Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 1 of 9 PageID #: 12273
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`SEAGEN INC.,
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`v.
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`Plaintiff,
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`CASE NO. 2:20-cv-00337-JRG
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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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’ SUR-REPLY IN SUPPORT OF ITS OPPOSITION
`TO PLAINTIFF’S MOTION TO STRIKE PORTIONS OF
`THE EXPERT REPORTS OF JOHN M. LAMBERT, PH.D.
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 2 of 9 PageID #: 12274
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`A.
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`Dr. Lambert’s Non-infringement Analysis Is Based
`on the POSA’s Understanding of the Claim as a Whole
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`Dr. Lambert’s Responsive Report appropriately presents a full non-infringement analysis
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`using the Court’s claim constructions as applicable based on the understanding of the POSA in
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`view of the claims as a whole.1 Dr. Lambert’s analysis explicitly acknowledges and applies the
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`Court’s constructions, and thus does not seek to re-hash any prior claim construction arguments.
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`Further, Seagen misstates the Court’s Markman Order. Rather than adopting the
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`construction offered by either Party, the Court relied on the lexicographical definition for
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`“intracellularly cleaved” “with the rest of the phrase having its plain and ordinary meaning.”2
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`Dr. Lambert’s analysis is fully consistent with this approach, and should be heard by the jury.
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`Seagen acknowledges that the Asserted Claims are directed to a whole ADC, and must be
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`analyzed as a whole.3 This requires the POSA to use the Court’s constructions for the terms
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`construed, the plain and ordinary meaning where the Court directs it, and the plain and ordinary
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`meaning for the portions of the claim that the Court did not construe.4 Seagen agrees that the
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`Court’s reference to plain and ordinary meaning was directed to “the rest of the phrase,” given
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`the Court only construed “intracellularly cleaved.”5 The entire phrase includes other concepts
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`including that it is “the drug moiety” that is intracellularly cleaved and that the cleavage must be
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`“in a patient.” The POSA therefore must, at a minimum, consider how “the drug moiety” of the
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`ADC must behave “in a patient.” Dr. Lambert’s conclusion that the drug moiety alone must be
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`cleaved from the linker is, therefore, appropriately based on the plain meaning of the phrase as a
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`1 See Dkt. No. 265, Ex. 2, Lambert Responsive Report Section VII.
`2 Markman Order, Dkt. 155 at 40-42. While Plaintiff was trying to read out the latter aspects of
`the term at issue, the Court specifically noted that the rest of the phrase has its plain and ordinary
`meaning. See Markman Hearing Transcript (Aug. 27, 2021) at 96-99.
`3 Dkt. No. 275 at Section E.
`4 Dkt. No. 265 at 2-3.
`5 Dkt. No. 275 at 1.
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 3 of 9 PageID #: 12275
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`whole, as well as the context of the rest of the Asserted Claims and the ’039 patent.
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`B.
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`References to Dr. Morita’s Testimony are Relevant to
`Considerations of Weight and Credibility of Evidence
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`Seagen’s focus on whether Dr. Morita may be affirmatively used as a fact witness is
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`irrelevant here. Dr. Lambert does not rely on Dr. Morita for new factual information to form his
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`opinions.6 Dr. Lambert explicitly states that he conducted his own independent analysis and
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`formed his own conclusions.7 Seagen, in fact, quotes Dr. Lambert’s report where he states “I
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`conclude the same based on my own review of the documents” showing Seagen recognizes this
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`fact.8 Rather, Seagen appears to dispute whether Dr. Lambert’s analysis is sufficiently reasoned
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`or credible. It is. Regardless, that is exactly the type of question the jury should be able to
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`consider. Further, as explained in Defendants’ Opposition, Seagen is not prejudiced by Dr.
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`Lambert’s reference to Dr. Morita’s statements as Seagen sought to have Dr. Morita testify, and
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`its own expert similarly cites to Dr. Morita’s testimony in her own reports.9
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`C.
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`The Jury Should Consider Dr. Lambert’s Full
`Enablement and Written Description Analyses
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`Seagen’s statement that Dr. Lambert “offers no opinion on enablement as of 2019”10
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`misses the point. Seagen misinterprets Defendants’ reliance on post-2004 art. That art
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`demonstrates that Seagen’s claimed invention was not enabled as of dates long after 2004, and so
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`could not have been enabled as of 2004. Defendants’ post-2004 citations illuminate the state of
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`the art as of 2004, just as Amgen and other controlling precedent contemplate.11 The Federal
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`6 Dkt. No. 265 at 5-6.
`7 Dkt. No. 265, Ex. 2, Lambert Responsive Report ¶¶ 143, 145.
`8 Dkt. No. 275 at 1-2.
`9 But see GREE, Inc. v. Supercell Oy, No. 2:19-cv-70-JRG-RSP, Dkt. 354, slip op. at 5 (E.D.
`Tex. July 26, 2020).
`10 Dkt. No. 275 at 2.
`11 Amgen Inc. v. Sanofi, 872 F.3d 1367, 1375 (Fed. Cir. 2017). Moreover, unlike in Amgen, the
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 4 of 9 PageID #: 12276
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`Circuit has held that excluding such evidence is error.
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`Drugs/Drug Attachments: Seagen claims Dr. Lambert focuses on “individual claim
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`elements . . . instead of the claim as a whole.”12 Not so. Dr. Lambert explained, “[t]here cannot
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`be sufficient disclosure of written description for the structure as a whole when, at a minimum,
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`the disclosure for each individual element is deficient.”13 Here, Dr. Lambert appropriately
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`opines that the disclosure for the “drug moiety” and “spacer” limitations are deficient. Seagen
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`seeks to prevent the jury from considering Dr. Lambert’s reliable and relevant scientific opinions
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`by misreading Amgen to create a “narrow exception” to a (nonexistent) rule that post-filing
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`evidence is inadmissible.14 To the contrary, Amgen reverses a ruling of inadmissibility, holding
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`that “such evidence could have been relevant to determining if the claims were enabled as of the
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`priority date and should not have been excluded simply because it post-dated the claims’ priority
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`date.”15 The evidence Dr. Lambert cites, including in Paragraph 110, shows that the POSA
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`would not have been able to make or use the full scope of the claimed invention as of 2004.
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`Intracellular Cleavage: Seagen seeks to exclude post-filing evidence that demonstrates
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`the incomplete understanding of intracellular cleavage in 2004 and how difficult it is to ascertain
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`the functional intracellular cleavage required by the Drug Moiety Intracellular Cleavage
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`Parties dispute the priority date. Seagen does not dispute that if the priority date is determined
`by the jury to be July 10, 2019, this evidence is appropriate for jury consideration. (See Dkt. No.
`265, Ex. 1, Opening Report Section VIII.B; see, e.g., ¶ 363.) Nevertheless, even if the priority
`date is 2004, Dr. Lambert appropriately uses this post-priority evidence to show that these
`developments were made later in time and could not have been described or enabled earlier.
`12 Dkt. No. 275 at 3.
`13 See Dkt. No. 265, Ex. 1, Opening Report Section VII.A.3; ¶ 115. See also Univ. Rochester v.
`G. D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir. 2003) (failure to describe limitation regarding
`compound renders claim to method of using said compound invalid as a matter of law).
`14 Dkt. No. 265 at 8.
`15 Amgen, 872 F.3d at 1375.
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 5 of 9 PageID #: 12277
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`Limitation. Unlike W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1556 (Fed. Cir.
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`1983), relied upon by Seagen, Dr. Lambert does not assert that the POSA would have been able
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`to determine intracellular cleavage as of 2004 but that subsequent developments in the art
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`complicated the inquiry. To the contrary, Dr. Lambert concludes that the priority applications do
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`not teach the POSA to make and use an ADC that meets the functional requirements of the
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`Asserted Claims as of 2004, and illustrates that conclusion using art that shows lack of
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`understanding even at much later dates.16 Enablement is a factual dispute for the jury to decide.
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`Seagen seeks to deprive the jury of relevant facts using inapposite case law as well as faulty
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`scientific presumptions.17
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`D.
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`Dr. Lambert Appropriately Analyzes the
`Asserted Claims’ Functional and Structural Limitations
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`As Seagen recognizes, the POSA must view the claim as a whole.18 The Asserted Claims
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`have both structural and functional limitations, and the functional limitations require that the
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`drug moiety of the claimed ADC be intracellularly cleaved in a patient.19 Dr. Lambert explained
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`that his discussion of therapeutic viability reflects and applies this functional limitation,20 as the
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`POSA would have to be able to test the ADC to determine if it falls within the Asserted Claims.
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`16 The presumption that ADC internalization is required to cause cell death was incorrect, and
`Dr. Lambert notes the evolving state of the art has only provided more tools. See, e.g., Dkt. No.
`265, Ex. 1, Opening Report ¶¶ 305-10, 314-16 (“[g]iven the understanding in the art in 2003-
`2004 time period regarding intracellular cleavage, in contrast to the evolution of the art since that
`time, more disclosure in the specification is required to enable the POSA to determine
`intracellular cleavage of the ADC’s drug moiety in a patient in vivo.”).
`17 Dkt. No. 265 at 10; Id. at 10 n.43; supra note 16.
`18 Dkt. No. 275 at Section E.
`19 The language in the Asserted Claims is analogous to the functional claim language in Idenix as
`both required the compound to perform a specified function. See, e.g., Idenix, 941 F.3d at 1159.
`20 Dkt. No. 265 at 11-13. Seagen asserts that paragraph 20 is “the only report paragraph
`Defendants cite in footnote 48,” however, Section VII.B (spanning paragraphs 121-332) is also
`cited, and provides a proper enablement analysis appropriate for jury consideration.
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 6 of 9 PageID #: 12278
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`His analysis does not apply an efficacy (or other unclaimed) requirement. Dr. Lambert’s
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`background discussion of design and testing issues such as “off-target toxicities,” “reduced
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`cytotoxicity” or “potency,” and “limited or mixed FDA success,” appropriately provides
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`important context for the challenges faced by the POSA seeking to make and test an ADC with
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`the claimed structural and functional limitations.21 Further, Seagen’s argument that the POSA
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`would know of “a variety of well-known drugs and spacer units,” 22 is specifically the type of
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`factual disagreement the jury should consider and evaluate based on the full record.
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`E.
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`Consistency of Evidence Should be Considered by the Jury
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`As explained in Defendants’ Opposition, Dr. Lambert does not, as Seagen alleges, rely on
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`any findings of the EPO or PTAB to provide a basis for his conclusions. Instead, he merely
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`notes consistency of his own review of the facts with statements made by the EPO and PTAB.23
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`Dr. Lambert similarly does not rely on the opinions of Mr. Manspeizer to form his
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`conclusions, but notes that the analyses of the overlapping underlying facts used by both experts
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`are consistent. Seagen attempts to invoke an inflated standard of admissibility of expert
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`testimony, but determinations of credibility and reliability, as well the weight of the evidence,
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`should be left to the jury.24
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`21 For the first time on Reply, Seagen explains its argument regarding “other unclaimed
`requirements” (Dkt. No. 275 at 4). As Dr. Lambert explains, these are important concepts within
`the knowledge and consideration of the POSA.
`22 Dkt. No. 275 at 5.
`23 In contrast, in the Mars case cited by Seagen, the party attempted to rely on foreign
`prosecution statements to limit scope during claim construction, and in Kinetic Concepts, the
`party attempted to rely on foreign invalidity findings to affirmatively justify its belief that certain
`patents were invalid. These cases are thus inapposite here.
`24 See Mobility Workx, LLC v. Cellco P’ship, No. 4:17-CV-00872, 2019 WL 5721814, at *6
`(E.D. Tex. Nov. 5, 2019) (citing Wallis v. Hornbeck Offshore Operators, 2014 WL 3809743, at
`*1 (E.D. La. Aug. 1, 2014)).
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 7 of 9 PageID #: 12279
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`Dated: February 3, 2021
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`Respectfully submitted,
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`/s/ Preston K. Ratliff II
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`Deron R. Dacus
`State Bar No. 00790553
`The Dacus Firm, P.C.
`821 ESE Loop 323, Suite 430
`Tyler, Texas, 75701
`+1 (903) 705-1117
`+1 (903) 581-2543 facsimile
`ddacus@dacusfirm.com
`
`J. Mark Mann
`State Bar No. 12926150
`mark@themannfirm.com
`MANN | TINDEL | THOMPSON
`300 West Main Street
`Henderson, Texas 75652
`(903) 657-8540
`(903) 657-6003 (fax)
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`Attorneys for Defendant Daiichi Sankyo Company,
`Limited
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`OF COUNSEL:
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`Preston K. Ratliff II
`Joseph M. O’Malley, Jr.
`Ashley N. Mays-Williams
`Paul Hastings LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
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`Jeffrey A. Pade
`Paul Hastings LLP
`2050 M Street NW
`Washington, DC 20036
`(202) 551-1700
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`Attorneys for Defendant Daiichi Sankyo
`Company, Limited
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 8 of 9 PageID #: 12280
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`/s/ David I. Berl
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`David I. Berl
`dberl@wc.com
`Thomas S. Fletcher
`tfletcher@wc.com
`Jessica L. Pahl
`jpahl@wc.com
`Kathryn S. Kayali
`kkayali@wc.com
`Kevin Hoagland-Hanson
`khoagland-hanson@wc.com
`Andrew L. Hoffman
`ahoffman@wc.com
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`Phone: (202) 434-5000
`Facsimile: (202) 434-5029
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`Jennifer Parker Ainsworth
`Texas State Bar No. 00784720
`jainsworth@wilsonlawfirm.com
`Wilson, Robertson & Cornelius, P.C.
`909 ESE Loop 323, Suite 400
`Tyler, Texas 75701
`Phone: (903) 509-5000
`Facsimile: (903) 509-5092
`Attorneys for AstraZeneca Pharmaceuticals
`LP and AstraZeneca UK Ltd.
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`Case 2:20-cv-00337-JRG Document 340 Filed 03/02/22 Page 9 of 9 PageID #: 12281
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that all counsel of record who have consented to
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`electronic service are being served with a copy of this document via electronic mail on February
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`3, 2022.
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`/s/ Preston K. Ratliff II
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