throbber
Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 1 of 16 PageID #: 6695
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`
`
`
`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`SEAGEN INC.,
`
`v.
`
`Plaintiff,
`
`DAIICHI SANKYO CO., LTD.,
`
`Defendant. and
`
`ASTRAZENECA PHARMACEUTICALS
`LP and ASTRAZENECA UK LTD.,
`
`Civil Action No. 2:20-CV-00337-JRG
`
`
`
`
`
`
`
`
`Intervenor-Defendants.
`
`PLAINTIFF SEAGEN INC.’S
`CLAIM CONSTRUCTION REPLY BRIEF
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 2 of 16 PageID #: 6696
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ............................................................................................................. 1
`ARGUMENT ..................................................................................................................... 1
`A.
`“D is a drug moiety” .............................................................................................. 1
`B.
`“Y is a Spacer unit”................................................................................................ 4
`C.
`“wherein Y is a self-immolative spacer” ............................................................... 6
`D.
`“p ranges from 1 to about 20” ................................................................................ 7
`E.
`“wherein the S is a sulfur atom on a cysteine residue of the antibody” ................. 8
`F.
`“wherein the drug moiety is intracellularly cleaved . . .” .................................... 10
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`I.
`II.
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 3 of 16 PageID #: 6697
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`
`TABLE OF AUTHORITIES
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`
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`Page(s)
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`Cases
`
`01 Communique Lab’y, Inc. v. LogMeIn, Inc.,
`687 F.3d 1292 (Fed. Cir. 2012)..............................................................................................8, 9
`
`Astrazeneca AB v. Mut. Pharm. Co.,
`384 F.3d 1333 (Fed. Cir. 2004)..................................................................................................2
`
`Baxalta Inc. v. Genentech, Inc.,
`972 F.3d 1341 (Fed. Cir. 2020)..................................................................................................2
`
`Cox Commc’ns, Inc. v. Sprint Commc’n Co. LP,
`838 F.3d 1224 (Fed. Cir. 2016)..................................................................................................5
`
`Hill-Rom Servs., Inc. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir. 2014)..............................................................................................1, 2
`
`Hillman Grp., Inc. v. KeyMe, LLC,
`No. 19-CV-209, 2020 WL 3605626 (E.D. Tex. July 2, 2020) ..................................................6
`
`KKG, LLC v. Rank Grp., PLC,
`No. 11-cv-00012-, 2013 WL 1643525 (E.D. Tex. Apr. 16, 2013) ............................................2
`
`Liqwd, Inc. v. L’Oreal USA, Inc.,
`720 Fed. App’x 623 (2018) ......................................................................................................10
`
`Luminara Worldwide, LLC v. Liown Elecs. Co.,
`814 F.3d 1343 (Fed. Cir. 2016)..............................................................................................1, 2
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ...................................................................................................................9
`
`Nevro Corp. v. Bos. Sci. Corp.,
`955 F.3d 35 (Fed. Cir. 2020)......................................................................................................5
`
`Oatey Co. v. IPS Corp.,
`514 F.3d 1271 (Fed. Cir. 2008)..................................................................................................5
`
`Panoptis Pat. Mgmt., LLC v. Blackberry Ltd.,
`No. 16-CV-62, 2017 WL 497571 (E.D. Tex. Feb. 7, 2017) ......................................................6
`
`Samsung Elecs. Am., Inc. v. Prisua Eng’g Corp.,
`948 F.3d 1342 (Fed. Cir. 2020)..................................................................................................5
`
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 4 of 16 PageID #: 6698
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`TABLE OF AUTHORITIES
`(continued)
`
`
`Verizon Servs. Corp. v. Vonage Holdings Corp.,
`503 F.3d 1295 (Fed. Cir. 2007)..................................................................................................5
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`Page(s)
`
`Whirlpool Corp. v. Ozcan,
`No. 2:15-cv-2103-, 2016 WL 7474517 (E.D. Tex. Dec. 29, 2016) ...........................................9
`
`Zeroclick, LLC v. Apple Inc.,
`891 F.3d 1003 (Fed. Cir. 2018)..................................................................................................5
`
`Statutes
`
`35 U.S.C. 112(f) ...............................................................................................................................6
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 5 of 16 PageID #: 6699
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`I.
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`INTRODUCTION
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`DSC’s response fails to overcome the presumption that claim terms carry their plain and
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`ordinary meaning to those skilled in the art. DSC ignores whole sections of the specification,
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`selectively choosing isolated examples in an effort to craft case-dispositive constructions. But
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`the patent as a whole does not clearly express an intent to redefine any of the terms in dispute.
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`Seagen’s expert, Dr. Pamela Trail, offered the view of how a person of ordinary skill in the art
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`would have understood the meaning of the terms in dispute based on the intrinsic evidence.
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`Instead of submitting evidence to rebut Dr. Trail, DSC relies solely on attorney argument.
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`II.
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`ARGUMENT
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`A.
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` “D is a drug moiety”
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`Based on the plain language of Claim 1 and Dr. Trail’s testimony, Seagen maintains that
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`“D” needs no construction, or alternatively, that it refers to the “drug portion” (or “unit”) of an
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`ADC. (Seagen Br. at 8-11.) DSC argues that a passage in Section 9.4 of the patent, stating that
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`the “drug moiety (D) . . . are of the dolastatin/auristatin type,” expressly defines the term. (DSC
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`Br. at 1, 7-8 (citing Ex. 11 (“’039 pat.”) at 71:19-37.) Enhertu’s drug moiety is not a dolastatin
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`or auristatin, so DSC hopes for a non-infringement home run. To act as its own lexicographer, a
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`patentee “must clearly set forth a definition of the disputed claim term other than its plain and
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`ordinary meaning and clearly express an intent to redefine the term.” Hill-Rom Servs., Inc. v.
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`Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014) (emphasis added); Luminara Worldwide,
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`LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353 (Fed. Cir. 2016). DSC has not met this standard.
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`First, the passage DSC relies on does not clearly set forth a definition for the claimed “D.”
`
`
`1 All citations to “Ex.” are to the Declaration of Teresa A. MacLean in Support of Plaintiff Seagen
`Inc.’s Claim Construction Brief (“MacLean Decl.”) and Declaration of Teresa A. MacLean in
`Support of Plaintiff Seagen Inc.’s Reply Claim Construction Brief (“MacLean Reply Decl.”).
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`The mere use of the words “are” or “is” does not mandate that the patentee be deemed to have
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`served as its own lexicographer. (DSC Br. at 8 (citing case law that “is” may signify and merely
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`weighs in favor of lexicography.) The passage does not indicate application to the claimed
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`invention, for example by using language in the specification such as “the present invention is” or
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`“according to the invention.” Hill-Rom, 755 F.3d at 1371; Luminara, 814 F.3d at 1353; cf
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`Astrazeneca AB v. Mut. Pharm. Co., 384 F.3d 1333, 1339-1340 (Fed. Cir. 2004) (cited in DSC Br.
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`at 8, n.9) (relying on language “[t]he solubilizers suitable according to the invention are defined
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`below” as definitional) (emphasis added). Instead, it appears in a section entitled “DETAILED
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`DESCRIPTION OF THE EXEMPLARY EMBODIMENTS,” and not even in the subsection
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`within it entitled “Definitions and Abbreviations.” See KKG, LLC v. Rank Grp., PLC, No. 11-cv-
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`00012-, 2013 WL 1643525, at *4–5 (E.D. Tex. Apr. 16, 2013); Hill-Rom, 755 F.3d at 1373.
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`Second, the patent as a whole does not clearly evince an intent to limit D to
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`dolastatin/auristatin. The Federal Circuit has declined to adopt similar language as definitional in
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`isolation from the rest of the patent. See Baxalta Inc. v. Genentech, Inc., 972 F.3d 1341, 1347
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`(Fed. Cir. 2020) (declining to adopt language in the specification beginning with “Antibodies are .
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`. .” as definitional). Claim 1 itself defines “D” as merely a “drug moiety – any drug moiety. The
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`development of auristatins as drug moieties was just one of the “problems and limitations of the
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`past” that the ’039 patent sought to address. (Id. at 4:27-29.) Other aspects of the invention
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`include drug moieties that work by different mechanisms, such as “a topoisomerase inhibitor”
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`(the type of drug DSC uses) or a “DNA binder.” (Id. at 19:4-11.) The specification elsewhere
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`refers to “this invention” as including many different types of chemotherapeutics: “[e]xamples of
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`cytotoxic drugs that can be derivatized into a prodrug form for use in this invention include, but
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`are not limited to, those chemotherapeutic agents described above.” (Id. at 35:2-5 (emphasis
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`added).) As Dr. Trail explained, the specification’s use of the term “prodrug” includes ADCs.
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`(Ex. 25, 7/27/21 Pamela Trail Deposition at 172:1-173:1; Trail Decl. ¶ 24.) And the specification
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`defines “chemotherapeutic agent” as a chemical compound useful in the treatment of cancer,
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`providing a list of drugs in various classes, not just including not only dolastatin type drugs, but
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`also doxorubicin, paclitaxel, mitomycin, calicheamicin, and camptothecin. (’039 pat. at 31:39-
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`33:31.) A person skilled in the art would not have read the entire specification to limit D to
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`dolastatin/auristatin derivatives. Nor would it be proper to limit the claims to the exemplary
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`embodiments that use auristatins. DSC failed to respond to these arguments, so no supplemental
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`briefing is necessary. (Seagen Br. at 8-11; DSC Br. at 7, n.2.)
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`
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`Dr. Trail’s testimony regarding Section 9.4 does not prove otherwise. Although she
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`testified that a portion of the passage from Section 9.4 (’039 pat. at 71:36-38) equated the terms
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`“drug moiety” and “drug unit,” this is consistent with Seagen’s proposal that the term can be
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`construed as a drug portion; Dr. Trail did not agree that this meant either term was limited to
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`dolastatin/auristatins. (Ex. 25 at 80:7-81:21, 117:22-119:7, 90:14-91:4 (“And used synonymously
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`here, it means that a drug moiety is an entity that induces pharmacology.”).) And far from her
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`deposition errata including “substantive edits” as DSC argues, the errata were entirely consistent
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`with her prior testimony. This contrasts with Glob. Mach. Tech., cited by DSC, where the errata
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`included extensive attorney interventions. (DSC Br. at 12.)
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`Third, as Seagen showed in its opening brief, the examiner specifically determined that D
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`encompasses non-dolastatin/auristatin-type drugs, including doxorubicin. Seagen did not
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`disagree with the examiner’s interpretation. (See Ex. 10 at 4 (finding D could be “the drug
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`moiety doxorubicin”); Ex. 26 at SGIEDTX0000065-69.) DSC’s only response to this lack of
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`disavowal is that the examiner “cannot override the specification’s clear definition.” (DSC Br. at
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`13.) But the examiner’s understanding further demonstrates that the language on which DSC
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`relies did not limit the claimed “D” to dolastatin/auristatin-type drugs. As shown by its other
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`patents and applications, Seagen understood how to claim dolastatin/auristatin type drugs. (See,
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`e.g., Ex. 27 at Claim 1; Ex. 28 at Claim 1.) Had Seagen intended to claim such drugs
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`specifically here, it would have done so.
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`B.
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`“Y is a Spacer unit”
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`This term either needs no construction, or it means simply a unit that links the amino acid
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`unit to a drug. (Seagen Br. at 5-7.) Attempting to narrowly restrict this term to avoid
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`infringement, DSC’s proposed construction piggybacks off its impermissibly restrictive
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`definition for “D.” DSC argues that because D is, in its view, limited to dolastatin/auristatin-type
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`drugs having a nitrogen atom that can form a bond with the Spacer, the Spacer unit must also
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`link to a nitrogen atom of D. (DSC Br. at 14.) As discussed above, however, DSC’s proposed
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`construction for “D” is overly restrictive and inconsistent with the specification as a whole.
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`Thus, its derivative definition for the Spacer unit also fails.
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`As Seagen pointed out in its opening brief, DSC’s definition also excludes embodiments
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`disclosed in the specification, violating precedent. (Seagen Br. at 6.) For example, the
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`specification provides multiple examples where the spacer unit is connected to groups on a drug
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`that do not contain nitrogen including a “carbonate, carbamate or ether group.” (’039 pat. at
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`68:51-57 (emphasis added to identify groups that do not contain a nitrogen atom); Ex. 25 at
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`199:16-25.) Figures 21 and 22 further exemplify these linkages. (’039 pat. at 21:5-10, Figs.
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`21-22.) DSC’s response to this disclosure is nonsensical: it argues this section is irrelevant to
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`ADCs because Fig. 21 uses the abbreviation “L” to depict a ligand generically, as opposed to an
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`antibody as claimed. (DSC Br. at 15.) But the Spacer unit (Y) does not even link to the ligand
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`(or the antibody Ab) – it links to the drug moiety (D). DSC’s arguments relating to the ligand
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`are therefore irrelevant. And regardless, the specification is clear that “L” includes antibodies,
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`such that the embodiments disclosed in Figures 21 and 22 are within the scope of the claims.
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`(’039 pat. at 77:26-40.) Because DSC’s construction would improperly exclude these
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`embodiments, it must be rejected. See, e.g., Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276-77
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`(Fed. Cir. 2008) (reversing a claim construction that excluded an embodiment); Verizon Servs.
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`Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (“We normally do not
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`interpret claim terms in a way that excludes disclosed examples in the specification.”).
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`As a last resort, DSC argues that Seagen’s definition should be rejected because it is
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`functional, and that it somehow converts the claim term into a means-plus-function term. (DSC
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`Br. at 16-17.) But there is nothing improper about functional claim language. Nevro Corp. v.
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`Bos. Sci. Corp., 955 F.3d 35, 39 (Fed. Cir. 2020); Cox Commc'ns, Inc. v. Sprint Commc'n Co.
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`LP, 838 F.3d 1224, 1232 (Fed. Cir. 2016). Nor does the mere presence of functional language
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`convert a claim term into a means-plus-function term absent the use of the word “means.”
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`Zeroclick, LLC v. Apple Inc., 891 F.3d 1003, 1008 (Fed. Cir. 2018) (“[T]he mere fact that the
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`disputed limitations incorporate functional language does not automatically convert the words
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`into means for performing such functions.”); Samsung Elecs. Am., Inc. v. Prisua Eng'g Corp.,
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`948 F.3d 1342, 1353 (Fed. Cir. 2020) (rebuttal presumption that section 112, paragraph 6 applies
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`in the absence of “means for”). In fact, DSC’s own proposed construction is functional: “one or
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`more atoms that links Ww to a nitrogen atom of D.” (DSC Br. at 14 (emphasis added).)
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`Moreover, DSC’s attempt to shoehorn this term into means-plus-language jurisprudence
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`focuses on only a portion of the term (“unit”) and ignores the understanding of skilled artisans.
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`The full term is “Y is a spacer unit,” not merely “unit.” The claim itself includes a formula that
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`structurally depicts how Y provides spacing between Ww and D. As Dr. Trail confirms, the art
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 10 of 16 PageID #: 6704
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`recognized the term “spacer” to refer to a unit that separates the drug from other moieties in the
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`conjugate, including between the amino acid unit and the drug. (Trail Decl. ¶ 19.) DSC has not
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`provided any evidence to the contrary. Thus, the addition of “spacer” to “unit” indicated a well-
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`understood meaning within the art, such that the term is not a generic or “nonce” term resulting in
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`the application of mean-plus-function jurisprudence. Panoptis Pat. Mgmt., LLC v. Blackberry
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`Ltd., No. 16-CV-62, 2017 WL 497571, at *3–10 (E.D. Tex. Feb. 7, 2017) (rejecting the argument
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`that “unit” terms—“determination unit”, “reception unit” and “transmission unit”—are nonce
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`words subject to means-plus-function jurisprudence). In any event, DSC did not disclose this
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`construction under the local patent rules, and the Court should disregard it for that reason alone.
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`Even if the term were construed as means-plus-function, DSC’s arguments would fail. A
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`means-plus-function claim limitation “shall be construed to cover the corresponding structure . . .
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`described in the specification and equivalents thereof.” 35 U.S.C. 112(f); Hillman Grp., Inc. v.
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`KeyMe, LLC, No. 19-CV-209, 2020 WL 3605626, at *16 (E.D. Tex. July 2, 2020). As discussed
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`above and in Seagen’s opening brief, DSC’s construction would exclude from the scope of the
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`claim disclosed embodiments in which the spacer unit is connected to the drug via groups that do
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`not contain a nitrogen atom. (Seagen Br. at 6.) Thus, even if the “spacer unit” were limited to the
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`structures disclosed in the specification and equivalents, DSC’s proposed construction would fail.
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`C.
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` “wherein Y is a self-immolative spacer”
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`As Seagen explained in its opening brief, one of ordinary skill would understand this
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`term to refer to the part of the ADC that degrades after cleavage of the amino acid unit to release
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`the drug. (Id. at 21-22.) DSC’s litigation-driven construction limiting “self-immolative spacer”
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`to release “without the need for a separate hydrolysis step” conflicts with the plain meaning of
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`the term as understood by skilled artisans. (Seagen Br. at 21-22; Trail Decl. ¶¶ 51-52, 54-58.)
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`Seagen pointed to a portion of the specification that provides several examples of self-
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`immolative spacers that, contrary to DSC’s construction, undergo a hydrolysis step to release the
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`drug, demonstrating that DSC’s proposed construction would impermissibly exclude such
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`embodiments. (Id. (citing ’039 pat. at 69:1-16).)
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`DSC’s response is merely: “Not so.” (DSC Br. at 19.) Over several pages of attorney
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`argument, DSC parses the particular chemicals involved in the reactions and purports to explain
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`how Seagen’s argument mischaracterizes the chemistry the specification discloses. (Id. at 18-20.)
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`But DSC has no evidence that a person of ordinary skill in the art would have understood the
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`chemistry in this way. Nor did DSC question Dr. Trail regarding this issue during her deposition.
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`DSC’s attorney arguments have no bearing on technical issues on which a qualified expert has
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`opined to the contrary. DSC’s proposal should be rejected as unsupported attorney argument
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`inconsistent with the intrinsic evidence and the understanding of skilled artisans.
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`D.
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`“p ranges from 1 to about 20”
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`As Seagen explained in its opening brief, this term needs no construction. (Seagen Br. at
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`11-13.) DSC’s proposed construction impermissibly narrows this term, requiring “p” to be an
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`integer. The specification, however, states that the “drug loading is represented by p, the
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`average number of drug molecules per antibody in a molecule.” (’039 pat. at 51:33-47
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`(emphasis added).) This is consistent with the understanding in the art. (See Trail Decl. ¶¶
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`28-34.) As the number is an average, the ratio will often be a non-integer value. (Id.) The
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`specification also describes many ADCs having non-integer p values (expressed as “drug/Ab”),
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`including Figure 7 (3.8, 4.1, and 4.8), Figure 8 (same), Figure 9 (3.8, 3.9, and 4.1), and Figure 10
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`(4.1, 3.3, and 3.7). (See, e.g., id. at Figs. 7-10, 19:63-20:19.) DSC’s construction would
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`improperly exclude these embodiments.
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`DSC argues that this term cannot refer to an average among several ADCs because by
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`referring to “an” antibody-drug-conjugate, the claim “recites a single antibody-drug conjugate.”
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 12 of 16 PageID #: 6706
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`(DSC Br. at 24-25.) DSC’s argument is contrary to clear Federal Circuit precedent that a claim’s
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`use of the singular such as “a” or “an” ordinarily means “one or more.” 01 Communique Lab’y,
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`Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012). Moreover, DSC’s argument makes
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`little sense in view of its own product, which despite commonly being referred to as an “ADC,” is
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`nevertheless a population of antibody-drug conjugate molecules. (Ex. 29 at 007488-89.) Thus,
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`nothing about the claims’ use of the singular dictates that “p” should be limited only to integers.
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`E.
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` “wherein the S is a sulfur atom on a cysteine residue of the antibody”
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`As Seagen demonstrated in its opening brief, this term is straightforward to a person of
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`ordinary skill and does not require construction. It refers to the way each drug-linker unit is
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`attached to the antibody, with each such unit being attached to its own cysteine residue in the
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`antibody through a sulfur atom within the cysteine residue. (Seagen Br. at 14-17.) DSC’s
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`proposed construction is nonsensical and chemically impossible: it would require all drug-linker
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`units to be attached to a single sulfur atom. (Id. at 15.) And nowhere does the specification
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`suggest that more than one drug-linker can be attached to a single sulfur atom on a single
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`cysteine. To the contrary, the specification provides a table of over 60 ADCs each having only
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`one drug-linker per reactive cysteine. (’039 pat. at 153:18-154:12.)
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`DSC’s strained construction is based on the placement of a single parenthesis. According
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`to DSC, the placement of the left-hand parenthesis in the claimed structure on the outside of the
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`“S” demonstrates that every drug-linker unit must be attached to a single sulfur atom. (DSC Br.
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`at 26-27.) DSC likens its argument to the placement of a single comma changing the meaning of
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`a sentence. (Id. at 27.) But a chemical structure is not a sentence, and the significance of the
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`parenthesis in a chemical structure is determined from the viewpoint of a skilled artisan, not from
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`the viewpoint of an ordinary speaker of English. When Dr. Trail was questioned about the
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`location of the parenthesis in the claimed structure as compared to the structure disclosed in the
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 13 of 16 PageID #: 6707
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`specification, she testified that although the parentheses were not in the same place in the two
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`structures, there was no “difference in terms of what is accomplished in these drawings.” (Ex. 25
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`at 263:11-265:20.) DSC’s argument is not based on any scientific reality.
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`In contrast, Seagen’s proposed construction is supported by Dr. Trail, who confirmed that
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`persons of ordinary skill in the art would not have understood the claims to require every drug-
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`linker unit to be attached to a single sulfur atom. (See Trail Decl. ¶ 40.) Dr. Trail’s testimony
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`that a sulfur atom is only able to form a bond with a single p unit does not prove otherwise, as
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`the claim is not limited to a single sulfur atom: the reference to “a” sulfur atom in Claim 1
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`would include “one or more” sulfur atoms. 01 Communique Lab’y, 687 F.3d at 1297. DSC’s
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`construction is also contrary to the notation used by its own scientists. For example, the article
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`by Nakada et al.—a publication by DSC scientists—provides a similar diagram to that found in
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`Claim 1’s formula, where a sulfur atom (S) appears outside the parentheses that illustrate the
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`drug-linker unit. (Ex. 18 at SGIEDTX00008241.) Thus, DSC’s own scientists have found that
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`this is a clear and definite way to notate an ADC that has the structure of Claim 1.
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`DSC also argues that this term is indefinite because under its strained definition, up to 20
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`drug-linker units may be attached to a single sulfur atom, despite sulfur only being able to form a
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`bond with a single p unit. Despite the standard for indefiniteness clearly requiring a
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`determination from the viewpoint of a person of ordinary skill in the art, DSC has again offered
`
`only attorney argument. See Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 908 (2014).
`
`DSC provides no evidence to rebut Dr. Trail, and hence, cannot meet its high burden to establish
`
`indefiniteness. Whirlpool Corp. v. Ozcan, No. 2:15-cv-2103-, 2016 WL 7474517, at *1, *3
`
`(E.D. Tex. Dec. 29, 2016) (finding defendant failed to establish indefiniteness because “[i]nstead
`
`of submitting evidence, such as an expert declaration, to demonstrate the understanding of a
`
`
`sf-4539299
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`9
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`

`

`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 14 of 16 PageID #: 6708
`
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`person of ordinary skill in the art, [Defendant] relies entirely on attorney argument based on the
`
`patent’s intrinsic evidence.”). Moreover, DSC’s own scientists’ use of the same notation in their
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`publications forecloses any argument that the term was not reasonably certain from the
`
`viewpoint of a person of ordinary skill in the art. Liqwd, Inc. v. L’Oreal USA, Inc., 720 Fed.
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`App’x 623, 631 (2018) (“evidence of challenger’s own ability to apply a term without
`
`unreasonable uncertainty counts against an indefiniteness contention”).
`
`F.
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`“wherein the drug moiety is intracellularly cleaved . . .”
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`As discussed in Seagen’s opening brief, this term does not require construction. The
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`plain and ordinary meaning of “intracellularly cleaved” is “separated within a cell.” (Seagen Br.
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`at 19.) In the alternative, Seagen is not opposed to the Court adopting the exact language in the
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`specification. (Id. at 20.) DSC’s proposed construction, however, is overly lengthy, potentially
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`confusing to jurors, and rewrites specification’s language in a misleading way.
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`DSC’s objection to Seagen’s proposed construction is focused on Seagen’s omission of
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`the word “free” from the language that appears in the specification. (Id. at 19.) Seagen omitted
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`“free” in its proposed construction to simplify the language and avoid jury confusion. Seagen is
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`not opposed to including “free” in the construction so long as it is understood that “free drug”
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`refers to the active drug component of an ADC. (See ’039 pat. at 34:50-35:5.) This
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`understanding is in line with Dr. Trail’s testimony, who stated that in the context of the
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`specification, a skilled artisan would have understood “free” solely to mean “no longer bound to
`
`the antibody.” (Ex. 25 at 226:12-19, 229:24-230:9, 231:2-6.) The meaning of “free drug” is
`
`agnostic as to whether any portion of the linker remains attached following intracellular cleavage.
`
`(Id.) Thus, in no way does the adoption of the word “free” in the construction result in a non-
`
`infringement position for DSC, as it now claims. (DSC Br. at 23.) Should the Court adopt the
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`language from the specification verbatim for construction of this term, DSC’s objection is moot.
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`sf-4539299
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`

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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 15 of 16 PageID #: 6709
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`Dated: August 6, 2021
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`
`
`By: /s/ Melissa R. Smith
`Michael A. Jacobs
`MJacobs@mofo.com
`Matthew A. Chivvis
`MChivvis@mofo.com
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105
`Telephone: 415.268.7000
`Facsimile: 415.268.7522
`
`Bryan Wilson
`BWilson@mofo.com
`Pieter S. de Ganon
`PdeGanon@mofo.com
`MORRISON & FOERSTER LLP
`755 Page Mill Road
`Palo Alto, California 94304-1018
`Telephone: 650.813.5600
`Facsimile: 650.494.0792
`
`Melissa R. Smith
`Texas State Bar No. 24001351
`melissa@gillamsmithlaw.com
`GILLAM & SMITH, LLP
`303 South Washington Avenue
`Marshall, Texas 75670
`Telephone: 903.934.8450
`Facsimile: 903.934.9257
`Of Counsel:
`T. John Ward, Jr.
`Texas State Bar No. 00794818
`jw@wsfirm.com
`Charles Everingham IV
`Texas State Bar No. 00787447
`ce@wsfirm.com
`Andrea L. Fair
`Texas State Bar No. 24078488
`andrea@wsfirm.com
`WARD, SMITH & HILL, PLLC
`1507 Bill Owens Parkway
`Longview, Texas 75604
`Telephone: 903.757.6400
`Facsimile: 903.757.2323
`
`Attorneys for Plaintiff Seagen Inc.
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`sf-4539299
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`Case 2:20-cv-00337-JRG Document 138 Filed 08/11/21 Page 16 of 16 PageID #: 6710
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that the foregoing document was filed electronically in
`compliance with Local Rule CV-5(a). Plaintiff’s counsel of record were served with a true and
`correct copy of the foregoing document by electronic mail on August 6, 2021.
`
`
`
`
`/s/ Melissa R. Smith
`Melissa R. Smith
`
`
`
`
`
`
`
`
`
`
`
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`
`
`sf-4539299
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`12
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`

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