Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 1 of 18 PageID #: 626
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 20-1524-LPS
`
`(cid:51)(cid:38)(cid:37)(cid:34)(cid:36)(cid:53)(cid:38)(cid:37)(cid:1)(cid:14)(cid:1)(cid:49)(cid:54)(cid:35)(cid:45)(cid:42)(cid:36)(cid:1)(cid:55)(cid:38)(cid:51)(cid:52)(cid:42)(cid:48)(cid:47)
`
`)))))))))))
`
`DAIICHI SANKYO, INC., DAIICHI
`SANKYO COMPANY, LIMITED, and
`ASTRAZENECA PHARMACEUTICALS LP,
`
`v.
`
`SEAGEN INC.,
`
`Plaintiffs,
`
`Defendant.
`
`REPLY BRIEF IN SUPPORT OF DEFENDANT SEAGEN’S
`MOTION TO STAY OR DISMISS
`
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`
`Anne Shea Gaza (No. 4093)
`Samantha G. Wilson (No. 5816)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6727
`agaza@ycst.com
`swilson@ycst.com
`
`Attorneys for Defendant
`Seagen Inc.
`
`Of Counsel:
`
`MORRISON & FOERSTER LLP
`Michael A. Jacobs
`Matthew A. Chivvis
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-7000
`mjacobs@mofo.com
`mchivvis@mofo.com
`
`Bryan Wilson
`Pieter S. de Ganon
`755 Page Mill Road
`Palo Alto, CA 94304-1018
`(650) 813-5600
`bwilson@mofo.com
`pdeganon@mofo.com
`
`Dated: February 1, 2021
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 2 of 18 PageID #: 627
`
`TABLE OF CONTENTS
`
`Page(s)
`
`B.
`
`TABLE OF AUTHORITIES ......................................................................................................... ii
`I.
`INTRODUCTION ............................................................................................................. 1
`II.
`ARGUMENT..................................................................................................................... 1
`A.
`This Case Should Be Stayed So That The Eastern District Of Texas Can
`Apply The First-To-File Rule ................................................................................ 1
`In Any Event, The First-To-File Rule Requires A Stay ........................................ 2
`1.
`The Subject Matter Is The Same................................................................ 2
`2.
`Complete Party Identity Is Not Required................................................... 3
`3.
`The Rule’s Exceptions Do Not Apply ....................................................... 4
`Plaintiffs’ Complaint Does Not Sufficiently State A Claim.................................. 7
`C.
`AstraZeneca Lacks Subject Matter Jurisdiction And Should Be Dismissed ......... 9
`D.
`CONCLUSION................................................................................................................ 10
`
`III.
`
`
`
`i
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 3 of 18 PageID #: 628
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`
`Arris Grp., Inc. v. British Telecomms. PLC,
`639 F.3d 1368 (Fed. Cir. 2011)..............................................................................................6, 9
`
`Boston Sci. Corp. v. Johnson & Johnson, Inc.,
`532 F. Supp. 2d 648 (D. Del. 2008)...........................................................................................4
`
`Constant Contact Inc. v. Umbanet Inc.,
`C.A. No. 12-1467-GMS, 2014 WL 975734 (D. Del. Mar. 12, 2014) .......................................6
`
`Corixa Corp. v. IDEC Pharms. Corp,
`C.A. No. 01-615-GMS, 2002 WL 265094 (D. Del. Feb. 25, 2002) ..........................................4
`
`E.E.O.C. v. Univ. of Pa.,
`850 F.2d 969 (3d Cir. 1988), aff’d, 493 U.S. 182 (1990) ..........................................................4
`
`Enzo Biochem, Inc. v. Calgene, Inc.,
`C.A.No. 93-11-JJF, 1993 WL 266518 (D. Del. May 18, 1993) ...............................................2
`
`Freedom Mortg. Corp. v. Irwin Fin. Corp.,
`C.A. No. 08-146 GMS, 2009 WL 763899 (D. Del. Mar. 23, 2009)..............................1, 2, 3, 5
`
`Fuisz Pharma LLC v. Theranos, Inc.,
`C.A. No. 11-1061-SLR-CJB, 2012 WL 1820642 (D. Del. May 18, 2012)...........................3, 5
`
`Genentech, Inc. v. Eli Lilly & Co.,
`998 F.2d 931 (Fed. Cir. 1993)................................................................................................5, 7
`
`Ivoclar Vivadent AG v. 3M Co.,
`C.A. No. 11-1183-GMS-SRF, 2012 WL 2374657 (D. Del. June 22, 2012) .........................2, 3
`
`Katz v. Lear Siegler, Inc.,
`909 F.2d 1459 (Fed. Cir. 1990)..................................................................................................6
`
`McDaniel v. GEICO Gen. Ins. Co.,
`No. 1:12-CV-2028 AWI JLT, 2013 WL 1790167 (E.D. Cal. Apr. 26, 2013)...........................7
`
`Micron Tech., Inc. v. Mosaid Techs., Inc.,
`518 F.3d 897 (Fed. Cir. 2008)....................................................................................................5
`
`Microsoft Corporation v. SynKloud Technologies, LLC,
`C.A. No. 20-0007-RGA, 2020 WL 5369199 (D. Del. Sept. 8, 2020) .............................7, 9, 10
`
`
`
`ii
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 4 of 18 PageID #: 629
`
`TABLE OF AUTHORITIES
`(Cont’d)
`
`Page(s)
`
`In re Mobile Telecomms. Techs., LLC,
`243 F. Supp. 3d 478 (D. Del. 2017)...........................................................................................4
`
`Nexon Am., Inc. v. Uniloc 2017 LLC,
`C.A. No. 19-1096-CFC, 2020 WL 3035647 (D. Del. June 5, 2020).........................................4
`
`Princeton Digital Image Corp. v. Konami Digital Entm’t Inc.,
`C.A. No. 12-1461-LPS-CJB, 2017 WL 239326 (D. Del. Jan. 19, 2017) ..................................8
`
`Time Warner Cable, Inc. v. GPNE Corp.,
`497 F. Supp. 2d 584 (D. Del. 2007)...........................................................................................3
`
`Time Warner Cable, Inc. v. USA Video Tech. Corp.,
`520 F. Supp. 2d 579 (D. Del. 2007)...........................................................................................3
`
`Wilson Wolf Mfg. Corp. v. Sarepta Therapeutics, Inc.,
`C.A. No. 19-2316-RGA, 2020 WL 7771039 (D. Del. Dec. 30, 2020)......................................9
`
`Wolverine World Wide, Inc. v. Nike, Inc.,
`38 F.3d 1192 (Fed. Cir. 1994)................................................................................................3, 6
`
`Commonwealth of Pa. ex rel. Zimmerman v. PepsiCo, Inc.,
`836 F.2d 173 (3d Cir. 1988).......................................................................................................8
`
`STATUTES
`
`28 U.S.C. § 1404(a) .........................................................................................................................1
`
`iii
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 5 of 18 PageID #: 630
`
`I.
`
`INTRODUCTION
`
`Seagen sued DSC in the Eastern District of Texas nearly one month before Plaintiffs sued
`
`here. Because both suits address the same subject matter, and because Enhertu’s manufacturer,
`
`DSC, is party to both, the first-to-file rule applies.
`
`DSI’s and AstraZeneca’s presence in this case is a transparent attempt to
`
`skirt the first-to-file rule. Moreover, identical motions to transfer are now pending in two
`
`different federal courts. DSC has asked the Eastern District of Texas for “transfer under 28
`
`U.S.C. § 1404(a) to this Court” (D.I. 17 (“Opp’n”) at 20), raising the same arguments Plaintiffs
`
`raise in their opposition here (id. at 15 n.12 (DSC “expanded on the below arguments in its brief
`
`in support of its Motion to Transfer in the Texas Action.”)). By moving the Eastern District of
`
`Texas to transfer the first-filed case here, Plaintiffs have set the stage for “differing outcomes on
`
`the same issue by two sister courts.” Freedom Mortg. Corp. v. Irwin Fin. Corp., C.A. No. 08-
`
`146 GMS, 2009 WL 763899, at *4 (D. Del. Mar. 23, 2009). To prevent inconsistency, this case
`
`should be stayed in favor of the first-filed Texas case.
`
`Nothing in Plaintiffs’ opposition cures their complaint. To the contrary, their post hoc
`
`attempt to invent a claim highlights their failure to plead a plausible claim for non-infringement.
`
`Nor does their opposition establish that AstraZeneca has standing. In a dispute between Seagen
`
`and DSC, AstraZeneca—neither DSC’s “contractual business partner” nor part of DSC’s
`
`“business group”—has manufactured a controversy, hoping to defeat Seagen’s chosen forum.
`
`Plaintiffs’ ploy should be rejected and their complaint stayed or dismissed.
`
`II.
`
`ARGUMENT
`
`A.
`
`This Case Should Be Stayed So That The Eastern District Of Texas
`Can Apply The First-To-File Rule
`
`
`
`1
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 6 of 18 PageID #: 631
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`Plaintiffs cannot dispute that the first-to-file rule serves to prevent duplicative lawsuits by
`
`different federal courts. Yet they ask this Court to pass on the very question they know the first-
`
`filed Eastern District of Texas court is poised to decide. While this Court may do so (D.I. 11
`
`(“Mot.”) at 10), the likelihood of inconsistent rulings counsels against it. If this Court decides
`
`that Seagen’s infringement case against DSC should be heard here and the Eastern District of
`
`Texas decides it should be heard there, “duplicative litigation in different fora” and “differing
`
`outcomes on the same issue by two sister courts” could well result. Freedom, 2009 WL 763899,
`
`at *4.
`
`Plaintiffs argue that second-filed courts “routinely” apply the first-to-file rule, but cite
`
`only one decision, Ivoclar Vivadent AG v. 3M Co., C.A. No. 11-1183-GMS-SRF, 2012 WL
`
`2374657 (D. Del. June 22, 2012), for support. (Opp’n at 19.) But Ivoclar is actually contrary to
`
`Plaintiffs’ position. The Ivoclar court found that “the risk of inconsistent rulings does not bar
`
`this Court from conducting the first-filed analysis in the instant matter because . . . no motion to
`
`transfer is pending in the [first-filed court].” 2012 WL 2374657, at *5 (emphasis added). Here,
`
`on the other hand, the first-filed court is entertaining a motion to transfer and is deciding the
`
`question. (Opp’n at 20; id. at 15 n.12.) Ivoclar is no outlier. In Enzo Biochem, Inc. v. Calgene,
`
`Inc., for instance, the court granted a stay to allow the first-filed court to pass on pending
`
`jurisdictional, venue, and transfer motions. C.A. No. 93-110-JJF, 1993 WL 266518, at *2 (D.
`
`Del. May 18, 1993). This case should be stayed to permit the Eastern District of Texas to decide
`
`jurisdiction and venue.
`
`B.
`
`In Any Event, The First-To-File Rule Requires A Stay
`
`1.
`
`The Subject Matter Is The Same
`
`As numerous courts in this District have noted, the question is not whether the parties’
`
`
`
`2
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 7 of 18 PageID #: 632
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`“actions” in both suits are the same. (Opp’n at 14.)1 It is not even “whether the legal claims at
`
`issue are identical.” Fuisz Pharma LLC v. Theranos, Inc., C.A. No. 11-1061-SLR-CJB, 2012
`
`WL 1820642, at *6 (D. Del. May 18, 2012), report and recommendation adopted, C.A. No.
`
`11-1061-SLR/CJB, 2012 WL 2090622 (D. Del. June 7, 2012). Rather, the “focus is on whether
`
`the same common subject matter exists among the two cases.” Id.; see also Freedom, 2009 WL
`
`763899, at *5 (first-filed rule applies “where the claims all pertain to the subject matter of
`
`another dispute already before a competent court”).
`
`In patent cases, where “[b]oth suits concern the alleged infringement of the [same patent]
`
`by [the same product],” the subject matter is the same. Time Warner Cable, Inc. v. USA Video
`
`Tech. Corp., 520 F. Supp. 2d 579, 586 (D. Del. 2007). Plaintiffs’ cases articulate the same test,
`
`which may explain why they provide no decisional support for their assertion that “the claims are
`
`different.” (Opp’n at 14.) In Ivoclar, for instance, the court found that “sufficient identity exists
`
`between the causes of action” where one case “seeks a declaratory judgment for noninfringement
`
`and invalidity of the [asserted patent]” and the other case “counterclaim[s] for infringement of
`
`the [asserted patent].” 2012 WL 2374657, at *4. That is precisely the situation here.
`
`2.
`
`Complete Party Identity Is Not Required
`
`The first-filed rule does not require complete identity of parties. Time Warner Cable,
`
`Inc. v. GPNE Corp., 497 F. Supp. 2d 584, 589 (D. Del. 2007). It is sufficient that the accused
`
`product’s manufacturer be party to both cases. This is confirmed by the three (and only three)
`
`
`1 Plaintiffs accuse Seagen of “misstat[ing] patent law,” claiming that a “product like
`Enhertu® does not infringe any patent.” (Opp’n at 14.) But it is Plaintiffs’ position that conflicts
`with Federal Circuit law. “[F]or a court to find infringement, the plaintiff must show the
`presence of every element or its substantial equivalent in the accused device.” Wolverine World
`Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994). The truism that someone must
`“make, use, sell, offer to sell, or import” the accused product does not change the requirement
`that the accused product must first be found to infringe for “an entity’s actions with respect to a
`product” to be unlawful. (Opp’n at 14 (emphasis in original).)
`
`
`
`3
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 8 of 18 PageID #: 633
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`decisions Plaintiffs cite where courts in this District have declined to follow the first-filed rule.
`
`(Opp’n at 13.) In each case, unlike here, the manufacturer was not a party to the first-filed
`
`action. Boston Sci. Corp. v. Johnson & Johnson, Inc., 532 F. Supp. 2d 648, 650–51 (D. Del.
`
`2008) (court denied transfer because BSC, manufacturer of accused Promus stents, was not a
`
`party to the first-filed action, and Abbot, manufacturer of accused Xience V stents, was not a
`
`party to the second-filed action); In re Mobile Telecomms. Techs., LLC, 243 F. Supp. 3d 478,
`
`485 (D. Del. 2017) (court declined to apply the first-filed rule because the manufacturer,
`
`“ARRIS[,] [wa]s not a party to the earlier Texas Actions and [the second-filed] case ha[d] a
`
`much broader scope” (emphasis in original)); Nexon Am., Inc. v. Uniloc 2017 LLC, C.A. No. 19-
`
`1096-CFC, 2020 WL 3035647, at *4 (D. Del. June 5, 2020) (court refused transfer to the first-
`
`filed Texas court because Nexon America, not a party in Texas, “alone developed and
`
`manufactures the accused” technology).
`
` Because DSC is party to
`
`both actions, the presence of DSI and AstraZeneca here but not in Texas does not “strongly
`
`counsel[] against [the] application of the first-filed rule.” (Opp’n at 13.)
`
`3.
`
`The Rule’s Exceptions Do Not Apply
`
`Reading AstraZeneca’s brief, one is left with the impression that first-to-file is the
`
`exception. It isn’t. Under Third Circuit law, which Plaintiffs do not address, absent “exceptional
`
`circumstances” the “court which first has possession of the subject must decide it.” E.E.O.C. v.
`
`Univ. of Pa., 850 F.2d 969, 971, 979 (3d Cir. 1988), aff’d, 493 U.S. 182 (1990) (emphasis
`
`added). This is consistent with Federal Circuit law, which “requires that the first-filed action be
`
`given preference absent special circumstances.” Corixa Corp. v. IDEC Pharms. Corp, C.A. No.
`
`01-615-GMS, 2002 WL 265094, at *1 (D. Del. Feb. 25, 2002) (emphasis added) (citing
`
`
`
`4
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 9 of 18 PageID #: 634
`
`Genentech, Inc. v. Eli Lilly & Co., 998 F.2d 931, 937 (Fed. Cir. 1993)). The “Federal Circuit,”
`
`moreover, “has a strong preference for adhering to the first-filed rule in actions involving the
`
`same patents.” Fuisz, 2012 WL 1820642, at *5. Because Plaintiffs provide no “sound reason
`
`that would make it unjust or inefficient to continue [in Texas],” Genentech, 998 F.2d at 938,
`
`Seagen’s choice of forum should not be disturbed.
`
`Plaintiffs’ declarations make it clear that DSC is the only “necessary or desirable part[y]”
`
`to this dispute. Id.
`
`
`
`
`
` Both venue and jurisdiction are thus
`
`proper in Texas (Mot. at 10), and Plaintiffs do not seriously argue to the contrary (Opp’n at 20).2
`
`AstraZeneca’s and DSI’s eagerness to enter the dispute does not transform them into
`
`necessary or desirable parties. Just as a “district court may consider a party’s intention to
`
`preempt another’s infringement suit when ruling on the dismissal of a declaratory action,”
`
`Micron Tech., Inc. v. Mosaid Techs., Inc., 518 F.3d 897, 904 (Fed. Cir. 2008), it may also
`
`consider a party’s attempt to “skirt the ‘first-filed’ rule by pleading around the [first-filed]
`
`action,” Freedom, 2009 WL 763899, at *5. In a dispute between Seagen and DSC, AstraZeneca
`
`and DSI have inserted themselves solely to try to defeat Seagen’s chosen forum. (See infra § D.)
`
`Under some circumstances, a later-filed suit between a patentee and a manufacturer will
`
`take precedence over an earlier-filed suit between the patentee and the manufacturer’s customer.
`
`
`2 Plaintiffs also fail to rebut Seagen’s argument that this Court should discretionarily
`decline declaratory jurisdiction. Aside from articulating the truism that the Court’s discretion
`should be exercised in accordance with the law (Opp’n at 19–20), Plaintiffs do not explain why
`requiring Seagen to litigate DSC’s infringement simultaneously in two fora is necessary to
`“settle the legal relations in dispute and afford relief from uncertainty or insecurity.” Genentech,
`998 F.2d at 937.
`
`
`
`5
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 10 of 18 PageID #: 635
`
`See Katz v. Lear Siegler, Inc., 909 F.2d 1459, 1464 (Fed. Cir. 1990) (articulating customer suit
`
`exception). AstraZeneca’s theory of venue turns that exception on its head. (See Opp’n at 7
`
`(analogizing its situation to that in Arris Grp., Inc. v. British Telecomms. PLC, 639 F.3d 1368
`
`(Fed. Cir. 2011), a customer suit exception case, id. at 1375).) AstraZeneca’s theory makes no
`
`sense for the very reason the customer suit exception makes sense. The “manufacturer is the true
`
`defendant in the customer suit” and the “resolution of the major issues [against the
`
`manufacturer], including patent infringement . . . will resolve these issues as to [its] customers.”
`
`Katz, 909 F.2d at 1464 (citation omitted). That the customer—or seller or marketer—suit might
`
`involve “additional issues” is of no moment where the “prosecution will be advanced if [the
`
`patentee] is successful . . . and may well be mooted if [it] is unsuccessful.” Id. So too here. If
`
`Seagen proves the “presence of every element [of the ’039 patent] or its substantial equivalent in
`
`[Enhertu],” then DSC infringes. Wolverine, 38 F.3d at 1199. As in Katz, this case should be
`
`stayed pending resolution of that threshold question in Texas. Katz, 909 F.2d at 1464.
`
`Moreover, discovery in Texas is already underway. Seagen served its infringement
`
`contentions on January 6, 2021. (Ex. 11.)3 And discovery is now proceeding on the very
`
`jurisdictional and convenience facts Plaintiffs’ cite in their opposition here—e.g., who imports
`
`Enhertu into the United States, DSC’s role in introducing Enhertu to the U.S. market, and
`
`Plaintiffs’ connections to Texas. (Exs. 12-14.) Because discovery, including jurisdictional
`
`discovery, has begun in Texas, judicial efficiency and Texas’s interest weigh in favor of a stay
`
`here. Cf. Constant Contact Inc. v. Umbanet Inc., C.A. No. 12-1467-GMS, 2014 WL 975734, at
`
`*4 (D. Del. Mar. 12, 2014) (start of discovery in first-filed infringement suit involving same
`
`
`3 Unless otherwise noted, all referenced exhibits are attached to the opening (D.I. 12) or
`reply declaration of Pieter S. de Ganon in support of Seagen’s Motion to Stay or Dismiss, the
`latter filed contemporaneously herewith.
`
`
`
`6
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 11 of 18 PageID #: 636
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`patents, technology, and product favors transfer of second-filed declaratory judgment suit).
`
`Finally, once AstraZeneca and DSI are excluded for reasons set forth here and in the
`
`opening brief (Mot. at 8-9), the “convenience and availability of witnesses” favors Texas.
`
`Genentech, 998 F.2d at 938. DSC’s material witnesses are all in Japan—including the “team of
`
`lead scientists that were involved in developing the Enhertu® formulations” (Pahl Decl. Ex. 5 ¶
`
`6), the “leaders who developed the manufacturing processes for Enhertu®” (id.), the “leaders who
`
`direct and plan the supply chain of Enhertu®” (id.), and the person who “manage[s] the supply of
`
`bulk vials of Enhertu® to . . . the United States” (id. ¶ 3). This Court should take judicial notice
`
`of the fact that the total travel time from Tokyo to Marshall, Texas (11.5 hours by air to Dallas
`
`plus 2.5 hours by car) is less than to Wilmington, Delaware (16.5 hours by air to Philadelphia
`
`plus 35 minutes by car). See, e.g., McDaniel v. GEICO Gen. Ins. Co., No. 1:12-CV-2028 AWI
`
`JLT, 2013 WL 1790167, at *8 n.3 (E.D. Cal. Apr. 26, 2013) (court took judicial notice of flight
`
`schedule on venue transfer motion).
`
`C.
`
`Plaintiffs’ Complaint Does Not Sufficiently State A Claim
`
`Plaintiffs’ effort to salvage their complaint hangs on one case, Microsoft Corporation v.
`
`SynKloud Technologies, LLC, C.A. No. 20-0007-RGA, 2020 WL 5369199, at *9 (D. Del. Sept.
`
`8, 2020), which, Plaintiffs claim in a parenthetical, “reject[ed] arguments analogous to
`
`Seagen’s.” (Opp’n at 10.) Not true. In Microsoft, the court rejected SynKloud’s arguments that
`
`Microsoft had failed to plead non-infringement because it did not specify the particular products
`
`for which Microsoft sought a declaration. Microsoft, 2020 WL 5369199, at *11–12. That is not
`
`Seagen’s challenge to the complaint here.
`
`Plaintiffs also claim that Microsoft stands for the proposition that a declaratory judgment
`
`plaintiff need do nothing more than “identif[y] the accused product and allege[] non-
`
`infringement.” (Opp’n at 10.) Also not true. The complaint must include “sufficient facts to
`
`
`
`7
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 12 of 18 PageID #: 637
`
`make out a plausible claim” for non-infringement. Princeton Digital Image Corp. v. Konami
`
`Digital Entm’t Inc., C.A. No. 12-1461-LPS-CJB, 2017 WL 239326, at *5 (D. Del. Jan. 19,
`
`2017), report and recommendation adopted, C.A. No. 12-1461-LPS-CJB, 2017 WL 1196642 (D.
`
`Del. Mar. 30, 2017). Plaintiffs’ complaint fails to do so. Merely “signaling that there are
`
`differences between [Enhertu] and the ’039 Patent’s claims” by using the phrase “on the other
`
`hand” (Opp’n at 11) is not a substitute for including facts sufficient to plausibly claim non-
`
`infringement.
`
`And Plaintiffs “one example” (id.) is nothing more than a post hoc attempt to create a
`
`claim. Purportedly quoting paragraphs 18 and 20 of their complaint, Plaintiffs claim that
`
`“the ’039 Patent requires free release of the drug moiety via intracellular cleavage,” which they
`
`(now) compare to the “form[ation] and release[]” of “a payload, DXd, that is different from the
`
`drug moiety DX-8951.” (Opp’n at 11 (emphases added).) But that is not remotely what those
`
`paragraphs say. Neither paragraph mentions “free release,” “DX-8951,” or “payload . . . that is
`
`different from the drug moiety.” (D.I. 1 ¶¶ 18, 20.) Plaintiffs’ “complaint may not be amended
`
`by the briefs in opposition to a motion to dismiss.” Commonwealth of Pa. ex rel. Zimmerman v.
`
`PepsiCo, Inc., 836 F.2d 173, 181 (3d Cir. 1988) (citation omitted).
`
`Finally, Plaintiffs’ section 271(e)(1) safe harbor allegations are neither “well-pleaded”
`
`nor “sufficient” (Opp’n at 11) because Seagen never “asserted the ’039 patent against various
`
`ADCs that have not been approved for marketing by the FDA” (D.I. 1 ¶ 28). Seagen’s assertions
`
`in Texas are clear that those products would be accused “should Seagen learn during the course
`
`of discovery that DSC has engaged in infringing activities as to these products”—i.e., should
`
`DSC seek to commercialize them in the United States. (Ex. 2 ¶ 5.) Plaintiffs cannot seriously
`
`allege that commercialization is reasonably related to regulatory submission, because post-
`
`approval commercial activities do not qualify for safe harbor protection as a matter of law. See
`
`
`
`8
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 13 of 18 PageID #: 638
`
`Wilson Wolf Mfg. Corp. v. Sarepta Therapeutics, Inc., C.A. No. 19-2316-RGA, 2020 WL
`
`7771039, at *2 (D. Del. Dec. 30, 2020) (safe harbor applies solely for regulatory uses).
`
`D.
`
`AstraZeneca Lacks Subject Matter Jurisdiction And Should Be
`Dismissed
`
`Plaintiffs fail to establish that the requisite case or controversy exists between
`
`AstraZeneca and Seagen. They point to no allegation of infringement directed to AstraZeneca.
`
`Their only argument—that Seagen has “implicitly accused” it of patent infringement—is
`
`insufficient to establish declaratory judgment jurisdiction. Their argument turns, moreover, on a
`
`strained interpretation of two words in Seagen’s complaint: “contractual business partners” and
`
`“business group.” (Opp’n at 6.) They conclude that these phrases “self-evidently” mean
`
`AstraZeneca. (Id. at 1.) They do not.
`
`Seagen has never communicated with, much less accused AstraZeneca of infringing
`
`its ’039 patent (Mot. at 16–17), a fact that Plaintiffs do not deny. While direct communication
`
`between a patentee and declaratory plaintiff is not always necessary to confer standing, Arris,
`
`639 F.3d at 1378–80, it is necessary where the declaratory plaintiff bases standing on “implicit
`
`accusations.” Thus, in Arris, which Plaintiffs cite (Opp’n at 7), standing was based on the
`
`“implied assertion [of] contributory infringement, and [the patentee] repeatedly communicat[ing]
`
`this implicit accusation directly to” the infringer. 639 F.3d at 1381. This requirement makes
`
`sense: Without the direct communication requirement, any creative declaratory plaintiff could
`
`assert jurisdiction based on “implicit accusations” made to no one in particular. Plaintiffs’ other
`
`case, Microsoft v. SynKloud, also supports Seagen. (Opp’n at 7.) The Microsoft court was clear
`
`that for jurisdiction to lie, the declaratory plaintiff must show, among other things, “an
`
`affirmative act” related to patent enforcement “directed at the ‘specific plaintiff[]’ seeking a
`
`
`
`9
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`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 14 of 18 PageID #: 639
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`declaratory judgment.” 2020 WL 5369199, at *2 (emphasis added).4
`
`As Seagen’s opening brief made clear, AstraZeneca is not DSC’s contractual business
`
`partner; it is not even a party to the global development and commercialization agreement with
`
`DSC. (Mot. at 17.) Plaintiffs’ opposition ignores this. Nor is AstraZeneca part of DSC’s
`
`business group, a phrase that means exactly what it says—the group of companies that comprise
`
`Daiichi Sankyo. (Ex. 15 (“The Daiichi Sankyo group is actively engaged in various measures
`
`and initiatives . . . .”), Ex. 16 (mentioning “51 Group companies”).) This group includes DSI.
`
`(Ex. 17 (the “Daiichi Sankyo Group is dedicated to the creation and supply of innovative
`
`pharmaceutical products . . . .”).) It does not include AstraZeneca. AstraZeneca’s declarant, Mr.
`
`Bucci, does not attest otherwise.
`
`
`
` Nowhere
`
`does he state that AstraZeneca is DSC’s contractual business partner or part of DSC’s business
`
`group. If it were, Mr. Bucci would have said so. Plaintiffs’ theory of jurisdiction based on
`
`Seagen’s purported “implicit accusations” fails.
`
`III.
`
`CONCLUSION
`
`Seagen first sued DSC, the manufacturer of the accused product, for patent infringement
`
`in the Eastern District of Texas. That first-filed action should proceed, and this case should be
`
`stayed or dismissed.
`
`
`4 Because Seagen never accused AstraZeneca of anything, much less of “promoting and
`encouraging the use” of Enhertu (cf. Opp’n at 7–8), Plaintiffs’ attempt to distinguish Proofpoint,
`Inc. v. InNova Patent Licensing, LLC fails. There, as here, the patentee did not accuse the
`declaratory plaintiff of infringing activity. C.A. No. 5:11-cv-02288-LHK, 2011 WL 4915847, at
`*5 (N.D. Cal. Oct. 17, 2011).
`
`
`
`10
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`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 15 of 18 PageID #: 640
`
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`
`/s/ Anne Shea Gaza
`Anne Shea Gaza (No. 4093)
`Samantha G. Wilson (No. 5816)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6727
`agaza@ycst.com
`swilson@ycst.com
`
`Attorneys for Defendant Seagen Inc.
`
`Dated: February 1, 2021
`
`Of Counsel:
`
`MORRISON & FOERSTER LLP
`Michael A. Jacobs
`Matthew A. Chivvis
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-7000
`mjacobs@mofo.com
`mchivvis@mofo.com
`
`Bryan Wilson
`Pieter S. de Ganon
`755 Page Mill Road
`Palo Alto, CA 94304-1018
`(650) 813-5600
`bwilson@mofo.com
`pdeganon@mofo.com
`
`27664811.1
`
`
`
`11
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 16 of 18 PageID #: 641
`
`CERTIFICATE OF SERVICE
`
`I, Anne Shea Gaza, Esquire, hereby certify that on February 9, 2021, I caused to be
`
`electronically filed a true and correct copy of the foregoing document with the Clerk of the Court
`
`using CM/ECF, which will send notification that such filing is available for viewing and
`
`downloading to the following counsel of record:
`
`Steven J. Balick
`Andrew C. Mayo
`ASHBY & GEDDES, P.A.
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashbygeddes.com
`amayo@ashbygeddes.com
`
`
`Attorneys for Plaintiffs Daiichi Sankyo, Inc. and
`Daiichi Sankyo Company, Limited
`
`Michael P. Kelly
`Daniel M. Silver
`Alexandra M. Joyce
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`
`Attorneys for Plaintiff AstraZeneca Pharmaceuticals LP
`
` I
`
` further certify that on February 9, 2021, I caused the foregoing document to be served
`
`via electronic mail upon the above-listed counsel and on the following counsel:
`
`
`
`
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 17 of 18 PageID #: 642
`
`
`Preston K. Ratliff II
`Joseph M. O’Malley
`Ashley N. Mays-Williams
`Isaac S. Ashkenazi
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`prestonratliff@paulhastings.com
`josephomalley@paulhastings.com
`ashleymayswilliams@paulhastings.com
`isaacashkenazi@paulhastings.com
`
`Naveen Modi
`Michael A. Stramiello
`Jeff A. Pade
`PAUL HASTINGS LLP
`2050 M Street NW
`Washington, DC 20036
`(202) 551-1700
`naveenmodi@paulhastings.com
`michaelstramiello@paulhastings.com
`jeffpade@paulhastings.com
`
`Attorneys for Plaintiffs Daiichi Sankyo, Inc. and
`Daiichi Sankyo Company, Limited
`
`David I. Berl
`Thomas S. Fletcher
`Jessica L. Pahl
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
`dberl@wc.com
`tfletcher@wc.com
`jpahl@wc.com
`
`Attorneys for Plaintiff AstraZeneca Pharmaceuticals LP
`
`
`
`
`
`
`
`2
`
`

`

`Case 1:20-cv-01524-LPS Document 26 Filed 02/09/21 Page 18 of 18 PageID #: 643
`
`Dated: February 9, 2021
`
`
`
`
`
`
`
`YOUNG CONAWAY STARGATT
` & TAYLOR, LLP
`
`/s/ Anne Shea Gaza
`Anne Shea Gaza (No. 4093)
`Samantha G. Wilson (No. 5816)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`agaza@ycst.com
`swilson@ycst.com
`
`Attorneys for Defendant Seagen Inc.
`
`3
`
`