Case 1:22-cv-02229-MKV Document 78 Filed 08/01/23 Page 1 of 2
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`quinn emanuel trial lawyers | new york
`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 NO.
`(212) 849-7412
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`WRITER'S EMAIL ADDRESS
`raynimrod@quinnemanuel.com
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`August 1, 2023
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`VIA ECF
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`Hon. Mary Kay Vyskocil
`United States District Court
`Southern District of New York
`500 Pearl Street, Room 2230
`New York, NY 10007
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`Re:
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`Acuitas Therapeutics Inc. v. Genevant Sciences GmbH et al.,
`Case No. 1:22-cv-02229-MKV
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`Dear Judge Vyskocil:
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`We write on behalf of Defendants Genevant Sciences GmbH and Arbutus Biopharma
`Corporation (collectively, “Defendants”), in advance of the August 9, 2023 status conference, to
`update the Court on the proceedings in Arbutus Biopharma Corp. et al. v. Pfizer Inc. et al., No.
`3:23-cv-01876-ZNQ (D.N.J.) (the “NJ Action”). In early April, the parties to this action submitted
`letters to the Court regarding the filing of the Complaint in the NJ Action. (DI 63, 69, & 70). On
`July 10, 2023, Pfizer Inc. and BioNTech SE (collectively, “Pfizer/BNT”) filed their Answer and
`Counterclaims in the NJ Action (the “NJ Counterclaims”). The NJ Counterclaims, attached as
`Exhibit A, are relevant to this action in several respects.
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`First, the NJ Counterclaims undermine Acuitas’s central argument in opposition to
`Defendants’ pending motion to dismiss. The first sentence of Acuitas’s opposition brief argues
`that subject matter jurisdiction exists here because its Amended Complaint purportedly falls into
`a long line of “declaratory judgment action[s] by a product supplier.” (DI 50 at 1). But the NJ
`Counterclaims demonstrate that Acuitas is not a product supplier for Pfizer/BNT’s vaccine, but
`instead simply a grantor of a license to intellectual property. Moreover, the license only covered
`two lipids rather than the entire LNP formulation included in the mRNA-LNP vaccine in question,
`much less the mRNA-LNP vaccine itself. (See Ex. A at 55). Those allegations regarding two lipids
`are impossible to square with Acuitas’s Amended Complaint, which suggests that Acuitas actually
`licenses and supplies the entire LNP in the vaccine and perhaps also the entire mRNA-LNP that
`comprises the vaccine. (See DI 42 ¶ 5 (“Acuitas’s mRNA-LNP is used, under license, in Pfizer
`and BioNTech’s COVID-19 vaccine”); ¶ 16 (“Acuitas has partnered with non-parties BioNTech
`and Pfizer to supply and license the LNP used in COMIRNATY”); ¶ 22 (Acuitas “joins a long
`history of product suppliers” in filing suit)).
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`quinn emanuel urquhart & sullivan, llp
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`Case 1:22-cv-02229-MKV Document 78 Filed 08/01/23 Page 2 of 2
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`Second, the NJ Counterclaims undermine Acuitas’s argument that it has an indemnity
`obligation to BioNTech that supports subject matter jurisdiction. As a threshold matter, the NJ
`Counterclaims do not allege or even suggest that Acuitas has such an indemnity obligation. More
`importantly, by confirming that Acuitas merely licensed two lipids, the NJ Counterclaims
`demonstrate that Acuitas has no indemnity obligation at all. That is because the indemnity
`agreement only covers liability based
` (DI 50 at 5) and
`it is now clear that the limited amount of technology that Acuitas licensed—i.e., the two lipids—
`could never be
` Rather, BioNTech
`liability for infringement of the patents asserted in the NJ Action would require the manufacture,
`sale, or offer for sale of a fully assembled RNA-LNP formulation (complete with RNA and at least
`three lipids), as required by each of the asserted patents.
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`Third, the NJ Counterclaims support discretionary denial of jurisdiction. Pfizer/BNT—the
`direct infringers—not only consented to personal jurisdiction and venue in the NJ Action, they are
`also seeking to resolve counterclaims of non-infringement and invalidity in that venue. (See Ex. A
`at 8, 10, 49-73). Thus, the NJ Action is uniquely suited to resolve the entire controversy between
`Pfizer/BNT—the direct infringers—and Defendants with respect to infringement of the asserted
`patents. In contrast, a final judgment in favor of Defendants in this action would not be binding
`on Pfizer/BNT, requiring Defendants to re-litigate infringement and validity in New Jersey.
`Moreover, no matter what the outcome here, Defendants would still need to litigate the
`infringement and validity issues for U.S. Patent Nos. 11,298,320 and 11,318,098, which are at
`issue in the NJ Action, but not in this action. (Ex. A at 37-46).
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`Finally, Pfizer and BioNTech’s decision to answer the Complaint and present their
`counterclaims in the NJ Action confirms that this Court should decide Defendants’ pending motion
`to dismiss irrespective of the proceedings in New Jersey. Pfizer and BioNTech have not attempted
`to implead Acuitas in the NJ Action; they have not moved to dismiss on the basis that Acuitas is a
`necessary party; they have not alleged or pled facts showing that Acuitas indirectly infringed
`Defendants’ patents or even supplied any component of the vaccine; and they have not alleged or
`pled that Acuitas has an indemnity obligation. The closest Pfizer and BioNTech have come to any
`of this is an affirmative defense that states, in its entirety, “Plaintiffs’ Complaint improperly failed
`to name or join Acuitas Therapeutics, Inc.” (Ex. A at 48). That assertion is unexplained,
`unsupported, and inconsistent with the fact that Defendants’ patents in this action are directed to
`RNA-LNP formulations that Acuitas neither licenses nor supplies.
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`We appreciate the Court’s time and attention and look forward to addressing these and
`related issues with the Court on August 9.
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`Respectfully submitted,
` /s/ Raymond N. Nimrod
`Raymond N. Nimrod
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`cc:
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`All Counsel of Record (via ECF)
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