Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 1 of 8 PageID #: 10756
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`Civil Action 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,
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`ASTRAZENECA PHARMACEUTICALS LP, and
`ASTRAZENECA UK LTD.,
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`Intervenor-Defendants.
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`SEAGEN’S REPLY IN SUPPORT OF ITS MOTION TO STRIKE
`PORTIONS OF THE EXPERT REPORTS OF JOHN M. LAMBERT
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 2 of 8 PageID #: 10757
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`A.
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`The Court Should Strike Dr. Lambert’s Claim Constructions
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`As Seagen’s Motion demonstrated, Dr. Lambert proposes constructions that the Court
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`expressly rejected. (Dkt. 252 at 2-3.) Defendants’ Opposition does not controvert this
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`showing. Instead, Defendants argue that Dr. Lambert’s opinions are permissible because, they
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`say, the Court’s Markman Order suggested “plain meaning” could be applied to the phrases he
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`now interprets. But the Court adopted its construction only after considering the very narrowing
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`Dr. Lambert now proposes in his report. (Dkt. 252-3, Markman Tr. at 102:4–103:11.) In doing
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`so, the Court necessarily found that the terms are not limited to that narrow meaning. (Dkt. 155
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`at 40.) Defendants cannot re-label their prior arguments to get around the Court’s well-reasoned
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`constructions. BMC Software, Inc. v. ServiceNow, Inc., No. 2:14-cv-903-JRG, Dkt. 325, slip op.
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`at 4 (E.D. Tex. Jan. 28, 2016).
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`Moreover, the Court did not, in fact, apply “plain meaning” to “free drug.” “Free drug”
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`is found only in the Court’s construction of “intracellularly cleaved.” The Court’s “plain
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`meaning” conclusion was not directed at its own construction; it was directed to the “the rest of
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`the phrase,” in which “free drug” is nowhere to be found. (Dkt. 155 at 41–42.)
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`B.
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`Dr. Lambert Should Not Be Permitted to Repeat Dr. Morita’s Improper
`Expert Testimony
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`Defendants do not dispute that they failed to disclose Dr. Morita as either a fact or expert
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`witness. That alone merits striking Dr. Lambert’s parroting of his testimony. (Dkt. 252 at 5
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`(citing GREE, Inc. v. Supercell Oy, No. 2:19-cv-70-JRG-RSP, Dkt. 354, slip op. at 4 (E.D. Tex.
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`July 26, 2020)).) Dr. Lambert’s discussion of Dr. Morita’s testimony should also be stricken
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`because Dr. Lambert offers no independent analysis; he merely repeats Dr. Morita’s testimony
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`without addressing the substance of the documents he purportedly reviewed. He then states in
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 3 of 8 PageID #: 10758
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`conclusory fashion, “I conclude the same based on my review of the documents.” (Dkt. 252-2,
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`Responsive Report ¶¶ 143, 145.)
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`C.
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`The Court Should Strike Dr. Lambert’s Reliance on Post-2004 Evidence
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`Defendants’ argument that the ’039 patent’s 2019 filing date permits Dr. Lambert to use
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`post-2004 evidence to challenge enablement is contradicted by Dr. Lambert himself: his report
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`states that he “assumed a priority date of November 5, 2004” for enablement. (Dkt. 265, Ex. 1,
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`Opening Report at ¶ 122.) Dr. Lambert offers no opinion on enablement as of 2019, so
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`Defendants’ argument that Seagen is not entitled to claim priority to 2004 is irrelevant to the
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`permissible scope of his testimony.
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`Drugs/Drug Attachments. Dr. Lambert’s use of post-filing evidence regarding drugs and
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`drug attachments finds no support in Amgen. Defendants do not dispute that the written
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`description sections of Dr. Lambert’s report do not cite the post-filing evidence to analyze
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`representative species, the narrow exception permitted by Amgen, but rather for other purposes.
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`(Compare Dkt. 265 at 9-10 with Dkt. 252 at 9-10 (referencing Opening Report ¶ 110).) Thus,
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`the Court should strike at least Paragraph 110 of his Opening Report.
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`Defendants also do not show that the post-filing evidence for drugs and drug attachments
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`meets the Amgen exception for enablement. There, the Federal Circuit remanded for the district
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`court to consider any post-filing evidence on whether the patentee “engaged in lengthy and
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`potentially undue experimentation to enable the full scope of the claims,” while adhering to
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`precedent that “evidence illuminating the state of the art subsequent to the priority date is not
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`relevant.” Amgen Inc. v. Sanofi, 872 F.3d 1367, 1373-75 (Fed. Cir. 2017). On remand, the
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`district court again excluded the post-filing evidence that defendants proffered, because it only
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`reflected the “subsequent state of the art” and defendants failed to show the evidence pertained to
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 4 of 8 PageID #: 10759
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`embodiments within the “claim scope.” Amgen Inc. v. Sanofi, No. 14-1317-RGA, 2019 U.S.
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`Dist. LEXIS 146305, at *41–42 (D. Del. Aug. 28, 2019) (“Amgen II”).
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`Defendants also fail to make that showing here. Instead, Dr. Lambert focuses—
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`impermissibly—on individual claim elements (the “drug moiety” and “spacer”) instead of the
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`claim as a whole. (See infra Section D.) Dr. Lambert does not even attempt to show that any of
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`the ADCs in the subsequent work meet all the requirements of the claims, the same issue that
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`was fatal to receipt of the similar evidence in Amgen II. Nor could he, as they involve different
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`linker structures than the structure in the ’039 patent claims. Post-filing evidence on the general
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`state of the art for these unclaimed linker types should be excluded from the enablement analysis.
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`Intracellular Cleavage. Defendants also fail to show, in response to Seagen’s motion
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`(Dkt. 252 at 10), that Dr. Lambert’s post-filing evidence on intracellular cleavage is directed to
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`ADCs that fall within the scope of the claims. As Dr. Lambert acknowledges, the MC-MMAF
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`and MC-MMAE linkers he refers to in Paragraph 210 of his report are “noncleavable” linkers by
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`design, and thus fall outside the scope of the claims. (Dkt. 252-1, Opening Report ¶ 210.) And
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`Seagen previously explained that Dr. Lambert’s other opinions are inadmissible under W.L. Gore
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`& Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 1557 (Fed. Cir. 1983) (post-filing evidence
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`cannot “render non-enabling . . . that which was enabling . . . at the time the application was
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`filed”). Defendants argue otherwise. But Dr. Lambert admits in a heading to his report that the
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`“Understanding of the Art Regarding Cleavage Location has Evolved” since the filing date (Dkt.
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`252-1, Opening Report ¶¶ 305-310, 314-316), and that as of 2004, skilled artisans would have
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`been able to determine intracellular cleavage using methods known at the time, even if later
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`developments changed how they might conduct that analysis (Dkt. 265, Ex. 4, Lambert Tr. at
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`97:13-98:19). Dr. Lambert’s discussion of post-filing knowledge about intracellular cleavage is
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 5 of 8 PageID #: 10760
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`exactly the type of evidence the Federal Circuit has found irrelevant to enablement. W.L. Gore,
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`721 F.2d at 1557.
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`D.
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`Dr. Lambert’s Enablement Opinions Based on Unclaimed Requirements
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`Defendants defend their attempt to insert “therapeutic effectiveness” requirements into
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`the claims by characterizing it as “therapeutic viability” (Dkt. 265 at 11), but neither is a claim
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`requirement. While they claim therapeutic viability relates to intracellular cleavage (id. at 12),
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`Dr. Lambert does not make that connection in his report. Paragraph 20, the only report
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`paragraph Defendants cite (id. at fn. 48), does not tie the two. In any event, the Federal Circuit
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`has admonished against importing limitations of this type, especially in the context of
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`composition of matter claims. Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-
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`1070, Dkt. 41, slip op. at 12 (Fed. Cir. Jan. 3, 2022). Defendants’ cited case Idenix is inapposite,
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`as the claim there required “an effective amount” of a compound. Idenix Pharms. LLC v. Gilead
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`Scis., Inc., 941 F.3d 1149, 1155, 1159 (Fed. Cir. 2019.) There is no similar limitation here.
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`Defendants do not even attempt to defend Dr. Lambert’s analysis of other unclaimed
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`requirements. (Dkt. 252 at 11–12 (“off-target toxicities” (Dkt. 265-1, Opening Report ¶¶ 133,
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`134, 137, 138, 141, 308); “reduced cytotoxicity” or “potency” (id. ¶¶ 128–29, 157–59, 168, 182–
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`83, 191–92, 284, 331); “limited” or “mixed” FDA success (id. ¶¶ 179–81).) They thus concede
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`that those paragraphs should be stricken.
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`E.
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`The Court Should Strike Dr. Lambert’s Testimony that Fails to Consider the
`Genus of Claimed ADCs as a Whole
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`Defendants confirm that Paragraphs 92–96 and 108–114 of Dr. Lambert’s report consider
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`individual claim elements rather than analyzing the claimed ADCs as a whole. (Dkt. 265 at 13–
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`14.) As this Court has found, “when a genus is well understood in the art and not itself the
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 6 of 8 PageID #: 10761
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`invention but is instead a component of the claim, background knowledge” can help support that
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`the patentee possessed the invention. Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276
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`F. Supp. 3d 629, 648–49 (E.D. Tex. 2017). Here, the ’039 patent establishes that there were a
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`variety of well-known drugs and spacer units that a skilled artisan could use in an ADC. (Dkt.
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`123-3, ’039 patent at 31:39-33:31; 68:14–70:17.) But unlike the prior art, Seagen describes a
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`specific overall structure for a protease-cleavable ADC, detailed with diagrams in the claims and
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`the specification that allow one to visualize the genus as a whole. Permitting Dr. Lambert’s
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`analysis of individual claim elements would only confuse the jury, even if he includes them only
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`for “helpful technical background.” (Dkt. 265 at 14.)
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`F.
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`The Court Should Exclude PTAB and EPO Proceedings
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`Defendants do not dispute that Dr. Lambert cites the PTAB and EPO proceedings only to
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`bolster his opinions. (Dkt. 262 at 14–15.) This is precisely the type of evidence this Court has
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`found is not proper for the jury to hear. (Dkt. 252 at 13–14.) Moreover, Defendants do not
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`dispute that the EPO proceedings are under a different legal standard and Dr. Lambert provides
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`no opinion on the applicability of EPO law to a U.S. patent. (Id.)
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`G.
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`Dr. Lambert Cannot Serve as a Conduit for Mr. Manspeizer
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`Defendants offer no reason why Dr. Lambert should be permitted to rely on Mr.
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`Manspeizer’s opinions on equitable issues to reach a technical conclusion. Dr. Lambert’s
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`conclusory discussion of the Mr. Manspeizer’s report draws no legal or factual nexus between
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`the issues each expert addresses, nor does it explain why Mr. Manspeizer’s analysis is relevant to
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`written description or enablement. (Dkt. 265-1, Opening Report ¶¶ 6, 69, 79.) The Court should
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`not permit Dr. Lambert to serve as a conduit to introduce analysis of equitable issues to the jury.
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 7 of 8 PageID #: 10762
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`Dated: January 27, 2022
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`By: /s/ Melissa R. Smith
`Michael A. Jacobs
`MJacobs@mofo.com
`Matthew A. Chivvis
`MChivvis@mofo.com
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105
`Telephone: 415.268.7000
`Facsimile: 415.268.7522
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`Bryan Wilson
`BWilson@mofo.com
`MORRISON & FOERSTER LLP
`755 Page Mill Road
`Palo Alto, California 94304-1018
`Telephone: 650.813.5600
`Facsimile: 650.494.0792
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`Melissa R. Smith
`Texas State Bar No. 24001351
`melissa@gillamsmithlaw.com
`GILLAM & SMITH, LLP
`303 South Washington Avenue
`Marshall, Texas 75670
`Telephone: 903.934.8450
`Facsimile: 903.934.9257
`Of Counsel:
`T. John Ward, Jr.
`Texas State Bar No. 00794818
`jw@wsfirm.com
`Charles Everingham IV
`Texas State Bar No. 00787447
`ce@wsfirm.com
`Andrea L. Fair
`Texas State Bar No. 24078488
`andrea@wsfirm.com
`WARD, SMITH & HILL, PLLC
`1507 Bill Owens Parkway
`Longview, Texas 75604
`Telephone: 903.757.6400
`Facsimile: 903.757.2323
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`Attorneys for Plaintiff Seagen Inc.
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`Case 2:20-cv-00337-JRG Document 288 Filed 02/03/22 Page 8 of 8 PageID #: 10763
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that counsel of record who are deemed to have
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`consented to electronic services are being served with a copy of this document via the Court’s
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`CM/ECF system per Local Rule CV-5(a)(3) on this the 27th day of January, 2022.
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`/s/ Melissa R. Smith
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