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`Case 1:22-cv-02229-MKV Document 31 Filed 06/24/22 Page 1 of 3
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`quinn emanuel trial lawyers | new york
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`51 Madison Avenue, 22nd Floor, New York, New York 10010-1601 | TEL (212) 849-7000 FAX (212) 849-7100
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`WRITER’S DIRECT DIAL & EMAIL
`(212) 849-7412
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`raymondnimrod@quinnemanuel.com
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`June 24, 2022
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`VIA ECF
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`The Honorable Edgardo Ramos
`Thurgood Marshall U.S. Courthouse
`40 Foley Square
`New York, NY 1007
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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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`I am writing on behalf of both Defendants pursuant to this Court’s Individual Practice Rule
`2.A.ii, to request a pre-motion conference concerning Defendants’ anticipated motion to dismiss
`the Complaint. The anticipated motion would seek dismissal on the basis that Plaintiff has not
`satisfied and cannot satisfy its burden to demonstrate federal subject matter jurisdiction in this
`declaratory judgment action.
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`Background
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`Plaintiff (“Acuitas”) filed this action on March 18, 2022. The Complaint names two
`Defendants: Genevant Sciences GmbH (“Genevant”) and Arbutus Biopharma Corporation
`(“Arbutus”), each of which is a biotechnology company. The Complaint does not seek damages.
`Rather, it seeks declaratory judgments concerning nine patents that Arbutus owns and has licensed
`to Genevant (the “Patents”). Specifically, the Complaint seeks declarations that the Covid-19
`vaccine made and sold by Pfizer and BioNTech (the “Vaccine”) does not infringe the Patents and
`that the Patents are invalid. Acuitas’s only connection to the Vaccine is as one of multiple
`companies that has licensed or supplied technology to Pfizer and BioNTech for use in the Vaccine.
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`Acuitas’s claims are incurably defective. Defendants have never accused Acuitas of
`infringing. They have never communicated with Acuitas concerning the Patents or the Vaccine at
`all. The Complaint does not allege otherwise. Moreover, Pfizer and BioNTech are large and
`sophisticated public companies; if either deems it necessary or appropriate to clarify whether their
`Vaccine infringes Defendants’ Patents, it is fully capable of initiating litigation to do so (provided
`of course that the claims are otherwise permissible). There is no reason why questions concerning
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`Case 1:22-cv-02229-MKV Document 31 Filed 06/24/22 Page 2 of 3
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`Defendants’ Patents and Pfizer/BioNTech’s Vaccine can or should be resolved in a litigation filed
`by Acuitas and to which Pfizer and BioNTech are not parties.
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`If permitted to proceed, this case will either be (i) a shadow litigation in which Acuitas is
`attempting to adjudicate the relationship between the Defendants and nonparties Pfizer and
`BioNTech in connection with a Vaccine that Acuitas does not make or sell, or (ii) a proxy litigation
`in which Pfizer and BioNTech are seeking to resolve those issues without appearing, while
`reserving the ability to seek a second bite at the apple by filing a case in their own names, later.
`The law does not permit either effort.
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`Argument
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`Defendants’ anticipated motion would seek dismissal of the Complaint on the basis that
`Acuitas has failed to demonstrate an actual controversy between itself and Defendants, or injury-
`in-fact, both of which are prerequisites of federal subject matter jurisdiction. Defendants’
`anticipated motion would also argue that, even if there were subject matter jurisdiction, the Court
`should exercise its discretion not to entertain Acuitas’s claims.
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`1.
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`No Actual Controversy
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`There is no actual controversy between Acuitas and Defendants because, as noted above,
`the Complaint does not allege that Defendants ever contacted Acuitas regarding the matters at
`issue in this suit, does not allege that Defendants ever accused Acuitas of infringing the Patents,
`and does not allege that Defendants ever attempted to enforce the Patents against Acuitas.
`Although the Complaint attempts to distract from those glaring pleading failures by citing two
`letters that Defendants sent to nonparties Pfizer and BioNTech beginning more than a year and a
`half ago, the letters were not sent to Acuitas, do not mention Acuitas, and do not accuse Acuitas
`of infringement. They do not create an actual controversy between Defendants and Acuitas.
`Indeed, the letters do not even create an actual controversy with Pfizer or BioNTech. They merely
`propose a collaboration in which Pfizer and BioNTech would gain the benefit of Genevant
`scientists’ experience and expertise (similar to a preexisting license agreement currently in effect
`between Genevant and BioNTech for applications other than Covid), noting that the Vaccine may
`infringe absent a license. Because the letters do not create a controversy with Pfizer and
`BioNTech, they do not create a controversy with Acuitas a fortiori.
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`2.
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`No Injury-In-Fact
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`Acuitas has also failed to allege injury-in-fact. The Complaint does not allege that Acuitas
`has lost Vaccine royalties or any other specific revenues because of the two letters Defendants sent
`to Pfizer and BioNTech, nor does the Complaint identify even a single business deal that Acuitas
`has lost. Rather, the Complaint relies on Acuitas’s subjective worries—for example, that “the
`prospect of future claims against other Acuitas licensees … threaten[s] to cause serious harm to
`Acuitas’s business,” and that “Acuitas’s ability to enter into new relationships with other potential
`partners” may be impacted. Compl. ¶¶ 13, 48; see id. ¶ 47 (speculating that Defendants’ letters
`might “hinder” Acuitas’s ability to “freely research, develop, and commercialize therapeutics”).
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`The Complaint’s allegations do not approach the type of concrete harm required to plead
`injury-in-fact. First, injury-in-fact is assessed using “an objective standard that cannot be met by
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`Case 1:22-cv-02229-MKV Document 31 Filed 06/24/22 Page 3 of 3
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`a purely subjective or speculative fear of future harm.” Asia Vital Components Co. v. Asetek
`Danmark A/S, 837 F.3d 1249, 1253 (Fed. Cir. 2016). Second, a company’s “economic interest in
`clarifying its customers’ rights … cannot form the basis of an actual controversy”—even if the
`company would “benefit[] if its customers had no fear of suit by [patentee],” and even if clarity
`might “facilitate[] the sale of [the company’s] products.” Microchip Tech., Inc. v. Chamberlain
`Grp., Inc., 441 F.3d 936, 943 (Fed. Cir. 2006).
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`Third, various specific allegations in the Complaint, and other facts that the Court can
`consider in ruling on the anticipated motion, confirm the absence of cognizable injury. Far from
`lost revenues, the Complaint touts the ongoing “amazing success story” of the Vaccine and alleges
`that “Acuitas is researching and will continue to research and collaborate with partners to develop
`drugs utilizing” the relevant technology. See Compl., ¶¶ 1, 29, 38, 42. Far from “prospect[ive]
`… threat[s]” to new licensing deals, Acuitas has publicly touted two licensing deals that it just
`recently inked, including one with Pfizer (an actual recipient of a Defendants’ letters). Far from
`“prospect[ive] future [litigation] claims” by Defendants against Acuitas’s customers, the
`Complaint does not identify even one such claim in the more than a year and a half since
`Defendants sent their first letter to Pfizer and BioNTech. And it was Acuitas itself that publicly
`disclosed the existence and substance of the previously private letters in its Complaint—those
`letters could not have been impacting potential deals with “other potential partners” because they
`were not public until Acuitas chose to make them so in its Complaint.
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`3.
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`Discretionary Assessment
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`Finally, even if the Complaint established subject matter jurisdiction (it did not), the Court
`should exercise its discretion not to entertain Acuitas’s claims. A licensing deal among
`Defendants, Pfizer, and BioNTech would moot Acuitas’s claims at any time—a relevant
`consideration because one of the very letters Acuitas relies on in its Complaint references licensing
`discussions and the Complaint does not allege anything to suggest the discussions have concluded.
`On the other hand, if there is no licensing deal and this Court determines that the Vaccine infringes
`or the Patents are not invalid, Pfizer and BioNTech could the very next day file an action for non-
`infringement and invalidity arguing that they are not bound by or estopped from challenging this
`Court’s judgment. It is improper to use the Declaratory Judgment Act as a contrivance for
`facilitating a second bite at the apple in this fashion.
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`Defendants thank the Court for its attention to this matter.
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`Respectfully submitted,
`/s/ Raymond Nimrod
`Raymond Nimrod
`Counsel for Genevant Sciences GmbH
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`Joined by:
` /s/ Daralyn Durie
`Daralyn Durie (pro hac vice application pending) (Counsel for Arbutus Biopharma Corp.)
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