Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 1 of 22 PageID #: 10575
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`SEAGEN INC.,
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`Plaintiff,
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`v.
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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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`CASE NO. 2:20-cv-00337-JRG
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`DEFENDANTS’ 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 273 Filed 01/27/22 Page 2 of 22 PageID #: 10576
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`TABLE OF CONTENTS
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`I.
`II.
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`III.
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`IV.
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`V.
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`B.
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`INTRODUCTION ...............................................................................................................1
`IT IS APPROPRIATE FOR THE JURY TO HAVE AN
`OPPORTUNITY TO EVALUATE DR. LAMBERT’S FULL
`TESTIMONY AS SET FORTH IN HIS RESPONSIVE REPORT ....................................1
`A.
`Dr. Lambert Provides Necessary Analysis Regarding
`the POSA’s Understanding of the Asserted Claims as a Whole ..............................1
`Dr. Lambert’s Opinions are Based on His Own Scientific
`and Technical Knowledge and Consistent with the Record ....................................4
`THE OPINIONS AND EVIDENCE SET FORTH IN
`DR. LAMBERT’S OPENING REPORT ARE APPROPRIATE
`FOR THE JURY’S CONSIDERATION IN DECIDING
`ISSUES OF ENABLEMENT AND WRITTEN DESCRIPTION ......................................7
`A.
`Dr. Lambert’s Opening Report Appropriately Cites Pre-2019 Evidence ................7
`B.
`Dr. Lambert Provides Analysis on the Understanding of the POSA of
`the Required Structural and Functional Limitations of the Asserted Claims ........11
`Dr. Lambert Appropriately Analyzes Written Description ....................................13
`C.
`DR. LAMBERT’S APPROPRIATE
`ADDITIONAL REFERENCES TO ANALYSIS AND
`CONCLUSIONS OF OTHERS CONSISTENT WITH HIS OWN ..................................14
`A.
`Consistency of Opinions Provided in Post-Grant Review Proceedings ................14
`B.
`Consistency with Factual Observations by the European Patent Office ................15
`C.
`Dr. Lambert Likewise Confirms Consistency with Mr. Manspeizer .....................15
`CONCLUSION ..................................................................................................................15
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 3 of 22 PageID #: 10577
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`TABLE OF AUTHORITIES
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`CASES
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`Page(s)
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`ALZA Corp. v. Andrx Pharms., LLC,
`603 F.3d 935 (Fed. Cir. 2010) .....................................................................................................8
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) ..................................................................................................2
`Amgen, Inc. v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017) .............................................................................................8, 10
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .....................................................................................10, 13, 14
`BMC Software, Inc. v. ServiceNow, Inc.,
`No. 2:14-cv-903-JRG, Dkt. 325, (E.D. Tex. Jan. 28, 2016) ........................................................3
`CFMT, Inc. v. Yieldup Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) ...................................................................................................9
`Eon Corp. IP Holdings LLC v. Silver Spring Networks, Inc.,
`815 F.3d 1314 (Fed. Cir. 2016) ...................................................................................................2
`GREE, Inc. v. Supercell Oy,
`No. 2:19-cv-71-JRG-RSP, 2020 WL 3893697 (E.D. Tex. July 9, 2020) ...........................2, 3, 5
`Hitachi Consumer Elecs. Co. v. Top Victory Elecs. (Taiwan) Co.,
`No. 2:10-CV-260-JRG, 2013 WL 5273326 (E.D. Tex. Sept. 18, 2013) .................................3, 4
`Idenix Pharms. LLC v. Gilead Sci., Inc.,
`941 F.3d 1149 (Fed. Cir. 2019) .....................................................................................10, 11, 12
`Mobility Workx, LLC v. Cellco P’ship,
`No. 4:17-CV-00872, 2019 WL 5721814 (E.D. Tex. Nov. 5, 2019) .................................1, 5, 15
`PerdiemCo, LLC v. Industrack LLC,
`No. 2:15-CV-727-JRG-RSP, 2016 WL 6432699 (E.D. Tex. Oct. 28, 2016) ..............................4
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ...................................................................................................2
`Pipitone v. Biomatrix, Inc.,
`288 F.3d 239 (5th Cir. 2002) .......................................................................................................7
`United Servs. Auto. Ass’n v. Wells Fargo Bank, N.A.,
`No. 2:18-cv-366-JRG-RSP, 2019 U.S.
`Dist. LEXIS 219186 (E.D. Tex. Dec. 19, 2019) .........................................................................5
`United States v. 14.38 Acres of Land, More or Less Situated in Leflore County,
`80 F.3d 1074 (5th Cir. 1996) .......................................................................................................5
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 4 of 22 PageID #: 10578
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`Wallis v. Hornbeck Offshore Operators,
`2014 WL 3809743 (E.D. La. Aug. 1, 2014) ................................................................................1
`W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .................................................................................................10
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`OTHER AUTHORITIES
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`Fed. R. Civ. P. 32(d)(3)(B) ..............................................................................................................7
`Fed. R. Evid. 702 .......................................................................................................................1, 14
`Fed. R. Evid. 703 .....................................................................................................................14, 15
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 5 of 22 PageID #: 10579
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`I.
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`INTRODUCTION
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`Dr. John Lambert is a leading pioneer of the antibody-drug conjugate field, having helped
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`to invent one of the first marketed ADCs and written several books on ADCs.1 Seagen did not
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`serve substantive responses to many of his opinions, and instead tries to exploit a process intended
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`to prevent unreliable evidence from being heard by the trier of fact to prevent Dr. Lambert from
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`appropriately presenting reliable and relevant scientific opinions to the jury—opinions that also
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`happen to be contrary to Seagen’s arguments.2 Seagen’s purported “Motion to Strike” nowhere
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`cites, let alone applies, the governing Rule 702.3 It should be denied.
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`II.
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`IT IS APPROPRIATE FOR THE JURY TO HAVE
`AN OPPORTUNITY TO EVALUATE DR. LAMBERT’S
`FULL TESTIMONY AS SET FORTH IN HIS RESPONSIVE REPORT
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`A.
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`Dr. Lambert Provides Necessary Analysis Regarding
`the POSA’s Understanding of the Asserted Claims as a Whole
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`Rather than move for summary judgment of infringement, Seagen attempts to undercut Dr.
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`Lambert’s ability to present evidence and conclusions regarding non-infringement to the jury by
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`falsely accusing him of disregarding the Court’s claim construction rulings.4 Dr. Lambert’s
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`Responsive Report and testimony, however, appropriately present his full non-infringement
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`analysis, and the jury should have an opportunity to decide this disputed issue based on the
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`complete record.
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`1 Ex. 1, Lambert Opening Report ¶¶ 8-16, Tab 1.
`2 See Mobility Workx, LLC v. Cellco P’ship, No. 4:17-CV-00872, 2019 WL 5721814, at *6 (E.D.
`Tex. Nov. 5, 2019) (“Put simply, a court ‘is not concerned with whether the opinion is correct,
`but whether the preponderance of the evidence establishes that the opinion is reliable.’”) (citing
`Wallis v. Hornbeck Offshore Operators, 2014 WL 3809743, at *1 (E.D. La. Aug. 1, 2014)).
`3 In filing this motion, Seagen also failed to meaningfully meet and confer with Defendants, as
`required, so as to allow an opportunity to clarify Seagen’s apparent misinterpretations.
`4 Seagen’s Motion to Strike Portions of the Expert Reports of John M. Lambert § II.A, Seagen
`Inc. v. Daiichi Sankyo Co., Ltd., No. 20-00447-JRG (E.D. Tex. Jan. 6, 2022) (Dkt. No. 252).
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 6 of 22 PageID #: 10580
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`In order to provide his expert conclusions regarding the alleged infringement by the
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`accused product, DS-8201, Dr. Lambert’s Responsive Report appropriately includes a comparison
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`between the Asserted Claims as a whole and the accused product.5 While the Court construed
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`certain terms in its Claim Construction Order, which Dr. Lambert references and explicitly applies
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`in his analysis, it also specifically stated that portions of the terms and phrases have their “plain
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`and ordinary meaning.”6 Further, other aspects of the claim language and limitations of the
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`Asserted Claims as a whole were never at issue during the Markman proceedings, and so are given
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`their “plain and ordinary meaning” as well.7 Those plain and ordinary meanings are not assessed
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`“in the abstract,” but rather must reflect the “meaning to the ordinary artisan after reading the entire
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`patent.”8
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`Consistent with these facts and legal principles, to establish the scope of the claims as a
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`whole, including the meaning of each limitation, Dr. Lambert sets forth and applies each of the
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`Court’s constructions. For those aspects of the claim language that the Court did not interpret, Dr.
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`Lambert explains and uses the plain and ordinary meaning as understood by the person of ordinary
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`skill in the art (“POSA”)9, which is determined in the context of the entire patent.10 An opinion
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`that the POSA would find the accused product does not meet a claim limitation constitutes a
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`non-infringement opinion, and does not amount to claim construction.11 Instead, it “constitutes a
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`5 Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1324 (Fed. Cir. 2003).
`6 Markman Order, Dkt. 155 at 15, 41-42.
`7 Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005).
`8 See Eon Corp. IP Holdings LLC v. Silver Spring Networks, Inc., 815 F.3d 1314, 1320 (Fed. Cir.
`2016).
`9 See, e.g., Ex. 2, Lambert Responsive Report ¶ 26.
`10 See Phillips, 415 F.3d at 1312 (explaining it is the “meaning to the ordinary artisan after
`reading the entire patent.”).
`11 See GREE, Inc. v. Supercell Oy, No. 2:19-cv-71-JRG-RSP, 2020 WL 3893697, at *2 (E.D.
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`non-infringement opinion” that is properly presentable to the jury.12 For terms given their plain
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`and ordinary meaning, the “jury is free to apply an expert’s description of the claims if it is
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`consistent with the jury’s understanding.”13
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`In particular, Dr. Lambert’s report discusses the Drug Moiety Intracellular Cleavage
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`Limitation as a whole14, and concludes that DS-8201 does not meet this limitation, as it would be
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`understood by the POSA. In reaching this conclusion, Dr. Lambert used the Court’s constructions,
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`where applicable, as well as the plain and ordinary meaning, as understood by the POSA in the
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`context of the entire patent, for portions of the claim the Court did not construe.15
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`In its Claim Construction Order, the Court specifically noted that “[t]he claim itself does
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`not have an express requirement on the meaning of ‘free drug,’ how the free drug moiety
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`dissociates, and whether the free drug dissociates as a result of a separate step. However, the claim
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`expressly requires ‘intracellularly cleaved,’ and the specification defines that term.”16 The Court
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`also stated the rest of the phrase has its plain and ordinary meaning.17 Dr. Lambert therefore
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`Tex. July 9, 2020). Dr. Lambert’s deposition testimony also in no way implies he was offering
`claim constructions, as Seagen alleges. Instead, the discussion Seagen highlights addresses the
`POSA’s understanding of the Drug Moiety Intracellular Cleavage Limitation as a whole,
`including aspects that, under this Claim Construction order, have their plain and ordinary
`meaning. Ex. 4, Lambert Tr. at 130:12-135:23.
`12 See GREE, 2020 WL 3893697, at *2.
`13 Hitachi Consumer Elecs. Co. v. Top Victory Elecs. (Taiwan) Co., No. 2:10-CV-260-JRG, 2013
`WL 5273326, at *10 (E.D. Tex. Sept. 18, 2013).
`14 Ex. 2, Lambert Responsive Report ¶ 11 (“wherein the drug moiety is intracellularly cleaved in
`a patient from the antibody of the antibody-drug conjugate or an intracellular metabolite of the
`antibody-drug conjugate”).
`15 See, e.g., Ex. 2, Lambert Responsive Report ¶ 51.
`16 Markman Order, Dkt. 155 at 40-42.
`17 Id. at 42. As Dr. Lambert expressly followed the Court’s directive of using the plain and
`ordinary meaning, Seagen’s reliance on BMC Software, Inc. v. ServiceNow, Inc., No. 2:14-cv-
`903-JRG, Dkt. 325, slip op (E.D. Tex. Jan. 28, 2016), where the expert attempted to opine on the
`meaning of a term that the Court considered and expressly rejected, is not appropriate here.
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 8 of 22 PageID #: 10582
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`applied the constructions provided by the Court and followed the Court’s directive that the rest of
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`the phrase has its plain and ordinary meaning.
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`Based on this analysis, Dr. Lambert explained
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`.18 This is also precisely what Claim 1’s structure depicts: D is the
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`portion of the molecule that is not Spacer (Yy) or tetrapeptide (Ww). Dr. Lambert then analyzes
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`. Seagen’s expert analyzes the structure differently. Who is
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`right poses a classic factual question for the jury.19
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`B.
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`Dr. Lambert’s Opinions are Based on His Own Scientific
`and Technical Knowledge and Consistent with the Record
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`In Section I.B, Seagen mischaracterizes Dr. Lambert’s Responsive Report
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`.20 Dr. Lambert, however,
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`independently evaluated the information cited by Dr. Bertozzi,
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`21 The cases Seagen cites are
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`18 Unlike in PerdiemCo, LLC v. Industrack LLC, No. 2:15-CV-727-JRG-RSP, 2016 WL
`6432699, at *1 (E.D. Tex. Oct. 28, 2016), where the expert argued for a special meaning after
`claim construction, Dr. Lambert uses the context of the ’039 patent, which draws a distinction
`between releasing drug-linker compounds and releasing drug moieties, yet only claims ADCs
`where “the drug moiety is intracellularly cleaved in a patient.” See Ex. 2, Lambert Responsive
`Report ¶ 53 (citing ’039 patent at 159:9-19 and Claim 1). Dr. Lambert’s non-infringement
`analysis thus does not contradict the Court’s construction, as Seagen alleges, but rather provides
`analysis on the plain and ordinary meaning of the rest of the phrase, which requires the intrinsic
`record for context.
`19 See Hitachi, 2013 WL 5273326, at *10.
`20 Dkt. No. 252 at 4.
`21 See Ex. 2, Lambert Responsive Report ¶¶ 143, 145.
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 9 of 22 PageID #: 10583
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`thus inapposite.22 Questions directed to what weight Dr. Lambert’s substantive opinions should
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`be given,
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`, are appropriately left to the jury.23
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`Dr. Lambert’s opinion that conjugating to an MC group on an antibody was known publicly
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`prior to the claimed priority date of the ’039 patent
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`, is based on his own review of the prior art,
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`.24
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`25,
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`.26
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`, they are relevant to issues of the credibility and
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`reliability of the provided evidence and opinions, and so are relevant for the jury to consider.27
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`Striking this discussion also will prejudice Defendants, as it would deprive the jury of additional
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`22 See GREE, Inc. v. Supercell Oy, No. 2:19-cv-70-JRG-RSP, Dkt. 354, slip op. at 4 (E.D. Tex.
`July 26, 2020) (striking testimony where experts used facts and information learned only from
`conversations with individuals not disclosed under Rule 26 to form the basis of their opinions);
`see also United Servs. Auto. Ass’n v. Wells Fargo Bank, N.A., No. 2:18-cv-366-JRG-RSP, 2019
`U.S. Dist. LEXIS 219186, at *10–11 (E.D. Tex. Dec. 19, 2019) (same).
`23 Mobility Workx, 2019 WL 5721814, at *6 (“In determining the admissibility of expert
`testimony, proper deference should be accorded to the role of the jury ‘as the arbiter of disputes
`between conflicting opinions.’”) (citing United States v. 14.38 Acres of Land, More or Less
`Situated in Leflore County, 80 F.3d 1074, 1077 (5th Cir. 1996)).
`24 Ex. 2, Lambert Responsive Report IX.C.
`25 See Ex. 2, Lambert Responsive Report ¶¶ 143, 145.
`26 Seagen’s reliance on GREE at 5, where prejudice was found where factual information was
`only disclosed through rebuttal expert reports preventing Plaintiff’s experts from opining on the
`information, is therefore inapplicable here.
`27 See Mobility Workx, 2019 WL 5721814, at *6, 8.
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 10 of 22 PageID #: 10584
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`information regarding Dr. Bertozzi’s mischaracterizations of the emails evaluated by Dr. Lambert.
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`Further, Seagen had the same opportunity to address Dr. Morita’s testimony in Dr. Bertozzi’s
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`Supplemental Report, eliminating any potential prejudice to Seagen.
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`Seagen also seeks to strike any reference to Dr. Morita’s deposition testimony from Dr.
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`Lambert’s report because Seagen asserts that Dr. Morita’s testimony allegedly was obtained
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`improperly.28 Seagen is incorrect. The testimony Dr. Lambert discussed in his report was provided
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`by Dr. Morita in response to issues raised by Seagen during its deposition cross-examination.
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`.30 Accordingly, Dr. Morita’s testimony was properly responsive,
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`as it was a further explanation, clarification, and correction allegations advanced by Seagen during
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`cross-examination.31
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`28 Dkt. No. 252 at 5-7.
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`30
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 11 of 22 PageID #: 10585
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`.32 As such, Dr. Lambert’s reference to
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`Dr. Morita’s testimony should not be struck, and the jury should have the opportunity to make its
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`own determination based on a complete record.
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`III. THE OPINIONS AND EVIDENCE SET FORTH IN DR. LAMBERT’S OPENING
`REPORT ARE APPROPRIATE FOR THE JURY’S CONSIDERATION
`IN DECIDING ISSUES OF ENABLEMENT AND WRITTEN DESCRIPTION
`A.
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`Dr. Lambert’s Opening Report Appropriately Cites Pre-2019 Evidence
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`In his Opening Report, Dr. Lambert provides his analysis and expert conclusions, inter
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`alia, on whether the full scope of each of the Asserted Claims is enabled from the perspective of
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`the POSA.33 Seagen attempts to limit the evidence and opinions Dr. Lambert would be able to
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`present to the jury on this central issue through several different arguments, none of which support
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`the striking of any portion of Dr. Lambert’s report.34
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`Seagen’s argument in Section III.A falters on its unstated premise that “post-filing” means
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`“after 2004.” The “filing date” of the ʼ039 patent is not 2004—it is July 2019. Seagen has not
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`cross-moved for summary judgment to establish its entitlement to an earlier filing date, and so in
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`the event the Court does not grant summary judgment of invalidity on this basis, the “filing date”
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`32 See Ex. 2, Lambert Responsive Report ¶¶ 143, 145.
`33 See Ex. 1, Lambert Opening Report Section VII.B, ¶ 20; see also Alcon Research Ltd. v. Barr
`Labs., Inc., 745 F.3d 1180, 1188 (Fed. Cir. 2014) (enablement is viewed from the perspective of
`the POSA).
`34 See Pipitone v. Biomatrix, Inc., 288 F.3d 239, 249-50 (5th Cir. 2002) (holding the fact-finder
`entitled to hear expert testimony and decide whether it should accept or reject it after
`“considering all factors that weigh on credibility,” including whether the facts on which the
`expert relied are accurate).
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 12 of 22 PageID #: 10586
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`will be determined at trial. Seagen does not dispute that all the evidence it seeks to strike is
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`admissible if the filing date is July 2019.
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`Seagen’s “Motion to Strike” is thus, at most, a premature request for a limiting instruction.
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`Even so, such an instruction would be inappropriate. Seagen’s argument begins with a
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`misstatement of law. Seagen urges the Court to “strike the portions of Dr. Lambert’s report where
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`he relies on post-filing evidence.”35 Granting such a sweeping request would be explicitly
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`contrary, however, to the Federal Circuit’s Amgen decision.36 As Amgen sets forth, post-filing
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`evidence may be relevant to various issues regarding enablement, including whether the patent’s
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`examples are “representative” of the claimed scope and whether the patentee could practice its
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`own patent without undue experimentation.37
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`Seagen next identifies swaths of Dr. Lambert’s report to strike without substantively
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`discussing what he actually said. As shown below, Seagen’s approach is misplaced, and
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`encompasses evidence and analysis that may be relevant and cannot be stricken at this juncture.
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`Drugs. For example, under the Court’s claim construction, the ʼ039 patent claims ADCs
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`containing any drug, “D,” and not just the “auristatin” class of drugs exemplified in the patent.
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`Paragraph 194 discusses a class of drugs (duocarmycins) that cannot chemically be attached to the
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`rest of the ADC like the patent’s auristatins. Dr. Lambert’s discussion of how Seagen subsequently
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`had to invent methods for attaching such drugs, supports that the ʼ039 patent does not teach how
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`to attach such drugs, and that the patentees could not do so at the time, and is thus relevant to
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`enablement of the full scope of the Asserted Claims. Further, Seagen’s subsequent patent admits
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`35 Dkt. No. 252 at 7.
`36 Amgen, Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017).
`37 Id. at 1374-75; ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941-43 (Fed. Cir. 2010).
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 13 of 22 PageID #: 10587
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`that the spacer taught in the ʼ039 patent is “unlikely to work for all alcohol containing drugs” and
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`that new technologies were needed “to attach drugs heretofore believed to be unsuitable for use as
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`ADCs.”38 These are precisely the types of facts on which the jury can rely to conclude that Seagen
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`did not enable the claims as of its alleged priority date.39 Paragraphs 264-268 expand on this point,
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`citing additional Seagen publications in this area.
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`Paragraphs 256-261 make a similar point involving another drug, the original auristatin.
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`The original auristatin had a “tertiary amine,” which could not be attached to an ADC by
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`“conventional conjugation technologies.”40 The alleged novelty of the ’039 patent family was the
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`addition of a monomethyl group on dolastatin/auristatin compounds (e.g., MMAE) to enable
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`attachment to an ADC. Several years later, Seagen in fact disclosed a new method for attaching
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`auristatins (e.g., Auristatin E) lacking a monomethyl group to an ADC. These facts are relevant
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`to § 112 as explained above, and provide critical context for the jury to understand the ʼ039 patent.
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`Finally, paragraph 217 makes a similar point, discussing another Seagen patent.
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`Spacers. The ʼ039 patent claims ADCs in which a spacer, “Yy,” connects the tetrapeptide
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`to the drug moiety. Per the Court’s construction, there is no limitation on the atoms or structures
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`that comprise the spacer. One issue in this case is whether the patent in fact describes and enables
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`the use of any atoms in that way. In paragraphs 110 and 196, Dr. Lambert discusses non-Seagen
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`ADCs that use “spacers” different from anything disclosed in the ʼ039 patent, to substantiate his
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`38 Ex. 1, Lambert Opening Report ¶ 194 (quoting US Pat. No. 11,116,847 at 1:45-49, 1:61-2:3).
`39 Seagen’s reliance on CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1340 (Fed. Cir. 2003)
`is premised on an incomplete quotation. The Federal Circuit actually wrote: “such
`developments do not alone cast doubt on enablement of the original invention.” Id. at 1340
`(emphasis added). The CMFT court nowhere suggested such developments were irrelevant to
`enablement, instead explaining how they fit into its assessment of the ultimate legal question.
`40 Ex. 1, Lambert Opening Report ¶¶ 256-58.
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 14 of 22 PageID #: 10588
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`opinion that the ’039 patent’s examples do not “permit the POSA to visualize” these other ADCs’
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`spacers. This analysis of structural features of various spacers within the claim scope constitutes
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`precisely the analysis required to assess whether the patent’s teachings are sufficient to claim a
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`genus,41 and this evidence plainly is relevant under Amgen v. Sanofi. It cannot be “stricken.”
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`Intracellular Cleavage. Determining whether an ADC is within the ʼ039 patent’s scope
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`also requires assessing the functional properties of the ADC, namely, whether it meets the Drug
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`Moiety Intracellular Cleavage Limitation. Dr. Lambert explains in his report how difficult it is to
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`ascertain this property, explaining the patent’s lack of guidance and some of his own publications
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`studying this phenomenon. Paragraph 210 analyzes whether some of the ʼ039 patent’s ADCs
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`“intracellularly cleave,” including discussion of Seagen’s scientific publications that show that, in
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`fact, these ADCs do not meet this limitation. These non-functional “examples” are relevant, inter
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`alia, to the experimentation required to practice the claim.42 There is no basis to strike this
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`discussion in the abstract, and certainly no basis to allow Seagen to hide from the jury that its
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`“examples” do not work simply because the proof that they do not work was published after an
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`application was filed. The art cited by Dr. Lambert in paragraphs 305-310 and 314-316 also serves
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`to substantiate his opinions that the patent teaches no method of determining whether this
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`limitation is met, and that a cancer cell dying is not proof the ADC intracellularly cleaved.43
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`41 Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc).
`42 Idenix Pharms. LLC v. Gilead Sci., Inc., 941 F.3d 1149, 1160-61 (Fed. Cir. 2019).
`43 Seagen’s unexplained citation to Garlock appears inapposite. In Garlock, the patent taught a
`method to determine “stretch rate” and the Federal Circuit explained that subsequent
`developments in polymer technology did not undermine the fact that the patent taught how to
`determine “stretch rate.” W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
`721 F.2d 1540 1540, 1551 (Fed. Cir. 1983). Here, the point is that there is no method taught.
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 15 of 22 PageID #: 10589
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`B.
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`Dr. Lambert Provides Analysis on the Understanding of the POSA of
`the Required Structural and Functional Limitations of the Asserted Claims
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`Seagen’s motion also asks the Court to strike myriad paragraphs of Dr. Lambert’s analysis,
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`alleging that Dr. Lambert somehow misapprehends the scope of the claims.44 Seagen’s entire
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`argument, however, hinges on a mischaracterization of Dr. Lambert’s report that ignores both the
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`statements and context provided in the report itself regarding therapeutic viability (not
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`effectiveness), and Dr. Lambert’s testimony explaining its relevance to the POSA’s analysis.45
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`While there is no dispute that the Asserted Claims have structural limitations, and do not
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`contain a limitation requiring that a claimed ADC be therapeutically effective, the Asserted Claims
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`have a functional requirement as well: the Asserted Claims require the ADC’s drug moiety to be
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`“intracellularly cleaved in a patient.” Section 112(a) requires that a patent’s disclosure enable the
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`POSA to make the full scope of the claimed invention without undue experimentation.46 Enabling
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`the Asserted Claims thus requires that the patent teach both how to make the ADCs and how to
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`identify the ADCs that possess the required functional characteristic where the drug moiety is
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`capable of being intracellularly cleaved in a patient.47 Dr. Lambert’s report addresses both.
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`As explained by Dr. Lambert, therapeutic viability is therefore directly tied to evaluating
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`whether the enablement requirement is satisfied as to the full scope of the Asserted Claims, as the
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`POSA must not only be able to make the ADC, but also be able to use the ADC in the way intended
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`44 Seagen’s motion to strike attempts to broadly encompass portions of Dr. Lambert’s
`enablement analysis that appropriately address structural and functional limitations, including
`ones that do not even reference the “therapeutic viability” issue at the core of their argument, for
`example ¶¶ 128-29. See, e.g., Dkt. No. 252 § III.B; Ex. 1, Lambert Opening Report ¶¶ 128-29.
`45 See Ex. 1, Lambert Opening Report ¶¶ 125, 126-29; see also Ex. 4, Lambert Tr. at 101:16-23
`(discussing therapeutic viability), 102:24-103:2 (same), 103:13-25 (same).
`46 Idenix, 941 F.3d at 1154.
`47 See, e.g., Idenix, 941 F.3d at 1159.
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`Case 2:20-cv-00337-JRG Document 273 Filed 01/27/22 Page 16 of 22 PageID #: 10590
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`by the Asserted Claims.48 In other words, the ADC’s drug moiety must intracellularly cleave in a
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`patient to meet the claimed limitations. The ’039 patent as a whole also recognizes that the claimed
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`ADC must be administered to patients, meaning evaluating enablement based on structure alone,
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`without consideration of the ADC’s use and function would be fruitless.49
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`In view of the limitations of the Asserted Claims, the context of the patent, and the POSA’s
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`own knowledge, the POSA would thus need to be able to make a usable ADC—one that could be
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`synthesized, tested, and have sufficient structural integrity to meet the Asserted Claims’ functional
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`requirements.50 As explained by Dr. Lambert during his deposition,
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`51 He further stated
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`52
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`As is evidenced by both Dr. Lambert’s report and his testimony, he therefore does not
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`equate “therapeutically viable” with any requirement or level of efficacy, but rather it addresses
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`48 See, e.g., Ex. 4, Lambert Tr. at 105:21-106:1; see also Ex. 1, Lambert Opening Report Section
`VII.B, ¶ 20.
`49 See, e.g., ’039 patent at Claim 1, 4:25-29 (“Accordingly, there is a clear need in the art for
`dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic
`efficiency.”), 10:16-20 (“In yet another aspect, the invention provides methods for preventing
`cancer including administering to a patient in need thereof an effective amount of a Drug-Ligand
`Conjugate having a cleavable Drug unit from the Drug-Ligand Conjugate.”).
`50 See, e.g., Idenix, 941 F.3d at 1159.
`51 Ex. 4, Lambert Tr. at 102:20-103:2.
`52 Ex. 4, Lambert Tr. at 105:21-106:1, 103:19-25
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`whether the POSA would be enabled to make ADCs meeting the full scope of both the structural
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`and functional limitations of the Asserted Claims without undue experimentation. In fact, Seagen
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`conveniently ignores paragraph 124, which immediately precedes the paragraphs Seagen seeks to
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`strike and refutes its mischaracterization of Dr. Lambert’s report:
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`53 As such, while the “viability” of an ADC appropriately takes into
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`consideration both the structural and functional limitations of the Asserted Claims, including
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`whether it can be synthesized, placed into a patient, and ultimately be intracellularly cleaved in the
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`patient, therapeutic effectiveness is explicitly excluded from Dr. Lambert’s enablement analysis.
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`C.
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`Dr. Lambert Appropriately Analyzes Written Description
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`Another central issue in this case is whether the ʼ039 patent adequately describes the
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`claimed genus of ADCs. This can be done in one of two ways: (