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United States Court of Appeals for the Federal Circuit Case: 20-1758 Document: 31 Page: 1 Filed: 08/31/2020 No. 20-1758 IN THE United States Court of Appeals for the Federal Circuit JUNO THERAPEUTICS, INC., SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH, Plaintiffs-Appellees, v. KITE PHARMA, INC., Defendant-Appellant. On Appeal from the United States District Court for the Central District of California No. 2:17-cv-07639-PSG-KS Hon. Philip S. Gutierrez NONCONFIDENTIAL OPENING BRIEF AND ADDENDUM FOR KITE PHARMA, INC. Jeffrey I. Weinberger E. Joshua Rosenkranz Ted G. Dane ORRICK, HERRINGTON & Garth T. Vincent SUTCLIFFE LLP Peter E. Gratzinger 51 West 52nd Street Adam R. Lawton New York, NY 10019 MUNGER, TOLLES & OLSON LLP (212) 506-5000 350 S. Grand Ave., 50th floor Los Angeles, CA 90071 Melanie L. Bostwick Jeremy Peterman Geoffrey D. Biegler Robbie Manhas FISH & RICHARDSON, P.C. ORRICK, HERRINGTON & 12390 El Camino Real, Ste. 100 SUTCLIFFE LLP San Diego, CA 92130 1152 15th Street NW Washington, DC 20005 Grant T. Rice FISH & RICHARDSON, P.C. One Marina Park Drive Boston, MA 02210 Counsel for Defendant-Appellant Case: 20-1758 Document: 31 Page: 2 Filed: 08/31/2020 U.S. PATENT NO. 7,446,190: CLAIMS 1-3, 5, 7-9, AND 11 (CLAIMS 3, 5, 9, AND 11 ASSERTED) 1. A nucleic acid polymer encoding a chimeric T cell receptor, said chimeric T cell receptor comprising (a) a zeta chain portion comprising the intracellular domain of human CD3 ζ chain, (b) a costimulatory signaling region, and (c) a binding element that specifically interacts with a selected target, wherein the costimulatory signaling region comprises the amino acid sequence encoded by SEQ ID NO:6. 2. The nucleic acid polymer of claim 1, wherein the binding element is an antibody. 3. The nucleic acid polymer of claim 2, wherein the antibody is a single chain antibody. 5. The nucleic acid polymer of claim 3, wherein the single chain antibody binds to CD19. 7. The nucleic acid polymer of claim 1, wherein the zeta chain portion comprises the sequence obtained by amplification of human zeta chain DNA with the primers of SEQ ID Nos 1 and 2. 8. The nucleic acid polymer of claim 7, wherein the binding element is an antibody. 9. The nucleic acid polymer of claim 8, wherein the antibody is a single chain antibody. 11. The nucleic acid polymer of claim 9, wherein the single chain antibody binds to CD19. Case: 20-1758 Document: 31 Page: 3 Filed: 08/31/2020 FORM 9. Certificate of Interest Form 9 (p. 1) July 2020 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT CERTIFICATE OF INTEREST Case Number 20-1758 Short Case Caption Juno Therapeutics, Inc. v. Kite Pharma, Inc. Filing Party/Entity Kite Pharma, Inc., Appellant Instructions: Complete each section of the form. In answering items 2 and 3, be specific as to which represented entities the answers apply; lack of specificity may result in non-compliance. Please enter only one item per box; attach additional pages as needed and check the relevant box. Counsel must immediately file an amended Certificate of Interest if information changes. Fed. Cir. R. 47.4(b). I certify the following information and any attached sheets are accurate and complete to the best of my knowledge. Date: _________________08/31/2020 Signature: S/ E. Joshua Rosenkranz Name: E. Joshua Rosenkranz Case: 20-1758 Document: 31 Page: 4 Filed: 08/31/2020 FORM 9. Certificate of Interest Form 9 (p. 2) July 2020 1. Represented 2. Real Party in 3. Parent Corporations Entities. Interest. and Stockholders. Fed. Cir. R. 47.4(a)(1). Fed. Cir. R. 47.4(a)(2). Fed. Cir. R. 47.4(a)(3). Provide the full names of Provide the full names of Provide the full names of all entities represented all real parties in interest all parent corporations by undersigned counsel in for the entities. Do not for the entities and all this case. list the real parties if publicly held companies they are the same as the that own 10% or more entities. stock in the entities. ☐X None/Not Applicable ☐ None/Not Applicable Kite Pharma, Inc. Gilead Sciences, Inc. Additional pages attached Case: 20-1758 Document: 31 Page: 5 Filed: 08/31/2020 FORM 9. Certificate of Interest Form 9 (p. 3) July 2020 4. Legal Representatives. List all law firms, partners, and associates that (a) appeared for the entities in the originating court or agency or (b) are expected to appear in this court for the entities. Do not include those who have already entered an appearance in this court. Fed. Cir. R. 47.4(a)(4). None/Not Applicable Additional pages attached Munger Tolles and Olson LLP: Fish and Richardson PC: W. Chad Shear, Gregory Gibson Dunn and Crutcher LLP: Omar Amin, Michael Sitzman, Blanca Young, Graham Cole, Markus Brazill and Vincent Ling Booker, John Farrell, Lance Wyatt and Megan Chacon Jane Love, Jaysen Chung, Jeffrey Thomas and Timothy Best Orrick, Herrington & Sutcliffe LLP: Eric Shumsky 5. Related Cases. Provide the case titles and numbers of any case known to be pending in this court or any other court or agency that will directly affect or be directly affected by this court’s decision in the pending appeal. Do not include the originating case number(s) for this case. Fed. Cir. R. 47.4(a)(5). See also Fed. Cir. R. 47.5(b). ✔ None/Not Applicable Additional pages attached 6. Organizational Victims and Bankruptcy Cases. Provide any information required under Fed. R. App. P. 26.1(b) (organizational victims in criminal cases) and 26.1(c) (bankruptcy case debtors and trustees). Fed. Cir. R. 47.4(a)(6). ✔ None/Not Applicable Additional pages attached Case: 20-1758 Document: 31 Page: 6 Filed: 08/31/2020 TABLE OF CONTENTS Page CERTIFICATE OF INTEREST ................................................................. i TABLE OF AUTHORITIES .................................................................... vii STATEMENT OF RELATED CASES ..................................................... xi INTRODUCTION ...................................................................................... 1 JURISDICTION ........................................................................................ 3 STATEMENT OF THE ISSUES ............................................................... 3 STATEMENT OF THE CASE .................................................................. 4 CAR-T Therapy Is In Its Infancy ..................................................... 4 Kite’s YESCARTA® Realizes The Promise Of CAR-T Therapy ... 10 Juno Licenses The ’190 Patent, Which Generically Claims A CAR-T Research Plan ........................................................... 13 A Belated Certificate Of Correction Extends The ’190 Patent Even Further, Capturing YESCARTA® ............................... 16 Juno Fails To Bring A Product To Market And Instead Sues Kite, Winning Over $1.2 Billion ........................................... 16 SUMMARY OF ARGUMENT ................................................................. 19 STANDARD OF REVIEW ....................................................................... 22 ARGUMENT ............................................................................................ 23 I. The Claims Are Invalid For Insufficient Written Description. ........................................................................... 23 A. The patent functionally claims extremely broad, varied genuses in an unpredictable field. ................... 25 B. The patent does not disclose representative species or common structural features showing which of the millions of billions of structural candidates would function as claimed. ....................... 33 C. At a minimum, a new trial is warranted because the court failed to adequately instruct the jury. ........ 40 iv Case: 20-1758 Document: 31 Page: 7 Filed: 08/31/2020 II. The Claims Are Invalid For Non-Enablement. ................... 42 III. Kite Does Not Infringe As A Matter Of Law Because The Certificate Of Correction Is Invalid. ............................. 46 A. The intrinsic evidence did not make it “clearly evident” that the original sequence was erroneous. ..................................................................... 49 B. The intrinsic evidence did not make it “clearly evident” that the CoC was the solution to any supposed error. ............................................................. 56 IV. The Damages Award, Multiples Of Any Reference License, Must Be Vacated. .................................................... 57 A. The $585 million upfront payment is based on an agreement that vastly overvalues the ’190 patent. .... 64 B. Dr. Sullivan failed to apportion the royalty rate and upfront payment to account for Kite’s undisputed contributions to YESCARTA®. ................. 68 C. The royalty rate and upfront payment are based on grossly excessive and legally impermissible multipliers. ................................................................... 73 V. Kite Did Not Willfully Infringe, And The Court Erred In Enhancing Damages. ........................................................ 75 A. As a matter of law, Kite did not willfully infringe. .... 75 B. The Court’s enhancement decision rests on legal error. ............................................................................. 79 CONCLUSION ........................................................................................ 80 ADDENDUM CERTIFICATE OF SERVICE CERTIFICATE OF COMPLIANCE CERTIFICATE OF COMPLIANCE WITH RULE 28(d) v Case: 20-1758 Document: 31 Page: 8 Filed: 08/31/2020 Material has been redacted from page 67 of the Nonconfidential Opening Brief and pages Appx47, Appx48, Appx54, Appx95, Appx98 of the addendum attached to the Nonconfidential
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