Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 1 of 22 PageID #: 9401
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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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`
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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 MOTION TO STRIKE PORTIONS OF THE EXPERT
`REPORTS OF JOHN M. LAMBERT
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 2 of 22 PageID #: 9402
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`TABLE OF CONTENTS
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`I.
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`II.
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`INTRODUCTION ............................................................................................................. 1
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`DR. LAMBERT’S RESPONSIVE REPORT .................................................................... 1
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`A.
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`B.
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`The Court Should Strike Dr. Lambert’s Opinions that Rely on His Own
`Claim Constructions............................................................................................... 1
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`The Court Should Strike the Portions of Dr. Lambert’s Responsive Report
`that Rely on Undisclosed Expert Testimony from a DSC Employee .................... 4
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`III.
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`DR. LAMBERT’S OPENING REPORT .......................................................................... 7
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`A.
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`The Court Should Strike the Portions of Dr. Lambert’s Report Where He
`Relies on Post-Filing Evidence .............................................................................. 7
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`1.
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`2.
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`Post-Filing Evidence Regarding Drugs and Drug Attachment .................. 8
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`Post-Filing Evidence Regarding Intracellular Cleavage .......................... 10
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`B.
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`C.
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`The Court Should Strike the Portions of Dr. Lambert’s Report that Rely on
`Therapeutic Effectiveness Requirements Not in the Claims ............................... 11
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`The Court Should Strike Dr. Lambert’s Opinions that Suggest Drug and
`Spacer Are Terms Without Common Structural Features ................................... 12
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`IV. DR. LAMBERT’S OPINIONS ON PROSECUTION AND PTAB
`PROCEEDINGS .............................................................................................................. 13
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`A.
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`B.
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`C.
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`The Court Should Strike Dr. Lambert’s Opinions Based on European
`Patent Office Proceedings .................................................................................... 13
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`The Court Should Strike Dr. Lambert’s Opinions Based on Post-Grant
`Review Proceedings ............................................................................................. 14
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`Dr. Lambert Should Not Be Permitted to Rely on Expert Opinions on
`Prosecution Directed to Equitable Issues ............................................................. 15
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`V.
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`CONCLUSION ................................................................................................................ 15
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 3 of 22 PageID #: 9403
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`Cases
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`TABLE OF AUTHORITIES
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`Page(s)
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`AbbVie Deutschland GmbH v. Janssen Biotech, Inc.,
`759 F.3d 1285 (Fed. Cir. 2014)..................................................................................................9
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`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003)................................................................................................12
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`Amgen Inc. v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017)..............................................................................................8, 9
`
`Amgen Inc. v. Sanofi,
`No. 14-1317-RGA, 2019 U.S. Dist. LEXIS 146305 (D. Del. Aug. 28, 2019) ........................10
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010)............................................................................................7, 12
`
`BMC Software, Inc. v. ServiceNow, Inc.,
`No. 2:14-cv-903-JRG, Dkt. 325, slip op. (E.D. Tex. Jan. 28, 2016) .........................................2
`
`CFMT, Inc. v. Yieldup Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003)............................................................................................9, 11
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`Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co.,
`276 F. Supp. 3d 629 (E.D. Tex. 2017) .....................................................................................12
`
`Factory Mut. Ins. Co. v. Alon USA L.P.,
`705 F.3d 518 (5th Cir. 2013) .....................................................................................................7
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`Fastship LLC v. U.S.,
`131 Fed. Cl. 592 (2017) .............................................................................................................9
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`GREE, Inc. v. Supercell Oy,
`No. 2:19-cv-70-JRG-RSP, Dkt. 354, slip op. (E.D. Tex. July 26, 2020) ..................................5
`
`Hamburger v. State Farm Mut. Auto. Ins. Co.,
`361 F.3d 875 (5th Cir. 2004) .....................................................................................................6
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`Implicit, LLC v. NetScout Sys., Inc.,
`No. 2:18-CV-00053-JRG, 2019 WL 6873030 (E.D. Tex. Nov. 21, 2019)..............................14
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`Intellectual Ventures II LLC v. Sprint Spectrum, L.P.,
`No. 2:17-cv-662-JRG-RSP, ECF No. 440 (E.D. Tex. Apr. 12, 2019).......................................6
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 4 of 22 PageID #: 9404
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`Kinetic Concepts, Inc. v. Wake Forest Univ. Health Scis.,
`No. SA-11-CV-163-XR, 2014 U.S. Dist. LEXIS 55437 (W.D. Tex. Apr. 22,
`2014) ........................................................................................................................................13
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`Mars, Inc. v. TruRX LLC,
`No. 6:13-CV-526, 2015 U.S. Dist. LEXIS 187875 (E.D. Tex. Aug. 6, 2015) ........................13
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`McRO, Inc. v. Bandai Namco Games Am. Inc.,
`959 F.3d 1091 (Fed. Cir. 2020)................................................................................................11
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`Novartis Pharms. Corp. v. Accord Healthcare, Inc.,
`No. 2021-1070, Dkt. 40, slip op. at 12 (Fed. Cir. Jan. 3, 2022) ..............................................11
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`Packet Intel. LLC v. NetScout Sys., Inc.,
`No. 2:16-CV-230-JRG, 2017 WL 11631146 (E.D. Tex. Sept. 29, 2017) ...............................14
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`PerdiemCo, LLC v. Industrack LLC,
`No. 2:15-CV-727-JRG-RSP, 2016 WL 6432699 (E.D. Tex. Oct. 28, 2016) ............................3
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`Personalized Media Commc’ns, LLC v. Zynga, Inc.,
`No. 2:12-CV-00068-JRG, 2013 WL 10253110 (E.D. Tex. Oct. 30, 2013) .............................14
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`Personalized Media Commc’ns, LLC v. Zynga, Inc.,
`No. 2:12-cv-68-JRG-RSP, ECF No. 227 (E.D. Tex. Nov. 7, 2013) ..........................................9
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`Revlon, Inc. v. Carson Prods. Co.,
`602 F. Supp. 1071 (S.D.N.Y. 1985).........................................................................................13
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`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`574 U.S. 318 (2015) ...............................................................................................................1, 2
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`Trs. of Bos. Univ. v. Everlight Elecs. Co.,
`896 F.3d 1357 (Fed. Cir. 2018)..................................................................................................8
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`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
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`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991)..................................................................................................7
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`W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983)................................................................................................10
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`Statutes
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`35 U.S.C. § 112 ..........................................................................................................................1, 14
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`35 U.S.C. § 282 ..............................................................................................................................13
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`iii
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 5 of 22 PageID #: 9405
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`Other Authorities
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`Fed. R. Civ. P. 30(c)(1) ....................................................................................................................5
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`Fed. R. Civ. P. 26 .................................................................................................................1, 5, 6, 7
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`Fed. R. Evid. 611(b) .........................................................................................................................5
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`iv
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 6 of 22 PageID #: 9406
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`I.
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`INTRODUCTION
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`Seagen moves to strike and exclude portions of Dr. John Lambert’s opening invalidity
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`report (Ex. 1, “Opening Report”) and responsive non-infringement report (Ex. 2, “Responsive
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`Report”). The defects in Dr. Lambert’s reports are many.
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`In his Responsive Report, he offers opinions that apply claim constructions different than,
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`and inconsistent with, those reached by the Court. Specifically, he advances definitions of “free
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`drug” and “drug moiety” that are the same as those Defendants advanced in Markman
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`proceedings—interpretations that this Court specifically rejected. Dr. Lambert also cites and
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`repeats testimony from a DSC fact witness that Defendants did not identify in their initial
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`disclosures, including an opinion from that witness for which there is no Rule 26 report.
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`Dr. Lambert’s Opening Report is also flawed. His non-enablement and written
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`description opinions improperly rely on post-filing evidence. Further, he inserts a requirement
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`for therapeutic effectiveness into the claims that is absent from the claim language, and focuses
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`on individual claim elements in a vacuum as opposed to how the POSA would understand the
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`claims as a whole.
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`In both reports, Dr. Lambert refers to foreign prosecution and U.S. patent office
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`proceedings that apply different legal standards and are thus irrelevant to the § 112 analysis that
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`the jury must perform. He also relies on another expert report that is directed to equitable issues.
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`II.
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`DR. LAMBERT’S RESPONSIVE REPORT
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`A.
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`The Court Should Strike Dr. Lambert’s Opinions that Rely on His Own
`Claim Constructions
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`The Court should strike paragraphs 14, 51–57, 89–99, and 102 of Dr. Lambert’s
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`Responsive Report on the ground that they apply claim constructions that differ from the Court’s
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`constructions. Claim construction is a matter for the Court, not experts, as “the ultimate question
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`1
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 7 of 22 PageID #: 9407
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`of the proper construction of the patent [is] a question of law.” Teva Pharms. USA, Inc. v.
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`Sandoz, Inc., 574 U.S. 318, 325 (2015).
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`During the Markman hearing, Defendants argued that “free drug” in the Court’s
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`construction of “intracellularly cleaved” should mean that “the drug moiety is released [with]
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`nothing attached to it.” (Ex. 3, Markman Tr. at 102:3–25 (“it can’t be understood that the free
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`drug moiety is only referring to – or is referring to the active drug component of an ADC. . . .
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`And it should be understood that that – what it really is talking about is the drug moiety being
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`released, completely free of anything. There’s nothing attached to it”).) The Court rejected
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`Defendants’ position. (Dkt. 155 at 40 (“Defendants’ modifications to the definition provided in
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`the specification are not warranted or appropriate. . . . The claim itself does not have an express
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`requirement on the meaning of ‘free drug,’ how the free drug moiety disassociates, and whether
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`the free drug dissociates as a result of a separate step”).) The Court also construed “D is a drug
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`moiety” to mean “D is a drug unit” without any further limitation. (Id. at 15.)
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`Despite the Court’s order, Dr. Lambert offers his own construction of the term “free
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`drug” that resurrects Defendants’ position, and he relies on it to assert that DSC does not infringe
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`the ’039 patent. (Ex. 2, Responsive Report ¶ 51 (“
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`”); see also ¶¶ 14, 52–57, 97–99, 102.) Dr. Lambert similarly asserts that the
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`claim term “drug moiety” must refer to a drug moiety without any part of a linker still attached,
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`even though that requirement appears nowhere in the Court’s construction of “D is a drug
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`moiety.” (Id. ¶¶ 89–96.) The Court should not permit Dr. Lambert to argue to the jury claim
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`interpretations “based on an interpretation of the Court’s construction that is the equivalent of
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`any construction that the Court previously considered and expressly rejected.” BMC Software,
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`2
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 8 of 22 PageID #: 9408
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`Inc. v. ServiceNow, Inc., No. 2:14-cv-903-JRG, Dkt. 325, slip op. at 4 (E.D. Tex. Jan. 28, 2016).
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`Defendants cannot claim that Dr. Lambert merely applies the Court’s constructions as a
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`POSA would understand them, instead of offering his own claim constructions. “[I]f an expert
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`testifies that [a] term . . . has a special meaning in light of the intrinsic record, the expert is
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`testifying about claim construction.” See PerdiemCo, LLC v. Industrack LLC, No. 2:15-CV-727-
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`JRG-RSP, 2016 WL 6432699, at *1 (E.D. Tex. Oct. 28, 2016) (emphasis in original). It is clear
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`from Dr. Lambert’s report that this is what he is doing because he points to intrinsic evidence in
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`the patent specification as support for his position. (See Ex. 2, Responsive Report ¶ 53 (“
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`”).)
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`”); ¶ 96 (
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`. . .
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 9 of 22 PageID #: 9409
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`(Ex. 4, Lambert Tr. 129:18–130:6; 135:18–23.) In both instances, he inserts the exact limitation
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`that Defendants earlier argued and the Court rejected. The Court should strike these opinions.
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`B.
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`The Court Should Strike the Portions of Dr. Lambert’s Responsive Report
`that Rely on Undisclosed Expert Testimony from a DSC Employee
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`The Court should strike paragraphs 143–147 of Dr. Lambert’s Responsive Report on the
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`ground that they rely on improper testimony of DSC employee Dr. Koji Morita. As the Court is
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`aware, DSC produced Dr. Morita for deposition only after the Court ordered him produced.
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`(Dkt. 230 at 2.) DSC first refused Dr. Morita’s deposition on the basis that it had not listed him
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`in its initial disclosures, and could not compel him to testify (even though DSC employs him).
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`(Ex. 5, K. Ozawa 8/4/2021 email.) Due to DSC’s refusal, Seagen was not able to depose Dr.
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`Morita until after the close of fact discovery and service of opening expert reports, at which time
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`DSC had him testify from the New York offices of its counsel.
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`The deposition revealed much about DSC’s use of Seagen information in the
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`development of the accused product.
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 10 of 22 PageID #: 9410
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`Dr. Lambert relies on this testimony in his own report. (Ex. 2, Responsive Report ¶¶ 143–147.)
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`First, the portions of Dr. Lambert’s Responsive Report in which he relies on Dr. Morita’s
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`testimony should be excluded because the testimony was a direct examination of a witness that
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`DSC did not properly disclose. GREE, Inc. v. Supercell Oy, No. 2:19-cv-70-JRG-RSP, Dkt. 354,
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`slip op. at 4 (E.D. Tex. July 26, 2020) (“[Defendant’s] experts cannot rely on information . . .
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`provided by non-disclosed fact witnesses”); see United Servs. Auto. Ass’n v. Wells Fargo Bank,
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`N.A., No. 2:18-cv-366-JRG-RSP, 2019 U.S. Dist. LEXIS 219186, at *10–11 (E.D. Tex. Dec. 19,
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`2019) (striking portions of expert report that relied on discussions with witnesses not named in
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`Rule 26(a) disclosures). DSC did not list Dr. Morita on its initial disclosures, and refused to
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`produce him for deposition in the fact discovery period. If DSC wanted to elicit direct testimony
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`from Dr. Morita, it should have disclosed him, and certainly should not have refused his
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`deposition. Seagen’s Court-ordered deposition of Dr. Morita was not the proper forum for DSC
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`to introduce self-serving direct testimony from a witness it claimed did not have relevant
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`information. (Ex. 5, K. Ozawa 8/4/2021 email.) Dr. Lambert should not be permitted to rely
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`upon or parrot this improperly disclosed testimony.
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`Moreover, Seagen did not prompt the testimony through any of its own actions. Seagen
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`never asked the witness about Dr. Bertozzi’s expert report, so his testimony was outside the
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`scope of cross. See Fed. R. Civ. P. 30(c)(1) (“The examination and cross-examination of a
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`deponent proceed as they would at trial under the Federal Rules of Evidence”); Fed. R. Evid.
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`611(b) (“Cross-examination should not go beyond the subject matter of the direct examination”).
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`Dr. Lambert’s reliance on Dr. Morita’s testimony should also be excluded because Dr.
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 11 of 22 PageID #: 9411
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`Morita gave opinion testimony that he should not have been able to, consistent with local
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`practice and the Federal Rules.
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` (Ex. 2, Responsive Report ¶ 146; Ex. 8, Morita Cont. Tr.
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`at 167:23–168:14.) The only reason Dr. Morita had the opportunity in his deposition to opine on
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`Dr. Bertozzi’s report was because DSC refused to produce him during fact discovery. DSC
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`should not be allowed to end run the staging of the fact and expert discovery periods set by this
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`Court’s DCO as a result of Seagen obtaining an order to compel Dr. Morita’s testimony. In any
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`event, Dr. Morita never provided a report of his own or any other disclosure that meets the
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`requirements of Rule 26. Nor did Defendants disclose him as a fact or employee-expert witness
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`in any other disclosures. Hence, there is no properly disclosed basis for his opinion on the
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`reliability of Dr. Bertozzi’s report. See, e.g., Hamburger v. State Farm Mut. Auto. Ins. Co., 361
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`F.3d 875, 884 (5th Cir. 2004) (“the trial court did not abuse its discretion in barring Dr.
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`Fitzgerald as an expert witness because Hamburger failed to timely identify her as required by
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`Rule 26(a)(2)(A).”); Intellectual Ventures II LLC v. Sprint Spectrum, L.P., No. 2:17-cv-662-
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`JRG-RSP, ECF No. 440 (E.D. Tex. Apr. 12, 2019) (striking late-disclosed employee-experts).
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`Any claim that Dr. Morita was providing solely fact, as opposed to opinion, testimony
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`would not withstand basic scrutiny. DSC could have asked him about specific documents that
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`Seagen used on cross, and what he believes those documents show.
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 12 of 22 PageID #: 9412
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` It is this opinion for which there was
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`no proper disclosure under Rule 26.
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`Dr. Lambert’s reliance on Dr. Morita’s testimony does not make that testimony
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`admissible, and the Court should bar Dr. Lambert from serving as a conduit for it. See Factory
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`Mut. Ins. Co. v. Alon USA L.P., 705 F.3d 518, 524 (5th Cir. 2013) (courts “must serve a gate-
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`keeping function with respect to Rule 703 opinions to ensure the expert isn’t being used as a
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`vehicle for circumventing the rules of evidence”) (citation and quotations omitted). If
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`Defendants wish to rely on any facts that Dr. Morita could testify to, they should seek to call him
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`at trial and address for the Court why they did not list him on their initial disclosures. He clearly
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`is not an unavailable witness. He is a DSC employee, whom DSC even flew out to New York
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`for his December deposition.
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`III. DR. LAMBERT’S OPENING REPORT
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`A.
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`The Court Should Strike the Portions of Dr. Lambert’s Report Where He
`Relies on Post-Filing Evidence
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`The Court should strike paragraphs 110, 194, 196, 210, 217, 256–261, 264–268, 305–
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`310, and 314–316 of Dr. Lambert’s Opening Report because they improperly rely on post-filing
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`evidence to argue non-enablement and lack of written description. It is black letter law that a
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`jury must determine enablement and written description based on the state of the art as of the
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`priority date of the asserted patent. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1566 (Fed.
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`Cir. 1991) (“Application sufficiency under § 112 . . . must be judged as of the filing date”)
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`(citations omitted); Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010)
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 13 of 22 PageID #: 9413
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`(finding post-filing evidence of written description “legally irrelevant”); Trs. of Bos. Univ. v.
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`Everlight Elecs. Co., 896 F.3d 1357, 1363 (Fed. Cir. 2018) (“The inquiry is whether the patent’s
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`specification taught one of skill in the art how to make such a device without undue
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`experimentation as of the patent’s effective filing date.”); Amgen Inc. v. Sanofi, 872 F.3d 1367,
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`1373-74 (Fed. Cir. 2017) (“[E]vidence illuminating the state of the art subsequent to the priority
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`date is not relevant.”). Dr. Lambert acknowledged that he was considering validity issues “as of
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`that 2003-2004 time period.” (Ex. 1, Opening Report ¶ 24.) Yet Dr. Lambert’s report is replete
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`with citations to post-filing events, mostly relating to Seagen’s further innovations on linkers
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`with specific spacers and drugs—two elements that do not have specific requirements in the
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`independent claim of the asserted patent. This work, although ultimately successful, is legally
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`irrelevant to the written description and enablement inquiry here.
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`1.
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`Post-Filing Evidence Regarding Drugs and Drug Attachment
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`Dr. Lambert cites to numerous advancements (many by Seagen) on specific drugs and
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`drug attachment chemistries as evidence purportedly showing that Seagen had not enabled the
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`drug and spacer limitations of the asserted claims. (Ex. 1, Opening Report ¶ 194 (
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`); ¶¶ 259–261 (
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`); ¶¶ 264–268
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`).) Subsequent improvements do not “cast doubt on enablement of the original
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`8
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 14 of 22 PageID #: 9414
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`invention.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1340 (Fed. Cir. 2003). A patent
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`specification need not enable more than what is known in the art at the time of filings, and it
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`need not describe “every conceivable and possible future embodiment of [an] invention.”
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`Fastship LLC v. U.S., 131 Fed. Cl. 592, 621 (2017) (quoting Epistar Corp. v. ITC, 566 F.3d
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`1321, 1336 (Fed. Cir. 2009)); Personalized Media Commc’ns, LLC v. Zynga, Inc., No. 2:12-cv-
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`68-JRG-RSP, ECF No. 227, at 3–4 (E.D. Tex. Nov. 7, 2013) (striking expert report on
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`enablement where expert considered defendant’s later-developed embodiments in analysis).
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`Dr. Lambert’s reliance on post-filing evidence does not fall within the limited exception
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`from Amgen allowing such evidence for assessing written description. Dr. Lambert does not rely
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`on this evidence to support an opinion that the “patent does not disclose a representative number
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`of species of a claimed genus,” the narrow issue on which post-filing evidence may be
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`considered. 872 F.3d at 1375. In Amgen, the accused infringer sought to introduce evidence of
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`additional antibodies developed after the filing date, including the antibody used in the accused
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`product, to argue the asserted patent did not disclose a representative number of species. Id. at
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`1373. The Amgen court relied on AbbVie Deutschland GmbH v. Janssen Biotech, Inc., where the
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`accused infringer relied on the accused product for its unrepresentativeness argument, finding the
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`evidence was proper for this limited purpose. 759 F.3d 1285, 1298–1300 (Fed. Cir. 2014).
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`In contrast to AbbVie, Dr. Lambert cannot state that the accused product’s drug class
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`(camptothecin) or functional group used for attachment (an alcohol) were unknown as of the
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`priority date of the ’039 patent. A 2002 article describes both, as does the specification. (Ex. 9
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`SGIEDTX00011627; Dkt. 123-3, ’039 patent at 31:51; 68:53–57 (referring to alcohol attachment
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`through a “carbonate” or “ether” group).) Rather, he opines that Seagen did not provide
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`adequate support, in 2003/2004, for every drug and drug attachment advancement that followed.
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 15 of 22 PageID #: 9415
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`(See supra.)
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`. (Ex. 1, Opening Report ¶ 110.)
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`Hence, Dr. Lambert is not using post-filing evidence to establish that representative drugs and
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`attachment chemistries were unknown as of the filing date. These facts alone distinguish Amgen.
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`The structure of Dr. Lambert’s report confirms he is not using post-filing evidence for a
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`representativeness argument. He has sections of his report on representative species (see
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`sections VII.A.1.a, VII.A.2.a), but in those sections he does not refer to the post-filing evidence
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`Seagen is seeking to exclude by way of this motion. That Dr. Lambert does not use this evidence
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`in those sections highlights that he only intends to use the evidence for an improper purpose.
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`Amgen Inc. v. Sanofi, No. 14-1317-RGA, 2019 U.S. Dist. LEXIS 146305, at *44–45 (D. Del.
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`Aug. 28, 2019) (“Amgen II”) (on remand, excluding post-filing evidence not directed to
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`representative species).
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`2.
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`Post-Filing Evidence Regarding Intracellular Cleavage
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`Dr. Lambert also relies on post-filing evidence to support his assertion that the ’039
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`patent specification does not enable a POSA to determine whether intracellular cleavage has
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`occurred. (Ex. 1, Opening Report ¶¶ 210; 305-310; 314–316.) But this evidence is, again,
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`irrelevant. Subsequent developments in the field cannot “render non-enabling . . . that which
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`was enabling . . . at the time the application was filed.” W.L. Gore & Assocs., Inc. v. Garlock,
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`Inc., 721 F.2d 1540, 1557 (Fed. Cir. 1983). Nor is the evidence relevant to the question of undue
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`experimentation because none of it demonstrates an attempt to practice the scope of the ’039
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`patent. Amgen II, 2019 U.S. Dist. LEXIS 146305, at *40 (excluding post-filing evidence where
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`post-filing work was not shown to be within scope of patent). Defendants cannot dispute that the
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`work involves ADCs with linker components that fall outside the scope of the claims.
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`10
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 16 of 22 PageID #: 9416
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`B.
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`The Court Should Strike the Portions of Dr. Lambert’s Report that Rely on
`Therapeutic Effectiveness Requirements Not in the Claims
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`The Court should strike paragraphs 125, 128–129, 133, 134, 137, 138, 141, 157–159,
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`166, 168, 179–183, 191–192, 284, 308, and 331 of Dr. Lambert’s Opening Report because these
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`opinions rely on limitations not found in the claims. “Section 112 requires enablement of ‘only
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`the claimed invention,’ not matter outside the claims.” McRO, Inc. v. Bandai Namco Games Am.
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`Inc., 959 F.3d 1091, 1100 (Fed. Cir. 2020) (quoting Union Carbide Chemicals & Plastics Tech.
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`Corp. v. Shell Oil Co., 308 F.3d 1167, 1186 (Fed. Cir. 2002)); Novartis Pharms. Corp. v. Accord
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`Healthcare, Inc., No. 2021-1070, Dkt. 40, slip op. at 12 (Fed. Cir. Jan. 3, 2022) (rejecting written
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`description argument that inventors did not know claimed dose “would be effective as of the
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`2006 priority date” because “efficacy is not a requirement of the claims[;] [t]he claims require
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`only administration of a 0.5 mg/day dose”); CFMT, 349 F.3d at 1338 (“Title 35 does not require
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`that a patent disclosure enable one of ordinary skill in the art to make and use a perfected,
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`commercially viable embodiment absent a claim limitation to that effect.”).
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`. (Ex. 1, Opening Report ¶ 125; see also ¶ 166.)
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`
`
`
`
`
`
`
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`” (Id. ¶ 134; see also
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`
`
`
`
`. (Id. ¶ 183; see also ¶¶
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`. (Id. ¶¶
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`¶¶ 133, 137, 138, 141, 308.)
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`128–129, 157–159, 168, 182, 191–192, 284, 331.)
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`11
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 17 of 22 PageID #: 9417
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`179–181.) None of these are claim requirements.
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`The asserted claims are structural. They are directed to ADCs that have a specific linker
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`architecture. Nothing in the claims requires that an ADC be therapeutically effective to infringe.
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`C.
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`The Court Should Strike Dr. Lambert’s Opinions that Suggest Drug and
`Spacer Are Terms Without Common Structural Features
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`The Court should strike paragraphs 92–96 and 108–114 of Dr. Lambert’s Opening Report
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`because in these portions he analyzes written description under the wrong legal standard. A
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`patentee can demonstrate sufficient description of a genus claim by disclosure of “structural
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`features common to the members of the genus so that one of skill in the art can visualize or
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`recognize the members of the genus.” Ariad, 598 F.3d at 1350 (citation and quotation omitted).
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`Where a claim element is itself not “new or unknown biological materials that ordinarily skilled
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`artisans would easily miscomprehend,” the terms of the claim itself can provide sufficient written
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`description of a genus. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1332 (Fed.
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`Cir. 2003) (for claims directed to recombinant human EPO from “mammalian” or “vertebrate”
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`cells, “mammalian” and “vertebrate” were sufficient to convey “distinguishing information
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`concerning their identity”); see also Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276 F.
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`Supp. 3d 629, 648–49 (E.D. Tex. 2017) (“when a genus is well understood in the art and not
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`itself the invention but is instead a component of the claim, background knowledge may provide
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`the necessary support”).
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`Here, that structure is the linker structure set forth in the claims as a whole, not each of
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`the elements in the abstract. But each of the elements is well understood in the art. Dr. Lambert
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`asserts that there is no support for “D is a drug moiety” but does not dispute that a POSA would
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`know what a drug (unit) is in the context of ADCs. (Ex. 1, Opening Report ¶¶ 92–96.) He
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`12
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 18 of 22 PageID #: 9418
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`
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`likewise asserts that the ’039 patent lacks support for “Y is a Spacer unit,” but what a spacer is in
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`an ADC was well known in the art. (Id. ¶¶ 108–114.) What he really means is that a POSA
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`would not have been able to list, in 2003/2004, all the drugs and spacers that would be
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`successfully used in ADCs by the time he wrote his report in 2021. (Id. ¶ 119.) But as discussed
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`above, this is not the proper inquiry. He does not dispute that a POSA would know, based on the
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`structure of the linker alone, whether any given ADC infringes the ’039 patent.
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`IV. DR. LAMBERT’S OPINIONS ON PROSECUTION AND PTAB PROCEEDINGS
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`A.
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`The Court Should Strike Dr. Lambert’s Opinions Based on European Patent
`Office Proceedings
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`The Court should strike paragraphs 81 and 341 of Dr. Lambert’s Opening Report and
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`paragraph 148 of his Responsive Report because they refer to European Patent Office (“EPO”)
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`findings regarding Seagen’s European patent applications. Due to “varying legal and procedural
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`requirements for obtaining patent protection” in foreign countries versus the U.S., courts do not
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`rely on statements made by foreign bodies regarding application of their patent laws. Mars, Inc.
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`v. TruRX LLC, No. 6:13-CV-526, 2015 U.S. Dist. LEXIS 187875, at *23–24 (E.D. Tex. Aug. 6,
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`2015) (quoting AIA Eng'g Ltd. v. Magotteaux Int'l S/A, 657 F.3d 1264, 1279 (Fed. Cir. 2011)).
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`Evidence that a patent was found invalid in foreign proceedings is irrelevant due to the
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`differences in applicable laws and regulations. See, e.g., Kinetic Concepts, Inc. v. Wake Forest
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`Univ. Health Scis., No. SA-11-CV-163-XR, 2014 U.S. Dist. LEXIS 55437, at *25 (W.D. Tex.
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`Apr. 22, 2014); accord Revlon, Inc. v. Carson Prods. Co., 602 F. Supp. 1071, 1081 (S.D.N.Y.
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`1985) (“there is no international standardized inquiry into patentability, and therefore the
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`issuance of a United States patent carries with it a presumption of validity under 35 U.S.C. §
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`282 that cannot be destroyed by determinations made by foreign patent offices”) (citing Timely
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`13
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`Case 2:20-cv-00337-JRG Document 258 Filed 01/14/22 Page 19 of 22 PageID #: 9419
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`Products Corp. v