Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 1 of 22 PageID #: 18728
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`CASE NO. 2:20-cv-00337-JRG
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`SEAGEN INC.,
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`v.
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`Plaintiff,
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`DAIICHI SANKYO CO., LTD.,
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`Defendant, and
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`ASTRAZENECA
`PHARMACEUTICALS LP and
`ASTRAZENECA UK LTD.,
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` Intervenor-Defendants.
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`DEFENDANTS’ MOTION FOR NEW TRIAL
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 2 of 22 PageID #: 18729
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`TABLE OF CONTENTS
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`Page
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`I. 
`II. 
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`III. 
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`INTRODUCTION AND LEGAL STANDARD ............................................................ - 1 - 
`ARGUMENT .................................................................................................................. - 1 - 
`A. 
`The Court Improperly Admitted Evidence ......................................................... - 1 - 
`1. 
`Improper Evidence of “Copying” and Collaboration ............................. - 1 - 
`2. 
`Improper Evidence Outside the Priority Application ............................. - 4 - 
`The Jury Verdict is Defective ............................................................................. - 5 - 
`Seagen’s Disclaimer of Claim 8 Renders the Jury Verdict
`1. 
`Defective ................................................................................................. - 5 - 
`Generality of Invalidity Verdict Does Not Permit Understanding
`of Potential Inconsistencies..................................................................... - 6 - 
`Even if This Court Can Cure the Now-Defective Remaining Claims,
`Enhertu® Does Not and Cannot Infringe the So-Narrowed Claims ................... - 6 - 
`The Court Issued Improper Jury Instructions Giving Rise to Outcome-
`Determinative Errors, With Each Error Necessitating a New Trial .................... - 8 - 
`The Court Improperly Excluded Two Statements of the Law, One
`1. 
`on Written Description and Another on Enablement .............................. - 8 - 
`The Court Misstated the Law on “Blazemarks” ................................... - 10 - 
`2. 
`The Court Improperly Excluded a Reasonable Royalty Instruction ..... - 11 - 
`3. 
`The Court Improperly Excluded Evidence ....................................................... - 11 - 
`Documents and Expert Testimony Regarding Seagen’s Prosecution
`1. 
`of Related Patent Applications before the European Patent Office ...... - 11 - 
`Email from Seagen’s CEO Acknowledging Enhertu®’s Potential
`and Asking Whose Technology It Is ..................................................... - 12 - 
`Testimony from Seagen Scientists That Seagen was Not in
`Possession of the Claimed Inventions as of Seagen’s Asserted
`Priority Date .......................................................................................... - 13 - 
`The Jury’s Willfulness Verdict is Against the Great Weight of the
`Evidence ............................................................................................................ - 13 - 
`The Jury’s Damages Award is Excessive ......................................................... - 14 - 
`G. 
`The Verdict Reflects Passion and Prejudice ..................................................... - 14 - 
`H. 
`CONCLUSION ............................................................................................................. - 15 - 
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`B. 
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`C. 
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`D. 
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`E. 
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`F. 
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`2. 
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`2. 
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`3. 
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 3 of 22 PageID #: 18730
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015)..................................................................................................9
`
`Bayer Healthcare LLC v. Baxalta Inc.,
`989 F.3d 964 (Fed. Cir. 2021)..................................................................................................13
`
`Cates v. Creamer,
`431 F.3d 456 (5th Cir. 2005) .....................................................................................................4
`
`Edwards v. Sears, Roebuck and Co.,
`512 F.2d 276 (5th Cir. 1975) .............................................................................................14, 15
`
`Genentech, Inc. v. Novo Nordisk, A/S,
`108 F.3d 1361 (Fed. Cir. 1997)..................................................................................................9
`
`Hartsell v. Doctor Pepper Bottling Co.,
`207 F.3d 269 (5th Cir. 2000) .....................................................................................................8
`
`KAIST IP US LLC v. Samsung Elecs. Co.,
`439 F. Supp. 3d. 860 (E.D. Tex. 2020) ....................................................................................14
`
`Novozymes A/S v. DuPont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013)................................................................................................10
`
`Peters v. Active Mfg. Co.,
`129 U.S. 530 (1889) ...................................................................................................................6
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`Smith v. Transworld Drilling Co.,
`773 F.2d 610 (5th Cir. 1985) .................................................................................................1, 4
`
`TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc.,
`529 F.3d 1364 (Fed. Cir. 2008)..................................................................................................7
`
`WesternGeco LLC v. ION Geophysical Corp.,
`913 F.3d 1067 (Fed. Cir. 2019)..............................................................................................5, 6
`
`Whitehead v. Food Max of Miss., Inc.,
`163 F.3d 265 (5th Cir. 1998) ...................................................................................................15
`
`Z4 Techs., Inc. v. Microsoft Corp.,
`507 F.3d 1340 (Fed. Cir. 2007)..................................................................................................8
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`ii
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 4 of 22 PageID #: 18731
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`Rules
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`Fed. R. Civ. P. 32 ...........................................................................................................................13
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`Fed. R. Civ. P. 59 .............................................................................................................................1
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`iii
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 5 of 22 PageID #: 18732
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`I.
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`INTRODUCTION AND LEGAL STANDARD
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`Defendant Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo Japan”) and Defendant-Intervenors
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`AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd. (“AstraZeneca”) (collectively,
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`“Defendants”) respectfully move for a new trial and remittitur under Federal Rule of Civil
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`Procedure 59, to the extent the Court does not grant Defendants’ JMOL motions (Dkt. Nos.
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`444-45). A new trial is appropriate when the jury’s verdict is against the great weight of the
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`evidence, the damages award is excessive, the trial was unfair, or prejudicial error was committed
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`in the course of the trial. Smith v. Transworld Drilling Co., 773 F.2d 610, 613 (5th Cir. 1985). If
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`the Court does not grant Defendants’ JMOL motions (Dkt. Nos. 444-45), a new trial should be
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`granted for the reasons stated therein. A new trial is also warranted for the additional reasons set
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`forth below.
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`II.
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`ARGUMENT
`A.
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`The Court Improperly Admitted Evidence
`1.
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`Improper Evidence of “Copying” and Collaboration
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`In their Motion in Limine (“MIL”) Nos. 1 and 3, Defendants requested that the Court
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`preclude (i) any evidence, testimony, or argument from Seagen relating to alleged copying of
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`technology in the public domain, and (ii) any evidence or suggestion that alleged copying prior to
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`issuance of the asserted patent (or the filing of the application that led to the asserted patent) can
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`form the basis of liability for patent damages and/or willful infringement. (Dkt. No. 313 at 1-2,
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`4-6.) Similarly, in their MIL No. 5, Defendants requested the prohibition of pejorative language
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`that would inflame the jury, including suggesting that Defendants “copied,” “trespassed,”
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`“misappropriated,” “stole,” or “pirated” Seagen’s technology. (Dkt. No. 313 at 8.) Despite
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`granting MIL Nos. 1 and 3 (Dkt. No. 347 at 7-8), and granting MIL No. 5 in part, including “with
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`respect to ‘copying’ or any variation thereof” (Dkt. No. 347 at 8-9 (emphasis added)), the Court
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 6 of 22 PageID #: 18733
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`nevertheless permitted Seagen to introduce evidence of (1) purported copying prior to the issuance
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`of the ’039 patent and (2) material that Seagen failed to show was not in the public domain.
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`Further, the Court permitted Seagen to question its expert witness at length while repeatedly using
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`the word “copying,” and even after Daiichi Sankyo Japan objected, Seagen was permitted to
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`continue by using the variation “duplicating.” (E.g., Trial Tr. (Day 4) at 112:19-114:17.)
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`Additionally, while the Court granted certain of Defendants’ MIL relating to purported
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`copying, the Court denied others. (Dkt. No. 347 at 8.) Specifically, in their denied MIL Nos. 2
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`and 4, Defendants requested that the Court preclude any evidence, testimony, or argument from
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`Seagen relating to (i) alleged copying of subject matter that is not an embodiment of the asserted
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`claims (Dkt. No. 313 at 2-4), and (ii) the prior Seagen and Daiichi Sankyo Japan collaboration
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`(which Seagen uses to suggest copying by Daiichi Sankyo Japan). (Dkt. No. 313 at 6-8.) This
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`provided Seagen an alternate avenue to introduce evidence that should have been excluded.
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`At trial, Seagen introduced significant amounts of evidence relating to purported copying
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`of subject matter that is not within the scope of the asserted claims, as well as the prior
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`collaboration between Seagen and Daiichi Sankyo Japan (relating to ADCs that are also not within
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`the scope of the asserted claims). (See PX-0180; PX-0184; PX-0208; PX-0209; PX-0210;
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`PX-0211; PX-0212; PX-0227; PX-0230; PX-0235; PX-0653; PX-0724; PX-0758; PX-0844; Trial
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`Tr. (Day 2) at 59:21-62:24, 86:16-87:11, 88:9-91:6, 91:7-21, 94:6-99:16, 157:14-169:11,
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`169:21-23; Trial Tr. (Day 4) at 132:17-133:3.) Further, Seagen failed to show that purportedly
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`copied information was not in the public domain, and included conduct before the filing of the
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`application for the ’039 patent.
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`For example, Seagen introduced an email and testimony from Daiichi Sankyo Japan’s
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`Dr. Koji Morita, concerning certain conjugation protocols used during the prior collaboration,
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 7 of 22 PageID #: 18734
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`(PX-0208; PX-0209; Trial Tr. (Day 2) at 89:14-90:10, 157:14-169:11, 169:21-23), and used this
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`document to elicit testimony from its expert, Dr. Bertozzi, alleging copying. (Trial Tr. (Day 2) at
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`89:14-90:10.) The ’039 patent, however, does not claim any conjugation methods, as Seagen’s
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`expert Dr. Bertozzi admitted, (see id. at 113:22-115:9), and the focus of the collaboration was an
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`entirely different ADC that is not an embodiment of the ’039 patent’s claims. (E.g., Trial Tr. (Day
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`3) at 47:14-48:2, 48:7-8, 65:3-66:15.) Moreover, the document predated the application for the
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`’039 patent by several years, and Seagen failed to show that the conjugation method in question
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`was not in the public domain. This evidence unquestionably should not have permitted in light of
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`the Court’s ruling granting Defendants’ MIL Nos. 1 and 3.
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`Seagen also introduced and elicited testimony regarding lab notebooks, including one lab
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`notebook that relates to conjugation methods and references “SG-type” conjugation. (PX-0227;
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`Trial Tr. (Day 2) at 88:13-89:4, 164:16-169:11, 169:21-23.) This evidence became the dominant
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`theme of Seagen’s case and confused the jury because, again, the ’039 patent does not claim any
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`conjugation method. (See, e.g., Trial Tr. (Day 2) at 113:22-115:9.) It is further irrelevant because
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`Seagen made no showing that any such conjugation was used to make the accused product
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`Enhertu®, and, in fact, the manufacturing processes used to make Enhertu® are “entirely different”
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`from those used during the collaboration. (Trial Tr. (Day 3) at 96:20-97:1.) Likewise, Dr. Bertozzi
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`testified regarding alleged copying of Seagen’s manufacturing protocol based on a compilation of
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`excerpts from a lab notebook, despite the fact that the ’039 patent does not claim any
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`manufacturing protocol, and also focused on cysteine conjugation and the MC group, despite those
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`elements not being proprietary to Seagen. (Trial Tr. (Day 2) at 90:11-91:21.)
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`As another example, Seagen introduced evidence and testimony from Dr. Bertozzi
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`regarding a meeting between Seagen and Daiichi Sankyo Japan concerning an unrelated ADC,
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 8 of 22 PageID #: 18735
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`asserting Seagen taught Daiichi Sankyo Japan its alleged proprietary manufacturing strategy. (PX-
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`0184; Trial Tr. (Day 2) at 59:21-61:15.) The ’039 patent, however, does not claim any
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`manufacturing process or strategy. (See, e.g., Trial Tr. (Day 2) at 113:22-115:9.)
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`The introduction of this evidence concerning alleged copying (including alleged copying
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`of subject matter that is not an embodiment of the asserted claims) caused significant prejudice to
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`Daiichi Sankyo Japan. Seagen utilized the documents and testimony to make inflammatory
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`accusations that Daiichi Sankyo Japan copied Seagen’s purported technology, without tying any
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`of the documents or testimony to the ’039 patent or any claim or defense in this lawsuit. The
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`documents and testimony thus also conflated irrelevant and relevant issues and confused the jury.
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`Thus, the introduction of this evidence was error that severely prejudiced Daiichi Sankyo
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`Japan and resulted in an unfair trial, warranting a new trial. Cates v. Creamer, 431 F.3d 456, 460
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`(5th Cir. 2005); Smith, 773 F.2d at 613.
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`2.
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`Improper Evidence Outside the Priority Application
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`Defendants’ Motion in Limine Nos. 6 and 7 sought to preclude Seagen from introducing or
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`relying on (i) prior art not included in the patent or priority applications, and (ii) internal testing
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`not included in the patent or priority applications. The Court granted Defendants’ motions as to
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`non-expert witnesses, but all such testimony should have been precluded. Seagen improperly
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`presented evidence of such internal testing even through its fact witnesses over Defendants’
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`objection. (See, e.g., Trial Tr. (Day 4) at 84:20-86:8.) Further, Dr. Bertozzi repeatedly and
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`improperly relied on experiments Seagen performed that were nowhere reported in the
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`specification of the ’039 patent or any application on which Seagen based its priority claim. (See,
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`e.g., Trial Tr. (Day 2) at 28:16-38:7.) Seagen also relied on a prior art publication nowhere
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`mentioned in the specification to assert that the POSA would have understood it as an example of
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`a tetrapeptide linker falling outside the claims to provide blazemarks to the claimed genus of
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 9 of 22 PageID #: 18736
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`tetrapeptide linkers consisting only of glycine and phenylalanine (“G/F-only tetrapeptide linkers”).
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`(See, e.g., Trial Tr. (Day 4) at 93:6-97:8.) This testimony was highly prejudicial to Defendants
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`because it erroneously suggested to the jury that Seagen’s priority claim could be supported by
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`data and information not included in the applications on which Seagen based its priority claim. Its
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`admission merits a new trial.
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`B.
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`The Jury Verdict is Defective
`1.
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`Seagen’s Disclaimer of Claim 8 Renders the Jury Verdict Defective
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`“[W]hen a jury was told it could rely on any of two or more independent legal theories,
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`one of which was defective, the general verdict must be set aside.” WesternGeco LLC v. ION
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`Geophysical Corp., 913 F.3d 1067, 1073 (Fed. Cir. 2019) (cleaned up). Thus, if a jury found
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`“infringement of a now-invalidated claim,” the verdict “cannot be sustained.” Id. at 1073.
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`Here, Seagen asserts that Defendants infringe one or more of Claims 1-5 and 9-10 of the
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`’039 patent (collectively, “Remaining Claims”). No other cause of action exists.
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`As discussed in Defendants’ Motion for Judgment (Dkt. No. 442), Seagen no longer has a
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`viable cause to support its infringement action for three independent reasons: (1) the Remaining
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`Claims are invalid because Seagen, through its disclaimer of Claims 6-8, surrendered property
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`rights in all claims that are patentably indistinct from Claims 6-8, including the Remaining Claims
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`(id. at Section V.A); (2) the Remaining Claims can no longer be asserted because the Patent and
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`Trial Appeal Board (“PTAB”) entered an adverse judgment against Seagen on Claims 6-8, thereby
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`extinguishing Seagen’s cause of action for infringement of all claims that are patentably indistinct
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`from Claims 6-8, (id. at Sections V.B-C); and (3) the Remaining Claims are invalid regardless of
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`whether they are patentably indistinct from Claims 6-8 because Seagen, through its disclaimer of
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`Claims 6-8, disavowed the full scope of the Remaining Claims, causing those claims to be
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`invalidated by improper amendment, (id. at Section V.D).
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 10 of 22 PageID #: 18737
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`The proper course of action is for this Court to rule that none of the Remaining Claims can
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`support a viable cause of action. Even if the Court rules otherwise, the jury verdict must
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`nevertheless be set aside if it finds any one of the Remaining Claims invalid and/or extinguished
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`from this case. In the present case, the infringement verdict was based on a general jury verdict
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`that simply asked whether “Seagen, the Plaintiff, prove[d] by a preponderance of the evidence that
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`Defendant DSC, infringed ANY of the [Remaining Claims]?” (Dkt. No. 369 at 4) (emphasis in
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`the original). Under these circumstances, this Court cannot determine which of the Remaining
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`Claims the jury actually found infringed. Accordingly, because the jury’s infringement verdict
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`may have been predicated solely on one or more of the invalidated and/or extinguished claims, the
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`general verdict is defective and “cannot be sustained.” WesternGeco, 913 F.3d at 1073.
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`2.
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`Generality of Invalidity Verdict Does Not
`Permit Understanding of Potential Inconsistencies
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`The jury verdict as to invalidity in this case merely stated that Defendants did not prove by
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`clear and convincing evidence that any of the Asserted Claims are invalid. It did not break out the
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`bases for finding no invalidity, including in particular whether the ’039 patent was entitled to
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`Seagen’s claimed 2004 priority date. (See Dkt. 328 at Exhibit 12; Trial Tr. (Day 5) at 48:3-9.)
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`Due to the generality of the verdict, it is impossible to know, e.g., whether the jury found the ’039
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`patent was not entitled to a 2004 priority date but that there was still no anticipation—a legally
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`incorrect finding if the jury’s infringement verdict is upheld. See Peters v. Active Mfg. Co., 129
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`U.S. 530, 537 (1889) (“That which infringes, if later, would anticipate, if earlier.”); (see also Dkt.
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`No. 444).) As such, the general verdict is defective.
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`C.
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`Even if This Court Can Cure the Now-Defective Remaining Claims,
`Enhertu® Does Not and Cannot Infringe the So-Narrowed Claims
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`Seagen disclaimed Claim 8, which—in effect—led to it disavowing and surrendering all
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`rights it previously had in ADCs covered by Claim 8, leaving the Remaining Claims defective for
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 11 of 22 PageID #: 18738
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`encompassing an invalid claim scope. (See Dkt. No. 442 at Section V.) The only way to cure such
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`defects is by carving out the now-invalid claim scope from (and thereby narrowing) the Remaining
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`Claims through a reissue, a procedure that only the United States Patent and Trademark Office
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`(“USPTO”) is authorized to complete. (Id. at Section V.D.) If, however, this Court deems itself
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`to have the authority to cure the otherwise defective ’039 patent, the result would still require a
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`ruling in Defendants’ favor because the claims presented to the jury were defective, and Enhertu®
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`does not and cannot meet all the limitations of the narrowed Remaining Claims.
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`Once the full scope of Claim 8 is carved out and removed from Claim 1 (the sole
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`independent claim), Seagen would need to prove that Enhertu® meets the following
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`scope-narrowing limitation (“Narrowing Limitation”) in order to show infringement of any
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`asserted claim:
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`Narrowing Limitation
`1. An antibody-drug conjugate . . . wherein
`the drug moiety is intracellularly cleaved in a
`patient from the antibody of the antibody-drug
`conjugate or an intracellular metabolite of the
`antibody-drug conjugate.
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`“[T]o find infringement, the accused device must contain each limitation of the claim . . . .”
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`Disclaimed Claim Scope
`8. The antibody-drug conjugate compound
`of claim 1, 2, 3, 4, or 5, wherein the drug
`moiety is intracellularly cleaved in a patient
`from an
`intracellular metabolite of
`the
`antibody-drug conjugate.
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`TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1379 (Fed. Cir. 2008) (internal
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`quotation marks omitted). Yet evidence presented at trial shows that Enhertu® does not meet the
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`Narrowing Limitation. (See, e.g., D.I. 442, Ex. A (“Lambert Dec.”) at ¶ 40.) Regardless of the
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`identity of Enhertu®’s “drug moiety,” it is undisputed that Enhertu® is never intracellularly cleaved
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`“from the antibody of the antibody-drug conjugate.” (E.g., DX-0064 at 8; Lambert Dec. at
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`¶¶ 39-41.) Seagen’s expert did not, and cannot, dispute that Enhertu® forms an intracellular
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`metabolite and this metabolite further degrades, meaning any alleged intracellular cleavage is not
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 12 of 22 PageID #: 18739
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`from the antibody of the antibody-drug conjugate. (See PX-0168 (cited by Dr. Bertozzi illustrating
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`the foregoing); Lambert Decl. ¶¶ 40-41.) For this reason, the judgment should be vacated and a
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`new trial granted, subject to briefing as to whether there remains any genuine issue of material fact
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`as to infringement of the narrowed claims, and to the extent it is legally possible for Seagen to
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`retain rights in patent claims where one half of their claim scope has been disclaimed.
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`D.
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`The Court Issued Improper Jury Instructions Giving Rise to
`Outcome-Determinative Errors, With Each Error Necessitating a New Trial
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`A party is entitled to a new trial if it can demonstrate that (1) “the charge as a whole
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`create[d] substantial and ineradicable doubt whether the jury has been properly guided in its
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`deliberations,” and (2) “the challenged instruction . . . affected the outcome of the case” based
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`upon the entire record. Z4 Techs., Inc. v. Microsoft Corp., 507 F.3d 1340, 1353 (Fed. Cir. 2007)
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`(citing Hartsell v. Doctor Pepper Bottling Co., 207 F.3d 269, 272 (5th Cir. 2000)). At trial, this
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`Court—over the express objections of Defendants—provided the jury with erroneous statements
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`of the law.1 Each provides a sufficient basis for granting Defendants’ request for a new trial.
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`1.
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`The Court Improperly Excluded Two Statements of the Law,
`One on Written Description and Another on Enablement
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`First, in instructing the jury in connection with the written description requirement, the
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`Court overruled Defendants’ objections and thereby failed to include the following instruction:
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`Finally, in considering written description, be aware that the actual possession of the
`invention outside of the specification is not relevant. Rather, it is the specification itself that
`must demonstrate possession such that one skilled in the art reading the original disclosure
`could reasonably discern the limitations at issue in a claim.
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`(Trial. Tr. (Day 5) at 39:8-24; Dkt. No. 367 at 27-28.)
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`1 Defendants raised these objections during the Formal Jury Instruction Charge and in the Parties’
`Proposed Final Jury Instructions. (See Dkt. No. 367.)
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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 13 of 22 PageID #: 18740
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`This clarification, as mandated by the Federal Circuit,2 was necessary given the amount of
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`evidence the jury heard about Seagen’s research that was not included in the ’039 patent. Failure
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`to provide this requested instruction, therefore, was not only a critical omission of the proper legal
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`standard; it was an outcome-determinative error that allowed the jury to assume improperly that
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`“actual possession of the invention outside of the specification” may be sufficient to overcome an
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`invalidity challenge based on lack of written description support.
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`Second, while instructing the jury regarding enablement, the Court overruled Defendants’
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`objections (Trial Tr. (Day 5) at 33:23-34:24; Dkt. No. 367 at 32), and, in so doing, failed to include
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`the following clarification directly rooted in Federal Circuit precedent:
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`Finally, it is the specification, not the knowledge of one skilled in the art, that must supply
`the novel aspects of an invention in order to constitute adequate enablement. It is insufficient
`if the specification provides only a starting point or a direction for further research.
`
`(Dkt. No. 367 at 32.)3
`
`Because Seagen presented extensive evidence on validity that went far beyond the
`
`specification, the Court’s failure to include this instruction was tantamount to allowing the jury to
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`assume improperly that all evidence presented—including information far beyond the confines of
`
`the specification—could be used to “supply the novel aspects of an invention in order to constitute
`
`adequate enablement.” See Genentech, 108 F.3d at 1366. Such error was outcome-determinative
`
`because, under a proper enablement analysis, no reasonable jury would have been able to find the
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`specification alone was sufficient to enable the claimed invention. (See Dkt. No. 444 at 10-19.)
`
`
`2 See, e.g., Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1309 (Fed. Cir. 2015) (“The written
`description requirement requires possession as shown in the specification, not as shown by prior
`experimental work.”).
`3 This instruction comes directly from Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1366
`(Fed. Cir. 1997), which notes a specification lacks enablement when it fails to teach what is new.
`
`
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`

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`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 14 of 22 PageID #: 18741
`
`
`
`
`
`2.
`
`The Court Misstated the Law on “Blazemarks”
`
`Over Defendants’ objections (Trial Tr. (Day 5) at 32:25-33:10; Dkt. No. 367 at 25), the
`
`Court misstated the law in instructing the jury on “blazemarks” pertinent to written description:
`
`Court’s instructions
`In this case, claims 1 through 5,
`9, and 10 of the ’039 Patent are
`directed to a group of antibody-
`drug
`conjugate molecules,
`which you’ve heard referred to
`as ADCs, which can be referred
`to as a genus. The specification
`must have blazemarks to guide
`the
`reader
`through
`the
`specification’s forest
`toward
`the specific examples of species
`within the particular genus that
`is claimed.
`
`Defendants’ proposed instructions
`In this case, claims 1-5, 9, and 10 of the ’039 patent are
`directed to a group of ADC molecules, which can be referred
`to as a ‘genus.’ The specification must have blazemarks to
`guide the reader through the specification’s ‘forest’ toward the
`particular genus that is claimed. Such blazemarks must be
`apparent without already knowing the claimed invention. It is
`inappropriate to identify blazemarks by working backwards,
`looking to the claimed invention, and then finding the various
`elements of the claim in the application or specification. In the
`absence of such blazemarks to the claims, simply describing a
`large genus of compounds is not sufficient to satisfy the
`written description requirement for claims to a narrower group
`of compounds within that large genus.
`
`The Court’s instruction was legally erroneous because it suggested that the blazemarks must point
`
`to examples of species within the genus. The law, however, requires the reverse: The blazemarks
`
`must point to the genus and these blazemarks must be apparent without hindsight knowledge of
`
`the invention, a critical nuance that was captured only by Defendants’ proposed instruction.
`
`Defendants’ instruction is firmly rooted in the Federal Circuit’s extensive discussion of written
`
`description specifically dealing with chemical sub-genuses, as summarized in Novozymes A/S v.
`
`DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013). (See Dkt. No. 367 at 25.)
`
`Here, the requested instruction was necessary in view of Dr. Bertozzi’s “highlight-the-
`
`limitations” approach that is virtually indistinguishable from the analysis that the Federal Circuit
`
`rejected in Novozymes. 723 F.3d at 1349-51. Because of the erroneous instruction, the jury was
`
`never placed in a position to make a proper written-description assessment. And, because the lack
`
`of blazemarks would have necessarily required the jury to find the asserted claims invalid for lack
`
`of written-description support, this Court’s misstatement of the law was outcome-determinative.
`
`
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`

`
`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 15 of 22 PageID #: 18742
`
`
`
`
`
`3.
`
`The Court Improperly Excluded a Reasonable Royalty Instruction
`
`Regarding reasonable royalty, the Court, over Defendants’ objection, failed to include a
`
`clarifying instruction agreed upon by the Parties and derived from Federal Circuit precedent (see
`
`Apple, Inc v Wi-LAN, Inc., 25 F.4th 960, 971-73 (Fed. Cir. 2022)) explaining how to evaluate
`
`comparable patent licenses. (Trial Tr. (Day 5) at 42:5-44:18; Dkt. No. 367 at 36-37.). This
`
`exclusion left the jury without sufficient guidance for assessing Seagen’s allegedly comparable
`
`licenses, and permitted the jury to draw improper conclusions, leading to an excessive damages
`
`award.
`
`E.
`
`The Court Improperly Excluded Evidence
`1.
`
`Documents and Expert Testimony Regarding Seagen’s Prosecution
`of Related Patent Applications before the European Patent Office
`
`The Court excluded documents regarding Seagen’s prosecution of related patent
`
`applications before the European Patent Office (“EPO”), (DX-0066, DX-0067, and DX-0433), and
`
`related testimony. (Pretrial Conf. Tr. (Day 1) at 80:1-9.) This was key evidence relevant to
`
`invalidity. Dr. Lambert testified that the broad scope of the claims of the ’039 patent,
`
`encompassing ADCs with any and all drug moieties, are not supported by its specification. (E.g.,
`
`Trial Tr. (Day 3) at 112:2-5, 112:-12-14.) The excluded evidence shows that the EPO reached
`
`consistent conclusions and that Seagen was improperly attempting to stretch the specification to
`
`encompass Daiichi Sankyo Japan’s already existing and breakthrough technology. The Court
`
`erroneously excluded the evidence on the basis that it would be confusing, (see Pretrial Conf. Tr.
`
`(Day 1) at 80:1-9), but any confusion would have been substantially outweighed by the probative
`
`nature of the evidence regarding invalidity and in reinforcing Dr. Lambert’s testimony. The
`
`documents should have been admitted and Daiichi Sankyo Japan should have been permitted to
`
`
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`

`

`
`Case 2:20-cv-00337-JRG Document 451 Filed 08/24/22 Page 16 of 22 PageID #: 18743
`
`
`
`
`
`elicit testimony related to them, particularly when DX-0067 is simply an excerpt of the file history
`
`of the ’039 patent asserted in this case.
`
`2.
`
`Email from Seagen’s CEO Acknowledging
`Enhertu®’s Potential and Asking Whose Technology It Is
`
`The Court also wrongly excluded an email from Seagen’s CEO, Dr. Clay Siegall. (DX-
`
`1179; Pretrial Conf. Tr. (Day 2) at 15:2-7.) That exclusion constituted prejudicial error resulting
`
`in an unfair trial and warranting a new trial. In this email, Dr. Siegall writes regarding Daiichi
`
`Sankyo Japan’s Enhertu®, asks