Case 1:22-cv-02229-MKV Document 69 Filed 04/05/23 Page 1 of 3
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`April 5, 2023
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`The Honorable Mary Kay Vyskocil
`United States District Court
`Southern District of New York
`Daniel Patrick Moynihan U.S. Courthouse
`500 Pearl Street
`New York, NY 10007-1312
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`Re: Acuitas Therapeutics Inc. v. Genevant Sciences GmbH and
`Arbutus Biopharma Corp., Case No. 22-cv-02229-MKV
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`Dear Judge Vyskocil:
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`I write on behalf of Plaintiff Acuitas Therapeutics Inc. in response to yesterday’s letter from
`Defendants Genevant Sciences GmbH and Arbutus Biopharma Corp. Acuitas respectfully submits
`that Defendants’ letter confirms why the Court should deny their pending motion to dismiss this
`action.
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`Acuitas brought this declaratory-judgment action over a year ago in March 2022 because Defendants
`were threatening Acuitas’s customers (BioNTech and Pfizer) with patent-infringement lawsuits
`based on their sale of the COVID-19 vaccine Comirnaty®, which uses Acuitas’s lipid nanoparticles.
`Those threats could expose Acuitas itself to infringement claims by Defendants or expose Acuitas to
`claims for indemnification by Acuitas’s customers, or both.
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`In support of its motion to dismiss, Defendants protested that the Court either has no jurisdiction
`or should decline jurisdiction in part because Defendants were supposedly just engaging in business
`collaborations with BioNTech and Pfizer, not threatening patent infringement actions. (See D.I. 44
`at 1–2, 22; D.I. 54 at 10.) For example, Defendants argued, “[t]here is no need to burden the Court
`with Acuitas’s premature side-show action when the actual parties to the discussions have not
`sought judicial intervention and a license could moot this case at any time.” (D.I. 44 at 4).
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`Defendants have now sued Pfizer and BioNTech in New Jersey. See Arbutus Biopharma Corp. et al v.
`Pfizer Inc. et al., No. 2:23-cv-01876-ZNQ (D.N.J.) (“NJ Complaint”). Their NJ Complaint confirms
`that there is, and has been, an actual controversy between Defendants and Acuitas as to whether
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`Comirnaty® infringes Defendants’ patents (compare D.I. 42 ¶¶ 114, 153, 179, with D.I. 63-1 ¶¶ 63–
`115), that this litigation is not, and never was, “premature”—it simply began sooner than
`Defendants would have liked—and that Defendants’ motion to dismiss in this Court was just a delay
`tactic to buy time to sue elsewhere. Indeed, three of the patents that the Defendants assert in New
`Jersey are among the ones Acuitas challenged in this Court first, and the other two New Jersey-case
`patents are from the same patent family as one of the ones at issue here in this case, U.S. Patent No.
`9,504,651. (D.I. 63-1 at *225, *255; D.I. 1-7 at 2.) Genevant had these two additional patents issue
`from the same families after Acuitas filed this action. Both patents expire in a matter of months, on
`June 30, 2023, and the timing of each appears to be a deliberate attempt by Defendants to try to
`ensnare Comirnaty®, as the applications for both patents were filed on May 25, 2021, after
`Comirnaty® was already being widely used throughout the world, and after information cited in the
`NJ Complaint as the ostensible basis for the infringement allegations had already been made public.
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`Defendants tout that their New Jersey lawsuit does not mention Acuitas. (D.I. 63 at 1.) That
`proves too much. Defendants wrote that complaint long after Acuitas had filed this case and
`Defendants had moved to dismiss it, and thus their omission of the name “Acuitas” in New Jersey
`was tactical. The entire theory of the NJ Complaint is that Defendants invented the “LNP
`technologies needed to deliver messenger ribonucleic acid (‘mRNA’) therapeutics” used in Pfizer
`and BioNTech’s Comirnaty® (D.I. 63-1 ¶ 1) and that this technology is allegedly “key” (id. ¶¶ 3–5,
`34–36), while the central allegation of Acuitas’s first-filed case before this Court is that Acuitas
`invented that technology and Defendants’ threats of infringement against Pfizer and BioNTech were
`meritless (see, e.g., D.I. 42 ¶¶ 5–13). The NJ Complaint does not allege that Pfizer and BioNTech are
`Defendants’ customers with respect to the LNP in the Comirnaty® vaccine, nor could it because
`Pfizer and BioNTech received their LNP technology for Comirnaty® from Acuitas. Furthermore,
`Defendants have not given Acuitas a covenant not to sue, or any other protection against suing
`Acuitas for induced infringement in the future. They just omitted the name “Acuitas” from their NJ
`Complaint so they could write a letter telling this Court they had done so.
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`Regarding the second basis of jurisdiction here—a risk of indemnification liability—Defendants’
`New Jersey lawsuit does nothing to reduce the risk that Acuitas might have to indemnify BioNTech;
`if anything, the filing of an actual lawsuit against BioNTech makes such a risk more acute.
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`To the extent the NJ Complaint has any bearing on Defendants’ motion to dismiss this action, it
`favors denying that motion. Defendants previously told this Court that they had no controversy
`with Pfizer and BioNTech (D.I. 54 at 1), that they “have not sued” Pfizer or BioNTech even after
`having sued Moderna (id. at 2), and that Acuitas’s lawsuit could be mooted “at any time” by
`“pending discussions” between Genevant and Pfizer and BioNTech. (D.I. 44 at 1.) But Defendants
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`Case 1:22-cv-02229-MKV Document 69 Filed 04/05/23 Page 3 of 3
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`have now sued Pfizer and BioNTech, and report in their complaint that the then-pending
`“discussions” have failed. (See D.I. 63-1 ¶ 7.)
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`The allegations in Defendants’ NJ Complaint undercut the assertions they made to this Court, in
`their motion to dismiss, that they had not threatened Pfizer or BioNTech with patent-infringement
`suits before Acuitas filed this action. In their NJ Complaint, Defendants now admit that their letters
`to Pfizer and BioNTech—the very letters on which Acuitas relied—were, in fact, 35 U.S.C. § 287(a)
`notices of infringement. (See D.I. 63-1 ¶¶ 42, 46, 57–59, 75, 92, 102.) Defendants also admit that
`they “reached out orally and in writing multiple times in the second half of 2021” to Pfizer and
`BioNTech, and that Pfizer and BioNTech refused to provide samples, implicitly admitting that
`Defendants requested samples. (See D.I. 63-1 ¶¶ 54–61.) A reasonable person would view these
`actions as a threat of patent infringement. Indeed, Defendants go so far as to allege willful
`infringement based on BioNTech and Pfizer having not acquiesced to their threats, meaning that—
`according to Defendants—Pfizer and BioNTech could not reasonably have concluded anything
`other than that there was an allegation of infringement. (See D.I. 63-1 ¶¶ 78, 96, 114.)
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`Defendants nevertheless argue that this Court should exercise its discretion to dismiss this case
`because the New Jersey lawsuit creates a risk of duplicative litigation. (D.I. 63 at 1; D.I. 44 at 24–
`25.) If that is true, it is a problem of Defendants’ own making. More than a year after Acuitas filed
`this lawsuit (D.I. 1 (filed March 18, 2022)), Defendants silently created—and were the sole entrants
`in—the slowest race to the courthouse ever, filing suit in New Jersey and thus creating the second,
`duplicative lawsuit. Notably, Pfizer is headquartered in New York and incorporated in Delaware;
`BioNTech is based in Germany with North American headquarters in Cambridge, Massachusetts.
`Defendants’ trip to Trenton appears to be nothing more than an effort to avoid filing in this Court.
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`Acuitas respectfully submits that Defendants’ belated opening of a second front in this controversy
`confirms that this Court had subject-matter jurisdiction to decide the issues raised by the first
`front—Acuitas’s request for a declaratory judgment—and that the Court should deny Defendants’
`motion to dismiss.
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`Respectfully submitted,
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`/s/ Nicholas Groombridge
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`Nicholas Groombridge
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`CC: All Counsel of Record (via ECF)
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