separate lawsuits against defendants for infringement of our U.S. Patent No. 9,375,405 (the ‘405 Patent), and 15 of these 18 lawsuits have been consolidated by the Delaware District Court. Amgen filed and the court signed stipulated dismissals of the lawsuits against defendants Apotex Inc. and Apotex Corp. (collectively, Apotex), on September 11, 2017, and against defendants Micro Labs Ltd. and Micro Labs USA, Inc., on September 20, 2017. On September 21, 2017, the Delaware District Court signed a consent judgment filed by Amgen and Breckenridge Pharmaceutical, Inc. (Breckenridge) stipulating to entry of judgment of infringement and validity of the ‘405 Patent and an injunction prohibiting the manufacture, use, sale, offer to sell, importation of, or distribution into the United States of the Breckenridge cinacalcet product during the term of the ‘405 Patent unless specifically authorized pursuant to the confidential settlement agreement. In addition, during September 2017, defendants Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. filed motions for judgment on the pleadings and to dismiss the complaint pending against them and Amgen filed oppositions to such motions. Sensipar® Pediatric Exclusivity Litigation As previously disclosed, Amgen filed a lawsuit in the U.S. District Court for the District of Columbia seeking effectively to reverse the U.S. Food and Drug Administration’s (FDA’s) May 22, 2017 rejection of Amgen’s request for pediatric exclusivity for cinacalcet hydrochloride (Sensipar®/ Mimpara®). On August 10, 2017, the court entered an expedited scheduling order for Amgen and the FDA to file cross-motions for summary judgment and a hearing on such motions is set for December 15, 2017. Amgen filed its motion for summary judgment on October 18, 2017. KYPROLIS® (carfilzomib) ANDA Patent Litigation As previously disclosed, the Delaware District Court consolidated ten separate lawsuits filed by our subsidiary Onyx Therapeutics, Inc. (Onyx Therapeutics) against defendants for infringement of certain of our patents. On August 17, 2017, Onyx Therapeutics filed an additional lawsuit in the Delaware District Court against InnoPharma, Inc. for infringement of U.S. Patent Nos. 7,232,818 (the ‘818 Patent); 7,491,704 (the ‘704 Patent); 8,129,346 (the ‘346 Patent); 8,207,125 (the ‘125 Patent); 8,207,126 (the ‘126 Patent); and 8,207,127 (the ‘127 Patent). Onyx Therapeutics filed two additional lawsuits in the Delaware District Court against Apotex, on August 24, 2017, and Qilu Pharma, Inc. and Qilu Pharmaceutical Co. Ltd. (collectively Qilu), on August 30, 2017, for infringement of the ‘818, ‘704, ‘346, ‘125, ‘126, ‘127 Patents and U.S. Patent Nos. 7,417,042 and 8,207,297. In each lawsuit, Onyx Therapeutics seeks an order of the Delaware District Court making any FDA approval of the defendant’s ANDA effective no earlier than the expiration of the applicable patents. On September 14, 2017, the Delaware District Court consolidated these three additional lawsuits for purposes of discovery into the existing consolidated case. Responses to these new complaints have been filed by InnoPharma, Inc., Apotex and Qilu alleging invalidity and, in certain instances, non-infringement of the patents. On September 20, 2017, by joint stipulation of the parties, Teva Pharmaceutical Industries Ltd. was dismissed from one of the previously-filed lawsuits, leaving Teva Pharmaceuticals USA, Inc. as the remaining defendant in that litigation. Amgen Biosimilars Litigation AMJEVITA™ (adalimumab-atto) Patent Litigation On September 27, 2017, Amgen and AbbVie Inc. and AbbVie Biotechnology Ltd. (collectively, AbbVie), entered into a global settlement and license agreement. Under the terms of the agreement, AbbVie will grant patent licenses for the use and sale of Amgen’s AMJEVITA™/AMGEVITA™ (a biosimilar to AbbVie’s HUMIRA® (adalimumab)) worldwide, on a country-by-country basis, and the companies have agreed to dismiss pending patent litigation. The agreement allows Amgen to begin marketing AMJEVITA™/AMGEVITA™ in the various countries at specified dates. On September 28, 2017, the Delaware District Court entered a stipulation to dismiss all claims and counterclaims of this litigation. MVASI™ (bevacizumab-awwb) Patent Litigation On October 6, 2017, Amgen filed a lawsuit in the U.S. District Court for the Central District of California against Genentech, Inc. (Genentech) and the City of Hope seeking a declaratory judgment that 27 patents listed by Genentech in the Biologics Price Competition and Innovation Act (BPCIA) exchange are invalid, unenforceable and not infringed by MVASI™, formerly ABP 215, Amgen’s biosimilar of Avastin® (bevacizumab). On October 7, 2017, Genentech and City of Hope filed a separate lawsuit in the Delaware District Court alleging Amgen’s infringement of 24 of the 27 patents which are the subject of the lawsuit in California. On October 10, 2017, Amgen filed a motion to transfer Genentech’s first Delaware lawsuit to California. On October 18, 2017, Genentech and City of Hope filed a second lawsuit in the Delaware District Court alleging Amgen’s infringement of 25 of the same 27 patents, and on October 23, 2017, Amgen filed a motion to transfer Genentech’s second Delaware lawsuit to California. Other Biosimilars Patent Litigation We have filed a number of lawsuits against manufacturers of products that purport to be biosimilars of certain of our products. In each case, our complaint alleges that the manufacturer’s actions infringe certain patents we hold and may also allege that the manufacturer has failed to comply with certain provisions of the BPCIA. Additionally, a number of manufacturers have challenged the validity of our applicable patents and/or contended that such patents are not infringed by such manufacturers’ biosimilar products. Filgrastim/Pegfilgrastim Litigation Sandoz (pegfilgrastim). Trial for this patent infringement case is scheduled for March 26, 2018. Sandoz (filgrastim). On September 13, 2017, by joint stipulation of the parties, the U.S. District Court for the Northern District of California (the California Northern District Court) dismissed from the case the parties’ respective claims and counterclaims related to U.S. Patent No. 6,162,427. Trial for the remaining patent infringement claim is scheduled for March 26, 2018. As previously disclosed, Sandoz filed a request of the Federal Circuit Court to remand the BPCIA litigation to the California Northern District Court to allow that court to address the questions of California law. On August 28, 2017, at the request of the Federal Circuit Court, the parties filed supplemental briefs stating their respective positions on the appropriate action to be taken by the California Northern District Court on remand. Apotex (pegfilgrastim/filgrastim). On October 3, 2017, the Federal Circuit Court heard argument on Amgen’s appeal of the judgment of the U.S. District Court for the Southern District of Florida finding that Apotex’s process of manufacturing its filgrastim and pegfilgrastim products do not infringe our U.S. Patent No. 8,952,138. Coherus (pegfilgrastim). As previously disclosed, Amgen filed a lawsuit in the Delaware District Court against Coherus BioSciences, Inc. (Coherus) for infringement of our U.S. Patent No. 8,273,707 (the ‘707 Patent). A claim construction hearing is scheduled for June 25, 2018, and trial is scheduled to commence on September 16, 2019. Mylan (pegfilgrastim). On September 22, 2017, Amgen and Amgen Manufacturing, Limited (AML) filed a lawsuit in the District Court for the Western District of Pennsylvania against Mylan Inc., Mylan Pharmaceuticals Inc., Mylan GmbH, and Mylan N.V. (collectively, Mylan) for infringement of our ‘707 Patent and U.S. Patent No. 9,643,997 (the ‘997 Patent). This lawsuit stems from Mylan’s submission of an application for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta® (pegfilgrastim) under the BPCIA. By their complaint, Amgen and AML seek, among other remedies, an injunction prohibiting Mylan from infringing the ‘707 and ‘997 Patents. Etanercept Litigation Sandoz (etanercept). On September 14, 2017, Amgen filed a motion for summary judgment that Sandoz infringed claim 1 of U.S. Patent No. 8,722,631 and, on October 23, 2017, Sandoz filed its brief in opposition to the motion. Coherus (etanercept). On August 4, 2017, Coherus filed a petition seeking to institute inter partes review (IPR) proceedings before the United States Patent and Trademark Office’s Patent Trial Appeal Board (PTAB) to challenge the patentability of each claim of U.S. Patent No. 8,163,522 (the ‘522 Patent). On September 7, 2017, Coherus filed a second IPR petition, seeking to institute PTAB proceedings to challenge the patentability of each claim of U.S. Patent No. 8,063,182 (the ‘182 Patent). Both the ‘522 Patent and the ‘182 Patent relate to Enbrel® (etanercept) and are exclusively licensed to our subsidiary Immunex Corporation by Hoffmann-La Roche Inc. The deadlines to file a patent owner preliminary response to the Coherus IPR petition regarding the ‘522 Patent and the ‘182 Patent are December 13, 2017 and December 26, 2017, respectively, and the deadlines expected for the PTAB to render a decision regarding whether to institute PTAB trial proceedings on the ‘522 Patent and the ‘182 Patent are March 13, 2018 and March 26, 2018, respectively. Epoetin Alfa Litigation Hospira (epoetin alfa). On September 7, 2017, the Delaware District Court denied a motion for summary judgment of non-infringement of the patents-in-suit by Hospira, Inc. (Hospira), a subsidiary of Pfizer. On September 22, 2017, after a five day jury trial, the jury returned a verdict finding U.S. Patent No. 5,856,298 (the ‘298 Patent) valid and infringed by Hospira and U.S. Patent No. 5,756,349 (the ‘349 Patent) not infringed. The jury awarded Amgen $70 million in damages for Hospira’s infringement. On October 23, 2017, Amgen moved for judgment as a matter of law that Hospira infringed the ‘349 Patent or, in the alternative, for a new trial on infringement of the ‘349 Patent. In addition, on October 23, 2017, Hospira moved for judgment as a matter of law of non-infringement and invalidity of the ‘298 Patent or, in the alternative, for reduction of the damage award or a new trial on the ‘298 Patent. State Derivative Litigation On July 3, 2017, defendants in this state stockholder derivative lawsuit filed demurrers seeking dismissal of all claims. A hearing on the demurrers was held on October 6, 2017. ERISA Litigation On August 10, 2017, the remaining plaintiff voluntarily dismissed his appeal of the settlement reached in this case. U.S. Attorney’s Office for the District of Massachusetts - Patient Assistance Investigation Amgen, together with other companies in our industry, has received inquiries from the U.S. Attorney’s Office for the District of Massachusetts relating to support of charitable 501(c)(3) organizations that provide financial assistance to Medicare patients. Amgen is cooperating with this ongoing inquiry.

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