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Contingencies and commitments | 3 Months Ended
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Mar. 31, 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; and 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. 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—including but not limited to patent validity and infringement, regulatory standards, and other matters—some of which present novel factual allegations and/or unique legal theories. In each of the matters described in this filing or 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, 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 or 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, 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: PCSK9 Antibody Patent Litigation U.S. Patent Litigation—Sanofi/Regeneron The U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) denied Amgen’s petition for rehearing en banc and issued a March 2, 2018 mandate, returning the case to the U.S. District Court for the District of Delaware (the Delaware District Court) for a new trial on two of the defendants’ challenges to the validity of our patents (lack of written description and enablement of the claimed inventions) and for further consideration of a permanent injunction. Trial has been set to begin on February 19, 2019. Sensipar® (cinacalcet) Litigation Sensipar® Abbreviated New Drug Application (ANDA) Patent Litigation During February 2018, the separate lawsuits filed by Amgen in December 2017 for infringement of our U.S. Patent No. 9,375,405 (the ’405 Patent) against (1) Watson Laboratories, Inc. and Actavis Pharma, Inc., (2) Teva Pharmaceuticals, USA, Inc., and (3) Barr Laboratories, Inc. were each dismissed by agreement between Amgen and the respective defendants. On March 5, 2018, the Delaware District Court commenced trial on the infringement claims and defenses in the Amgen Inc. v. Aurobindo Pharma Ltd. et al. consolidated lawsuit. The Delaware District Court has scheduled post-trial briefing on this portion of the trial for May 2018, but has not yet scheduled trial on defendants’ challenges to the validity of the ’405 Patent. During March and April 2018, the Delaware District Court signed consent judgments filed by Amgen and each of (1) Cipla Limited and Cipla USA, Inc., (2) Strides Pharma Global Pte. Limited and Strides Pharma, Inc., (3) Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc., and (4) Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. (defendants in the second consolidated lawsuit, Amgen Inc. v. Alkem at al.). In each of these four consent judgments, the parties stipulated to an 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 applicable defendants’ cinacalcet product during the term of the ’405 Patent unless specifically authorized pursuant to the confidential settlement agreement. In March and April 2018, the Delaware District Court also entered orders dismissing the following defendants on stipulations between Amgen and each of (1) Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc., (2) Mylan Pharmaceuticals Inc. and Mylan Inc., and (3) Lupin Ltd. and Lupin Pharmaceuticals, Inc. (also defendants in the second consolidated lawsuit) subject to terms of confidential settlement agreements. Sensipar® Pediatric Exclusivity Litigation On February 17, 2018, the U.S. District Court for the District of Columbia (the D.C. District Court) entered a final judgment for the U.S. Food and Drug Administration (FDA). On February 19, 2018, Amgen filed its notice of appeal of the final judgment. Amgen also filed with the D.C. District Court an emergency motion for injunctive relief pending appeal, which was denied on February 22. On February 23, 2018, Amgen filed an emergency motion for injunction pending appeal in the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit Court). On March 2, 2018, the D.C. Circuit Court denied the motion for an injunction pending appeal. Briefing on Amgen’s appeal has been completed and oral arguments are scheduled for May 17, 2018. KYPROLIS® (carfilzomib) ANDA Patent Litigation As previously disclosed, the Delaware District Court consolidated for purposes of discovery a number of patent infringement lawsuits filed by our subsidiary Onyx Therapeutics, Inc. (Onyx Therapeutics) into Onyx Therapeutics, Inc. v. Cipla Limited, et al. On February 7, 2018, the Delaware District Court also consolidated for purposes of discovery the lawsuit against Aurobindo Pharma USA, Inc. into Onyx Therapeutics, Inc. v. Cipla Limited, et al. On February 14, 2018, by joint stipulation of the parties, Teva Pharmaceuticals USA Inc. was dismissed from the applicable lawsuit filed in the Delaware District Court in April 2017. On March 20, 2018, the Delaware District Court entered a stipulation between the parties providing Aurobindo a covenant not to sue on our U.S. Patent Nos. 7,232,818 (the ’818 Patent); 7,491,704 (the ’704 Patent); 8,129,346 (the ’346 Patent); and 8,207,297 (the ’297 Patent). On February 15, 2018, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Breckenridge Pharmaceutical, Inc. (Breckenridge) for patent infringement, and subsequently amended the complaint on March 9, 2018 to assert infringement of U.S. Patent Nos. 7,417,042 (the ’042 Patent); 7,737,112 (the ’112 Patent); 8,207,125 (the ’125 Patent); 8,207,126 (the ’126 Patent); and 8,207,127 (the ’127 Patent). On April 11, 2018, Breckenridge filed a response to the complaint alleging invalidity and, in certain instances, non-infringement of the patents. On April 20, 2018, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Cipla Limited and Cipla USA, Inc. for patent infringement of the ’042, ’112, ’125, ’126 and ’127 Patents. In each new lawsuit, Onyx Therapeutics seeks an order of the Delaware District Court making any FDA approval of the respective defendant’s Abbreviated New Drug Application (ANDA) effective no earlier than the expiration of the applicable patents. As previously disclosed, Onyx Therapeutics filed lawsuits in the Delaware District Court against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s), against Apotex Inc. and Apotex Corp. (collectively, Apotex), and against Sagent Pharmaceuticals, Inc. (Sagent) for infringement of a number of our patents. Each of these defendants responded by filing defenses of invalidity and, in certain instances, non-infringement of the patents. During April 2018, the Delaware District Court entered orders on stipulations between Onyx Therapeutics and each of Apotex, Dr. Reddy’s and Sagent, respectively, that each defendant infringes the ’042, ’112, ’125, ’126, and ’127 Patents, and that Onyx Therapeutics will not assert patent infringement of the ’818, ’704, ’346, and ’297 Patents against certain of the respective defendants’ ANDA applications and products. NEUPOGEN® (filgrastim)/ Neulasta® (pegfilgrastim) Litigation Adello NEUPOGEN® Patent Litigation On March 8, 2018, Amgen Inc. and Amgen Manufacturing Ltd., (collectively, Amgen), filed a lawsuit in the U.S. District Court for the District of New Jersey (the New Jersey District Court) against Adello Biologics, LLC (Adello). This lawsuit stems from Adello’s submission of an application for FDA licensure of a filgrastim product as biosimilar to Amgen’s NEUPOGEN®. Amgen has asserted infringement of 17 our patents. Amgen seeks an injunction to prohibit Adello from commercializing its biosimilar filgrastim product in the United States prior to the expiry of these patents. Apotex NEUPOGEN®/Neulasta® Patent Litigation As previously disclosed, on February 17, 2017, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office granted Apotex’s petition to institute an inter partes review (IPR) of our U.S. Patent No. 8,952,138 (the ’138 Patent), challenging claims of the ’138 Patent as unpatentable. On February 15, 2018, the PTAB issued a final decision on the IPR of the ’138 Patent holding all but one claim of the ’138 Patent as unpatentable. On March 16, 2018, Apotex filed a request for rehearing on the PTAB’s finding that this one claim is patentable. Coherus Neulasta® Patent Litigation On April 18, 2018, the Delaware District Court entered final judgment dismissing Amgen’s complaint for infringement of our patent, having previously granted Coherus BioSciences, Inc.’s (Coherus) motion to dismiss. Mylan Neulasta® Patent Litigation On April 6, 2018, Mylan Inc., Mylan Pharmaceuticals Inc., Mylan GmbH and Mylan N.V. filed a motion for judgment on the pleadings of non-infringement of U.S. Patent No. 8,273,707. ENBREL (etanercept) Litigation Sandoz ENBREL Patent Litigation The New Jersey District Court has rescheduled trial to start on September 11, 2018. Coherus ENBREL Patent Challenge On March 9, 2018, the PTAB denied Coherus’ petitions to institute IPR trial proceedings on U.S. Patent No. 8,063,182 and U.S. Patent No. 8,163,522, which relate to ENBREL and are exclusively licensed to our subsidiary Immunex Corporation by F. Hoffmann-La Roche Ltd. On April 9, 2018, Coherus filed requests for rehearing on these two denied petitions. MVASI™ (bevacizumab-awwb) Patent Litigation On April 17, 2018, the Delaware District Court granted Amgen’s motion to dismiss certain claims by Genentech Inc. and City of Hope that Amgen had not complied with the Biologics Price Competition and Innovation Act. Trial is scheduled to start June 1, 2020.

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