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AMGEN INC. v. APOTEX INC.

2016-1308.

827 F.3d 1052 (2016)

AMGEN INC., Amgen Manufacturing Limited, Plaintiffs-Appellees v. APOTEX INC., Apotex Corp., Defendants-Appellants.

United States Court of Appeals, Federal Circuit.

Decided: July 5, 2016.

Attorney(s) appearing for the Case

NICHOLAS P. GROOMBRIDGE , Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, argued for plaintiffs-appellees. Also represented by ERIC ALAN STONE , CATHERINE NYARADY , JENNIFER GORDON , PETER SANDEL , JENNIFER H. WU , STEPHEN ACCURSIO MANISCALCO ; WENDY A. WHITEFORD , LOIS M. KWASIGROCH , KIMBERLIN L. MORLEY , Amgen Inc., Thousand Oaks, CA; JOHN F. O'SULLIVAN , ALLEN P. PEGG , JASON STERNBERG , Hogan Lovells US LLP, Miami, FL.

KERRY BRENDAN McTIGUE , Cozen O'Connor, Washington, DC, argued for defendants-appellants. Also represented by AARON S. LUKAS , WILLIAM BLAKE COBLENTZ , BARRY P. GOLOB , DONALD R. McPHAIL ; JOHN CHRISTOPHER ROZENDAAL , DAVID CHARLES FREDERICK, MILES SWEET , Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC, Washington, DC.

CARLOS T. ANGULO , Zuckerman Spaeder LLP, Washington, DC, for amicus curiae Biosimilars Council.

WILLIAM A. RAKOCZY , Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for amicus curiae Mylan Inc. Also represented by LARA E. FITZSIMMONS .

CHARLES B. KLEIN , Winston & Strawn LLP, Washington, DC, for amici curiae Hospira, Inc., Celltrion Healthcare Co., Ltd., Celltrion, Inc. Also represented by STEFFEN NATHANAEL JOHNSON , ANDREW CURTIS NICHOLS ; SAMUEL S. PARK , DAN HOANG, Chicago, IL.

GREGORY DISKANT , Patterson Belknap Webb & Tyler LLP, New York, NY, for amicus curiae Janssen Biotech, Inc. Also represented by IRENA ROYZMAN , ARON RUSSELL FISCHER .

LISA BARONS PENSABENE , O'Melveny & Myers LLP, New York, NY, for amicus curiae Biotechnology Innovation Organization. Also represented by FILKO PRUGO , DANIEL BENJAMIN O'BOYLE ; DEANNA MARIE RICE , Washington, DC.

Before WALLACH, BRYSON, and TARANTO, Circuit Judges.

This appeal involves an action brought by Amgen Inc. and Amgen Manufacturing Limited (collectively Amgen) against Apotex Inc. and Apotex Corp. (collectively Apotex) under the Biologics Price Competition and Innovation Act of 2009 (Biologics Act or BPCIA). Apotex has an application pending with the Food and Drug Administration...

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