`
`
`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`SEAGEN INC.,
`
`v.
`
`Civil Action No. 2:20-CV-00337-JRG
`
`Plaintiff,
`
`
`
`DAIICHI SANKYO CO., LTD.,
`
`Defendant,
`
`ASTRAZENECA PHARMACEUTICALS LP,
`and ASTRAZENECA UK LTD,
`
`Intervenor-Defendants.
`
`SEAGEN’S SUR-REPLY TO DEFENDANTS’ MOTION
`FOR JUDGMENT OF INVALIDITY AS A MATTER OF LAW
`
`
`
`
`
`
`
` SF-4950840
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 2 of 15 PageID #: 21254
`
`TABLE OF CONTENTS
`
`
`PAGE
`
`
`I.
`II.
`
`III.
`
`INTRODUCTION ............................................................................................................. 1
`ARGUMENT ..................................................................................................................... 1
`A.
`Defendants Fail to Address Their Burden of Proof ............................................... 1
`B.
`Defendants Have Not Shown that No Reasonable Jury Could Conclude the
`Shared Specification Adequately Discloses Gly/Phe Tetrapeptides ...................... 2
`Defendants Have Not Shown that No Reasonable Jury Could Conclude the
`Shared Specification Adequately Discloses the Drug Moiety Element ................. 6
`Defendants Have Not Shown that No Reasonable Jury Could Conclude
`that the Shared Specification Satisfies the Enablement Requirement ................... 8
`CONCLUSION ................................................................................................................ 10
`
`D.
`
`C.
`
`
` SF-4950840
`
`i
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 3 of 15 PageID #: 21255
`
`TABLE OF AUTHORITIES
`
`
`PAGE(S)
`
`
`Cases
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010)..................................................................................................6
`
`Core Wireless Licensing S.a.r.l. v. LG Elecs., Inc.,
`344 F. Supp. 3d 890 (E.D. Tex. 2018) .......................................................................................9
`
`Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co.,
`276 F. Supp. 3d 629 (E.D. Tex. 2017) .......................................................................................7
`
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996)................................................................................................3, 4
`
`GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.,
`744 F.3d 725 (Fed. Cir. 2014)....................................................................................................7
`
`Hybritech, Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986)..................................................................................................8
`
`Janssen Pharmaceutica N.V. v. Teva Pharms. USA, Inc. (In re ’318 Pat.
`Infringement Litig.),
`583 F.3d 1317 (Fed. Cir. 2009)..................................................................................................9
`
`McRO, Inc. v. Bandai Namco Games Am. Inc.,
`959 F.3d 1091 (Fed. Cir. 2020)..............................................................................................1, 2
`
`Nalpropion Pharms., Inc. v. Actavis Lab’ys FL, Inc.,
`934 F.3d 1344 (Fed. Cir. 2019)..................................................................................................2
`
`Rivera v. Int’l Trade Comm'n,
`857 F.3d 1315 (Fed. Cir. 2017)..................................................................................................5
`
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ...............................................................................................5, 6
`
`United Servs. Auto. Ass’n v. PNC Bank N.A.,
`No. 2:20-cv-00319-JRG-RSP, 2022 WL 1444758 (E.D. Tex. Apr. 29, 2022) ..........................1
`
`In re Wako Pure Chem. Indus. Ltd.,
`4 F. App’x 853 (Fed. Cir. 2001) ................................................................................................3
`
`
`
`
` SF-4950840
`
`ii
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 4 of 15 PageID #: 21256
`
`
`
`
`I.
`
`INTRODUCTION
`
`Rather than address the substantial evidence Seagen offered in its opposition, Defendants
`
`instead seek to frame their motion as a wholly legal question. In so doing, Defendants fail to
`
`confront Seagen’s significant trial evidence demonstrating the adequacy of the shared
`
`specification in disclosing the tetrapeptide and drug moiety claim elements and enabling a POSA
`
`to construct an intracellular cleavable ADC. Defendants needed to establish invalidity by clear
`
`and convincing evidence at trial, and they have fallen far short. They proffer no undisputed
`
`evidence that meets this high bar, and the jury was entitled to credit Seagen’s showing over
`
`Defendants’, or simply to find that Defendants failed to meet their burden. Having failed to
`
`address Seagen’s evidence, Defendants cannot establish that no reasonable jury would reject
`
`their invalidity defenses, and their request for judgment as a matter of law should be denied.
`
`II.
`
`ARGUMENT
`
`A.
`
`Defendants Fail to Address Their Burden of Proof
`
`As Seagen explained in its opposition, in seeking judgment as a matter of law,
`
`Defendants must demonstrate that, despite construing all facts in a light most favorable to
`
`Seagen, no reasonable jury could conclude the ’039 patent to be valid. (Dkt. 467 at 1.) Faced
`
`with the substantial evidence Seagen put forth at trial in support of the patent’s validity,
`
`Defendants now attempt to bypass a rigorous evaluation of the facts by framing their request for
`
`judgment as a matter of law as a strictly legal inquiry. (Dkt. 474 at 1, 7–10.) But both written
`
`description and enablement require a highly complex factual analysis. See, e.g., United Servs.
`
`Auto. Ass’n v. PNC Bank N.A., No. 2:20-cv-00319-JRG-RSP, 2022 WL 1444758, at *1 (E.D.
`
`Tex. Apr. 29, 2022) (“Enablement is determined by analysis of all the underlying facts.”);
`
`McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 1096 (Fed. Cir. 2020)
`
`(“[W]hether a patent satisfies the enablement requirement is a question of law based on
`
` SF-4950840
`
`1
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 5 of 15 PageID #: 21257
`
`
`underlying factual findings.”); Nalpropion Pharms., Inc. v. Actavis Lab’ys FL, Inc., 934 F.3d
`
`1344, 1348 (Fed. Cir. 2019) (“Whether a claim satisfies the written description requirement is a
`
`question of fact.”). Neither can be decided as a purely legal issue, especially in light of the
`
`evidence Seagen presented.
`
`Defendants already failed to prove their invalidity defenses by clear and convincing
`
`evidence at trial. Now, despite multiple briefs, Defendants still cannot overcome Seagen’s
`
`substantial evidence to justify their request for judgment as a matter of law. They fail to show
`
`why no reasonable jury would accept Nobel laureate Dr. Bertozzi’s competing testimony on
`
`disputed issues over Dr. Lambert’s.1 Nor do they cite any undisputed evidence that addresses the
`
`evidence Seagen set forth in its opposition. And they offer only improper hearsay in defense of
`
`Dr. Lambert applying the wrong legal standard for invalidity.2 Defendants’ conclusory rebuttal
`
`and failure to grapple with Seagen’s evidence simply cannot meet their high burden for obtaining
`
`the relief they seek.
`
`B.
`
`Defendants Have Not Shown that No Reasonable Jury Could Conclude the
`Shared Specification Adequately Discloses Gly/Phe Tetrapeptides
`
`Defendants reiterate the same arguments they presented in their opening motion on the
`
`purported lack of written description for the tetrapeptide unit, citing again to Wako and
`
`Fujikawa. (Dkt. 474 at 8.) Defendants claim that the Federal Circuit found a failure to satisfy
`
`the written description requirement in both Wako and Fujikawa because the claims at issue in
`
`those cases “require first selecting a category and then making an additional selection to claim a
`
`
`1 Dr. Bertozzi recently won the Nobel Prize in Chemistry. (See https://news.stanford.edu/press-
`releases/2022/10/05/carolyn-bertozzi-nobel-chemistry/.) Defendants have no basis to suggest
`her testimony was not credible.
`2 Defendants dismiss Dr. Lambert’s application of the wrong legal standards as a failure to “fully
`state the legal standard he had applied.” (Dkt. 474 at 1 n.2.) Not so. His report is hearsay that
`was not admitted at trial and cannot support application of a standard that differs from that to
`which he testified.
`
`
` SF-4950840
`
`2
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 6 of 15 PageID #: 21258
`
`
`subset of that category.” (Dkt. 474 at 9 (emphasis in original).) But contrary to Defendants’
`
`assertion, neither case suggests the need to make a two-tiered selection to reach the claimed
`
`invention was determinative. And as Seagen already explained in its opposition, both cases are
`
`readily distinguishable. (Dkt. 467 at 11–13.)
`
`In Wako, the patent specification disclosed seven possible groups for the side chains R1
`
`and R2. See In re Wako Pure Chem. Indus. Ltd., 4 F. App’x 853, 855 (Fed. Cir. 2001). The
`
`patent claims, however, required that R1 and R2 to be chemical groups that were neither explicitly
`
`disclosed nor exemplified in the specification. Id. The Federal Circuit held that Wako would
`
`have satisfied the written description requirement if it had claimed precisely the “C1–10 straight-
`
`chain, branched or cyclic alkyl group” disclosed as one of the seven options in the specification
`
`rather than an arbitrary, undisclosed subset of that group. Id. at 855, 857. Here, unlike Wako,
`
`the shared specification does exactly what the Federal Circuit explained to be necessary: it
`
`discloses the claimed tetrapeptides as a length option for the amino acid unit and also discloses
`
`the claimed H (glycine) and benzyl (phenylalanine) groups as side chain options for the amino
`
`acids to be used in the peptide unit. (Dkt. 467 at 5–6, 11–12.)
`
`Fujikawa is distinguishable based on the procedural posture of that case. There, the
`
`Federal Circuit upheld the patent office’s findings under the deferential clear-error standard of
`
`review and its decision did not necessarily constitute an endorsement of those findings.3
`
`Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). (“While Fujikawa’s arguments
`
`are not without merit, we cannot say, on this record, the Board’s decision was clearly
`
`
`3 The Federal Circuit in Wako was likewise reviewing a Board’s decision under a deferential
`standard of review. Id. at 854 (“We review the Board’s decision on whether the disclosure of the
`Japanese patent application has a written description that supports claims 1 and 4–6 of the Urano
`patent for substantial evidence.”).
`
`
` SF-4950840
`
`3
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 7 of 15 PageID #: 21259
`
`
`erroneous.”). The court found no reversible error in the Board’s determination that the
`
`specification lacked sufficient blazemarks, a highly factual inquiry. Id. Here, in contrast,
`
`Seagen presented substantial testimony and documentary evidence supporting that, to the extent
`
`required, the shared specification contains blazemarks directing a POSA towards the use of
`
`tetrapeptides, glycine, and phenylalanine, and jury implicitly credited Seagen’s evidence over
`
`Defendants’. (Dkt. 467 at 7–9, 12–13; Dkt. 369 at 5 (jury verdict).) There is no legal basis to
`
`reject these implicit factual findings.
`
`Having failed to provide the clear and convincing evidence necessary to overcome
`
`Seagen’s substantial competing evidence before the jury, Defendants now seek to discredit
`
`Dr. Bertozzi’s testimony as an improper “obviousness” analysis. But their position—relying
`
`solely on Dr. Bertozzi’s one-time use of the phrase “a straightforward leap”—misconstrues the
`
`record. (Trial Tr. (Day 2) at 50:25–51:02.) As noted in Seagen’s opposition and exemplified
`
`below, her complete testimony demonstrates that she properly addressed whether shared
`
`specification has “blazemarks” pointing to gly/phe-tetrapeptides.
`
`Questioning Attorney: [C]an you tell us at a high level why you disagree with what
`Doctor Lambert has asserted here [with regards to the lack of blazemarks]?
`
`Dr. Bertozzi: I disagree because I do find such blazemarks, as they’re called, which is
`guidance both from the patent document itself as well as from the prior art to arrive at the
`tetrapeptide sequences that we’re discussing.
`
`. . .
`
`Questioning Attorney: What do we see at the top here, and can you tell us whether that
`give us any blazemarks?
`
`Dr. Bertozzi: Yes. So this structure shows an example of tetrapeptides, and that table
`with R20, R21, R22, and R23 are examples of amino acids that could be in this tetrapeptide.
`. . . [T]he first row in that table has R20 H, that’s G. R21 is benzyl, that’s F. R22 isobutyl,
`that’s an amino acid L. And then, finally, R23 is H, and that’s G again. . . . There are three
`Gs and Fs in this four amino acid peptide.
`
`. . .
`
`
` SF-4950840
`
`4
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 8 of 15 PageID #: 21260
`
`
`Questioning Attorney: How would one of ordinary skill in the art take direction from
`what is presented in tables 8 and 9 of the 2004 patent application with respect to
`tetrapeptides?
`
`Dr. Bertozzi: The person of skill in the art who wanted to make tetrapeptides for their
`ADC would look at these sequences and understand that F at P2 would be a choice that is
`clearly stated in this patent specification, and they might take that knowledge and put F in
`P2 of their tetrapeptide. . . . [T]he tetrapeptide sequence with the sequence GFLG . . . [has]
`three Gs and F[s] and one amino acid that is not G or F, but that one amino acid that is not
`G or F is in the P2 position, and that tripeptide example teaches the person of ordinary skill
`to put F in the P2 position. So combining these two [examples in the shared specification],
`a G/F tetrapeptide I think is a very clear choice to pursue.
`
`(Trial Tr. (Day 4) at 88:07–13, 89:10–23, 92:11–93:05; see also Dkt. 467 at 7–11.) The jury
`
`implicitly acknowledged the same. (Dkt. 369 at 5.)
`
`Defendants renew their accusation that Dr. Bertozzi improperly referenced prior art in her
`
`blazemarks analysis, citing again to Rivera v. International Trade Commission. (Dkt. 474 at 9–
`
`10.) But unlike Rivera, in which the patentee used prior art to teach a limitation that was clearly
`
`excluded by the specification, Dr. Bertozzi relied on prior art solely to corroborate her opinion on
`
`what a POSA would have known as of the filing date of the 2004 application. (Dkt. 467 at 10.)
`
`See Rivera v. Int’l Trade Comm'n, 857 F.3d 1315, 1320 (Fed. Cir. 2017) (specification does not
`
`disclose the claimed integrated filter—in which the filter and the cartridge are one unit—because
`
`“every embodiment and teaching in the specification shows the ‘pod’ and the cartridge or
`
`container as distinct elements.”). Dr. Bertozzi was not using the prior art to justify the use of an
`
`amino acid or peptide length that was never contemplated by the shared specification.
`
`Defendants newly rely on In re Ruschig to dismiss Dr. Bertozzi’s blazemarks analysis,
`
`but that case is inapposite. In Ruschig, the claims were directed to a single compound that was
`
`never used in any examples in the specification nor specifically disclosed as an option for the
`
`claimed element. In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967). The court in Ruschig
`
`rejected the patent owner’s argument that the exemplary disclosure of a structurally similar—but
`
`
` SF-4950840
`
`5
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 9 of 15 PageID #: 21261
`
`
`fundamentally different—compound provided sufficient blazemarks for the claimed element. Id.
`
`Here, unlike Ruschig, the ’039 patent does not claim a single compound nor attempt to use
`
`disclosures of completely unrelated compounds as purported blazemarks. Rather, as Seagen
`
`previously explained, the shared specification provides exemplary tetrapeptides that demonstrate
`
`the use of glycine and phenylalanine amino acids. (See Dkt. 467 at 7–8.) A POSA would
`
`recognize the specification to be highlighting tetrapeptides as well as glycine and phenylalanine
`
`out of the variety of peptide length and amino acid options. In other words, the shared
`
`specification “single[s] out particular trees” of tetrapeptides, glycine, and phenylalanine. In re
`
`Ruschig, 379 F.2d at 995.
`
`C.
`
`Defendants Have Not Shown that No Reasonable Jury Could Conclude the
`Shared Specification Adequately Discloses the Drug Moiety Element
`
`Defendants offer no new argument in support of their position that the shared
`
`specification fails to provide adequate written description support for the claimed genus of drug
`
`moieties that the jury had not already evaluated.
`
`Defendants attempt to dismiss the shared specification’s disclosure of these drug moieties
`
`as irrelevant on the basis that the drug compounds are listed in the background section. But as
`
`the Federal Circuit set forth in Ariad, “the test [for written description] requires an objective
`
`inquiry into the four corners of the specification from the perspective of a person of ordinary
`
`skill in the art.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
`
`(emphasis added). The background section of the shared specification falls within the four
`
`corners of the specification and sets the table for the disclosure that follows. As Dr. Bertozzi
`
`explained and Defendants acknowledge, the disclosure of drug moieties in the background
`
`section “describes the state of the art” and are those a POSA would have recognized to be usable
`
`in an ADC, such as that claimed in the ’039 patent. (Dkt. 474 at 2; Dkt. at 14.)
`
`
` SF-4950840
`
`6
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 10 of 15 PageID #: 21262
`
`
`Defendants assert that the shared specification lacks common “structural” features in the
`
`claimed genus of drug moieties, arguing that such features must be physical structures. (Dkt.
`
`474 at 3–4.) But as Seagen noted in its opposition, common features do not need to be physical
`
`features. Rather, “physical properties, or other properties, of species falling within the genus
`
`sufficient to distinguish the genus from other materials” can satisfy the written description
`
`requirement. GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., 744 F.3d 725, 730 (Fed. Cir.
`
`2014) (internal quotations omitted). The shared specification’s description of the common
`
`cell-killing properties of the cytotoxins—precisely identified as inducing cell death by “tubulin
`
`binding, DNA binding, or topoisomerase inhibition”—is therefore sufficient to describe the
`
`genus, although the specification also describes physical structures useful for attaching drug
`
`moieties. (Dkt. 467 at 16.)
`
`Defendants argue that these physical structures are insufficient because the functional
`
`group can vary for each class of drug compounds. (Dkt. 474 at 4.) But Defendants offer no
`
`authority indicating that the shared features for a genus must be identical for all members of the
`
`genus. Nor could they. This Court has made clear that a genus may be divided into subgenera
`
`with different features and a POSA would be able to “visualize or recognize the members of the
`
`genus by looking for any one of those [subgenera] features.” Erfindergemeinschaft UroPep GbR
`
`v. Eli Lilly & Co., 276 F. Supp. 3d 629, 653 (E.D. Tex. 2017) (internal quotations omitted).
`
`Seagen elicited substantial evidence at trial that a POSA would be able to recognize the genus of
`
`drug compounds usable for the claimed invention by looking for any of the known functional
`
`groups useful for attachment to the claimed ADC, such as alcohol, amine, or thiol groups. (Dkt.
`
`467 at 16.) Defendants offer no undisputed evidence to the contrary, and instead rely on the
`
`unsupported statement that “linkage through a single atom is not sufficient to identify the
`
`
` SF-4950840
`
`7
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 11 of 15 PageID #: 21263
`
`
`claimed genus.” (Dkt. 474 at 4.) This conclusory statement, even when considered with
`
`Dr. Lambert’s testimony, cannot meet their burden. The jury was free to reject this position, and
`
`instead credit Seagen’s evidence.
`
`D.
`
`Defendants Have Not Shown that No Reasonable Jury Could Conclude that
`the Shared Specification Satisfies the Enablement Requirement
`
`Defendants argue yet again that the shared specification only discloses ADCs with
`
`dolastatin/auristatin drugs and lacks disclosure of the chemistry needed to attach other drug
`
`compounds. (Dkt. 474 at 4–6.) But as Dr. Bertozzi explained, the same chemistry that the
`
`specification teaches for attaching dolastatin/auristatin drugs can also be applied to other drug
`
`moieties. (Dkt. 467 at 20.) Even if the shared specification’s disclosure of certain spacer units
`
`would not independently allow attachment of all drug classes, as Defendants contend, many
`
`other drugs can be attached to ADCs using known, traditional chemical techniques that were
`
`“developed before the field of ADCs even started.” (Trial Tr. (Day 4) at 104:21–22; see also
`
`Dkt. 467 at 19.) A specification need not disclose what was already well-known. Hybritech,
`
`Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (a patent specification
`
`“need not teach, and preferably omits, what is well known in the art.”). And to the extent that
`
`Defendants are making an argument that the spacer unit is not adequately enabled, they have
`
`waived this argument by failing to raise it in their Rule 50(a) motion or opening brief.
`
`Defendants insist that they should be allowed to rely on post-2004 developments in
`
`drug-attachment techniques to show that Seagen scientists did not understand how to attach all
`
`drug classes as of the filing date of the priority application.4 As Seagen noted in its opposition,
`
`
`4 Defendants argue that post-2004 evidence is relevant because they are challenging the priority
`date of the ’039 patent. (Dkt. 474 at 5 n.9.) But until Defendants have shown that the
`’039 patent is not entitled to its 2004 priority date, Defendants cannot conclude that the
`appropriate filing date of the ’039 patent is July 2019. Defendants cite no authority to the
`contrary.
`
`
` SF-4950840
`
`8
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 12 of 15 PageID #: 21264
`
`
`such post-filing evidence is irrelevant because “[e]nablement is determined as of the effective
`
`filing date of the patent’s application.” (Dkt. 467 at 21–22; Janssen Pharmaceutica N.V. v. Teva
`
`Pharms. USA, Inc. (In re ’318 Pat. Infringement Litig.), 583 F.3d 1317, 1323 (Fed. Cir. 2009).)
`
`Seagen’s development of new methods of attachment bears no relevance to the enablement of the
`
`claims of the ’039 patent. The existence of alternate methods of attachment for certain drug
`
`classes cannot prove that the methods in existence as of 2004 were insufficient to attach those
`
`drug classes to the claimed ADC. (Id.) Moreover, the shared specification does not fail to
`
`support the claims merely because Defendants hypothesized that some disclosed drug classes
`
`may have been difficult to attach in 2004. As this Court has explained, “[E]ven if some of the
`
`claimed combinations were inoperative, the claims are not necessarily invalid ... the party
`
`alleging inoperability must show that each disclosed embodiment in the patents was impossible
`
`or not enabled.” Core Wireless Licensing S.a.r.l. v. LG Elecs., Inc., 344 F. Supp. 3d 890, 895
`
`(E.D. Tex. 2018) (emphasis added). Defendants have made no such showing.
`
`In addition to challenging the shared specification’s support for the drug moiety,
`
`Defendants again contend the shared specification does not sufficiently enable a POSA to
`
`determine whether intracellular cleavage occurs in a patient.5 (Dkt. 474 at 6–7.) The jury
`
`implicitly rejected Defendants’ argument on this issue and Seagen also already addressed this
`
`exact argument in its opposition. Publications available as of the 2004 priority date of the
`
`’039 patent make clear that in vitro and in vivo assays can demonstrate intracellular cleavage in a
`
`
`5 Defendants attempt to characterize the intracellular cleavage claim limitation as an “activity
`requirement.” (Dkt. 474 at 6.) This is incorrect. Nothing in the claims require the ADC to have
`any therapeutic efficacy. Contrary to Defendant’s insinuations, the Court’s refusal to strike
`Dr. Lambert’s expert report sections on therapeutic efficacy does not insert an activity
`requirement into the claims. Nor does it suggest that the Court construed to the claims to have
`such an activity requirement. (Id. at 6 n.10.)
`
`
` SF-4950840
`
`9
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 13 of 15 PageID #: 21265
`
`
`patient. (Dkt. 467 at 23–26.) And the shared specification teaches that peptide-cleavable ADC
`
`linkers of the type it discloses are designed to cleave intracellularly. (PX-0001 at 2:07–53,
`
`18:56–61, 66:43–46, 159:09–13, 163:41–46.) As explained in Seagen’s opposition, the shared
`
`specification sufficiently enables a POSA to construct an intracellularly-cleaving ADC. (Dkt.
`
`467 at 23–26.) Defendants have not provided unrebutted clear and convincing evidence to the
`
`contrary, and the jury was free to find they failed to meet their burden to establish invalidity on
`
`this basis.
`
`III. CONCLUSION
`
`Defendants’ reply fails to confront the substantial evidence Seagen elicited at trial
`
`supporting the validity of the ’039 patent and does not show that no reasonable jury could have
`
`found they failed to meet their burden of establishing invalidity by clear and convincing
`
`evidence. Having failed to make the required showing on both fronts, their motion must be
`
`denied.
`
`
` SF-4950840
`
`10
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 14 of 15 PageID #: 21266
`
`
`
`
`Dated: October 21, 2022
`
`
`
`By: /s/ Michael A. Jacobs
`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
`
`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
`
`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
`Wesley Hill
`Texas State Bar No. 24032294
`wh@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
`Attorneys for Plaintiff Seagen Inc.
`
` SF-4950840
`
`1
`
`
`
`Case 2:20-cv-00337-JRG Document 477 Filed 10/21/22 Page 15 of 15 PageID #: 21267
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that counsel of record who are deemed to have
`
`consented to electronic services are being served with a copy of this document via the Court’s
`
`CM/ECF system per Local Rule CV-5(a)(3) on this the 21st day of October, 2022.
`
`
`
`/s/ Melissa R. Smith
`
`
`
`
` SF-4950840
`
`2
`
`
`
`