Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 1 of 45
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
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`ACUITAS THERAPEUTICS INC.,
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`Plaintiffs,
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`v.
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`GENEVANT SCIENCES GMBH, AND
`ARBUTUS BIOPHARMA CORP.
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`Defendants.
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`C.A. No. 22-cv-2229-MKV
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`FIRST AMENDED COMPLAINT FOR DECLARATORY JUDGMENT OF
`NON-INFRINGEMENT AND INVALIDITY
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`Acuitas Therapeutics Inc. (“Acuitas”), for its First Amended Complaint against Genevant
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`Sciences GmbH (“Genevant”) and Arbutus Biopharma Corp. (“Arbutus”) (collectively,
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`“Defendants”), alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`COVID-19 has presented the worst public health crisis in a century. Two years
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`later, however, the pandemic is receding. That is in large part due to the amazing success story of
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`the mRNA vaccines against the virus that causes COVID-19. Those vaccines exist only because
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`of decades of hard work and ingenuity by the Plaintiff, Acuitas, and others, to develop the
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`technology that allowed the rapid development of a vaccine to combat the pandemic.
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`2.
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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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`3.
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`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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`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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`4.
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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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`5.
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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 320 million doses of COMIRNATY® have been administered in the United States.
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`6.
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`The Defendants here, Arbutus and Genevant, had nothing to do with that success.
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`Neither has a COVID-19 vaccine, neither has created any component of such a vaccine, and neither
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`has commercialized an LNP that can effectively wrap and protect any mRNA molecule. On the
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`contrary, only after COMIRNATY® achieved worldwide commercial success did Arbutus and
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`Genevant emerge to make the spurious claim that COMIRNATY® may infringe Arbutus’s patents,
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`and, on information and belief, to seek hundreds of millions, if not billions, of dollars in wholly
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`unjustified payments. Arbutus and Genevant seek the benefits flowing from COMIRNATY®
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`without having borne any of the burden of developing it. Their claim to rights in—and payment
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`for—COMIRNATY® is baseless.
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`7.
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`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 lipid nanoparticles to deliver new classes of drugs based on a
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`type of nucleic acid called small interfering RNA, or “siRNA,” which are short pieces of RNA that
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`interfere with the body’s ability to make certain proteins that may cause disease. Some of this
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`research led to the development of an siRNA therapeutic called ONPATTRO®.
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`8.
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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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`9.
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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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`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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`10. 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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`11.
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`Acuitas’s scientists solved those problems. They identified appropriate formulation
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`conditions to allow efficient encapsulation of mRNA into LNPs and, importantly, to protect the
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`mRNA from degradation during the formulation process. They tested hundreds of different LNPs
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`with mRNA in order to determine the characteristics for successful encapsulation. And Acuitas’s
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`scientists, in collaborations with its partners, evaluated different LNPs for use in a variety of
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`different vaccines. This research has been published in leading scientific journals, including in
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`Nature.
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`12.
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`Acuitas’s research has also focused on the design and synthesis of novel lipids that
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`provide more efficient and safe delivery of mRNA. This research has resulted in the identification
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`of hundreds of novel lipids with improved activity and safety. Acuitas partners with companies
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`who are marketing or seeking to market therapeutics, including vaccines targeting COVID-19 and
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`other viruses, to address unmet clinical needs. Acuitas has also patented its novel discoveries,
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`which include the ionizable cationic lipid known as ALC-0315, which is used in the LNP in
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`COMIRNATY®. By November 9, 2020, it had been publicly reported that Acuitas had partnered
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`with BioNTech, and that Acuitas’s lipids and LNPs were used in Pfizer and BioNTech’s
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`COMIRNATY® vaccine. On November 20, 2020, based on very high interim vaccine-efficacy
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`results in a Phase 3 clinical study, Pfizer and BioNTech submitted a request for Emergency Use
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`Authorization (“EUA”) of COMIRNATY® to the U.S. Food and Drug Administration (“FDA”).
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`FDA approved that emergency use shortly thereafter. Acuitas and its researchers have received
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`global praise, recognition, and awards for their role in developing the LNP technology required
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`for mRNA vaccines, including the critical LNP component of COMIRNATY®. These awards
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`include the 2021 Global Impact Award by Life Sciences British Columbia, the Prince Mahidol
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`Award, the VinFuture Grand Prize, the BIAL Award in Biomedicine, and the admission of Dr.
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`Pieter Cullis to the Order of Canada.
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`13. 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, Arbutus and Genevant sent a 35
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`U.S.C. § 287(a) notice, which is a predicate for recovery of damages in a patent-infringement
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`action, to Pfizer, copying Acuitas’s licensee and partner BioNTech, threatening to assert eight
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`patents against the sale and use of the COMIRNATY® vaccine. At that time, COMIRNATY® was
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`being evaluated for Emergency Use Authorization by the FDA, so Arbutus and Genevant knew
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`that it 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. The same is true of their second such letter,
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`sent on October 12, 2021, which added a ninth patent that issued on the same day. On information
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`and belief, Arbutus and Genevant seek hundreds of millions, if not billions, of dollars in royalties
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`on sales of COMIRNATY®.
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`14.
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`Arbutus and Genevant’s 35 U.S.C. § 287(a) patent infringement notices, their
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`seeking substantial royalties, and the prospect of future claims against other Acuitas licensees
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`seeking to use Acuitas’s LNPs for other mRNA vaccines and therapeutics, threaten to cause serious
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`harm to Acuitas’s business. Acuitas therefore brings this action pursuant to Federal Rule of Civil
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`Procedure 57 and 28 U.S.C. § 2201 for a declaratory judgment that the following nine Arbutus
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`patents—the same patents that Arbutus and Genevant alleged COMIRNATY® infringes—are not
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`infringed by the manufacture, use, offer for sale, sale, or importation into the United States of
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`COMIRNATY® and are, in any event, invalid: U.S. Patent Nos. 8,058,069 (the “’069 patent”);
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`8,492,359 (the “’359 patent”); 8,822,668 (the “’668 patent”); 9,006,417 (the “’417 patent”);
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`9,364,435 (the “’435 patent”); 9,404,127 (the “’127 patent”); 9,504,651 (the “’651 patent”);
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`9,518,272 (the “’272 patent”); and 11,141,378 (the “’378 patent”) (collectively the “Arbutus
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`Patents”).
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`THE PARTIES
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`15.
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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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`16.
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`Acuitas itself specializes in the development of mRNA-LNP formulations for use
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`as 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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`17.
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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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`18.
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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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`Street Suite 1600, Vancouver, British Columbia, V6E 3X1, Canada and with research headquarters
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`at 701 Veterans Circle, Warminster, Pennsylvania 18974.
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`19.
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`On information and belief, non-party Roivant Sciences Ltd. owns approximately
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`84% of Genevant Sciences Ltd., and Arbutus owns the remaining approximately 16% of Genevant
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`Sciences Ltd. On information and belief, Roivant has offices at 151 W. 42nd Street, 15th Floor,
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 8 of 45
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`New York, New York 10036. On information and belief, Roivant has acted as an agent for Arbutus
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`and Genevant with respect to acts giving rise to this First Amended Complaint.
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`20.
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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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`21.
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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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`22.
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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 threats of patent infringement against their partners and
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`customers by bringing a declaratory-judgment action against the party making the threats. Acuitas
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`will 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 delivery system incorporated in COMIRNATY®.
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`23.
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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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`24.
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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, sending 35 U.S.C. § 287(a) notices of patent infringement to BioNTech and
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`Pfizer. Inherent in these notices is Arbutus and Genevant’s belief that Acuitas’s LNP used in
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`COMIRNATY® infringes an element of their patent claims. That creates a risk of Acuitas itself
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`facing the possibility of liability under 35 U.S.C. § 271(b) for inducing its customers’ infringement
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`or under § 271(c) for contributing to it.
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`25.
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`On November 23, 2020—the same day that they sent their first 35 U.S.C. § 287(a)
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`notice to Pfizer and BioNTech—Arbutus and Genevant sent a similar patent infringement notice
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`to the only other company with a COVID-19 mRNA vaccine, Moderna. They followed up that
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`notice by suing Moderna for patent infringement on February 28, 2022, asserting six of the same
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`patents that are subject to this action.
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`26.
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`Acuitas’s license agreement with BioNTech contains indemnification provisions.
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`Citing these provisions, and after receiving patent-infringement notices from Arbutus and
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`Genevant, in January 2022, BioNTech gave notice to Acuitas of a claim for indemnification.
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`Specifically, BioNTech identified the nine patents in suit in this action, and asserted that under the
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`license agreement, Acuitas was obligated to indemnify BioNTech for any damages, litigation
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`costs, or other expenses if Arbutus and Genevant sued BioNTech for infringement of the patents.
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`In August 2022, BioNTech again made this assertion. Whether or not Acuitas ultimately would
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`have indemnification obligations, BioNTech’s assertion that it has indemnification rights is
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`sufficient to create declaratory-judgment jurisdiction to resolve Acuitas’s challenges to the
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`asserted patents.
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`27.
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`Based on the facts alleged in this First Amended Complaint, and incorporated
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`herein, this Court has subject-matter jurisdiction over a declaratory-judgment action by a supplier
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`(here, Acuitas) against a patentee (here, Arbutus and Genevant) that has threatened the supplier’s
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`partners, customer, and licensee (here, Pfizer and BioNTech) either (i) where the supplier faces
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`the possibility of liability under 35 U.S.C. § 271(b) for inducing its customers’ infringement or
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`under § 271(c) for contributing to it, or (ii) where the supplier may have to indemnify its customers
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`under their contracts.
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`28.
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`This Court has personal jurisdiction over Genevant and Arbutus because each of
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`them purposely availed itself of this jurisdiction by sending demand letters into this District
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`alleging potential patent infringement. Specifically, on November 23, 2020 and October 12, 2021,
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`Genevant and Arbutus sent letters to Pfizer’s headquarters on 42nd Street in Manhattan, within
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`this District, pursuant to 35 U.S.C. § 287(a), asserting that the making, use, sale, or offer for sale
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`of COMIRNATY® may infringe each of the Arbutus Patents. On information and belief, Arbutus
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`was aware of, and authorized and participated in, Genevant’s sending of those letters, as Arbutus
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`is a significant shareholder in Genevant and is the assignee of the patents that Genevant threatened
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`to assert, and Arbutus’s President and CEO signed both letters. By sending the letters, each of
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`Genevant and Arbutus acted at least in part through their agent Roivant, which is itself
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`headquartered in this District.
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`29.
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`On information and belief, Pfizer and BioNTech sell COMIRNATY® in this
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`District.
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`30.
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`Arbutus’s and Genevant’s accusations that the making, use, sale, or offer for sale
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`of COMIRNATY® may infringe each of the Arbutus Patents has caused Acuitas harm in this
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`District, at least because it has impaired or affected Acuitas’s ability to license its LNPs to
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`companies headquartered or incorporated within this State and District, including Pfizer.
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`31.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b) and (c), and
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`1400(b).
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 11 of 45
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`Acuitas
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`BACKGROUND
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`32.
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`The founders of Acuitas, Drs. Madden, Cullis, and Hope, have been working on
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`lipids and LNP formulations for drug delivery for decades, including at Acuitas and when they
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`were at Arbutus’s predecessor companies, Inex and Tekmira.
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`33.
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`Acuitas designs and synthesizes novel lipids, such as cationic lipids and pegylated
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`lipids, formulates those lipids with mRNA into LNPs, optimizes such formulations using scalable
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`components and processes, and performs analytical and biophysical characterization and
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`preclinical characterization of the LNPs to ensure they have the most advantageous safety and
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`efficacy profiles.
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`34.
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`Acuitas has synthesized hundreds of novel cationic lipids and has evaluated these
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`novel compounds in mRNA-LNP formulations, including determining the potency and safety of
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`the mRNA-LNPs for the delivery of therapeutic nucleic acid payloads. In collaboration with other
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`scientists, Acuitas has elucidated the mechanism by which mRNA-LNPs are taken up by cells.
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`Acuitas has also undertaken the biophysical characterization of such novel mRNA-LNPs and has
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`conducted correlation analyses to determine which structural and biophysical properties of the
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`components, including which structural and biophysical properties of the cationic lipids, are
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`critical for activity and safety. Acuitas has used this knowledge to guide subsequent lipid and
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`mRNA-LNP development. This design and screening approach has allowed for the identification
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`of mRNA-LNP formulations with greatly improved safety and efficacy profiles, including
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`COMIRNATY®.
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`35.
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`Acuitas is researching and will continue to research and collaborate with partners
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`to develop drugs utilizing Acuitas LNP technology to combat difficult-to-treat conditions and
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 12 of 45
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`provide novel methods of treatment for disease. This work, and the potential benefit of the Acuitas
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`mRNA-LNP technology, goes far beyond a vaccine against the virus that causes COVID-19,
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`notwithstanding the enormous success of COMIRNATY®.
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`COMIRNATY®
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`36.
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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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`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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`37.
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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 started 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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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 13 of 45
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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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`38.
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`In May 2020, Pfizer and BioNTech initiated a Phase 1/2 clinical trial, which showed
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`that healthy volunteers who took the vaccine could produce antibodies against the SARS-CoV-2
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`coronavirus and could recruit immune-system T cells that respond to, target, and destroy the
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`SARS-CoV-2 coronavirus.
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`39.
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`Phase 2/3 trials of COMIRNATY® began in July 2020, and were one of the two
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`large studies of safety and efficacy of a COVID-19 vaccine in the United States. Pfizer and
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`BioNTech’s Phase 2/3 trials tested whether COMIRNATY® was efficacious in preventing
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`COVID-19 infections and/or reducing the severity of COVID-19 infections. The results of the
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`COMIRNATY® Phase 2/3 clinical trials were extremely promising, showing an efficacy rate of
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`95%.
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`40. While Phase 2/3 clinical trials were ongoing, the federal government recognized
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`the 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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`41.
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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 3 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 7 days after the second dose of the vaccine.
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 14 of 45
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`42.
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`On December 11, 2020, COMIRNATY® was approved by the FDA under an
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`Emergency Use Authorization to prevent COVID-19 in individuals 16 years of age and older. That
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`EUA approval came less than ten months after BioNTech first created an mRNA molecule coding
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`for the spike protein of the SARS-CoV-2 virus.
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`43.
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`COMIRNATY® immediately started being deployed nationwide in vaccination
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`efforts.
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`44.
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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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`45.
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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 12. Later, on October 29, 2021, the Emergency
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`Use Authorization was expanded to children as young as 5.
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`46.
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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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`47.
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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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`48.
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`To date, Pfizer and BioNTech have delivered billions 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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`14
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 15 of 45
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`Arbutus and Genevant
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`49.
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`Arbutus’s origins also began with the founders of Acuitas. In 1992, Acuitas
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`founders Dr. Cullis, Dr. Madden, and Dr. Hope founded Arbutus’s predecessor Inex (later
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`rebranded as Tekmira). Dr. Cullis left Tekmira in 2005; Dr. Madden and Dr. Hope left Tekmira
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`in 2008.
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`50.
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`Although Arbutus, including its predecessors Inex, Protiva, and Tekmira, has
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`worked on LNP technology, COMIRNATY® does not utilize lipids or LNP formulations
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`developed by Genevant, Arbutus, or their shareholder Roivant. Neither Arbutus nor Genevant has
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`a COVID-19 vaccine product competing against COMIRNATY® on the market nor, on
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`information and belief, has either ever attempted to develop or commercialize an mRNA-based
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`COVID-19 vaccine product.
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`51.
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`Yet just days after BioNTech and Pfizer announced their positive Phase 3 COVID-
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`19 vaccine results on November 18, 2020, on November 23, 2020, Genevant and Arbutus wrote a
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`letter to Pfizer, stating: “We believe and notify you as contemplated by 35 U.S.C. § 287(a) that
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`the manufacture, importation, offer for sale, sale, and/or use of your COVID-19 vaccine may
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`infringe Arbutus patents, including at least U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668,
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`9,006,417, 9,404,127, 9,364,435, 9,504,651, and 9,518,272.”
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`52.
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`On October 12, 2021, Genevant and Arbutus wrote another letter to Pfizer, stating:
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`“[W]e believe, and notify Pfizer and BioNTech under 35 U.S.C. § 287(a), that the manufacture,
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`importation, offer for sale, sale, and/or use of the Pfizer-BioNTech COVID-19 vaccine
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`Comirnaty® may infringe Arbutus[’s] U.S. Patent No. 11,141,378, in addition to at least the
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`Arbutus patents that were identified in our November 23, 2020 letter.”
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`15
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 16 of 45
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`53.
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`On information and belief, Genevant seeks hundreds of millions, if not billions, of
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`dollars in unjustified royalties on sales of COMIRNATY®. That demand hinders the ability of
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`Acuitas, as well as its partners such as BioNTech and Pfizer, to freely research, develop, and
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`commercialize therapeutics utilizing Acuitas’s LNP technology, including COVID-19 vaccines.
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`54.
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`Arbutus’s and Genevant’s demands make it such that Acuitas and any company
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`that works with Acuitas or utilizes Acuitas’s LNPs or LNP technology face the risk of suit for
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`infringement of one or more claims of the Arbutus Patents. Acuitas’s business model is to develop
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`LNP technology and license it to partners who will use the technology to develop mRNA-based
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`vaccines and other therapeutic products. It is very important to Acuitas’s business that partners
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`and prospective partners can use the licensed Acuitas LNP technology free and clear of any third-
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`party patents. Arbutus’s and Genevant’s demands, and recent litigation against Moderna, thus
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`impact the relationship between Acuitas and its current partners, including BioNTech and Pfizer,
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`as well as Acuitas’s ability to enter into new relationships with other potential partners, particularly
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`as potential licensing partners have raised concerns about Arbutus’s and Genevant’s demands
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`against Pfizer and BioNTech.
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`55.
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`Accordingly, Acuitas seeks a declaratory judgment that COMIRNATY® does not
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`infringe any claim of the Arbutus Patents, and/or that each of the Arbutus Patents is invalid. Such
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`a declaration of the rights of the parties is appropriate and necessary for Acuitas to continue
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`providing its critical lipids and LNP formulations for the production of COMIRNATY® and for
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`Acuitas to freely conduct its LNP research and partner with entities to develop additional
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`therapeutics.
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`16
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`Case 1:22-cv-02229-MKV Document 42 Filed 09/06/22 Page 17 of 45
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`U.S. Patent No. 8,058,069
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`THE PATENTS IN SUIT
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`56.
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`On information and belief, Arbutus is the owner of all rights, title, and interest in
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`the ’069 patent, entitled “Lipid Formulations for Nucleic Acid Delivery.” The United States Patent
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`and Trademark Office issued the ’069 patent on November 15, 2011. The ’069 patent names
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`Edward Yaworski, Kieu Lam, Lloyd Jeffs, Lorne Palmer, and Ian MacLachlan as inventors. All
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`the named inventors assigned the ’069 patent to Protiva, which subsequently amalgamated into
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`Arbutus. A copy of the ’069 patent is attached to this First Amended Complaint as Exhibit A.
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`57.
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`The ’069 patent contains one independent claim, claim 1, which claims a “nucleic
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`acid-lipid particle comprising” “a nucleic acid,” “a cationic lipid comprising from 50 mol % to 65
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`mol % of the total lipid,” “a non-cationic lipid comprising a mixture of a phospholipid and
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`cholesterol or a derivative thereof,” and “a conjugated lipid that inhibits aggregation of particles.”
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`U.S. Patent No. 8,492,359
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`58.
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`On information and belief, Arbutus is the owner of all rights, title