Contingencies and commitments	6 Months Ended
Jun. 30, 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; 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; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2018. 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, 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, or in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ending March 31, 2018, 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, 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, or in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ending March 31, 2018, 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 As previously disclosed, the U.S. Court of Appeals for the Federal Circuit 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 Amgen’s patents (lack of written description and enablement of the claimed inventions) and for further consideration of a permanent injunction. On July 23, 2018, Amgen filed a petition for certiorari with the U.S. Supreme Court seeking review of the U.S. Court of Appeals for the Federal Circuit conclusion that the judgment affirming the validity of Amgen’s patents was based, in part, on an erroneous application of the law of written description. Sensipar^® (cinacalcet) Litigation Sensipar^®Abbreviated New Drug Application (ANDA) Patent Litigation As previously disclosed, the Delaware District Court held trial on the infringement claims and defenses in the Amgen Inc. v. Aurobindo Pharma Ltd. et al. consolidated lawsuit. Post-trial briefing on the infringement claims and defenses was completed on May 18, 2018. On June 12, 2018, the Delaware District Court entered an order dismissing the lawsuit filed in December 2017 against Torrent Pharmaceuticals Ltd. on stipulation between the parties and subject to the terms of a confidential settlement agreement. In June 2018, Amgen filed lawsuits in the Delaware District Court and the U.S. District Court for the Middle District of North Carolina, each against Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. (collectively, Accord) for infringement of our U.S. Patent No. 9,375,405 (the ’405 Patent). In each lawsuit, Amgen seeks an order making any U.S. Food and Drug Administration (FDA) approval of Accord’s generic version of Sensipar^® effective no earlier than the expiration of the ’405 Patent in 2026. Sensipar^®Pediatric Exclusivity Litigation As previously disclosed, on February 17, 2018, the U.S. District Court for the District of Columbia entered final judgment for the FDA in the lawsuit filed by Amgen seeking effectively to reverse the FDA’s May 22, 2017 rejection of Amgen’s request for pediatric exclusivity for cinacalcet hydrochloride (Sensipar^®/ Mimpara^®). A grant of pediatric exclusivity by the FDA would have provided Amgen with an additional six months of exclusivity (i.e., through September 8, 2018) following the March 8, 2018 expiration of Amgen’s U.S. composition of matter patent. Oral arguments in the U.S. Court of Appeals for the District of Columbia Circuit on Amgen’s appeal of the final judgment took place on May 17, 2018. KYPROLIS^® (carfilzomib) ANDA Patent Litigation During May, June and July of 2018, the Delaware District Court entered orders on stipulations between Onyx Therapeutics, Inc. (Onyx Therapeutics) and each of Fresenius Kabi, USA LLC and Fresenius Kabi USA, Inc.; Breckenridge Pharmaceutical, Inc.; Aurobindo Pharma USA, Inc.; Cipla Limited and Cipla USA, Inc. (collectively, Cipla); and Innopharma, Inc., respectively, that each defendant infringes U.S. Patent Nos. 7,417,042; 7,737,112 (the ’112 Patent); 8,207,125; 8,207,126; and 8,207,127. Onyx Therapeutics had previously provided those defendants a covenant that it would not assert patent infringement of U.S. Patent Nos. 7,232,818; 7,491,704; 8,129,346; and 8,207,297 against certain of the respective defendants’ ANDA applications and products. On June 4, 2018, the Delaware District Court also entered an order on a stipulation between Onyx Therapeutics and MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, MSN), that MSN infringes the ’112 Patent. In June and July 2018, the Delaware District Court consolidated for purposes of discovery into the existing consolidated case Onyx Therapeutics, Inc. v. Cipla Limited, et al., the lawsuits that were filed against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. in December 2017; against Apotex Corp. and Apotex Inc. in January 2018; against Breckenridge Pharmaceuticals, Inc. in February 2018; and against Cipla in April 2018, respectively. NEUPOGEN^® (filgrastim)/ Neulasta^®(pegfilgrastim) Litigation Adello NEUPOGEN^® Patent Litigation As previously disclosed, Amgen Inc. and Amgen Manufacturing Ltd. (collectively, Amgen) filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Adello Biologics, LLC (Adello). On May 17, 2018, Adello responded to the lawsuit, denying infringement and seeking judgment that the patents-in-suit are invalid and not infringed. Coherus Neulasta^® Patent Litigation As previously disclosed, the Delaware District Court entered final judgment dismissing Amgen’s complaint against Coherus BioSciences, Inc. (Coherus) for infringement of our U.S. Patent No. 8,273,707. On May 17, 2018, Amgen filed an appeal of the Delaware District Court’s judgment. Pfizer NEUPOGEN^® Patent Litigation On July 18, 2018, Amgen Inc. and Amgen Manufacturing Ltd. (collectively, Amgen) filed a lawsuit in the Delaware District Court against Pfizer Inc. and Hospira Inc. (collectively, Pfizer). This lawsuit stems from Pfizer’s submission of an application for FDA licensure of a filgrastim product as biosimilar to Amgen’s NEUPOGEN^®. Amgen has asserted infringement of U.S. Patent No. 9,643,997 and seeks, among other remedies, injunctive relief to prohibit Pfizer from practicing the patented invention prior to the expiry of this patent. ENBREL (etanercept) Litigation Coherus ENBREL Patent Challenge As previously disclosed, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office denied Coherus’ petitions to institute inter partes review trial proceedings on U.S. Patent Nos. 8,163,522 and 8,063,182 and Coherus filed requests for rehearing on these two denied petitions. On July 13, 2018 the PTAB denied both requests for rehearing. MVASI^™ (bevacizumab-awwb) Patent Litigation As previously disclosed, Genentech, Inc. (Genentech) and City of Hope filed lawsuits in the Delaware District Court alleging infringement of a number of patents listed by Genentech in the Biologics Price Competition and Innovation Act (BPCIA) exchange by MVASI^™, Amgen’s biosimilar version of Avastin^® (bevacizumab), and for non-compliance with certain provisions of the BPCIA. On June 5, 2018, Amgen responded to the complaint denying patent infringement and any violation of the BPCIA and seeking judgment that the patents-in-suit are invalid, unenforceable and/or not infringed by Amgen. On June 19, 2018, Genentech and City of Hope moved to dismiss all of Amgen’s counterclaims and certain of Amgen’s defenses. KANJINTI^™ (trastuzumab) Patent Litigation On June 21, 2018, Genentech and City of Hope filed a lawsuit in the Delaware District Court alleging Amgen’s infringement of 37 patents by Amgen’s submission of an application for FDA licensure of KANJINTI^™, Amgen’s biosimilar version of Genentech’s Herceptin^® (trastuzumab). On July 19, 2018, Genentech, City of Hope and Amgen filed a joint stipulation to dismiss certain of the patents from the lawsuit and Genentech and City of Hope filed an amended complaint narrowing its allegations of infringement to 18 of the 37 patents. Among other remedies, Genentech and City of Hope seek injunctive relief prohibiting patent infringement.

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; 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; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2018.

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, 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, or in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ending March 31, 2018, 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, 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, or in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ending March 31, 2018, 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

As previously disclosed, the U.S. Court of Appeals for the Federal Circuit 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 Amgen’s patents (lack of written description and enablement of the claimed inventions) and for further consideration of a permanent injunction. On July 23, 2018, Amgen filed a petition for certiorari with the U.S. Supreme Court seeking review of the U.S. Court of Appeals for the Federal Circuit conclusion that the judgment affirming the validity of Amgen’s patents was based, in part, on an erroneous application of the law of written description.

Sensipar^® (cinacalcet) Litigation

Sensipar^®Abbreviated New Drug Application (ANDA) Patent Litigation

As previously disclosed, the Delaware District Court held trial on the infringement claims and defenses in the Amgen Inc. v. Aurobindo Pharma Ltd. et al. consolidated lawsuit. Post-trial briefing on the infringement claims and defenses was completed on May 18, 2018.

On June 12, 2018, the Delaware District Court entered an order dismissing the lawsuit filed in December 2017 against Torrent Pharmaceuticals Ltd. on stipulation between the parties and subject to the terms of a confidential settlement agreement.

In June 2018, Amgen filed lawsuits in the Delaware District Court and the U.S. District Court for the Middle District of North Carolina, each against Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. (collectively, Accord) for infringement of our U.S. Patent No. 9,375,405 (the ’405 Patent). In each lawsuit, Amgen seeks an order making any U.S. Food and Drug Administration (FDA) approval of Accord’s generic version of Sensipar^® effective no earlier than the expiration of the ’405 Patent in 2026.

Sensipar^®Pediatric Exclusivity Litigation

As previously disclosed, on February 17, 2018, the U.S. District Court for the District of Columbia entered final judgment for the FDA in the lawsuit filed by Amgen seeking effectively to reverse the FDA’s May 22, 2017 rejection of Amgen’s request for pediatric exclusivity for cinacalcet hydrochloride (Sensipar^®/ Mimpara^®). A grant of pediatric exclusivity by the FDA would have provided Amgen with an additional six months of exclusivity (i.e., through September 8, 2018) following the March 8, 2018 expiration of Amgen’s U.S. composition of matter patent. Oral arguments in the U.S. Court of Appeals for the District of Columbia Circuit on Amgen’s appeal of the final judgment took place on May 17, 2018.

KYPROLIS^® (carfilzomib) ANDA Patent Litigation

During May, June and July of 2018, the Delaware District Court entered orders on stipulations between Onyx Therapeutics, Inc. (Onyx Therapeutics) and each of Fresenius Kabi, USA LLC and Fresenius Kabi USA, Inc.; Breckenridge Pharmaceutical, Inc.; Aurobindo Pharma USA, Inc.; Cipla Limited and Cipla USA, Inc. (collectively, Cipla); and Innopharma, Inc., respectively, that each defendant infringes U.S. Patent Nos. 7,417,042; 7,737,112 (the ’112 Patent); 8,207,125; 8,207,126; and 8,207,127. Onyx Therapeutics had previously provided those defendants a covenant that it would not assert patent infringement of U.S. Patent Nos. 7,232,818; 7,491,704; 8,129,346; and 8,207,297 against certain of the respective defendants’ ANDA applications and products. On June 4, 2018, the Delaware District Court also entered an order on a stipulation between Onyx Therapeutics and MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, MSN), that MSN infringes the ’112 Patent. In June and July 2018, the Delaware District Court consolidated for purposes of discovery into the existing consolidated case Onyx Therapeutics, Inc. v. Cipla Limited, et al., the lawsuits that were filed against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. in December 2017; against Apotex Corp. and Apotex Inc. in January 2018; against Breckenridge Pharmaceuticals, Inc. in February 2018; and against Cipla in April 2018, respectively.

NEUPOGEN^® (filgrastim)/ Neulasta^®(pegfilgrastim) Litigation

Adello NEUPOGEN^® Patent Litigation

As previously disclosed, Amgen Inc. and Amgen Manufacturing Ltd. (collectively, Amgen) filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Adello Biologics, LLC (Adello). On May 17, 2018, Adello responded to the lawsuit, denying infringement and seeking judgment that the patents-in-suit are invalid and not infringed.

Coherus Neulasta^® Patent Litigation

As previously disclosed, the Delaware District Court entered final judgment dismissing Amgen’s complaint against Coherus BioSciences, Inc. (Coherus) for infringement of our U.S. Patent No. 8,273,707. On May 17, 2018, Amgen filed an appeal of the Delaware District Court’s judgment.

Pfizer NEUPOGEN^® Patent Litigation

On July 18, 2018, Amgen Inc. and Amgen Manufacturing Ltd. (collectively, Amgen) filed a lawsuit in the Delaware District Court against Pfizer Inc. and Hospira Inc. (collectively, Pfizer). This lawsuit stems from Pfizer’s submission of an application for FDA licensure of a filgrastim product as biosimilar to Amgen’s NEUPOGEN^®. Amgen has asserted infringement of U.S. Patent No. 9,643,997 and seeks, among other remedies, injunctive relief to prohibit Pfizer from practicing the patented invention prior to the expiry of this patent.

ENBREL (etanercept) Litigation

Coherus ENBREL Patent Challenge

As previously disclosed, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office denied Coherus’ petitions to institute inter partes review trial proceedings on U.S. Patent Nos. 8,163,522 and 8,063,182 and Coherus filed requests for rehearing on these two denied petitions. On July 13, 2018 the PTAB denied both requests for rehearing.

MVASI^™ (bevacizumab-awwb) Patent Litigation

As previously disclosed, Genentech, Inc. (Genentech) and City of Hope filed lawsuits in the Delaware District Court alleging infringement of a number of patents listed by Genentech in the Biologics Price Competition and Innovation Act (BPCIA) exchange by MVASI^™, Amgen’s biosimilar version of Avastin^® (bevacizumab), and for non-compliance with certain provisions of the BPCIA. On June 5, 2018, Amgen responded to the complaint denying patent infringement and any violation of the BPCIA and seeking judgment that the patents-in-suit are invalid, unenforceable and/or not infringed by Amgen. On June 19, 2018, Genentech and City of Hope moved to dismiss all of Amgen’s counterclaims and certain of Amgen’s defenses.

KANJINTI^™ (trastuzumab) Patent Litigation

On June 21, 2018, Genentech and City of Hope filed a lawsuit in the Delaware District Court alleging Amgen’s infringement of 37 patents by Amgen’s submission of an application for FDA licensure of KANJINTI^™, Amgen’s biosimilar version of Genentech’s Herceptin^® (trastuzumab). On July 19, 2018, Genentech, City of Hope and Amgen filed a joint stipulation to dismiss certain of the patents from the lawsuit and Genentech and City of Hope filed an amended complaint narrowing its allegations of infringement to 18 of the 37 patents. Among other remedies, Genentech and City of Hope seek injunctive relief prohibiting patent infringement.