Case 1:22-cv-02229-MKV Document 34 Filed 07/08/22 Page 1 of 3
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`(212) 373-3000
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`(212) 757-3990
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`ngroombridge@paulweiss.com
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`July 8, 2022
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`By ECF
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`The Honorable Edgardo Ramos
`Thurgood Marshall U.S. Courthouse
`40 Foley Square
`New York, NY 10007
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`Re:
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`Acuitas Therapeutics Inc. v. Genevant Sciences GmbH
`and Arbutus Biopharma Corp., Case No. 1:22-cv-02229-ER
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`Your Honor:
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`Pursuant to this Court’s Individual Practice Rule 2.A.ii and its June 27, 2022 Order [D.I.
`33], I write on behalf of Plaintiff Acuitas Therapeutics Inc. in response to Defendants’ June 24,
`2022 letter [D.I. 31], which sought permission to move to dismiss the Complaint.
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`Defendants intend to argue that there is no subject-matter jurisdiction here, and that even
`if there were jurisdiction the Court should exercise its discretion to dismiss the case. Because each
`argument lacks merit, and because the motion would unnecessarily delay resolution of the
`important issues raised here, the Court should reject Defendants’ request to move to dismiss.
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`1.
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`Declaratory Judgment Actions Are Common In Precisely This Circumstance
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`This case is about the messenger RNA (“mRNA”) vaccines used to create immunity to the
`COVID-19 virus. Acuitas invented a key component of such mRNA vaccines: the delivery system
`based on lipid nanoparticles (“LNPs”) that functions to protect the mRNA and effectively deliver
`it within a patient’s body. Acuitas partners with companies who are marketing or seeking to
`market therapeutics, including vaccines targeting COVID-19 and other viruses, to address unmet
`clinical needs. One well-known partner is BioNTech, which, together with Pfizer, is marketing
`the vaccine against COVID-19, Comirnaty®, which uses Acuitas’s LNP technology.
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`The Defendants own patents that, they claim, cover Comirnaty®. They specifically
`contend that Comirnaty® includes a lipid nanoparticle that uses lipids that Acuitas invented and
`licensed to BioNTech. Defendants proclaim that they, not Acuitas, are the rightful inventors of
`that LNP. Defendants sent letters to BioNTech and Pfizer identifying specific patents and
`demanding that BioNTech and Pfizer pay them royalties because of Defendants’ patents.
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`Case 1:22-cv-02229-MKV Document 34 Filed 07/08/22 Page 2 of 3
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`The Honorable Edgardo Ramos
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`Acuitas then brought this action, seeking a declaratory judgment that Defendants’ patents
`are invalid and/or not infringed by Comirnaty®. In doing so, Acuitas joined a long history of
`product suppliers who, under circumstances like these, respond to threats of patent infringement
`against their customers by bringing a declaratory-judgment action against the party making the
`threats. See, e.g., Arris Grp., Inc. v. Brit. Telecomms. PLC, 639 F.3d 1368 (Fed. Cir. 2011);
`Microsoft Corp. v. DataTern, Inc., 755 F.3d 899 (Fed. Cir. 2014).
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`2.
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`The Court Has Subject Matter Jurisdiction Over This Action
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`A district court has subject-matter jurisdiction over a declaratory-judgment action by a
`supplier against a patentee that has threatened the supplier’s customers either (i) where the supplier
`faces the possibility of liability under 35 U.S.C. § 271(b) for inducing its customers’ infringement
`or under § 271(c) for contributing to it, or (ii) where the supplier may have to indemnify its
`customers under their contracts. See Microsoft, 755 F.3d at 903–04. Both are true here.
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`Indirect infringement: Defendants do not and cannot deny that they sent demand letters
`to Acuitas’s partner (BioNTech), and its collaborator (Pfizer), identifying specific patents that they
`say cover BioNTech and Pfizer’s COVID-19 vaccine. Inherent in the letters is Defendants’ belief
`that an Acuitas LNP used in Comirnaty® infringes an element of their patent claims. Liability
`against Acuitas for induced or contributory infringement is not so speculative or remote as to defeat
`subject-matter jurisdiction; while Acuitas would have defenses to such a claim, it is sufficient here
`that Acuitas is “potentially an inducer of infringement.” Microchip Tech., Inc. v. Chamberlain
`Grp., Inc., 441 F.3d 936, 943 (Fed. Cir. 2006) (citing Arrowhead Indus. Water, Inc. v. Ecolochem,
`Inc., 846 F.2d 731, 739 (Fed. Cir. 1988)). Microchip, on which Defendants rely, is distinguishable
`for two reasons: first, Microchip disclaimed any possibility of itself being sued by the patent-
`holder, from which it claimed to have a license, see 441 F.3d at 942; second, in Microchip the
`Federal Circuit assessed whether Microchip had a “reasonable apprehension of being sued,” id., a
`test that the Supreme Court later invalidated as too narrow in MedImmune, Inc. v. Genentech, Inc.,
`549 U.S. 118, 127 (2007).
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`Defendants also contend that there is no injury-in-fact because their letters to Pfizer and
`BioNTech were not really threats to sue those companies, but were instead merely offers of
`collaboration. The letters themselves—both of them, the November 23, 2020 and October 12,
`2021 letters to Pfizer and BioNTech—state that they are 35 U.S.C. § 287(a) notices of
`infringement, which is a predicate for recovery of damages in a patent-infringement action. See
`Compl. [D.I. 1] ¶¶ 13, 22, 45–47. The basis of this lawsuit, then, is not (as Defendants’ letter
`asserts) Acuitas’s “subjective worries” and “speculative fear” [D.I. 31] at 2–3; the basis of this
`lawsuit is Defendants’ explicit threat to file suit. There is no reason to think that is hollow:
`Defendants sent a demand letter to Moderna about its COVID-19 vaccine on the same day that
`they sent a letter to Pfizer and BioNTech, and Defendants have since actually sued Moderna. See
`Arbutus Biopharma Corp. v. Moderna, Inc., 1:22-cv-00252-MSG (D. Del. Feb. 28, 2022). Such
`“[p]rior litigious conduct is one circumstance to be considered in assessing whether the totality of
`circumstances creates an actual controversy.” Hewlett-Packard Co. v. Acceleron LLC, 587 F.3d
`1358, 1364 n.1 (Fed. Cir. 2009) (internal quotations omitted).
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`Case 1:22-cv-02229-MKV Document 34 Filed 07/08/22 Page 3 of 3
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`The Honorable Edgardo Ramos
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`Indemnification: Acuitas’s license agreement with BioNTech contains indemnification
`provisions. BioNTech has given notice to Acuitas of a claim for indemnification if BioNTech
`were found liable to Defendants for patent infringement. Whether or not Acuitas ultimately would
`have indemnification obligations, BioNTech’s assertion that it has indemnification rights is
`sufficient to create declaratory-judgment jurisdiction. Arris, 639 F.3d 1375. That fact also
`distinguishes Microsoft, in which there were no contractual indemnity provisions and the supplier
`conceded that “no such obligation exists.” Microsoft, 755 F.3d at 904.
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`Importantly, this is not a case where the supplier is a bystander to a dispute between its
`customers and the patent-owner. Rather, “the declaratory plaintiff and the patentee[s] [a]re
`competitors in the” LNP “industry.” Microchip, 441 F.3d at 943 (citing Arrowhead, 846 F.2d at
`733). Defendants are claiming credit for the lipids and LNPs that Acuitas itself invented and
`licensed. And this is not the first fight between Defendants and Acuitas about the inventorship of
`LNP technology. As detailed in the Complaint, Defendants and Acuitas, as corporations, arose
`from common ancestors, and—by agreement in 2012—spent the last decade pursuing different
`scientific pathways: Acuitas sought to develop LNPs that could deliver mRNA, while Defendants
`Arbutus sought to develop LNPs for an entirely different kind of nucleic acid called short-
`interfering RNA. See Compl. [D.I. 1] ¶¶ 5–14. Now that Acuitas’s LNPs have been used in
`mRNA vaccines that have helped save the world from a pandemic, Defendants—which have no
`mRNA and no anti-COVID product—have shown up, falsely claiming to have invented that
`lifesaving technology, sending a notice of infringement to BioNTech and Pfizer and suing
`Moderna.
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`3.
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`The Court Should Not Use Its Discretion To Dismiss The Complaint
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`Defendants also assert that the Court should decline jurisdiction as an act of discretion.
`That would be unwarranted: “there is an actual controversy and a declaratory judgment would
`settle the legal relations in dispute and afford relief from uncertainty or insecurity.” SanDisk Corp.
`v. STMicroelectronics, Inc., 480 F.3d 1372, 1383 (Fed. Cir. 2007) (internal quotations omitted).
`Discretion to decline jurisdiction “must be supported by a sound basis for refusing to adjudicate
`an actual controversy.” Id. There is no sound basis to dismiss this case. While Defendants assert
`that a settlement with Pfizer/BioNTech could moot this dispute, that is always true. See id. at 1381
`(“It is quite possible for two parties to simultaneously consider … settlement of a dispute, while
`at the same time maintaining an awareness that either settlement is improbable or that litigation is
`equally likely.”) (internal quotations omitted).
`* * * *
`Acuitas looks forward to discussing these issues at the July 15, 2022 conference.
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`Respectfully submitted,
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`/s/Nicholas Groombridge
`Nicholas Groombridge
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