Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 1 of 42 PageID #: 7867
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`MEMORANDUM OPINION AND ORDER
`Before the Court is the opening claim construction brief of Plaintiff Seagen Inc.
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`CIVIL ACTION NO. 2:20-CV-00337-JRG
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`SEAGEN INC.,
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`v.
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`DAIICHI SANKYO CO., LTD.,
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`ASTRAZENECA PHARMACEUTICALS
`LP, and ASTRAZENECA UK LTD
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`Plaintiff,
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`Defendant,
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`Intervenor-Defendants.
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`(“Plaintiff”) (Dkt. No. 121), the response of Defendant Daiichi Sankyo Co., Ltd. and Intervenor-
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`Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd. (collectively, the
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`“Defendants”) (Dkt. No. 130, filed on July 30, 2021), and the reply of Plaintiff (Dkt. No. 135, filed
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`on August 6, 2021). The Court held a claim construction hearing on August 27, 2021 (see Dkt.
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`No. 149). Having considered the arguments and evidence presented by the parties at the hearing
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`and in their claim construction briefing, the Court issues this Claim Construction Order.
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 2 of 42 PageID #: 7868
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`Table of Contents
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`I.
`BACKGROUND ................................................................................................................. 3
`II. LEGAL PRINCIPLES ....................................................................................................... 4
`A. Claim Construction ............................................................................................................... 4
`B. Departing from the Ordinary Meaning of a Claim Term ...................................................... 7
`C. Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA)/§ 112(b) (AIA) ................................... 8
`III. CONSTRUCTION OF DISPUTED TERMS ................................................................... 9
`“D is a drug moiety” ................................................................................................................... 9
`“Y is a spacer unit” ................................................................................................................... 15
`“wherein Y is a self-immolative spacer” .................................................................................. 20
`“p ranges from 1 to about 20” ................................................................................................... 25
`“wherein the S is a sulfur atom on a cysteine residue of the antibody” ................................... 30
`“wherein the drug moiety is intracellularly cleaved …” .......................................................... 37
`IV. CONCLUSION ................................................................................................................. 42
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 3 of 42 PageID #: 7869
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`I.
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`BACKGROUND
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`Plaintiff brings suit alleging infringement of U.S. Patent No. 10,808,039 (“the ʼ039
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`Patent”). The ʼ039 Patent is entitled “Monomethylvaline Compounds Capable of Conjugation to
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`Ligands.” The application leading to the ʼ039 Patent was filed on July 10, 2019 and issued on
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`October 20, 2020, and it is a continuation application of a series of patent applications and patents
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`that ultimately claims priority to a provisional patent application filed on November 6, 2003.
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`The ʼ039 Patent relates to a particular type of molecule known as an antibody-drug
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`conjugate (“ADC”). ʼ039 Patent at 1:58-2:3. The disclosed ADC enables the delivery of
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`chemotherapeutic drugs directly to cancer cells by linking them to antibodies. See id. at 1:58-3:14.
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`As described generally in the specification and in claim 1, an ADC composes primary components
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`that interact together, including (1) an antibody (Ab) connected to (2) a drug moiety (D) via (3) a
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`linker (A-W-Y). The parties dispute the meaning of terms within claims 1 and 2 of the ʼ039 Patent.
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`Claim 1 is the sole independent claim in the ʼ039 Patent and is reproduced below:
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 4 of 42 PageID #: 7870
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`The Abstract of the ʼ039 Patent is reproduced below:
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`Auristatin peptides, including MeVal-Val-Dil-Dap-Norephedrine (MMAE) and
`MeVal-Val-Dil-Dap-Phe (MMAF), were prepared and attached to Ligands through
`various linkers, including maleimidocaproyl-val-cit-PAB. The resulting ligand
`drug conjugates were active in vitro and in vivo.
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`II.
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`LEGAL PRINCIPLES
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`A.
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`Claim Construction
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`“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude.’” Phillips, 415 F.3d 1303 at 1312 (en banc)
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`(quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed.
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`Cir. 2004)). The Court first examines a patent’s intrinsic evidence to define the patented
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`invention’s scope. Id. at 1313–14; Bell Atl. Network Servs., Inc. v. Covad Commc’ns Group, Inc.,
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`262 F.3d 1258, 1267 (Fed. Cir. 2001). Intrinsic evidence includes the claims themselves, the
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`specification and the prosecution history. Phillips, 415 F.3d at 1312–13; C.R. Bard, Inc. v. U.S.
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`Surgical Corp., 388 F.3d 858, 861 (Fed. Cir. 2004). The general rule—subject to certain specific
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`exceptions discussed infra—is that each claim term is construed according to its ordinary and
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`accustomed meaning as understood by one of ordinary skill in the art at the time of the invention
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`in the context of the patent. Phillips, 415 F.3d at 1312–13; Alloc, Inc. v. Int’l Trade Comm’n, 342
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`F.3d 1361, 1368 (Fed. Cir. 2003); see also Azure Networks, LLC v. CSR PLC, 771 F.3d 1336, 1347
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`(Fed. Cir. 2014) (“There is a heavy presumption that claim terms carry their accustomed meaning
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`in the relevant community at the relevant time.”).
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`“The claim construction inquiry. . . begins and ends in all cases with the actual words of
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`the claim.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998).
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`“[I]n all aspects of claim construction, ‘the name of the game is the claim.’” Apple Inc. v.
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`Motorola, Inc., 757 F.3d 1286, 1298 (Fed. Cir. 2014) (quoting In re Hiniker Co., 150 F.3d 1362,
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`1369 (Fed. Cir. 1998)). First, a term’s context in the asserted claim can be instructive. Phillips,
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`415 F.3d at 1314. Other asserted or unasserted claims can also aid in determining the claim’s
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`meaning, because claim terms are typically used consistently throughout the patent. Id.
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`Differences among the claim terms can also assist in understanding a term’s meaning. Id. For
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`example, when a dependent claim adds a limitation to an independent claim, it is presumed that
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`the independent claim does not include the limitation. Id. at 1314–15.
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`“[C]laims ‘must be read in view of the specification, of which they are a part.’ ” Id.
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`(quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995)). “[T]he
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`specification ‘is always highly relevant to the claim construction analysis. Usually, it is
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`dispositive; it is the single best guide to the meaning of a disputed term.’” Id. (quoting Vitronics
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`Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); Teleflex, Inc. v. Ficosa N. Am.
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`Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). In the specification, a patentee may define his own
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`terms, give a claim term a different meaning than it would otherwise possess, or disclaim or
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`disavow some claim scope. Phillips, 415 F.3d at 1316. Although the Court generally presumes
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`terms possess their ordinary meaning, this presumption can be overcome by statements of clear
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`disclaimer. See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337,
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`1343–44 (Fed. Cir. 2001). This presumption does not arise when the patentee acts as his own
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`lexicographer. See Irdeto Access, Inc. v. EchoStar Satellite Corp., 383 F.3d 1295, 1301 (Fed. Cir.
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`2004).
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`“Although the specification may aid the court in interpreting the meaning of disputed claim
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`language, particular embodiments and examples appearing in the specification will not generally
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`be read into the claims.” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir.
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 6 of 42 PageID #: 7872
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`1998) (quoting Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988));
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`see also Phillips, 415 F.3d at 1323. “[I]t is improper to read limitations from a preferred
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`embodiment described in the specification—even if it is the only embodiment—into the claims
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`absent a clear indication in the intrinsic record that the patentee intended the claims to be so
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`limited.” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004).
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`The prosecution history is another tool to supply the proper context for claim construction
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`because, like the specification, the prosecution history provides evidence of how the U.S. Patent
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`and Trademark Office (“PTO”) and the inventor understood the patent. Phillips, 415 F.3d at 1317.
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`However, “because the prosecution history represents an ongoing negotiation between the PTO
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`and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the
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`specification and thus is less useful for claim construction purposes.” Id. at 1318; see also Athletic
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`Alternatives, Inc. v. Prince Mfg., 73 F.3d 1573, 1580 (Fed. Cir. 1996) (ambiguous prosecution
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`history may be “unhelpful as an interpretive resource”).
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`Although extrinsic evidence is useful, it is “less significant than the intrinsic record in
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`determining the legally operative meaning of claim language.” Phillips, 415 F.3d at 1317 (quoting
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`C.R. Bard, Inc., 388 F.3d at 862) (internal quotation marks omitted). Technical dictionaries and
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`treatises may help a court understand the underlying technology and the manner in which one
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`skilled in the art might use claim terms, but technical dictionaries and treatises may provide
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`definitions that are too broad or may not be indicative of how the term is used in the patent. Id. at
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`1318. Similarly, expert testimony may aid a court in understanding the underlying technology and
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`determining the particular meaning of a term in the pertinent field, but an expert’s conclusory,
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`unsupported assertions as to a term’s definition are not useful. Id. Generally, extrinsic evidence
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`is “less reliable than the patent and its prosecution history in determining how to read claim terms.”
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`Id.
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`B.
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`Departing from the Ordinary Meaning of a Claim Term
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`There are “only two exceptions to [the] general rule” that claim terms are construed
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`according to their plain and ordinary meaning: “1) when a patentee sets out a definition and acts
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`as his own lexicographer, or 2) when the patentee disavows the full scope of the claim term either
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`in the specification or during prosecution.” Golden Bridge Tech., Inc. v. Apple Inc., 758 F.3d 1362,
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`1365 (Fed. Cir. 2014) (quoting Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365
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`(Fed. Cir. 2012)); see also GE Lighting Solutions, LLC v. AgiLight, Inc., 750 F.3d 1304, 1309
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`(Fed. Cir. 2014) (“[T]he specification and prosecution history only compel departure from the
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`plain meaning in two instances: lexicography and disavowal.”). “The standards for finding
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`lexicography or disavowal are ‘exacting.’ ” GE Lighting Solutions, 750 F.3d at 1309.
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`To act as his own lexicographer, the patentee must “clearly set forth a definition of the
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`disputed claim term,” and “clearly express an intent to define the term.” Id. (quoting Thorner, 669
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`F.3d at 1365); see also Renishaw, 158 F.3d at 1249. The patentee’s lexicography must appear
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`“with reasonable clarity, deliberateness, and precision.” Renishaw, 158 F.3d at 1249.
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`To disavow or disclaim the full scope of a claim term, the patentee’s statements in the
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`specification or prosecution history must amount to a “clear and unmistakable” surrender. Cordis
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`Corp. v. Boston Sci. Corp., 561 F.3d 1319, 1329 (Fed. Cir. 2009); see also Thorner, 669 F.3d at
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`1366 (“The patentee may demonstrate intent to deviate from the ordinary and accustomed meaning
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`of a claim term by including in the specification expressions of manifest exclusion or restriction,
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`representing a clear disavowal of claim scope.”). “Where an applicant’s statements are amenable
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`to multiple reasonable interpretations, they cannot be deemed clear and unmistakable.” 3M
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`Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1326 (Fed. Cir. 2013).
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`C.
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`Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA)/§ 112(b) (AIA)
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`Patent claims must particularly point out and distinctly claim the subject matter regarded
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`as the invention. 35 U.S.C. § 112, ¶ 2. A claim, when viewed in light of the intrinsic evidence,
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`must “inform those skilled in the art about the scope of the invention with reasonable certainty.”
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`Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). If it does not, the claim fails
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`§ 112, ¶ 2 and is therefore invalid as indefinite. Id. at 901. Whether a claim is indefinite is
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`determined from the perspective of one of ordinary skill in the art as of the time the application for
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`the patent was filed. Id. at 911. As it is a challenge to the validity of a patent, the failure of any
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`claim in suit to comply with § 112 must be shown by clear and convincing evidence. BASF Corp.
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`v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017). “[I]ndefiniteness is a question of
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`law and in effect part of claim construction.” ePlus, Inc. v. Lawson Software, Inc., 700 F.3d 509,
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`517 (Fed. Cir. 2012).
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`“When a ‘word of degree’ is used, the court must determine whether the patent provides
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`‘some standard for measuring that degree.’” Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d
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`1374, 1378 (Fed. Cir. 2015). “‘Reasonable certainty’ does not require ‘absolute or mathematical
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`precision.’” BASF, 875 F.3d at 1365, quoting Biosig, 783 F.3d at 1381. Likewise, when a
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`subjective term is used in a claim, the “court must determine whether the patent’s specification
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`supplies some standard for measuring the scope of the [term].” Datamize, LLC v. Plumtree
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`Software, Inc., 417 F.3d 1342, 1351 (Fed. Cir. 2005). The standard “must provide objective
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`boundaries for those of skill in the art.” Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371
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`(Fed. Cir. 2014).
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 9 of 42 PageID #: 7875
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`III. CONSTRUCTION OF DISPUTED TERMS
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`The parties’ positions and the Court’s analysis as to the disputed terms within the claims
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`of the Asserted Patent are presented below.
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`“D is a drug moiety”
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`Plaintiff’s
`Proposed Construction
`Plain meaning/no construction is
`necessary.
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`Alternatively: “D is a drug portion.”
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`(1) The Parties’ Positions
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`Defendants’
`Proposed Construction
`“a drug of the dolastatin/auristatin-type having
`a nitrogen atom that can form a bond with the
`Spacer unit when y=1 or 2, or with the C-
`terminal carboxyl group of an Amino Acid unit
`when y=0”
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`Plaintiff argues that the term is readily understood and does not need construction. See,
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`e.g., Dkt. No. 121, Plaintiff’s Opening Claim Construction Brief, at 8–11. Plaintiff argues that, to
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`the extent helpful for jurors, the “moiety” term could be construed as “portion.” Id. at 8. Plaintiff
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`argues that Defendants’ construction adds limitations that do not appear in the claim and do not
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`comport with the plain meaning of the term. Id. In particular, Defendants’ construction limits the
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`term to drugs “of the dolastatin/auristatin-type” and to drug-linkages involving a “nitrogen atom.”
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`Id. Plaintiff argues that Defendants’ construction contradicts the intrinsic evidence. Id. at 9–10.
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`Plaintiff argues that the extrinsic evidence confirms the plain meaning of the term (as proposed by
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`Plaintiff). Id. at 11.
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`Defendants argue that the term was given a specific definition in the specification, and thus
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`lexicography governs. See, e.g., Dkt. No. 130, Defendants’ Responsive Claim Construction Brief,
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`at 7–14. Defendants argue that several paragraphs in Section 9.4 of the specification on the drug
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`moiety term evidences lexicographic intent. Id. at 8–11. Defendants further argue that Plaintiff’s
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`technical expert confirmed in testimony that a definition of the drug moiety could be found in this
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 10 of 42 PageID #: 7876
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`section. Id. at 11–12. Defendants argue that Plaintiff’s intrinsic and extrinsic evidence citations
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`do not override the lexicographical definition. Id. at 12–13.
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`In its Reply, Plaintiff argues that the term needs no construction. See, e.g., Dkt. No. 135,
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`Plaintiff’s Reply Claim Construction Brief, at 1–4. Plaintiff argues that there is no clear intent to
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`redefine the term, and the references to a particular type of drug is merely an embodiment. Id.
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`Plaintiff argues that its expert did not agree to the construction offered by Defendants. Id. at 3.
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`(2) Analysis
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`The parties dispute whether the term has its plain and ordinary meaning. In particular, the
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`parties dispute whether a different meaning to the term is warranted based on the specification and
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`an alleged lexicographical definition.
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` Claim 1 requires an antibody-drug conjugate (ADC) having the following formula:
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`Claim 1 specifies that “D is a drug moiety.” The claims, by themselves, do not specify or
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`require that the drug be limited to a dolastatin/auristatin-type drug, or that it has a nitrogen atom
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`that can form a bond to a spacer unit.
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`The patent is entitled “Monomethylvaline Compounds Capable of Conjugation to
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`Ligands,” which appears to be a reference to dolastatin/auristatin-type drugs. The Abstract of the
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`ʼ039 Patent mentions “auristatin peptides.” The background section of the patent teaches that
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`antibody-drug conjugates (ADCs) can be delivered with particular agents or drugs (e.g., a drug
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`moiety) to kill or inhibit tumor cells for cancer treatment. ʼ039 Patent, 2:43–49. The background
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`section provides many different examples of drugs that can be used, including dolastatin type drugs
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`and auristatin type drugs. See id. at 2:43–4:20. The background specification teaches that “there
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`is a clear need in the art for dolastatin/auristatin derivates having significantly lower toxicity yet
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`useful therapeutic efficiency.” Id. at 4:23–27. The Summary of the Invention section and Section
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`9.2 (the Compounds of the Invention section) likewise are directed to dolastatin/auristatin type
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`drug moieties. See id. at 6:31–67, 7:43–57; 44:57–45:25). Most of the specification is directed to
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`dolastatin/auristatin type drugs. While the specification provides numerous examples of drugs that
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`are not limited to a dolastatin/auristatin-type drug (see id. at 31:39–33:31), Defendants dispute that
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`these are drugs in relation to a drug moiety as opposed to general chemotherapeutic agents in
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`addition to the claimed drug. Overall, it is clear that a primary embodiment of the patent is
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`dolastatin/auristatin-type drugs, but it is not clear that the invention is necessarily limited to such
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`drugs.
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`The specification discusses the Drug Unit (Moiety) in Section 9.4 and provides a
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`description of the drug moiety with the following language:
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`The drug moiety (D) of the antibody drug conjugates (ADC) are of the
`dolastatin/auristatin type (U.S. Pat. Nos. 5,635,483; 5,780,588) which have been
`shown to interfere with microtubule dynamics, GTP hydrolysis, and nuclear and
`cellular division (Woyke et al. (2001) Antimicrob. Agents and Chemother.
`45(12):3580-3584) and have anti-cancer (U.S. Pat. No. 5,663,149) and antifungal
`activity (Pettit et al. (1998) Antimicrob. Agents Chemother. 42:2961-2965)
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`D is a Drug unit (moiety) having a nitrogen atom that can form a bond with the
`Spacer unit when y=1 or 2, with the C-terminal carboxyl group of an Amino Acid
`unit when y=0, with the carboxyl group of a Stretcher unit when w and y=0, and
`with the carboxyl group of a Drug unit when a, w, and y=0. It is to be understood
`that the terms “drug unit” and “drug moiety” are synonymous and used
`interchangeably herein.
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 12 of 42 PageID #: 7878
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`ʼ039 Patent, 71:20–37 (emphasis added). The specification states that a “drug unit” is synonymous
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`with “drug moiety.” Id. at 71:36–37. Defendants allege this section is a lexicographical definition
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`of the term, while Plaintiff argues that it is not a lexicographical definition.
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`On balance, the Court is not persuaded by Defendants’ arguments. In particular, the Court
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`is not convinced that the section on drug moiety in section 9.4 of the specification is a
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`lexicographical definition as opposed to a non-limiting embodiment. The patent specification
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`provides a separate section for express definitions in Section 9.1, entitled “Definitions and
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`Abbreviations,” which provides many definitions of various terms. See ʼ039 Patent, 21:55–44:53.
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`In general, each paragraph in Section 9.1 provides a term and then defines it by using language
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`such as the phrase “refers” to, “as used herein,” or “means,” or even “is” in some instances. Section
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`9.1 is clear that it is providing lexicographical definitions. In contrast, the language in Section 9.4
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`for “drug moiety” is more exemplary in format as opposed to definitional statements. On balance,
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`the Court finds that the paragraphs in Section 9.4 relating to Defendants’ proposed limitations are
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`not definitional. While the specification mentions that a “drug moiety” is synonymous with “drug
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`unit,” such a comparison does not necessarily mean the other sentences contain lexicographical
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`definitions. Further, the Court rejects Defendants’ arguments relating to the testimony of
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`Plaintiff’s expert and finds that at no point did Plaintiff’s expert agree that the drug moiety of claim
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`1 is limited to dolastatin/auristatin drugs.
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`Overall, Defendants’ arguments and citations to the intrinsic evidence are not persuasive.
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`First, the claim language does not require the limitations proposed by Defendants. Claim 1 simply
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`requires D as a drug moiety. Nothing in the claim requires the drug to be a particular type of drug
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`or have a nitrogen atom that bonds with the spacer unit. Had the patentee wanted to limit the
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`claims to a particular drug or have particular limitations, it could have easily done so. Indeed, the
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`patentee did claim dolastatin/auristatin type drugs in prior related patents to the ʼ039 Patent (see
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`Plaintiff’s Exhibits 27, 28 (U.S. Patent Nos. 7,994,135 and 8,703,714, respectively)), evidencing
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`the fact that patentee did not intend to limit the broad drug moiety term in claim 1 of the ʼ039
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`Patent. Overall, the fact that the claim does not limit the type of drug is highly persuasive. Second,
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`the prosecution history supports Plaintiff’s construction. There is no disavowal or disclaimer in
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`the prosecution history, and no evidence that the Examiner considered the meaning of the drug
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`moiety D to be important. In particular, the Examiner applied prior art drugs that were not limited
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`to non-dolastatin/auristatin-type drugs. See November 6, 2019 Office Action on the ʼ039 Patent
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`at 4 (Examiner finding that D could be the drug moiety “doxorubicin”). In other words, the
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`Examiner did not understand the drug moiety to be limited to dolastatin/auristatin-type drugs or
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`have the limitations proposed by Defendants. Third, as discussed in more detail above, the Court
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`finds that there is no lexicography, disavowal or disclaimer in the specification to require the
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`limitations suggested by Defendants. While there are certainly embodiments within the patent that
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`reference a drug having a nitrogen atom for bonding or being of a dolastatin/auristatin-type drug,
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`at no point do they rise to the level of a disclaimer, disavowal, or lexicographical definition.
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`Defendants’ relied upon portions of the specification do not otherwise equate or limit the “drug”
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`term to the limitations proposed by the Defendants. At best, they are non-limiting embodiments
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`that should not be imported into the claims. The Federal Circuit has consistently held that
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`“particular embodiments appearing in the written description will not be used to limit claim
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`language that has broader effect.” Innova/Pure Water, 381 F.3d at 1117. Even where a patent
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`describes only a single embodiment, absent a “clear intention to limit the claim scope,” it is
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`improper to limit the scope of otherwise broad claim language by resorting to a patent’s
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`specification. Id.; see also Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir.
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 14 of 42 PageID #: 7880
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`2004) (citing numerous cases rejecting the contention that the claims of the patent must be
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`construed as being limited to the single embodiment disclosed and stating that claims are to be
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`given their broadest meaning unless there is a clear disclaimer or disavowal); Comark Commc’ns,
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`Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1988) (“Although the specification may aid
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`the court in interpreting the meaning of disputed claim language, particular embodiments and
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`examples appearing in the specification will not generally be read into the claims.”); Arlington
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`Indus., Inc. v. Bridgeport Fittings, Inc., 632 F.3d 1246, 1254 (Fed. Cir. 2011) (“even where a
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`patent describes only a single embodiment, claims will not be read restrictively unless the patentee
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`has demonstrated a clear intention to limit the claim scope using words of expressions of manifest
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`exclusion or restriction.”); Phillips, 415 F.3d at 1323.
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`Defendants admit that they do not disagree about the ordinary meaning of “drug moiety”
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`outside the context of the specification. See Defendants’ Responsive Brief at 7. The Court finds
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`that a plain and ordinary meaning construction for this disputed term is consistent with the intrinsic
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`record. The Court finds that one of ordinary skill in the art, based upon the specification and the
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`claims, would understand the disputed term to have its plain and ordinary meaning. Outside the
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`context of the specification, the “moiety” term is widely understood to people of skill in the art.
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`See McGraw-Hill Dictionary of Scientific and Technical Terms, 6th Ed., Ex. 11 of Plaintiff’s
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`Opening Brief (“moiety: a part or portion of a molecule, generally complex, having a characteristic
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`chemical or pharmacological property.”); see also Trail Declaration ¶¶ 24–25. The use of the
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`“drug moiety” term in the claims and in the specification is consistent with the plain meaning of
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`the term. Nevertheless, while a plain meaning approach might be appropriate, the Court finds that
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`a construction as to this term would be helpful to resolve the dispute between the parties. The
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`patent specification equates “drug moiety” with “drug unit” in Section 9.4 and repeatedly uses
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 15 of 42 PageID #: 7881
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`“drug unit” throughout the specification. The Court finds that the specification equates “drug
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`moiety” to “drug unit,” which is consistent with the plain meaning of the term.
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`Because this resolves the dispute between the parties, the Court finds that no other terms
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`within the disputed phrase requires further construction. See U.S. Surgical Corp. v. Ethicon, Inc.,
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`103 F.3d 1554, 1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed
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`meanings and technical scope, to clarify and when necessary to explain what the patentee covered
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`by the claims, for use in the determination of infringement. It is not an obligatory exercise in
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`redundancy.”); see also O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362
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`(Fed. Cir. 2008) (“[D]istrict courts are not (and should not be) required to construe every limitation
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`present in a patent’s asserted claims.”) (citing U.S. Surgical, 103 F.3d at 1568).
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`The Court hereby construes the phrase “D is a drug moiety” to mean “D is a drug unit.”
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`“Y is a spacer unit”
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`Plaintiff’s
`Proposed Construction
`Plain meaning/no construction is
`necessary.
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`Alternatively: “Y is a unit that links the
`amino acid unit to a drug.”
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`(1) The Parties’ Positions
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`Defendants’
`Proposed Construction
`“one or more atoms that links Ww to a nitrogen
`atom of D, the drug moiety”
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`
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`Plaintiff argues that the term is readily understood and does not need construction. See,
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`e.g., Dkt. No. 121, Plaintiff’s Opening Claim Construction Brief, at 5–7. Plaintiff argues that the
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`term “Y is a Spacer unit” refers to the part of an ADC that links an amino acid unit to a drug unit.
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`Id. at 5. Plaintiff argues that “spacer unit” is a commonly understood term within the field of
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`ADCs and it does not require construction. Id. Plaintiff argues that Defendants’ construction adds
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`limitations that do not appears in the claim and do not comport with the plain meaning of the term.
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 16 of 42 PageID #: 7882
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`Id. Plaintiff argue that Defendants’ construction contradicts the intrinsic evidence. Id. at 6.
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`Plaintiff argues that extrinsic evidence confirms the plain meaning of the term (as proposed by
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`Plaintiff). Id. at 7.
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`
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`Defendants argue that its proposed construction provides a structural limitation to the
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`component in view of the claim language and the specification’s disclosure. See, e.g., Dkt. No.
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`130, Defendants’ Responsive Claim Construction Brief, at 14–17. Defendants argue that their
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`construction is warranted by the disclosures within the specification showing that a spacer unit is
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`linked to a nitrogen atom on the drug unit. Id. at 14. Defendants argue that Plaintiff’s relied upon
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`specification citations are not persuasive. Id. at 15. Defendants argue that Plaintiff’s construction
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`does not limit the structure of the spacer unit in any meaningful way. Id. at 16.
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`
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`In its Reply, Plaintiff argues that the term needs no construction. See, e.g., Dkt. No. 135,
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`Plaintiff’s Reply Claim Construction Brief, at 4–6. Plaintiff argues that Defendants’ arguments
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`fail for the same reason the arguments to the “drug moiety” term fail. Id. at 4. Plaintiff argues
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`that Defendants’ construction excludes embodiments from the specification. Id. at 4-5. Plaintiff
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`also argues that the mere fact the term includes functional language does not automatically convert
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`it into a means-plus-function limitation. Id. at 5.
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`(2) Analysis
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`The parties dispute whether the term has its plain and ordinary meaning. The dispute
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`between the parties is whether the term is limited to an embodiment in the specification, and in
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`particular, whether the spacer unit must connect to a nitrogen atom of D.
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`Claim 1 requires an antibody-drug conjugate (ADC) having the following formula:
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`Case 2:20-cv-00337-JRG Document 155 Filed 09/14/21 Page 17 of 42 PageID #: 7883
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`Claim 1 specifies that “Y is a Spacer unit” and “y is 0, 1, or 2.” Claim 2 specifies that Y
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`is a “self-immolative spacer.” The claims, by themselves, do not specify or require that the spacer
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`unit is linked to a nitrogen atom of D.
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`Section 9.3.3 of the patent specification discusses the “Spacer Unit (Y).” The specification
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`is clear that the spacer unit (Y), when present, “links an Amino Acid unit to the Drug moiety when
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`an Amino Acid unit is present.” ʼ039 Patent, 68:14–16. Alterna