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`Case 1:22-cv-02229-MKV Document 63-1 Filed 04/04/23 Page 1 of 285
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`(cid:3)
`(cid:40)(cid:91)(cid:75)(cid:76)(cid:69)(cid:76)(cid:87)(cid:3)(cid:36)(cid:3)
`Exhibit A
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`

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`Arnold B. Calmann
`Katherine A. Escanlar
`SAIBER LLC
`One Gateway Center, 9th Floor
`Newark, NJ 07102-5308
`(973) 622-3333
`abc@saiber.com
`kescanlar@saiber.com
`
`Attorneys for Plaintiffs Arbutus Biopharma
`Corp. & Genevant Sciences GmbH
`
`
`
`Raymond N. Nimrod
`Isaac Nesser
`Nicola R. Felice
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`(212) 849-7000
`raynimrod@quinnemanuel.com
`isaacnesser@quinnemanuel.com
`nicolafelice@quinnemanuel.com
`
`Attorneys for Plaintiff Genevant Sciences GmbH
`
`Daralyn J. Durie
`Adam R. Brausa
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-7000
`ddurie@mofo.com
`abrausa@mofo.com
`
`Attorneys for Plaintiff Arbutus Biopharma Corp.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`ARBUTUS BIOPHARMA CORP. and
`GENEVANT SCIENCES GMBH,
`
`
`Plaintiffs,
`v.
`
`PFIZER INC. and BIONTECH SE,
`
`Defendants.
`
`
`
`Civil Action No. ___________
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`Document Filed Electronically
`
`Jury Trial Demanded
`
`
`
`Arbutus Biopharma Corp. (“Arbutus”), with its principal place of business at 701 Veterans
`
`Circle, Warminster, Pennsylvania, 18974, and Genevant Sciences GmbH (“Genevant”)
`
`(collectively, “Plaintiffs”), with its principal place of business at Viaduktstrasse 8, 4051 Basel,
`
`Switzerland, by and through their attorneys, bring this Complaint against Pfizer Inc. (“Pfizer”),
`
`with its principal place of business in New York City and significant operations in New Jersey,
`
`10298-00001/13614952.14
`
`
`
`

`

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`and BioNTech SE (“BioNTech”) (collectively, “Defendants”), with its principal place of business
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`in Germany and its North American headquarters in Cambridge, Massachusetts, and allege as
`
`follows:
`
`INTRODUCTION
`
`1.
`
`Arbutus invented and was awarded numerous patents on the breakthrough lipid
`
`nanoparticle (“LNP”) technologies needed to deliver messenger ribonucleic acid (“mRNA”)
`
`therapeutics to human cells. Genevant, a world leader in nucleic acid drug delivery and
`
`development, licenses these patents from Arbutus.
`
`2.
`
`When the world was thrust into a devastating pandemic and urgently needed LNP
`
`technologies to deliver an mRNA-based COVID-19 vaccine to cells in the body, the necessary
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`LNP technologies had, fortunately, already been invented by Arbutus’s scientists years before and
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`stood ready for use. Defendants could not have accomplished the feat of creating and
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`manufacturing a vaccine at a speed unprecedented in the history of medicine but for their use of
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`Plaintiffs’ existing and proven LNP technologies. Yet Defendants never paid Plaintiffs to use
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`those technologies. And Defendants continue to knowingly use the technologies to make and sell
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`the vaccine, amassing tens of billions of dollars in revenues. Plaintiffs have thus filed this case to
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`obtain fair compensation for their inventions, without which the vaccine would not exist.
`
`3.
`
`Defendants’ vaccine works by delivering a synthetic mRNA to the body’s cells.
`
`The biggest technological barrier to mRNA-based medicines is not the mRNA itself—BioNTech’s
`
`CEO designed the mRNA over a weekend. The biggest barrier is instead how to deliver the mRNA
`
`to cells safely and effectively. As Pfizer’s CEO Albert Bourla has explained, “[t]he whole mRNA
`
`[vaccine] platform is not how to build an mRNA molecule; that’s the easy thing.” The hard thing
`
`2
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`

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`is “how to make sure the mRNA molecule will go into your cells and give the instructions.”1 A
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`Nobel Prize-winner has similarly explained that the key to RNA therapeutics was “delivery,
`
`delivery, delivery.”2
`
`4.
`
`The delivery problem had persisted for decades until a team of Arbutus scientists,
`
`many now at Genevant companies, developed and refined technologies that solved the problem,
`
`for which they were awarded many patents. Their solution involved microscopic particles, built
`
`from four carefully-selected types of fat-like molecules, that are stable enough to shelter and
`
`protect fragile ribonucleic acid (“RNA”) molecules on a voyage through the human body to a
`
`target cell, and then through the target cell’s membrane, before finally releasing the RNA. These
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`particles are called lipid nanoparticles and their invention was widely recognized as a major
`
`achievement that is essential for mRNA vaccines.
`
`5.
`
`Arbutus also developed the technologies needed to manufacture these LNPs.
`
`Before Arbutus’s scientists tackled the manufacturing challenges, methods of manufacturing LNPs
`
`for RNA employed harsh conditions that would damage the RNA that the LNPs were supposed to
`
`protect. Arbutus’s scientists developed new, elegant manufacturing methods that preserved the
`
`RNA and allowed for it to reach target cells in an undamaged state. Their solution used what is
`
`called a T-connector to mix together flows of lipids and dissolved RNAs in a process that ensures
`
`the RNA is both encapsulated and protected during the formulation process.
`
`6.
`
`Defendants have long recognized the value of Plaintiffs’ LNP technologies and
`
`patent rights. For example, in 2018, BioNTech paid for a license to use the technologies in a
`
`
`1 Nathan Vardi, Covid’s Forgotten Hero: The Untold Story Of The Scientist Whose Breakthrough
`Made The Vaccines Possible, Forbes, Aug. 17, 2021 (https://tinyurl.com/86ud83kj).
`2 Erika Check, RNA to the Rescue?, Nature, 425:10-12 (2003)
`(www.nature.com/articles/425010a).
`
`3
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`

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`contract that described Genevant’s platform as “the best lipid nanoparticle technology.” The
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`license only permitted BioNTech to use the technology in specific cancer and rare liver disease
`
`treatments and did not extend to uses for infectious diseases like COVID-19. Pfizer, on
`
`information and belief, has long known about that license and Plaintiffs’ patents. Yet neither
`
`BioNTech nor Pfizer asked for a license to use Plaintiffs’ LNP technologies in a COVID-19
`
`vaccine. They just used the technologies without paying for them—keeping for themselves tens
`
`of billions in revenue that would never have existed were it not for Plaintiffs’ innovation.
`
`7.
`
`Plaintiffs have licensed their technologies to many companies and would have
`
`granted a license to Defendants on reasonable terms for use in a COVID-19 vaccine. Indeed, the
`
`parties engaged in licensing discussions that unfortunately failed to result in a settlement. Plaintiffs
`
`have therefore been left no choice but to file this lawsuit to seek fair compensation in the form of
`
`a reasonable royalty for Defendants’ unlicensed use of Plaintiffs’ patents.
`
`NATURE OF THE ACTION
`
`8.
`
`This is a civil action by Plaintiffs against Defendants under the patent laws of the
`
`United States, 35 U.S.C. § 101 et seq., seeking damages for Defendants’ infringing manufacture,
`
`use, sale, offer for sale, and/or importation of their COVID-19 vaccine and any COVID-19 mRNA-
`
`LNP vaccine products, including: pediatric doses; booster doses; supplemental doses;
`
`reformulations; boosters or re-vaccinations; variant-specific formulations; bivalent formulations;
`
`and the products known or marketed as Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine,
`
`Comirnaty, Tozinameran, BNT162b2, or PF-07302048 (collectively, the “Accused Product” or
`
`“Defendants’ vaccine”).
`
`9.
`
`Defendants’ manufacture, use, sale, offer to sell, and/or importation of the Accused
`
`Product directly and/or indirectly infringes or will infringe, or actively induces or will actively
`
`induce infringement of, one or more valid enforceable claims of, and Plaintiffs’ rights arising
`
`4
`
`

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`under, the following patents relating to nucleic acid-lipid particles, compositions thereof, their
`
`manufacture, and/or their use to deliver mRNA and/or other nucleic acid-based medicines: U.S.
`
`Patent Nos. 9,504,651 (Exhibit A); 8,492,359 (Exhibit B); 11,141,378 (Exhibit C); 11,298,320
`
`(Exhibit D); and 11,318,098 (Exhibit E) (collectively, the “Asserted Patents”). At all relevant
`
`times, Arbutus owned the Asserted Patents and licensed exclusive rights to sublicense, practice,
`
`and sue for infringement of them to Genevant in certain fields of use that include the vaccine
`
`application at issue in this Complaint, with certain exceptions not relevant here (hereinafter,
`
`Genevant’s “Exclusive Rights”).
`
`PARTIES
`
`10.
`
`Plaintiff Arbutus Biopharma Corporation is a Canadian corporation with its
`
`principal place of business at 701 Veterans Circle, Warminster, Pennsylvania, 18974. The
`
`company’s
`
`research and development efforts
`
`include discovering, developing, and
`
`commercializing a cure for chronic hepatitis B virus, as well as drug discovery and development
`
`for treating coronaviruses, including SARS-CoV-2, which causes COVID-19.
`
`11.
`
`Plaintiff Genevant Sciences GmbH is a Swiss company with its principal place of
`
`business at Viaduktstrasse 8, 4051 Basel, Switzerland. Together with its affiliated companies, it
`
`maintains an office in Cambridge, Massachusetts, and Vancouver, British Columbia. Genevant is
`
`a technology-focused nucleic acid delivery solutions company with cutting-edge LNP platforms.
`
`Genevant owns or licenses the industry’s most important LNP intellectual property—that of
`
`Arbutus—and has decades of experience and expertise in nucleic acid drug delivery and
`
`development. Genevant’s mission is to utilize its LNP and other technologies to deliver innovative
`
`new medicines that use mRNA or other nucleic acids.
`
`12.
`
`Defendant Pfizer is a Delaware corporation with its principal place of business in
`
`New York City and significant operations in New Jersey. According to Pfizer’s 2022 annual
`
`5
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`report, Pfizer’s global supply “leadership teams” are located primarily in New York City and New
`
`Jersey.
`
`13.
`
`Defendant BioNTech SE is a German corporation with its principal place of
`
`business in Germany and its North American headquarters in Cambridge, Massachusetts.
`
`14.
`
`Pfizer and BioNTech are and have been operating jointly and as agents of one
`
`another as to Defendants’ vaccine and share equally in profits from sales of the vaccine. For
`
`example:
`
` A March 17, 2020, Collaboration Agreement reflects Pfizer and BioNTech’s agreement
`to engage in “collaborative research and development” to develop and launch a Covid-
`19 vaccine “in all countries of the Territory,” and their “wish that Pfizer
`Commercialize[]
`the Product
`in all countries of
`the Territory,” where (i)
`“Commercialize” is defined as “market, promote, distribute, offer for sale, sell, have
`sold, import, have imported, export, have exported or otherwise commercialize a
`compound or product,” and (ii) “Territory” is defined to include the United States.
`
` Pfizer’s 2022 annual report, published on or about February 23, 2023, states that Pfizer
`and BioNTech have been “collaborat[ing]” to “jointly develop[] and commercialize[]”
`the vaccine; discusses “Comirnaty-related manufacturing activities performed [by
`Pfizer] on behalf of BioNTech”; and explains that Pfizer and BioNTech “equally share
`the costs of development” and “share gross profits equally from commercialization.”
`Similarly, Pfizer and BioNTech’s press releases have stated that “BioNTech is the
`Marketing Authorization Holder [for the vaccine]… and the holder of emergency use
`authorizations … in the United States (jointly with Pfizer).”
`
`
`
`In a Complaint filed July 25, 2022, Pfizer and BioNTech alleged that they “partnered
`together, and continue to work together” on the vaccine; “partnered together to develop,
`manufacture, and secure regulatory approval” of the vaccine, including as to “clinical
`testing [and] distribution”; and “agreed to share the costs of developing” the vaccine.
`The Complaint also alleges that “Pfizer, on behalf of itself and BioNTech, submitted
`clinical trial data as part of an Emergency Use Authorization (‘EUA’) request to the
`FDA for administering the Pfizer-BioNTech COVID-19 vaccine….”3
`
`
`3 Complaint, BioNTech SE, BioNTech Manufacturing GMBH, and Pfizer Inc. v. Curevac AG,
`Case No. 1:22-cv-11202 (D. Mass. July 25, 2022) at ⁋⁋ 1, 2, 48, 49, 55.
`
`6
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`JURISDICTION AND VENUE
`
`A.
`
`Subject Matter Jurisdiction
`
`15.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`
`1338(a) because this is an action for infringement under the patent laws of the United States, Title
`
`35 of the United States Code.
`
`B.
`
`Personal Jurisdiction
`
`16.
`
`This Court has personal jurisdiction over Pfizer because it maintains a regular and
`
`established place of business in this District.
`
`17.
`
`This Court has personal jurisdiction over both Pfizer and BioNTech because they
`
`transact business relating to Plaintiffs’ claims in this District, engage in systematic and continuous
`
`business contacts here, and have purposefully availed themselves of the benefits and protections
`
`of New Jersey’s laws such that they should reasonably anticipate being haled into court here.
`
`18.
`
`Among other things, Pfizer and BioNTech operate jointly and/or as agents of one
`
`another to develop, manufacture, import, market, distribute, offer to sell, and/or sell the Accused
`
`Product in the State of New Jersey and throughout the United States, for use in the State of New
`
`Jersey and throughout the United States. Directly or through others, Pfizer and BioNTech make,
`
`use, induce others to use, offer for sale, and/or sell the Accused Product within the United States,
`
`and/or import the same into the United States, including into the District of New Jersey. They
`
`have also contracted with one another with the purpose and intent of inducing and participating in
`
`sales of the Accused Product in the United States, including in this State and District.
`
`19.
`
`For example, on December 11, 2020, Defendants received Emergency Use
`
`Authorization (“EUA”) from the United States Food and Drug Administration (“FDA”) for
`
`Defendants’ vaccine to be distributed and administered to people 16 years of age and older
`
`throughout the United States, including in the District of New Jersey, and, on August 23, 2021,
`
`7
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`the FDA approved Defendants’ Biologics License Application (“BLA”) for the vaccine. Upon
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`information and belief, as of April 2, 2023, more than 11.9 million doses of Defendants’ vaccine
`
`have been administered in the State of New Jersey.4 Therefore, Pfizer and BioNTech transact
`
`business within New Jersey relating to Plaintiffs’ claims and have engaged in systematic and
`
`continuous business contacts here.
`
`20.
`
`For the above reasons, there is nothing unreasonable or fundamentally unfair about
`
`requiring Pfizer and BioNTech to litigate this action in this District, and the Court has personal
`
`jurisdiction over them here.
`
`C.
`
`Venue
`
`21.
`
`Venue is proper in this District as to Pfizer pursuant to 28 U.S.C. § 1400(b) because
`
`Pfizer has committed acts of infringement in this District and has a regular and established place
`
`of business in this District. Among other things, Pfizer has committed acts of infringement in this
`
`District by making, using, selling, and/or offering for sale in this District the Accused Product and
`
`inducing others to use the Accused Product in this District. Moreover, Pfizer has a campus in this
`
`District, where leadership teams are located.
`
`22.
`
`Venue is proper in this District as to BioNTech pursuant to 28 U.S.C. §§ 1400
`
`and 1391 because it is subject to personal jurisdiction here.
`
`BACKGROUND
`
`A.
`
`Nucleic Acids
`
`23.
`
`Defendants’ vaccine belongs to a new class of medicines that delivers nucleic acids,
`
`such as mRNA, into the cells of the body to treat diseases or, in the case of Defendants’ vaccine,
`
`to trigger an immune response to protect a person from future infection.
`
`
`4 https://www.nj.gov/health/cd/topics/covid2019_dashboard.shtml.
`
`8
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`24.
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`Nucleic acids are molecules that encode the genetic information essential to sustain
`
`all forms of life. One type of nucleic acid is deoxyribonucleic acid, or “DNA.” Every human
`
`(except identical twins) has a unique set of genetic information in the “genes” (composed of DNA)
`
`within his or her chromosomes. Among other things, these genes spell out the instructions for
`
`producing proteins that make human cells and bodies function.
`
`25.
`
`In order to make the protein encoded by a particular gene, cells first convert the
`
`genetic code in the gene’s DNA into another type of nucleic acid known as messenger ribonucleic
`
`acid, or “mRNA.” mRNA is effectively a copy of the portion of DNA that the cell’s protein-
`
`making machinery uses as a blueprint to assemble the protein encoded by the gene.
`
`B.
`
`How Vaccines Work
`
`26.
`
`A virus is typically a small packet of DNA or RNA. If a virus enters a living host
`
`cell—for example, after being ingested, transmitted through bodily fluids, or inhaled through a
`
`person’s mouth or nose—the virus’s DNA or RNA hijacks the cell’s machinery and instructs the
`
`cell to make copies of the virus. These copies, often numbering into the millions, leave the infected
`
`cell and enter other cells where the process repeats. Infected cells can be damaged or die while
`
`hosting the virus. Left unchecked, the host organism itself can die.
`
`27.
`
`Although vaccines targeting viruses may have varying mechanisms of action, they
`
`traditionally work by injecting into the body a weakened or inactive form of the virus that is unable
`
`to cause infection but retains features of the infectious virus and can teach the immune system to
`
`recognize and attack the infectious virus if it invades in the future. These vaccines take tremendous
`
`amounts of time to develop and bring to patients due to the extensive amount of work needed to
`
`target specific infectious agents, associated regulatory hurdles, and other factors.
`
`28.
`
`In a 2021 essay, Pfizer’s CEO observed that “the typical vaccine development
`
`program can take up to 10 years and cost anywhere from $1 billion to more than $2 billion,”
`
`9
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`including because “[t]raditionally, making a vaccine starts with growing weakened forms of the
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`virus, which can take months.”5
`
`29.
`
`Thus, scientists began experimenting with a new, mRNA-based approach.
`
`Fundamentally, the proposed mRNA vaccines would work the same way as any other vaccine—
`
`exposing people to a piece of a virus or pathogen so as to trigger the immune system and induce
`
`adaptive immunity. However, with an mRNA vaccine, the immune system would not be triggered
`
`by a piece of virus or pathogen manufactured in a laboratory, as with older vaccines. Instead, the
`
`trigger would be manufactured in and by a person’s own cells.
`
`30.
`
`A major advantage of mRNA-based vaccines, if they could be made to work, was
`
`that they could be used with any mRNA. Rather than requiring years of development as with
`
`traditional vaccines, it was envisioned that the relevant mRNA could be identified and generated
`
`using existing technology, inserted into a general-use delivery mechanism, and made ready to
`
`inject into people, all in the space of days or weeks.
`
`C.
`
`Challenges for RNA-Based Medicines and Arbutus’s Pioneering Solutions
`
`31.
`
`Vaccines and other medicines using RNA technologies are an emerging frontier
`
`with the potential to revolutionize medicine. RNA-based medicines can employ a type of RNA
`
`called small interfering RNA (“siRNA”) to treat certain diseases by interfering with the expression
`
`of unwanted proteins to reduce the amounts produced—a process called RNA interference
`
`(“RNAi”). RNA-based medicines also can employ mRNA to cause or increase the production of
`
`certain proteins. mRNA vaccines, for example, can cause cells to express a protein (or a piece of
`
`a protein) that is part of a particular virus or that is found on a particular tumor. The presence of
`
`
`5 Albert Bourla, The CEO of Pfizer on Developing a Vaccine in Record Time, Harvard Bus. Rev.
`Magazine, May-June 2021 (https://hbr.org/2021/05/the-ceo-of-pfizer-on-developing-a-vaccine-
`in-record-time).
`
`10
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`that protein (or piece of a protein) teaches the body’s immune system to recognize it if it is
`
`encountered in the future and destroy it.
`
`32.
`
`RNA-based medicines hold great promise for addressing many previously
`
`intractable diseases, including viruses like COVID-19 that cause or threaten global pandemics.
`
`33.
`
`Despite their promise, however, RNA-based medicines were difficult to develop.
`
`By their nature, RNA molecules are fragile. Without adequate protection, RNA molecules are
`
`susceptible to degradation in the body; moreover, if and when RNA molecules get to a cell, they
`
`cannot cross the cell membrane to enter the cell.
`
`34.
`
`For decades, the need for an effective delivery technology had been the most
`
`significant challenge in the development of RNA-based medicines. In particular, without the
`
`means to protect mRNA and facilitate its entry into target cells, mRNA-based vaccines and other
`
`medicines have been ineffective.
`
`35.
`
`Dr. Katalin Karikó, former BioNTech Senior Vice President and lead vaccine
`
`development scientist, was among the scientists who recognized the significance of the delivery
`
`problem. One author quotes Dr. Karikó, speaking in regard to an unsuccessful effort in the years
`
`after 2005 to obtain lipids that she believed might be useful in delivering mRNA to human cells,
`
`as follows: “I was close to getting on my knees…. It was my lowest moment.”6
`
`36.
`
`For a long time, the “delivery problem” appeared unsolvable. Indeed, although
`
`nucleic acid vaccine development had initially attracted optimism, enthusiasm, and research
`
`funding, those trends reversed. As explained in a feature in Nature, “in the 1990s and for most of
`
`the 2000s, nearly every vaccine company that considered working on mRNA opted to invest its
`
`resources elsewhere,” because “mRNA was seen as too unstable and expensive to be used as a
`
`
`6 Gregory Zuckerman, A SHOT TO SAVE THE WORLD (2021) at 82.
`
`11
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`drug or a vaccine.”7 Companies that abandoned the field included one of the world’s largest
`
`vaccine developers, which according to the same feature in Nature “evaluated the mRNA
`
`technology in mice with the aim of creating an influenza vaccine, but then abandoned that
`
`approach” because, in the words of a scientist who worked on the project, “‘[t]he cost and
`
`feasibility of manufacturing just gave us pause.’” As another industry participant explained,
`
`“[t]here were many, many skeptics…. People used to say that if you looked at [mRNA] wrong it
`
`would fall apart.”8
`
`37.
`
`Functional RNA-based medicines eluded researchers until pioneering work by
`
`Arbutus scientists resulted in the discovery and development of the leading nucleic acid delivery
`
`technology in use today. Decades ago, a group of ambitious research scientists working at a
`
`predecessor company to Arbutus began to tackle the nucleic acid delivery problems that had long
`
`stymied the field. After years of tireless effort, these scientists solved these problems by
`
`developing both novel lipid formulations and innovative manufacturing processes. These
`
`scientists developed LNP technology that relies on fat-like molecules called lipids that encapsulate
`
`and protect nucleic acids like mRNA from degradation in the body and enable them to cross cell
`
`membranes. Once inside a cell, the LNP releases the nucleic acid it encapsulates so that, in the
`
`case of an mRNA vaccine for example, the nucleic acid can cause the cell to express the protein
`
`that the nucleic acid encodes.
`
`38.
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`The lipid components of the Arbutus technology include: structural lipids, such as
`
`phospholipids and cholesterol; “cationic” (positive charge-bearing) lipids, including “ionizable”
`
`
`7 Elie Dolgin, The Tangled History Of mRNA Vaccines, Nature, Sept. 14, 2021
`(https://www.nature.com/articles/d41586-021-02483-w).
`8 Ryan Cross, Without These Lipid Shells, There Would Be No mRNA Vaccines For COVID-19,
`Chem. & Engineering News, Mar. 6, 2021 (https://cen.acs.org/pharmaceuticals/drug-
`delivery/Without-lipid-shells-mRNA-vaccines/99/i8).
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`lipids that are positive charge-bearing at certain pH levels; and conjugated lipids, such as lipids
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`attached to a polyethyleneglycol (“PEG”) polymer. Arbutus scientists discovered that nucleic
`
`acid-lipid particles combining particular lipid components could achieve much more effective
`
`delivery of nucleic acids through cell membranes and into cells.
`
`39.
`
`Arbutus scientists spent almost two decades researching and developing their
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`nucleic acid-lipid delivery technology. Their efforts led to the first FDA-approved RNA-LNP
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`therapeutic, a drug called Onpattro®. Onpattro® is an RNAi treatment for a form of amyloidosis,
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`a rare disease that causes certain proteins to accumulate in organs. The company that developed
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`Onpattro®, Alnylam Pharmaceuticals, did so under an LNP license from Arbutus and received
`
`FDA approval in August 2018. Building on that success, Arbutus has licensed its LNP technology
`
`to other companies, and Genevant now has several ongoing LNP product development
`
`collaborations, some directed to COVID-19 and some directed to other diseases and disorders.
`
`D.
`
`The United States Awards Patents Recognizing Arbutus’s Innovations
`
`40.
`
`In recognition of Arbutus’s research and development efforts, the United States
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`Patent and Trademark Office has granted several families of patents claiming nucleic acid-lipid
`
`particles and lipid vesicles, as well as compositions and methods of using and manufacturing them.
`
`Among those patents are the Asserted Patents:
`
`a. U.S. Patent No. 9,504,651, “Lipid Compositions for Nucleic Acid Delivery,” issued
`on November 29, 2016 (the “’651 Patent”).
`
`b. U.S. Patent No. 8,492,359, “Lipid Formulations for Nucleic Acid Delivery,” issued
`on July 23, 2013 (the “’359 Patent”).
`
`c. U.S. Patent No. 11,141,378, “Lipid Formulations for Nucleic Acid Delivery,”
`issued on October 12, 2021 (the “’378 Patent”).
`
`d. U.S. Patent No. 11,298,320, “Liposomal Apparatus and Manufacturing Methods,”
`issued on April 12, 2022 (the “’320 Patent”).
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`e. U.S. Patent No. 11,318,098, “Liposomal Apparatus and Manufacturing Methods,”
`issued on May 3, 2022 (the “’098 Patent”).
`
`41.
`
`True and correct copies of the Asserted Patents are attached hereto as Exhibits A
`
`through E. All are valid and enforceable under United States patent laws. All are assigned to and
`
`owned by Arbutus, and, at all times since Arbutus and Genevant entered into a license agreement,
`
`Genevant has held Exclusive Rights to all of the Asserted Patents.
`
`E.
`
`Defendants’ Knowledge Of, And Background With, Arbutus’s Patents
`
`42.
`
`Defendants have been on actual notice of Arbutus’s patents but nonetheless
`
`knowingly used Arbutus’s technology in nucleic acid-based products and product candidates,
`
`including the Accused Product, without permission.
`
`43.
`
`For example, on July 4, 2018, BioNTech signed a license agreement with Genevant
`
`in which BioNTech agreed to pay for the right to use Plaintiffs’ LNP technology to develop and
`
`potentially commercialize certain cancer or rare liver disease treatments. The first page of the
`
`agreement confirms how critical Plaintiffs’ LNP technology was: It not only notes Genevant’s
`
`exclusive license “to certain intellectual property rights relating to RNA-based therapeutics
`
`enabled by lipid nanoparticle delivery technologies,” but also states that “the Parties wish to jointly
`
`develop pharmaceutical products that combine the best mRNA payloads with the best lipid
`
`nanoparticle technology”—a reference to Arbutus’s technology.
`
`44.
`
`The license agreement shows, among other things, that BioNTech knew about
`
`Arbutus’s technology and patents, including the asserted ’651 and ’359 patents, at least as of 2018.
`
`It also shows that BioNTech knew it could not use Arbutus’s technology without obtaining and
`
`paying for the right to do so. Indeed, BioNTech’s annual reports for 2019, 2020, and 2021 referred
`
`to “many issued and pending patent filings that claim aspects of technologies that we may need
`
`for our mRNA product candidates or other product candidates, including patent filings that relate
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`to relevant delivery technologies.” On information and belief, that warning referred at least in
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`part to patents at issue in this litigation.
`
`45.
`
`On information and belief, Pfizer has received and reviewed a copy of the
`
`BioNTech-Genevant license agreement, including potentially (i) in the summer of 2018, as part of
`
`due diligence Pfizer conducted before signing a different contract with BioNTech, and (ii) in early
`
`2020, as part of due diligence Pfizer conducted before agreeing to collaborate with BioNTech on
`
`Defendants’ vaccine.
`
`F.
`
`BioNTech Designs Its COVID-19 Vaccine with Unprecedented Speed, Aided by the
`Unauthorized Use of Arbutus’s LNP Technology
`
`46.
`
`Defendants have used and continue to use Arbutus’s LNP technology without
`
`authority or license to do so and are willfully infringing the Asserted Patents jointly and/or as
`
`agents of one another.
`
`47.
`
`On January 10, 2020, with the novel SARS-CoV-2 virus quickly spreading around
`
`the world, scientists identified the virus’s complete genetic sequence and posted it on the internet.
`
`This public disclosure revealed the complete RNA sequence that encodes the virus’s components,
`
`including its distinctive “spike protein.” With that information in the public domain, researchers
`
`around the world were able to begin designing vaccines to target the virus.
`
`48.
`
`On Friday, January 24, 2020, BioNTech’s CEO read an article about the public
`
`health risks posed by COVID-19. According to statements he has given to the press, it was the
`
`first time he had focused on COVID-19 as a serious public health threat. Over the weekend, he
`
`designed several candidates for an mRNA vaccine, targeting the virus that causes COVID-19
`
`usi