Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 1 of 37 PageID #: 18651
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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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`
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`DEFENDANTS’ RENEWED MOTION FOR
`JUDGMENT OF INVALIDITY AS A MATTER OF LAW
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 2 of 37 PageID #: 18652
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION .......................................................................................................... - 1 -
`LEGAL STANDARD ..................................................................................................... - 3 -
`ARGUMENT .................................................................................................................. - 3 -
`A.
`No Reasonable Jury Could Find That Defendants Failed to Demonstrate
`That the Asserted Claims Are Invalid Under 35 U.S.C. § 112(a) For Lack
`Of Adequate Written Description ....................................................................... - 3 -
`1.
`Defendants Presented Clear and Convincing Evidence
`Demonstrating That the ’039 Patent Discloses Zero Species Within
`the Claimed Genus .................................................................................. - 5 -
`Defendants Presented Clear and Convincing Evidence
`Demonstrating That the ’039 Patent Fails to Disclose Sufficient
`Common Structural Features of the Claimed Genus to Allow the
`POSA to Visualize the Genus ................................................................. - 9 -
`No Reasonable Jury Could Find That Defendants Failed to Demonstrate
`That the Asserted Claims Are Invalid Under 35 U.S.C. § 112(a) For Lack
`Of Enablement .................................................................................................. - 10 -
`1.
`Defendants Presented Clear and Convincing Evidence That the
`’039 Patent Provides Zero Guidance in a Complex and
`Unpredictable Field and Fails to Teach How to Make the Full
`Scope of the Claimed ADCs Without Undue Experimentation............ - 11 -
`Defendants Presented Clear and Convincing Evidence That the
`’039 Patent Does Not Teach How to Make or Use the Full Scope
`of the Claimed ADCs Requiring Intracellular Cleavage in a Patient
`Without Undue Experimentation .......................................................... - 15 -
`No Reasonable Jury Could Find That Defendants Failed to Demonstrate
`that the Asserted Claims Are Invalid Under 35 U.S.C. § 102 as a Matter
`of Law ............................................................................................................... - 19 -
`1.
`No Reasonable Jury Could Find That the 2004 Application
`Provides Adequate Written Description or Enablement Support for
`ADCs Comprising Any Drug Moiety ................................................... - 19 -
`No Reasonable Jury Could Find That the 2004 Application
`Provides Adequate Written Description for ADCs with Gly/Phe-
`Only Tetrapeptide Linkers .................................................................... - 20 -
`If Enhertu® Infringes the Asserted Claims, as Seagen Contends, the
`Asserted Claims are Fully Anticipated by the 2015/2016
`Publications ........................................................................................... - 29 -
`CONCLUSION ............................................................................................................. - 30 -
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`2.
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`2.
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`2.
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`3.
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`B.
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`C.
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`I.
`II.
`III.
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`IV.
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`ii
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 3 of 37 PageID #: 18653
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`TABLE OF AUTHORITIES
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`Page(s)
`
`Cases
`
`AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc.,
`759 F.3d 1285 (Fed. Cir. 2014)..............................................................................................8, 9
`
`Abraham v. Alpha Chi Omega,
`708 F.3d 614 (5th Cir. 2013) .....................................................................................................3
`
`Agilent Techs., Inc. v. Affymetrix, Inc.,
`567 F.3d 1366 (Fed. Cir. 2009)................................................................................................21
`
`Amgen Inc. v. Sanofi, Aventisub LLC,
`987 F.3d 1080 (Fed. Cir. 2021)..............................................................................................1, 2
`
`Application of Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) .................................................................................................26
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010)..................................................................................8, 9, 26, 28
`
`Bos. Sci. Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011)................................................................................................29
`
`In re Driscoll,
`562 F.2d 1245 (C.C.P.A. 1977) .........................................................................................25, 26
`
`Eli Lilly & Co. v. Aradigm Corp.,
`376 F.3d 1352 (Fed. Cir. 2004)..................................................................................................3
`
`Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006)................................................................................................20
`
`In re Fisher,
`427 F.2d 833 (C.C.P.A. 1970) ...........................................................................................10, 11
`
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996).......................................................................................... passim
`
`FWP IP ApS v. Biogen MA, Inc.,
`749 F. App’x 969 (Fed. Cir. 2018) ....................................................................................21, 26
`
`Goeddel v. Sugano,
`617 F.3d 1350 (Fed. Cir. 2010)................................................................................................28
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`

`

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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 4 of 37 PageID #: 18654
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`
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`Idenix Pharms. LLC v. Gilead Scis. Inc.,
`941 F.3d 1149 (Fed. Cir. 2019)..........................................................................................15, 16
`
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997)..........................................................................................28, 29
`
`Novartis Pharms. Corp. v. Accord Healthcare, Inc.,
`21 F.4th 1362 (Fed. Cir. 2022) ................................................................................................29
`
`PowerOasis, Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008)................................................................................................28
`
`Rivera v. Int’l Trade Comm.,
`857 F.3d 1315 (Fed. Cir. 2017)..........................................................................................28, 29
`
`Seal-Flex, Inc. v. Athletic Track & Court Constr.,
`172 F.3d 836 (Fed. Cir. 1999)..................................................................................................29
`
`TGIP, Inc. v. AT&T Corp.,
`527 F. Supp. 2d 561 (E.D. Tex. 2007) .......................................................................................3
`
`Upsher-Smith Lab’ys, Inc. v. Pamlab, L.L.C.,
`412 F.3d 1319 (Fed. Cir. 2005)................................................................................................19
`
`In re Vaeck,
`947 F.2d 488 (Fed. Cir. 1991)..................................................................................................10
`
`In re Wako Pure Chem. Indus. Ltd.,
`4 F. App’x 853 (Fed. Cir. 2001) ........................................................................................25, 26
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988)..................................................................................................10
`
`Wyeth & Cordis Corp. v. Abbott Lab’ys,
`720 F.3d 1380 (Fed. Cir. 2013)....................................................................................15, 16, 18
`
`Statutes
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`35 U.S.C. § 112(a) ...............................................................................................................3, 10, 11
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`Rules
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`Fed. R. Civ. P. 50(a) ........................................................................................................................3
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`iv
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 5 of 37 PageID #: 18655
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`I.
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`INTRODUCTION
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`Defendant Daiichi Sankyo Company, Limited
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`(“Daiichi Sankyo Japan”) and
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`Defendant-Intervenors AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd, (collectively,
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`“Defendants”) move for judgment of invalidity as a matter of law.
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`
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`First, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Defendants failed to show by clear and convincing evidence that the claims of U.S. Patent No.
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`10,808,039 (“the ’039 patent”) are invalid for the specification’s failure to show adequate support
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`for the claimed antibody-drug conjugates (“ADCs”) as a whole, including all the required claim
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`limitations for Claims 1-5, 9, and 10 (the “Asserted Claims”), particularly with respect to the broad
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`claim term “D is a Drug Moiety.” Further, Defendants presented clear and convincing evidence,
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`and Seagen did not dispute, that every embodiment, example, figure, and assay in the ’039 patent
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`that purports to disclose an ADC of the alleged invention includes a drug moiety of the
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`dolastatin/auristatin-type. (See generally DX-0001; see, e.g., Trial Tr. (Day 1) at 245:13-25; Trial
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`Tr. (Day 3) at 107:16-108:10, 111:9-112:5; Trial Tr. (Day 4) at 64:9-12.)
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`Second, no reasonable jury would have a legally sufficient evidentiary basis to find that
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`Defendants failed to show by clear and convincing evidence that the ’039 patent fails to enable the
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`person of ordinary skill in the art (“POSA”) to make and use the full scope of the Asserted Claims.
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`Where the specification discloses only a starting point, or an invitation for further research in an
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`unpredictable and poorly understood field, the claims are not enabled as a matter of law. In this
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`action, Defendants presented clear and convincing evidence that ADC design and synthesis is
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`unpredictable and that the ’039 patent provides no guidance to teach how to make and use the
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`claimed ADCs without undue experimentation. Indeed, it is not unusual for the Federal Circuit to
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`overturn a jury’s enablement verdict. See, e.g., Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d
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`- 1 -
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 6 of 37 PageID #: 18656
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`1080 (Fed. Cir. 2021) (finding lack of enablement despite two separate juries returning verdicts
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`finding that lack of enablement was not proven).
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`Third, no reasonable jury would have a legally sufficient evidentiary basis to find that the
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`’039 patent is entitled to a priority date any earlier than July 10, 2019, the filing date of U.S. Patent
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`Application No. 16/507,839 (the “’839 Application”). On its face, the ’039 patent purports to
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`claim priority to four earlier-filed provisional patent applications and six earlier-filed non-
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`provisional patent applications that date back to November 6, 2003. (DX-0001; DX-0002; DX-
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`0003; DX-0004; DX-0005; DX-0007; DX-0008; DX-0009; DX-0010; DX-0011; DX-0012,; DX-
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`0013; DX-0014; DX-0015; DX-0016.) Seagen has asserted that the ’039 patent is entitled to a
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`priority date of no later than November 5, 2004, the filing date of U.S. Patent Application No.
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`10/983,340 (the “2004 Application”), which led to U.S. Patent No. 7,498,298 (the “’298 patent”).
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`(See Dkt. 328 at 7; see also Trial Tr. (Day 3) at 127:21-23; DX-0002 at 1).1 Defendants presented
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`clear and convincing evidence, however, that the 2004 Application, and all earlier-filed patent
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`applications, fail to provide written description and enablement support for the ADCs claimed in
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`the ’039 patent for at least the same reasons discussed for the ’039 patent specification. Further,
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`Defendants’ trial evidence showed that the first time ADCs with a glycine and/or phenylalanine-
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`only (“Gly/Phe-only”) tetrapeptide linker are disclosed in any of the patents or patent applications
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`in the ’039 patent family is in the filed claims of the July 2019 patent application that led to the
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`’039 patent. (See Trial Tr. (Day 3) at 125:7-20.) Thus, no reasonable jury would have a legally
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`sufficient evidentiary basis to find that the priority date of the ’039 patent is earlier than the July
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`1 There are no relevant differences between the 2004 Application and the ’039 patent
`specification. (Compare DX-0001 with DX-0002, DX-0007 at 14-341, and PX-0073.) It is
`undisputed that the 2004 Application and the other non-provisional priority applications share
`the same specification as the ’039 patent.
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`- 2 -
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 7 of 37 PageID #: 18657
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`10, 2019 filing date of the ’839 Application. It then follows, to the extent the Court upholds the
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`jury’s verdict finding that Enhertu® falls within the scope of the Asserted Claims, that Defendants
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`have presented clear and convincing evidence (unrebutted by Seagen) that the Asserted Claims are
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`anticipated as a matter of law by the earlier disclosure of Enhertu®, as shown in DX-0109 (“Ogitani
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`2016 – Clin. Cancer Res.”), DX-0110 (“Ogitani 2016 – Cancer Sci.”), and DX-0111 (“2015 Abe
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`Poster”) (collectively, “Daiichi Sankyo 2015/2016 Publications”).
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`II.
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`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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`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.” Id.
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`(quoting Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1363 (Fed. Cir. 2004)).
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`III. ARGUMENT
`A.
`
`No Reasonable Jury Could Find That Defendants Failed
`to Demonstrate That the Asserted Claims Are Invalid Under
`35 U.S.C. § 112(a) For Lack Of Adequate Written Description
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`Defendants presented clear and convincing evidence that the Asserted Claims of the ’039
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`patent are invalid under 35 U.S.C. § 112(a) for lack of an adequate written description, such that
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`no reasonable jury would have a legally sufficient evidentiary basis to find otherwise.
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`- 3 -
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 8 of 37 PageID #: 18658
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`Independent Claim 1 recites a genus of ADCs with the following formula:
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`“. . .wherein the drug moiety is intracellularly cleaved in a patient from the antibody of the
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`antibody-drug conjugate or an intracellular metabolite of the antibody-drug conjugate.” (DX-0001
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`at Claim 1.)
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`Pursuant to the Court’s Claim Construction Memorandum Opinion and Order, the drug
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`moiety (i.e., “D”) is broad enough to encompass all drug moieties, and not just dolastatin/auristatin
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`derivatives. (Dkt. 155 at 12-13; see also id. at 10 (“The claims, by themselves, do not specify or
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`require that the drug moiety be limited to a dolastatin/auristatin-type drug.”)) While dependent
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`Claims 2-5, 9, and 10 further limit the structure of the antibody, the spacer, or the drug-antibody
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`ratio of the ADCs of Claim 1, none of the claims further limit D, the drug moiety. (DX-0001 at
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`Claims 2-5, 9, and 10.) The structural and functional requirements of Claim 1 further require the
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`claimed genus of ADCs to include a tetrapeptide comprised of Gly/Phe-only amino acids.
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`(DX-0001 at Claim 1.)
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`Defendants’ clear and convincing evidence showed that the ʼ039 patent does not describe
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`this claimed genus, because its disclosure is limited to ADCs containing dolastatin/auristatin-type
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`drugs as the drug moiety, and none of the ADCs disclosed comprise the claimed Gly/Phe-only
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`tetrapeptide linker. (See, e.g., Tr. (Day 3) at 125:11-17, 127:12-20, 128:11-14, 132:19-133:3,
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`135:4-8, 140:8-11.) As such, the ’039 patent does not describe any ADCs within the scope of the
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`Asserted Claims that are also capable of meeting the functional limitation of intracellular cleavage
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 9 of 37 PageID #: 18659
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`in a patient. Accordingly, because the ʼ039 patent fails to describe even one species falling within
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`the claimed genus, there is no question that it cannot provide a representative number of species.
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`Defendants’ evidence further showed that the ʼ039 patent’s disclosure does nothing to illuminate
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`the “common structural features” of ADCs comprising drug moieties of any structure.
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`1.
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`Defendants Presented Clear and Convincing
`Evidence Demonstrating That the ’039 Patent
`Discloses Zero Species Within the Claimed Genus
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`The’039 patent plainly focuses on ADCs containing dolastatin/auristatin-type drugs. (See
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`generally DX-0001; Trial Tr. (Day 3) at 108:6-10; Trial Tr. (Day 4) at 64:9-12.) The title of the
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`’039 patent is “Monomethylvaline Compounds Capable of Conjugation to Ligands.” (DX-0001
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`at Title; Trial Tr. (Day 1) at 245:16-19; Trial Tr. (Day 3) at 68:2-6.) Monomethylvaline
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`compounds are limited to the dolastatin/auristatin class of drug moieties (not all drug moieties can
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`be so classified). (See, e.g., Trial Tr. (Day 3) 62:18-25, 67:23-68:1.) Seagen did not rebut
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`Defendants’ clear and convincing evidence that the abstract makes plain that the ’039 patent as a
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`whole is solely directed to dolastatin/auristatin-type drug moieties, including monomethyl
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`auristatin E (“MMAE”) and monomethyl auristatin F (“MMAF”), and that those drug moieties
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`were, in turn, attached to ligands through various linkers. (DX-0001 at Abstract; Trial Tr. (Day 3)
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`at 68:7-14.)
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`Further, Defendants presented clear and convincing evidence that the ’039 patent’s
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`specification consistently conveys that the drug moieties of the invention encompass
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`dolastatin/auristatin compounds and nothing more. In the background of the invention section, the
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`’039 patent states that there is “a clear need in the art for dolastatin/auristatin derivatives having
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`significantly lower toxicity, yet useful therapeutic efficiency [sic]” and that these “problems of the
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`past are addressed by the present invention.” (DX-0001 at 4:22-29 (emphasis added).)
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`Additionally, Section 9.2, titled, “The Compounds of the Invention,” lists compounds where the
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 10 of 37 PageID #: 18660
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`drug moiety is only of the dolastatin/auristatin-type. (DX-0001 at 44:55-63:15.) Notably, Section
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`9.4 of the ’039 patent is titled, “The Drug Unit (Moiety).” (DX-0001 at 71:19.) Within this
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`section, the “drug moiety (D)” of the ADCs are all “of the dolastatin/auristatin-type.” (DX-0001
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`at 71:19-77:22.) Consistent with the title, abstract, and the proclaimed purposes of the invention
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`in the specification, Section 9.4 describes various dolastatin/auristatin-type compounds, including
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`MMAE and MMAF, and nothing more. (Id.)
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`Seagen did not rebut Defendants’ evidence that every embodiment, example, figure, and
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`assay in the ’039 patent that purports to disclose an ADC of the alleged invention includes a drug
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`moiety of the dolastatin/auristatin-type only. (See generally DX-0001; see, e.g., Trial Tr. (Day 1)
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`at 245:13-25; Trial Tr. (Day 3) at 107:16-108:10, 111:9-112:5; Trial Tr. (Day 4) at 64:9-12.)
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`Indeed, every “exemplary” ADC in the ’039 patent contains either MMAE or MMAF as its drug
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`moiety. (See generally DX-0001; Trial Tr. (Day 3) at 107:16-108:10, 111:9-112:5.)
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`Separate from the ’039 patent’s singular focus on dolastatin/auristatin-type drugs,
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`Defendants presented clear and convincing evidence that the specification discloses no examples
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`of any ADC with a tetrapeptide comprised of Gly/Phe-only amino acids. (See generally DX-0001;
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`see, e.g., Trial Tr. (Day 3) at 125:10-17, 128:1-7, 130:6-15; Trial Tr. (Day 4) at 84:5-9, 119:11-16,
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`123:16-19.) Thus, while the ’039 patent discloses examples of ADCs comprising auristatins,
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`Defendants showed that none of the disclosed ADCs fall within the scope of the Asserted Claims,
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`even for the limited subset of dolastatin/auristatin-type drug moieties. (See, e.g., Trial Tr. (Day 3)
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`at 107:16-108:10, 138:25-139:10.)
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`As shown by the clear and convincing evidence presented by Defendants, the’039 patent
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`also otherwise lacks adequate written description of any drug moiety suitable for an ADC that is
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`not of the dolastatin/auristatin-type. (See generally DX-0001; see, e.g., Trial Tr. (Day 3) at
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 11 of 37 PageID #: 18661
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`107:16-108:10, 111:9-112:5.) In the background of the invention section, the ’039 patent mentions
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`ADCs and cytotoxic compounds that were known and discussed in the art, none of which fall
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`within the Asserted Claims nor provide support for the claimed genus of ADCs having any drug
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`moiety; a fact undisputed by Seagen. (See DX-0001 at 2:5-6:30.) The only other mention in the
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`’039 patent’s specification of any compounds other than those of the dolastatin/auristatin-type is a
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`separate listing of hundreds of chemotherapeutic agents. Defendants showed that the POSA would
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`understand these chemotherapeutic agents are to be used in combination therapy with
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`dolastatin/auristatin-type ADCs, rather than as drug moieties for the ADCs themselves. (See
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`DX-0001 at 31:39-33:31; Trial Tr. (Day 3) at 107:16-112:5.)
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`As Defendants showed at trial, and as went wholly unrebutted by Seagen, this broad listing
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`of chemotherapeutic agents includes combinations of compounds (e.g., FOLFOX and CHOP) that
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`are treatment regimens comprising multiple drugs that would be impossible to use as a drug moiety
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`in the context of the ’039 patent. (See DX-0001 at 31:39-33:6; Trial Tr. (Day 3) at 110:14-111:8.)
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`Defendants further showed that other listed chemotherapeutic agents, like maytansine, for
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`example, are likewise indisputably unable to be used as the drug moiety in the claimed ADCs
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`without modification, which would result in an entirely different drug moiety. (See, e.g., Trial Tr.
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`(Day 3) at 113:9-16, 113:24-114:5, 114:16-115:7, 116:14-117:5; DX-0070 at 3-4; DX-0179 at 1;
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`see also DDX 4-58 (D.I. 384, Ex D); DX-0205 at 3.) The unmodified chemotherapeutic agents
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`disclosed in the ’039 patent, therefore, would never be understood by the POSA to be a recitation
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`of drug moieties suitable for use in an ADC as required by the claims. (See, e.g., Trial Tr. (Day 3)
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`at 113:9-16, 115:15-116:21.) Accordingly, no reasonable jury would have a legally sufficient
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`evidentiary basis to find that the listed chemotherapeutic agents are a disclosure of potential drug
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`moieties, rather than compounds plainly intended for use in combination therapy with the claimed
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 12 of 37 PageID #: 18662
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`ADCs. In fact, Section 9.4 discussing “The Drug Unit (Moiety),” makes no mention of any of the
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`listed chemotherapeutic agents. (See DX-0001 at 71:19-77:22.)
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`Further, Claim 1 is directed to ADCs having any drug moiety that also are capable of
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`undergoing intracellular cleavage in a patient to release said drug moiety. As Dr. Lambert
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`explained, and as Seagen’s witnesses did not dispute, the ’039 patent does not describe how ADCs
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`with non-dolastatin/auristatin drug moieties function or whether such ADCs are capable of
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`reaching the target cells in a patient, much less whether the drug moiety is cleaved intracellularly.
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`(Trial Tr. (Day 3) at 119:16-120:1.) Considering the complexity and unpredictability of ADCs
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`(see id. at 119:12-121:9), Defendants presented clear and convincing evidence that the ’039 patent
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`fails to offer any disclosure or description of ADCs that potentially comprise any and all drug
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`moieties, and are also capable of undergoing intracellular cleavage to release this broad scope of
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`claimed drug moieties in a patient.
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`Defendants’ trial evidence showed that all of the disclosed species in the ’039 patent
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`contain dolastatin/auristatin-type drug moieties, a very narrow sliver of the claimed genus that
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`covers all drug moieties. (See, e.g., id. at 107:16-112:5); see also AbbVie Deutschland GmbH &
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`Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1299-300 (Fed. Cir. 2014) (although the patent
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`disclosed hundreds of species within the scope of the claimed genus, they were “not representative
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`of the full variety or scope of the genus.”). The absence of any disclosure of an ADC that includes
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`any other drug moiety, let alone any ADCs within the scope of the Asserted Claims, forecloses
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`any possibility of satisfying the en banc Federal Circuit’s standard for written description. See
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`Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The
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`species disclosed within the genus is limited to ADCs with dolastatin/auristatin-type drug moieties,
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`which are “not representative” of the full variety or scope of the genus, and thus no reasonable
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 13 of 37 PageID #: 18663
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`jury would have a legally sufficient evidentiary basis to find that the specification provides
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`adequate written description support for the Asserted Claims. See AbbVie, 759 F.3d at 1299-300.
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`2.
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`Defendants Presented Clear and Convincing
`Evidence Demonstrating That the ’039 Patent Fails
`to Disclose Sufficient Common Structural Features of
`the Claimed Genus to Allow the POSA to Visualize the Genus
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`No reasonable jury would have a legally sufficient evidentiary basis to find that members
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`of the claimed genus could be visualized by the POSA because Defendants presented clear and
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`convincing evidence that the ’039 patent fails to disclose “structural features common to the
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`members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of
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`the genus.” Ariad, 598 F.3d at 1350. Defendants showed that the ʼ039 patent plainly fails this
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`prong of Ariad, as it does not identify sufficient common structural features of the claimed ADCs,
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`particularly with respect to the “drug moiety.”
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`As Defendants’ unrebutted evidence showed, the ’039 patent discloses no common
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`structural features shared by the full scope of the claimed genus of ADCs comprising any “drug
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`moiety.” (See generally DX-0001.) All guidance provided in the ’039 patent is limited to ADCs
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`containing dolastatins/auristatins-type drug moieties, which is insufficient to visualize or
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`synthesize ADCs containing all other drug moieties encompassed in the claimed genus. (Id.; see,
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`e.g., Trial Tr. (Day 3) at 111:9-112:5.) Dr. Lambert explained that the ’039 patent discloses only
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`structures of MMAE, MMAF, and derivatives thereof, (see, e.g., Trial Tr. (Day 3) at 108:6-10),
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`but there are many different compounds in existence that exert pharmacological effects, and there
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`are no structural features common to all of them. Moreover, even if a drug moiety is capable of
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`attachment, not all drug moieties attach to or orient in ADCs in the same way. Their attachment,
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`therefore, forms structurally different ADCs, a point Seagen’s witnesses did not rebut. Indeed, Dr.
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`Lambert explained that the linear core structure of an auristatin-type compound is particularly
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 14 of 37 PageID #: 18664
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`different from the rigid, six-ring structure of Enhertu®—a camptothecin. (Trial Tr. (Day 3) at
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`71:21-25.) Because the ’039 patent fails to disclose common structural features shared by the
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`genus (i.e., ADCs comprising any drug moiety), no reasonable jury would have a legally sufficient
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`evidentiary basis to find in favor of Seagen on this issue.2
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`B.
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`No Reasonable Jury Could Find That Defendants
`Failed to Demonstrate That the Asserted Claims
`Are Invalid Under 35 U.S.C. § 112(a) For Lack Of Enablement
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`Defendants presented clear and convincing evidence that the ’039 patent is invalid under
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`35 U.S.C § 112(a) because the ʼ039 patent fails to enable the POSA to make and use the full scope
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`of the claimed ADCs, and no reasonable jury would have a legally sufficient evidentiary basis to
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`conclude otherwise.
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`To be enabling, a specification must teach the POSA how to make and use the claimed
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`invention without “undue experimentation.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
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`Further, there must be a reasonable correlation between the scope of the claims and the scope of
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`enablement and in evaluating that correlation, the degree of predictability of the relevant art may
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`be a key consideration. See In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970); see also In re Vaeck,
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`947 F.2d 488, 495 (Fed. Cir. 1991). Defendants’ trial evidence established, inter alia, that the
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`design and synthesis of ADCs capable of being administered to patients and reaching targeted cells
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`is highly complex—a point which Seagen’s scientists and inventors acknowledged. (See, e.g.,
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`Trial Tr. (Day 3) at 34:8-37:1, 37:18-24, 39:15-41:5, 58:23-59:8, 59:15-17; Trial Tr. (Day 4) at
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`2 Given the 2004 Application and the other non-provisional priority applications share the same
`specification as the ’039 patent, the non-provisional priority applications likewise lack written
`description support for the Asserted Claims for at least the same reasons as the ’039 patent. To
`the extent that the as-filed claims or provisional applications include additional disclosures, those
`do not cure the deficiencies in the shared specification.
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`Case 2:20-cv-00337-JRG Document 449 Filed 08/24/22 Page 15 of 37 PageID #: 18665
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`30:21-25, 33:7-36:10, 78:21-79:15.) Indeed, when the invention involves unpredictable factors,
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`the disclosure required for enablement can vary inversely with the degree of unpredictability
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`involved. See Fisher, 427 F.2d at 839. In this action, Defendants presented clear and convincing
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`evidence that the ’039 patent not only fails to teach the POSA how to make and use the full scope
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`of the claimed subject matter in the complex field of ADCs—it does not mention anywhere how
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`to make and use even a single ADC that meets the Asserted Claims. (Trial Tr. (Day 3) at
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`119:3-120:4.) At best, the ’039 patent reflects an unguided invitation to make an innumerable
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`number of compounds that are structurally unrelated and functionally unpredictable, which is
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`insufficient to enable the POSA as a matter of law. There was no showing by Seagen that the
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`POSA would have known how to make or use such ADCs without undue experimentation.
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`Accordingly, no reasonable jury would have a legally sufficient evidentiary basis to find
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`that the ’039 patent specification satisfies the requirements of 35 U.S.C. § 112(a). Defendants
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`demonstrated that the ʼ039 patent fails to enable the POSA to make the full scope of the claimed
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`genus of ADCs, and similarly fails to enable the POSA to identify which compounds within that
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`broad scope will be capable of being “intracellularly cleaved” in the cells of a patient.
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`1.
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`Defendants Presented Clear and Convincing Evidence That
`the ’039 Patent Provides Zero Guidance in a Complex and
`Unpredictable Field and Fails to Teach How to Make the
`Full Scope of the Claimed ADCs Without Undue Experimentation
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`
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`It is undisputed that Claim 1 of the ’039 patent recites a structure in which the drug moiety
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`“D” is covalently attached to either Yy, a “Spacer unit,” or, when Y is zero, Ww, a tetrapeptide
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`comprised of only Gly or Phe peptides. (DX-0001 at Claim 1; see also supra Section III.A.) The
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`drug moiety “D” is not limited to any particular drug moiety or structural class