Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 1 of 28 PageID #: 465
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`DAIICHI SANKYO, INC., DAIICHI
`SANKYO COMPANY, LIMITED, and
`ASTRAZENECA PHARMACEUTICALS
`LP,
`
`Plaintiffs,
`
`v.
`
`SEAGEN INC.,
`
`Defendant.
`
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`)
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`)
`)
`)
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`
`C.A. No. 20-1524-LPS
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`
`
`
`
`
`
`ASTRAZENECA PHARMACEUTICALS LP’S OPPOSITION
`TO MOTION TO STAY OR DISMISS
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`
`
`
`
`
`
`PUBLIC VERSION FILED: January 26, 2021
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 2 of 28 PageID #: 466
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`
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`TABLE OF CONTENTS
`
`II. 
`III. 
`
`INTRODUCTION ......................................................................................................................... 1 
`NATURE AND STAGE OF THE PROCEEDINGS .................................................................... 2 
`SUMMARY OF ARGUMENT ..................................................................................................... 2 
`COUNTERSTATEMENT OF FACTS ......................................................................................... 3 
`ARGUMENT ................................................................................................................................. 5 
`THIS COURT HAS SUBJECT-MATTER JURISDICTION OVER
`I. 
`ASTRAZENECA US’S CLAIMS ......................................................................... 5 
`There Is a Substantial Controversy as to AstraZeneca US’s Legal
`A. 
`Rights ......................................................................................................... 5 
`The Dispute Has Sufficient Immediacy and Reality .................................. 8 
`B. 
`THE COMPLAINT SUFFICIENTLY STATES A CLAIM ............................... 10 
`THIS CASE SHOULD PROCEED IN DELAWARE
`NOTWITHSTANDING SEAGEN’S INVOCATION OF THE FIRST-
`FILED RULE ....................................................................................................... 12 
`This Action Should Proceed Because the Parties and Claims Are
`A. 
`Different from the Texas Action .............................................................. 13 
`Delaware Is the Far More Appropriate Forum ........................................ 14 
`Convenience and Suitability Weigh Heavily in Favor of
`(1) 
`Proceeding in Delaware ............................................................... 15 
`The Interest of Justice Requires that This Action Proceed .......... 18 
`(2) 
`This District Can and Should Resolve the Venue and First-To-File
`Issue that Exists Between Plaintiffs and Seagen ...................................... 19 
`CONCLUSION ............................................................................................................................ 20 
`
`B. 
`
`C. 
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`i
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 3 of 28 PageID #: 467
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`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Allergan, Inc. v. Alcon Labs., Inc.,
`324 F.3d 1322 (Fed. Cir. 2003)..................................................................................................7
`
`Arkema Inc. v. Honeywell Int’l, Inc.,
`706 F.3d 1351 (Fed. Cir. 2013)..................................................................................................7
`
`Arris Grp., Inc. v. British Telecomms. PLC,
`639 F.3d 1368 (Fed. Cir. 2011)....................................................................................6, 7, 9, 10
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .................................................................................................................10
`
`AstraZeneca UK Ltd. v. Watson Labs., Inc. (NV),
`905 F. Supp. 2d 596 (D. Del. 2012) .........................................................................................14
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) .................................................................................................................10
`
`Benitec Austl., Ltd. v. Nucleonics, Inc.,
`495 F.3d 1340 (Fed. Cir. 2007)..............................................................................................5, 9
`
`Boston Sci. Corp. v. Johnson & Johnson Inc.,
`532 F. Supp. 2d 648 (D. Del. 2008) .........................................................................................13
`
`Cat Tech LLC v. TubeMaster, Inc.,
`528 F.3d 871 (Fed. Cir. 2008)....................................................................................................8
`
`Cellectis S.A. v. Precision Biosciences, Inc.,
`881 F. Supp. 2d 609 (D. Del. 2012) .........................................................................................19
`
`Chase Nat’l Bank v. City of Norwalk,
`291 U.S. 431 (1934) .................................................................................................................19
`
`Commc’ns Test Design, Inc. v. Contec, LLC,
`952 F.3d 1356 (Fed. Cir. 2020)..........................................................................................15, 18
`
`Crosley Corp. v. Westinghouse Elec. & Mfg. Co.,
`130 F.2d 474 (3d Cir. 1942).....................................................................................................19
`
`Datex-Ohmeda, Inc. v. Hill-Rom Servs., Inc.,
`185 F. Supp. 2d 407 (D. Del. 2002) .........................................................................................16
`
`DIFF Scale Operation Res., LLC v. MaxLinear Inc.,
`C.A. No. 19-2019-LPS, 2020 WL 2220031 (D. Del. May 7, 2020) ........................................12
`
`ii
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 4 of 28 PageID #: 468
`
`
`
`Endeavor Meshtech, Inc. v. Aclara Techs. LLC,
`C.A. No. 13-1618-GMS, 2015 WL 849211 (D. Del. Feb. 25, 2015) ......................................16
`
`Freedom Mortg. Corp. v. Irwin Fin. Corp.,
`C.A. No. 08-146-GMS, 2009 WL 763899 (D. Del. Mar. 23, 2009)........................................14
`
`Futurewei Techs., Inc. v. Acacia Rsch. Corp.,
`737 F.3d 704 (Fed. Cir. 2013)............................................................................................13, 15
`
`Gen. Elec. Co. v. Raytheon Techs. Corp.,
`No. 2019-1319, 2020 WL 7635982 (Fed. Cir. Dec. 23, 2020) ..................................................8
`
`Genentech, Inc. v. Eli Lilly & Co.,
`998 F.2d 931 (Fed. Cir. 1993)........................................................................................2, 15, 19
`
`In re Genentech, Inc.,
`566 F.3d 1338 (Fed. Cir. 2009)................................................................................................16
`
`In re Mobile Telecomms. Techs., LLC,
`243 F. Supp. 3d 478 (D. Del. 2017) .........................................................................................13
`
`In re TS Tech USA Corp.,
`551 F.3d 1315 (Fed. Cir. 2008)................................................................................................17
`
`Ivoclar Vivadent AG v. 3M Co.,
`C.A. No. 11-1183-GMS-SRF, 2012 WL 2374657 (D. Del. June 22, 2012) ...........................19
`
`Jumara v. State Farm Ins. Co.,
`55 F.3d 873 (3d Cir. 1995).......................................................................................................15
`
`Kahn v. Gen. Motors Corp.,
`889 F.2d 1078 (Fed. Cir. 1989)................................................................................................19
`
`MedImmune, Inc. v. Genentech, Inc.,
`549 U.S. 118, 127 (2007) ...........................................................................................................5
`
`Microchip Tech. Inc. v. Chamberlain Grp., Inc.,
`441 F.3d 936 (Fed. Cir. 2006)....................................................................................................5
`
`Micron Tech., Inc. v. Mosaid Techs., Inc.,
`518 F.3d 897 (Fed. Cir. 2008)......................................................................................14, 15, 20
`
`Microsoft Corp. v. SynKloud Techs., LLC,
`C.A. No. 20-0007-RGA, 2020 WL 5369199 (D. Del. Sept. 8, 2020) ................................7, 10
`
`Nexon Am. Inc. v. Uniloc 2017 LLC,
`C.A. No. 19-1096-CFC, 2020 WL 3035647 (D. Del. June 5, 2020) .......................................13
`
`iii
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 5 of 28 PageID #: 469
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`
`
`Parklane Hosiery Co. v. Shore,
`439 U.S. 322 (1979) .................................................................................................................19
`
`Prasco, LLC v. Medicis Pharm. Corp.,
`537 F.3d 1329 (Fed. Cir. 2008)..............................................................................................8, 9
`
`Princeton Digit. Image Corp. v. Konami Digit. Ent. Inc.,
`C.A. No. 12-1461-LPS-CJB, 2017 WL 239326 (D. Del. Jan. 19, 2017) ................................12
`
`Proofpoint, Inc. v. InNova Pat. Licensing, LLC
`C.A. No. 5:11-cv-02288-LHK, 2011 WL 4915847 (N.D. Cal. Oct. 17, 2011) .....................7, 8
`
`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
`556 F.3d 1294 (Fed. Cir. 2009)................................................................................................10
`
`SanDisk Corp. v. STMicroelectronics, Inc.,
`480 F.3d 1372 (Fed. Cir. 2007)............................................................................................6, 10
`
`Serco Servs. Co., L.P. v. Kelley Co.,
`51 F.3d 1037 (Fed. Cir. 1995)..................................................................................................17
`
`Teleconference Sys. v. Proctor Gamble Pharms.,
`676 F. Supp. 2d 321 (D. Del. 2009) .........................................................................................18
`
`Time Warner Cable, Inc. v. USA Video Tech. Corp.,
`520 F. Supp. 2d 579 (D. Del. 2007) ...................................................................................13, 14
`
`TSMC Tech., Inc. v. Zond, LLC,
`C.A. No. 14-721-LPS-CJB, 2014 WL 7498398 (D. Del. Jan 8, 2014) .....................................8
`
`Statutes
`
`28 U.S.C. § 1404 ......................................................................................................................15, 20
`
`35 U.S.C. § 271 ............................................................................................................1, 2, 7, 11, 14
`
`Other Authorities
`
`Fed. R. Civ. P. 8 .........................................................................................................................2, 10
`
`Fed. R. Civ. P. 15 ...........................................................................................................................12
`
`Fed. R. Civ. P. 45 ...........................................................................................................................18
`
`D. Del. LR 7.1.2 .............................................................................................................................15
`
`iv
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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 6 of 28 PageID #: 470
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`
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`INTRODUCTION
`
`
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`Plaintiffs AstraZeneca Pharmaceuticals LP (“AstraZeneca US”) and Daiichi Sankyo, Inc.
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`(“Daiichi Sankyo US”) are the companies that market Enhertu® in the United States, a fact
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`reflected on the package insert for Enhertu® itself. Daiichi Sankyo US is the only company
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`licensed by the United States Food and Drug Administration (“FDA”) to sell Enhertu® in the
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`United States. In a recent patent infringement action filed in Texas1—which did not include either
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`AstraZeneca US or Daiichi Sankyo US as parties—Defendant Seagen, Inc. (“Seagen”) alleged that
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`“promoting and encouraging” the use of Enhertu® constituted actionable infringement. (Exh. 1,
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`Tex. Compl. ¶25.)2 Moreover, Seagen alleged that Daiichi Sankyo Company, Limited (“Daiichi
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`Sankyo Japan”)—which manufactures Enhertu® outside of the United States and is the sole
`
`defendant in the Texas Action—“act[ed] in concert” with “subsidiaries” and “contractual business
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`partners” that formed a “business group” making decisions about infringing uses of Enhertu® in
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`the United States. (Id. ¶¶10–11.) This “business group” self-evidently includes AstraZeneca US
`
`and Daiichi Sankyo US, yet Seagen did not name them as defendants—presumably because venue
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`in Texas would have been improper if it had.
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`
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`This case can, and should, proceed in Delaware—where venue is proper as to the materially
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`interested and desirable parties. Seagen’s own allegations have created a sufficient case and
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`controversy to support declaratory jurisdiction. As to the claims pertaining to AstraZeneca US
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`specifically, there is a substantial and immediate dispute over legal rights—namely whether
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`AstraZeneca US’s conduct constitutes actionable inducement under 35 U.S.C. § 271(b). And
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`
`1 Civil Action No. 2:20-cv-00337-JRG (E.D. Tex. filed Oct. 19, 2020) (the “Texas Action”).
`2 “Exh.” refer to the exhibits attached to the Declaration of Jessica L. Pahl submitted concurrently
`with this Opposition. These exhibits include declarations from employees of AstraZeneca US,
`Daiichi Sankyo US, and Daiichi Sankyo Japan submitted previously in support of Daiichi Sankyo
`Japan’s motion to dismiss and motion to transfer filed in the Texas Action.
`
`1
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`

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`
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`although Seagen seeks to avoid this litigation by invoking the so-called “first-filed” rule,
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`exceptions to that rule are “not rare,” Genentech, Inc. v. Eli Lilly & Co., 998 F.2d 931, 937 (Fed.
`
`Cir. 1993), and the rule poses no bar to proceeding in Delaware. Key parties—namely
`
`AstraZeneca US and Daiichi Sankyo US—are parties to this litigation, not the Texas Action.
`
`Relevant witnesses and documents are located in or near Delaware, not Texas. The majority of
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`the parties (including Seagen) are Delaware entities and/or have principal places of business in or
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`near Delaware, not Texas. Under governing Federal Circuit law, this case should proceed in
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`Delaware, and Seagen’s motion should be denied.
`
`NATURE AND STAGE OF THE PROCEEDINGS
`
`This is an action for Declaratory Judgment of Non-Infringement regarding, inter alia, the
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`sale and marketing of Enhertu® in the United States. It was filed in November 2020 by the two
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`entities that jointly market Enhertu® in the United States—AstraZeneca US and Daiichi Sankyo
`
`US, both of which are Delaware entities.3
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`SUMMARY OF ARGUMENT
`
`1.
`
`This Court has subject matter jurisdiction over AstraZeneca US’s claims. Seagen’s
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`own conduct and allegations have put AstraZeneca US’s legal interests at issue—namely whether
`
`its current conduct constitutes prohibited inducement under 35 U.S.C. § 271(b).
`
`2.
`
`The Complaint satisfies Rule 8(a) of the Federal Rules of Civil Procedure as it
`
`contains allegations adequate to provide Seagen with notice of the claims.
`
`3.
`
`The existence of the Texas Action does not counsel in favor of a stay or dismissal.
`
`Seagen did not include (and could not have included) AstraZeneca US and Daiichi Sankyo US as
`
`
`3 The third co-plaintiff, Daiichi Sankyo Japan, is a foreign entity.
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`2
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`

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`
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`parties in that action and there is no material connection between Texas and the subject of this
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`dispute. Rather, Delaware has an overwhelming interest in deciding these issues.
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`COUNTERSTATEMENT OF FACTS
`
`In December 2019, the FDA granted accelerated approval for Enhertu®, a revolutionary
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`and life-saving breast cancer treatment. Daiichi Sankyo US is the Biologics License Application
`
`(“BLA”) holder for Enhertu®. As the BLA holder, Daiichi Sankyo US is the only company
`
`licensed by the FDA to introduce Enhertu® (or deliver it for introduction) into interstate commerce.
`
`(Exh. 3, Switzer Decl. ¶3; D.I. 1 ¶13.)
`
`
`
`
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` It then oversees the
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` sale of
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`Enhertu® to specialty distributors and pharmacies who in turn sell Enhertu® to customers in the
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`United States. (Exh. 3, Switzer Decl. ¶3; Exh. 4, Smith Decl. ¶4; D.I. 1 ¶15.)
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`As part of a more than $6.9 billion global collaboration announced in 2019 between Daiichi
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`Sankyo Japan and AstraZeneca US’s affiliate, the commercialization of Enhertu® in the United
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`States is handled by AstraZeneca US and Daiichi Sankyo US. AstraZeneca US and Daiichi Sankyo
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`US are listed on the package insert for Enhertu® as the two entities that market the product. (Exh.
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`4, Smith Decl. ¶3.)
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`
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`
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`AstraZeneca US is a Delaware entity with its headquarters in Wilmington, Delaware and
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`significant operations in nearby Gaithersburg, Maryland. (Exh. 2, Bucci Decl. ¶4; D.I. 1 ¶3.)
`
`Daiichi Sankyo US is a Delaware entity based in Basking Ridge, New Jersey. (D.I. 1 ¶1.)
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`3
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 9 of 28 PageID #: 473
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`After AstraZeneca and Daiichi Sankyo announced their global collaboration, Seagen
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`claimed that Daiichi Sankyo Japan was required to assign its patent rights in Enhertu® to Seagen
`
`under the terms of a prior collaboration agreement between those two parties. That dispute led to
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`a declaratory judgment action in this Court and an arbitration. The arbitration remains pending,
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`and the Delaware action has been administratively closed pending that proceeding. Seagen also
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`filed a patent application trying to cover Enhertu®, which issued as U.S. Patent No. 10,808,039
`
`(“the ʼ039 Patent”) on October 20, 2020, almost a year after Enhertu® was approved by the FDA.
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`In response, Daiichi Sankyo US and AstraZeneca US recently filed a Petition for Post-Grant
`
`Review of the ʼ039 Patent, which challenges the ʼ039 Patent claims based, in part, on lack of
`
`written description and lack of enablement.
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`On October 19, 2020 (at 11:02pm CT, the day before the ’039 Patent issued), Seagen filed
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`suit for patent infringement in the Eastern District of Texas. Although Seagen named only Daiichi
`
`Sankyo Japan as a defendant, it predicated its infringement claims on actions taken by Daiichi
`
`Sankyo Japan’s “subsidiaries and contractual business partners” who act as “agents” and part of a
`
`“business group” along with Daiichi Sankyo Japan. (Exh. 1, Tex. Compl. ¶11.) Seagen further
`
`alleged that Daiichi Sankyo Japan “actively encourages others to infringe” the ’039 Patent by
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`“promoting and encouraging the use” of Enhertu®. (Id. ¶25.) On January 5, 2021, Daiichi Sankyo
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`Japan moved to dismiss the Texas Action for lack of subject matter jurisdiction (because the suit
`
`was filed prematurely) and for lack of personal jurisdiction. Daiichi Sankyo Japan also filed a
`
`motion to transfer the Texas Action to this Court. Briefing on those motions has not concluded.
`
`4
`
`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 10 of 28 PageID #: 474
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`
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`In light of Seagen’s Texas Action and its efforts to enforce the ’039 Patent, AstraZeneca
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`US and Daiichi Sankyo US, along with Daiichi Sankyo Japan, initiated this action.
`
`ARGUMENT
`
`I.
`
`THIS COURT HAS SUBJECT-MATTER JURISDICTION OVER
`ASTRAZENECA US’S CLAIMS
`
`This Court has subject-matter jurisdiction over the claims of each of three Plaintiffs here.
`
`Seagen’s efforts to avoid resolution of AstraZeneca US’s claims must be rejected, as Seagen
`
`cannot disavow its own judicial admissions in the Texas Action. As the Supreme Court explained
`
`in MedImmune, Inc. v. Genentech, Inc., jurisdiction exists under the Declaratory Judgment Act
`
`when “the facts alleged, under all the circumstances, show that there is a substantial controversy,
`
`between parties having adverse legal interests, of sufficient immediacy and reality to warrant the
`
`issuance of a declaratory judgment,” 549 U.S. 118, 127 (2007) (internal quotation marks and
`
`citation omitted). In so ruling, the Supreme Court “express[ly] disapprov[ed]” of the Federal
`
`Circuit’s more stringent “‘reasonable apprehension of imminent suit’ test.” Benitec Austl., Ltd. v.
`
`Nucleonics, Inc., 495 F.3d 1340, 1343 (Fed. Cir. 2007) (emphasis and citation omitted). Here,
`
`under “all the circumstances,” there is a substantial, immediate controversy between AstraZeneca
`
`US and Seagen.
`
`A.
`
`There Is a Substantial Controversy as to AstraZeneca US’s Legal Rights
`
`A determination of whether a substantial controversy exists between AstraZeneca US and
`
`Seagen warranting declaratory relief requires examining whether the parties have “adverse legal
`
`interests.” MedImmune, 549 U.S. at 127; see also Microchip Tech. Inc. v. Chamberlain Grp.,
`
`Inc., 441 F.3d 936, 942–43 (Fed. Cir. 2006). In declaratory judgment cases involving patent
`
`claims “Article III jurisdiction may be met where the patentee takes a position that puts the
`
`declaratory judgment plaintiff in the position of either pursuing arguably illegal behavior or
`
`5
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`

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`
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`abandoning that which he claims a right to do.” SanDisk Corp. v. STMicroelectronics, Inc., 480
`
`F.3d 1372, 1381 (Fed. Cir. 2007) (emphasis added). Here, this standard is met based on both direct
`
`and indirect allegations against AstraZeneca US.
`
`First, Seagen’s Texas Complaint directly alleges that AstraZeneca US’s conduct in
`
`marketing and promoting Enhertu® is illegal without specifically naming AstraZeneca US. For
`
`example, Seagen alleges:
`
` “[Daiichi Sankyo Japan] acts in concert with others to purposefully and voluntarily
`place the infringing products in a distribution chain that foreseeably leads to the
`infringing products being offered for sale, sold and used in Texas and this district
`as part of the ordinary stream of commerce,” (Exh. 1, Tex. Compl. ¶10 (emphasis
`added)); and
`
` “[Daiichi Sankyo Japan’s] subsidiaries and contractual business partners have
`operated as agents of [Daiichi Sankyo Japan] as parts of a business group in which
`executives of [Daiichi Sankyo Japan] make important operational decisions
`regarding the manufacture, importation, offer for sale, sale, and intended use of the
`infringing products, including DS-8201 [Enhertu®],” (id. ¶11 (emphases added)).
`
`It is beyond dispute that AstraZeneca US is within the so-called “business group” that
`
`commercializes Enhertu® in the United States. See supra pp. 3–4.
`
`Incredibly, Seagen now self-servingly seeks to re-write those allegations, apparently to
`
`allege infringement by every one of Daiichi Sankyo Japan’s “business partners” and members of
`
`its supposed “business group” except AstraZeneca US. (D.I. 11 at 17.) But Seagen cannot avoid
`
`declaratory judgment by pretending that its Texas Complaint does not mean what it says. See,
`
`e.g., Arris Grp., Inc. v. British Telecomms. PLC, 639 F.3d 1368, 1379–80 (Fed. Cir. 2011) (finding
`
`patentee’s “disclaimer that nothing in its assertion is meant to accuse any particular supplier of
`
`infringement” was merely a “transparent attempt” to defeat the supplier’s standing).
`
`Second, even if Seagen’s effort to back away from its allegations somehow were credited,
`
`that does not destroy jurisdiction. As the Federal Circuit repeatedly has held, when a patentee
`
`takes a position about a particular product that would render the declaratory judgment plaintiff’s
`
`6
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 12 of 28 PageID #: 476
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`
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`conduct arguably illegal, jurisdiction exists even in the absence of allegations directly against the
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`declaratory plaintiff. For example, in Arris, the Federal Circuit found jurisdiction in a case in
`
`which allegations against a customer gave rise to “implicit” assertions that the supplier had
`
`infringed the patent. Id. at 1375–81; see also, e.g., Arkema Inc. v. Honeywell Int’l, Inc., 706 F.3d
`
`1351, 1357 (Fed. Cir. 2013) (“Nor is it necessary that a patent holder make specific accusations
`
`against either the potential direct infringers or Arkema.”).4
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`Here, Seagen’s allegations that “promoting and encouraging the use” of Enhertu®
`
`(precisely what AstraZeneca US does) is actionable conduct, (Exh. 1, Tex. Compl. ¶25), are
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`implicit allegations against AstraZeneca US for inducement under 35 U.S.C. § 271(b) and more
`
`than sufficient to confer jurisdiction. See, e.g., Microsoft Corp. v. SynKloud Techs., LLC, C.A.
`
`No. 20-0007-RGA, 2020 WL 5369199, at *9 (D. Del. Sept. 8, 2020) (“substantial controversy”
`
`requirement can be satisfied by “‘allegations by the patentee or other record evidence that establish
`
`at least a reasonable potential that such a claim could be brought’” (emphasis added)); Allergan,
`
`Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1332 (Fed. Cir. 2003) (declaratory judgment suits can be
`
`used “by a potential defendant for a determination that its conduct does not induce infringement”).
`
`Finally, the cases Seagen cites to argue that there is not a sufficient controversy are
`
`unavailing. For example, Seagen relies on Proofpoint, Inc. v. InNova Patent Licensing, LLC, but
`
`that case’s reasoning actually supports finding jurisdiction here. C.A. No. 5:11-cv-02288-LHK,
`
`2011 WL 4915847 (N.D. Cal. Oct. 17, 2011). The court highlighted that the patentee’s parallel
`
`infringement suit against other parties alleged only that the “use” of the product constituted
`
`
`4 A lack of direct communications between Seagen and AstraZeneca US likewise cannot defeat
`AstraZeneca US’s standing. See, e.g., Arris, 639 F.3d at 1378 (“[D]irect communication between
`a patentee and a declaratory plaintiff is not necessary to confer standing . . . .”). Even Seagen
`admits that the lack of any direct pre-suit communications is “not dispositive.” (D.I. 11 at 16.)
`
`7
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 13 of 28 PageID #: 477
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`
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`infringement, but that the declaratory plaintiff in Proofpoint did not engage in that conduct. Id. at
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`*5.5 In contrast, as discussed above, Seagen has alleged that the very conduct in which
`
`AstraZeneca US engages—“promoting and encouraging” the use of Enhertu®—is actionable.
`
`Supra p. 7. The other cases on which Seagen relies provide no further support, as each is easily
`
`distinguishable. In TSMC Tech., Inc. v. Zond, LLC, C.A. No. 14-721-LPS-CJB, 2014 WL 7498398
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`(D. Del. Jan 8, 2014) (report and recommendation), the declaratory plaintiff did not attempt to
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`allege how its conduct was actionable and did not even include itself in the allegations in its own
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`declaratory complaint describing “the existence of a legal controversy.” Id. at *4. Similarly, in
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`Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329 (Fed. Cir. 2008), the declaratory plaintiff
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`relied primarily on the fact that the patentee had sued it years earlier based on a different patent
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`and a different product. Id. at 1341. The allegations here involve the same patent and product.
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`B.
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`The Dispute Has Sufficient Immediacy and Reality
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`There also is “sufficient immediacy and reality” to support jurisdiction. Generally, this
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`second MedImmune prong “focuse[s] on the declaratory judgment plaintiff’s conduct, and
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`examine[s] whether there had been ‘meaningful preparation’ to conduct potentially infringing
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`activity.” Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871, 879 (Fed. Cir. 2008) (cited in D.I. 11
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`at 17) (finding jurisdiction existed); see also, e.g., Gen. Elec. Co. v. Raytheon Techs. Corp., No.
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`2019-1319, 2020 WL 7635982, at *5 (Fed. Cir. Dec. 23, 2020) (“[I]t is generally sufficient for the
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`[party seeking to establish Article III jurisdiction] to show that it has engaged in, is engaging in,
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`or will likely engage in activity that would give rise to a possible infringement suit” even in the
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`5 Seagen’s reliance on Proofpoint is further unavailing because it relied upon a Federal Circuit
`opinion that was later vacated in its entirety. See Proofpoint, 2011 WL 4915847, at *3 (citing
`Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir.
`2011), cert. granted, judgment vacated sub nom. Ass’n for Molecular Pathology v. Myriad
`Genetics, Inc., 566 U.S. 902 (2012), and opinion vacated, appeal reinstated, 467 F. App’x 890
`(Fed. Cir. 2012)).
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`8
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 14 of 28 PageID #: 478
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`
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`absence of a “specific threat of infringement litigation by the patentee.”). Here, AstraZeneca US
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`has far surpassed “meaningful preparation” because it currently markets Enhertu® in the United
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`States.6
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`That fact is central to the Court’s inquiry, and Seagen does not dispute it. Seagen instead
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`argues that “[t]he mere existence of any real or theoretical ‘adverse economic interest’ between
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`Seagen and AstraZeneca US is insufficient to confer declaratory judgment jurisdiction.” (D.I. 11
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`at 18.) That principle, however, applies only when there is also an “absence of a controversy as to
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`a legal right.” Arris, 639 F.3d at 1374–75. Here, though Seagen’s actions indisputably threaten
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`AstraZeneca US’s economic interests by potentially impacting its marketing efforts and
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`compensation for those efforts, the proper focus is on whether there is a controversy between
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`AstraZeneca US and Seagen as to a legal right.7 As explained in Section I.A, supra, there are
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`adverse legal interests here.8 Tellingly, Seagen has not promised to refrain from bringing suit
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`against AstraZeneca US, and instead states (incorrectly) that nothing it has “said or done” to date
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`demonstrates an intent to bring suit against AstraZeneca US. (D.I. 11 at 17.) But Seagen’s mere
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`protest that it has not yet demonstrated an intent to sue is insufficient to moot the dispute. Cf., e.g.,
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`6 In contrast, in Benitec Australia, Ltd. v. Nucleonics, Inc., on which Seagen relies, the Federal
`Circuit found that there was not sufficient immediacy and reality when the allegedly infringing
`product was still several years away from FDA approval, and might not ever be approved. 495
`F.3d at 1346–47. That obviously is not the case here.
`7 Seagen focuses solely on the relief it currently seeks in the Texas court. But that is not necessarily
`determinative of the relief that it might seek in a later lawsuit.
`8 Seagen also again cites Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329 (Fed. Cir. 2008),
`purportedly for the proposition that a “damages-only” suit in Texas does not present “evidence of
`real, immediate or even future injury” as to AstraZeneca US. (D.I. 11 at 17.) But Prasco makes
`no such holding. Instead, it dealt with an inapposite situation where the patentee did not even
`“know about the existence” of the allegedly infringing product until the complaint in the
`declaratory judgment action was served. 537 F.3d at 1334. The patentee did not accuse the
`declaratory plaintiff of infringement, assert rights to the allegedly infringing product, or take “any
`actions which imply such claims.” Id. at 1340. That stands in stark contrast to the situation here.
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`9
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`

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`Case 1:20-cv-01524-LPS Document 20 Filed 01/26/21 Page 15 of 28 PageID #: 479
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`
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`Arris, 639 F.3d at 1379–81 (Article III case or controversy existed despite patentee’s “express
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`disclaimer” of any infringement allegations); SanDisk, 480 F.3d at 1382 (“direct and unequivocal
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`statement” that patentee had “absolutely no plan whatsoever to sue” was insufficient to moot
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`dispute). Seagen’s retention of the right to sue provides further support that it has “preserved th[e]
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`controversy at a level of ‘sufficient immediacy and reality.’” Revolution Eyewear, Inc. v. Aspex
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`Eyewear, Inc., 556 F.3d 1294, 1300 (Fed. Cir. 2009).
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`II.
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`THE COMPLAINT SUFFICIENTLY STATES A CLAIM
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`To state a claim upon which relief can be granted, a plaintiff’s allegations need only contain
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`a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R.
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`Civ. P. 8(a)(2). They must allege sufficient factual matter to “state a claim to relief that is plausible
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`on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); see also Ashcroft v. Iqbal, 556
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`U.S. 662, 678 (2009). This standard is satisfied when the factual allegations allow the court to
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`draw the reasonable inference that the defendant is liable. Iqbal, 556 U.S. at 678; Twombly, 550
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`U.S. at 555-56. On a Rule 12(b)(6) motion, “the court must accept as true all factual allegations
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`in the complaint and view them in the light most favorable to the plaintiff.” Microsoft Corp., 2020
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`WL 5369199, at *2.
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`For a claim for declaratory judgment o