Case: 19-1364 Document: 32 Page: 1 Filed: 04/15/2019 No. 19-1364 In the United States Court of Appeals For the Federal Circuit __________________ BIOGEN, INC., Appellant, v. UNITED STATES Intervenor. __________________ ON APPEAL FROM THE U.S. PATENT AND TRADEMARK OFFICE Case No. IPR2017-01168 ________________________ APPELLANT’S OPENING BRIEF __________________ Rachelle H. Thompson Brian D. Schmalzbach MCGUIREWOODS LLP Lyle D. Kossis 434 Fayetteville Street MCGUIREWOODS LLP Suite 2600 Gateway Plaza Raleigh, NC 27601 800 East Canal Street Telephone: (919) 775-6572 Richmond, VA 23219 Facsimile: (919) 775-6591 Telephone: (804) 775-4746 [email protected] Facsimile: (804) 698-2304 [email protected] [email protected] Counsel for Appellant Biogen, Inc. Case: 19-1364 Document: 32 Page: 2 Filed: 04/15/2019 FORM 9. Certificate of Interest Form 9 Rev. 10/17 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT Biogen, Inc.v. Pfizer, Inc. Case No. 19-1364 CERTIFICATE OF INTEREST Counsel for the: (petitioner) (appellant) (respondent) (appellee) (amicus) (name of party) Biogen, Inc. 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 For Biogen, Inc.: None. For Genentech, Inc.: Genentech, Inc. is a wholly owned subsidiary of Roche Holdings Inc. Roche Holdings Inc.’s ultimate parent, Roche Holdings Ltd., is a publicly held Swiss corporation traded on the Swiss Stock Exchange. Upon information and belief, more than Biogen, Inc. Genentech, Inc. 10% of Roche Holdings Ltd.’s voting shares are held either directly or indirectly by Novartis AG, a publicly held Swiss corporation. 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: Irell & Manella LLP - Michael R. Fleming, Gary N. Frischling, Keith A. Orso, Yite John Lu, David I. Gindler Case: 19-1364 Document: 32 Page: 3 Filed: 04/15/2019 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 4/15/2019 /s/ Rachelle H. Thompson Date Signature of counsel Please Note: All questions must be answered Rachelle H. Thompson Printed name of counsel cc: Counsel of Record Reset Fields Case: 19-1364 Document: 32 Page: 4 Filed: 04/15/2019 TABLE OF CONTENTS PAGE STATEMENT OF RELATED CASES ........................................................................... vii INTRODUCTION ......................................................................................................... 1 JURISDICTION ............................................................................................................ 5 STATEMENT OF THE ISSUES ....................................................................................... 5 STATEMENT OF THE CASE ......................................................................................... 6 I. The ’873 patent describes an innovative treatment combination specifically designed for DLCL patients older than 60. ...................................................................................... 6 II. As of the priority date, a POSA knew that a patient’s age and type of lymphoma were critical prognostic factors. ........... 10 III. The Board determined that the challenged claims are unpatentable as obvious over a five-reference combination. ..................................................................................... 12 SUMMARY OF ARGUMENT ...................................................................................... 17 STANDARD OF REVIEW ........................................................................................... 19 ARGUMENT ............................................................................................................. 20 I. A POSA would not have been motivated to combine the prior art to make the claimed invention. ..................................... 21 A. A POSA would not have combined all three treatments together without evidence that any two of the treatments were better in combination than either one given individually. ............................................. 22 B. The foundational reference—Moreau—provides no evidence that the tested combination therapy was better than either treatment individually. ......................... 26 C. The other prior art contains no evidence or data that any combination of two therapies was more effective than the individual treatments alone. ................ 28 -i- Case: 19-1364 Document: 32 Page: 5 Filed: 04/15/2019 D. The Board’s determination that a POSA would have combined the references is legal error and separately lacks substantial evidence. ............................... 35 i. The Board erred as a matter of law by not viewing the prior art from the POSA’s perspective. .................................................................. 36 ii. The Board’s decision lacks substantial evidence because it disregarded uncontroverted evidence about what would have motivated a POSA. ............................................ 37 iii. The Board’s decision lacks substantial evidence because the Board did not explain how a POSA would have combined the references to arrive at the claimed invention. ........ 39 II. A POSA would not have had a reasonable expectation of success in treating DLCL patients older than 60 with the claimed invention. ........................................................................... 45 A. As a factual matter, a reasonable expectation of success as of the priority date required evidence that a combination therapy improved the prognosis of DLCL patients older than 60. .......................................... 46 B. The prior art contained no evidence or data that any combination therapy, let alone all three treatments combined, successfully improved prognoses for elderly DLCL patients. ......................................................... 49 C. The Board’s conclusion that there was a reasonable expectation of success lacks substantial evidence and constitutes legal error. ................................................ ..55 i. The Board erred by relying on conclusory expert testimony. ........................................................ 55 ii. The Board’s decision lacks substantial evidence because it misread the prior art. .............. 57 -ii- Case: 19-1364 Document: 32 Page: 6 Filed: 04/15/2019 iii. The Board erred as a matter of law by not viewing the prior art from the POSA’s perspective. .................................................................. 60 III. The Board erred in finding claim 4 obvious because the prior art did not disclose treatment outcomes for DLCL patients older than 60 with bone marrow involvement. ........... 61 CONCLUSION .......................................................................................................... 63 -iii- Case: 19-1364 Document: 32 Page: 7 Filed: 04/15/2019 TABLE OF AUTHORITIES PAGE Cases Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355 (Fed. Cir. 2016) ............................................................. 35, 57, 64 Arkie Lures, Inc. v. Gene Larew Tackle, Inc., 119 F.3d 953 (Fed. Cir. 1997) ..................................................................... 37, 61 Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331 (Fed. Cir. 2016) ......................................................................... 19 In re Brimonidine Patent Litig., 643 F.3d 1366 (Fed. Cir. 2011) ..................................................................passim CRFD Research, Inc. v. Matal, 876 F.3d 1330 (Fed. Cir. 2017) ......................................................................... 39 Cutsforth, Inc. v. MotivePower, Inc., 636 F. App’x 575 (Fed. Cir. 2016) ................................................................... 57 Dickinson v. Zurko, 527 U.S. 150 (1999) ............................................................................................ 19 DSS Tech. Mgmt., Inc. v. Apple Inc., 885 F.3d 1367 (Fed. Cir. 2018) ......................................................................... 63 Ecolochem, Inc. v. S. California Edison Co., 227 F.3d 1361 (Fed. Cir. 2000) ......................................................................... 55 Envtl. Designs, Ltd. v. Union Oil Co. of California, 713 F.2d 693 (Fed. Cir. 1983) ........................................................................... 45 Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., 716 F. App’x 1006 (Fed. Cir. 2017) ................................................................. 30 Hagmeyer v. Dep’t of Treasury, 757 F.2d 1281 (Fed. Cir. 1985) ......................................................................... 41 -iv- Case: 19-1364 Document: 32 Page: 8 Filed: 04/15/2019 Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A. DE C.V., 865 F.3d 1348 (Fed. Cir. 2017) ......................................................................... 46 Institut Pasteur & Universite Pierre Et Marie