Paper No.
`Filed: December 30, 2015
`
`Filed on behalf of: Junior Party Biogen MA Inc.
`
`By: Michele C. Bosch
`Barbara C. McCurdy
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`michele.bosch@finnegan.com
`barbara.mccurdy@finnegan.com
`202-408-4193 tel
`202-408-4400 fax
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BIOGEN MA INC.,
`Junior Party
`Patent 8,399,514 B2,
`
`v.
`
`FORWARD PHARMA A/S,
`Senior Party
`Application 11/576,871.
`
`Patent Interference 106,023 (McK)
`Technology Center 1600
`
`REVISED BIOGEN MOTION 4
`
`(for judgment based on priority)
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`Page 1 of 78
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`Biogen Exhibit 2029
`Mylan v. Biogen
`IPR2018-01403
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`

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`
`TABLE OF CONTENTS
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`
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`I.
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`II.
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`III.
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`IV.
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`INTRODUCTION .................................................................................................. 1
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`PRECISE RELIEF REQUESTED .......................................................................... 6
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`EVIDENCE RELIED UPON ................................................................................. 6
`
`REASONS WHY THE RELIEF SHOULD BE GRANTED ................................. 9
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`A.
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`APPLICABLE LAW .................................................................................. 9
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`1.
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`2.
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`3.
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`Conception ...................................................................................... 9
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`First Inventor and Diligence ........................................................... 9
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`Reduction to Practice: Actual and Constructive ........................... 11
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`B.
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`BIOGEN IS ENTITLED TO JUDGMENT ON PRIORITY
`BECAUSE IT WAS FIRST TO CONCEIVE AND WAS
`DILIGENT THROUGH CONSTRUCTIVE AND ACTUAL
`REDUCTIONS TO PRACTICE............................................................... 12
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`1.
`
`Dr. O’Neill’s Corroborated Conception at least by February
`19, 2004 was Before FP’s Earliest Alleged Conception on
`October 8, 2004 ............................................................................. 12
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`2.
`
`Biogen’s Constructive and Actual Reductions to Practice ........... 14
`
`i.
`
`ii.
`
`Each of Biogen’s Applications is a Constructive
`Reduction to Practice ........................................................ 14
`
`Practicing the Method of the Count throughout
`Biogen’s Phase III Clinical Trials Constitutes a
`Series of Actual Reductions to Practice ............................ 16
`
`3.
`
`Biogen Was Diligent from before October 8, 2004 through
`Constructive and Actual Reductions to Practice ........................... 16
`
`i.
`
`ii.
`
`The BG-12 Program Involved Many People and
`Teams ................................................................................ 18
`
`Biogen Worked Every Day during the Diligence
`Period on Activities Toward Reduction to Practice .......... 21
`
`(a)
`
`Category 1: Nonclinical (Animal) Studies
`(Sept. 2004 – June 2007) ...................................... 21
`
`i
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`Page 2 of 78
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`(b)
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`(c)
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`(d)
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`Category 2: Phase IIb Clinical Trial
`Planning and Operation (at least Sept. 2004
`– Mar. 2006).......................................................... 22
`
`Category 3: Advancing Clinical
`Development Toward Phase III (Dec. 2004
`– Mar. 2007).......................................................... 27
`
`Category 4: Phase III Clinical Trial
`Operation and Evaluation (Mar. 2007 – Apr.
`2011) ..................................................................... 32
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`4.
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`Daily Diligence: Detailed Monthly Descriptions ......................... 35
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`i.
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`ii.
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`iii.
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`iv.
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`Category 1: Nonclinical (Animal) Studies (at least
`Sept. 2004 – June 2007) .................................................... 36
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`Category 2: Phase IIb Clinical Trial Planning and
`Operation (Sept. 2004 – Mar. 2006) ................................. 37
`
`Category 3: Advancing Clinical Development
`Toward Phase III (Dec. 2004 – Mar. 2007) ...................... 42
`
`Category 4: Phase III Clinical Trial Operation and
`Evaluation (Mar. 2007 – Apr. 2011) ................................. 47
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`V.
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`CONCLUSION ..................................................................................................... 49
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`APPENDIX 1 - List of Cited Exhibits
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`APPENDIX 2 - Copy of Authority
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`APPENDIX 3 - Daily Dosing Date Ranges
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`APPENDIX 4 - BG-12 Program Structure
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`APPENDIX 5 - List of Abbreviations
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`APPENDIX 6 - Daily Activity Chart
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`ii
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`Page 3 of 78
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`Federal Cases
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`
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`TABLE OF AUTHORITIES
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`
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`Page(s)
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`Brown v. Barbacid,
`436 F.3d 1376 (Fed. Cir. 2006)..................................................................................................9
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`Coleman v. Dines,
`754 F.2d 353, 224 U.S.P.Q. 857 (Fed. Cir. 1985) .....................................................................9
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`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998)................................................................................................11
`
`De Solms v. Schoenwald,
`15 U.S.P.Q.2d 1507 (B.P.A.I. 1990)........................................................................................10
`
`Hyatt v. Boone,
`146 F.3d 1348 (Fed. Cir. 1998)......................................................................................6, 11, 12
`
`Hybritech Inc. v. Abbott Labs.,
`No. CV 86-7461, 4 U.S.P.Q.2d 1001 (C.D. Cal. 1987), aff’d, 849 F.2d 1446
`(Fed. Cir. 1988) ..........................................................................................................................5
`
`In re Jolley,
`308 F.3d 1317 (Fed. Cir. 2002)................................................................................................11
`
`Jones v. Evans,
`46 F.2d 197 (C.C.P.A. 1931) ...................................................................................................11
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`Keizer v. Bradley,
`270 F.2d 396, 123 U.S.P.Q. 215 (C.C.P.A. 1959) .............................................................11, 15
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`Lacotte v. Thomas,
`758 F.2d 611 (Fed. Cir. 1985)............................................................................................11, 12
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`Louis v. Okada,
`Intf. No. 104,311, Paper 293, at 12, 2002 WL 31358222, at *6 (B.P.A.I. Oct.
`16, 2002) ..................................................................................................................................10
`
`Price v. Symsek,
`988 F.2d 1187, 26 U.S.P.Q.2d 1031 (Fed. Cir. 1993) ...............................................................9
`
`Rines v. Morgan,
`250 F.2d 365 (C.C.P.A. 1957) .................................................................................................10
`
`Scott v. Koyama,
`281 F.3d 1243 (Fed. Cir. 2002)................................................................................................10
`
`iii
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`Page 4 of 78
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`Vogt v. Neuschotz,
`154 U.S.P.Q. 376 (B.P.A.I. 1966)............................................................................................11
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`
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`Federal Statutes
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`35 U.S.C. 102(g)(1) .........................................................................................................................6
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`35 U.S.C. § 112 ..............................................................................................................................15
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`35 U.S.C. § 112, ¶ 1 .......................................................................................................................11
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`Regulations
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`37 C.F.R. § 41.201 .....................................................................................................................6, 15
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`iv
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`I.
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`INTRODUCTION
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`Biogen proves by a preponderance of the evidence a clear and complete earlier
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`corroborated conception coupled with an exceptional amount of daily diligent work toward
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`developing and reducing to practice Tecfidera®, Biogen’s oral therapy of 480 mg per day of
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`dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS). Ex. 2076-2081. Biogen
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`therefore is entitled to priority of the invention of the Count.
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`Biogen will demonstrate its right to priority in this interference by showing that Biogen
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`inventor Dr. Gilmore O’Neill was the first to conceive (Ex. 2076 at ¶¶ 3, 4, 16, 17, 40, 137; Ex.
`
`2079 at ¶¶ 5-8, 23-26, 101; Ex. 2077 at ¶ 7; Ex. 2078 at ¶¶ 10-13), and that Biogen diligently
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`reduced to practice the subject matter of the Count (Ex. 2076 at ¶¶ 3-15, 23-137; Ex. 2079 at
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`¶¶ 5-8, 11-22, 27-100, 102; Ex. 2077 at ¶¶ 8-152, 157; Ex. 2078 at ¶¶ 3-8, 15-29; Ex. 2080 at ¶¶
`
`17-53, 55-63, 73). The Count recites:
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`A method of treating a human in need of treatment for multiple sclerosis
`comprising
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`orally administering to the human a pharmaceutical composition
`consisting essentially of
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`(a) a therapeutically effective amount of dimethyl fumarate [DMF],
`monomethyl fumarate [MMF], or a combination thereof, and
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`(b) one or more pharmaceutically acceptable excipients,
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`wherein the therapeutically effective amount of dimethyl fumarate, monomethyl
`fumarate, or a combination thereof is about 480 mg per day.
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`As set forth herein and in the accompanying exhibits, Dr. Gilmore O’Neill conceived the
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`subject matter of the Count at least by Feb. 2004, before FP’s earliest alleged date of conception
`
`and constructive reduction to practice on Oct. 8, 2004. Ex. 2309 at 6, 14, 16, 21; Ex. 2076 at ¶¶
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`3, 4, 16, 17, 40, 137; Ex. 2079 at ¶¶ 5-8, 23-26, 101; Ex. 2077 at ¶ 7; Ex. 2078 at ¶¶ 12-13; see
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`FP Priority Statement (Paper No. 169.) Dr. O’Neill and Biogen then diligently reduced to
`
`1
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`practice the method of the Count within a clearly-defined, highly-organized and FDA-regulated
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`drug-development program that Biogen called “BG-12.” Ex. 2076 at ¶¶ 3-15, 23-137; Ex. 2079
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`at ¶¶ 5-8, 11-22, 27-100, 102; Ex. 2077 at ¶¶ 8-152, 157; Ex. 2078 at ¶¶ 3-8, 15-29; Ex. 2080 at
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`¶¶ 17-53, 55-63, 73. Biogen worked continuously throughout this high-priority development
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`program to support and achieve the safe administration of a DMF-only (i.e., DMF as the sole
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`active agent) drug product to humans and to treat MS patients with a therapeutically effective
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`amount of DMF, wherein the therapeutically effective amount is 480 mg/day. Id.
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`Indeed, in addition to its extensive planning for various phases of development and
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`detailed preparation of required regulatory submissions, Biogen1 diligently conducted several
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`nonclinical (animal) and clinical (human) drug studies, which involved the administration of a
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`DMF-only pharmaceutical composition to a human patient, animal subject, or both on each and
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`every day of the critical diligence period. See, e.g., Ex. 2076 at ¶¶ 5, 6, 23-46, 137; Ex. 2079 at
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`¶¶ 8, 27-37; Ex. 2077 at ¶¶ 14-19, 33-34, 82; Ex. 2078 at ¶¶ 7, 8, 19, 27, 28; Ex. 2080 at ¶¶ 17-
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`35, 44, 46-48, 53, 56-63; see also Appendix 3 (graphically showing the overlapping daily-dosing
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`periods of Biogen’s nonclinical and clinical studies). As detailed herein, all of these continuous,
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`overlapping activities were directly related to Biogen’s development and the FDA’s approval of
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`Tecfidera®—an oral therapy of 480 mg per day of DMF to treat MS—and hence were also
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`1 Within the context of preparing for and carrying out nonclinical and clinical trials, reference to
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`“Biogen” throughout this motion also includes the numerous entities and individuals contracted
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`to perform trial-related services on Biogen’s behalf, such as Contract Research Organizations
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`(CROs) and other vendors, manufacturers, laboratories, medical researchers, technicians, etc., as
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`explained further below.
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`2
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`directly related to and in furtherance of the reduction to practice of the Count. See, e.g., Ex.
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`2076 at ¶¶ 5, 16-21, 23-25, 33-46, 137; Ex. 2079 at ¶¶ 5-8, 27-37, 102; Ex. 2078 at ¶¶ 4-8; Ex.
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`2080 at ¶¶ 17-39, 44-49, 53, 55-63, 73.
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`Biogen’s drug-development process culminated with pivotal Phase III clinical trials
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`conducted over a continuous, four-year period (2007-2011). See, e.g., Ex. 2076 at ¶¶ 5, 6, 34-41,
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`137; Ex. 2077 at ¶¶ 33, 82; Ex. 2078 at ¶¶ 8, 27, 28; Ex. 2080 at ¶¶ 56-63, 73; Ex. 2081 at ¶ 7.
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`Throughout this period, hundreds of MS patients around the world were successfully treated with
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`480 mg per day of DMF as recited in the Count. See, e.g., Ex. 2076 at ¶¶ 38-41, 137; Ex. 2077
`
`at ¶ 152; Ex. 2078 at ¶¶ 27-29; Ex. 2081 at ¶¶ 18-19. Biogen relies upon its Phase III clinical
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`trials as a series of actual reductions to practice of the Count. See, e.g., Ex. 2076 at ¶¶ 38-41,
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`137; Ex. 2077 at ¶¶ 33-34, 82, 150-152; Ex. 2078 at ¶¶ 27-29; Ex. 2080 at ¶¶ 56-63, 73; Ex.
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`2081 at ¶¶ 6-7, 18-19. Thus, Biogen is entitled to an award of priority based on its earlier
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`conception, reasonable diligence, and actual reductions to practice.
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`Biogen is also entitled to an award of priority in this proceeding based on its earlier
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`conception, reasonable diligence, and constructive reductions to practice. Biogen filed U.S.
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`Provisional Application No. 60/888,921 on Feb. 8, 2007, followed by corresponding PCT
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`Application No. PCT/US2008/001602 on Feb. 7, 2008, leading to the ’514 patent. Each of these
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`applications describes and enables the subject matter of the Count and thus each constitutes a
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`constructive reduction to practice.
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`Dr. O’Neill’s conception and Biogen’s reductions to practice and continuous and
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`reasonable diligence are corroborated by the testimony of multiple witnesses who worked in
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`collaboration in Biogen’s BG-12 drug-development program. See, e.g., Ex. 2076 at ¶¶ 10-13,
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`17, 36, 41; Ex. 2079 at ¶¶ 5-8, 11-22; Ex. 2077 at ¶¶ 7, 13-40, 82-83, 157; Ex. 2078 at ¶¶ 4-29;
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`Ex. 2080 at ¶¶ 1-4, 11-22; Ex. 2081 at ¶¶ 9-19. Also confirming conception, reductions to
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`practice and reasonable diligence are the many documents generated during the program,
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`including team meeting minutes, presentations, nonclinical and clinical study reports, protocols,
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`regulatory agency submissions and correspondence. Ex. 2082-2378.
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`Among the key events discussed in detail herein is a Feb. 19, 2004, presentation
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`establishing that Dr. O’Neill had conceived the specific and complete idea of orally
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`administering 480 mg per day of DMF to treat MS patients, as recited in the Count. Ex. 2309 at
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`6, 14, 16, 21; Ex. 2076 at ¶¶ 16, 17; Ex. 2079 at ¶¶ 23-26; Ex. 2078 at ¶ 13. In particular, on
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`that date, Dr. O’Neill presented to the Biogen Clinical Trial Review Board (CTRB) his proposed
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`protocol concept options for a Phase IIb clinical trial in which DMF would be orally
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`administered to MS patients to evaluate safety and efficacy. Id. Based on his conviction that
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`480 mg per day of DMF could be effective to treat MS patients, Dr. O’Neill’s preferred protocol
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`concept options included orally administering 480 mg per day of DMF. Id.
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`Following Dr. O’Neill’s conception, Biogen diligently pushed forward on several fronts
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`and on a daily basis throughout the entire diligence period, conducting activities toward the
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`development and approval of a therapeutically effective amount of DMF to treat MS patients.
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`Ex. 2076 at ¶¶ 4-15, 23-137; Ex. 2079 at ¶¶ 5-8, 11-22, 27-100, 102; Ex. 2077 at ¶¶ 13-152, 157;
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`Ex. 2078 at ¶¶ 3-8, 15-29; Ex. 2080 at ¶¶ 18-53, 55-63, 73; Ex. 2081 at ¶¶ 11-20. Among other
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`activities pertinent to reasonable diligence, Biogen planned, conducted and evaluated numerous
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`nonclinical (animal) studies; planned, conducted and evaluated a Phase IIb clinical trial on MS
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`patients; prepared and submitted an MS Investigational New Drug Application (IND) to the
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`FDA; and planned, conducted and evaluated pivotal Phase III clinical trials on MS patients in the
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`U.S. and abroad. Id. These intensive efforts culminated in FDA approval and the subsequent
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`marketing of Tecfidera®, Biogen’s oral therapy of 480 mg per day of DMF to treat MS as
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`
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`described in the Count. See Ex. 2033.
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`The FDA drug-approval process is inherently lengthy, requiring numerous and extensive
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`safety and efficacy studies before a company can market a drug for use in humans. See, e.g., Ex.
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`2079 at ¶¶ 12, 56; Ex. 2078 at ¶ 5; Ex. 2080 at ¶¶ 18-22, 46-49, 55, 56-63, 73. In this case, the
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`drug-approval process understandably and reasonably spanned many years, from 2004 to 2011.
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`See, e.g., Ex. 2076 at ¶ 137; Ex. 2079 at ¶¶ 8, 102; Ex. 2077 at ¶¶ 4, 32-34; Ex. 2078 at ¶¶ 4-8;
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`Ex. 2080 at ¶¶ 11, 18-22; Ex. 2081 at ¶¶ 6-7. As explained in detail below, Biogen was more
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`than reasonably diligent throughout the critical period for diligence as it was “pursuing [its] goal
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`in a reasonable fashion” and “doing the things reasonably necessary to reduce the idea to
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`practice.” Hybritech Inc. v. Abbott Labs., No. CV 86-7461, 4 U.S.P.Q.2d 1001, 1006 (C.D. Cal.
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`1987), aff’d, 849 F.2d 1446 (Fed. Cir. 1988).
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`The following Priority Timeline illustrates Biogen’s basis on multiple grounds for an
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`award of priority, including Biogen’s earlier corroborated conception coupled with diligence
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`through its constructive and actual reductions to practice:
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`Priority Timeline
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`Biogen should prevail on priority without the need to consider Biogen’s priority evidence
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`because neither FP’s involved application nor any FP priority application provides a constructive
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`reduction to practice of the subject matter of the Count. Specifically, as set forth in Biogen
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`Motion 1 (Paper 171, lack of written description and enablement) and Biogen Motion 3 (Paper
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`174, lack of benefit), FP’s involved applications do not describe or enable a single embodiment
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`within the scope of the claims or the Count. Lack of written description and enablement is not
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`only a patentability issue; it is also a priority issue. An application that fails to describe and
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`enable at least one embodiment within the scope of the Count is not a constructive reduction to
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`practice. 37 C.F.R. § 41.201 (“Constructive reduction to practice means a described and enabled
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`anticipation under 35 U.S.C. 102(g)(1) in a patent application of the subject matter of the count”)
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`(emphasis added). Therefore, because none of FP’s involved applications describe or enable
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`even one embodiment within the scope of the Count, none is a constructive reduction to practice.
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`Id.; Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed. Cir. 1998).
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`If FP’s copied claims are proven to lack written description, FP should be found to lack
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`standing to remain in this interference, and has no right to challenge Biogen’s patent on
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`patentability grounds or on priority grounds. 37 C.F.R. § 41.201.
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`II.
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`PRECISE RELIEF REQUESTED
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`Biogen respectfully requests that the Board grant Motion 4, award priority in Biogen’s
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`favor, enter judgment against FP, and terminate the interference.
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`III.
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`EVIDENCE RELIED UPON
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`Biogen relies upon the testimony of the following witnesses to prove and corroborate a
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`date of invention prior to FP’s earliest alleged constructive reduction to practice date of Oct. 8,
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`2004. The testimony also establishes and corroborates Biogen’s diligent reduction to practice.
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`Biogen exhibits relied upon in this motion are listed in Appendix 1.
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`Gilmore O’Neill, M.D. (Ex. 2076) is an inventor on Biogen’s involved ’514 patent. Ex.
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`2076 at ¶¶ 1-4. By at least Feb. 2004, Dr. O’Neill conceived of treating MS with 480 mg per day
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`of DMF, by orally administering to a human patient a pharmaceutical composition consisting
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`essentially of DMF and one or more pharmaceutically acceptable excipients. Id. at ¶ 4. As
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`Medical Director from Sept. 2003 to July 2006 of the Biogen MS “BG-12” program, Dr. O’Neill
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`led a team at Biogen through approximately the first three years of drug development of
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`Tecfidera®, including, among other activities, numerous nonclinical (animal) studies, a Phase IIb
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`clinical trial conducted on MS patients, preparation and submission to the FDA of Biogen’s MS
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`IND, and preparations for pivotal Phase III clinical trials on MS patients. Id. at ¶¶ 5-6. Dr.
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`O’Neill thus provides testimony on conception, diligence and reduction to practice. Id. at ¶¶ 1-
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`137.
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`In July 2006, Dr. O’Neill transitioned out of his role as Medical Director of the MS BG-
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`12 program, transferring his responsibilities to Dr. Katherine Dawson. Id. at ¶ 5. Dr. O’Neill
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`remained informed as to the progress of the MS BG-12 program and returned in 2011 near the
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`end of the Phase III clinical trials. Id. at ¶¶ 5, 36.
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`Katherine T. Dawson, M.D. (Ex. 2077) joined the MS BG-12 team in June 2006 and
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`succeeded Dr. O’Neill as Medical Director in July 2006. Ex. 2077 at ¶ 8. Dr. Dawson oversaw
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`the Phase III clinical trials of Tecfidera®. In particular, Dr. Dawson details Biogen’s
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`preparations for the Phase III clinical trials from June 2006 to Mar. 2007 and the Phase III
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`clinical trials she and others supervised from Mar. 2007 to Apr. 2011, when the “first look”
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`results from the Phase III trial were presented. Id. at ¶¶ 8-157. Dr. Dawson corroborates Dr.
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`O’Neill’s testimony regarding conception, diligence and reduction to practice. Id. at ¶¶ 1-157.
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`Cara Lansden (Ex. 2079) was Manager of Clinical Development in the BG-12 program
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`beginning around Dec. 2003. In that role, Ms. Lansden assisted in creating and maintaining the
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`BG-12 clinical development plans and managed operational strategies. These responsibilities
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`required Ms. Lansden to work closely with Dr. O’Neill throughout his time as Medical Director
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`of the BG-12 program. Ms. Lansden and Dr. O’Neill communicated regularly, both formally
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`and informally, regarding BG-12, typically attended the same meetings, and received or were
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`copied on the same communications. Ms. Lansden corroborates Dr. O’Neill’s testimony
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`regarding conception and diligence at least up to July 2006. Ex. 2079 at ¶¶ 1-104.
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`Carmen Bozic, M.D. (Ex. 2078) oversaw the BG-12 team’s development of Tecfidera®,
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`particularly as to the approval of clinical trial protocols and safety and risk management
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`throughout drug development. Ex. 2078 at ¶¶ 1-4. Dr. Bozic explains the continuous efforts at
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`Biogen between 2003 and 2011 to develop Tecfidera® and obtain FDA approval to bring it to
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`market. Id. at ¶ 5. Dr. Bozic corroborates Dr. O’Neill’s testimony regarding conception,
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`diligence, and reduction to practice. Id. at ¶¶ 1-31.
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`Tammy Sarnelli (Ex. 2080) is currently a Senior Director of Regulatory Affairs at
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`Biogen and first became involved with the BG-12 program in or around Feb. of 2006 (as
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`Associate Director, Regulatory Affairs) and has remained involved to this day. Ex. 2080 at ¶¶ 1-
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`17. As the Regulatory Affairs officer on the MS BG-12 team, Ms. Sarnelli has been responsible
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`for interactions with various regulatory authorities, including the FDA, regarding the testing and
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`approval of Tecfidera®. Ms. Sarnelli also has been responsible for ensuring that BG-12-related
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`communications, submissions, and filings with regulatory authorities (including those that
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`occurred prior to her joining the BG-12 MS team) are documented, filed, and maintained
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`according to Biogen corporate policy and/or as required by law. Ms. Sarnelli’s testimony
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`corroborates Dr. O’Neill’s testimony regarding diligence and reduction to practice. Id. at ¶¶ 1-
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`75.
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`John O’Gorman (Ex. 2081) was the head biostatistician for the Phase III MS clinical
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`trials from 2010-2011. Mr. O’Gorman analyzed the results of Biogen’s Phase III double-blinded
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`studies when they first became available under the FDA-approved protocol and presented the
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`results to others at Biogen in Apr. 2011. Mr. O’Gorman corroborates Dr. O’Neill’s testimony
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`regarding reduction to practice. See Ex. 2081 at ¶¶ 1-20.
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`IV.
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`REASONS WHY THE RELIEF SHOULD BE GRANTED
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`A.
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`APPLICABLE LAW
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`1.
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`Conception
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`Priority of invention is a question of law, based on findings of evidentiary fact directed to
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`conception, reduction to practice, and diligence. See Price v. Symsek, 988 F.2d 1187, 1190, 26
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`U.S.P.Q.2d 1031, 1033 (Fed. Cir. 1993). To establish conception, “a party must show
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`possession of every feature recited in the count, and that every limitation of the count [was]
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`known to the inventor . . . .” Coleman v. Dines, 754 F.2d 353, 359, 224 U.S.P.Q. 857, 862 (Fed.
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`Cir. 1985). This motion and the supporting evidence demonstrates that Dr. O’Neill conceived
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`the invention of the Count by at least Feb. 2004, many months before the earliest invention date
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`alleged by FP. Dr. O’Neill’s conception is corroborated by the testimony of multiple witnesses
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`and documents.
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`2.
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`First Inventor and Diligence
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`The party that is first to conceive “is entitled to the patent based on prior conception if, as
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`first to conceive he exercised reasonable diligence from a time before the other party’s
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`conception date to his own reduction to practice date.” Brown v. Barbacid, 436 F.3d 1376, 1378
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`(Fed. Cir. 2006). “The purpose of requiring reasonable diligence by the first to conceive the
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`invention but second to reduce to practice is to assure that the invention was not abandoned or
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`unreasonably delayed by the first inventor during the period after the second inventor entered the
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`field.” Id. at 1379. The evidence submitted with this motion shows that the dedicated efforts of
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`Dr. O’Neill and many other professionals at and on behalf of Biogen to bring an oral MS
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`treatment, i.e., 480 mg/day of DMF, to market were continuous, steady and more than
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`“reasonably diligent.”
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`Whether an inventor has exercised reasonable diligence is a question that is determined
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`by the particular circumstances of each individual case. See Rines v. Morgan, 250 F.2d 365, 369
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`(C.C.P.A. 1957). “[A]ctivities that may be considered in a showing of diligence can take a
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`diversity of forms.” Scott v. Koyama, 281 F.3d 1243, 1248 (Fed. Cir. 2002). Preparations
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`directly aimed at achieving actual practice of a process on a commercial scale evidence diligence
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`to reduction to practice. Id. The scale of the intended practice does not disqualify the activity
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`that was taken in order to achieve it. Id. Nor does the length of time it takes to reduce to
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`practice. De Solms v. Schoenwald, 15 U.S.P.Q.2d 1507, 1511 (B.P.A.I. 1990) (“[I]t is not
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`material to the question of diligence that Schoenwald did not take the most expeditious course,
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`so long as there was diligent activity toward the end in view.”). “Diligence is directed to
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`continuous, steady, or constant effort, and not necessarily to any quick result.” Louis v. Okada,
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`Intf. No. 104,311, Paper 293, at 12, 2002 WL 31358222, at *6 (B.P.A.I. Oct. 16, 2002).
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`Inventors may rely upon the activities of others in establishing diligence. De Solms v.
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`Schoenwald, 15 U.S.P.Q.2d 1507, 1511 (B.P.A.I. 1990) (“It is a principle of diligence that . . .
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`the inventor may avail himself of the activities of others.”).
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`Activities that are “part of an overall scheme of inventive activity directed toward
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`reducing the invention to practice” may be relied upon to prove diligence, whether or not that
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`activity falls within the Count. In re Jolley, 308 F.3d 1317, 1326-28 (Fed. Cir. 2002) (screening
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`research with polyglycol outside the count considered diligent activity because it was a “first
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`step” toward practicing the invention of the Count). Thus, activities carried out “in pursuit of [a
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`system or method] falling within the limitations of an interference count” are evidence of
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`diligence. Id. at 1328. Similarly, activities “geared to [a government sponsor’s] needs and
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`desires” may be credited as diligence. Vogt v. Neuschotz, 154 U.S.P.Q. 376, 378 (B.P.A.I.
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`1966).
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`An inventor’s testimony as to the facts of the invention must be corroborated by
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`independent evidence. Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998). The fact that
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`activities take place as part of an organized program of research helps demonstrate the requisite
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`corroboration. See Lacotte v. Thomas, 758 F.2d 611, 613 (Fed. Cir. 1985). A document and
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`those who receive it can corroborate a conception communicated to them. Jones v. Evans, 46
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`F.2d 197, 199-200 (C.C.P.A. 1931). The evidence submitted with this motion establishes that
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`Dr. O’Neill’s conception was diligently reduced to practice throughout Biogen’s well-structured
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`and highly-organized MS BG-12 drug-development program. His testimony is corroborated by
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`many witnesses who worked in collaboration with him on the BG-12 program.
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`3.
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`Reduction to Practice: Actual and Constructive
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`Activity toward reduction to practice may conclude with either constructive or actual
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`reduction to practice. See Keizer v. Bradley, 270 F.2d 396, 398, 400, 123 U.S.P.Q. 215, 216, 218
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`(C.C.P.A. 1959) (“It is of no moment that the end of that period [of engineering activity] is fixed
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`by a constructive, rather than an actual, reduction to practice.”).
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`A patent application may constitute a constructive reduction to practice if it contains a
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`written description of the subject matter of the count and meets the enablement requirement in
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`accordance with 35 U.S.C. § 112, ¶ 1. See Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed. Cir.
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`1998). A claimed method is actually reduced to practice when the method is practiced. Lacotte
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`v. Thomas, 758 F.2d 611, 613 (Fed. Cir. 1985).
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`B.
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`BIOGEN IS ENTITLED TO JUDGMENT ON PRIORITY
`BECAUSE IT WAS FIRST TO CONCEIVE AND WAS DILIGENT
`THROUGH CONSTRUCTIVE AND ACTUAL REDUCTIONS TO
`PRACTICE
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`1.
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`Dr. O’Neill’s Corroborated Conception at least by February
`19, 2004 was Before FP’s Earliest Alleged Conception on
`October 8, 2004
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`In 2003, Biogen recognized a need for an oral therapy to treat MS, a chronic and
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`debilitating disease. Ex. 2076 at ¶ 8; Ex. 2078 at ¶ 10. At that time, the only FDA-approved MS
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`treatments were administered by injection. Ex. 2076 at ¶ 8; Ex. 2078 at ¶ 10. Not long after Dr.
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`O’Neill joined Biogen in the second quarter of 2003, and subject to a confidentiality agreement,
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`he learned of a proprietary drug candidate program called “FAG-201” being pursued by a
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`company called Fumapharm AG. Ex. 2076 at ¶ 8. Under its program, Fumapharm had studied a
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`DMF-only drug product in psoriasis patients. Id.
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`In late Sept. 2003, Biogen licensed certain exclusive worldwide rights from Fumapharm
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`to develop and market a treatment for MS and a treatment for psoriasis using a DMF-only (i.e.,
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`DMF as the sole active agent) drug product. Ex. 2076 at ¶ 9; Ex. 2078 at ¶ 11; Ex. 2079 at ¶ 11.
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`Biogen called this development program “BG-12.” Id. Under the BG-12 program, Biogen
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`simultaneously began working on two therapeutic areas: an MS indication (MS BG-12 team) and
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`a psoriasis indication (psoriasis BG-12 team), with additional possible indications to follow. Id.
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`Upon initiation of the BG-12 program at Biogen, Dr. O’Neill became the Medical
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`Director for the MS BG-12 program. Ex. 2076 at ¶¶ 10, 16; Ex. 2078 at ¶ 12; Ex. 2079 at ¶ 7.
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`As Medical Director, he was responsible for, inter alia, the design of an ongoing Clinical
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`Development Plan for the MS indication which included the design of a Phase IIb proof-of-
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