Case 1:22-cv-02229-MKV Document 49-2 Filed 11/01/22 Page 1 of 52
`Case 1:22-cv-02229-MKV Document 49-2 Filed 11/01/22 Page 1 of 52
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`EXHIBIT B
`EXHIBIT B
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`MODERNA, INC. and MODERNATX, INC.,
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`C.A. No. ______________
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` JURY TRIAL DEMANDED
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`v.
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`Plaintiffs,
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`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH
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`(“Genevant”) file this Complaint seeking patent infringement damages against Defendants
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`Moderna, Inc. and ModernaTX, Inc. (collectively, “Moderna”) and allege the following:
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`INTRODUCTION
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`1.
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`The impact of the COVID-19 pandemic, one of the greatest public health
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`challenges in modern history, would be immeasurably worse but for the rapid, widespread
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`availability of cutting-edge mRNA-based vaccines like Moderna’s. Moderna brought its vaccine
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`from lab bench to arms in record speed. That unprecedented accomplishment was made possible
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`by Moderna’s use of breakthrough technology Arbutus had already created and patented—a
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`revolutionary lipid nanoparticle (“LNP”) delivery platform that took the scientists of Arbutus
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`years of painstaking work to develop and refine. Moderna was well aware of Arbutus’s LNP
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`patents and licensed them for other product programs, but it chose not to do so for its COVID-19
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`vaccine. Instead, it attempted to invalidate several of the patents before the United States Patent
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`and Trademark Office, and when those efforts largely failed, Moderna simply used the patented
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`technology without paying for it or even asking for a license. Plaintiffs do not seek an injunction
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`or any relief in this case that would impede the sale or manufacture of Moderna’s life-saving
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`vaccine. They seek only fair compensation for the use of patented technology they developed
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`with great effort and at great expense, without which Moderna’s COVID-19 vaccine would not
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`have been successful.
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`2.
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`Medicines using messenger ribonucleic acid (or “mRNA”) technology, like
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`Moderna’s COVID-19 vaccine, rely on synthetic mRNA that enters the body’s cells and instructs
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`them to make proteins they would not necessarily make on their own. Moderna’s COVID-19
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`vaccine, in particular, uses mRNA to cause cells to make a small piece of the virus that causes
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`COVID-19 called the “spike protein.” That small piece, which is harmless in isolation, prompts
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`the body’s immune system to produce antibodies that will recognize the spike protein if it is
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`encountered in the future and destroy it. In this way, the vaccine equips a person’s body ahead
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`of time with antibodies to fight the COVID-19 virus if that person experiences a subsequent
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`exposure.
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`3.
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`Ever since the vast potential for mRNA-based vaccines and other mRNA-based
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`medicines began to catch the attention of scientists more than two decades ago, the biggest
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`technological hurdle to developing and deploying them has been devising a safe and effective
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`way to deliver the mRNA to the cell. Without adequate protection, mRNA quickly degrades in
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`the body. For mRNA vaccines like Moderna’s to work, they must incorporate a mechanism for
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`protecting the fragile mRNA, delivering it through cell membranes, and then releasing it inside
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`2
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`the cell. In the words of one Nobel Prize winning scientist, the secret for making RNA-based
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`products work has always been “delivery, delivery, delivery.”1
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`4.
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`Having vexed experts in the field for years, that problem eventually found a
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`solution in the innovative research of Arbutus scientists. Their solution was ingenious:
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`microscopic particles built from four carefully selected types of fat-like molecules, so small that
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`they are measured in nanometers but still stable enough to shelter and protect an RNA molecule
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`on a voyage through the human body to a target cell, and then through the target cell’s
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`membrane, before finally releasing the RNA. These tiny fat-like particles are called “lipid
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`nanoparticles,” or “LNPs.” The United States Patent and Trademark Office has granted Arbutus
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`several patents for its groundbreaking LNP technologies.
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`5.
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`LNPs identified through Arbutus’s pioneering work have been described as
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`“crucial” to Moderna’s COVID-19 vaccine, the first mRNA product the company was able to
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`commercialize and the keystone of its financial success.2 Without the LNPs Arbutus invented to
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`safeguard the mRNA and deliver it into cells, the mRNA in Moderna’s vaccine would degrade
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`before ever reaching the cells it needs to enter and the vaccine would not work.
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`6.
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`Moderna has long been aware of Arbutus’s LNP intellectual property and its
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`importance as a component of mRNA-based vaccines and other mRNA-based medicines.
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`Several years before the pandemic, Moderna obtained licenses to use Arbutus’s LNP patents for
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`certain mRNA products directed to specific viral targets. But those licenses did not grant
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`Moderna rights to use the technology for products targeting SARS-CoV-2, the virus that causes
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`1 Erika Check, “RNA to the Rescue,” Nature 425:10-12 (2003), available at
`https://www.nature.com/articles/425010a.
`2 Nathan Vardi, “Moderna’s Mysterious Coronavirus Vaccine Delivery System,” Forbes.com,
`July 29, 2020, available at https://www.forbes.com/sites/nathanvardi/2020/07/29/modernas-
`mysterious-coronavirus-vaccine-delivery-system/.
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`3
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`COVID-19 and that the vaccines at issue here target. Before it decided to use Arbutus’s proven
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`and patented technology as a crucial part of its COVID-19 vaccine, Moderna did not ask for a
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`license to do so. Instead, it tried to convince the United States Patent and Trademark Office and,
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`later, the United States Court of Appeals for the Federal Circuit to cancel several of Arbutus’s
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`LNP-related patents. But despite the failure of Moderna’s attempts to eliminate Arbutus’s
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`patents, and despite Plaintiffs’ efforts to resolve this dispute without litigation, Moderna has
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`remained unwilling to pay for its use of Arbutus’s technology in a vaccine that has earned
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`Moderna billions of dollars in profits.
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`7.
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`Moderna’s intransigence has forced Arbutus and Genevant, a company
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`spearheaded by former Arbutus scientists, to bring this infringement action. Plaintiffs are proud
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`that their LNP technology has had such a profound impact on the heroic fight against the
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`COVID-19 pandemic, and they do not seek to impede by an injunction or otherwise the
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`production or distribution of Moderna’s COVID-19 vaccine, including boosters. All Plaintiffs
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`seek is the compensation due to them under the patent laws of the United States and as a matter
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`of simple fairness.
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`NATURE OF THE ACTION
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`8.
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`This is a civil action under the patent laws of the United States, 35 U.S.C. § 101 et
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`seq., seeking damages for Moderna’s infringing manufacture, use, sale, offer for sale, and/or
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`importation of its mRNA-1273 COVID-19 mRNA LNP vaccine product (“Moderna’s COVID-
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`19 vaccine”) or any supplemental or booster COVID-19 mRNA LNP vaccine product
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`(collectively, the “Accused Product”).
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`9.
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`As alleged herein, the manufacture, use, sale, offer to sell, and/or importation of
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`the Accused Product infringes or will infringe, actively induces or will actively induce
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`4
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`infringement of, or contributes or will contribute to the infringement of, one or more claims of
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`the following patents relating to nucleic acid-lipid particles, compositions thereof, and their use
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`to deliver nucleic acid-based medicines: U.S. Patent Nos. 8,058,069 (Exhibit A), 8,492,359
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`(Exhibit B), 8,822,668 (Exhibit C), 9,364,435 (Exhibit D), 9,504,651 (Exhibit E), and
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`11,141,378 (Exhibit F) (collectively, the “Asserted Patents”). At all relevant times, Arbutus
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`owned the Asserted Patents and licensed exclusive rights to sublicense, practice, and sue for
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`infringement of them to Genevant in certain fields of use that include the vaccine application at
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`issue in this Complaint, with certain exceptions not relevant here (hereinafter, Genevant’s
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`“Exclusive Rights”).
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`THE PARTIES
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`10.
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`Plaintiff Arbutus Biopharma Corporation is a corporation organized and existing
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`under the laws of Canada, with its principal place of business at 701 Veterans Circle,
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`Warminster, Pennsylvania, 18974. The company’s research and development efforts include
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`discovering, developing, and commercializing a cure for chronic hepatitis B virus, as well as
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`drug discovery and development efforts for treating coronaviruses, including SARS-CoV-2,
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`which causes COVID-19.
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`11.
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`Plaintiff Genevant Sciences GmbH is a company organized and existing under the
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`laws of Switzerland, with its principal place of business at Viaduktstrasse 8, 4051 Basel,
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`Switzerland. Genevant is a technology-focused nucleic acid delivery solutions company with
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`cutting-edge LNP platforms. Genevant owns or licenses the industry’s most important LNP
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`intellectual property—that of Arbutus—and has decades of experience and expertise in nucleic
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`acid drug delivery and development. Genevant, together with its affiliated companies, maintains
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`offices in Cambridge, Massachusetts and Vancouver, British Columbia, Canada. Genevant’s
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`5
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`mission is to utilize its LNP and other technologies to deliver innovative new medicines that use
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`mRNA or other nucleic acids.
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`12.
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`Defendant Moderna, Inc. is a corporation organized and existing under the laws of
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`the State of Delaware, with its principal place of business at 200 Technology Square, Cambridge,
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`Massachusetts, 02139. Moderna, Inc., itself and through its subsidiary ModernaTX, Inc.,
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`develops, manufactures, imports, markets, distributes, offers to sell, and/or sells vaccines and
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`other medicines in the State of Delaware and throughout the United States, for use in the State of
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`Delaware and throughout the United States.
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`13.
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`Defendant ModernaTX, Inc. is a wholly owned subsidiary of Moderna, Inc.
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`(collectively, “Moderna”). ModernaTX, Inc. is also a corporation organized and existing under
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`the laws of the State of Delaware, with its principal place of business at 200 Technology Square,
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`Cambridge, Massachusetts, 02139. ModernaTX, Inc. develops, manufactures, imports, markets,
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`distributes, offers to sell, and/or sells vaccines and other medicines in the State of Delaware and
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`throughout the United States, for use in the State of Delaware and throughout the United States.
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`JURISDICTION AND VENUE
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`A.
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`Subject-Matter Jurisdiction
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`14.
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`Because this is an action for infringement under the patent laws of the United
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`States, Title 35 of the United States Code, the Court has subject matter jurisdiction pursuant to
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`28 U.S.C. §§ 1331 and 1338(a).
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`B.
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`Personal Jurisdiction
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`15.
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`This Court has personal jurisdiction over Moderna because, among other things,
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`Moderna, Inc. and ModernaTX, Inc. have purposefully availed themselves of the benefits and
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`protections of Delaware’s laws such that they should reasonably anticipate being haled into court
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`6
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`here. Because Defendants are organized and exist under the laws of Delaware, are qualified to
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`do business in Delaware, and have appointed registered agents for service of process in
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`Delaware, Moderna, Inc. and ModernaTX, Inc. have consented to general jurisdiction in
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`Delaware.
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`16.
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`Additionally, Moderna, Inc. and ModernaTX, Inc., directly or through others,
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`make, use, induce others to use, offer for sale, and/or sell the Accused Product, and/or a
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`component, combination, or composition constituting a material part of the Accused Product,
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`within the United States, and/or import the same into the United States, including into the
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`District of Delaware. For example, on December 18, 2020, Moderna received Emergency Use
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`Authorization (“EUA”) from the United States Food and Drug Administration (“FDA”) for its
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`COVID-19 vaccine to be distributed and administered to people throughout the United States,
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`including in the District of Delaware and, on January 31, 2022, the FDA approved Moderna’s
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`Biologics License Application (“BLA”) for its COVID-19 vaccine. Upon information and
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`belief, as of February 24, 2022, over 835,000 doses of Moderna’s COVID-19 vaccine have been
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`delivered to the State of Delaware.3 Therefore, Moderna, Inc. and ModernaTX, Inc. transact
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`business within Delaware relating to Plaintiffs’ claims and have engaged in systematic and
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`continuous business contacts here.
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`17.
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`For the above reasons, there is nothing unreasonable or fundamentally unfair
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`about requiring Moderna, Inc. and ModernaTX, Inc. to litigate this action in this District, and the
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`Court has personal jurisdiction over them here.
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`3 Delaware Environmental Public Health Tracking Network, Vaccine Tracker,
`https://myhealthycommunity.dhss.delaware.gov/locations/state/vaccine-tracker (last visited Feb.
`25, 2022).
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`7
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`C.
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`Venue
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`18.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(c)(2) and 1400(b)
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`because both Moderna, Inc. and ModernaTX, Inc. are corporations organized and existing under
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`the laws of the State of Delaware and are therefore subject to suit in this District.
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`A.
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`How Vaccines Work
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`BACKGROUND
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`19.
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`Viruses are typically small packets of DNA or RNA. If a virus enters a living
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`host cell—for example, after being ingested, transmitted through bodily fluids, or inhaled
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`through a person’s mouth or nose—the virus’s DNA or RNA hijacks the cell’s machinery and
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`instructs the cell to make copies of the virus. These copies, often numbering into the millions,
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`leave the infected cell and enter other cells where the process repeats. Infected cells can be
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`damaged or die while hosting the virus. Left unchecked, the host organism itself can die.
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`20.
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`Although vaccines targeting viruses have different mechanisms of action, they
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`traditionally work by injecting into the body a weakened or inactive form of the virus that is
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`unable to cause infection, but nonetheless retains features of the infectious virus and can teach
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`the immune system to recognize and attack the infectious virus if it invades in the future.
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`B.
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`Nucleic Acid Medicines and Delivery Technologies
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`21. Moderna’s COVID-19 vaccine belongs to a new class of medicines that deliver
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`nucleic acids into the cells of the body to treat diseases or, in the case of Moderna’s COVID-19
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`vaccine, to trigger an immune response to protect a person from future infection.
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`22.
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`Nucleic acids are molecules that encode the genetic information essential to
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`sustain all forms of life. One type of nucleic acid is deoxyribonucleic acid, or “DNA,” which is
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`found in our chromosomes. In humans, each person (except identical twins) has a unique set of
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`8
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`genetic information in the “genes” within his or her chromosomes. Among other things, these
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`genes spell out the instructions for producing proteins that make our cells and bodies function.
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`23.
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`In order to make the protein encoded by a particular gene, the cell first converts
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`the genetic code in the gene’s DNA into another type of nucleic acid known as messenger
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`ribonucleic acid, or “mRNA.” mRNA is effectively a copy of the portion of DNA that the cell’s
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`protein-making machinery uses as a blueprint to assemble the protein encoded by the gene.
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`24.
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`Vaccines and other medicines using ribonucleic acid, or “RNA,” technologies are
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`an emerging frontier with the potential to revolutionize medicine. RNA-based medicines can
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`employ a type of RNA called small interfering RNA (“siRNA”) to treat certain diseases by
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`interfering with the expression of unwanted proteins to reduce the amounts produced—a process
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`called RNA interference (“RNAi”). RNA-based medicines also can employ mRNA to cause or
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`increase the production of certain proteins. mRNA vaccines, for example, cause cells to express
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`a protein (or a piece of a protein) that is normally found on a particular tumor or that is part of a
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`particular virus. The presence of that protein (or piece of a protein) teaches the body’s immune
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`system to recognize it if it is encountered in the future and destroy it. These and other RNA-
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`based medicines hold great promise for addressing many previously intractable diseases and, as
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`in the present circumstances, new viruses that cause or threaten worldwide pandemics.
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`25.
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`Despite their promise, however, RNA-based medicines have been difficult to
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`develop. By their nature, RNA molecules are fragile. Without adequate protection, RNA
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`molecules are susceptible to degradation in the body, and, if and when they get to a cell, cannot
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`cross the cell membrane to enter the cell. For decades, the need for an effective delivery
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`technology had been the most significant challenge in the development of RNA-based products.
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`In particular, without the means to protect mRNA and facilitate its entry into target cells,
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`mRNA-based vaccines and other medicines have been ineffective.
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`26.
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`Indeed, functional RNA-based medicines eluded researchers until the pioneering
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`work by Arbutus scientists, many now at Genevant companies, resulting in the discovery and
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`development of the leading nucleic acid delivery technology in use today. Decades ago, a group
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`of ambitious research scientists working at a predecessor company to Arbutus began to tackle the
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`nucleic acid delivery problem that had long stymied the field. Years of tireless effort by these
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`scientists resulted in a solution to the problem. The solution was LNP technology that relies
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`on fat-like molecules called lipids that encapsulate and protect nucleic acids like mRNA from
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`degradation in the body and enable them to cross cell membranes. Once inside a cell, the LNP
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`releases the nucleic acid it encapsulates so that, in the case of an mRNA vaccine for example, the
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`nucleic acid can express the protein it encodes.
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`27.
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`The lipid components of the Arbutus technology include: structural lipids, such as
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`phospholipids and cholesterol; “cationic” (positive charge-bearing) lipids, including “ionizable”
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`lipids that are positive charge-bearing at certain pH levels; and conjugated lipids, which are
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`lipids attached to a polymer such as polyethyleneglycol (“PEG”). Arbutus scientists discovered
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`that nucleic acid-lipid particles combining particular lipid components in particular ratios could
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`achieve much more effective delivery of nucleic acids through cell membranes and into cells.
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`28.
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`These Arbutus scientists spent more than a decade researching and developing
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`this nucleic acid-lipid delivery technology. Their efforts led to the first FDA-approved RNA-
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`based therapeutic in the form of a drug called Onpattro®, an RNAi treatment for a form of
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`amyloidosis, a rare disease that causes certain proteins to accumulate in organs. The company
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`that developed Onpattro®, Alnylam Pharmaceuticals, did so under an LNP license from Arbutus
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`10
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`and received FDA approval in August 2018. Building on this initial success, Arbutus has
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`granted licenses to its LNP technology to other companies, and Genevant now has several
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`ongoing LNP product development collaborations, some directed to COVID-19 and some
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`directed to other diseases and disorders. Several entities developing mRNA-LNP vaccines
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`against COVID-19 have come to Genevant for a license to Arbutus’s technology, including
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`companies that have produced promising candidates in clinical trials. And Genevant’s COVID-
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`19 development collaborations include efforts to provide a vaccine to parts of the developing
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`world.
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`C.
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`The United States Awards Patents Recognizing Arbutus’s Innovations
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`29.
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`In recognition of Arbutus’s extensive and groundbreaking research and
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`development efforts, the United States Patent and Trademark Office has granted several families
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`of patents claiming nucleic acid-lipid particles and lipid vesicles, as well as compositions and
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`methods of using them. The Asserted Patents are among them:
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`a. U.S. Patent No. 8,058,069, “Lipid Formulations for Nucleic Acid Delivery,”
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`issued on November 15, 2011 (the “’069 Patent”).
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`b. U.S. Patent No. 8,492,359, “Lipid Formulations for Nucleic Acid Delivery,”
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`issued on July 23, 2013 (the “’359 Patent”).
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`c. U.S. Patent No. 8,822,668, “Lipid Formulations for Nucleic Acid Delivery,”
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`issued on September 2, 2014 (the “’668 Patent”).
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`d. U.S. Patent No. 9,364,435, “Lipid Formulations for Nucleic Acid Delivery,”
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`issued on June 14, 2016 (the “’435 Patent”).
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`e. U.S. Patent No. 9,504,651, “Lipid Compositions for Nucleic Acid Delivery,”
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`issued on November 29, 2016 (the “’651 Patent”).
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`11
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`f. U.S. Patent No. 11,141,378, “Lipid Formulations for Nucleic Acid Delivery,”
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`issued on October 12, 2021 (the “’378 Patent”).
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`30.
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`True and correct copies of the Asserted Patents are attached hereto as Exhibits A
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`through F. All are valid and enforceable under United States patent laws. All are assigned to
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`and owned by Arbutus, and, at all times since Arbutus and Genevant entered into a license
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`agreement, Genevant has held Exclusive Rights to all of the Asserted Patents in various fields of
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`use including the vaccine application at issue here. Under the terms of the license, Genevant’s
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`Exclusive Rights include the right to sue for the infringement alleged in this Complaint.
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`D. Moderna’s Knowledge of, and Background with, the Asserted Patents
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`31. Moderna has been on actual notice of Arbutus’s patents since before its
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`development of the Accused Product and has knowingly used Arbutus’s technology as an
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`essential component of its nucleic acid products and product candidates, including its COVID-19
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`vaccine.
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`32.
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`Years before the COVID-19 pandemic, Moderna recognized that Arbutus’s LNP
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`technology could fuel its own work in RNA-based vaccines and other medicines. Accordingly,
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`in or about May 2015, Moderna attempted to acquire rights to Arbutus’s LNP delivery
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`technology for four specific viral targets (none of which is COVID-19) through sublicense from
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`a Canadian company called Acuitas Therapeutics. Although Acuitas had licensed Arbutus’s
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`LNP technology in 2012, its license agreement expressly limited Acuitas’s ability to grant
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`sublicenses. That limitation prohibited Acuitas from granting the sublicense that it granted to
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`Moderna.
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`33.
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`In August 2016, after learning of the Moderna-Acuitas sublicense agreements,
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`Arbutus notified Acuitas of material breach. In October 2016, Acuitas filed suit in the Supreme
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`Court of British Columbia seeking to prevent Arbutus from terminating the Arbutus-Acuitas
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`agreement. Arbutus counterclaimed for a declaration that the license had been terminated and
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`sought an injunction barring Acuitas from further sublicensing Arbutus’s LNP technology.
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`34.
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`In February 2018, Arbutus and Acuitas settled their dispute. The settlement
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`agreement provided that Acuitas no longer could use Arbutus’s LNP technology, with the four
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`specific sublicenses to Moderna for vaccines targeting specific viruses remaining in effect.
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`SARS-CoV-2, the virus that causes COVID-19 and the target of the vaccine accused of
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`infringement in this Complaint, is not among the surviving sublicenses.
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`35.
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`Deprived of a broad license to Arbutus’s valuable LNP technology and hoping to
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`make unrestricted use of that technology without having to pay royalties, Moderna began filing
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`inter partes review (“IPR”) petitions requesting that the Patent and Trademark Office cancel
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`certain of Arbutus’s patents, including some asserted here.
`
`36. Moderna’s first IPR petition, filed in February 2018, challenged Arbutus’s U.S.
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`Patent No. 9,404,127 (“the ’127 Patent”), which, like the Asserted Patents, is directed to
`
`Arbutus’s LNP technology. The Patent Trial and Appeal Board (“PTAB”) ruled that all claims
`
`of the ’127 Patent should be cancelled. An appeal of that decision remains pending before the
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`United States Court of Appeals for the Federal Circuit.
`
`37. Moderna’s IPRs against the Asserted Patents were less successful. Its second IPR
`
`petition, filed in March 2018, ended with the PTAB rejecting Moderna’s arguments challenging
`
`the validity of ten of the ’435 Patent’s twenty claims. Moderna challenged that ruling on appeal,
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`13
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`but in a December 2021 decision, the United States Court of Appeals for the Federal Circuit
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`dismissed Moderna’s appeal for lack of standing.4
`
`38. Moderna’s third IPR petition, filed in January 2019, was even less successful.
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`The PTAB completely rejected Moderna’s challenge to all claims of the ’069 Patent, and the
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`United States Court of Appeals for the Federal Circuit affirmed that ruling in December 2021.
`
`E. Moderna Designs Its COVID-19 Vaccine Over a Single Weekend Aided by the
`Unauthorized Use of Arbutus’s LNP Technology
`
`39.
`
`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 for
`
`free on the internet. This public disclosure revealed the complete RNA sequence that encodes
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`the virus’s components, including its distinctive “spike protein.” With that information in the
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`public domain, researchers around the world were able to begin designing vaccines to target the
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`virus.
`
`40. Moderna was one of many companies that began work on a vaccine in earnest
`
`once the genetic sequence was published.
`
`41.
`
`Relying on Arbutus’s LNP technology covered by the Asserted Patents, Moderna
`
`was able to begin producing its COVID-19 vaccine within just a few days of the SARS-CoV-2
`
`genomic sequence entering the public domain. The design component of the effort was even
`
`faster: According to Moderna President Stephen Hoge, “[w]e did it in an hour, and it worked
`
`brilliantly.”5 Compared to the timelines of prior vaccine-development efforts, Moderna’s
`
`accomplishment was unprecedented. In the words of Moderna’s CEO Stéphane Bancel, “11
`
`
`4 Arbutus cross-appealed the PTAB’s decision, challenging the invalidation of the ten claims of
`the ’435 Patent that were not upheld. On December 1, 2021, the Federal Circuit affirmed the
`PTAB’s decision as to those claims.
`5 “Stephen Hoge, MD ’03: Turns out, designing a COVID vaccine was easy,” UCSF Alumni,
`available at https://alumni.ucsf.edu/stories/stephen-hoge.
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`14
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`months since the DNA sequence of the virus became available, you will have two approved
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`mRNA vaccines, which has never happened before with any technology. That is amazing.”6
`
`42. Moderna’s success was chronicled in an article first published online on June 11,
`
`2020, by individuals affiliated with the company and collaborators at the National Institutes of
`
`Health. According to this article—the “Moderna/NIH preprint”—“the release of SARS-CoV-2
`
`sequences triggered immediate rapid manufacturing of an mRNA vaccine” by Moderna.7
`
`Moderna “decide[d] on [the] mRNA-1273 sequence” on January 13, 2020, just three days after
`
`the publication of the viral sequence, and “initiate[d] cGMP production” the very next day, on
`
`January 14, 2020.8 On February 24, 2020, Moderna shipped clinical drug product, and, less than
`
`a month later, Phase I trials began.9
`
`43. Moderna’s COVID-19 vaccine could not have been developed, much less on a
`
`timeline unprecedented in human history, without Arbutus’s proven and patented LNP delivery
`
`technology—technology that had transformed vaccine design from a years-long project into one
`
`that could be performed within an hour over a January weekend.
`
`44. Moderna’s co-founder Robert Langer has been quoted as saying “I don’t think
`
`people realized just how important the delivery systems are . . . .”10 LNPs are so crucial to
`
`
`6 Antonio Regalado, “‘None of us were ready’ to manufacture genetic vaccines for a billion
`people,” MIT Technology Review (December 17, 2020), available at
`https://www.technologyreview.com/2020/12/17/1014989/moderna-vaccine-availability-
`stephane-bancel-ceo/.
`7 “SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen Preparedness,”
`bioRvix.org (June 11, 2020) available at
`https://www.biorxiv.org/content/10.1101/2020.06.11.145920v1.full.
`8 Id.
`9 Id.
`10 Tim Loh, “Lipids Are Delivering the Vaccine Revolution,” Bloomberg (March 6, 2021),
`available at https://www.bloomberg.com/news/newsletters/2021-03-06/lipids-are-delivering-the-
`vaccine-revolution.
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`15
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`Moderna’s mRNA vaccines that Giuseppe Ciaramella, head of infectious diseases at Moderna
`
`from 2014 to 2018, called LNPs “the unsung hero of the whole thing,”11 while Moderna CEO
`
`Stéphane Bancel stated in December 2020 that “[w]e always said it is . . . about developing the
`
`right delivery technology. And this is something that takes years, not two weeks.”12
`
`45.
`
`The Moderna/NIH preprint detailed Moderna’s use of Arbutus’s LNP technology
`
`and its infringement of the Asserted Patents. The scientists who worked on the vaccine and
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`contributed to the article explained that Moderna’s COVID-19 vaccine is composed of mRNA
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`encoding a modified version of the SARS-CoV-2 spike (S) protein that was synthesized,
`
`purified, “and encapsulated into lipid nanoparticles (LNP),” with a lipid molar ratio of
`
`“50:10:38.5:1.5 (ionizable lipid:DSPC:cholesterol:PEG-lipid).” Specifically, the Moderna/NIH
`
`preprint indicates that the Accused Product includes lipid particles comprising the following
`
`lipids in the following ratio: 50 mol % of an ionizable lipid that is cationic; 10 mol % of a
`
`phospholipid (DSPC); 38.5 mol % of cholesterol; and 1.5 mol % of a conjugated lipid that
`
`inhibits aggregation of particles (PEG-lipid).
`
`46.
`
`These components are within the ranges of, among other claims of the Asserted
`
`Patents, Claim 1 of Arbutus’s ’069 Patent, which recites a “nucleic acid-lipid particle comprising
`
`(a) a nucleic acid; (b) a cationic lipid compr