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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 1 of 25
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`ACUITAS THERAPEUTICS INC.,
`
`
`Plaintiff,
`
`
`GENEVANT SCIENCES GMBH and
`ARBUTUS BIOPHARMA CORP.,
`
`
`Defendants.
`
`v.
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`
`
`
`
`C.A. No. 1:22-cv-02229-MKV
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`PLAINTIFF ACUITAS THERAPEUTICS INC.’S OPPOSITION TO
`DEFENDANTS’ MOTION TO DISMISS THE FIRST AMENDED COMPLAINT
`
`
`
`
`
`
`
`
`
`
`
`
`
`Nicholas Groombridge
`Eric Alan Stone
`Josephine Young
`Allison C. Penfield
`Chih-wei Wu
`PAUL, WEISS, RIFKIND, WHARTON
`& GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-3000
`
`Saurabh Gupta (pro hac vice granted)
`PAUL, WEISS, RIFKIND, WHARTON
`& GARRISON LLP
`Washington, D.C. 20006-1047
`(202) 223-7300
`
`Attorneys for Plaintiff Acuitas Therapeutics Inc.
`
`Dated: November 1, 2022
`
`
`
`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 2 of 25
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`
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`TABLE OF CONTENTS
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`Preliminary Statement ......................................................................................................................1
`
`Statement of Facts ............................................................................................................................4
`
`Argument .........................................................................................................................................9
`
`I.
`
`This Court Has Subject Matter Jurisdiction Because Acuitas’s Declaratory
`Judgment Action Presents “a Case of Actual Controversy” Between the Parties .............10
`
`A.
`
`B.
`
`The Risk of Having To Indemnify BioNTech Creates Subject Matter
`Jurisdiction Over Acuitas’s Declaratory Judgment Action ...................................10
`
`The Risk That Arbutus and Genevant Could Sue Acuitas for Indirect
`Infringement Creates Subject Matter Jurisdiction Over Acuitas’s
`Declaratory Judgment Action ................................................................................14
`
`C.
`
`Defendants’ “Four Reasons” Provide No Basis to Dismiss the Complaint ...........15
`
`II.
`
`The Court Should Not Exercise Its Discretion To Dismiss the Complaint .......................18
`
`III. While No Dismissal Is Warranted, Any Dismissal Would Be Without Prejudice ............20
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`Conclusion .....................................................................................................................................21
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`
`i
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 3 of 25
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`
`
`Cases
`
`3M Co. v. Avery Denison Corp.,
`673 F.3d 1372 (Fed. Cir. 2012)..........................................................................................10, 12
`
`ABB Inc. v. Cooper Indus., Inc.,
`635 F.3d 1345 (Fed. Cir. 2011)..........................................................................................13, 14
`
`Allied Mineral Prods., Inc. v. OSMI, Inc.,
`870 F.3d 1337 (Fed. Cir. 2017)................................................................................................17
`
`Arbutus Biopharma Corp. v. Moderna, Inc.,
`1:22-cv-00252-MSG (D. Del. Feb. 28, 2022) ..........................................................................17
`
`Arris Grp., Inc. v. British Telecomms. PLC,
`639 F.3d 1368 (Fed. Cir. 2011)..........................................................................................15, 16
`
`BroadSign Int’l, LLC v. T-Rex Prop. AB,
`No. 16 CV 04586-LTS, 2018 WL 357317 (S.D.N.Y. Jan. 10, 2018)......................................12
`
`Cedars-Sinai Med. Ctr. v. Watkins,
`11 F.3d 1573 (Fed. Cir. 1993)............................................................................................10, 20
`
`Commn’s Test Design, Inc. v. Contec, LLC,
`952 F.3d 1356 (Fed. Cir. 2020)................................................................................................19
`
`EMC Corp. v. Norand Corp.,
`89 F.3d 807 (Fed. Cir. 1996)....................................................................................................20
`
`Hewlett-Packard Co. v. Acceleron LLC,
`587 F.3d 1358 (Fed. Cir. 2009)........................................................................................ passim
`
`Intel Corp. v. Future Link Sys., LLC,
`No. CV 14-377-LPS, 2015 WL 649294 (D. Del. Feb. 12, 2015) ............................................12
`
`Lifeguard Licensing Corp. v. Kozak,
`371 F. Supp. 3d 114 (S.D.N.Y. 2019)......................................................................................21
`
`MedImmune, Inc. v. Genentech, Inc.,
`549 U.S. 118 (2007) .................................................................................................................10
`
`Micron Tech., Inc. v. Mosaid Techs., Inc.,
`518 F.3d 897, 903 (Fed. Cir. 2008)..........................................................................................19
`
`Microsoft Corp. v. DataTern, Inc.,
`755 F.3d 899 (Fed. Cir. 2014)......................................................................................11, 12, 15
`
`ii
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 4 of 25
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`
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`Microsoft Corp. v. SynKloud Techs., LLC,
`484 F. Supp. 3d 171 (D. Del. 2020) .........................................................................................12
`
`Mitek Sys., Inc. v. United Servs. Auto. Ass’n,
`34 F.4th 1334 (Fed. Cir. 2022) ........................................................................................ passim
`
`Monolithic Power Sys., Inc. v. O2 Micro Int’l Ltd.,
`No. C 07-2363 CW, 2008 WL 3266647 (N.D. Cal. Aug. 6, 2008) .........................................17
`
`Organic Seed Growers & Trade Ass’n v. Monsanto Co.,
`718 F.3d 1350 (Fed. Cr. 2013) .................................................................................................16
`
`Proofpoint, Inc. v. InNova Pat. Licensing, LLC,
`No. 5:11-CV-02288-LHK, 2011 WL 4915847 (N.D. Cal. Oct. 17, 2011) ........................12, 21
`
`SanDisk Corp. v. STMicroelectronics, Inc.,
`480 F.3d 1372 (Fed. Cir. 2007)..........................................................................................19, 20
`
`SRI Int’l Inc. v. Advanced Tech. Lab’ys, Inc.,
`127 F.3d 1462 (Fed. Cir. 1997)................................................................................................13
`
`Tasini v. New York Times Co.,
`184 F. Supp. 2d 350 (S.D.N.Y. 2002)......................................................................................21
`
`Univ. of Pittsburgh v. Varian Med. Sys., Inc.,
`569 F.3d 1328 (Fed. Cir. 2009)................................................................................................20
`
`Warner-Lambert Co. v. Apotex Corp.,
`316 F.3d 1348 (Fed. Cir. 2003)................................................................................................15
`
`Statutes
`
`28 U.S.C. § 2201 ............................................................................................................................10
`
`35 U.S.C. § 271 ........................................................................................................................14, 15
`
`35 U.S.C. § 287 ...................................................................................................................... passim
`
`Other Authorities
`
`Fed. R. Civ. P. 41(b) ......................................................................................................................20
`
`Fed. R. Civ. P. 12(b)(1)............................................................................................................20, 21
`
`
`
`
`iii
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 5 of 25
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`PRELIMINARY STATEMENT
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`This case presents a controversy over which federal courts have subject-matter jurisdiction:
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`A declaratory judgment action by a product supplier against patent owners who have threatened
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`to sue that supplier’s customers, in circumstances that could implicate the supplier’s own liability.
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`The Federal Circuit reconfirmed the justiciability of such cases earlier this year, in an opinion that
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`Defendants omit. See Mitek Sys., Inc. v. United Servs. Auto. Ass’n, 34 F.4th 1334 (Fed. Cir. 2022).
`
`This case is about Comirnaty®, commonly known as the “Pfizer vaccine” against
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`COVID-19. Despite the shorthand, Pfizer actually worked with a company called BioNTech to
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`develop Comirnaty®. One of the critical components of Comirnaty®, a messenger RNA
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`(“mRNA”) vaccine, is a lipid nanoparticle (“LNP”) made up of compounds called lipids that can
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`protect the mRNA so that it can be safely delivered into the person’s cells. Pursuant to a license
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`agreement, Plaintiff Acuitas provided BioNTech with the lipids in Comirnaty®. Acuitas worked
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`for over a decade to develop those lipids. Acuitas’s hard work and insights were essential to
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`Comirnaty®’s success.
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`Defendants Arbutus and Genevant, on the other hand, had nothing to do with the
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`development of Comirnaty®, or of Acuitas’s lipids used therein. None of Defendants’ own lipids
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`or mRNA-LNPs are used in any approved product. Yet they appear to have been writing patent
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`claims to try to ensnare Comirnaty®, and they sent demand letters to Pfizer, copying Acuitas’s
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`licensee and partner BioNTech, preserving their right to seek damages for patent infringement
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`under nine Arbutus patents they say Comirnaty® may infringe. All of those patents allegedly
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`encompass compositions containing lipids and mRNA.
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`In response to Defendants’ letters, BioNTech formally notified Acuitas of an
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`indemnification claim under the Acuitas-BioNTech License Agreement. Acuitas then brought this
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`1
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 6 of 25
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`
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`action, seeking a declaration either that Comirnaty® does not infringe the patents listed in
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`Defendants’ demand letters, or that the patents are invalid, or both.
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`Defendants have moved to dismiss Acuitas’s complaint for lack of subject-matter
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`jurisdiction, asserting that there is no controversy between themselves and Acuitas. Defendants
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`are wrong. Controlling Federal Circuit precedent identifies two independent “sufficient conditions
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`for finding a case or controversy” in a case like this: the Court has jurisdiction either if the product
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`supplier faces a “reasonable potential” of having to indemnify its customer, or if the claims
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`threatened against the customer imply potential liability on the part of the product supplier for
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`indirect infringement. Mitek, 34 F.4th at 1341. Each is true here: BioNTech has formally made
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`an indemnification claim under its License Agreement with Acuitas and, separately, the allegation
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`that Comirnaty® directly infringes patents claiming, in part, lipids creates a risk that Acuitas itself
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`might face liability for indirect infringement.
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`Defendants do not challenge the truth of any of Acuitas’s allegations. Instead, Defendants’
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`motion rests on legal propositions that are invalid after Mitek. Thus, Defendants announce in bold
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`italics that declaratory judgment jurisdiction would require an affirmative act directed at Acuitas.
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`(Br. at 2.) The facts of Mitek disprove that. Defendants also contend, also in bold italics, that as
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`a “plaintiff-supplier,” Acuitas “must allege that it is actually obligated to indemnify its customer.”
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`(Br. at 4.) Mitek rejected that very argument. 34 F.4th at 1341. Indeed, that argument would
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`defeat the purpose of the Declaratory Judgment Act, which allows plaintiffs to seek relief to clear
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`the air, rather than choosing between abandoning their activities or waiting to be sued. Likewise,
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`Defendants contend that their demand letters to Pfizer and BioNTech were too vague to constitute
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`threats of infringement suits. But the Federal Circuit has held that the very language used in those
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`letters—that the recipient “may infringe” a patent—creates a justiciable controversy.
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`2
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 7 of 25
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`This case thus presents a controversy squarely within this Court’s jurisdiction. The Court
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`should deny this motion and the case should proceed.
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`3
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 8 of 25
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`STATEMENT OF FACTS
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`Acuitas draws these facts from its Amended Complaint (D.I. 42), the accompanying
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`Declaration of Allison Penfield in opposition to Defendants’ motion to dismiss, and the
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`Declaration of Matthew Robson (D.I. 45) that Defendants submitted in support of that motion.
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`Acuitas’s Invention of Lipids and Co-Development of mRNA Lipid Nanoparticles
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`The COVID-19 pandemic is receding in large part due to the amazing success story of
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`“mRNA” vaccines. D.I. 42 ¶ 1. Those vaccines exist only because of decades of hard work and
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`ingenuity by Acuitas and others. Id. Whereas traditional vaccines create immunity by injecting a
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`person with pieces of (or an inactive form of) the target virus, mRNA vaccines work by injecting
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`the person with mRNA that instructs the person’s natural protein-production mechanisms to make,
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`in the person’s own cells, a piece of the virus. Id. ¶¶ 2, 3. When the person’s cells then display
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`that viral protein, or a fragment of it, on their surface, the person’s immune system recognizes the
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`protein as foreign and develops an immune response to it. Id. ¶ 3. Because the mRNA creates
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`only a piece of the virus, there is no risk of viral infection from the vaccine itself. Id.
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`For all its advantages, however, mRNA presents prodigious challenges as a therapeutic.
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`Id. ¶ 4. mRNA is exceptionally fragile and breaks down quickly when injected into the body. Id.
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`And mRNA is physically too large to enter into human cells on its own. Id. An effective mRNA
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`vaccine therefore requires a delivery system that will protect the mRNA after injection into the
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`person and will transport the mRNA into the person’s cells. Id.
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`In the decade before COVID-19 emerged, Acuitas labored to solve that delivery-system
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`problem. Id. ¶ 5. Acuitas painstakingly engineered lipids that can be used in a nanosphere of fats
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`called a lipid nanoparticle, or LNP, that envelops and protects the fragile mRNA, allows it to cross
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`the cell membrane and enter a person’s cells, and then releases the mRNA so that the cell’s protein-
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`production mechanism can use it to create the viral protein. Id.
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`4
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 9 of 25
`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 9 of 25
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`Acuitas’s Partnership with BioNTech
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`Acuitas partners with companies that are developing mRNA-based therapeutics to address
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`challenging diseases such as tuberculosis, HIV, and cancer, as well as the development of
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`therapeutics in various other applications, including genomeediting. Jd. § 12. Two of Acuitas’s
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`lipids, “ALC-315” and “ALC-159,” are used in Comimaty®, the COVID-19 vaccine from Pfizer
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`and BioNTech. Jd. §§ 5, 12, 36-37, 48. Acuitas licensed that technology to BioNTech,id. § 12,
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`which partnered with Pfizer.
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`Acuitas’s and BioNTech’s partnership with respect to Comimaty® is governed by several
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`contracts, including an April 7, 2020 Non-Exclusive License Agreement.
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`Jd. 926. As the
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`Amended Complaint pleads, that License Agreement contains indemnification provisions.
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`Id.
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`This is the relevant indemnification provision:
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`. (b) Indemnification by Acuitas. Acuitas will indemnify
`.
`9.6 Indemnification. .
`BioNTech, its Affiliates and their respective directors, officers, employees and
`agents, and their respective successors, heirs and assigns (collectively, “BioNTech
`Indemnitees”), and defend and hold each of them harmless, from and against any
`and all Losses in connection with any and all Third Party Claims against BioNTech
`Indemnitees to the extent arising
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`from or occurring as a result of: . ..
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`Penfield Decl. Ex. A § 9.6(b). “Losses” are “any and all losses, damages, liabilities, costs and
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`expenses (including reasonable attorneys’ fees and expenses).” Jd. § 9.6(a).
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`Defendants’ First Demand Letter
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`Defendants Genevant and Arbutus had nothing to do with the developmentor success of
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`Comimaty®, and have not commercialized any LNP that can effectively wrap and protect any
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`mRNA molecule. D.I. 42 96. Nevertheless, on November 23, 2020, Defendants sent a letter to
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`the Chairman/CEO and the General Counsel of Pfizer (copying the CEO, CFO, and United States
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 10 of 25
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`
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`General Counsel of BioNTech) asserting that sales of the then-in-development Pfizer/BioNTech
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`vaccine may infringe “at least” eight patents held by Arbutus. D.I. 45-2 at 2, 3.
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`Some historical context is helpful: By November 9, 2020, a few weeks before Defendants
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`sent their first letter, it had been widely reported that Acuitas had partnered with BioNTech and
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`that Acuitas’s lipids were being used in the vaccine that Pfizer and BioNTech were testing. D.I.
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`42 ¶ 12. The vaccine was already being used in clinical trials, id. ¶¶ 12-13, 51, and on November
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`18, 2020, Pfizer and BioNTech announced positive results from their Phase 3 (i.e., final phase)
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`trials in humans, id. ¶¶ 41, 51. Those results were so impressive that just two days later, on
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`November 20th, Pfizer/BioNTech submitted a request to the Food and Drug Administration for an
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`Emergency Use Authorization for their vaccine. Id. ¶¶ 12, 42, 46.
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`Just three days after that, Defendants sent their letter to Pfizer with a copy to BioNTech.
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`The timing is not a coincidence: the letter states “[w]e were very pleased to read about your
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`encouraging data.” D.I. 45-2 at 2; see also D.I. 42 ¶¶ 6, 13-14, 28, 51. Defendants’ letter was
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`carefully crafted to touch all the legal bases for a patent-infringement-suit demand letter while
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`poorly disguised as an offer to partner with Pfizer. Thus, it includes a boldfaced disclaimer that
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`Defendants “will not seek an injunction” and “do not intend to file a case asserting patent
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`infringement in the near future, unless litigation is initiated against us.” D.I. 45-2 at 2 (emphasis
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`added and omitted). But also it declared that Defendants “believe and notify you as contemplated
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`by 35 U.S.C. § 287(a) that the manufacture, importation, offer for sale, sale, and/or use of your
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`COVID-19 vaccine may infringe Arbutus patents, including at least” eight patents identified by
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`their patent numbers. Id.; see also D.I. 42 ¶ 51. Notice under Section 287(a) is required before a
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`patentee may receive damages for patent infringement.
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`6
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 11 of 25
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`
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`According to the Defendants, these patents cover mRNA-LNP vaccines. They so alleged
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`in asserting some of those patents in a separate case against Moderna regarding its COVID-19
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`vaccine. Penfield Decl. Ex. B ¶¶ 1, 26. In fact, Defendants’ complaint against Moderna pleads
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`that on the very day that Defendants sent their first letter to Pfizer and BioNTech, they sent a
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`similar letter to Moderna, asserting that Moderna’s then-in-development COVID-19 vaccine also
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`“may infringe claims of” Defendants’ patents. Penfield Decl. Ex. B ¶ 59.
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`Each of the patents cited in Defendants’ first letter claim combinations of a nucleic acid
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`(whether mRNA or nucleic acids more generally) with lipids of various types. For example,
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`claim 1 of U.S. Patent No. 8,058,069 covers:
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`1. A nucleic acid-lipid particle comprising:
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`(a) a nucleic acid;
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`(b) a cationic lipid comprising from 50 mol % to 65 mol % of the total lipid present
`in the particle;
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`(c) a non-cationic lipid comprising a mixture of a phospholipid and cholesterol or
`a derivative thereof, wherein the phospholipid comprises from 4 mol % to 10 mol
`% of the total lipid present in the particle and the cholesterol or derivative thereof
`comprises from 30 mol % to 40 mol % of the total lipid present in the particle; and
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`(d) a conjugated lipid that inhibits aggregation of particles comprising from 0.5 mol
`% to 2 mol % of the total lipid present in the particle.
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`And claim 1 of U.S. Patent No. 9,504,651 covers:
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`1. A lipid vesicle formulation comprising:
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`(a) a plurality of lipid vesicles, wherein each lipid vesicle comprises:
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`a cationic lipid;
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`an amphipathic lipid; and
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`a polyethyleneglycol (PEG)-lipid; and
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`(b) messenger RNA (mRNA), wherein at least 70% of the mRNA in the
`formulation is fully encapsulated in the lipid vesicles.
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`7
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 12 of 25
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`
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`Comirnaty’s Success, Defendants’ Second Letter, and BioNTech’s Notice of Indemnity
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`FDA granted Emergency Use Authorization to Comirnaty® on December 11, 2020, D.I.
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`42 ¶ 42, and full approval on August 23, 2021, id. ¶¶ 12, 42, 46. As of the date of the Amended
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`Complaint, over 320 million doses of Comirnaty® had been administered in the United States.
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`After FDA gave full approval, on October 12, 2021, Defendants sent another 35 U.S.C.
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`§ 287(a) notice letter to Pfizer with a copy to BioNTech. Id. ¶¶ 13-14, 28, 52; Defs. Decl. Ex. C
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`(D.I. 45-3). They added another patent to the list of Arbutus patents that they believe Comirnaty®
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`may infringe: “[W]e believe, and notify Pfizer and BioNTech under 35 U.S.C. § 287(a), that the
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`manufacture, importation, offer for sale, sale, and/or use of the Pfizer-BioNTech COVID-19
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`vaccine Comirnaty® may infringe Arbutus U.S. Patent No. 11,141,378, in addition to at least the
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`Arbutus patents that were identified in our November 23, 2020 letter.” Am. Compl. (D.I. 42) ¶ 52;
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`Defs. Decl. Ex. C (D.I. 45-3). (Once again, Defendants sent a similar letter to Moderna on the
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`same day, giving notice under Section 287(a) with respect to the same additional patent. Penfield
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`Decl. Ex. B ¶ 180.)
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`After receiving the second demand letter from Defendants, on January 24, 2022, BioNTech
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`cited the indemnity provisions of the License Agreement, and asserted that under those provisions
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`Acuitas was obligated to indemnify BioNTech under their License Agreement for any claim of
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`infringement by Defendants under any of the nine patents listed in Defendants’ letters. Am.
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`Compl. (D.I. 42) ¶¶ 26-27. BioNTech repeated this assertion in August 2022. Id. Given that there
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`had been over 320 million doses of Comirnaty® administered in the United States as of the filing
`
`of the Amended Complaint, any royalty could run to the hundreds of millions, if not billions, of
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`dollars. Id. ¶¶ 5, 6.
`
`8
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 13 of 25
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`
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`Defendants’ Suit Against Moderna
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`On February 28, 2022, Defendants made good on their threats to sue Moderna, asserting
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`six of the patents they had identified in their letters. Penfield Decl. Ex. B. All six patents had been
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`listed in Defendants’ demand letters to Pfizer/BioNTech as well. And Defendants’ complaint
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`against Moderna mentioned Acuitas by name sixteen times, showing that Defendants do allege
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`that Acuitas’s technology violates their patents, at least when combined with mRNA. Id. ¶¶ 32-
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`34, 77, 96, 118, 142, 161.
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`Acuitas’s Suit Against Defendants
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`On March 18, 2022, Acuitas brought this action seeking a declaratory judgment that
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`Defendants’ U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,006,417, 9,364,435, 9,404,127,
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`9,504,651, 9,518,272, and 11,141,378 are either not infringed by the making, using, selling,
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`offering for sale, or importation of Comirnaty®, or are invalid, or both. D.I. 1.
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`On June 24, 2022, Defendants sought permission to move to dismiss for lack of subject
`
`matter jurisdiction. D.I. 31. Acuitas responded on July 8, 2022. D.I. 34. On August 16, 2022,
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`the Court granted Defendants leave to file their motion, and allowed Acuitas to amend its
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`complaint in response to the arguments in the parties’ letters. D.I. 37 at 1. Acuitas amended its
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`complaint on September 6, 2022. D.I. 42. On October 4, 2022, Defendants moved to dismiss
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`Acuitas’s claims with prejudice for lack of subject matter jurisdiction, because Defendants assert
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`there is no actual controversy. (Br. at 1.) This is Acuitas’s brief in opposition to that motion.
`
`ARGUMENT
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`Federal Circuit law governs subject matter jurisdiction in patent cases, including under the
`
`Declaratory Judgment Act. See, e.g., Mitek, 34 F.4th at 1340 (reviewing de novo and reversing
`
`dismissal of declaratory judgment action). Defendants bring a “facial” attack on Acuitas’s
`
`pleading, assailing the legal sufficiency of Acuitas’s allegations, rather than a “factual” attack on
`
`9
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`

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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 14 of 25
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`
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`the truth of those allegations. See 3M Co. v. Avery Denison Corp., 673 F.3d 1372, 1375 (Fed. Cir.
`
`2012); Cedars-Sinai Med. Ctr. v. Watkins, 11 F.3d 1573, 1583-84 (Fed. Cir. 1993). As such, the
`
`allegations in the Amended Complaint “are taken as true and construed in a light most favorable
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`to” Acuitas. Cedars-Sinai, 11 F.3d at 1583.
`
`I.
`
`This Court Has Subject Matter Jurisdiction Because Acuitas’s Declaratory
`Judgment Action Presents a “Case of Actual Controversy” Between the Parties
`
`A district court may issue a declaratory judgment about the validity or infringement of a
`
`patent in a “case of actual controversy.” 28 U.S.C. § 2201(a). That requirement is coextensive
`
`with the Article III “case or controversy” requirement. See MedImmune, Inc. v. Genentech, Inc.,
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`549 U.S. 118, 127 (2007). The test is whether “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 judgement.” Id.
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`Where, as here, “a patent holder accuses customers of direct infringement based on the sale
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`or use of a supplier’s equipment,” there are two, independent “sufficient conditions” that allow the
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`supplier “to commence a declaratory judgment action” against the patent holder. Mitek, 34 F.4th
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`at 1341. One is that the supplier has a “‘reasonable potential’ of … indemnification liability” to
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`its customers. Id. at 1346. The other is that “there is a controversy between the patentee and the
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`supplier as to the supplier’s liability for induced or contributory infringement based on the alleged
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`acts of direct infringement by its customers.” Id. at 1341. Each condition is met here.
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`A.
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`The Risk of Having To Indemnify BioNTech Creates Subject Matter
`Jurisdiction Over Acuitas’s Declaratory Judgment Action
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`BioNTech responded to Defendants’ Section 287(a) demand letters by formally notifying
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`Acuitas of a claim for indemnification based on Arbutus’s and Genevant’s demand letters.
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`BioNTech has identified an indemnification provision in its License Agreement with Acuitas that,
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`BioNTech asserts, would require Acuitas to indemnify BioNTech if BioNTech were found liable
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 15 of 25
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`to Arbutus or Genevant. That provision affords indemnity to BioNTech for
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` Penfield Decl. Ex. A § 9.6(b). The
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`patents-in-suit all involve claims that require mRNA-LNP components, and Acuitas provided lipid
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`components in Comirnaty®. It does not matter whether Acuitas would have defenses to a claim
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`of indemnity by BioNTech. Under modern Federal Circuit precedent, as long as BioNTech’s
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`assertion of an indemnity claim creates a “reasonable potential” that Acuitas might have to
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`indemnify BioNTech, this Court has subject matter jurisdiction over Acuitas’s claim that the
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`Defendants’ patents are invalid or not infringed by Comirnaty®. Mitek, 34 F.4th at 1341, 1346.
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`Defendants contend otherwise, and assert that Acuitas must plead that “it is actually
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`obligated to indemnify” BioNTech. (Br. at 4 (emphasis Defendants’); accord id. at 15-17.)
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`Defendants rely on older Federal Circuit cases that described the sufficient condition for subject
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`matter jurisdiction as being that “the supplier is obligated to indemnify its customers from
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`infringement liability.” (Br. at 15-16 (citing Arris Grp., Inc. v. British Telecomms. PLC, 639 F.3d
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`1368, 1375 (Fed. Cir. 2011))); see also Microsoft Corp. v. DataTern, Inc., 755 F.3d 899, 904 (Fed.
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`Cir. 2014). But in Mitek the court, discussing these very cases, noted that while its opinions have
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`“sometimes used the language of ‘obligation’ when referring to the indemnity issue in this
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`context,” other Federal Circuit opinions “refer only to the ‘existence of an indemnity agreement,’
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`not its conceded applicability in the particular case.” 34 F.4th at 1346 (quoting Arris, 639 F.3d at
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`1375; Microchip Tech. Inc. v. Chamberlain Grp., Inc., 441 F.3d 936, 943 (Fed. Cir. 2006)). The
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`court noted that it has “never held that the validity of an indemnity demand, i.e., the applicability
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`of an indemnity agreement to the demander’s circumstances, needs to be conceded to establish
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`subject matter jurisdiction,” and concluded that the “required concrete stake” for a declaratory
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 16 of 25
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`judgment action is satisfied by the “‘reasonable potential’ of … indemnification liability.” Id. at
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`1341, 1346 (emphasis added). To the extent Defendants’ cases imposed a duty to allege an
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`“obligation” to indemnify, they are no longer good law.1
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`Defendants also contend that there is no subject matter jurisdiction over Acuitas’s claim as
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`a supplier because—Defendants assert—they never actually accused BioNTech and Pfizer of
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`infringing their patents. That would matter, if it were true, because subject matter jurisdiction over
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`Acuitas’s declaratory judgment claim requires “an actual infringement controversy between”
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`Defendants and Pfizer/BioNTech that “would have sufficed for” Pfizer/BioNTech themselves “to
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`seek declaratory relief.” Mitek, 34 F.4th at 1345. But that baseline requirement is easily met here.
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`Defendants admit they sent letters to Pfizer/BioNTech alleging, “under 35 U.S.C. § 287(a),
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`that the making, using, selling, offering for sale, or importing into the United States of Comirnaty
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`may infringe Defendants’ Patents.” (Br. at 6 (emphasis added)); D.I. 45-2, -3; Am. Compl. (D.I.
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`42) ¶¶ 6, 28, 51-52. Section 287(a) notices are predicates to seeking damages for patent
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`infringement. “[C]onduct that can be reasonably inferred as demonstrating intent to enforce a
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`patent can create declaratory judgment jurisdiction.” Hewlett-Packard Co. v. Acceleron LLC, 587
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`F.3d 1358, 1363 (Fed. Cir. 2009)). And it does not matter that the letters said “may infringe”
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`rather than “does infringe”; either articulation, when coupled with an offer to license patents,
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`creates a case or controversy between Defendants and Pfizer/BioNTech. 3M Co., 673 F.3d at
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`1379.
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`1 These include DataTern, 755 F.3d at 904; Microsoft Corp. v. SynKloud Technologies, LLC,
`484 F. Supp. 3d 171, 179 (D. Del. 2020); BroadSign International, LLC v. T-Rex Property AB,
`No. 16 CV 04586-LTS, 2018 WL 357317, at *1 (S.D.N.Y. Jan. 10, 2018); Intel Corp. v. Future
`Link Systems, LLC, No. CV 14-377-LPS, 2015 WL 649294, at *12 (D. Del. Feb. 12, 2015); and
`Proofpoint, Inc. v. InNova Patent Licensing, LLC, No. 5:11-CV-02288-LHK, 2011 WL
`4915847, at *5 (N.D. Cal. Oct. 17, 2011).
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`Case 1:22-cv-02229-MKV Document 48 Filed 11/01/22 Page 17 of 25
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`Defendants’ brief tries to flee from their demand letters. Defendants assert that their
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`invocation of 35 U.S.C. § 287(a) was merely to preserve their ability to seek damages, but that the
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`gestalt of their letters was to re-establish their long-standing collaboration with BioNTech. (Br. at
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`22 n.8, 23.) It is difficult to imagine trying to re-establish a collaboration by threatening to sue
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`and promising not to seek an injunction. Moreover, while Defendants say that they want to assist
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`with Pfizer/BNT’s “LNP-related storage, transport, and manufacturing capacity challenges” (Br.
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`at 23), the patents cited in their letters have nothing to do with storage, transport, or manufacturing
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`capacity challenges. The patents claim compositions containing mRNA and lipids. Further, any
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`suggestion that Defendants were seeking to collaborate on the Pfizer/BioNTech vaccine is belied
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`by the fact that the vaccine was already known to work through Phase III clinical trials when
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`Defendants sent their letters. Notably, Defendants also primarily addressed their letters to Pfizer
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`when BioNTech was the partner responsible for the