Case 1:22-cv-02229-MKV Document 36 Filed 08/01/22 Page 1 of 7
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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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`August 1, 2022
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`By ECF
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`The Honorable Mary Kay Vyskocil
`Daniel Patrick Moynihan U.S. Courthouse
`500 Pearl Street
`New York, NY 10007-1312
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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-MKV
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`Dear Judge Vyskocil:
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`I represent Plaintiff Acuitas Therapeutics Inc. and write pursuant to the Court’s July 25,
`2022 Order [D.I. 35] to submit this joint status letter on behalf of Acuitas and Defendants Genevant
`Sciences GmbH and Arbutus Biopharma Corp.
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`1) A brief statement of the nature of the case, the principal claims and defenses, and the
`major legal and factual issues that are most important to resolving the case
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`Acuitas seeks a declaratory judgment that patents owned by Arbutus and licensed to
`Genevant (the “Arbutus Patents”) are not infringed by the manufacture, use, offer for sale, or sale
`in the United States, or importation into the United States, of Comirnaty®, a COVID-19 vaccine
`made and sold by nonparties Pfizer and BioNTech, and that the Arbutus Patents are invalid under
`35 U.S.C. §§ 102, 103, and/or 112.1
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`Before the case was re-assigned to Your Honor, the Defendants timely requested leave to
`move to dismiss the Complaint for lack of subject matter jurisdiction. [D.I. 31 (attached here as
`Exhibit A)]. Acuitas opposed that request. [D.I. 34 (attached here as Exhibit B)]. As such,
`Defendants have not answered the Complaint. The Defendants contend that the principal claims
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`1 The Arbutus Patents are U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,006,417,
`9,364,435, 9,404,127, 9,504,651, 9,518,272, and 11,141,378.
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`The Honorable Mary Kay Vyskocil
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`and defenses and the major legal and factual issues will involve whether an actual controversy and
`injury-in-fact exists as necessary for a declaratory judgment. Beyond that, the Parties agree that
`the principal claims and defenses and the major legal and factual issues will involve whether
`making, using, selling, offering for sale, or importing into the United States the Comirnaty®
`vaccine infringes any valid and enforceable claim of any of the Arbutus Patents (including patent-
`law issues such as claim construction, novelty, obviousness, and sufficiency of the patents’
`disclosures).
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`Plaintiff’s Statement of the Nature of the Case
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`Acuitas is a private Canadian biotechnology company and global leader in the development
`of delivery systems for nucleic acid therapeutics, including messenger RNA (“mRNA”) vaccines,
`based on lipid nanoparticles (“LNPs”). Acuitas partners with companies that market, or seek to
`market, such vaccines to address unmet clinical needs, including vaccines targeting COVID-19
`and other viruses.
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`As relevant here, Acuitas invented an LNP delivery system that protects the mRNA in
`Comirnaty®, the vaccine for COVID-19 from Pfizer/BioNTech, effectively delivering that mRNA
`within a patient’s body, allowing the patient to mount an immune response that will then protect
`against COVID-19 infection. Acuitas expects that there will be no dispute that Comirnaty®
`employs the lipid technology it provided to Pfizer/BioNTech. In part due to its use of Acuitas’s
`LNP delivery system, Comirnaty® has been a global success in fighting COVID-19.
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`Defendants Arbutus and Genevant had nothing to do with that success. They did not invent
`any part of Comirnaty®, or even participate in that invention. But after Comirnaty® achieved
`worldwide success, Defendants sent demand letters to both BioNTech and Pfizer, identifying
`specific patents that they allege cover mRNA-LNP delivery systems such as those in Comirnaty®
`and demanding payment under those patents. They also sent apparently similar demand letters to
`Moderna, Inc., the manufacturer of the other mRNA vaccine against COVID-19, and followed up
`this threat with an infringement lawsuit against Moderna in the District of Delaware in which they
`assert several of the same patents that are the subject of this action.
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`Acuitas then brought this action, joining a long history of product suppliers who partner
`with others, and under circumstances like these, respond to threats of patent infringement against
`their partners and customers by bringing a declaratory-judgment action against the party making
`the threats. Acuitas will demonstrate that the Arbutus patents are invalid, and also that they are
`not infringed by Comirnaty® or by Acuitas’s LNP delivery system incorporated in Comirnaty®.
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`As described below, Defendants have raised a threshold issue in the case: They contend
`that there is no actual controversy between them and Acuitas, that Acuitas has suffered no injury-
`in-fact, and that this is merely a “shadow litigation” that the Court should dismiss. As further
`described below, Defendants are wrong. A product supplier like Acuitas may bring a declaratory
`judgment action like this one against Defendants like these, who threaten the supplier’s partners
`and customers, where there is a possibility either that the supplier might have to indemnify its
`partners or customers for damages owed to the Defendants or where the supplier itself might be
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`The Honorable Mary Kay Vyskocil
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`liable for induced or contributory infringement. And, as Acuitas alleges in its Complaint [D.I. 1],
`Defendants’ actions have caused concerns with Acuitas’s ability to license its LNP technology
`freely without the possibility of litigation—a very real possibility given Defendants’ recent
`litigious conduct. This is not a request, as Defendants suggest, for an advisory opinion: this is a
`request for a declaratory judgment to adjudicate an actual patent-infringement controversy that
`poses real harm to Acuitas. No more is required for this Court to have subject-matter jurisdiction.
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`Defendants’ Statement of the Nature of the Case
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`Acuitas has no factual or legal basis for bringing this suit, which seeks to adjudicate
`whether a product Acuitas admittedly does not make or sell infringes Defendants’ patents.
`Acuitas’s alleged concerns about whether nonparties might or might not be infringing Defendants’
`patents do not create an actual controversy between Acuitas and Defendants. The Complaint fails
`to establish, or even plead, any enforcement threat by Defendants against Acuitas or any
`cognizable injury-in-fact. Simply put, Acuitas is seeking an advisory opinion regarding Pfizer and
`BioNTech’s product and those nonparties’ need for a license. The Court should not endorse
`Acuitas’s shadow litigation, which seeks to resolve the rights of nonparties who have not sought
`judicial intervention.
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`Genevant is a technology-focused nucleic acid delivery company and a world leader in the
`LNP space, with world-class platforms, the industry’s most robust and expansive LNP patent
`portfolio, and decades of expertise in nucleic acid drug delivery and development. Genevant has
`licensed LNP-related patents from Arbutus, which is a clinical-stage biopharmaceutical company
`with deep virology expertise and an unwavering focus on curing a variety of conditions.
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`In 2018, Genevant and BioNTech entered a co-development and license agreement in
`which BioNTech licensed Defendants’ LNP technology, but the license was limited to the
`development of certain cancer or rare disease treatments. In November 2020, Genevant and
`Arbutus sent a letter to Pfizer and BioNTech offering to discuss a nonexclusive license for Covid-
`19 vaccine applications and a partnering agreement that would enable Pfizer and BioNTech to
`benefit from Genevant scientists’ extensive experience and expertise. Defendants’ letter also
`identified Arbutus patents that the Comirnaty® vaccine may infringe. In October 2021, Genevant
`and Arbutus sent a second letter identifying another Arbutus patent and noting ongoing licensing
`discussions between Defendants and BioNTech (acting also on behalf of Pfizer).
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`There is no actual controversy between Defendants and Acuitas. Defendants have never
`communicated with Acuitas concerning the Arbutus Patents or the Comirnaty® vaccine at all,
`much less accuse Acuitas of infringement. Moreover, licensing discussions between Defendants
`and BioNTech regarding Comirnaty® have not concluded—Acuitas has no role in these
`discussions and is prohibited under confidentiality restrictions from even being privy to them.
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`Although Acuitas asserts above that jurisdiction exists because Acuitas “might have to
`indemnify its partners or customers,” the Complaint does not even mention the word “indemnity,”
`much less include a clear, direct allegation that Acuitas is actually obligated to indemnify anyone
`as the case law requires. Moreover, although Acuitas asserts above that jurisdiction exists because
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`The Honorable Mary Kay Vyskocil
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`Acuitas “might be liable for induced or contributory infringement,” the Complaint does not and
`cannot allege that Defendants accused Acuitas of such infringement. Unlike cases in which the
`patentee accuses the declaratory judgment plaintiff of induced or contributory infringement,
`Defendants’ letters here did not even mention Acuitas or refer to any of its acts.
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`Furthermore, Acuitas has not alleged injury-in-fact, such as the loss of specific business
`deals or royalties, resulting from the letters Defendants sent to Pfizer and BioNTech. Acuitas
`instead seeks to rely on its speculative and otherwise non-cognizable subjective fear of potential
`litigation against unspecified potential licensees. Any such alleged harm would not only fail as a
`matter of law but also be self-inflicted—Defendants’ private letters to Pfizer and BioNTech were
`not known to the public until Acuitas itself chose to disclose them in its Complaint.
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`2) A brief statement by the plaintiff as to the basis of subject matter jurisdiction and
`venue, and a brief statement by each other party as to the presence or absence of
`subject matter jurisdiction and venue.
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`Plaintiff Acuitas’s Jurisdictional Statement
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`This Court has federal-question subject-matter jurisdiction under 28 U.S.C. §§ 1331,
`1338(a), and 2201 because this is a declaratory-judgment action addressing an actual controversy
`between the parties regarding the validity and infringement of United States patents. Acuitas
`further alleges that venue is proper under 28 U.S.C. §§ 1391(b)–(c) and 1400(b) because
`Defendants purposefully availed themselves of this jurisdiction by sending demand letters into this
`District, e.g., to Pfizer’s headquarters in Manhattan, alleging potential patent infringement,
`affecting Acuitas’s ability to license its LNPs to companies headquartered and incorporated within
`this District.
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`Acuitas recognizes that the Defendants dispute the existence of subject-matter jurisdiction
`and propose that the Court exercise its discretion to dismiss this case even if there is jurisdiction.
`For the reasons set forth in Acuitas’s pre-motion letter [D.I. 34], the Defendants’ jurisdictional
`concerns are baseless. In brief: Where patent owners threaten a product-supplier’s partners or
`customers with patent infringement suits based on the partners’ or customers’ use of the supplier’s
`product—as Defendants did to BioNTech and Pfizer here, alleging infringement of the Arbutus
`Patents based in part on Comirnaty®’s use of Acuitas’s LNP technology—the product supplier
`itself may bring a declaratory-judgment action seeking a declaration that the patents are invalid
`and/or not infringed—as Acuitas did here with respect to the Arbutus Patents. Such declaratory-
`judgment actions are cognizable in either of two circumstances: where the supplier might have to
`indemnify its partners or customers for damages owed to the patent owners, or where the supplier
`itself might face liability for indirect patent infringement for selling the component of the accused
`product. Both are true here. BioNTech, Acuitas’s customer, has notified Acuitas of a claim for
`indemnification if BioNTech were found to owe damages to Arbutus and Genevant for
`infringement of the Arbutus Patents. And the possibility of a claim of indirect-infringement
`against Acuitas itself is not so remote or speculative as to moot any case or controversy between
`Acuitas and the Defendants. This is exactly the circumstance in which courts decide declaratory-
`judgment cases exactly like this one.
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`The Honorable Mary Kay Vyskocil
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`Defendants’ Jurisdictional Statement
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`Acuitas has not satisfied its burden to establish subject matter jurisdiction because it has
`not alleged and cannot allege an actual controversy or injury-in-fact, both of which are
`prerequisites to jurisdiction.
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`The issues are detailed in Defendants’ pre-motion letter [D.I. 31]. In brief, the Complaint:
`(i) does not allege that Defendants ever contacted Acuitas regarding the vaccine, accused Acuitas
`of infringement, or sought to enforce the Arbutus Patents against Acuitas; (ii) relies on private
`communications, the first of which was sent over a year and a half ago without any subsequent
`legal action, from Defendants to Pfizer and BioNTech (not Acuitas); and (iii) does not allege
`objective concrete injury to Acuitas. Moreover, as discussed above, Acuitas’s efforts to ground
`jurisdiction in a potential indemnification obligation fail, not only because a potential obligation
`is legally insufficient but also because the Complaint does not mention indemnity at all. Likewise,
`Acuitas’s arguments regarding indirect infringement fail because unlike cases in which the
`patentee specifically accused the declaratory judgment plaintiff of induced or contributory
`infringement, Defendants here have never asserted that Acuitas induced Pfizer or BioNTech to
`infringe and Defendants’ letters to nonparties, on which Acuitas relies, did not even mention
`Acuitas.
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`Moreover, even if subject matter jurisdiction existed (it does not), the Court should use its
`discretion to decline to exercise declaratory judgment jurisdiction because (i) licensing discussions
`regarding Comirnaty® have not concluded and a licensing deal between Defendants and
`Pfizer/BioNTech would moot Acuitas’s claims at any time, and (ii) if Defendants prevail in this
`suit, either or both of Pfizer and BioNTech could render this Court’s judgment a nullity by filing
`a new suit in their own names the next day, arguing that they are not bound by or estopped from
`challenging this Court’s judgment.
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`3) A statement of procedural posture
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`Acuitas filed the Complaint on March 18, 2022 [D.I. 1], and the parties stipulated to extend
`Defendants’ time to respond to the Complaint to June 24, 2022 [D.I. 20]. On that day, pursuant to
`the Individual Practices of Judge Edgardo Ramos, Defendants filed a letter seeking a pre-motion
`conference regarding their intended motion to dismiss the case for lack of subject-matter
`jurisdiction or in the Court’s discretion [D.I. 31]. The filing of the pre-motion letter stayed the
`deadline for Defendants to respond to the Complaint. Acuitas responded to the pre-motion letter
`on July 8, 2022 [D.I. 34]. Judge Ramos recused himself at the start of the pre-motion conference
`on July 15, 2022, and the case was re-assigned to Your Honor. Defendants’ request to move to
`dismiss the case remains pending. Given that posture, Defendants have not answered the
`Complaint, and no scheduling order has been implemented.
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`The Honorable Mary Kay Vyskocil
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`a) A brief description of any (i) motions that have been made and decided,
`(ii) motions that any party seeks or intends to file, including the principal legal
`and other grounds in support of and opposition to the motion, (iii) pending
`motions and (iv) other applications that are expected to be made
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`No motions have been made or decided.
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`Defendants have requested, and hereby renew their request for, leave to move to dismiss
`the Complaint for the reasons set forth in their letter to Judge Ramos [D.I. 31 (Exhibit A hereto)].
`Acuitas opposed the filing of that motion, and would oppose the motion on its merits were it filed,
`for the reasons set forth in its letter to Judge Ramos [D.I. 34 (Exhibit B hereto)].
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`Based on the facts and information currently known to the parties, there are no other
`applications that the parties expect to make other than the usual possibilities of summary judgment
`and pre-trial in limine motions.
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`b) A brief description of any discovery that has already taken place, and a brief
`description of any discovery that the parties intend to take in the future
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`No discovery has taken place to date. If the case proceeds to discovery, the parties
`anticipate that discovery will encompass the factual and legal issues identified in Section 1,
`including document discovery and depositions of the parties, document discovery and depositions
`from nonparties Pfizer, BioNTech, and others, and expert discovery.
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`c) A statement describing the status of any settlement discussions and whether the
`parties would like a settlement conference
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`The parties have not held any settlement discussions and do not seek a settlement
`conference at this time.
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`4) Any other information the parties believe may assist the Court in resolving the action
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`None at this time.
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`/s/ Nicholas Groombridge
`Nicholas Groombridge
`Eric Alan Stone
`Josephine Young
`Allison C. Penfield
`PAUL, WEISS, RIFKIND, WHARTON &
`GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-2000
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`Saurabh Gupta
`PAUL, WEISS, RIFKIND, WHARTON &
`GARRISON LLP
`2001 K Street, NW
`Washington, DC 20006
`(202) 223-7300
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`Attorneys for Plaintiff Acuitas Therapeutics
`Inc.
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`Respectfully submitted,
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` /s/ Isaac Nesser
`Raymond N. Nimrod
`Isaac Nesser
`Matthew D. Robson
`QUINN, EMANUEL, URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York NY 10010
`(212) 849-7000
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`Kevin P.B. Johnson
`QUINN, EMANUEL, URQUHART & SULLIVAN, LLP
`555 Twin Dolphin Drive, 5th Floor
`Redwood Shores, CA 94065
`(650) 801-5000
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`Sandra Haberny
`QUINN, EMANUEL, URQUHART & SULLIVAN, LLP
`865 S. Figueroa Street, 10th Floor
`Los Angeles, CA 90017
`(213) 443-3000
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`Attorneys
`GmbH
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`/s/ Daralyn Durie
`Daralyn J. Durie
`Eric C. Wiener
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`(415) 362-6666
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`Kira A. Davis
`DURIE TANGRI LLP
`953 E. 3rd Street
`Los Angeles, CA 90013
`(213) 992-4499
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`Attorneys for Defendant Arbutus Biopharma
`Corp.
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`for Defendant Genevant Sciences
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