Case 3:23-cv-04200-ZNQ-TJB Document 13-1 Filed 10/13/23 Page 1 of 30 PageID: 753
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`Civil Action No. 3:23-4200-ZNQ-TJB
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`Motion Date: November 6, 2023
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`ORAL ARGUMENT REQUESTED
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`Defendants.
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`Plaintiffs,
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`v.
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`ACUITAS THERAPEUTICS INC.,
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`ARBUTUS BIOPHARMA CORP. and
`GENEVANT SCIENCES GMBH,
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`BRIEF IN SUPPORT OF DEFENDANTS’
`MOTION TO DISMISS THE COMPLAINT
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`Raymond N. Nimrod
`Isaac Nesser
`Nicola R. Felice
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`T: 212-849-7000
`
`John Yang
`QUINN, EMANUEL, URQUHART &
`SULLIVAN, LLP
`3100 McKinnon St, Suite 1125
`Dallas, TX 75201
`T: 469-902-3600
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`Attorneys for Defendant Genevant
`Sciences GMBH
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`Arnold B. Calmann
`Katherine A. Escanlar
`SAIBER LLC
`18 Columbia Turnpike, Suite 200
`Florham Park, NJ 07932
`(973) 622-3333
`abc@saiber.com
`kescanlar@saiber.com
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`Attorneys for Defendants Arbutus Biopharma Corp. &
`Genevant Sciences GmbH
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`Daralyn J. Durie
`Eric C. Wiener
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`T: 415-362-6666
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`Kira A. Davis
`DURIE TANGRI LLP
`953 E. 3rd Street
`Los Angeles, CA 90013
`T: 213-992-4499
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`Attorneys for Defendant Arbutus Biopharma Corp.
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`Case 3:23-cv-04200-ZNQ-TJB Document 13-1 Filed 10/13/23 Page 2 of 30 PageID: 754
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ...........................................................................................................................1
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`BACKGROUND .............................................................................................................................4
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`A.
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`B.
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`The Defendants’ Patents And The Vaccine .............................................................4
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`Procedural History ...................................................................................................6
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`LEGAL STANDARDS ...................................................................................................................8
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`ARGUMENT ...................................................................................................................................9
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`I.
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`THE COMPLAINT SHOULD BE DISMISSED FOR LACK OF SUBJECT
`MATTER JURISDICTION .................................................................................................9
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`A.
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`The Complaint Does Not Allege A Reasonable Potential Of Indirect
`Infringement Liability ............................................................................................10
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`1.
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`2.
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`Contributory Infringement .........................................................................10
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`Induced Infringement .................................................................................13
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`The Complaint Does Not Allege A Reasonable Potential Of Indemnity
`Liability ..................................................................................................................15
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`The Complaint Does Not Allege Jurisdiction Based On Possible Economic
`Harm In Potential Future Business Dealings .........................................................19
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`The Complaint Does Not Even Allege A Controversy Between
`Defendants And Pfizer/BNT For Five Patents.......................................................21
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`B.
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`C.
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`D.
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`II.
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`THE COURT SHOULD EXERCISE ITS DISCRETION TO DECLINE TO
`HEAR THIS DECLARATORY JUDGMENT ACTION .................................................22
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`CONCLUSION ..............................................................................................................................25
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`i
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`TABLE OF AUTHORITIES
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`Cases
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`Page
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`Acra Turf Club, LLC v. Zanzuccki,
`561 F. App’x 219 (3d Cir. 2014) .............................................................................................23
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`Acuitas Therapeutics Inc. v. Genevant Scis. GmbH et al.,
`No. 22-cv-02229-MKV (S.D.N.Y.) ...........................................................................................3
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`Adenta GmbH v. OrthoArm, Inc.,
`501 F.3d 1364 (Fed. Cir. 2007)..................................................................................................9
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`Allied Min. Prod., Inc. v. Osmi, Inc.,
`870 F.3d 1337 (Fed. Cir. 2017)................................................................................................20
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`Alnylam Pharms., Inc. v. Pfizer, Inc.,
`No. 22-336 (D. Del. Mar. 17, 2022), Dkt. 13 ............................................................................6
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`Arbutus Biopharma Corp. et al. v. Pfizer Inc. et al.,
`No. 3:23-cv-01876-ZNQ (D.N.J.)..............................................................................................1
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`Arris Grp., Inc. v. Brit. Telecommunications PLC,
`639 F.3d 1368 (Fed. Cir. 2011)....................................................................................11, 12, 20
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`Asia Vital Components Co. v. Asetek Danmark A/S,
`837 F.3d 1249 (Fed. Cir. 2016)................................................................................................20
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`Bio-Tech. Gen. Corp. v. Genentech, Inc.,
`80 F.3d 1553 (Fed. Cir. 1996)..................................................................................................24
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`In re Burlington Coat Factory Sec. Litig.,
`114 F.3d 1410 (3d Cir. 1997).....................................................................................................5
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`Commc’ns Test Design, Inc. v. Contec, LLC,
`952 F.3d 1356 (Fed. Cir. 2020)................................................................................................22
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`Creative Compounds, LLC v. Starmark Lab’ys,
`651 F.3d 1303 (Fed. Cir. 2011)................................................................................................21
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`Fiskars, Inc. v. Hunt Mfg. Co.,
`221 F.3d 1318 (Fed. Cir. 2000)................................................................................................24
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`Gould Elec. Inc. v. United States,
`220 F.3d 169 (3d Cir. 2000)...........................................................................................9, 15, 18
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`ii
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`Hartig Drug Co. v. Senju Pharm. Co.,
`836 F.3d 261 (3d Cir. 2016).....................................................................................................18
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`Hoots v. Commonwealth of Pa.,
`672 F.2d 1133 (3d Cir. 1982)...................................................................................................24
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`Intel Corp. v. Future Link Sys., LLC,
`No. CV 14-377-LPS, 2015 WL 649294 (D. Del. Feb. 12, 2015) ............................................12
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`MedImmune, Inc. v. Genentech, Inc.,
`549 U.S. 118 (2007) ...................................................................................................................8
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`Microchip Tech., Inc. v. Chamberlain Grp., Inc.,
`441 F.3d 936 (Fed. Cir. 2006)..................................................................................................20
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`Microsoft Corp. v. DataTern, Inc.,
`755 F.3d 899 (Fed. Cir. 2014).......................................................................................... passim
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`Mitek Sys., Inc. v. United Servs. Auto. Ass’n,
`34 F.4th 1334 (Fed. Cir. 2022) ........................................................................................ passim
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`Pension Ben. Guar. Corp. v. White Consol. Indus., Inc.,
`998 F.2d 1192 (3d Cir. 1993).....................................................................................................5
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`Prasco, LLC v. Medicis Pharm. Corp.,
`537 F.3d 1329 (Fed. Cir. 2008)................................................................................................19
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`Priore v. Caravan Ingredients, Inc.,
`No. CIV. 13-5229 KSH CLW, 2014 WL 2931182 (D.N.J. June 30, 2014) ............................18
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`Rules / Statutes
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`35 U.S.C. § 287(a) ...........................................................................................................................5
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`Fed. R. Civ. P. 12(b)(1)................................................................................................................1, 5
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`iii
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`INTRODUCTION
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`Acuitas Therapeutics Inc. (“Acuitas”) filed this declaratory judgment action against
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`Genevant Sciences GmbH (“Genevant”) and Arbutus Biopharma Corp. (“Arbutus” and, together
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`with Genevant, “Defendants”) with respect to ten patents that Arbutus owns and licensed to
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`Genevant (“Defendants’ Patents”). The Complaint seeks declarations that the manufacture, use,
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`offer to sell, and sale of the COVID-19 vaccine COMIRNATY® (“Comirnaty”) does not infringe
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`any claim of Defendants’ Patents and that the patents are invalid. Comirnaty is manufactured and
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`sold by nonparties Pfizer, Inc. (“Pfizer”) and BioNTech SE (“BNT”). Defendants hereby move to
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`dismiss the Complaint for lack of subject matter jurisdiction under Fed. R. Civ. P. 12(b)(1) because
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`Acuitas has not met its burden to allege an actual controversy between Acuitas and Defendants.
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`In the alternative, the Court should exercise its discretion to decline to hear this declaratory
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`judgment action.
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`The Complaint’s allegations do not establish a controversy between Acuitas and
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`Defendants, because there is none. Acuitas does not make or sell Comirnaty, which is the sole
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`product at issue, and Defendants have never accused Acuitas of infringing Defendants’ Patents or
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`indicated an intent to sue Acuitas. Indeed, the Complaint does not allege that Defendants have
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`ever accused Acuitas of infringing Defendants’ Patents (whether directly or indirectly), that
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`Defendants have ever sent Acuitas any communication regarding Comirnaty whatsoever, or that
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`Defendants have ever tried to stop Acuitas from licensing or supplying any lipid or LNP
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`technology to Pfizer/BNT for use in Comirnaty. The only controversy is between Defendants and
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`the nonparties Pfizer and BNT, which make and sell Comirnaty—a controversy that is currently
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`being litigated in a separate action pending before this Court which does not involve Acuitas. See
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`Arbutus Biopharma Corp. et al. v. Pfizer Inc. et al., No. 3:23-cv-01876-ZNQ (D.N.J.) (the
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`“Pfizer/BNT Action”). The Complaint should therefore be dismissed.
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`Acuitas argued three bases for subject matter jurisdiction in its recent letter to the Court
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`(D.I. 9), but none of its theories withstands scrutiny. First, Acuitas asserts that there is a case or
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`controversy between Defendants and Acuitas based on a potential claim of indirect infringement
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`(i.e., contributory or induced infringement). Acuitas does not allege that it indirectly infringes
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`Defendants’ Patents, unsurprisingly, and Defendants have made no assertions from which Acuitas
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`can contend that it could be liable for contributory or induced infringement. Specifically,
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`Defendants have never alleged that the lipids that Acuitas licenses to Pfizer and BNT are unsuitable
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`for substantial noninfringing uses or that Acuitas encouraged Pfizer and BNT to infringe. Acuitas
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`therefore has no basis to allege that it faces potential liability for indirect infringement.
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`Second, Acuitas alleges that it has received indemnity demands from BNT as to liability
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`that BNT may incur in the Pfizer/BNT Action. Those allegations are insufficient because, under
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`binding Federal Circuit authority, bare indemnity demands do not create subject matter
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`jurisdiction. Mitek Sys., Inc. v. United Servs. Auto. Ass’n, 34 F.4th 1334, 1345-46 (Fed. Cir. 2022).
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`A declaratory judgment plaintiff must instead allege facts showing a reasonable potential of
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`indemnity liability. The Complaint here alleges nothing of the sort.
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`Notably, Acuitas’s failure to allege facts concerning its purported indemnity liability is not
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`an unintentional omission but rather evidence of the fundamental shortcoming of its jurisdictional
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`theory. Acuitas has now had multiple opportunities to plead subject matter jurisdiction adequately,
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`yet it has never provided any factual basis for its alleged reasonable potential of indemnity
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`2
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`liability.1 Moreover, it has repeatedly resisted providing the alleged indemnity demands or an
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`unredacted indemnity agreement to Defendants.2
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`Third, in its response to Defendants’ premotion letter, Acuitas argued that jurisdiction
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`exists because of harm Acuitas may purportedly incur in its business dealings with other
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`customers. That theory was not asserted as a basis for jurisdiction in the Complaint, which includes
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`a specific section entitled “Jurisdiction and Venue” that never mentions this new ground. D.I. 1
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`at 16. But the theory fails in any event because it is based on a hypothetical future harm, rather
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`than the concrete injury required to establish subject matter jurisdiction.
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`Moreover, even if one of Acuitas’s three foregoing arguments were correct (they are not),
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`there is a separate, independent, and indisputable reason for dismissal of Acuitas’s declaratory
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`judgment claims as to at least five of Defendants’ Patents. Specifically, Defendants have not
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`asserted those patents in the Pfizer/BNT Action, nor have Pfizer and BNT asserted counterclaims
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`on those patents against Defendants. Acuitas’s claims regarding those patents should be dismissed
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`on that basis as well.
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`Finally, even if Acuitas could establish subject matter jurisdiction (it cannot), the Court
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`should exercise its discretion to decline to hear this declaratory judgment action because
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`1 Acuitas previously sued Defendants in the Southern District of New York, asserting claims
`substantively identical to those here based on equally threadbare jurisdictional allegations. See
`Acuitas Therapeutics Inc. v. Genevant Scis. GmbH et al., No. 22-cv-02229-MKV (S.D.N.Y.) (the
`“SDNY Action”). When Defendants noted the lack of subject matter jurisdiction in a premotion
`letter there, Acuitas took the opportunity to amend its Complaint but chose not to disclose or
`meaningfully describe the scope and terms of any indemnity agreement or the basis or potential
`merits of any indemnity demands. When Acuitas then voluntarily dismissed the SDNY Action
`and refiled here, it again chose not to describe or disclose any factual basis for its purported
`potential of indemnity liability.
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`2 On the afternoon before the present brief was due to be filed, Acuitas proposed to send a redacted
`version of the agreement subject to multiple unacceptable terms and conditions. Defendants
`rejected that belated and unreasonable proposal.
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`3
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`Pfizer/BNT are sufficiently representing Acuitas’s interest in the Pfizer/BNT Action. Proceeding
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`with this action would merely complicate the issues already pending before the Court by
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`introducing patents not relevant to the Pfizer/BNT Action and needlessly create additional issues
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`relating to damages and discovery. Those facts favor discretionary dismissal.
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`The Court should dismiss Acuitas’s Complaint for lack of subject matter jurisdiction or, in
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`the alternative, in the exercise of its discretion.
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`A.
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`The Defendants’ Patents And The Vaccine
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`BACKGROUND
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`Genevant is a technology-focused nucleic acid delivery company and a world leader in the
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`lipid nanoparticle (“LNP”) space, with the industry’s most robust and expansive LNP patent
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`portfolio and decades of expertise in nucleic acid drug delivery and development. Genevant has
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`licensed LNP-related patents from Arbutus, which is a clinical-stage biopharmaceutical company
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`with deep virology expertise and an unwavering focus on curing a variety of conditions.
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`Defendants’ Patents cover important aspects of LNP technology for delivering RNA to cells in the
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`body for therapeutic effect and are generally directed to nucleic acid lipid particles comprising
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`specific types of lipids, sometimes in required ratios. See, e.g., Dkt. 1-1 (U.S. Patent No.
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`8,058,069, claim 1). All of Defendants’ Patents require both a nucleic acid (e.g., mRNA) and an
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`LNP with specific lipid types.
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`Genevant and BNT have a long history of collaboration on LNP-related research and
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`development programs. In 2018, BNT licensed Defendants’ Patents from Genevant, among other
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`patents, in connection with BNT’s development of therapeutics in the oncology field. Pfizer/BNT
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`Action, D.I. 1 ¶ 6. This 2018 license was limited, however, to the development of certain cancer
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`or rare disease treatments and did not cover infectious diseases such as COVID-19. Id.
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`4
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`Accordingly, on November 23, 2020, Defendants sent a letter to Pfizer/BNT asking for the
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`opportunity to discuss a partnering arrangement that would enable Pfizer/BNT to benefit from
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`Genevant scientists’ extensive expertise with the formulation and manufacture of LNP delivery
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`systems and welcoming discussions of licensing Defendants’ Patents. D.I. 1 ¶ 35. On October
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`12, 2021, Defendants sent a second letter identifying another Arbutus patent relevant to the
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`proposed discussion. Id. ¶ 36. And on June 3, 2022, Defendants sent a third letter identifying two
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`more newly issued patents. Id. ¶ 37. These letters also noted, under 35 U.S.C. § 287(a), that the
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`making, using, selling, offering for sale, or importing into the United States of Comirnaty may
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`infringe Defendants’ Patents. See D.I. 1 ¶¶ 35-37; Exs. A, B, & C.3 The letters did not analyze
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`potential infringement claims (e.g., by attaching claim charts).
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`Defendants did not publicize the foregoing letters, nor did they send them to Acuitas. There
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`was no reason to send them to Acuitas, whose only connection to Comirnaty is to license
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`technology to Pfizer and BNT for use in Comirnaty. For example, although Pfizer/BNT have
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`alleged that two of the lipids in Comirnaty implicate technology disclosed in Acuitas’s patents,
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`they have not alleged that Pfizer/BNT actually obtain those lipids (or any other component of
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`Comirnaty) from Acuitas. Pfizer/BNT Action, D.I. 17 at 55. Likewise, Acuitas alleges here that
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`its technology—the ALC-315 cationic lipid and the ALC-159 polyethylene glycol (PEG)-lipid
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`conjugate—“is used, under license, in Pfizer and BioNTech’s COVID-19 vaccine.” D.I. 1 ¶ 12;
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`see also id. ¶¶ 6, 21. Furthermore, no one has ever suggested, much less alleged, that Acuitas’s
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`3 References to “Ex. __” are exhibits to the accompanying Declaration of Nicola R. Felice. On a
`Rule 12(b)(1) facial challenge, the Court may consider documents “explicitly relied upon in the
`complaint.” In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997)); see
`also Pension Ben. Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993)
`(“[C]ourt may consider an undisputedly authentic document [attached] … to a motion to dismiss
`if the plaintiffs[’] claims are based on the document.”).
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`5
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`license agreement with Pfizer/BNT precludes Pfizer/BNT from licensing additional LNP-related
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`technology from Genevant, Arbutus, or anyone else. To the contrary, Pfizer itself has alleged that
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`BNT licensed technology used in the vaccine from “multiple partners,” of which Acuitas is only
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`one. Alnylam Pharms., Inc. v. Pfizer, Inc., No. 22-336 (D. Del. Mar. 17, 2022), D.I. 13 at 26-27.
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`This is common, as there is no inherent conflict between licensors of LNP technology. Defendants
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`have never told Acuitas to stop licensing or supplying any lipid or LNP technology to Pfizer/BNT.
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`B.
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`Procedural History
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`On March 18, 2022, before discussions between Defendants and Pfizer/BNT had
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`concluded, Acuitas filed a declaratory judgment action against Defendants in the Southern District
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`of New York, as to nine of Defendants’ Patents. SDNY Action, D.I. 1 ¶ 14. The complaint sought
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`declarations that Comirnaty did not infringe Defendants’ Patents and that those patents are invalid.
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`Defendants promptly sought leave to move to dismiss the SDNY Action for lack of subject matter
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`jurisdiction because Acuitas had failed to meet its burden to allege an actual controversy between
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`it and Defendants. SDNY Action, D.I. 36-1. As Defendants explained, questions concerning
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`Defendants’ Patents and Comirnaty should not be resolved in a litigation filed by Acuitas, with
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`which Defendants had never even communicated regarding their patents or Comirnaty.
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`On September 6, 2022, at the SDNY Court’s invitation, Acuitas amended its complaint.
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`SDNY Action, D.I. 42. The amended complaint did not allege any new information material to
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`the existence of a case or controversy. Accordingly, on October 4, 2022, Defendants moved to
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`dismiss that complaint, arguing among other things that Acuitas’s bare allegations of potential
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`liability for indemnity and indirect infringement failed to demonstrate an actual controversy.
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`SDNY Action, D.I. 44. Acuitas disagreed and, for the first time in its opposition brief, disclosed
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`redacted excerpts of a purported indemnification agreement with BNT. As discussed in
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`6
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`Defendants’ subsequent reply brief, those redacted excerpts remained insufficient to demonstrate
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`subject matter jurisdiction. SDNY Action, D.I. 50, 54.
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`On April 4, 2023, after discussions between Defendants and Pfizer/BNT failed to result in
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`a license agreement, Defendants sued Pfizer and BNT in this District, alleging that their
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`manufacture, use, offer to sell, and sale of Comirnaty infringes five of Defendants’ Patents.
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`Pfizer/BNT Action, D.I. 1. Pfizer and BNT filed counterclaims of noninfringement and invalidity
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`as to those patents. Pfizer/BNT Action, D.I. 17. Pfizer and BNT have never moved to add Acuitas
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`as a party, nor has Acuitas tried to become a party to that case, which remains pending before this
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`Court.4 On August 4, 2023, after Defendants’ motion to dismiss the SDNY Action had been fully
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`briefed, Acuitas voluntarily dismissed the SDNY Action and refiled here, again seeking
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`declarations that Comirnaty does not infringe ten of Defendants’ Patents and that those patents are
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`invalid. D.I. 1.5 Acuitas’s Complaint here is essentially identical to the one it had filed in the
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`SDNY Action as to the alleged basis for subject matter jurisdiction.
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`Notably, although Acuitas’s Complaint relies on its purported indemnity obligations as a
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`basis for jurisdiction, it does not quote or include even the redacted excerpts of the purported
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`indemnity agreement that Acuitas belatedly introduced in its briefing in the SDNY Action. On
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`4 Acuitas’s premotion letter accuses Defendants of previously implying in the SDNY Action that
`they had no intention of ever suing Pfizer and BNT. D.I. 9 at 1. That is incorrect. As Acuitas
`knows, Defendants never stated that they had no intention of suing Pfizer and BNT. All
`Defendants said was that, given the then ongoing discussions between Genevant and Pfizer/BNT,
`there was “no compelling reason for judicial relief at th[at] time.” SDNY Action, D.I. 44 at 25.
`Defendants also noted that “[s]hould those negotiations ultimately not succeed, any litigation
`regarding Comirnaty and the LNP technology it uses will flow from those discussions between the
`actual parties to the negotiation.” Id. Defendants’ action against Pfizer/BNT is entirely consistent
`with its prior statements.
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`5 The patents at issue here and in the SDNY Action are identical except that one of the patents
`there (U.S. Patent No. 9,404,127) is not at issue here, and two of the patents here (U.S. Patent Nos.
`11,298,320 and 11,318,098) were not at issue there.
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`7
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`August 21, 25, and 29, 2023, Defendants asked Acuitas for the full unredacted agreement to enable
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`the parties and Court to efficiently address any relevance it might have to subject matter
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`jurisdiction. See D.I. 8 at 2. And on August 29, 2023, Defendants also asked Acuitas for the
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`alleged indemnity demand letters from BNT and related correspondence. Id. On the same date,
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`Defendants asked BNT for the same materials. In both cases, Defendants agreed to designate the
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`requested materials as Outside Attorneys’ Eyes Only. BNT refused and Acuitas did not respond
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`until the afternoon before the present brief was due to be filed.
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`On September 15, 2023, Defendants filed a letter with the Court seeking a premotion
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`conference on the present motion to dismiss. In that letter, Defendants addressed Acuitas’s failure
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`to provide the unredacted license agreement and indemnity demands and explained that
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`Defendants sought those materials to “to assess the need for motion practice or to address fully
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`[their] relevance to the jurisdictional issues in briefing to the Court.” D.I. 8 at 2. In response to
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`Defendant’s letter, Acuitas again chose not to provide or offer to provide Defendants with the
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`requested materials. D.I. 9. Moreover, as explained below, Acuitas should not be allowed to rely
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`on these materials because they constitute evidence extrinsic to the Complaint are thus irrelevant
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`to the analysis of Defendants’ facial challenge.
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`LEGAL STANDARDS
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`The threshold question for declaratory judgment jurisdiction is “whether the facts alleged,
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`under all the circumstances, show that there is a substantial controversy, between parties having
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`adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory
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`judgment.” MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007). It is Acuitas’s burden
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`to plead facts sufficient to establish subject matter jurisdiction at the time of the complaint.
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`Microsoft Corp. v. DataTern, Inc., 755 F.3d 899, 903 (Fed. Cir. 2014). On a facial challenge to
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`subject matter jurisdiction—i.e., an argument that considers a complaint on its face and asserts that
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`it is insufficient to create subject matter jurisdiction—“the court must only consider the allegations
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`of the complaint and documents referenced therein and attached thereto, in the light most favorable
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`to the plaintiff.” Gould Elec. Inc. v. United States, 220 F.3d 169, 176 (3d Cir. 2000) (emphasis
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`added). Where a declaratory judgment action concerns patent rights, Federal Circuit law controls
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`the subject matter jurisdiction inquiry. Adenta GmbH v. OrthoArm, Inc., 501 F.3d 1364, 1368
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`(Fed. Cir. 2007).
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`ARGUMENT
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`I.
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`THE COMPLAINT SHOULD BE DISMISSED FOR LACK OF SUBJECT
`MATTER JURISDICTION
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`The Complaint does not allege that Defendants have ever accused Acuitas of direct or
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`indirect infringement, that Defendants have ever threatened to sue Acuitas, or that Defendants have
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`ever even communicated with Acuitas regarding Comirnaty or Defendants’ Patents. Instead,
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`relying on a jurisdictional theory involving entities that supply product to an accused infringer, the
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`Complaint asserts that subject matter jurisdiction exists based on Defendants’ infringement claims
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`against Pfizer and BNT. See, e.g., D.I. 1 ¶¶ 51-54. None of Acuitas’s articulated bases for subject
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`matter jurisdiction withstands scrutiny. The Complaint does not allege that Defendants have ever
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`asserted that Acuitas meets any of the numerous legal elements required for induced or
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`contributory infringement (see infra § I(A)). Acuitas did not (and cannot) allege a reasonable
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`potential of indemnity liability to BNT ((see infra § I(B)). Acuitas’s vague suggestion that
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`Defendants’ claims against Pfizer/BNT will cause it potential economic harm cannot, under the
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`law, sustain subject matter jurisdiction (see infra § I(C)). Additionally, there is an indisputable
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`absence of a case or controversy regarding the five patents included in this suit that Defendants
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`have not asserted against Pfizer/BNT (see infra § I(D)). For these reasons, the Complaint must be
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`dismissed.
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`9
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`

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`Case 3:23-cv-04200-ZNQ-TJB Document 13-1 Filed 10/13/23 Page 14 of 30 PageID: 766
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`
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`A.
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`The Complaint Does Not Allege A Reasonable Potential Of Indirect
`Infringement Liability
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`Acuitas has not met its burden to establish jurisdiction on theories of indirect infringement.
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`Unsurprisingly, Acuitas does not allege that it indirectly infringes Defendants’ Patents, which is,
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`of course, what it would ultimately seek to disprove in this action. Instead, the Complaint relies
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`on Defendants’ letters to Pfizer (copying BNT) and Defendants’ suit against Pfizer/BNT to support
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`its allegation that jurisdiction exists here based on Acuitas’s potential liability for indirect
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`infringement. But to establish jurisdiction on theories of indirect infringement “‘there must be
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`allegations by the patentee [i.e., Defendants] or other record evidence that establish at least a
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`reasonable potential that [claims for indirect infringement] could be brought’” against Acuitas.
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`Mitek, 34 F.4th at 1343 (quoting Microsoft, 755 F.3d at 905) (emphasis added). This requires
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`separate consideration of the different types of indirect infringement—induced and contributory—
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`and the facts alleged in light of the elements of those two potential causes of action. Microsoft,
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`755 F.3d at 904–05; Mitek, 34 F.4th at 1343. The mere existence of litigation against a customer
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`does not suffice to establish a supplier’s reasonable potential of suit for indirect infringement.
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`Microsoft, 755 F.3d at 904. Rather, there must be at least an “implied[] assert[ion]” by the patentee
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`that the supplier committed acts meeting the elements required to establish a claim of contributory
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`or induced infringement. Id. at 905.
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`Here, there has been no such assertion, implied or otherwise, creating a potential for
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`indirect infringement liability. Neither Defendants’ letters to Pfizer/BNT nor Defendants’ suit
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`against Pfizer/BNT mention Acuitas, let alone imply that Acuitas committed acts that would meet
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`any of the elements of contributory or induced infringement.
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`1.
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`Contributory Infringement
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`To state a claim for contributory infringement, a patent holder must allege, inter alia, that:
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`10
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`Case 3:23-cv-04200-ZNQ-TJB Document 13-1 Filed 10/13/23 Page 15 of 30 PageID: 767
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`(a) the [component] supplier’s product was used to commit acts of direct
`infringement; (b) the product’s use constituted a “material part of the invention”;
`(c) the supplier knew its product was “especially made or especially adapted for
`use in an infringement” of the patent; and (d) the product is “not a staple article or
`commodity of commerce suitable for substantial noninfringing use.”
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`Arris Grp., Inc. v. Brit. Telecommunications PLC, 639 F.3d 1368, 1376 (Fed. Cir. 2011) (citation
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`omitted). Accordingly, for a supplier to have a reasonable potential of suit for contributory
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`infringement, the patentee must have at least “impliedly assert[ed]” both that the supplier’s product
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`is “not a staple article or commodity of commerce suitable for substantial noninfringing use,” see
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`Microsoft, 755 F.3d at 906, and that the supplier knew its product is especially made or especially
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`adapted for use in infringing the relevant patent. Id. The inquiry thus necessarily focuses on the
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`patentee’s communications concerning the supplier.
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`Here, Acuitas does not allege that Defendants’ communications—their letters to
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`Pfizer/BNT and their Complaint in the Pfizer/BNT Action—even mentioned Acuitas, much less
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`contended that (i) the lipids Acuitas allegedly licenses are unsuitable for substantial noninfringing
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`uses, or (ii) Acuitas knew the lipids were especially made or adapted for use in infringing
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`Defendants’ Patents. Those lacking allegations are dispositive.
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`For example, in Microsoft, the supplier/declaratory judgment plaintiff (Microsof