Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 1 of 32 PageID #: 18689
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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’ RENEWED MOTION FOR JUDGMENT AS A MATTER OF LAW AS
`TO NON-INFRINGEMENT AND DAMAGES
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`

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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 2 of 32 PageID #: 18690
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION .......................................................................................................... - 1 - 
`BACKGROUND ............................................................................................................ - 2 - 
`LEGAL STANDARD ..................................................................................................... - 2 - 
`ARGUMENT .................................................................................................................. - 3 - 
`No Reasonable Jury Could Find That Daiichi Sankyo Japan Infringed the
`A. 
`’039 Patent .......................................................................................................... - 3 - 
`No Reasonable Jury Could Find That Daiichi Sankyo Japan
`1. 
`Directly Infringed the ’039 Patent Because the Accused Product
`Enhertu® Does Not Meet All Limitations of the ’039 Patent and
`Daiichi Sankyo Japan Has Not Committed an Infringing Act ................ - 3 - 
`No Reasonable Jury Could Find That Daiichi Sankyo Japan
`Induced Infringement of the ’039 Patent .............................................. - 10 - 
`No Reasonable Jury Could Find That Daiichi Sankyo Japan
`Willfully Infringed the ’039 Patent ....................................................... - 12 - 
`No Reasonable Jury Could Award Damages Beyond $10.4 Million ............... - 19 - 
`B. 
`CONCLUSION ............................................................................................................. - 24 - 
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`2. 
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`3. 
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`I. 
`II. 
`III. 
`IV. 
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`V. 
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 3 of 32 PageID #: 18691
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Abraham v. Alpha Chi Omega,
`708 F.3d 614 (5th Cir. 2013) .....................................................................................................2
`
`Am. Tech. Ceramics Corp. v. Presidio Components, Inc.,
`No. 14-CV-6544, 2019 WL 2330855 (E.D.N.Y. May 31, 2019) ............................................15
`
`Anascape, Ltd. v. Microsoft Corp.,
`No. 9:06-CV-158, 2008 WL 7182476 (E.D. Tex. Apr. 25, 2008) ...........................................15
`
`Apple Inc. v. Samsung Elecs. Co., Ltd.,
`258 F. Supp. 3d 1013 (N.D. Cal. 2017) ...................................................................................13
`
`Apple Inc. v. Wi-LAN Inc.,
`25 F.4th 960 (Fed. Cir. 2022) ......................................................................................20, 22, 23
`
`Autoficio, LLC v. Cimble Corp.,
`No. 4:17-cv-00404, 2020 U.S. Dist. LEXIS 103730 (E.D. Tex. June 15, 2020) ....................10
`
`Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
`512 F.3d 1338 (Fed. Cir. 2008)................................................................................................15
`
`Bayer AG v. Elan Pharm. Rsch. Corp.,
`212 F.3d 1241 (Fed. Cir. 2000)..................................................................................................3
`
`Bayer HealthCare LLC v. Baxalta Inc.,
`989 F.3d 964 (Fed. Cir. 2021)..................................................................................................12
`
`Cohen v. United States,
`487 F.2d 525 (Ct. Cl. 1973) .....................................................................................................12
`
`Commil USA, LLC v. Cisco Sys., Inc.,
`135 S.Ct. 1920 (2015) ..............................................................................................................11
`
`Dow Jones & Co. v. Ablaise Ltd.,
`606 F.3d 1338 (Fed. Cir. 2010)................................................................................................10
`
`Duncan Parking Techs., Inc. v. IPS Grp., Inc.,
`914 F.3d 1347 (Fed. Cir. 2019)..................................................................................................3
`
`Eli Lilly & Co. v. Aradigm Corp.,
`376 F.3d 1352 (Fed. Cir. 2004)..................................................................................................3
`
`
`
`ii
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`

`

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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 4 of 32 PageID #: 18692
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`
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`
`
`In re Google LLC,
`949 F.3d 1338 (Fed. Cir. 2020)..................................................................................................9
`
`Grain Processing Corp. v. American Maize–Prods. Co.,
`185 F.3d 1341 (Fed. Cir. 1999)................................................................................................19
`
`Gustafson, Inc. v. Intersystems Industrial Prods., Inc.,
`897 F.2d 508 (Fed. Cir. 1990)..................................................................................................18
`
`Halo Elecs., Inc. v. Pulse Elecs., Inc.,
`579 U.S. 93 (2016) ...................................................................................................................12
`
`Imonex Servs., Inc. v. W.H. Münzprüfer Dietmar Trenner GmbH,
`408 F.3d 1374 (Fed. Cir. 2005)................................................................................................12
`
`Intellectual Ventures II LLC v. Sprint Spectrum, L.P.,
`No. 2:17-cv-00662-JRG-RSP, 2019 WL 1987172 (E.D. Tex. Apr. 12, 2019)........................13
`
`Kaufman Co., Inc. v. Lantech, Inc.,
`807 F.2d 970 (Fed. Cir. 1986)..................................................................................................14
`
`Koninklijke Philips N.V. v. Zoll Med. Corp.,
`656 F. App’x 504 (Fed. Cir. 2016) ..........................................................................................11
`
`Limelight Networks, Inc. v. Akamai Techs., Inc.,
`572 U.S. 915 (2014) .................................................................................................................10
`
`Maxell Ltd. v. Apple Inc.,
`No. 5:19-CV-00036-RWS, 2019 WL 7905455 (E.D. Tex. Oct. 23, 2019) .............................13
`
`Medgraph, Inc. v. Medtronic, Inc.,
`111 F. Supp. 3d 346 (W.D.N.Y. 2015) ....................................................................................10
`
`MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp.,
`420 F.3d 1369 (Fed. Cir. 2005)..................................................................................................9
`
`nCube Corp. v. SeaChange Int’l, Inc.,
`436 F.3d 1317 (Fed. Cir. 2006)................................................................................................12
`
`Packet Intelligence LLC v. NetScout Sys., Inc.,
`No. 2:16-CV-00230-JRG, 2019 WL 2375218 (E.D. Tex. June 5, 2019) ..........................12, 13
`
`ResQNet.com, Inc. v. Lansa, Inc.,
`594 F.3d 860 (Fed. Cir. 2010)............................................................................................19, 20
`
`Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC,
`30 F.4th 1109 (Fed. Cir. 2022) ................................................................................................11
`
`
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`iii
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 5 of 32 PageID #: 18693
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`
`
`
`
`Sears, Roebuck & Co. v. Stiffel Co.,
`376 U.S. 225 (1964) .................................................................................................................15
`
`Sonos, Inc. v. D&M Holdings Inc.,
`No. CV 14-1330-WCB, 2017 WL 5633204 (D. Del. Nov. 21, 2017) .....................................14
`
`State Indus., Inc. v. A.O. Smith Corp.,
`751 F.2d 1226 (Fed. Cir. 1985)................................................................................................13
`
`TGIP, Inc. v. AT&T Corp.,
`527 F. Supp. 2d 561 (E.D. Tex. 2007) ...................................................................................2, 3
`
`TrafFix Devices, Inc. v. Marketing Displays, Inc.,
`532 U.S. 23 (2001) ...................................................................................................................15
`
`Uniloc USA, Inc. v. Microsoft Corp.,
`632 F.3d 1292 (Fed. Cir. 2011)....................................................................................19, 20, 21
`
`Vita-Mix Corp. v. Basic Holding, Inc.,
`581 F.3d 1317 (Fed. Cir. 2009)................................................................................................11
`
`Zenith Labs., Inc. v. Bristol-Myers Squibb Co.,
`19 F.3d 1418 (Fed. Cir. 1994)....................................................................................................4
`
`Zoltek Corp. v. U.S.,
`672 F.3d 1309 (Fed. Cir. 2012)..................................................................................................9
`
`Statutes
`
`35 U.S.C. § 271 ..................................................................................................................3, 8, 9, 11
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`Rules
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`Fed. R. Civ. P. 50(a) ..................................................................................................................2, 10
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`iv
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 6 of 32 PageID #: 18694
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`I.
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`INTRODUCTION
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`Defendant Daiichi Sankyo Company, Limited (“Daiichi Sankyo Japan”) and Defendant-
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`Intervenors AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd, (collectively,
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`“Defendants”) move for judgment as a matter of law as to non-infringement, willfulness, and
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`damages (should a finding of infringement stand).
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`First, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Daiichi Sankyo Japan directly infringed any of the Asserted Claims 1-5, 9-10 of U.S. Patent No.
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`10,808,309 (“the ’039 patent”), because Plaintiff Seagen Inc. (“Seagen”) did not present sufficient
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`evidence to prove (a) the accused product Enhertu®—a life-saving, life-extending cancer drug
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`created and developed by Daiichi Sankyo Japan—satisfies the limitations required by the Asserted
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`Claims, and (b) Daiichi Sankyo Japan directly commits an infringing act.
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`Second, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Seagen established that Daiichi Sankyo Japan indirectly infringed the Asserted Claims of the ’039
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`patent because (a) Seagen has not presented sufficient evidence to prove direct infringement and
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`(b) the record lacks any evidence demonstrating Daiichi Sankyo Japan’s subjective knowledge
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`regarding its acts constituting patent infringement.
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`Third, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Seagen established that Daiichi Sankyo Japan willfully infringed the Asserted Claims of the ’039
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`patent because (a) Seagen’s claim is primarily based on pre-issuance conduct legally irrelevant to
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`Seagen’s claims of post-issuance willfulness, (b) Seagen’s claim is based largely on conjugation
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`methods it admits are not claimed in the ’039 patent, (c) Seagen’s allegedly copied materials were
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`in the public domain, and (d) Daiichi Sankyo Japan presented evidence that it did not use Seagen’s
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`information in the development of Enhertu®, which Seagen weakly attempted to rebut.
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 7 of 32 PageID #: 18695
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`Fourth, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Seagen established it is entitled to damages of more than $10.4 million, because Defendants
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`presented overwhelming evidence that Seagen’s damages expert, Ms. Carrie Distler, reached her
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`5-8% reasonable royalty amount (an 8% royalty of the agreed-upon damages base of $522.752
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`million corresponds to the jury’s award of $41.82 million) through a legally flawed analysis of
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`agreements that encompass significantly more value than a hypothetical negotiation concerning a
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`non-exclusive license to a single patent.
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`II.
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`BACKGROUND
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`Seagen brought this lawsuit at 12:02 am Eastern Time on October 20, 2020, alleging that
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`Daiichi Sankyo Japan infringes the ’039 patent.1 At the close of the Parties’ cases, Defendants
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`moved for judgment as a matter of law under Rule 50(a) on non-infringement, willful
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`infringement, and damages, among other issues, and the Court denied that motion. (Dkt. 365; see,
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`e.g., Trial Tr. (Day 4) at 315:17-316:11, 317:20-318:8, 332:10-333:3, 334:4-18, 335:21-336:6.)
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`The jury found infringement (and willful infringement) of the ’039 patent and awarded Seagen
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`$41.82 million in damages. (Dkt. 369.)
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`III. LEGAL STANDARD
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`“Judgment as a matter of law is proper when ‘a reasonable jury would not have a legally
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`sufficient evidentiary basis to find for the party on that issue.’” Abraham v. Alpha Chi Omega,
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`708 F.3d 614, 620 (5th Cir. 2013) (quoting Fed. R. Civ. P. 50(a)). The non-moving party must
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`identify “substantial evidence” to support its positions. TGIP, Inc. v. AT&T Corp., 527 F. Supp.
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`1 AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd (together, “AstraZeneca”)
`intervened in this action on July 28, 2021. (Dkt. 128.) Pursuant to a March 2019 collaboration
`agreement, AstraZeneca is involved in the domestic commercialization and sale of the accused
`product Enhertu®. (Id.)
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 8 of 32 PageID #: 18696
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`2d 561, 569 (E.D. Tex. 2007). “Substantial evidence is more than a mere scintilla. It means such
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`relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Eli
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`Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1363 (Fed. Cir. 2004).
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`IV. ARGUMENT
`A.
`
`No Reasonable Jury Could Find That
`Daiichi Sankyo Japan Infringed the ’039 Patent
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`Daiichi Sankyo Japan is entitled to judgment as a matter of law on non-infringement
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`because no reasonable jury would have a legally sufficient evidentiary basis to find that Daiichi
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`Sankyo Japan directly or indirectly infringed the ’039 patent. Seagen has the burden to prove
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`infringement by a preponderance of the evidence. Duncan Parking Techs., Inc. v. IPS Grp., Inc.,
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`914 F.3d 1347, 1360 (Fed. Cir. 2019).
`
`1.
`
`No Reasonable Jury Could Find That Daiichi Sankyo
`Japan Directly Infringed the ’039 Patent Because the Accused
`Product Enhertu® Does Not Meet All Limitations of the ’039 Patent
`and Daiichi Sankyo Japan Has Not Committed an Infringing Act
`
`No reasonable jury would have a legally sufficient evidentiary basis to find that Seagen
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`presented sufficient evidence demonstrating that the accused product Enhertu® directly infringes
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`the ’039 patent. If any one of the claim limitations is not present in the accused product, there is
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`no infringement. Bayer AG v. Elan Pharm. Rsch. Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000).
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`Moreover, Seagen failed to establish that Daiichi Sankyo Japan—on its own or through its alleged
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`agent Daiichi Sankyo, Inc. (“Daiichi Sankyo US”)—directly committed an infringing act as
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`required by 35 U.S.C. § 271.
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`a.
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`Seagen Failed to Prove Enhertu®’s Drug
`Moiety is Intracellularly Cleaved in a Patient
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`Claim 1, the only independent claim of the ’039 patent, requires that an ADC must have
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`“D”, “a drug moiety,” that “is intracellularly cleaved in the patient from the antibody” of the ADC.
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 9 of 32 PageID #: 18697
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`(DX-0001 at Claim 1.) In its claim construction order, the Court construed “intracellularly
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`cleaved” to mean a “metabolic process or reaction inside a cell” whereby “the linker[] between the
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`drug moiety (D) and the antibody (Ab) is broken, resulting in the free drug dissociated from the
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`antibody inside the cell” (the “Drug Moiety Intracellular Cleavage Limitation”). (Dkt. 155 at 41-
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`42 (emphasis added).) In other words, the Court’s construction makes plain that the Drug Moiety
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`Intracellular Cleavage Limitation requires the drug moiety (D) to disassociate as a “free drug.”
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`This is unsurprising. The ’039 patent specification explicitly distinguishes between “drug
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`moieties” (which disassociate as a “free drug”) and “drug-linker compounds” (which disassociate
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`with part of the ADC linker attached),2 yet the ’039 patent only claims “drug moieties.”3 (DX-0001
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`at 159:9-18, Claim 1.) As such, for Seagen to carry its burden on infringement with respect to the
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`Drug Moiety Intracellular Cleavage Limitation, it must prove that Enhertu®’s “drug moiety”
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`disassociates from its antibody as a “free drug.” Seagen has not—and cannot—carry this burden.
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`First, Seagen has failed to meet its burden of proof to demonstrate Enhertu® meets the Drug
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`Moiety Intracellular Cleavage Limitation because it put forth no experimental evidence to
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`demonstrate that Enhertu® meets this in vivo functional limitation. See Zenith Labs., Inc. v. Bristol-
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`Myers Squibb Co., 19 F.3d 1418, 1423-24 (Fed. Cir. 1994) (finding plaintiff did not prove that an
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`in vivo functional claim limitation was met where its technical expert’s theory was not supported
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`by proper experimental data). The overwhelming evidence (including named inventors’
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`2 Where the payload is a drug-linker compound, it comprises the drug moiety and at least part of
`the linker, which could be portions of the stretcher unit, the amino acid unit, or the spacer unit.
`(DX-0001 at 61:5-62:5.)
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`3 As Dr. Lambert explained, the art refers to ADCs which release payloads with linker moieties
`still attached (i.e., “drug-linker compounds”) as having “non-traceless linkers,” and refers to
`ADCs which release payloads without linker moieties still attached (i.e., “free drug”) as having
`“traceless linkers.” (Trial Tr. (Day 3) at 60:23-62:5, 193:23-24.) The ’039 patent only claims
`ADCs having traceless linkers. (Trial Tr. (Day 3) at 61:1-4.)
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 10 of 32 PageID #: 18698
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`admissions) demonstrated that in vivo intracellular cleavage cannot be assumed and—at a
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`minimum—requires experimental testing to prove. (See, e.g., Trial Tr. (Day 4) at 78:21-79:12
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`(Q: “So until you do an assay like the one you've described, you wouldn't know whether the linker
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`you have engineered is going to be successfully intracellularly cleaved by the enzyme. A: “In
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`science you never -- in science you never know anything until you assay it.”).) In fact, Dr.
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`Lambert’s undisputed testimony established that there are still no assays that can definitively
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`determine where cleavage occurs (i.e., intracellularly or extracellularly) in a patient as the Asserted
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`Claims require. (Trial Tr. (Day 3) at 123:18-124:10.) Similarly, there are still no assays to
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`determine what dissociates from the antibody inside the cell.4 (Id.)
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`As Defendants showed, the fact that an ADC is effective in killing cells, for example, does
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`not prove that any part of the ADC is actually cleaved intracellularly, given ADCs with
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`non-cleavable linkers have been shown to cause cell death. (Trial Tr. (Day 3) at 121:10-122:10.)
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`In addition, cell death is also not indicative of intracellular cleavage because payloads can diffuse
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`across membranes resulting in cell death. In other words, an ADC may cleave extracellularly and
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`the released payload could then diffuse across the cell membrane and kill the cell. (Trial Tr. (Day
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`3) at 120:8-122:15.) Dr. Lambert’s own research illustrates how the same ADC can release
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`multiple different products in vitro and such complexity makes determining what products are
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`released in vivo nearly impossible.5 (Trial Tr. (Day 3) at 122:16-124:10; DX-0074.)
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`4 Dr. Lambert presented unrebutted testimony and evidence regarding both the difficulty of
`determining where a given ADC is cleaved in a patient and determining what, if anything, is
`cleaved or dissociated from the antibody in a patient. (Trial Tr. (Day 3) at 119:16-124:10,
`129:16-120:10; DX-0075; DX-0085; DX-0093; DX-0096; DX-0140; DX-0145; DX-0191; DX-
`0219.)
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`5 In fact, the industry even recognized that determining the activity of an ADC as a routine assay
`would be very difficult as it cannot be standardized and used across multiple programs. (Trial
`Tr. (Day 3) at 124:11-6; DX-75.)
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 11 of 32 PageID #: 18699
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`Seagen’s reliance on conclusory expert testimony and inapposite documents (see infra)—
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`without experimental evidence—is not sufficient to demonstrate infringement.
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`Second, the overwhelming evidence presented to the jury demonstrates that the “drug
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`moiety” in Enhertu® —in view of the specific context of the disclosures and claims of the ’039
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`patent—is DX-8951. (E.g., Trial Tr. (Day 3) at 76:4-77:24, 204:25-205:3; see also id. at 13:24-
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`25, 28:7-13; DX-0114; DX-0940; DX-0941.) This is consistent with how Dr. Naito invented and
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`designed Enhertu®. (Trial Tr. (Day 2) at 240:21-241:11; Trial Tr. (Day 3) at 28:7-13.) As
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`explained at trial by Dr. Lambert and Dr. Naito, DX-8951 was the compound that Dr. Naito and
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`other Daiichi Sankyo Japan scientists linked to the GGFG tetrapeptide through a variety of
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`different spacers to make an ADC, as well as the compound that is attached to the antibody and
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`linker/spacer when Enhertu® is designed and made. (See, e.g., Trial Tr. (Day 2) 245:23-247:24;
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`Trial Tr. (Day 3) at 76:10-81:4.) Enhertu®, however, does not release DX-8951 as its payload
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`(i.e., DX-8951 does not disassociate from the antibody). (Trial Tr. (Day 3) at 82:9-21.) As Dr.
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`Lambert explained, Enhertu® instead releases DX-8951 with part of the spacer attached as its
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`payload (also called DXd, which is recognized as a derivative of the drug moiety).6 (Trial Tr. (Day
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`3) at 82:9-21, 85:6-11; see also Trial Tr. (Day 2) at 242:1-13; Trial Tr. (Day 3) at 13:20-25, 28:7-
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`13.) In other words, Enhertu® releases a “drug-linker compound” (DXd) not “free drug” (DX-
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`8951).
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`Further, as explained by Dr. Lambert, the public statements made by Daiichi Sankyo Japan
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`about “free drug” and “intracellular cleavage” were taken out of their specific context by Seagen
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`6 Dr. Naito’s innovative design allows Enhertu® to release a modified payload, which is less
`toxic and has different characteristics than would an ADC that released the drug moiety
`DX-8951 alone. (Trial Tr. (Day 3) at 13:20-25, 81:22-82:21, 85:6-11; Trial Tr. (Day 2) at 242:1-
`13, 243:1-17.) This design is one of the reasons Enhertu® is uniquely efficacious.
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 12 of 32 PageID #: 18700
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`and not evaluated within the meaning of those terms as used in the ’039 patent. (E.g., Trial Tr.
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`(Day 3) at 82:22-84:3, 224:3-11.) In other words, that Daiichi Sankyo Japan stated Enhertu®
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`undergoes “intracellular linker cleavage” in a regulatory document does not mean its “drug moiety
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`is intracellularly cleaved in a patient” as construed by the Court. Moreover, several of the
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`statements regarding “intracellular cleavage” relied upon by Dr. Bertozzi were merely statements
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`of intent. (E.g., PX-1137 (“The linker was designed to be cleaved . . .”) (emphasis added); PX-
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`0163 at 6 (“it is postulated that DS-8201a is cleaved by lysosomal enzymes . . . .) (emphasis
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`added).)
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`Because (1) Seagen relied on inapposite circumstantial evidence (without any experimental
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`data) to prove the existence of an in vivo functional limitation and (2) the Drug Moiety Intracellular
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`Cleavage Limitation of Claim 1 requires that “free drug disassociate from the antibody inside the
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`cell,” Enhertu® does not infringe Claim 1, and no reasonable jury would have a legally sufficient
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`basis to conclude otherwise based on the evidence presented by the Parties at trial.
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`b.
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`Seagen Failed to Prove That
`Enhertu® Contains a Self-Immolative Spacer
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`No reasonable jury would have a legally sufficient evidentiary basis to conclude that
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`Enhertu® contains a “self-immolative spacer,” as required by Claim 2 of the ’039 patent. (DX-
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`0001 at Claim 2.) The Court has construed the term “self-immolative spacer” to mean one “that
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`spontaneously degrades to release the drug” after cleavage. (Dkt. 155 at 25.) Therefore, an ADC
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`covered by Claim 2 must release “the drug,” meaning the drug unit alone after cleavage.
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`Defendants presented overwhelming evidence that Enhertu® does not contain a self-immolative
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`spacer because, as discussed supra, it releases the drug unit DX-8951 with part of the spacer
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`attached and not the drug moiety alone. (Trial Tr. (Day 3) at 13:20-25, 28:7-13, 82:9-21, 85:6-11;
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`Trial Tr. (Day 2) at 242:1-13.)
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 13 of 32 PageID #: 18701
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`As presented by Defendants at trial, the ’039 patent and its specification support this
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`interpretation. The patent unambiguously distinguishes a self-immolative spacer from a “non self-
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`immolative spacer” “in which part or all of the Spacer unit remains bound to the Drug moiety after
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`cleavage.” (DX-0001 at 68:20-25.) Figures 21 and 22 depict spacer units releasing a drug with
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`no portion of the spacer remaining attached, i.e., self-immolative spacers. (Id. at Figures 21-22.)
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`Like Claim 1, Claim 2 is directed to ADCs with a traceless linker (see supra n.3) designed to
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`deliver unmodified drug moieties alone as the payload. (DX-0001 at Claim 2.)
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`As discussed supra, the evidence admitted at trial therefore conclusively demonstrates that
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`Enhertu® has a non self-immolative spacer, as that term is explained and distinguished in the ’039
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`patent, because a portion of its spacer unit remains attached to the drug moiety. (See, e.g., Trial
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`Tr. (Day 3) at 82:9-21.) Without a self-immolative spacer that releases the drug moiety alone,
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`Enhertu® cannot infringe Claim 2 or Claims 3, 4, 5, 9, and 10 (which depend from Claim 2). No
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`reasonable jury would have a legally sufficient basis to conclude otherwise based on the evidence
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`presented at trial.
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`c.
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`No Reasonable Jury Could Find That Daiichi
`Sankyo Japan Committed an Act of Direct Infringement
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`No reasonable jury would have a legally sufficient evidentiary basis to find that Seagen
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`carried its burden to demonstrate that Daiichi Sankyo Japan—on its own or through the acts of an
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`agent—“makes, uses, offers to sell, or sells . . . within the United States or imports into the United
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`States” Enhertu®. 35 U.S.C. § 271(a) (emphases added). To the contrary, the evidence
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`demonstrates Daiichi Sankyo Japan manufactures Enhertu® in Japan, Daiichi Sankyo Japan sells
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`bulk vials of Enhertu® to Daiichi Sankyo US, Daiichi Sankyo US imports Enhertu® into the United
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`States, and Daiichi Sankyo US and AstraZeneca sell and market Enhertu® to third-party
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 14 of 32 PageID #: 18702
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`distributors in the United States. (Trial Tr. (Day 2) at 171:25-173:7, 174:18-175:4, 175:10-13.)
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`None of these acts constitute an infringing act by Daiichi Sankyo Japan.
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`Seagen argues that Daiichi Sankyo Japan offers to sell and sells Enhertu® to Daiichi Sankyo
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`US within the United States, yet has proffered no evidence on where such offers occur. Similarly,
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`although Seagen may argue that the location of title transfer indicates Daiichi Sankyo Japan’s sale
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`of bulk vials of Enhertu® occurs within the United States, the Federal Circuit has indicated that the
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`“more familiar places of contracting and performance” may take precedence over the passage of
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`legal title. MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369,
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`1377 (Fed. Cir. 2005). Seagen, however, has offered no evidence on the location of contracting
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`the relevant agreements.
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`Moreover, Seagen argues that Daiichi Sankyo Japan imports Enhertu® into the United
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`States, again focusing on the passage of title. The Patent Act does not define “imports,” but courts
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`have defined “imports” under § 271 similar to its common meaning. See Zoltek Corp. v. U.S., 672
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`F.3d 1309, 1326 (Fed. Cir. 2012) (noting under § 271(g) “[i]mportation occurs when the product
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`crosses the United States’ border, and use occurs within the United States”). Defendants presented
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`overwhelming evidence that Daiichi Sankyo US (not Daiichi Sankyo Japan) controls the process
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`whereby Enhertu® “crosses the United States’ border.” (Trial Tr. (Day 2) at 175:3-4); see Zoltek,
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`672 F.3d at 1326.
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`Likewise, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Daiichi Sankyo Japan is liable for infringement under an agency theory of liability, because Seagen
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`has failed to satisfy the requisite legal elements. In re Google LLC, 949 F.3d 1338, 1345 (Fed.
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`Cir. 2020) (“The essential elements of agency are (1) the principal's right to direct or control the
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`agent's actions, (2) the manifestation of consent by the principal to the agent that the agent shall
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 15 of 32 PageID #: 18703
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`act on his behalf, and (3) the consent by the agent to act.”) (internal quotations omitted). “The law
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`does not presume agency, and the party asserting agency has the burden to prove it.” Autoficio,
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`LLC v. Cimble Corp., No. 4:17-cv-00404, 2020 U.S. Dist. LEXIS 103730, *14 (E.D. Tex. June
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`15, 2020) (internal citation omitted); see also Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338,
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`1349 (Fed. Cir. 2010) (“[I]t is well-settled law that, absent a piercing of the corporate veil (which
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`neither party alleges), a parent company is not liable for the acts of its subsidiary.”) Seagen has
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`not carried its burden to demonstrate Daiichi Sankyo Japan’s right to control Daiichi Sankyo US’s
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`actions, nor the requisite consent by both companies. The evidence instead shows only that Daiichi
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`Sankyo US purchases bulk vials of Enhertu®, imports those bulk vials into the United States, sells
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`Enhertu® to third-party distributors in the United States (receiving payment for such sales), and
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`co-markets Enhertu® with AstraZeneca. Because this limited evidence establishes neither an
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`infringing act by Daiichi Sankyo Japan nor an agency relationship7 between Daiichi Sankyo Japan
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`and Daiichi Sankyo US, no reasonable jury would have a legally sufficient evidentiary basis to
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`find that Daiichi Sankyo Japan infringed the ’039 patent.
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`2.
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`No Reasonable Jury Could Find That Daiichi
`Sankyo Japan Induced Infringement of the ’039 Patent
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`Seagen alleges that Daiichi Sankyo Japan induced Daiichi Sankyo US to engage in direct
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`infringement of the Asserted Claims of the ’039 patent. (See Dkt. 328 at 5; Trial Tr. (Day 5) at
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`75:4-9.) As a threshold matter, inducement requires direct infringement. See, e.g., Medgraph,
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`Inc. v. Medtronic, Inc., 111 F. Supp. 3d 346, 357 (W.D.N.Y. 2015), aff’d, 843 F.3d 942 (Fed. Cir.
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`2016); Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 924 (2014) (where no direct
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`7 Similarly, as described in Daiichi Sankyo Japan’s Motion to Dismiss and Defendants Rule
`50(a) Motion (see Dkts. 22, 69, 365), the Court lacks personal jurisdiction over Daiichi Sankyo
`Japan.
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`Case 2:20-cv-00337-JRG Document 450 Filed 08/24/22 Page 16 of 32 PageID #: 18704
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`infringement was committed, there is no liability for inducing infringement). Because no
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`reasonable jury would have a legally sufficient evidentiary basis to find direct infringement (see
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`supra Section IV.A.1), Daiichi Sankyo Japan cannot be held liable for induced infringement as a
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`matter of law.
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`More specifically, induced infringement under § 271(b) requires that Seagen prove by a
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`preponderance of the evidence that Daiichi Sankyo Japan took affirmative acts to bring about the
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`commission by others of acts of infringement and had “knowledge that the induced acts constitute
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`patent infringemen