`
`SEAGEN INC.,
`
`
`
`
`v.
`
`Plaintiff,
`
`
`DAIICHI SANKYO CO., LTD.,
`
`
`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`
`CASE NO. 2:20-cv-00337-JRG
`
`
`
`
`
`Defendant, and
`
`
`ASTRAZENECA
`PHARMACEUTICALS LP and
`ASTRAZENECA UK LTD.,
`
`
`Intervenor-Defendants.
`
`
`
`DEFENDANTS’ REPLY IN SUPPORT OF THEIR MOTION FOR JUDGMENT
`OF INVALIDITY BASED ON SEAGEN’S POST-TRIAL DISCLAIMER
`AND FOR DISMISSAL OF INFRINGEMENT CLAIMS AS MOOT
`
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 2 of 14 PageID #: 20992
`
`
`
`Nothing Seagen writes in its Opposition changes the fact that Seagen voluntarily
`
`disclaimed its patent rights to glycine and/or phenylalanine-only (“G/F-only”) tetrapeptide ADCs
`
`“wherein the drug moiety is intracellularly cleaved in a patient from an intracellular metabolite of
`
`the antibody-drug conjugate.” (DX-0001 at Claim 8.) This patent right was literally recited in,
`
`and part of, all claims tried to the jury. (See DX-0001 at Claims 1-5, 9, 10.)
`
`Seagen asks this Court to treat the disclaimer statute, 35 U.S.C. § 253(a), as an empty
`
`formalism. Seagen maintains that when it disclaimed these patent rights, it surrendered only the
`
`verbal recitation of that right appearing at Column 332:59-62 (Claim 8), but that it maintains
`
`exclusive rights in the exact same subject matter stated in the exact same words at Columns
`
`331:36-332:48 (Claims 1-5). (See Ex. 1 (annotation of patent claims).) That is a nonsensical
`
`position. Courts before and after the 1952 Patent Act have uniformly held that by disclaimer a
`
`patentee relinquishes the right to exclude others from the claim’s subject matter, and the public is
`
`free to practice the subject matter in question as if it were never part of the patent. By operation
`
`of Seagen’s disclaimer, and independently by the adverse judgment it secured from the Patent Trial
`
`and Appeal Board (“PTAB”), all Asserted Claims are invalid. And because Seagen no longer has
`
`standing or a cause of action for infringement, this case should be dismissed as moot.
`
`A reissue proceeding (which would permit Seagen to amend its non-disclaimed claims) is
`
`the only vehicle for salvaging potentially patentable subject matter. Alternatively, even if any
`
`Asserted Claims survive, they can only be construed to cover the subject matter not disclaimed
`
`(i.e., G/F-only tetrapeptide ADCs where the drug moiety is intracellularly cleaved from the
`
`antibody itself). Because it cannot be credibly argued that Enhertu®’s drug moiety is intracellularly
`
`cleaved from the antibody of the ADC, judgment is warranted in Defendants favor as a result of
`
`Seagen’s voluntary disclaimer. (See Dkt. 442 (“Mot.”), Ex. A at ¶ 40.)
`
`- 1 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 3 of 14 PageID #: 20993
`
`
`
`A.
`
`Seagen’s Procedural Challenge Is Flawed
`
`Defendants’ motion is procedurally proper. A party can bring a motion to raise defenses
`
`arising from external events arising pendente lite whether or not expressly anticipated in the Rules.
`
`See, e.g., Brooks v. District of Columbia, 841 F. Supp. 2d 253 (D.D.C. 2012) (motion for mootness
`
`after summary judgment when student graduated from school); Mendenhall v. Barber-Greene Co.,
`
`26 F.3d 1573, 1577-78 (Fed. Cir. 1994) (reversing the district court for denying a motion to vacate
`
`judgment on collateral estoppel grounds). Further, this Court assures its subject-matter
`
`jurisdiction, even sua sponte, and can dismiss the case “at any time” it finds jurisdiction lacking.
`
`Fed. R. Civ. P. 12(h)(3); Arena v. Graybar Elec. Co., Inc., 669 F.3d 214, 223 (5th Cir. 2012).
`
`When a party loses rights in the asserted claims, the party lacks standing and the cause of action is
`
`extinguished; the case must be dismissed as moot absent a final and unappealable judgment. (Mot.
`
`at 13-14); TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2208 (2021) (standing must be established
`
`for each claim and throughout the litigation). In any event, this Motion requesting the Court to
`
`alter or amend its judgment to enter instead a judgment in favor of Defendants, and dismiss the
`
`action as moot, fits within both Federal Rules of Civil Procedure 59(e) and 12(b)(1).
`
`B.
`
`Seagen’s Disclaimer Surrendered to the Public Its Right
`to Exclude Others From Practicing the Claimed ADCs
`
`As this Court has declared, “[a] patentee’s statutory disclaimer ‘relinquishes the rights of
`
`the patent owner’ and cancels the claims subject to the disclaimer.” Lemaire Illumination Techs.,
`
`LLC v. HTC Corp., No. 2:18-CV-00021-JRG, 2019 WL 1489065, at *2 (E.D. Tex. Apr. 4, 2019)
`
`(quoting Rembrandt Wireless Techs., LP v. Samsung Elecs. Co., 853 F.3d 1370, 1383 (Fed. Cir.
`
`2017)) (emphasis added). “[B]y filing a statutory disclaimer, [the patentee] relinquished any right
`
`to exclude others from the subject matter of [the claim],” and “the public [i]s entitled to
`
`manufacture and use the device originally claimed as freely as though it had been abandoned.”
`
`- 2 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 4 of 14 PageID #: 20994
`
`
`
`Guinn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir. 1996) (emphasis added) (quoting Altoona Publix
`
`Theatres, Inc. v. American Tri–Ergon Corp., 294 U.S. 477, 492 (1935)). Thus, by disclaiming
`
`Claim 8, Seagen has relinquished rights to the recited ADCs of Claims 1-5 “wherein the drug
`
`moiety is intracellularly cleaved in a patient from an intracellular metabolite of the antibody drug
`
`conjugate.” (DX-0001 at 332:60-62.) Because that exact language is present in Claim 1 (and
`
`incorporated in Claims 2-5 and 9-10), and none of the Asserted Claims are patentably distinct,
`
`disclaimer renders those claims invalid. (Mot. at 5-11, 15-27.) Seagen cannot give with one hand
`
`and take away with the other. The public is not free to practice the ADCs recited in Claim 8 if
`
`Seagen can exclude the public from the same ADCs via the Asserted Claims.
`
`Seagen’s counterarguments proceed by misdirection, marshaling precedents that do not
`
`support its position. Seagen quotes Magdo v. Kooi, 699 F.2d 1325, 1329 (Fed. Cir. 1983), for the
`
`proposition that “disclaimer extends only to the particular claims involved and does not affect any
`
`other claims.” (Dkt. 465 (“Opp.”) at 5.) But Magdo directly rejects Seagen’s formalistic approach.
`
`The quoted clause is an express paraphrase of the rule of Hartford-Empire Co. v. Hazel-Atlas Glass
`
`Co., 59 F.2d 399 (3d Cir. 1932), vacated on other grounds, 322 U.S. 238 (1944), that a disclaimer
`
`“must be restricted to the particular matter of the claim relinquished.” Id. at 412-13 (emphasis
`
`added). Hartford-Empire held that each relinquished claim “was drawn to fit and disclose some
`
`structure other than and functionally different from the structure of the [current] patent,” and none
`
`“was directed to the combination or method of the patent in suit.” Id. Thus, Magdo embraces the
`
`inquiry that Seagen seeks to avoid: namely, whether the disclaimer addresses the same subject
`
`matter as the claims at issue. Here, by disclaiming G/F-only tetrapeptide ADCs “wherein the drug
`
`moiety is intracellularly cleaved in a patient from an intracellular metabolite of the antibody-drug
`
`conjugate,” Seagen has also surrendered to the public the exact same subject matter that is
`
`- 3 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 5 of 14 PageID #: 20995
`
`
`
`expressly claimed in Claim 1.
`
`Seagen also quotes Jones v. Hardy, 727 F.2d 1524, 1528 (Fed. Cir. 1984), for the
`
`proposition that “each claim must be considered as defining a separate invention.” (Opp. at 5.)
`
`But while each claim is a separate “formal definition of the invention,” Corning Glass Works v.
`
`Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1258 (Fed. Cir. 1989), that does not mean the subject
`
`matter of each claim is patentably distinct. The well-settled law of claiming, both before and after
`
`the 1952 Patent Act, permits the inventor to “express the same invention in more than one claim”
`
`so long as he avoids “undue multiplicity.” Application of Barnett, 155 F.2d 540, 545-46 (CCPA
`
`1946) (emphasis added) (quoting In re Clark, 97 F.2d 628, 631 (CCPA 1938)); Application of
`
`Chandler, 319 F.2d 211, 225 (CCPA 1963). But the function of claims is “particularly pointing
`
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`
`invention.” 35 U.S.C. § 112(b) (emphasis added). If a patentee disclaims certain subject matter,
`
`the patentee is giving up its exclusionary right to the subject matter, no matter how many claims
`
`recite it.1
`
`
`
`Seagen correctly observes that disclaimer “leaves the patent ‘as if the disclaimed claims
`
`had never existed.’” (Opp. at 5 (quoting Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Lab’ys, Inc., 933
`
`F.3d 1367, 1373 (Fed. Cir. 2019)).) The statutory retroactivity provision that the disclaimer “shall
`
`thereafter be considered as part of the original patent,” 35 U.S.C. § 253(a), prevents the patentee
`
`from recovering for pre-disclaimer infringement. But what is disclaimed ab initio is the subject
`
`matter claimed as the invention; Seagen has no right to exclude others from disclaimed subject
`
`matter (here, the G/F-only tetrapeptide ADCs recited in Claims 1-5 where the drug moiety is
`
`
`1 Seagen relies on the presumption of validity of each claim under 35 U.S.C. § 282, (Opp. at 5),
`but that presumption is overcome if the other claims are not patentably distinct. MaxLinear, Inc.
`v. CF CRESPE LLC, 880 F.3d 1373, 1377 (Fed. Cir. 2018).
`
`- 4 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 6 of 14 PageID #: 20996
`
`
`
`intracellularly cleaved from an ADC metabolite). See Guinn, 96 F.3d at 1422 (applying
`
`retroactivity rule to find that disclaimer relinquished the patentee’s exclusive rights).
`
`Seagen also incorrectly contends that the 1952 Patent Act vitiated the prior Supreme Court
`
`disclaimer precedents that are fatal to its position. As the Federal Circuit has observed, the 1952
`
`Patent Act changed disclaimer law in two respects: (1) it altered the object of the disclaimer, which
`
`must be a “complete claim,” 35 U.S.C. § 253(a), rather than “such parts of the thing patented as
`
`he should not choose to claim,” 35 U.S.C. § 65 (1946), and (2) in new 35 U.S.C. § 288 it abolished
`
`the rule that a patentee could not sue on otherwise valid parts of the patent “if he has unreasonably
`
`neglected or delayed to enter a disclaimer” of that to which he was not entitled, 35 U.S.C. § 71
`
`(1946) (Mot., Ex. C). See Allen Archery, Inc. v. Browning Mfg. Co., 819 F.2d 1087, 1096-97 (Fed.
`
`Cir. 1987). But nothing in the 1952 Patent Act altered the nature and effect of disclaimer as
`
`established in Supreme Court precedent. Thus, in concluding that a disclaimer under Section
`
`253(a) “relinquished any right to exclude others from the subject matter of [the claim],” the Federal
`
`Circuit in 1996 relied on the Supreme Court’s 1935 Altoona decision that upon disclaimer “the
`
`public was entitled to manufacture and use the device originally claimed as freely as though it had
`
`been abandoned.” Guinn, 96 F.3d at 1422 (quoting Altoona, 294 U.S. at 492). The Federal Circuit
`
`does not agree with Seagen that Altoona is defunct (see Opp. at 7). For the same reasons, the
`
`Supreme Court’s decision in Maytag Co. v. Hurley Mach. Co., 307 U.S. 243 (1939), is still binding
`
`precedent on the question presented (whether disclaimer relinquishes rights in the claimed subject
`
`matter, even if stated in a different claim). (Mot. at 7-9.)2
`
`
`2 Seagen misreads Maytag. (Opp. at 5-7.) The Maytag patentee disclaimed complete claims
`(Claims 1 and 38), see id. at 245, and that disclaimer would have been effective under current
`section 253(a). By disclaiming Claim 38, the patentee held no invention “in the method disclosed
`therein” (i.e., Claim 38’s subject matter). Id. at 245. Because Claims 38 and 39 “describe the
`
`- 5 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 7 of 14 PageID #: 20997
`
`
`
`Even apart from the precedential force of Maytag, Seagen cannot escape the fundamental
`
`principle that disclaimer necessarily “relinquishe[s] any right to exclude others from the subject
`
`matter of [the] claim[s],” Guinn, 96 F.3d at 1422, and thus the “subject matter which the
`
`inventor . . . regards as the invention,” 35 U.S.C. § 112(b). The universal rule is that when a
`
`particular claim is disclaimed and thereby surrendered to the public, patentably indistinct claims
`
`likewise fall. (Mot. at 10-11.) Seagen urges that its disclaimer is different from the nonstatutory
`
`double patenting doctrine that expiration of a patent extinguishes patently indistinct claims of other
`
`patents because otherwise the patentee would have “an unjustified termwise extension of those
`
`exclusive rights.” (Opp. at 21 (internal quotation marks omitted).) But that doctrine proves
`
`Defendants’ point. What matters is that the claimed subject matter of a claim has entered the
`
`public domain, even if the term for another claim has not expired. Whether the claimed invention
`
`enters the public domain through expiration of a different patent or disclaimer of a different claim,
`
`patently indistinct claims cannot survive.3
`
`C.
`
`The PTAB Adverse Judgment Extinguishes the Asserted Claims
`
`While disclaimer alone cancels a claim, Guinn, 96 F.3d at 1422, the PTAB’s adverse
`
`
`same method,” the Court held that, by the disclaimer of Claim 38, the patentee also had no rights
`to the method of Claim 39. Maytag, 307 U.S. at 246-47. The Court applied then-Section 71’s
`provision that an infringement action cannot be brought if the patentee has “unreasonably
`neglected or delayed to enter a disclaimer” of parts of the patent claimed without right, 35 U.S.C.
`§ 71 (1946), and held that “the patent is void for failure to disclaim claim 39.” Maytag, 307 U.S.
`at 244, 246. Only that latter holding of Maytag is no longer good law given the abrogation of
`former Section 71; “[t]he failure of a patentee to disclaim an invalid patent claim does not prevent
`the patentee from enforcing any remaining claims in the same patent which are otherwise valid.”
`Allen Archery, 819 F.2d at 1097. But Allen Archery recognized that a patent claim is “invalid” if
`its subject matter has been previously disclaimed.
`
`3 Contrary to Seagen’s suggestion, Opp. at 8, LeMaire did not address the effect of disclaimer on
`patentably indistinct claims, but simply dismissed claims for infringement of the disclaimed claims
`as moot. 2019 WL 1489065 at *3.
`
`- 6 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 8 of 14 PageID #: 20998
`
`
`
`judgment cancelling Claim 8 independently extinguishes patentably indistinct claims, and requires
`
`dismissal of this action as moot. (Mot. at 12-15.) It does so in three ways.
`
`First, Seagen is estopped from pursuing the Asserted Claims pursuant to 37 C.F.R.
`
`§ 42.73(d)(3). Seagen incorrectly argues that the PTO did not have authority to (and did not)
`
`extend estoppel to district court actions. (Opp. at 9-10.) The PTO promulgated this regulation
`
`under the authority of 35 U.S.C. §§ 316(a)(4) (IPRs) and 326(a)(4) (PGRs). See 77 Fed. Reg.
`
`48611, 48625 (Aug. 14, 2012). Section 326(a)(4) provides that the Director has the power to
`
`promulgate regulations “establishing and governing a post-grant review under this chapter and the
`
`relationship of such review to other proceedings under this title.” 35 U.S.C. § 326(a)(4)
`
`(emphasis added). Proceedings under Title 35 include actions for patent infringement under 35
`
`U.S.C. § 281. Congress thus broadly authorized the PTO to prescribe the effects of post-grant
`
`review on both Office and judicial proceedings under Title 35, within constitutional limits.4
`
`Notably, in 42.73(d)(3), unlike 42.73(d)(1) and (d)(2), the PTO did not limit the estoppel
`
`effect of a judgment to proceedings in “the Office”; instead, without limitation, it prohibited the
`
`patent owner categorically from “taking action inconsistent with the adverse judgment,” including,
`
`as one example, obtaining a patent on patentably indistinct inventions.
`
` 37 C.F.R.
`
`§ 42.73(d)(1)-(3). Section 42.73(d)(3) also stands in stark contrast to the regulation governing
`
`judgments in other types of contested cases, where the PTO specifically provided that after
`
`judgment a losing party “may not take action in the Office after the judgment that is inconsistent
`
`with that party's failure to move” for relief on an issue. Id. § 41.127 (emphasis added); § 41.1
`
`(limiting § 41.127 to appeals and interferences). The PTO consciously chose not to restrict Rule
`
`
`4 Seagen mischaracterizes Apple Inc. v. Softview LLC, No. 2021-005530, 2022 WL 1210851
`(P.T.A.B. Apr. 6, 2022), as holding that Rule 42.73(d)(3) does not apply to infringement actions,
`Opp. at 10; the Board instead merely observed that the point was not disputed. Id. at *17 n.7.
`
`- 7 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 9 of 14 PageID #: 20999
`
`
`
`42.73(d)(3) estoppel to actions in the Office. Seagen’s infringement suit is an action to enforce
`
`claims that are patentably indistinct from those against which adverse judgment was entered.
`
`Suing on these claims is just as “inconsistent” with the adverse judgment as obtaining them would
`
`have been. 37 C.F.R. § 42.73(d)(3). Seagen does not contest patentable distinction except with
`
`regard to issue preclusion (addressed below), and thus Defendants are entitled to judgment based
`
`on regulatory estoppel.
`
`Second, Seagen’s suit is barred by claim preclusion. Contrary to Seagen’s arguments, Opp.
`
`at 12 n.2, Defendants have asserted the claim preclusive effect of the PTAB judgment. (Mot.
`
`at 13.) An adverse judgment based on disclaimer is a merits judgment that the claimed subject
`
`matter has been surrendered to the public, and that judgment is preclusive of patentably indistinct
`
`claims. See Simple Air, Inc. v. Google LLC, 884 F.3d 1160, 1167 (Fed. Cir. 2018); Regents of the
`
`Univ. of Minn. v. LSI Corp., 926 F.3d 1327, 1345 n.5 (Fed. Cir. 2019) (concurrence of Dyk,
`
`Wallach, and Hughes). Contrary to Seagen’s assertion, there is no need to prove a common cause
`
`of action as one must with in personam judgments. A PGR (like an IPR) is an in rem proceeding,
`
`see id. at 1344-46, and an in rem judgment binds all persons who claim an interest in the property.
`
`Restatement (Second) of Judgments § 30 (1982). Because the PTAB judgment extinguishes
`
`Seagen’s rights in the Asserted Claims, Seagen is barred from pursuing an infringement action.
`
`Third, issue preclusion also warrants judgment in favor of Defendants. The PTAB’s
`
`institution decision on priority was actually decided and necessary to the judgment because it
`
`established the patent’s eligibility for post-grant review. (Mot. at 15.) Seagen’s reliance on
`
`Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345 (Fed. Cir. 2018), is misplaced; Arthrex held
`
`that the PTO regulations authorize the PTAB to enter adverse judgment prior to an institution
`
`decision, id. at 1350, but did not (and could not) hold that the PTAB could enter adverse judgment
`
`- 8 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 10 of 14 PageID #: 21000
`
`
`
`on a patent ineligible for PGR review. More broadly, Seagen requested an adverse judgment, that
`
`judgment was granted, and that judgment “disposes of all issues that were, or by motion reasonably
`
`could have been, raised and decided,” 37 C.F.R. § 42.73(a). That judgment has preclusive force.
`
`See Yachts America, Inc. v. United States, 673 F.2d 356, 361 (Ct. Cl. 1982) (enforcing
`
`issue-preclusive consent decree).
`
`Finally, Seagen contends that issue preclusion’s inquiry into whether “the differences
`
`between the unadjudicated patent claims and adjudicated patent claims . . . materially alter the
`
`question of invalidity,” Ohio Willow Wood Co. v. Alps S., LLC, 735 F.3d 1333, 1342 (Fed. Cir.
`
`2013), does not involve traditional patentable-distinction analysis. (Opp. at 15-16.) That legal
`
`contention is flawed, Mot. at 15-16, but also does not save Seagen’s claims. Seagen points to
`
`Defendants’ enablement and written-description analysis, Opp. at 16-19, but whether the
`
`specification describes and enables a claim has nothing to do with the required comparison of the
`
`claims for patentable distinction. Seagen does not (and cannot) compare the Asserted Claims with
`
`Claim 8 to show any material alteration of the question of invalidity.5
`
`D.
`
`Seagen Cannot Enforce Exclusive Rights That It Has Disclaimed
`
`Regardless of whether Claims 1-5 and 9-10 are deemed patentably distinct, they are
`
`
`5 (See Mot. at 15-27.) Because the Claim 8 ADCs are deemed to be in the public domain from the
`inception of the patent, 35 U.S.C. § 253(a), there is no basis for claiming that the Asserted Claims
`are separately patentable. If a narrower claim is invalid, so too are broader ones. Ormco Corp. v.
`Align Tech., Inc., 498 F.3d 1307, 1319 (Fed. Cir. 2007). Moreover, Claims 1-5 are broader only
`in that they optionally claim ADCs with intracellular cleavage from the antibody, and invalidity
`does not require satisfaction of optional limitations. Unwired Planet, LLC v. Google Inc., 841 F.3d
`995, 1002 (Fed. Cir. 2016). Claims 9 and 10 are narrower than Claim 8 only in that they restrict
`the ADCs to monoclonal or humanized monoclonal antibodies. But the disclaimer of Claim 8
`encompasses all recited ADCS with monoclonal antibodies, and so there is nothing independently
`patentable in Claims 9 and 10 post-disclaimer based on the antibody limitation. Regardless, Claim
`8 anticipates Claims 9 and 10, and Dr. Lambert attested without refutation that it would be obvious
`from the prior art to use monoclonal and specifically humanized monoclonal antibodies in
`composing the recited ADCs. (Mot. at 18-27.)
`
`- 9 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 11 of 14 PageID #: 21001
`
`
`
`defective for another reason: they all expressly recite the disclaimed subject matter of Claim 8 as
`
`alternative limitations: namely, the same ADCs “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.” (DX-0001 at Claim 1) (emphasis added).) Reissue
`
`is the sole remedy to address the defect of these claims. (Mot. at 27-29.)
`
`
`
`Seagen argues that Soundscriber Corp. v. United States, 360 F.2d 954 (Ct. Cl. 1966) (per
`
`curiam), is to the contrary, but Soundscriber did not address independent claims that expressly
`
`recite the disclaimed subject matter (and can only potentially be remedied through reissue). See
`
`id. at 960-61; (U.S. Patent No. 2,750,449 (Claims 6, 10).) Regardless, Soundscriber is fatal to
`
`Seagen’s position; it provides that “[t]he construction of a patent, after a disclaimer has been
`
`properly entered, must be the same that it would have been if the matter so disclaimed had never
`
`been claimed,” citing Dunbar v. Myers, 94 U.S. 187, 194 (1876). 360 F.2d at 961 (emphasis
`
`added). Dunbar holds that disclaimers “limit and qualify the claims of the patent,” and “[m]atters
`
`properly disclaimed cease to be a part of the invention; and it follows that the construction of the
`
`patent must be the same as it would be if such matters had never been included in the description
`
`of the invention or the claims of the specification.” 94 U.S. at 193-94 (emphasis added). Thus, at
`
`best, the Asserted Claims must be construed as limited to G/F-only tetrapeptide ADCs “wherein
`
`the drug moiety is intracellularly cleaved in a patient from the antibody of the antibody-drug
`
`conjugate . . . .” (DX-0001 at Claim 1.) The jury was not so instructed, and, because it is
`
`undisputed that Enhertu® does not meet that limitation, judgment should be granted to Defendants
`
`under that construction. (Dkt. 446 at 6-8.)
`
`CONCLUSION
`
`Seagen’s tactical decision to disclaim its patent rights voluntarily to avoid review at the
`
`PTAB is fatal to it maintaining this infringement action. Defendants’ motion should be granted.
`
`- 10 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 12 of 14 PageID #: 21002
`
`Dated: October 6, 2022
`
`
`
`
`
`By: /s/ Preston K. Ratliff II
`
`Deron R. Dacus
`State Bar No. 00790553
`THE DACUS FIRM, P.C.
`821 ESE Loop 323, Suite 430
`Tyler, Texas 75701
`Telephone: 903.705.1117
`Facsimile: 903.581.2543
`
`J. Mark Mann
`State Bar No. 12926150
`mark@themannfirm.com
`G. Blake Thompson
`State Bar No. 24042033
`Blake@themannfirm.com
`MANN | TINDEL | THOMPSON
`300 West Main Street
`Henderson, Texas 75652
`Telephone: 903.657.8540
`Facsimile: 903.657.6003
`
`Of Counsel:
`
`Preston K. Ratliff II
`prestonratliff@paulhastings.com
`Ashley N. Mays-Williams
`ashleymayswilliams@paulhastings.com
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, New York 10166
`Telephone: 212.318.6000
`
`Jeffrey A. Pade
`jeffpade@paulhastings.com
`PAUL HASTINGS LLP
`2050 M Street NW
`Washington, DC 20036
`Telephone: 202.551.1700
`
`Attorneys for Defendant Daiichi Sankyo
`Company, Limited
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`- 11 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 13 of 14 PageID #: 21003
`
`Dated: October 6, 2022
`
`
`
`
`
`
`
`
`By: /s/ David I. Berl
`
`David I. Berl
`dberl@wc.com
`Jessamyn S. Berniker
`jberniker@wc.com
`Thomas S. Fletcher
`tfletcher@wc.com
`Jessica L. Pahl
`jpahl@wc.com
`Kathryn S. Kayali
`kkayali@wc.com
`Kevin Hoagland-Hanson
`khoagland-hanson@wc.com
`Andrew L. Hoffman
`ahoffman@wc.com
`Angela Gao
`agao@wc.com
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`Telephone: 202.434.5000
`Facsimile: 202.434.5029
`
`Jennifer Parker Ainsworth
`Texas State Bar No. 00784720
`jainsworth@wilsonlawfirm.com
`WILSON, ROBERTSON & CORNELIUS,
`P.C.
`909 ESE Loop 323, Suite 400
`Tyler, Texas 75701
`Telephone: 903.509.5000
`Facsimile: 903.509.5092
`
`Attorneys for Intervenor-Defendants AstraZeneca
`Pharmaceuticals LP and AstraZeneca UK Ltd.
`
`
`
`
`
`
`
`- 12 -
`
`
`
`Case 2:20-cv-00337-JRG Document 470 Filed 10/06/22 Page 14 of 14 PageID #: 21004
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that all counsel of record who have consented to
`
`electronic service are being served with a copy of this document via electronic mail on October 6,
`
`2022.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Preston K. Ratliff II
`
`
`
`
`
`
`
`
`
`