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Contingencies and commitments
6 Months Ended
Jun. 30, 2016
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 and other matters that are complex in nature and have outcomes that are difficult to predict. We describe our legal proceedings and other matters that are significant or that we believe could be significant in this Note, in Note 18, Contingencies and commitments to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2015, and in Note 13, Contingencies and commitments to our condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2016.
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 class actions 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 and securities law—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 our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2015, or in Note 13, Contingencies and commitments to our condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2016, 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 our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2015, or in Note 13, Contingencies and commitments to our condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2016, 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 Litigations
Patent Disputes in the European Region
As previously disclosed, Amgen was served with a patent revocation action in the Patent Court of the Chancery Division of the High Court of Justice of England and Wales (the UK Patent Court) by Pfizer Inc. seeking to revoke European Patent (UK) No. 2,215,124. Trial is scheduled for October 2017.
We are also involved in and expect future involvement in additional disputes regarding our proprotein convertase subtilisin/kexin type 9 (PCSK9) patents in other jurisdictions and regions, including matters we have filed in the United Kingdom (U.K.) and Germany.
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/or that the manufacturer has failed to comply with certain provisions of the Biologics Price Competition and Innovation Act (BPCIA).
Sandoz Pegfilgrastim Litigation
On May 3, 2016, Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (collectively Sandoz) filed a motion to dismiss this lawsuit pending in the U.S. District Court for the District of New Jersey, which stems from Sandoz’s abbreviated Biologics License Application (BLA) seeking U.S. Food and Drug Administration (FDA) authorization to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product. On July 22, 2016, the court dismissed the case for lack of subject matter jurisdiction.
On May 12, 2016, Amgen filed a separate lawsuit in the U.S. District Court for the Northern District of California (the California Northern District Court) against Sandoz and Lek Pharmaceuticals d.d. for infringement of U.S. Patent Nos. 8,940,878 and 5,824,784 in accordance with the patent provisions of the BPCIA.
Sandoz Filgrastim Litigation
On July 1, 2016, the California Northern District Court held a claim construction hearing with respect to the patent infringement claim and counterclaims.
As previously disclosed, Sandoz filed a petition for certiorari seeking review of the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) ruling concluding that a biosimilar applicant must give 180-day advance notice of first marketing and that notice may only be given after the FDA has licensed the biosimilar product and Amgen filed a conditional cross-petition for certiorari seeking review of 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 20, 2016, the U.S. Supreme Court invited the Solicitor General to file briefs expressing the views of the United States on both Sandoz’s petition and Amgen’s conditional cross-petition.
Apotex Pegfilgrastim/Filgrastim Litigation
On July 5, 2016, the Federal Circuit Court affirmed the U.S. District Court for the Southern District of Florida (the Florida Southern District Court) injunction, holding that the 180-day notice of commercial marketing is mandatory under the BPCIA and can only be given post-FDA licensure of the biosimilar product.
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 U.S. Patent No. 8,952,138 (the ’138 Patent) filed by Apotex, Inc. and Apotex Corp. (collectively Apotex) and denying the motion with respect to no infringement under the doctrine of equivalents. On June 15, 2016, the Florida Southern District Court dismissed without prejudice all claims and counterclaims related to U.S. Patent Nos. 6,162,427 and 5,824,784 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 July 11, 2016, trial began on infringement of the ’138 Patent and Apotex’s counterclaims and defenses. At the conclusion of trial on July 18, 2016, the Florida Southern District Court entered partial judgment in Amgen’s favor that the asserted claims of the ’138 patent are not invalid for anticipation, obviousness, indefiniteness or lack of written description and deferred decision on Apotex’s motion for judgment of no infringement under the doctrine of equivalents. The case was taken under submission and the parties were directed to file proposed findings of fact and conclusions of law on or before August 18, 2016.
Hospira Epoetin Alfa Litigation
On June 3, 2016, Amgen filed a notice of appeal seeking review of the U.S. District Court of Delaware’s order that Hospira, Inc. (Hospira), a subsidiary of Pfizer Inc., need not provide Amgen discovery of certain of its manufacturing processes that Hospira withheld during the BPCIA dispute resolution process. On July 8, 2016, Hospira filed a motion to dismiss the appeal and Amgen filed an opposition brief on July 18, 2016.
Onyx Litigation
As previously disclosed, the plaintiffs and the Onyx director defendants in this class action lawsuit filed a notice of settlement with the Superior Court of the State of California for the County of San Mateo for an immaterial amount. On July 26, 2016, the court preliminarily approved the settlement.
Federal Securities LitigationIn re Amgen Inc. Securities Litigation
On July 20, 2016, the parties agreed to settle this securities class action case for an immaterial amount. The settlement remains subject to court approval.
ERISA Litigation
On June 27, 2016, the parties reached an agreement in principle to settle this case for an immaterial amount. The settlement remains subject to court approval.