XML 68 R22.htm IDEA: XBRL DOCUMENT
v3.19.3

Contingencies and commitments | 9 Months Ended
--- | ---
Sep. 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; or in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2019 and June 30, 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 Reports on Form 10-Q for the periods ended March 31, 2019 and June 30, 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 Reports on Form 10-Q for the periods ended March 31, 2019 and June 30, 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 September 17, 2019 and October 8, 2019, Novartis Pharma AG and Amgen, respectively, each filed its motion for judgment on the pleadings. Sensipar® (cinacalcet) Litigation Cipla Ltd. v. Amgen Inc. On October 15, 2019, Amgen moved to dismiss Cipla Limited and Cipla USA, Inc.’s (collectively, Cipla) antitrust and fraud claims brought in the U.S. District Court for the District of Delaware (the Delaware District Court) for lack of standing and failure to state a claim. Abbreviated New Drug Application (ANDA) Patent Litigation Amgen Inc. v. Amneal Pharmaceuticals LLC, et al. Consolidated Case As previously disclosed, (i) Amgen appealed the Delaware District Court’s judgment of noninfringement of Amgen’s U.S. Patent No. 9,375,405 (the ’405 Patent) in favor of Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (collectively, Amneal), and Piramal Healthcare UK Limited (Piramal), and (ii) Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively, Zydus) appealed the Delaware District Court’s judgment of infringement by Zydus of Amgen’s ’405 Patent. On October 1, 2019, oral arguments for these appeals were held before the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court). - v. Cipla, et al. As previously disclosed, Amgen filed a motion requesting the Federal Circuit Court to vacate the Delaware District Court’s judgment of noninfringement of Amgen’s ’405 Patent with respect to Watson Laboratories, Inc. and Actavis Pharma, Inc. Cipla filed an opposition to this motion and moved to participate in the appeal as either an intervenor or as amicus curiae. On September 13, 2019, the Federal Circuit Court denied Amgen’s motion, lifted the stay of the briefing schedule which had been stayed pending disposition of Amgen’s motion to vacate, and granted Cipla permission to file a brief as amicus curiae. - v. Sun Pharmaceutical Industries Ltd., et al. On September 18, 2019, the Delaware District Court denied the motion filed by Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun), rejecting Sun’s contention that its settlement agreement with Amgen permitted Sun’s generic cinacalcet to enter the market without liability. Amgen Inc. v. The ACME Laboratories Ltd. On September 11, 2019, Amgen filed a lawsuit in the Delaware District Court against The ACME Laboratories Ltd. for infringement of Amgen’s ’405 Patent. Amgen Inc. v. Accord Healthcare, Inc. On October 21, 2019, based on a joint request of the parties, the Delaware District Court entered judgment of infringement and validity of Amgen’s ’405 Patent and an injunction prohibiting the manufacture, use, sale, offer to sell, or importation into the United States of Accord Healthcare, Inc.’s cinacalcet product during the term of the ’405 Patent unless specifically authorized pursuant to the confidential settlement agreement. Sensipar® Antitrust Class Actions On July 31, 2019, the multidistrict litigation panel entered an order consolidating in the Delaware District Court the four class action lawsuits brought by plaintiffs on behalf of a putative class of direct or indirect purchasers of Sensipar® against Amgen and various entities affiliated with Teva Pharmaceutical Industries Ltd. On September 13, 2019, the plaintiffs filed amended complaints, and on October 15, 2019, Amgen filed its motion to dismiss both the direct purchaser plaintiffs’ consolidated class action complaint and the indirect purchaser end payor plaintiffs’ complaint. Repatha® (evolocumab) Patent Litigation Amgen Inc., et al. v. Sanofi, et al. On August 28, 2019, the Delaware District Court ruled on the post-trial motions by Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC (formerly doing business as Aventis Pharmaceuticals Inc.) and Regeneron Pharmaceuticals, Inc., denying their request for a new trial and their request to reverse the jury verdict that U.S. Patent Nos. 8,829,165 (the ’165 Patent) and 8,859,741 (the ’741 Patent) provide written description support for the claimed inventions. The Delaware District Court also ruled as a matter of law that claims 19 and 29 of the ’165 Patent and claim 7 of the ’741 Patent are invalid for failing to meet the enablement requirement, overturning the jury verdict. On October 23, 2019, Amgen filed a notice of appeal to the Federal Circuit Court. Patent Disputes in the International Region The European Patent Office’s decision on November 30, 2018 confirming the validity of Amgen’s European Patent No. 2,215,124 has been appealed to the Technical Board of Appeal and a two-day hearing is scheduled to begin on March 24, 2020. We are also involved in and expect future involvement in additional disputes regarding our proprotein convertase subtilisin/kexin type 9 (PCSK9) patents in other jurisdictions and regions, including matters filed against us and that we have filed in the United Kingdom, Germany, France and Japan. ENBREL (etanercept) Patent Litigation Immunex Corporation, et al. v. Samsung Bioepis Co., Ltd. On August 5, 2019, defendant Samsung Bioepis Co., Ltd. responded to the complaint by Immunex Corporation (Immunex, a wholly-owned subsidiary of Amgen Inc.), Amgen Manufacturing, Limited (AML) and Hoffmann-La Roche Inc., denying infringement and seeking judgment that the patents-in-suit are invalid, unenforceable, and/or not infringed. Immunex Corporation, et al. v. Sandoz Inc., et al. On August 9, 2019, the U.S. District Court for the District of New Jersey (the New Jersey District Court) issued its decision upholding the validity of U.S. Patent Nos. 8,063,182 and 8,163,522. On October 8, 2019, by stipulation of Immunex and AML, and Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (collectively, Sandoz), the New Jersey District Court entered final judgment and a permanent injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz’s etanercept product, and, on the same day, Sandoz appealed the final judgment to the Federal Circuit Court. NEUPOGEN® (filgrastim) / Neulasta® (pegfilgrastim) Patent Litigation Amgen Inc., et al. v. Apotex Inc., et al. On August 27, 2019, the U.S. District Court for the Southern District of Florida granted an unopposed motion to substitute Accord BioPharma in place of defendants Apotex Inc. and Apotex Corp. In a separate challenge at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB), on October 4, 2019, the PTAB granted judgment adverse to Apotex Biologics, LLC, Apotex Inc., and Apotex Corp. in post-grant review proceeding on Amgen’s U.S. Patent No. 9,856,287 (the ’287 Patent). The review proceedings continue with Kashiv Biosciences, LLC (Kashiv) as the sole petitioner. Amgen Inc., et al. v. Kashiv Biosciences, LLC, et al. On September 16, 2019, the New Jersey District Court entered Amgen and Kashiv’s stipulation to dismiss without prejudice the causes of action directed solely to U.S. Patent No. 8,952,138 (the ’138 Patent), in light of the PTAB’s May 20, 2019 amended final written decision finding that claim 18 of the ’138 Patent was obvious. In a separate challenge by Kashiv at the PTAB, on September 11, 2019, the PTAB instituted the inter partes review (IPR) of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997 (the ‘997 Patent). Amgen Inc., et al. v. Mylan Inc., et al. The District Court for the Western District of Pennsylvania entered judgment of noninfringement of Amgen’s U.S. Patent No. 8,273,707 and the ’997 Patent on August 21, 2019, and September 17, 2019, respectively, based on a joint request of Amgen and Mylan Inc., Mylan Pharmaceuticals Inc., Mylan GmbH, and Mylan N.V., resolving the patent disputes that had been the subject of the lawsuit. Amgen Inc., et al. v. Sandoz Inc., et al. On September 3, 2019, the Federal Circuit Court denied Amgen’s petition for rehearing en banc in the consolidated appeal and reissued its opinion with amendment, but without disturbing its affirmance of grant of summary judgment of noninfringement in favor of Sandoz by the U.S. District Court for the Northern District of California. Amgen Inc., et al. v. Tanvex BioPharma USA, Inc., et al. On September 23, 2019, defendants Tanvex BioPharma USA, Inc., Tanvex BioPharma, Inc., and Tanvex Biologics Corporation responded to Amgen’s complaint, denying infringement and seeking judgment of noninfringement and invalidity of Amgen’s ’287 Patent. Fresenius PTAB Challenge On October 16, 2019, the PTAB denied the petition by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBiosim GmbH to institute the IPR with respect to the patentability of Amgen’s ’287 Patent. Hospira EPOGEN® (epoetin alfa) Patent Litigation Amgen Inc., et al. v. Hospira, Inc. On September 30, 2019, the Federal Circuit Court heard argument on the appeal by Hospira, Inc. (Hospira), a subsidiary of Pfizer, and the cross-appeal by Amgen and AML, of the Delaware District Court’s final judgment that Amgen’s U.S. Patent No. 5,856,298 is valid and infringed by Hospira, that Amgen’s U.S. Patent No. 5,756,349 is not infringed by Hospira, and awarding Amgen $70 million in damages for Hospira’s infringement. Litigation relating to our Biosimilar Products KANJINTI TM* (trastuzumab-anns) Patent Litigation Genentech, Inc. v. Amgen Inc. As previously disclosed, Genentech, Inc. (Genentech) appealed the Delaware District Court’s denial of Genentech’s motion for a preliminary injunction and requested the Federal Circuit Court to enter an injunction prohibiting Amgen from continuing with its launch of KANJINTI TM until final resolution of the appeal. On August 7, 2019, the Federal Circuit Court denied Genentech’s motion for an injunction pending appeal. On September 4, 2019, Genentech filed its third amended complaint adding a demand for a jury trial and an award of damages for infringement. On September 23, 2019, the Delaware District Court ordered a stipulated dismissal with prejudice of all claims for infringement of certain asserted patents, leaving four patents asserted by Genentech in the litigation. On September 24, 2019, Amgen filed its answer to Genentech’s third amended complaint denying infringement of any valid patent claim. On September 26, 2019, the Delaware District Court ordered that a 5-day jury trial on the patent issues commence on December 9, 2019, and the trial on damages (and therefore willfulness) be tried separately at a later date, if necessary. MVASI TM (bevacizumab-awwb) Patent Litigation Genentech, Inc. and City of Hope v. Immunex Rhode Island Corp. and Amgen Inc. On August 16, 2019, the Federal Circuit Court denied Genentech’s motion requesting the Federal Circuit Court enter an injunction prohibiting Amgen from marketing MVASI TM until final resolution of Genentech’s appeal. Genentech, Inc. and City of Hope v. Amgen Inc. On August 22, 2019 and October 29, 2019, by stipulation of the parties, the Delaware District Court entered judgment of noninfringement, in each instance, with respect to one of the patents asserted in the consolidated lawsuit, leaving a total of six remaining patents asserted by Genentech in the litigation. Humira® Biosimilar Antitrust Class Actions As previously disclosed, twelve purported class actions against Amgen, along with AbbVie Inc. and AbbVie Biotechnology Ltd. were filed in the U.S. District Court for the Northern District of Illinois (the Illinois Northern District Court). On August 9, 2019, the plaintiffs filed their consolidated complaint in the Illinois Northern District Court. On October 11, 2019, the defendants filed a joint motion to dismiss the consolidated complaint (as well as brief individual motions), challenging the legal sufficiency of the plaintiffs’ allegations to state any claim for relief under the law. No argument date has been set and plaintiffs’ response to the motions is due on November 19, 2019. * Registered in the U.S.

X
- References No definition available. + Details
Name: | us-gaap_CommitmentsAndContingenciesDisclosureAbstract
Namespace Prefix: | us-gaap_
Data Type: | xbrli:stringItemType
Balance Type: | na
Period Type: | duration

X
- Definition The entire disclosure for commitments and contingencies. + References Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef -Publisher FASB -Name Accounting Standards Codification -Topic 450 -URI http://asc.fasb.org/topic&trid=2127136 Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef -Publisher FASB -Name Accounting Standards Codification -Topic 440 -URI http://asc.fasb.org/topic&trid=2144648 + Details
Name: | us-gaap_CommitmentsAndContingenciesDisclosureTextBlock
Namespace Prefix: | us-gaap_
Data Type: | nonnum:textBlockItemType
Balance Type: | na
Period Type: | duration