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Contingencies and commitments | 12 Months Ended
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Dec. 31, 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 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-including but not limited to patent validity and infringement, regulatory standards, marketing, and other corporate and commercial matters-some of which present novel factual allegations and/or unique legal theories. In each of the matters described in this filing, 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 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 of our legal proceedings and other matters are discussed below: PCSK9 Antibody Patent Litigation U.S. Patent Litigation—Sanofi/Regeneron On October 17, 2014, Amgen initiated a series of lawsuits in the U.S. District Court for the District of Delaware (the Delaware District Court) against Sanofi, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc., and Regeneron Pharmaceuticals, Inc. (Regeneron) for patent infringement. On December 15, 2014, these lawsuits were consolidated by the Delaware District Court into a single case against Sanofi, Sanofi-Aventis U.S. LLC and Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc. (collectively, Sanofi) and Regeneron, addressing seven of our patents: U.S. Patent Nos. 8,563,698; 8,829,165 (the ’165 Patent); 8,859,741 (the ’741 Patent); 8,871,913; 8,871,914; 8,883,983; and 8,889,834. These patents describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). By its complaints, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron’s alirocumab, a monoclonal antibody targeting PCSK9. On January 29, 2016, the Delaware District Court granted Amgen’s motion to amend the complaint to add Amgen Manufacturing, Limited (AML) and Amgen USA Inc. as plaintiffs and to add the allegation that defendants’ infringement of Amgen’s patents is willful. On February 22, 2016, the Delaware District Court entered a stipulated order finding alirocumab and the drug product containing it, PRALUENT®, infringe certain of Amgen’s patents, including claims 2, 7, 9, 15, 19 and 29 of the ’165 Patent and claim 7 of the ’741 Patent. On March 18, 2016, the Delaware District Court entered judgment in favor of Amgen following a five-day jury trial and a unanimous jury verdict that these patent claims from the ’165 Patent and the ’741 Patent are all valid. On January 3, 2017, the Delaware District Court denied Sanofi and Regeneron’s post-trial motions seeking a new trial and for judgment as a matter of law, and on January 5, 2017, granted Amgen’s motion for a permanent injunction prohibiting the infringing manufacture, use, sale, offer for sale or import of alirocumab in the United States. On January 12, 2017, Sanofi and Regeneron filed an appeal of the judgment and the permanent injunction to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court). Following a motion by Sanofi and Regeneron, the Federal Circuit Court ordered an expedited briefing schedule for the appeal and, on February 8, 2017, entered a stay of the permanent injunction during the pendency of the appeal. On October 5, 2017, the Federal Circuit Court reversed-in-part the judgment of 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 the ’165 Patent and claim 7 of the ’741 Patent 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. On December 6, 2017, Amgen petitioned the Federal Circuit Court for rehearing en banc. Patent Disputes in the European Region On February 24, 2016, the European Patent Office (EPO) granted European Patent No. 2,215,124 (EP 2,215,124) to Amgen. This patent describes and claims monoclonal antibodies to PCSK9 and methods of treatment. On February 24, 2016, Sanofi filed an opposition to the patent in the EPO seeking to invalidate it. In November 2016, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A. and Sanofi Winthrop Industrie S.A. filed a joint opposition against Amgen’s patent, and each of Eli Lilly and Company, Regeneron, and Strawman Ltd. also filed oppositions to Amgen’s patent. Amgen filed its response on May 2, 2017. The EPO has scheduled oral proceedings to begin on November 28, 2018. We are also involved in and expect future involvement in additional disputes regarding our PCSK9 patents in other jurisdictions and regions, including matters filed against us and that we have filed in the United Kingdom, Germany and France. Sensipar® (cinacalcet) Litigation Sensipar® Abbreviated New Drug Application (ANDA) Patent Litigation Beginning in September 2016, Amgen filed 14 separate lawsuits in the Delaware District Court for infringement of our U.S. Patent No. 9,375,405 (the ’405 Patent) against: (1) Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc., (2) Micro Labs Ltd. and Micro Labs USA, Inc. (collectively, Micro Labs), (3) Watson Laboratories, Inc., Actavis, Inc. and Actavis Pharma, Inc., (4) Cipla Limited and Cipla USA, Inc. (collectively, Cipla), (5) Strides Pharma Global PTE Limited and Strides Pharma, Inc., (6) Sun Pharma Global FZE and Sun Pharmaceutical Industries, Inc. (collectively, Sun), (7) Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s), (8) Ajanta Pharma Limited and Ajanta Pharma USA, Inc. (collectively, Ajanta), (9) Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, and Amneal Pharmaceuticals Co. India Private Limited, (10) Apotex Inc. and Apotex Corp. (collectively, Apotex), (11) Hetero USA Inc., Hetero Labs Ltd. and Hetero Labs Ltd. Unit V (collectively, Hetero), (12) Breckenridge Pharmaceutical, Inc. (Breckenridge), (13) Mylan Pharmaceuticals Inc. and Mylan Inc., and (14) Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively, Zydus). In November 2016, Actavis, Inc. was dismissed from the applicable lawsuit by joint stipulation of the parties. The Delaware District Court consolidated these 14 lawsuits into a single case, Amgen Inc. v. Aurobindo Pharma Ltd. et al., which is scheduled for trial on March 5, 2018. The ’405 Patent is entitled “Rapid Dissolution Formulation of a Calcium Receptor-Active Compound” and expires in 2026. Amgen seeks an order of the Delaware District Court making any U.S. Food and Drug Administration (FDA) approval of the defendants’ generic versions of Sensipar® effective no earlier than the expiration of the ’405 Patent. All defendants have responded to the complaint denying infringement and seeking judgment that the ’405 Patent is invalid and/or not infringed. Amgen filed, and the Delaware District Court signed, stipulated dismissals of the lawsuit against defendants Apotex on September 11, 2017, and Micro Labs on September 20, 2017. The Delaware District Court signed consent judgments filed by Amgen and Breckenridge on September 21, 2017, by Amgen and Sun on November 2, 2017, by Amgen and Hetero on November 2, 2017, and by Amgen and Ajanta on November 9, 2017, each 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 respective defendant’s cinacalcet product during the term of the ’405 Patent unless specifically authorized pursuant to the confidential settlement agreement. In June 2017, Amgen filed four additional lawsuits in the Delaware District Court for infringement of the ’405 Patent against: (1) Piramal Healthcare UK Limited (Piramal), (2) Alkem Laboratories Ltd. (Alkem), (3) Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin), and (4) Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. (collectively, Macleods). In each lawsuit, all defendants have responded to the complaint denying infringement and seeking a declaration of non-infringement and invalidity of the ’405 Patent. Macleods’ response also included a counterclaim alleging sham litigation in violation of the Sherman Antitrust Act, which Amgen has denied. On August 15, 2017, the Delaware District Court consolidated the lawsuit filed against Piramal into the existing consolidated case. The Delaware District Court consolidated the lawsuits filed against Alkem, Lupin and Macleods into a separate single case, Amgen Inc. v. Alkem et al., on December 13, 2017, stayed Macleods’ Sherman Antitrust counterclaim pending resolution of the patent claims, and has scheduled trial on the patent claims for April 29, 2019. In December 2017, Amgen filed four additional lawsuits in the Delaware District Court for infringement of the ’405 Patent against (1) Watson Laboratories, Inc. and Actavis Pharma Inc., (2) Teva Pharmaceuticals, USA, Inc., (3) Barr Laboratories, Inc., and (4) Torrent Pharmaceuticals Ltd. Sensipar® Pediatric Exclusivity Litigation On May 25, 2017, Amgen filed a lawsuit in the U.S. District Court for the District of Columbia (the D.C. District Court) seeking effectively to reverse the FDA’s May 22, 2017 rejection of Amgen’s request for pediatric exclusivity for cinacalcet hydrochloride (Sensipar®/Mimpara®). Four companies seeking to market generic versions of Sensipar® were granted leave to intervene, but all but Amneal Pharmaceuticals LLC have subsequently withdrawn from the case. On January 26, 2018, the D.C. District Court granted in part and denied in part the summary judgment motions filed separately by each of the parties and remanded the case to the FDA for the limited purpose of the FDA addressing whether the FDA’s denial of pediatric exclusivity in the case is inconsistent with a prior FDA pediatric exclusivity decision on a different drug. The FDA has responded that its denial of pediatric exclusivity for cinacalcet hydrochloride was appropriate and not inconsistent with its prior decisions. The parties await the court’s ruling on the remaining portions of their summary judgment motions. KYPROLIS® (carfilzomib) ANDA Patent Litigation Beginning in October 2016, our subsidiary Onyx Therapeutics, Inc. (Onyx Therapeutics), filed four separate lawsuits in the Delaware District Court against: Cipla; Sagent Pharmaceuticals, Inc.; Breckenridge; and Fresenius Kabi, USA LLC, Fresenius Kabi USA, Inc., Fresenius Pharmaceuticals Holding, Inc., and Fresenius Kabi Oncology Limited; each for infringing U.S. Patent Nos. 7,232,818 (the ’818 Patent); 7,417,042 (the ’042 Patent); 7,491,704 (the ’704 Patent); 7,737,112 (the ’112 Patent); 8,129,346 (the ’346 Patent); 8,207,125 (the ’125 Patent); 8,207,126 (the ’126 Patent); 8,207,127 (the ’127 Patent); and 8,207,297 (the ’297 Patent). By joint stipulation of the parties, Fresenius Pharmaceuticals Holding, Inc. and Fresenius Kabi Oncology Limited were subsequently dismissed from that lawsuit. In October and November 2016, Onyx Therapeutics also filed four separate lawsuits in the Delaware District Court against: MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, MSN); Dr. Reddy’s; Qilu Pharma, Inc. and Qilu Pharmaceutical Co. Ltd. (collectively, Qilu); and Apotex; each for infringing the ’112 Patent; and a separate lawsuit against InnoPharma, Inc. for infringement of the ’042, ’112 and ’297 Patents. In April 2017, Onyx Therapeutics filed a separate lawsuit in the Delaware District Court against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. for infringement of the ’818, ’042, ’704, ’112, ’346, ’125, ’126, ’127 and ’297 Patents. The Delaware District Court has consolidated these ten lawsuits for purposes of discovery into a single case, Onyx Therapeutics, Inc. v. CIPLA Ltd., et al. These ten lawsuits are based on ANDAs that seek approval to market generic versions of KYPROLIS® before expiration of the asserted patent or patents. 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. Responses to the complaints have been filed by all defendants alleging invalidity and, in certain instances, non-infringement of the patents. Trial is scheduled to commence on March 11, 2019. In August 2017, Onyx Therapeutics filed additional lawsuits in the Delaware District Court against InnoPharma, Inc. for infringement of the ’818, ’704, ’346, ’125, ’126 and ’127 Patents; and against Apotex and Qilu for infringement of the ’818, ’042, ’704, ’346, ’125, ’126, ’127 and ’297 Patents. 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. In September 2017, by joint stipulation of the parties, Teva Pharmaceutical Industries Ltd. was dismissed from the patent infringement lawsuit that was filed in the Delaware District Court in April 2017, leaving Teva Pharmaceuticals USA, Inc. as the remaining defendant in that litigation. In November 2017, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Aurobindo Pharma USA, Inc. for infringement of the ’818, ’042, ’704, ’112, ’346, ’125, ’126, ’127 and ’297 Patents. In December 2017, Onyx Therapeutics filed additional lawsuits in the Delaware District Court against Dr. Reddy’s for infringement of the ’818, ’042, ’704, ’346, ’125, ’126, ’127 and ’297 Patents, and against MSN for infringement of the ’112 Patent. In January, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Apotex for infringement of the ’818, ’042, ’704, ’112, ’346, ’125, ’126, ’127 and ’297 Patents. 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. Responses to these complaints have been filed by Auobindo Pharma USA, Inc., Dr. Reddy’s, and MSN alleging invalidity and, in certain instances, non-infringement of the patents. In February 2018, Qilu was dismissed from the applicable lawsuit by joint stipulation of the parties. NEUPOGEN® (filgrastim)/ Neulasta® (pegfilgrastim) Litigation Sandoz NEUPOGEN® Patent Litigation On October 24, 2014, Amgen Inc. and AML (collectively, Amgen) filed a lawsuit in the U.S. District Court for the Northern District of California (the California Northern District Court) against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (collectively, Sandoz) for infringement of our U.S. Patent No. 6,162,427 (the ’427 Patent) and various state law claims. The lawsuit stems from Sandoz filing an application for FDA licensure of a filgrastim product as biosimilar to NEUPOGEN® under the Biologics Price Competition and Innovation Act (BPCIA), while having deliberately failed to comply with the BPCIA’s disclosure requirement to Amgen as the reference product sponsor. By its complaint, Amgen seeks, among other remedies, an injunction to cease Sandoz’s unauthorized reliance on Amgen’s Biologics License Application (BLA) for filgrastim and an injunction to prevent Sandoz from infringing, or inducing any infringing use of, filgrastim. On March 19, 2015, the California Northern District Court issued an order dismissing with prejudice Amgen’s state law claims, and entered judgment in favor of Sandoz Inc. on its cross-motion for partial judgment on the pleadings. The order also denied Amgen’s motion for a preliminary injunction, as well as Amgen’s motion for partial judgment on the pleadings. On a joint motion of the parties, on March 25, 2015, the California Northern District Court entered final judgment on the claims and counterclaims decided by the court’s March 19 order. The remaining patent infringement claim, counterclaim and defenses were stayed by the court pending appeal. On March 25, 2015, Amgen appealed both the judgment in favor of Sandoz Inc. and the denial of Amgen’s motion for preliminary injunction to the Federal Circuit Court. On May 5, 2015, the Federal Circuit Court entered an injunction prohibiting Sandoz Inc. from marketing, selling, offering for sale, or importing into the United States Sandoz’s FDA-approved Zarxio® biosimilar product until the Federal Circuit Court resolved the appeal. On July 21, 2015, the Federal Circuit Court affirmed the California Northern District Court’s dismissal of Amgen’s state law claims concluding that the only remedies available for a biosimilar applicant’s failure to provide its BLA by the statutory deadline is to bring a patent infringement claim and seek those patent remedies provided by the statute. The Federal Circuit Court also concluded that a biosimilar applicant must give 180-day advance notice of first commercial marketing after the FDA has licensed the biosimilar product. Accordingly, the Federal Circuit Court entered an order that its previously entered injunction be extended through September 2, 2015 (180 days from Sandoz Inc.’s notice given after FDA approval). On February 16, 2016, Sandoz filed a petition for certiorari with the U.S. Supreme Court seeking review of the Federal Circuit Court ruling concluding that a biosimilar applicant must give 180-day advance notice of first marketing and that notice can be given only after the FDA has licensed the biosimilar product. On March 21, 2016, Amgen filed a brief in opposition to Sandoz’s petition and a conditional cross-petition for certiorari requesting that the U.S. Supreme Court also review the Federal Circuit Court’s ruling that the only remedy available when a biosimilar applicant refuses to provide its BLA is to bring a patent infringement claim. On June 12, 2017, the U.S. Supreme Court reversed the Federal Circuit Court ruling that a biosimilar applicant must wait to give the 180-day advance notice of first commercial marketing until after the FDA has licensed the biosimilar product, holding that such notice can be given either before or after the FDA approval. On a second issue, the U.S. Supreme Court vacated the Federal Circuit Court’s decision that the only remedy available when a biosimilar applicant refuses to provide its BLA is to bring a patent infringement claim. The U.S. Supreme Court agreed with the Federal Circuit Court that there is no remedy under federal law for failing to make the disclosure but remanded the case to the Federal Circuit Court to determine whether California law would treat noncompliance with such requirement as unlawful and, if so, to determine whether the BPCIA pre-empts any additional remedy available under state law and whether Sandoz forfeited any pre-emption defense. On December 14, 2017, the Federal Circuit Court affirmed the California Northern District Court’s dismissal of Amgen’s state law claims, holding that the BPCIA pre-empts state law remedies for a biosimilar applicant’s failure to comply with the BPCIA’s disclosure requirement. Following the California Northern District Court’s September 8, 2015 lift of the stay of the case, the parties continued to litigate the remaining patent infringement claim, counterclaim and defenses. On October 15, 2015, Amgen filed a first supplemental and amended complaint adding to the lawsuit Sandoz’s infringement of U.S. Patent No. 8,940,878 (the ’878 Patent), which covers methods of purifying proteins. On September 13, 2017, by joint stipulation of the parties, the California Northern District Court dismissed from the case the parties’ respective claims and counterclaims related to the ’427 Patent. On October 25, 2017, Sandoz filed motions for summary judgment of noninfringement of the ’878 Patent and for summary judgment regarding damages. On December 19, 2017, the California Northern District Court granted Sandoz’s summary judgment of noninfringement. Sandoz’s motion for summary judgment regarding damages was denied as moot. On January 8, 2018, the California Northern District Court entered judgment of noninfringement of the ’878 and ’427 Patents and dismissed without prejudice Sandoz’s counterclaims of invalidity of the ’878 and ’427 Patents. Amgen filed an appeal of the judgment on February 5, 2018. Sandoz Neulasta® Patent Litigation On May 12, 2016, Amgen filed a lawsuit in the California Northern District Court against Sandoz and Lek Pharmaceuticals d.d. for infringement of the ’878 Patent and 5,824,784 (the ’784 Patent) in accordance with the patent provisions of the BPCIA. The lawsuit stems from Sandoz filing an application for FDA licensure of a pegfilgrastim product as biosimilar to Neulasta®. On June 23, 2016, Sandoz responded to the complaint, denying infringement and seeking judgment that the patents-in-suit are invalid and/or not infringed. On December 7, 2016, by joint stipulation of the parties, the California Northern District Court dismissed from the case all claims and counterclaims related to the ’784 Patent. On October 25, 2017, Sandoz filed motions for summary judgment of noninfringement of the ’878 Patent and for summary judgment regarding damages. On December 19, 2017, the California Northern District Court granted Sandoz’s summary judgment of noninfringement of the ’878 Patent. Sandoz’s motion for summary judgment regarding damages was denied as moot. On January 8, 2018, the California Northern District Court entered judgment of noninfringement of the ’878 Patent and dismissed without prejudice Sandoz’s counterclaims of invalidity of the ’878 Patent. Amgen filed an appeal of the judgment on February 5, 2018. Apotex NEUPOGEN®/Neulasta® Patent Litigation On August 6 and October 2, 2015, Amgen filed two separate lawsuits in the U.S. District Court for the Southern District of Florida (the Florida Southern District Court) against Apotex for infringement of our U.S. Patent Nos. 8,952,138 (the ’138 Patent), the ’784 Patent and the ’427 Patent, in accordance with the patent provisions of the BPCIA and for a declaration that Apotex’s pre-licensure notice of commercial marketing is legally ineffective. These lawsuits stem from Apotex’s submissions of applications for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta®, and a filgrastim product as biosimilar to Amgen’s NEUPOGEN®, respectively. By its complaints, Amgen seeks, among other remedies, an injunction prohibiting Apotex from infringing the ’138, ’784 and ’427 Patents and enjoining Apotex from commencing commercial marketing of any biosimilar pegfilgrastim product or biosimilar filgrastim product, respectively, until a date that is at least 180 days after Apotex provides legally effective notice to Amgen. Apotex answered the August 6 complaint on October 5, 2015, denying patent infringement, alleging that the patents are invalid, alleging sham litigation in violation of the Sherman Antitrust Act, seeking a declaration that the ’138 Patent is unenforceable for patent misuse and seeking a declaration on the interpretation of the BPCIA commercial notice provision. On November 3, 2015, the Florida Southern District Court consolidated the two lawsuits into a single case. On December 9, 2015, the Florida Southern District Court granted Amgen’s motion for preliminary injunction prohibiting Apotex from commercializing its biosimilar pegfilgrastim product until a date that is at least 180 days after Apotex provides legally effective commercial notice to Amgen. On July 5, 2016, the Federal Circuit Court affirmed the Florida Southern District Court injunction, holding that the 180-day notice of commercial marketing is mandatory under the BPCIA and can be given only post-FDA licensure of the biosimilar product. On September 9, 2016, Apotex petitioned the U.S. Supreme Court for certiorari, seeking review of the Federal Circuit Court holding. On December 12, 2016, the U.S. Supreme Court denied Apotex’s petition for certiorari. On June 15, 2016, the Florida Southern District Court dismissed without prejudice all claims and counterclaims related to the ’427 and ’784 Patents on the parties’ joint stipulation of dismissal. In a separate order that same day, the Florida Southern District Court also dismissed without prejudice all counterclaims related to unlawful monopolization in violation of the Sherman Antitrust Act on the parties’ joint stipulation of dismissal. On June 24, 2016, the Florida Southern District Court issued a further claim construction decision granting the motion for summary judgment of no literal infringement of the ’138 Patent filed by Apotex and denying the motion with respect to no infringement under the doctrine of equivalents. On July 11, 2016, trial began on infringement of the ’138 Patent and Apotex’s counterclaims and defenses. On September 16, 2016, the Florida Southern District Court entered final judgment that Apotex’s process of manufacturing its filgrastim and pegfilgrastim products do not infringe the ’138 Patent, dismissing without prejudice Apotex’s remaining invalidity counterclaim for patent invalidity, and making permanent the injunction compelling Apotex to provide 180-day advance notice of first commercial marketing of its filgrastim and pegfilgrastim products if and when the FDA approves these products. Amgen appealed and on November 13, 2017, the Federal Circuit Court affirmed the Florida Southern District Court’s judgment. 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 the ’138 Patent, challenging claims of the ’138 Patent as unpatentable. On May 22, 2017, Amgen filed its response and oral argument was held before the PTAB on December 13, 2017. Coherus Neulasta® Patent Litigation On May 10, 2017, 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). This lawsuit stems from Coherus’ submission of an application for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta® under the BPCIA. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Coherus from infringing the ’707 Patent. On June 1, 2017, Coherus filed a motion to dismiss the complaint as purportedly failing to state a claim of patent infringement. On December 7, 2018, a magistrate judge recommended that the motion be granted with prejudice. Amgen filed objections to the recommendation and awaits a ruling by the court on Coherus’ motion to dismiss. A claim construction hearing is scheduled for June 25, 2018, and trial is scheduled to commence on September 16, 2019. Mylan Neulasta® Patent Litigation On September 22, 2017, Amgen Inc. and AML (collectively, Amgen) 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® under the BPCIA. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Mylan from infringing the ’707 and ’997 Patents. On November 22, 2017, Mylan answered the complaint, denying patent infringement and alleging that the patents are invalid. ENBREL (etanercept) Litigation Sandoz ENBREL Patent Litigation On February 26, 2016, two affiliates of Amgen Inc. (Immunex Corporation and AML (collectively, Amgen)), along with Hoffmann-La Roche Inc. (Roche), filed a lawsuit in U.S. District Court for the District of New Jersey (the New Jersey District Court) against Sandoz. This lawsuit stems from Sandoz’s submission of an application for 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 ’552 Patent); 7,915,225; 8,119,605; and 8,722,631 (the ’631 Patent). By their complaint, Amgen and Roche seek an injunction to prohibit Sandoz from commercializing its biosimilar etanercept product in the United States prior to the expiry of such patents. Responses have been filed by all Sandoz defendants denying infringement and/or asserting that the patents at issue are invalid. On August 11, 2016, and subject to the terms of a confidential stipulation, the New Jersey District Court entered a preliminary injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz’s etanercept product. Trial is scheduled to start on April 17, 2018. On August 30, 2016, the FDA approved Sandoz’s Erelzi™, a biosimilar to ENBREL. On September 14, 2017, Amgen filed a motion for summary judgment that Sandoz infringed claim 1 of the ’631 Patent and, on October 23, 2017, Sandoz filed its brief in opposition to the motion. Coherus ENBREL Patent Challenge On August 4 and September 7, 2017, Coherus filed separate petitions seeking to institute IPR proceedings before the PTAB of the U.S. Patent and Trademark Office to challenge the patentability of each claim of the ’522 Patent and the ’182 Patent, respectively. Both the ’522 Patent and the ’182 Patent relate to ENBREL and are exclusively licensed to our subsidiary Immunex Corporation by Roche. Patent owner preliminary responses to the Coherus IPR petition were filed on December 13, 2017 regarding the ’522 Patent and on December 15, 2017 regarding the ’182 Patent, explaining that Coherus’ petitions are without merit and requesting that the PTAB not institute IPR proceedings. The deadlines by which the PTAB is expected to render a decision regarding whether to institute IPR trial proceedings on the ’522 Patent and the ’182 Patent are March 15 and March 26, 2018, respectively. Hospira EPOGEN® (epoetin alfa) Patent Litigation On September 18, 2015, Amgen filed a lawsuit in the Delaware District Court against Hospira, Inc. (Hospira), a subsidiary of Pfizer, for infringement of Amgen’s U.S. Patent Nos. 5,856,298 (the ’298 Patent) and 5,756,349 (the ’349 Patent) in accordance with the patent provisions of the BPCIA and for a declaration that Hospira has failed to comply with certain requirements of the BPCIA. This lawsuit stems from the submission by Hospira under the BPCIA of an application for FDA licensure of an epoetin product as biosimilar to Amgen’s EPOGEN®. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Hospira from using or selling infringing cells and/or product manufactured during the ’298 or the ’349 Patent terms and enjoining Hospira from commencing commercial marketing of any biosimilar epoetin product until a date that is at least 180 days after Hospira provides legally effective notice to Amgen. On August 19, 2016, Hospira responded to the complaint denying patent infringement and any violation of the BPCIA and seeking judgment that the patents-in-suit are invalid and not infringed by Hospira. On January 23, 2017, the Delaware District Court entered an order construing the claims of the ’349 and ’298 Patents and holding that two claims of the ’298 Patent are invalid for failure to properly narrow the claim on which they depend. On September 22, 2017, after a five-day trial, the jury returned a verdict finding the ’298 Patent valid and infringed by Hospira and the ’349 Patent not infringed. The jury awarded Amgen $70 million in damages for Hospira’s infringement. 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. 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 (the California Central District Court) against Genentech, Inc. (Genentech) and City of Hope seeking a declaratory judgment that 27 patents listed by Genentech in the BPCIA exchange are invalid, unenforceable and/or not infringed by MVASI™, Amgen’s biosimilar of Avastin® (bevacizumab). On February 2, 2018, the California Central District Court granted Genentech and City of Hope’s motion to dismiss for lack of subject matter jurisdiction. On October 6 and October 18, 2017, Genentech and City of Hope filed separate lawsuits in the Delaware District Court alleging Amgen’s infringement of (i) 24 of the 27 patents listed by Genentech in the BPCIA exchange and (ii) 25 of the same 27 patents and, in each case, for non-compliance with certain provisions of the BPCIA. On December 6, 2017, Genentech and City of Hope amended their complaints to allege that Amgen will also infringe newly issued U.S. Patent No. 9,795,672. On January 22, 2018, Amgen’s motions to transfer the two Delaware lawsuits to the California Central District Court were denied. State Derivative Litigation The three state stockholder derivative complaints filed against Amgen, Kevin W. Sharer, George J. Morrow, Dennis M. Fenton, Brian M. McNamee, Roger M. Perlmutter, David Baltimore, Gilbert S. Omenn, Judith C. Pelham, Frederick W. Gluck, Jerry D. Choate, J. Paul Reason, Frank J. Biondi, Jr., Leonard D. Schaeffer, Frank C. Herringer, Richard D. Nanula, Willard H. Dere, Edward V. Fritzky, Franklin P. Johnson, Jr. and Donald B. Rice as defendants (the State Defendants) on May 1, 2007 (Larson v. Sharer, et al., & Anderson v. Sharer, et al.), and August 13, 2007 (Weil v. Sharer, et al.) in the Superior Court of the State of California, Ventura County (the Ventura County Superior Court) were consolidated by the Ventura County Superior Court under one action captioned Larson v. Sharer, et al. The consolidated complaint was filed on July 5, 2007. The complaint alleges that the State Defendants breached their fiduciary duties, wasted corporate assets, were unjustly enriched and violated the California Corporations Code. Plaintiffs allege that the State Defendants failed to disclose and/or misrepresented results of Aranesp® clinical studies, marketed both Aranesp® and EPOGEN® for off-label uses and that these actions or inactions caused stockholders to suffer damages. The complaints also allege insider trading by the State Defendants. The plaintiffs seek treble damages based on various causes of action, reformed corporate governance, equitable and/or injunctive relief, restitution, disgorgement of profits, benefits and other compensation, and legal costs. An amended consolidated complaint was filed on March 13, 2008, adding Anthony Gringeri as a State Defendant and removing the causes of action for insider selling and misappropriation of information, violation of California Corporations Code Section 25402 and violation of California Corporations Code Section 25403. On July 14, 2008, the Ventura County Superior Court dismissed without prejudice the consolidated state derivative class action. On July 24, 2013, the plaintiffs filed an amended complaint asserting additional grounds for the defendants’ alleged breaches of fiduciary duty. By stipulation of the parties, the case was stayed pending resolution of the In re Amgen Inc. Securities Litigation action. Final settlement by the parties of the In re Amgen Inc. Securities Litigation action was approved by the court in October 2016, and on February 10, 2017, the Ventura County Superior Court lifted the stay in Larson v. Sharer, et al. On June 2, 2017, plaintiffs filed a third amended complaint with the Ventura County Superior Court in this case (now captioned Anderson v. Sharer, et. al), adding Robert A. Bradway, François de Carbonnel, Vance D. Coffman, Robert A. Eckert, Rebecca M. Henderson, Tyler Jacks, and Ronald D. Sugar as additional State Defendants and removing Chris Larson as a plaintiff. The third amended complaint adds additional allegations, including that Amgen engaged in improper marketing with respect to ENBREL, Vectibix®, Sensipar®, and XGEVA®. On July 3, 2017, the State Defendants filed demurrers seeking dismissal of all claims. On November 13, 2017, the Ventura County Superior Court granted the State Defendants’ demurrers without leave to amend. On December 20, 2017, the Ventura County Superior Court entered a judgment in favor of the State Defendants and dismissed the matter with prejudice. 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. Commitments Lease commitments We lease certain facilities and equipment related primarily to administrative, R&D, sales and marketing activities under noncancelable operating leases that expire through 2043. The following table summarizes the minimum future rental commitments under noncancelable operating leases as of December 31, 2017 (in millions):
| Amount
2018 | $ | 158 |
2019 | 126 |
2020 | 116 |
2021 | 100 |
2022 | 59 |
Thereafter | 91 |
Total minimum operating lease commitments | $ | 650 |
Included in the table above are future rental commitments for abandoned leases in the amount of $264 million. There were no material charges for lease abandonments related to the restructuring plan that commenced in 2014. See Note 2, Restructuring. We expect to receive total future rental income of $205 million relating to noncancelable subleases of abandoned facilities. Rental expense on operating leases for the years ended December 31, 2017, 2016 and 2015, was $159 million, $134 million and $133 million, respectively. U.S. repatriation tax commitments Under the 2017 Tax Act, we will elect to pay the repatriation tax primarily related to our prior indefinitely invested earnings of our foreign operations in eight annual installments beginning in April 2018. See Note 5, Income taxes. As of December 31, 2017, we expect to pay $7.3 billion in repatriation taxes during the following years (in millions):
| Amount
2018 | $ | 585 |
2019 | 585 |
2020 | 585 |
2021 | 585 |
2022 | 585 |
Thereafter | 4,391 |
Total U.S. repatriation tax commitments | $ | 7,316 |

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