Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 1 of 23 PageID #: 9443
`
`
`
`SEAGEN INC.,
`
`
`
`
`v.
`
`Plaintiff,
`
`
`DAIICHI SANKYO CO., LTD.,
`
`
`Defendant, and
`
`
`
`
`
`CASE NO. 2:20-cv-00337-JRG
`
`
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`ASTRAZENECA PHARMACEUTICALS
`LP and ASTRAZENECA UK LTD.,
`
`
`Intervenor-Defendants.
`
`DAIICHI SANKYO COMPANY, LIMITED’S MOTION FOR SUMMARY
`JUDGMENT OF NO PROVISIONAL RIGHTS OR PRE-ISSUANCE DAMAGES
`
`1
`
`
`
`
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 2 of 23 PageID #: 9444
`
`
`
`
`
`STATEMENT OF ISSUE TO BE DECIDED BY THE COURT
`
`Whether Seagen’s claim amendments during prosecution of the patent-in-suit, U.S. Patent
`
`No. 10,808,039 (the “’039 patent”), altered the claims of the originally published U.S. Patent
`
`Application No. 16/507,839 (the “’839 application”) such that they are not substantially identical
`
`to the asserted claims, and therefore as a matter of law under 35 U.S.C. § 154(d), Seagen is not
`
`entitled to provisional rights and/or patent damages for any activities prior to the October 20, 2020
`
`issuance of the ’039 patent.1
`
`STATEMENT OF UNDISPUTED MATERIAL FACTS
`
`The ’039 patent issued on October 20, 2020.
`
`Claims 1-5, 9, and 10 of the ’039 patent are the only asserted claims in this case.
`
`Claim 1 of the ’039 patent is an independent claim. All other asserted claims
`
`1.
`
`2.
`
`3.
`
`ultimately depend from Claim 1. (Ex. 1 at 331:35-332:66.)2
`
`4.
`
`The ’039 patent issued from the ’839 application, which was filed on July 10, 2019
`
`and published on November 7, 2019. (Ex. 1 at [21], [22], [65]; Ex. 2 at 16.)
`
`5.
`
`The published ’839 application contained 29 patent claims, but in response to the
`
`Patent Examiner’s September 4, 2019 request, on September 26, 2019, Seagen chose to proceed
`
`with only published Claims 1-19. (Ex. 3 at 175-76; Ex. 4 at DSC_ENHERTU_00001534.)
`
`
`1 Plaintiff Seagen Inc. is referred to herein as “Seagen.” Defendant Daiichi Sankyo Company,
`Limited is referred to herein as “Daiichi Sankyo Japan.”
`
`2 “Ex.” refers to the exhibits attached to the January 6, 2022 Declaration of Preston K. Ratliff II
`submitted in support of Daiichi Sankyo Japan’s Motion for Summary Judgment of No
`Provisional Rights or Pre-Issuance Damages.
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 3 of 23 PageID #: 9445
`
`
`
`6.
`
`Claim 1 of the published ’839 application reads:
`
`An antibody-drug conjugate having the formula:
`
`
`
`
`
`or a pharmaceutically acceptable salt thereof, wherein:
`Ab is an antibody,
`S is sulfur,
`each W is independently an Amino Acid unit,
`w is an integer ranging from 0 to 12,
`Y is a Spacer unit,
`y is 0, 1 or 2,
`D is a drug moiety, and
`p ranges from 1 to about 20, and
`wherein the antibody is attached to the drug linker compound through a
`cysteine residue of the antibody as denoted in the above formula.
`
`(Ex. 3 at 175.)
`
`7.
`
`On November 6, 2019, the Patent Examiner rejected published Claims 1-19 as
`
`anticipated and/or obvious over prior art.3 (Ex. 4 at DSC_ENHERTU_00001532, -34-35, -37-40,
`
`-42.)
`
`8.
`
`On May 4, 2020, Seagen filed amendments to the claims and responded to the
`
`November 6, 2019 office action. Seagen’s claim amendments, among other things, (i) changed
`
`the “each W is independently an Amino Acid unit” and “w is an integer ranging from 0 to 12”
`
`claim limitations of published Claim 1 to “each —Ww— unit is a tetrapeptide; wherein each —
`
`W— unit is independently an Amino Acid unit having the formula denoted below in the square
`
`
`3 As published in US. Patent Publication No. 2019/0338045.
`
`- 2 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 4 of 23 PageID #: 9446
`
`
`
`
`
`bracket:
`
` wherein R19 is hydrogen or benzyl”; and (ii) changed the “wherein
`
`the antibody is attached to the drug linker compound through a cysteine residue of the antibody as
`
`denoted in the above formula” claim limitation of published Claim 1 to “wherein S is a sulfur atom
`
`on a cysteine residue of the antibody.” (Ex. 4 at DSC_ENHERTU_00001837-38, -46.)
`
`9.
`
`On May 20, 2020, the Patent Examiner issued another rejection of the application,
`
`finding the amended claims obvious over prior art. (Ex. 4 at DSC_ENHERTU_00001964, -67.)
`
`10.
`
`On June 26, 2020, Seagen filed a response and further amended its patent claims.
`
`The amendments, among other things, introduced to Claim 1 a new limitation “wherein the drug
`
`moiety is intracellularly cleaved in a patient from the antibody of the antibody-drug conjugate or
`
`an intracellular metabolite of the antibody-drug conjugate” (the “Intracellular Cleavage
`
`Limitation”). (Ex. 4 at DSC_ENHERTU_00001994-95, -98.)
`
`11.
`
`In the June 26, 2020 response and claim amendment, in a section of Seagen’s
`
`remarks titled “The Claims are Not Obvious over the Cited References under 35 U.S.C. § 103,”
`
`Seagen argued that “in an antibody-drug conjugate, the antibody, with a drug-linker attached, must
`
`be capable of entering a cell expressing a cell-surface receptor specific for the antibody such that
`
`the drug moiety in the antibody-drug conjugate is intracellularly cleaved (as recited in Claim 1 as
`
`amended).” (Ex. 4 at DSC_ENHERTU_00001999, -2001, -2003 (emphasis added).)
`
`12.
`
`On July 17, 2020, the Patent Examiner issued a Notice of Allowance, allowing the
`
`pending claims (as amended by Seagen multiple times) over the previously-identified prior art “for
`
`the reasons presented
`
`in [Seagen’s] arguments filed June 26, 2020.”
`
` (Ex. 4 at
`
`DSC_ENHERTU_00002011, -17.)
`
`- 3 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 5 of 23 PageID #: 9447
`
`
`
`13.
`
`Claim 1 of the issued ’039 patent reads:
`
`An antibody-drug conjugate having the formula:
`
`
`
`
`
`or a pharmaceutically acceptable salt thereof, wherein:
`Ab is an antibody,
`S is sulfur,
`each —Ww— unit is a tetrapeptide; wherein each —W— unit is
`independently an Amino Acid unit having the formula denoted below
`in the square bracket:
`
`
`
`
`
`wherein R19 is hydrogen or benzyl,
`Y is a Spacer unit,
`y is 0, 1 or 2,
`D is a drug moiety, and
`p ranges from 1 to about 20,
`wherein the S is a sulfur atom on a cysteine residue of the antibody, and
`wherein the drug moiety is intracellularly cleaved in a patient from the
`antibody of the antibody-drug conjugate or an intracellular metabolite
`of the antibody-drug conjugate.
`
`(Ex. 1 at 331:36-332:40.)
`
`- 4 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 6 of 23 PageID #: 9448
`
`
`
`
`
`ARGUMENT
`
`On November 7, 2017, Daiichi Sankyo Japan was granted U.S. Patent No. 9,808,537
`
`covering the Accused Product in this case, DS-8201.4 Further, on December 18, 2018 and
`
`February 5, 2019, respectively, Daiichi Sankyo Japan was granted U.S. Patent Nos. 10,155,821
`
`and 10,195,288 also covering the Accused Product DS-8201.5 On December 20, 2019, the FDA
`
`granted Daiichi Sankyo Japan’s subsidiary, non-party Daiichi Sankyo Inc., approval to sell the
`
`Accused Product in the United States, and Daiichi Sankyo Inc. began selling the Accused Product
`
`in the United States in early January 2020.6 More than nine months after all those pioneering
`
`developments and accomplishments, and more than six-and-half years after Daiichi Sankyo Japan
`
`filed its priority patent application disclosing the Accused Product on October 11, 2012, Seagen
`
`filed its ’839 application on July 10, 2019, which issued as the ’039 patent on October 20, 2020
`
`after multiple claim amendments. This case concerns that single asserted patent.
`
`Seagen’s originally presented claims were repeatedly denied as, among other things,
`
`obvious over prior art, requiring Seagen to make two rounds of claim amendments before the
`
`claims were allowed and issued. Seagen asserts a claim for provisional rights and pre-issuance
`
`damages for the period between publication of the original ’839 application on November 7, 2019
`
`and issuance of the ’039 patent on October 20, 2020. As a matter of law, patentees may only reach
`
`back to allege infringement and seek damages for such pre-issuance periods if the issued patent
`
`claims are “substantially identical” to the claims in the original published patent application.
`
`35 U.S.C. § 154(d). Here, they are not.
`
`
`4 (Ex. 5 at 20:2-13, 21:13-22:8.)
`
`5 (Ex. 5 at 26:20-29:15.)
`
`6 (Ex. 6 at DSC_ENHERTU_00011475.)
`
`- 5 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 7 of 23 PageID #: 9449
`
`
`
`
`
`Between the original published application and the issued patent-in-suit, Seagen made two
`
`rounds of amendments to Claim 1, each of which constitutes a substantive change that renders the
`
`issued claim not substantially identical to the published claim (and, because all of the other asserted
`
`claims depend from Claim 1, they likewise all are not substantially identical to published claims).
`
`In the first round, Seagen amended Claim 1 to narrow a claim limitation that originally required
`
`just “an Amino Acid unit” to now requiring a tetrapeptide with amino acid units of a particular
`
`formula involving glycine or phenylalanine. Also in the first round, Seagen further amended
`
`Claim 1 to specify a single location for the sulfur atom (S), whereas the published application
`
`version of Claim 1 encompassed subject matter with at least two potential locations for that sulfur
`
`atom (S). In the second round, Seagen amended Claim 1 to include the limitation “wherein the
`
`drug moiety is intracellularly cleaved in a patient from the antibody of the antibody-drug conjugate
`
`or an intracellular metabolite of the antibody-drug conjugate” (the Intracellular Cleavage
`
`Limitation). This limited the claimed subject matter in all of the ’039 patent’s claims to one in
`
`which the drug moiety is cleaved intracellularly and in vivo, whereas the published application
`
`version of Claim 1 encompassed subject matter in which the drug moiety could be cleaved, at least
`
`partially, extracellularly.
`
`These were thus narrowing amendments, which independently and collectively render the
`
`issued claims of the ’039 patent (including Claim 1 and all of the other asserted claims, which
`
`depend from Claim 1) not substantially identical to the published claims of the ’839 application.
`
`Accordingly, Daiichi Sankyo Japan requests that the Court grant this Motion and enter summary
`
`judgment that Seagen is not entitled to provisional rights or any pre-issuance damages even if the
`
`patent-in-suit is found to be valid, enforceable, and infringed.
`
`- 6 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 8 of 23 PageID #: 9450
`
`
`I.
`
`
`
`
`LEGAL STANDARDS
`
`Summary Judgment
`
`A.
`
`Summary judgment is appropriate where “the movant shows that there is no genuine
`
`dispute as to any material fact and the movant is entitled to judgment as a matter of law.” FED. R.
`
`CIV. P. 56(a); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Matsushita Elec. Indus.
`
`Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).
`
`The moving party bears the initial burden of identifying the basis for granting summary
`
`judgment and identifying evidence demonstrating the absence of a genuine dispute of material
`
`fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). The party opposing summary judgment
`
`may not rest upon mere allegations and must identify specific evidence in the record that supports
`
`its claim. See Anderson, 477 U.S. at 249-50. Entry of summary judgment is mandated “against a
`
`party who fails to make a showing sufficient to establish the existence of an element essential to
`
`that party’s case, and on which that party will bear the burden of proof at trial.” Celotex, 477 U.S.
`
`at 322-23.
`
`Summary judgment is appropriate where the issue is a question of law and the movant is
`
`entitled to judgment as a matter of law. See Int’l Ass’n of Machinists v. Texas Steel Co., 538 F.2d
`
`1116, 1119 (5th Cir. 1976); see also Rosebud LMS Inc. v. Adobe Sys. Inc., 812 F.3d 1070, 1075-
`
`76 (Fed. Cir. 2016) (affirming district court’s grant of summary judgment on claim for pre-
`
`issuance damages).
`
`Provisional Rights and Pre-Issuance Damages
`
`B.
`
` A
`
` patent owner may obtain a reasonable royalty for infringement during the period from
`
`publication of the patent application to issuance of the patent only if “the invention as claimed in
`
`the patent is substantially identical to the invention as claimed in the published patent application.”
`
`- 7 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 9 of 23 PageID #: 9451
`
`
`35 U.S.C. § 154(d)(1), (2).7 “[C]laims are ‘identical’ to their original counterparts if they are
`
`
`
`‘without substantive change.’” Innovention Toys, LLC v. MGA Entm’t, Inc., 611 F. App’x 693,
`
`699 (Fed. Cir. 2015), vacated, 136 S. Ct. 2483 (2016), remanded to 667 F. App’x 992, 993 (Fed.
`
`Cir. 2016) (reinstating 2015 opinion on provisional right issue) (quoting Laitram Corp. v. NEC
`
`Corp., 163 F.3d 1342, 1346 (Fed. Cir. 1998) (reexamination and reissue contexts) (Laitram II)).
`
`Whether issued patent claims are “substantially identical” to published application claims
`
`is a matter of claim construction and thus an issue of law that is exclusively within the jurisdiction
`
`of the Court to decide. See Laitram II, 163 F.3d at 1347 (explaining “the interpretation and
`
`construction of patent claims, which define the scope of the patentee’s rights under the patent, is a
`
`matter of law, exclusively for the court” (internal quotation marks omitted)); R+L Carriers, Inc.
`
`v. Qualcomm, Inc., 801 F.3d 1346, 1349-50 (Fed. Cir. 2015) (“Because we are reviewing the scope
`
`of the reexamined and original claims, this is a matter of claim construction.”).
`
`“To determine whether a claim change is substantive it is necessary to analyze the claims
`
`of the original [application] and the [issued] patents in light of the particular facts, including the
`
`prior art, the prosecution history, other claims, and any other pertinent information.” Laitram
`
`Corp. v. NEC Corp., 952 F.2d 1357, 1362–63 (Fed. Cir. 1991) (Laitram I). In the context of this
`
`analysis, amendments resulting in the allowance of claims that had been rejected over prior art is
`
`“a highly influential piece of prosecution history.” Laitram II, 163 F.3d at 1348. Indeed, “it is
`
`
`7 Provisional rights and pre-issuance damages also require showing the alleged infringer had
`“actual notice of the published patent application.” 35 U.S.C. § 154(d)(1)(B). This Motion
`relates only to the “substantially identical” prong, as it is both dispositive and a question of law
`well-suited for summary judgment. Although not the subject of this Motion, Daiichi Sankyo
`Japan disputes that it had actual notice of the published patent application and, if it did have
`actual notice, when it obtained such actual notice. Daiichi Sankyo Japan reserves all rights to
`present arguments, evidence, and defenses as to that issue at trial or otherwise during these
`proceedings.
`
`- 8 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 10 of 23 PageID #: 9452
`
`
`difficult to conceive of many situations in which the scope of a rejected claim that became
`
`
`
`allowable when amended is not substantively changed by the amendment.” Id. Thus, in such
`
`circumstances where an amendment renders allowable a claim that had been rejected over prior
`
`art, the courts’ analyses frequently result in a determination that the issued claims are not
`
`“substantially identical” to the published claims. See, e.g., R+L Carriers, 801 F.3d at 1351.8
`
`An analytical framework the Federal Circuit has employed in conducting this analysis is
`
`that an amended claim is narrower (and thus not substantially identical) if “there is any product or
`
`process that would infringe the original claim, but not infringe the amended claim.” R+L Carriers,
`
`801 F.3d at 1350.
`
`II.
`
`THE ASSERTED CLAIMS ARE NOT SUBSTANTIALLY
`IDENTICAL TO THE PUBLISHED CLAIMS, AND SO THERE
`CAN BE NO PROVISIONAL RIGHTS OR PRE-ISSUANCE DAMAGES
`
`The claims recited in the ’839 application were rejected multiple times by the Patent
`
`Examiner as obvious over prior art. (See Statement of Undisputed Material Facts (“UMF”) ¶¶ 7,
`
`9.) Seagen had to amend its claims multiple times before they were allowed and the ’039 patent
`
`issued. (UMF ¶¶ 8, 10-12.) Those amendments substantively changed and, in particular, narrowed
`
`the scope of Seagen’s claims, thus rendering the issued claims not substantially identical to the
`
`
`8 See also, e.g., Capella Photonics, Inc. v. Fujitsu Network Commc’ns, Inc., 2021 WL 2810078,
`at *3 (E.D. Tex. Feb. 27, 2021) (in Report and Recommendation, Magistrate Judge holding “[i]t
`is clear from the narrowing amendment that the Asserted Claims are not substantially identical to
`the Original Claims”); Abbey v. Robert Bosch GMBH, 217 F.3d 853, 1999 WL 819683, at *3
`(Fed. Cir. Oct. 6, 1999) (finding claims not substantially identical where patentee “added
`limitations . . . so that the claim covers only a particular type of” item, and emphasizing the
`patentee “amended the claim in response to a prior art rejection”); Neupak, Inc. v. Ideal Mfg. &
`Sales Corp., 41 F. App’x 435, 444 (Fed. Cir. 2002) (finding claims not substantially identical
`where prosecution history indicated addition of word in amended claim was to distinguish it over
`the prior art); Yoon Ja Kim v. Earthgrains Co., 451 F. App’x 922, 925-26 (Fed. Cir. 2011)
`(finding amendment from “consisting essentially of” to “consisting of” to be a substantive
`change, and asking “Why, if the claims are of identical scope, did [the patentee] amend them?”).
`
`- 9 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 11 of 23 PageID #: 9453
`
`
`published claims. The change is illustrated by the following side-by-side comparison of the
`
`
`
`original published Claim 1 from the ’839 application and the ultimate issued Claim 1 from the
`
`’039 patent (additions are shown in blue, deletions are shown in red, and the three changes are
`
`labeled):
`
`
`
`Published Claim 1
`An antibody-drug conjugate having the
`formula:
`
`Issued Claim 1
`An antibody-drug conjugate having the
`formula:
`
`
`
`or a pharmaceutically acceptable salt
`thereof, wherein:
`Ab is an antibody,
`S is sulfur,
`
`
`each W is independently an Amino
`Acid unit,
`w is an integer ranging from 0 to 12,
`
`
`
`
`
`
`
`or a pharmaceutically acceptable salt
`thereof, wherein:
`Ab is an antibody,
`S is sulfur,
`
`
`each —Ww— unit is a tetrapeptide;
`wherein each —W— unit is
`independently an Amino Acid unit
`having the formula denoted below
`in the square bracket:
`
`
`
`
`
`wherein R19 is hydrogen or
`benzyl,
`w is an integer ranging from 0 to 12,
`
`
`Y is a Spacer unit,
`y is 0, 1 or 2,
`D is a drug moiety, and
`p ranges from 1 to about 20, and
`
`
`Y is a Spacer unit,
`y is 0, 1 or 2,
`D is a drug moiety, and
`p ranges from 1 to about 20, and
`
`
`
`
`- 10 -
`
`
`
` Change 1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 12 of 23 PageID #: 9454
`
`
`
`wherein the antibody is attached to
`the drug linker compound
`through S is a sulfur atom on a
`cysteine residue of the antibody
`as denoted in the above formula.,
`and
`
`
`
`wherein the drug moiety is
`intracellularly cleaved in a patient
`from the antibody of the antibody-
`drug conjugate or an intracellular
`metabolite of the antibody-drug
`conjugate.
`
`wherein the antibody is attached to
`the drug linker compound through
`a cysteine residue of the antibody
`as denoted in the above formula.
`
`
`
`
`
`
`
`
` Change 2
`
`
`
`
`
`
`
`
` Change 3
`
`
`
`
`
`
`
`
`(UMF ¶¶ 6, 13.) Because Claim 1 is an independent claim, and all of the other asserted claims
`
`depend from Claim 1, these changes to Claim 1 flow through to the other asserted claims as well.
`
`A.
`
`Seagen’s Amendment to Claim 1 Narrowing “An
`Amino Acid Unit” to a Tetrapeptide with Amino Acid
`Units of a Particular Formula Was a Substantive Change
`Rendering Issued Claim 1 Not Substantially Identical to the Published Claim
`
`
`Seagen’s amendment changing the language in Claim 1 from stating “each W is
`
`independently an Amino Acid unit” and “w” being an integer ranging from 0 to 12, to language
`
`reciting more specifically that each “Ww” is a tetrapeptide with amino acid units of a particular
`
`formula involving glycine or phenylalanine (“Change 1” in the chart supra) was a substantive
`
`(and narrowing) change.
`
`In the published Claim 1, “W” is defined to be “an Amino Acid unit” without any
`
`specification or limitation on what amino acid(s) that can be, while “w” is an integer ranging from
`
`0 to 12. Seagen’s amendment of that language significantly narrowed that claim limitation,
`
`limiting it to tetrapeptides (i.e., excluding dipeptides, tripeptides, etc.) and further limiting it to
`
`tetrapeptides having amino acids of the particular formula involving glycine or phenylalanine set
`
`forth in the issued Claim 1.
`
`- 11 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 13 of 23 PageID #: 9455
`
`
`
`
`
`Seagen’s amendment limiting the possible amino acids thus narrowed the scope of the
`
`claim to get around prior art, meaning it was a substantive change rendering the issued claim not
`
`substantially identical to the original published claim. See R+L Carriers, 801 F.3d at 1351.
`
`B.
`
`Seagen’s Amendment Adding a Limitation on the
`Location of the Sulfur Atom (S) Was a Substantive Change
`Rendering Issued Claim 1 Not Substantially Identical to the Published Claim
`
`
`Seagen’s amendment changing the language in Claim 1, “wherein the antibody is attached
`
`to the drug linker compound through a cysteine residue of the antibody as denoted in the above
`
`formula,” to “wherein the S is a sulfur atom on a cysteine residue of the antibody,” (“Change 2”
`
`in the chart supra) was another substantive (and narrowing) change.
`
`The specifications accompanying the ’839 application indicate that the original published
`
`language encompassed two different structures: (i) a structure where the sulfur atom (S) is a part
`
`of the drug linker compound and the antibody is attached to S through a cysteine residue (i.e., an
`
`S-S structure), (see Ex. 3 at [0568], [0677], [0733]-[0734]); and (ii) a structure where S is just part
`
`of the antibody (i.e., S refers to the sulfur atom of the antibody’s cysteine residue), (see id. at
`
`[0694]). In other words, based on the language of the published claim and the specifications, the
`
`“S” in the formula could either be part of the drug linker or part of the antibody’s cysteine residue.
`
`When Seagen amended and narrowed the language to specify “the S is a sulfur atom on a cysteine
`
`residue of the antibody,” it ruled out the first of those structures and limited the claim to the second
`
`structure.
`
`Seagen’s amendment specifying the location of the sulfur atom “S” thus narrowed the
`
`scope of the claim to get around prior art, meaning it was a substantive change rendering the issued
`
`claim not substantially identical to the original published claim. This is another independent basis
`
`supporting a summary judgment that Seagen cannot seek provisional rights or pre-issuance
`
`- 12 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 14 of 23 PageID #: 9456
`
`
`damages. See R+L Carriers, 801 F.3d at 1351.
`
`
`
`C.
`
`Seagen’s Amendment Adding the Intracellular Cleavage
`Limitation to Claim 1 Was a Substantive Change Rendering
`Issued Claim 1 Not Substantially Identical to the Published Claims
`
`
`The addition of the Intracellular Cleavage Limitation to Claim 1 (“Change 3” in the chart
`
`supra) was yet another substantive (and narrowing) change. In particular, the inclusion of that
`
`additional limitation introduced requirements that were not previously present in the published
`
`application claim; namely, that the cleavage of the drug moiety occur within cells (i.e.,
`
`intracellularly) and that it also occur within a patient (i.e., in vivo). The amendment was thus
`
`narrowing and so constitutes a substantive change.
`
`Notably, the amendment adding the Intracellular Cleavage Limitation to Claim 1 was not
`
`“a mere clarification of language to make specific what was always implicit or inherent” for an
`
`antibody-drug conjugate. Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 828
`
`(Fed. Cir. 1984). The original (dependent) Claim 14 and specification [0272] stated that “a
`
`substantial amount of the drug moiety is not cleaved from the antibody until the antibody-drug
`
`conjugate compound enters a cell with a cell-surface receptor specific for the antibody of the
`
`antibody-drug conjugate, and the drug moiety is cleaved from the antibody when the antibody-
`
`drug conjugate does enter the cell.” (Ex. 3 at [0272], 175.) That does not include any limitation
`
`that the cleavage occurs in cells within a patient. Moreover, the statement in that published
`
`dependent Claim 14 that “a substantial amount,” rather than “all,” of the drug moiety “is not
`
`cleaved from the antibody until the antibody-drug conjugate compound enters a cell” means that
`
`published dependent Claim 14 (and the published independent Claim 1 from which it depends)
`
`contemplated and encompassed some cleavage occurring extracellularly. The issued Claim 1
`
`including the Intracellular Cleavage limitation forecloses any such extracellular and non-in vivo
`
`- 13 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 15 of 23 PageID #: 9457
`
`
`cleavage, and so it was a narrowing amendment and thus a substantive change rendering the
`
`
`
`original Claim 1 not substantially identical to the issued Claim 1.
`
`Indeed, Seagen emphasized this intracellular cleavage point in its arguments to get past the
`
`prior art (which formed the basis for the Examiner allowing the second amended claims to issue).
`
`In responding to the Examiner’s Second Rejection, Seagen argued: “in an antibody-drug
`
`conjugate, the antibody, with a drug-linker attached, must be capable of entering a cell expressing
`
`a cell-surface receptor specific for the antibody such that the drug moiety in the antibody-drug
`
`conjugate is intracellularly cleaved (as recited in Claim 1 as amended).” (UMF ¶¶ 10-12.)
`
`Seagen thus made a narrowing amendment to get around the prior art when it added the
`
`Intracellular Cleavage Limitation, and the Patent Examiner agreed and allowed the claims to issue
`
`as a result of that amendment. Seagen cannot seek provisional rights or pre-issuance damages
`
`under these circumstances. See R+L Carriers, 801 F.3d at 1351.
`
`D.
`
`The Opinion of Seagen’s Expert Witness Does Not
`Compel a Contrary Conclusion or Defeat Summary Judgment
`
`
`Whether the issued claims are substantially identical to the published claims is a matter of
`
`claim construction and a question of law that is exclusively within the purview of the Court (not a
`
`jury) to decide. See Laitram II, 163 F.3d at 1347; R+L Carriers, 801 F.3d at 1349-50. Seagen’s
`
`expert witness, Carolyn Bertozzi, Ph.D., opined in her November 22, 2021 corrected expert report
`
`that the issued claims of the patent-in-suit are substantially identical to the claims of the ’839
`
`application. (See Ex. 7 ¶¶ 169-174.) Dr. Bertozzi’s opinion on this legal issue, however, does not
`
`create any basis for denying summary judgment or deferring the issue to trial. This is because Dr.
`
`Bertozzi should be given no deference on this question of law and claim construction.
`
`Further, Dr. Bertozzi’s analysis actually confirms that the issued claims are not
`
`substantially identical to the published claims.
`
`
`
`- 14 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 16 of 23 PageID #: 9458
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` See, e.g., Versa Corp.
`
`v. Ag-Bag Int’l Ltd., 392 F.3d 1325, 1329-30 (Fed. Cir. 2004) (doctrine of claim differentiation
`
`creates “a presumption that each claim in a patent has a different scope” (internal quotation marks
`
`omitted)); Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (“[T]he presence of a
`
`dependent claim that adds a particular limitation gives rise to a presumption that the limitation in
`
`question is not present in the independent claim.”); Koninklijke KPN N.V. v. Samsung Elecs. Co.,
`
`Nos. 2:14-CV-1165-JRG, 2:15-CV-948-JRG, 2016 WL 2610649, at *20-22, 24 (E.D. Tex. May
`
`6, 2016) (applying claim differentiation principle in construing claims); Biosonix, LLC v.
`
`Hydrowave, LLC, 230 F. Supp. 3d 598, 607-09 (E.D. Tex. 2017) (explaining “claim differentiation
`
`teaches that two claims of a patent are presumptively of different scope” and that the principle is
`
`at its strongest between independent and dependent claims). So, importing a portion of one
`
`dependent claim into an independent claim means adding something substantively different, and
`
`thus making a substantive change, to the independent claim.
`
`Dr. Bertozzi’s opinion is further incorrect and fails to defeat summary judgment for
`
`
`9 Published Claim 2 included only the limitation requiring amino acids with a specific formula
`involving glycine or phenylalanine, published Claim 5 included only the limitation requiring a
`tetrapeptide, and published Claim 17 included only the Intracellular Cleavage Limitation. (Ex. 3
`at 175.)
`
`- 15 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 17 of 23 PageID #: 9459
`
`
`multiple reasons.
`
`
`
`First, the importation of narrowing limitations previously relegated to separate individual
`
`dependent claims into the sole independent claim constitutes a substantive change, even if the
`
`literal language of those limitations is not significantly altered in so importing. For example, the
`
`Intracellular Cleavage Limitation, see Section II.C, supra, was confined to dependent Claim 17 in
`
`the ’839 application. That published dependent Claim 17 depended only from published Claim 1,
`
`and no other published claims depended from Claim 17. (Ex. 3 at 175.) So, published Claim 1
`
`was broader than Claim 17’s limitations, and the Intracellular Cleavage Limitation only applied to
`
`a single, dependent claim (published Claim 17). By contrast, in the issued ’039 patent, the
`
`Intracellular Cleavage Limitation is incorporated in the sole independent claim, Claim 1, thus
`
`limiting Claim 1 and all other claims of the patent.
`
`It is illustrative to apply the framework enunciated in R+L Carriers, that an amendment is
`
`narrowing if something would have infringed the published claim but not the issued claim. 801
`
`F.3d at 1350. Here, if an antibody-drug conjugate met all of the claim elements of published Claim
`
`1 but did not include the aspect that the drug moiety is intracellularly cleaved in a patient from the
`
`antibody of the antibody-drug conjugate (or an intracellular metabolite thereof), then that drug
`
`would infringe published Claim 1 but not issued Claim 1.10 That confirms that issued Claim 1
`
`(and the other asserted claims, which all depend from Claim 1) is narrower than, and thus not
`
`substantially identical to, the published claims.
`
`Second, the amendment limiting S to being on the antibody’s cysteine residue (i.e., the
`
`
`10 Likewise, if an antibody-drug conjugate met all of the claim limitations of published Claim 17
`but did not include a tetrapetride with amino acid units of the specific formula set forth in issued
`Claim 1, then that antibody-drug conjugate would infringe published Claim 17 but not issued
`Claim 1.
`
`- 16 -
`
`

`

`Case 2:20-cv-00337-JRG Document 260 Filed 01/14/22 Page 18 of 23 PageID #: 9460
`
`
`amendment changing “wherein the antibody is attached to the drug linker compound through a
`
`
`
`cysteine residue of the antibody as denoted in the above formula,” to “wherein the S is a sulfur
`
`atom on a cysteine residue of the antibody,” labeled “Change 2” in the chart supra, see Section
`
`II.B, supra), did not come from published Claims 2, 5, 17, or any of the other published claims.
`
`(See Ex. 3 at 175.) Thus, even if Dr. Bertozzi’s opini