Case: 20-1074 Document: 55 Page: 1 Filed: 02/21/2020 No. 20-1074 IN THE United States Court of Appeals FOR THE FEDERAL CIRCUIT AMGEN INC., AMGEN MANUFACTURING, LIMITED, AND AMGEN USA, INC., Plaintiffs-Appellants, V. SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., AND SANOFI-AVENTIS U.S. LLC, Defendants-Appellees. On Appeal from the United States District Court for the District of Delaware, in No. 1:14-cv-01317-RGA BRIEF FOR PLAINTIFFS-APPELLANTS AMGEN INC., AMGEN MANUFACTURING, LIMITED, AND AMGEN USA, INC. Stuart L. Watt Jeffrey A. Lamken Wendy A. Whiteford Counsel of Record Erica S. Olson Michael G. Pattillo, Jr. Steven D. Tang Sarah J. Newman Emily C. Johnson MOLOLAMKEN LLP AMGEN, INC. The Watergate, Suite 500 One Amgen Center Drive 600 New Hampshire Avenue, N.W. Thousand Oaks, CA 91320 Washington, D.C. 20037 (805) 447-1000 (telephone) (202) 556-2000 (telephone) (805) 447-1090 (facsimile) (202) 556-2001 (facsimile) [email protected] [email protected] Counsel for Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Additional Counsel Listed on Inside Cover) Case: 20-1074 Document: 55 Page: 2 Filed: 02/21/2020 Keith R. Hummel Sara E. Margolis CRAVATH, SWAINE & MOORE MOLOLAMKEN LLP LLP 430 Park Avenue, Floor 6 Worldwide Plaza New York, NY 10022 825 Eighth Avenue (212) 607-8160 (telephone) New York, NY 10019-7475 (212) 607-8161 (facsimile) (212) 474-1000 (telephone) [email protected] (212) 474-3700 (facsimile) [email protected] Lauren Martin QUINN EMANUEL URQUHART & William G. Gaede, III SULLIVAN, LLP MCDERMOTT WILL & EMERY LLP 111 Huntington Ave., Suite 520 275 Middlefield Road, Suite 100 Boston, MA 02199 Menlo Park, CA 94025 (617) 712-7100 (telephone) (650) 815-7400 (telephone) (617) 712-7200 (facsimile) (650) 815-7401 (facsimile) [email protected] [email protected] Christopher B. Mead Sarah C. Columbia SCHERTLER ONORATO MEAD & K. Nicole Clouse SEARS LLP MCDERMOTT WILL & EMERY LLP 901 New York Avenue, NW 28 State Street Suite 500 West Boston, MA 02109-1775 Washington, DC 20001 (617) 535-4074 (telephone) (202) 628-4199 (telephone) (617) 535-3800 (facsimile) (202) 628-4177 (facsimile) [email protected] [email protected] Melanie K. Sharp James L. Higgins YOUNG CONAWAY STARGATT & TAYLOR, LLP 1000 North King Street Wilmington, DE 19801 (302) 571-6600 (telephone) (302) 576-3333 (facsimile) [email protected] Counsel for Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. Case: 20-1074 Document: 55 Page: 3 Filed: 02/21/2020 FORM 9. Certificate of Interest Form 9 Rev. 10/17 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT Amgen Inc., et al. v. Sanofi, et al. Case No. 20-1074 CERTIFICATE OF INTEREST Counsel for the: (petitioner) (appellant) (respondent) (appellee) (amicus) (name of party) certifies the following (use “None” if applicable; use extra sheets if necessary): 2. Name of Real Party in interest 3. Parent corporations and 1. Full Name of Party (Please only include any real party publicly held companies Represented by me in interest NOT identified in that own 10% or more of Question 3) represented by me is: stock in the party Amgen Inc. None None Amgen Manufacturing, Limited None Amgen Inc. Amgen USA, Inc. None Amgen Inc. 4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court (and who have not or will not enter an appearance in this case) are: Please see attached. Case: 20-1074 Document: 55 Page: 4 Filed: 02/21/2020 FORM 9. Certificate of Interest Form 9 Rev. 10/17 5. The title and number of any case known to counsel to be pending in this or any other court or agency that will directly affect or be directly affected by this court’s decision in the pending appeal. See Fed. Cir. R. 47. 4(a)(5) and 47.5(b). (The parties should attach continuation pages as necessary). None. 2/21/2020 /s/ Jeffrey A. Lamken Date Signature of counsel Please Note: All questions must be answered Jeffrey A. Lamken Printed name of counsel cc: All counsel by ECF Reset Fields Case: 20-1074 Document: 55 Page: 5 Filed: 02/21/2020 CERTIFICATE OF INTEREST Appellants Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (collectively “Amgen”) state that the following partners or associates have appeared on their behalf before the district court or are expected to appear in this Court: From Young Conaway Stargatt & Taylor LLP: Melanie K. Sharp, James L. Higgins, and Michelle M. Ovanesian.1 From McDermott Will & Emery LLP: William G. Gaede, III, Sarah C. Columbia, K. Nicole Clouse, Mandy H. Kim, Bhanu K. Sadasivan, David L. Larson, Rebecca Harker Duttry, Eric W. Hagen, Terry W. Ahearn, Shane G. Smith, Michael V. O’Shaughnessy, Esther E. Lin, and Evan Boetticher.2 From Schertler & Onorato, LLP: Christopher B. Mead. From Cravath, Swaine & Moore LLP: Keith R. Hummel, David N. Greenwald, Lauren A. Moskowitz, Andrei Harasymiak, Geoffrey G. Hu, Sharonmoyee Goswami, and Amal El bakhar. 1 Michelle M. Ovanesian no longer practices with Young Conaway Stargatt & Taylor LLP and is not expected to enter an appearance on behalf of Amgen in this appeal. 2 Eric W. Hagen, Terry W. Ahearn, Shane G. Smith, Michael V. O’Shaughnessy, Esther E. Lin, and Evan Boetticher no longer practice with McDermott Will & Emery LLP and are not expected to enter appearances on behalf of Amgen in this appeal. Case: 20-1074 Document: 55 Page: 6 Filed: 02/21/2020 From Quinn Emanuel Urquhart & Sullivan, LLP: Lauren N. Martin and Megan Y. Yung.3 From King & Spalding LLP: Daryl L. Joseffer and Adam M. Conrad.4 From Amgen, Inc.: Stuart L. Watt, Wendy A. Whiteford, Erica S. Olson, Steven D. Tang, Emily C. Johnson, Dennis J. Smith, and Joshua Mack.5 From MoloLamken LLP: Jeffrey A. Lamken, Michael G. Pattillo, Jr., Sarah J. Newman, and Sara E. Margolis.6 3 Megan Y. Yung no longer practices at Quinn Emanuel Urquhart & Sullivan, LLP, and is not expected to enter an appearance on behalf of Amgen in this appeal. 4 Daryl L. Joseffer and Adam M. Conrad no longer practice with King & Spalding LLP and are not expected to enter appearances on behalf of Amgen in this appeal. 5 Joshua Mack is no longer employed by Amgen, Inc., and is not expected to enter an appearance on behalf of Amgen in this appeal. 6 In the prior appeal in this case (No. 17-1480), Christopher R. Healy, Merritt E. McAlister, and Joshua N. Mitchell from King & Spalding LLP appeared before this Court on behalf of Amgen. Those attorneys are not expected to enter appearances on behalf of Amgen in this appeal. Case: 20-1074 Document: 55 Page: 7 Filed: 02/21/2020 TABLE OF CONTENTS Page INTRODUCTION ..................................................................................................... 1 JURISDICTIONAL STATEMENT .......................................................................... 4 STATEMENT OF THE ISSUE ................................................................................. 4 STATEMENT OF THE CASE .................................................................................. 5 I. Factual Background ......................................................................................... 5 A. Amgen Invents Antibodies To Treat Heart Disease by Dramatically Lowering LDL Cholesterol ............................................. 5 B. Amgen’s Patents Claim a Class of PCSK9 Antibodies That Bind the “Sweet Spot” ................................................................ 10 C. Amgen’s Patents Provide a Detailed Roadmap for Making the Claimed Antibodies ......................................................... 13 D. Amgen’s Patents Disclose a Prior-Art Method of Making “Variants” .............................................................................. 16 II. Proceedings Below ........................................................................................ 18 A. First Trial and Appeal ......................................................................... 18 B. Second Trial and the District Court’s JMOL Decision ....................... 19 1. Written Description ................................................................... 19 2. Enablement ................................................................................ 20 SUMMARY OF ARGUMENT ............................................................................... 26 STANDARD OF REVIEW ..................................................................................... 30 i Case: 20-1074 Document: 55 Page: 8 Filed: 02/21/2020 ARGUMENT ........................................................................................................... 31 I. Substantial Evidence Showed—and Wands Confirms—That Amgen’s Claims Are Enabled ....................................................................... 32 A. Amgen’s Patents Contain a Roadmap for POSAs To Practice the Invention’s Full Scope ............................................... 32 B. Wands Confirms That Amgen’s Claims Are Enabled ........................ 34 C. Sanofi-Regeneron’s Failure To Show Any Difficult-To- Make Embodiments Confirms Enablement ........................................ 37 II. The Jury Was Not Required To Accept Sanofi-Regeneron’s Theory That the Genus Encompasses Millions of Antibodies That Would Need To Be Tested .................................................................... 39 A. The Evidence Showed That the Claims’ Scope Is Narrow ................. 40 B. The Possibility of “Conservative Substitutions” Does Not Yield Millions of Antibodies