Case 3:23-cv-04200-ZNQ-TJB Document 1 Filed 08/04/23 Page 1 of 53 PageID: 1
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`MARINO, TORTORELLA & BOYLE, P.C.
`Kevin H. Marino
`John D. Tortorella
`437 Southern Boulevard
`Chatham, NJ 07928
`kmarino@khmarino.com
`jtortorella@khmarino.com
`Tel.: 973-824-9300; Fax.: 973-824-8425
`
`
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`Nicholas Groombridge*
`Eric Alan Stone
`Josephine Young*
`Allison C. Penfield*
`Chih-Wei Wu*
`565 Fifth Avenue, Suite 2900
`New York, NY 10017
`nick.groombridge@groombridgewu.com
`eric.stone@groombridgewu.com
`josephine.young@groombridgewu.com
`allison.penfield@groombridgewu.com
`chihwei.wu@groombridgewu.com
`Tel.: 332-263-0030; Fax: 332-262-5334
`
`Saurabh Gupta*
`801 17th Street, NW, Suite 1050
`Washington, DC 20006
`saurabh.gupta@groombridgewu.com
`Tel.: 202-505-6566; Fax: 202-595-0359
`
`*Pro hac vice applications forthcoming
`Attorneys for Plaintiff Acuitas Therapeutics Inc.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`GENEVANT SCIENCES GMBH, AND
`ARBUTUS BIOPHARMA CORP.
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`Defendants.
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`ACUITAS THERAPEUTICS INC.,
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`Plaintiffs,
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`v.
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`Civil Action No. ___________
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
`OF NON-INFRINGEMENT
`AND INVALIDITY
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`Jury Trial Demanded
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`
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`Acuitas Therapeutics Inc. (“Acuitas”), for its Complaint against Genevant Sciences GmbH
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`(“Genevant”) and Arbutus Biopharma Corp. (“Arbutus”) (collectively, “Defendants”), alleges as
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`follows:
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`NATURE OF THE ACTION
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`1.
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`COVID-19 presented the worst public-health crisis in a century. Three years later,
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`however, the pandemic is over. That is in large part due to the amazing success story of the mRNA
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`vaccines against the virus that causes COVID-19. Those vaccines exist only because of decades
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`of hard work and ingenuity by Acuitas and others to develop the technology that allowed the rapid
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`development of a vaccine to combat the pandemic.
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`2.
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`As the pandemic receded, however, litigation proliferated regarding who invented
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`various components of the mRNA vaccines. Despite not having invented or produced any
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`COVID-19 vaccine of their own (or any mRNA vaccine for any virus), Arbutus and Genevant
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`threatened Pfizer and BioNTech (which market an mRNA vaccine for COVID-19,
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`COMIRNATY®) with patent infringement. Acuitas invented and provides an essential component
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`used in COMIRNATY®, a lipid nanoparticle (“LNP”) that encapsulates the mRNA payload for
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`delivery, and its constituent lipids. This action arises out of Defendants’ threats to sue, and suit
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`against, Pfizer and BioNTech, based in part on their use of Acuitas’s LNP and lipids.
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`THE PROCEDURAL POSTURE
`This is the second time Acuitas has had to seek a declaratory judgment against
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`3.
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`Arbutus and Genevant. Acuitas first sued Arbutus and Genevant on March 18, 2022, in the
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`Southern District of New York, seeking a declaratory judgment that Arbutus’s patents are invalid
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`and not infringed by COMIRNATY®, after Arbutus and Genevant sent patent-infringement threat
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`letters to Pfizer and BioNTech. See Acuitas Therapeutics Inc. v. Genevant Scis. GmbH, Case No.
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`22-cv-02229-MKV (S.D.N.Y. Mar. 18, 2022) (the “New York Action”). Arbutus and Genevant
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`moved to dismiss the New York Action, arguing that a declaratory-judgment action by Acuitas
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`was unnecessary because Arbutus and Genevant had not, in fact, threatened Pfizer or BioNTech
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`with patent infringement, and might well reach an out-of-court agreement with them.
`2
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`4.
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`That was not accurate. While Arbutus and Genevant’s motion to dismiss Acuitas’s
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`New York Action was pending, Arbutus and Genevant did exactly what they implied to the New
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`York Court they had no intention of doing: On April 3, 2023, they sued Pfizer and BioNTech for
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`patent infringement. But rather than doing so in the Southern District of New York, where
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`Acuitas’s case was pending, they sued in this Court. See Arbutus Biopharma Corp. et al v. Pfizer
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`Inc. et al., No. 3:23-cv-01876-ZNQ (D.N.J.) (“Arbutus’s New Jersey Action”). Arbutus and
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`Genevant explicitly identified Acuitas’s lipids and LNP, while studiously not using the word
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`“Acuitas” in their complaint. In answering the complaint in Arbutus’s New Jersey Action, Pfizer
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`and BioNTech raised as a defense that Arbutus and Genevant had failed to name or join Acuitas
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`as a “required party.” Arbutus Biopharma Corp. v. Pfizer Inc., No. 2:23-cv-01876-ZNQ (D.N.J.)
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`(ECF 17, Fifth Affirmative Defense).
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`5.
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`Acuitas’s declaratory-judgment claim against Arbutus and Genevant being heard
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`in the same Court in which Arbutus’s and Genevant’s claims against Pfizer and BioNTech are
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`heard will conserve judicial resources and help ensure consistent outcomes.
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`6.
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`The claims are legally distinct. Acuitas’s business model is to develop LNP
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`technology and license it to partners who will use the technology to develop mRNA-based
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`vaccines for pathogens far beyond COVID-19. It is public, for example, that Acuitas is partnering
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`with companies other than Pfizer and BioNTech to investigate therapies directed at a broad range
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`of indications and applications. It is vital to Acuitas’s business that its partners and prospective
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`partners can use the licensed Acuitas LNP technology free and clear of interference by threats of
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`suit arising from third party patents. Instead, customers and potential customers of Acuitas must
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`now contend with the risk of avaricious litigation by Arbutus and Genevant, who have
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`demonstrated their willingness to sue Acuitas’s customers that use Acuitas LNP technology,
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`3
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`despite the fact that Arbutus and Genevant did not invent and had nothing to do with the success
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`of Acuitas’s lipids or vaccines that use them. That threat to other customers and potential
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`customers, and thus the threat to Acuitas itself, would remain even if Arbutus and Genevant were
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`to resolve their dispute with Pfizer and BioNTech. While Acuitas contends that Arbutus and
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`Genevant’s claims of infringement are baseless and that their patents are invalid, without a
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`declaratory judgment so holding, Acuitas faces (i) uncertainty with respect to the use of its
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`technology free from the threat of patent infringement, (ii) the possibility of liability under 35
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`U.S.C. § 271(b) for inducing its customers’ infringement or under § 271(c) for contributing to it,
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`or (iii) the possibility of indemnity obligations to its customers under their contracts.
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`7.
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`There are, however, substantial overlapping legal and factual issues between
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`Arbutus’s New Jersey Action and Acuitas’s declaratory-judgment claims. Acuitas thus suggested
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`to Arbutus and Genevant that they consent to transfer the New York Action to this Court. Arbutus
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`and Genevant refused. But on August 1, this Tuesday, they wrote to the New York Court to
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`assert—without mentioning their refusal to transfer Acuitas’s New York Action to this Court—
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`that Arbutus’s New Jersey Action “is uniquely suited to resolve the controversy between Pfizer,”
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`BioNTech, and the Defendants. In that letter, Arbutus and Genevant argued that the New York
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`Court should decide their pending motion to dismiss in part because Pfizer and BioNTech did not
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`move “to dismiss” Arbutus’s New Jersey Action “on the basis that Acuitas is a necessary party,”
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`and that “[t]he closest Pfizer and BioNTech have come” to doing so “is an affirmative defense that
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`states, in its entirety, ‘Plaintiffs’ Complaint improperly failed to name or join Acuitas
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`Therapeutics, Inc.’” That is not accurate. While Pfizer and BioNTech’s Answer and
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`Counterclaims do contain that sentence, it is not the entirety of that defense: The defense is entitled
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`“FAILURE TO JOIN A REQUIRED PARTY.” Arbutus Biopharma Corp. v. Pfizer Inc., No.
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`4
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`2:23-cv-01876-ZNQ (D.N.J.) (ECF 17, Fifth Affirmative Defense). And Pfizer and BioNTech
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`included an entire section entitled “BIONTECH’S RELATIONSHIP WITH ACUITAS.” Id. at
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`¶¶ 31–34. That Arbutus and Genevant mischaracterize Pfizer and BioNTech’s allegations about
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`Acuitas confirms that Arbutus and Genevant recognize the interrelationship between Acuitas’s
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`claims and Arbutus’s New Jersey Action.
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`8.
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`Accordingly, Acuitas is withdrawing its New York Action without prejudice, and
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`is filing this declaratory-judgment action in this Court. Acuitas will designate this case as related
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`to Arbutus’s New Jersey Action, and is open to working with counsel for all parties in that action
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`to coordinate discovery and case schedules. Acuitas has independent claims that should be
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`adjudicated, but it is logical and efficient to coordinate those claims with the claims and
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`counterclaims in Arbutus’s New Jersey Action.
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`THE SCIENTIFIC CONTEXT
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`9.
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`Traditional vaccines create immunity by injecting a patient with pieces of the virus,
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`or an inactive form of that virus. The vaccines that Acuitas helped to develop utilize messenger
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`RNA (“mRNA”) technology, do not require injection of the virus, and were developed much more
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`quickly than traditional vaccines. All living organisms, including both humans and viruses, make
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`proteins, which are the workhorses that complete the tasks needed by that organism. In humans
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`the “blueprint” for these proteins is carried in genes (i.e., DNA), but that blueprint needs to be
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`converted into an mRNA message that tells the body to make a particular protein.
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`10. mRNA vaccines work by introducing into a person the mRNA message that
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`instructs the body to make a foreign protein that is itself a piece of a virus. When that viral protein
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`is made, or “expressed,” by the person’s cells, that person’s immune system then recognizes that
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`the protein is foreign and develops an immune response to it. If that person is later infected with
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`5
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`the virus itself, his or her immune system is primed to protect against or minimize the significance
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`of the viral infection. Because the mRNA contained in the vaccine represents a protein that is only
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`a piece of the virus, the entire virus is never introduced into the body and there is thus no risk of
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`infection from the vaccine.
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`11.
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`For all of its advantages, however, working with mRNA presents prodigious
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`challenges. First, mRNA is exceptionally fragile and, when injected into the body, breaks down
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`extremely quickly. Second, mRNA is too large a molecule to enter into human cells on its own.
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`An mRNA vaccine therefore requires a delivery system that protects the mRNA after it is injected
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`into the person and transports the mRNA into the person’s cells.
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`12.
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`In the decade before COVID-19 emerged, Acuitas worked to solve that delivery-
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`system problem: it painstakingly engineered a microscopic sphere of fats called a Lipid
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`Nanoparticle, or “LNP,” that can envelop and protect the mRNA. These mRNA-LNPs protect the
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`fragile mRNA, allow it to cross the membrane of a human cell, and then release the mRNA so that
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`it can be used to create the proteins that will in turn generate an immune response. One of Acuitas’s
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`mRNA-LNPs
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`is used, under
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`license,
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`in Pfizer and BioNTech’s COVID-19 vaccine,
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`COMIRNATY®, which has been a global success in protecting people from COVID-19. To date,
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`over 350 million doses of COMIRNATY® have been administered in the United States.
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`13.
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`Arbutus and Genevant had nothing to do with that success. Neither has a COVID-
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`19 vaccine, neither has created any component of such a vaccine, and neither has commercialized
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`an LNP that can effectively wrap and protect any mRNA molecule. On the contrary, only after
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`COMIRNATY® achieved worldwide commercial success did Arbutus and Genevant emerge to
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`make the spurious claim, in threat letters and a lawsuit in this District, that COMIRNATY®
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`infringes Arbutus’s patents, and, on information and belief, to seek hundreds of millions, if not
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`6
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`billions, of dollars in wholly unjustified payments. Arbutus and Genevant seek the benefits
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`flowing from COMIRNATY® without having borne any of the burden of developing it. Their
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`claim to rights in—and payment for—COMIRNATY® is baseless.
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`14. What is now Arbutus was originally founded as Inex Pharmaceuticals Inc. in the
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`early 1990s, by leading LNP scientists Dr. Pieter Cullis, Dr. Thomas Madden, and Dr. Michael
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`Hope, to develop therapeutics incorporating lipid-based nanomaterials. This research led to the
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`development of anticancer therapeutics that provided greater potency in fighting tumors while
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`reducing the side effects often seen with such drugs. Subsequently, Inex (later known as Tekmira
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`Pharmaceuticals Corp.) developed LNPs to deliver new classes of drugs based on a type of nucleic
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`acid called small interfering RNA, or “siRNA,” which are short pieces of RNA that interfere with
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`the body’s ability to make certain proteins that may cause disease. Some of this research led to
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`the development of an siRNA therapeutic called ONPATTRO®.
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`15.
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`By 2008 the company that is now Arbutus was no longer interested in supporting
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`the work that Dr. Madden and Dr. Hope were pursuing, and terminated their employment.
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`Together with Dr. Cullis, Drs. Madden and Hope founded Acuitas Therapeutics Inc. (originally
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`called AlCana Technologies Inc.) to develop LNP technology, and, by 2012, Acuitas had decided
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`to focus on the development of LNP technology for the delivery of mRNA. Conversely, Arbutus
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`chose to focus its business on the much less challenging problem of developing LNP carriers to
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`encapsulate siRNA.
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`16.
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`There were good scientific reasons for Arbutus to have bet on siRNA therapeutics
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`rather than mRNA therapeutics. Despite the similarity in their names, siRNA and mRNA are
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`fundamentally different in ways that may frustrate the design of LNPs to encapsulate mRNA. For
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`starters, there is the size difference: mRNA molecules are much larger than siRNA molecules,
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`7
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`with the mRNA in COMIRNATY® some 200 times longer than an average siRNA molecule. Then
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`there is the rigidity difference: siRNA molecules are akin to short, sturdy rods, while the longer
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`mRNA molecules can fold and wind into complex shapes. The technology needed to wrap an
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`siRNA molecule in a lipid nanoparticle is thus vastly different (and simpler) than what is needed
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`to wrap an mRNA molecule. Importantly, mRNA is also much less stable than siRNA,
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`significantly complicating mRNA’s formulation and encapsulation in LNP and the manufacture
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`of mRNA vaccines.
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`17. While the hope for an mRNA therapeutic is over thirty years old, mRNA’s inherent
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`instability and its inability to enter cells presented major barriers to its clinical use. In addition,
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`previously known ways to package and deliver mRNA were either ineffective or toxic.
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`18.
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`Acuitas’s scientists—including Drs. Madden, Cullis, and Hope, who have been
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`working on lipids and LNP formulations for drug delivery for decades—solved those problems.
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`Acuitas’s research focused on the design and synthesis of novel lipids that provide more efficient
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`and safe delivery of mRNA. They identified appropriate formulation conditions to allow efficient
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`encapsulation of mRNA into LNPs and, importantly, to protect the mRNA from degradation
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`during the formulation process. Acuitas’s research involved analytical, biophysical, and
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`preclinical characterization of lipid and lipid component properties to guide lipid and LNP
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`development and to ensure they have the most advantageous safety and efficacy profiles. Acuitas
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`elucidated the mechanism by which mRNA-LNPs are taken up by cells. Acuitas also conducted
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`biophysical analyses of novel mRNA-LNPs and determined which structural and biophysical
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`properties of the LNP components are critical for activity and safety. This research resulted in the
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`identification of hundreds of novel lipids with improved activity and safety. Acuitas tested
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`hundreds of different LNPs with mRNA in order to determine the characteristics for successful
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`8
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`encapsulation. And Acuitas’s scientists, in collaborations with its partners, evaluated different
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`LNPs for use in a variety of different vaccines, including COMIRNATY®. This research was
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`published in leading scientific journals, including in Nature.
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`19.
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`Acuitas partners with companies who are developing or seeking to develop
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`therapeutics, including vaccines targeting COVID-19 and other viruses, to address unmet clinical
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`needs. This work, and the potential benefit of the Acuitas mRNA-LNP technology, goes far
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`beyond a vaccine against the virus that causes COVID-19. Acuitas also patented its novel
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`discoveries, which include the ionizable cationic lipid known as ALC-0315, which is used in the
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`LNP in COMIRNATY®.
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`20.
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`Acuitas and its researchers received global praise, recognition, and awards for their
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`role in developing the LNP technology required for mRNA vaccines, including the critical LNP
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`component of COMIRNATY®. These awards include the 2021 Global Impact Award by Life
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`Sciences British Columbia, the Prince Mahidol Award, the VinFuture Grand Prize, the BIAL
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`Award in Biomedicine, and the admission of Dr. Pieter Cullis to the Order of Canada.
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`DEVELOPMENT OF COMIRNATY®
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`21.
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`The origins of COMIRNATY® lie in collaborations between Acuitas and
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`BioNTech that preceded the COVID-19 pandemic. In 2017, Acuitas and BioNTech began to
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`collaborate on the development of mRNA therapeutic products using the Acuitas LNP technology.
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`At or around the same time, Acuitas had also been collaborating with another German company,
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`CureVac N.V. (“CureVac”), which in 2019 began a Phase 1 clinical trial of an mRNA vaccine
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`against rabies, using Acuitas’s LNP technology. In January 2020, CureVac released the results of
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`this clinical trial, showing a strong immune response to the vaccine at a remarkably low dose.
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`These very encouraging clinical data were released at the same time as the global threat from
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`9
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`COVID-19 was becoming apparent. Acuitas therefore quickly engaged with CureVac and
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`BioNTech to discuss use of the same LNP technology to develop an mRNA vaccine against
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`COVID-19. The LNP used in the rabies vaccine contained the proprietary Acuitas lipids ALC-
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`315 and ALC-159, and Acuitas recommended that the planned COVID-19 vaccine use the same
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`LNP composition.
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`22.
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`The development of COMIRNATY® itself began in January 2020, at the onset of
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`the pandemic, when BioNTech started creating an mRNA molecule that codes for the “spike
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`protein” of the COVID-19 SARS-CoV-2 coronavirus. BioNTech began working with Pfizer in
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`March 2020 to develop and produce a COVID-19 vaccine. The rapid development of
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`COMIRNATY® was possible in part because BioNTech had access to the Acuitas LNP
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`technology, and had been collaborating with Acuitas on the use of that technology for several
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`years. Further, Acuitas actively supported the formulation and evaluation of various COVID-19
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`vaccine candidates and worked with BioNTech and Pfizer to support scale-up of the manufacturing
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`process to allow subsequent production of the billions of vaccine doses needed globally.
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`23.
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`Clinical trials of COMIRNATY® began in late April of 2020, with preliminary
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`Phase 3 results demonstrating their safety and efficacy published in just over six months.
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`24. While clinical trials were ongoing, the federal government recognized the
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`importance of the vaccine and announced a $1.95 billion contract to purchase 100 million doses
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`of COMIRNATY® in July of 2020 and announced another $1.95 billion contract for another 100
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`million doses of COMIRNATY® by December 2020, bringing the government’s total purchase
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`commitment to almost $4 billion.
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`10
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`25.
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`By November 9, 2020, it had been publicly reported that Acuitas had partnered with
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`BioNTech, and that Acuitas’s lipids and LNPs were used in Pfizer and BioNTech’s
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`COMIRNATY® vaccine.
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`26.
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`On November 18, 2020, BioNTech and Pfizer announced that their COVID-19
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`vaccine met all the primary efficacy endpoints in their Phase three study, demonstrating an efficacy
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`rate of 95% (p < 0.0001) in participants without prior SARS-CoV-2 infection (first primary
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`objective) and also in participants with and without prior SARS-CoV-2 infection (second primary
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`objective), as measured from seven days after the second dose of the vaccine.
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`27.
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`On November 20, 2020, based on very high interim vaccine-efficacy results in a
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`Phase 3 clinical study, Pfizer and BioNTech submitted a request for Emergency Use Authorization
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`(“EUA”) of COMIRNATY® to the U.S. Food and Drug Administration (“FDA”).
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`28.
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`On December 10, 2020, COMIRNATY® was approved by the FDA under an
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`Emergency Use Authorization to prevent COVID-19 in individuals sixteen years of age and older.
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`That EUA approval came less than ten months after BioNTech first created an mRNA molecule
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`coding for the spike protein of the SARS-CoV-2 virus.
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`29.
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`COMIRNATY® immediately started being deployed nationwide in vaccination
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`efforts.
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`30.
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`By summer 2021, the federal government and the European Union had negotiated
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`deals with Pfizer and BioNTech to purchase billions of doses of COMIRNATY®.
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`31.
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`On May 10, 2021, the FDA expanded the Emergency Use Authorization of
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`COMIRNATY® to include children as young as twelve. Later, on October 29, 2021, the
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`Emergency Use Authorization was expanded to children as young as five.
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`11
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`32.
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`As a result of the safety profile and efficacy of COMIRNATY®, including
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`information obtained as a result of the successful vaccination efforts during 2020 and early 2021,
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`and in conjunction with further scientific studies, the FDA gave full approval of COMIRNATY®
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`on August 23, 2021. COMIRNATY® was the first COVID-19 vaccine to receive such approval.
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`33.
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`Following full approval, COMIRNATY® was found to be efficacious in combating
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`not just the original COVID-19 strains but also the Beta, Delta, and Omicron variants that swept
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`the world following the initial 2020 outbreak.
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`34.
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`To date, Pfizer and BioNTech have delivered millions of doses of COMIRNATY®
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`worldwide to combat the COVID-19 pandemic, all containing the lipids and lipid nanoparticles
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`innovated by Acuitas that deliver this critical mRNA therapeutic.
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`THE DEFENDANTS’ DEMAND LETTERS
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`35. When Arbutus saw the tremendous success of the mRNA vaccines for COVID-19,
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`it realized that having chosen to pursue siRNA therapeutics instead of mRNA was a bad decision,
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`both scientifically and financially. On November 23, 2020, just three days after seeing the
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`successful clinical-trial results and recognizing the real possibility that COMIRNATY® would be
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`the first COVID-19 vaccine to be authorized in the United States, Defendants sent a 35 U.S.C.
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`§ 287(a) notice, which is a predicate for recovery of damages in a patent-infringement action, to
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`Pfizer, copying Acuitas’s licensee and partner BioNTech, threatening to assert eight patents
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`against the sale and use of the COMIRNATY® vaccine. At that time, COMIRNATY® was being
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`evaluated for Emergency Use Authorization by the FDA, so Arbutus and Genevant knew that it
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`would be impossible for Pfizer and BioNTech to consider Arbutus and Genevant’s LNP
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`technology in connection with COMIRNATY®. Thus, while Arbutus and Genevant’s November
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`23, 2020 letter included generic language asserting there would be a benefit for Pfizer to partner
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`with Genevant, the true purpose of the letter—as confirmed by its timing and citation to 35 U.S.C.
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`§ 287(a)—was a threat of a patent-infringement suit.
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`36.
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`The same is true of their second such letter, sent on October 12, 2021, which added
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`a ninth patent that issued on the same day.
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`37.
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`On June 3, 2022, Defendants sent a third patent-infringement notice letter to
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`BioNTech, copying Pfizer, adding two more newly issued patents.
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`ACUITAS’S NEW YORK ACTION AND THIS ACTION
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`38.
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`Defendants’ 35 U.S.C. § 287(a) patent-infringement notices, their seeking
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`substantial royalties, and the prospect of future claims against other Acuitas licensees seeking to
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`use Acuitas’s LNPs for other mRNA vaccines and therapeutics, threaten to cause serious harm to
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`Acuitas’s business and expose Acuitas to potential claims of indirect infringement and/or
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`indemnity obligations under its contracts with its customers and partners. Therefore, on March
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`18, 2022, after Arbutus and Genevant sent their second demand letter, Acuitas filed the New York
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`Action, seeking a declaratory judgment that the nine Arbutus patents, cited in Arbutus and
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`Genevant’s November 2020 and October 2021 letters, are not infringed by the manufacture, use,
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`offer for sale, sale, or importation into the United States of COMIRNATY® and are, in any event,
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`invalid.
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`39.
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`Arbutus and Genevant moved to dismiss the New York Action on October 4, 2022,
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`arguing that there was a lack of substantial controversy and adverse legal interests between Acuitas
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`and them, because Arbutus and Genevant were supposedly just engaging in business collaborations
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`with BioNTech and Pfizer and “[t]here is no need to burden the Court with Acuitas’s premature
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`side-show action when the actual parties to the discussions have not sought judicial intervention
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`and a license could moot this case at any time.”
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`Case 3:23-cv-04200-ZNQ-TJB Document 1 Filed 08/04/23 Page 14 of 53 PageID: 14
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`40.
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`Despite their “nothing to see here” assurances to the New York court, within six
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`months of these assurances and over a year after Acuitas filed the New York Action, on April 3,
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`2023, Arbutus and Genevant sued Pfizer and BioNTech in this Court, relying on the same demand
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`letters as a basis for contentions of willfulness and explicitly identifying Acuitas’s lipids and LNPs
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`in alleging that COMIRNATY® infringes their patents. On information and belief, Arbutus and
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`Genevant seek hundreds of millions, if not billions, of dollars in royalties on sales of
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`COMIRNATY®. On July 10, 2023, Pfizer and BioNTech filed their answer and counterclaims in
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`Arbutus’s New Jersey Action, raising as a defense that Arbutus and Genevant had improperly
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`failed to name or join Acuitas as a “required party.”
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`41.
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`As of the date of this Complaint, Acuitas’s New York Action had not progressed
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`past the pleadings stage; Arbutus’s and Genevant’s motion to dismiss remained pending. In the
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`interest of judicial economy, conservation of parties’ resources, and avoidance of inconsistent
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`outcomes, today Acuitas voluntarily, and without prejudice, dismissed its New York Action
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`pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i), and is filing this action in this District.
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`42.
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`Specifically, pursuant to Federal Rule of Civil Procedure 57 and 28 U.S.C. § 2201,
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`Acuitas seeks a declaratory judgment that the following ten Arbutus patents—the same patents
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`that were included in Arbutus and Genevant’s demand letters and five of the same patents are
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`asserted in Arbutus’s New Jersey Action—are not infringed by the manufacture, use, offer for sale,
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`sale, or importation into the United States of COMIRNATY® and are, in any event, invalid: U.S.
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`Patent Nos. 9,364,435 (the “’435 patent”); 8,058,069 (the “’069 patent”); 8,492,359 (the “’359
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`patent”); 8,822,668 (the “’668 patent”); 9,006,417 (the “’417 patent”); 9,504,651 (the “’651
`
`
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`Case 3:23-cv-04200-ZNQ-TJB Document 1 Filed 08/04/23 Page 15 of 53 PageID: 15
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`patent”); 9,518,272 (the “’272 patent”); 11,141,378 (the “’378 patent”); 11,298,320 (the “’320
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`patent”); 11,318,098 (the “’098 patent”) (collectively the “Arbutus Patents”).1
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`THE PARTIES
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`43.
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`Plaintiff Acuitas is a leading biotechnology company that collaborates with partner
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`companies and academic institutions to develop new therapies to address unmet clinical needs. It
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`is a Canadian corporation organized and existing in British Columbia, Canada, with a principal
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`place of business at 6190 Agronomy Road, Suite 405, Vancouver, British Columbia, V6T 1Z3,
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`Canada.
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`44.
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`Acuitas specializes in the development of mRNA-LNP formulations for use as
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`therapeutics. Acuitas has partnered with non-parties BioNTech and Pfizer to supply and license
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`the LNP used in COMIRNATY®, a COVID-19 vaccine being administered to protect people
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`around the world. COMIRNATY® has received full approval for use by the FDA.
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`45.
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`On information and belief, Defendant Genevant Sciences GmbH, an indirect
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`wholly owned subsidiary of Genevant Sciences Ltd. (itself a Bermuda holding company), is a
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`limited-liability company organized and existing under the laws of Switzerland with a principal
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`place of business at Viaduktstrasse 8, 4051 Basel, Switzerland.
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`46.
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`On information and belief, Defendant Arbutus Biopharma Corp. (variously known
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`in the past as Tekmira, Protiva, and Inex, and referred to herein as “Arbutus”) is a corporation
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`organized and existing under the laws of Canada with corporate headquarters at 1066 W. Hastings
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`
`1 Acuitas’s New York Action included a count seeking a declaratory judgment that Arbutus’s
`U.S. Patent No. 9,404,127 (the “’127 patent”) is invalid and not infringed by COMIRNATY®.
`Subsequently, however, the United States Court of Appeals for the Federal Circuit affirmed the
`invalidity of all claims of the ’127 patent. See Arbutus Biopharma Corp. v. ModernaTx, Inc.,
`No. 2020-1183, Docket Nos. 94, 95 (Fed. Cir. Apr. 11, 2023). Acuitas is therefore not including
`the ’127 patent in this case.
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`
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`Street Suite 1600, Vancouver, British Columbia, V6E 3X1, Canada and with research headquarters
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`and principal place of business at 701 Veterans Circle, Warminster, Pennsylvania 18974.
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`47.
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`Arbutus is the owner of all rights, title and interest to each of the Arbutus Patents.
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`Upon information and belief, Genevant holds a license to each of the Arbutus Patents.
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`JURISDICTION AND VENUE
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`48.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a), and
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`2201.
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`49.
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`In bringing this action, Acuitas joins a long history of product suppliers who, under
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`circumstances like these, respond to patent-infringement actions against their partners and
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`customers by bringing a declaratory-judgment action against the patentee. Acuitas will
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`demonstrate that the Arbutus Patents are invalid, and also that they are not infringed by
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`COMIRNATY® or by Acuitas’s LNP incorporated in COMIRNATY®.
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`50.
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`Arbutus and Acuitas are competitors in the LNP industry. Arbutus and Genevant
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`are claiming credit for the lipids and LNPs that Acuitas itself invented and licensed. And this is
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`not the first fight between the two companies about the inventorship of LNP technology. In the
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`past there have been two litigations between them involving LNP technology. By agreement
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`reached in 2012, Acuitas and Arbutus spent the last decade pursuing different scientific pathways:
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`Acuitas sought to develop LNPs that could deliver mRNA, while Arbutus sought to develop LNPs
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`for an entirely different kind of nucleic acid called siRNA.
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`51.
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`Now that Acuitas’s LNPs have been used in mRNA vaccines that have helped save
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`the world from a pandemic, Arbutus and Genevant—which have no FDA-approved and on-the-
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`market mRNA and anti-COVID product—have shown up, falsely claiming to have invented that
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`lifesaving technology, and filing patent-infringement lawsui