Contingencies and commitments	6 Months Ended
Jun. 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 Note 12, Contingencies and commitments to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 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—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, 2016, or in Note 12, Contingencies and commitments to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 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 the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2016, or in Note 12, Contingencies and commitments to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2017, 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 June 6, 2017, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) heard argument on the appeal by defendants Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc., and Regeneron Pharmaceuticals, Inc. (Regeneron) of the judgment of the U.S. District Court for Delaware (the Delaware District Court), which had found that the patents in suit are valid and infringed by the defendants and 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. Patent Disputes in the European Region On May 2, 2017, Amgen filed its response to five oppositions seeking to invalidate European Patent No. 2,215,124 granted to Amgen by the European Patent Office and filed by each of Sanofi, Eli Lilly and Company, Regeneron, and Strawman Ltd., and a joint opposition filed by Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A. and Sanofi Winthrop Industrie S.A. Sensipar^® (cinacalcet) Patent Litigation On April 6, 2017, the Delaware District Court consolidated Amgen’s lawsuit against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. with 13 lawsuits previously consolidated that were filed by Amgen against defendants for infringement of our U.S. Patent No. 9,375,405 (the ‘405 Patent). These lawsuits are based on defendants’ separate Abbreviated New Drug Applications (ANDAs) that seek approval to market generic versions of Sensipar^® before expiration of the asserted patent. The Delaware District Court issued a claim construction ruling on July 19, 2017. Amgen filed an additional four lawsuits that have not been consolidated in the Delaware District Court for infringement of the ‘405 Patent against: (1) Piramal Healthcare UK Limited (Piramal) on June 9, 2017; (2) Alkem Laboratories Ltd. on June 23, 2017; (3) Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) on June 23, 2017; and (4) Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. (MacLeods) on June 23, 2017. Responses seeking a declaration of non-infringement and invalidity of the ‘405 Patent were filed by Piramal on June 30, 2017, MacLeods on July 17, 2017, and Lupin on July 19, 2017. MacLeod’s response included a counterclaim alleging sham litigation in violation of the Sherman Antitrust Act. KYPROLIS^® (carfilzomib) Patent Litigation On April 18 and July 3, 2017, the Delaware District Court consolidated for purposes of discovery ten previously-disclosed lawsuits filed by Amgen against defendants for infringement of certain of our patents into a single case. These lawsuits are based on defendants’ separate ANDAs that seek approval to market generic versions of KYPROLIS^® before expiration of the asserted patent or patents. Responses to Amgen’s complaints have been filed by defendants in all lawsuits alleging invalidity and, in certain instances, non-infringement of our patents. A claim construction hearing has been scheduled for March 26, 2018 and trial is scheduled to commence on March 11, 2019. Other Biosimilars Patent Litigations 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 Biologics Price Competition and Innovation Act (BPCIA). Sandoz Filgrastim Litigation 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 U.S. Food and Drug Administration (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 Biologics License Application 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 Inc. (Sandoz) forfeited any pre-emption defense. On June 29, 2017, Sandoz filed a request of the Federal Circuit Court to remand the case to the U.S. District Court for the Northern District of California to allow that court to address the questions of California law. Apotex Pegfilgrastim/Filgrastim Litigation On May 22, 2017, Amgen filed its response to the previously-disclosed inter partes review of our U.S. Patent Nos. 8,952,138 instituted by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office in response to Apotex’s petition. Oral argument on the inter partes review, if requested, is scheduled for December 13, 2017. Hospira Epoetin Alfa Litigation On May 12, 2017, Hospira, Inc. (Hospira) filed a motion for summary judgment of non-infringement of the patents-in-suit and, on June 28, 2017, the Delaware District Court heard arguments on this motion. 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^®(epoetin alfa). Trial is scheduled to commence on September 18, 2017. Coherus Pegfilgrastim Litigation On May 10, 2017, Amgen filed a lawsuit in the District Court of Delaware 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^® (pegfilgrastim) 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. State Derivative Litigation On June 2, 2017, plaintiffs in the consolidated state stockholder derivative cases (now captioned Andersen v. Sharer, et. al) filed a third amended complaint with the Ventura County Superior Court, adding Robert A. Bradway, François de Carbonnel, Vance D. Coffman, Robert A. Eckert, Rebecca M. Henderson, Tyler Jacks, and Ronald D. Sugar as defendants (together with the previously-disclosed defendants, the State Defendants) and removing Chris Larson as a plaintiff. The third amended 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^® (darbepoetin alfa) clinical studies, marketed both Aranesp^® and EPOGEN^® for off-label uses and that these actions or inactions caused stockholders to suffer damages. The complaint also alleges insider trading by the State Defendants and that Amgen engaged in improper marketing with respect to Enbrel^®(eternacept), Vectibix^®(panitumumab), Sensipar^®, and XGEVA^®(denosumab). 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. ERISA Litigation As previously disclosed, the U.S. District Court for the Central District of California entered a final order approving the settlement of this class action lawsuit on April 5, 2017. On May 4, 2017, plaintiff Don Hanks filed an appeal of the settlement with the U.S. Court of Appeals for the Ninth Circuit. Pediatric Exclusivity Litigation On May 25, 2017, Amgen filed a lawsuit in the U.S. District Court for the District of Columbia seeking effectively to reverse the FDA’s May 22, 2017 rejection of Amgen’s request for pediatric exclusivity for cinacalcet hydrochloride (Sensipar^®/Mimpara^®). On June 5, 2017, this litigation was stayed through early August 2017 pending additional review by the FDA of Amgen’s request for pediatric exclusivity.

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 Note 12, Contingencies and commitments to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 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—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, 2016, or in Note 12, Contingencies and commitments to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 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 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 the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2016, or in Note 12, Contingencies and commitments to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2017, 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 June 6, 2017, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) heard argument on the appeal by defendants Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc., and Regeneron Pharmaceuticals, Inc. (Regeneron) of the judgment of the U.S. District Court for Delaware (the Delaware District Court), which had found that the patents in suit are valid and infringed by the defendants and 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.

Patent Disputes in the European Region

On May 2, 2017, Amgen filed its response to five oppositions seeking to invalidate European Patent No. 2,215,124 granted to Amgen by the European Patent Office and filed by each of Sanofi, Eli Lilly and Company, Regeneron, and Strawman Ltd., and a joint opposition filed by Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A. and Sanofi Winthrop Industrie S.A.

Sensipar^® (cinacalcet) Patent Litigation

On April 6, 2017, the Delaware District Court consolidated Amgen’s lawsuit against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. with 13 lawsuits previously consolidated that were filed by Amgen against defendants for infringement of our U.S. Patent No. 9,375,405 (the ‘405 Patent). These lawsuits are based on defendants’ separate Abbreviated New Drug Applications (ANDAs) that seek approval to market generic versions of Sensipar^® before expiration of the asserted patent. The Delaware District Court issued a claim construction ruling on July 19, 2017.

Amgen filed an additional four lawsuits that have not been consolidated in the Delaware District Court for infringement of the ‘405 Patent against: (1) Piramal Healthcare UK Limited (Piramal) on June 9, 2017; (2) Alkem Laboratories Ltd. on June 23, 2017; (3) Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) on June 23, 2017; and (4) Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. (MacLeods) on June 23, 2017. Responses seeking a declaration of non-infringement and invalidity of the ‘405 Patent were filed by Piramal on June 30, 2017, MacLeods on July 17, 2017, and Lupin on July 19, 2017. MacLeod’s response included a counterclaim alleging sham litigation in violation of the Sherman Antitrust Act.

KYPROLIS^® (carfilzomib) Patent Litigation

On April 18 and July 3, 2017, the Delaware District Court consolidated for purposes of discovery ten previously-disclosed lawsuits filed by Amgen against defendants for infringement of certain of our patents into a single case. These lawsuits are based on defendants’ separate ANDAs that seek approval to market generic versions of KYPROLIS^® before expiration of the asserted patent or patents. Responses to Amgen’s complaints have been filed by defendants in all lawsuits alleging invalidity and, in certain instances, non-infringement of our patents. A claim construction hearing has been scheduled for March 26, 2018 and trial is scheduled to commence on March 11, 2019.

Other Biosimilars Patent Litigations

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 Biologics Price Competition and Innovation Act (BPCIA).

Sandoz Filgrastim Litigation

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 U.S. Food and Drug Administration (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 Biologics License Application 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 Inc. (Sandoz) forfeited any pre-emption defense. On June 29, 2017, Sandoz filed a request of the Federal Circuit Court to remand the case to the U.S. District Court for the Northern District of California to allow that court to address the questions of California law.

Apotex Pegfilgrastim/Filgrastim Litigation

On May 22, 2017, Amgen filed its response to the previously-disclosed inter partes review of our U.S. Patent Nos. 8,952,138 instituted by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office in response to Apotex’s petition. Oral argument on the inter partes review, if requested, is scheduled for December 13, 2017.

Hospira Epoetin Alfa Litigation

On May 12, 2017, Hospira, Inc. (Hospira) filed a motion for summary judgment of non-infringement of the patents-in-suit and, on June 28, 2017, the Delaware District Court heard arguments on this motion. 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^®(epoetin alfa). Trial is scheduled to commence on September 18, 2017.

Coherus Pegfilgrastim Litigation

On May 10, 2017, Amgen filed a lawsuit in the District Court of Delaware 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^® (pegfilgrastim) 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.

State Derivative Litigation

On June 2, 2017, plaintiffs in the consolidated state stockholder derivative cases (now captioned Andersen v. Sharer, et. al) filed a third amended complaint with the Ventura County Superior Court, adding Robert A. Bradway, François de Carbonnel, Vance D. Coffman, Robert A. Eckert, Rebecca M. Henderson, Tyler Jacks, and Ronald D. Sugar as defendants (together with the previously-disclosed defendants, the State Defendants) and removing Chris Larson as a plaintiff. The third amended 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^® (darbepoetin alfa) clinical studies, marketed both Aranesp^® and EPOGEN^® for off-label uses and that these actions or inactions caused stockholders to suffer damages. The complaint also alleges insider trading by the State Defendants and that Amgen engaged in improper marketing with respect to Enbrel^®(eternacept), Vectibix^®(panitumumab), Sensipar^®, and XGEVA^®(denosumab). 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.

ERISA Litigation

As previously disclosed, the U.S. District Court for the Central District of California entered a final order approving the settlement of this class action lawsuit on April 5, 2017. On May 4, 2017, plaintiff Don Hanks filed an appeal of the settlement with the U.S. Court of Appeals for the Ninth Circuit.

Pediatric Exclusivity Litigation

On May 25, 2017, Amgen filed a lawsuit in the U.S. District Court for the District of Columbia seeking effectively to reverse the FDA’s May 22, 2017 rejection of Amgen’s request for pediatric exclusivity for cinacalcet hydrochloride (Sensipar^®/Mimpara^®). On June 5, 2017, this litigation was stayed through early August 2017 pending additional review by the FDA of Amgen’s request for pediatric exclusivity.