Case 1:22-cv-00252-MSG Document 133-5 Filed 09/27/23 Page 1 of 19 PageID #: 1793
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`Exhibit E
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`Case 1:22-cv-00252-UNA Document 1 Filed 02/28/22 Page 1 of 51 PageID #: 1Case 1:22-cv-00252-MSG Document 133-5 Filed 09/27/23 Page 2 of 19 PageID #: 1794
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ______________
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` JURY TRIAL DEMANDED
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`MODERNA, INC. and MODERNATX, INC.,
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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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`63.
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`Arbutus and Genevant fully support Moderna’s efforts to supply vaccines to
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`people in the United States and worldwide and in no way seek to interfere with those efforts.
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`Accordingly, no injunctive relief is sought in this case.
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`64.
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`However, Moderna has made extensive use of, and earned billions in profits
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`exploiting, Arbutus’s patented technology, including the technology described and claimed in the
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`Asserted Patents. Moderna’s actions have caused harm, and continue to cause harm, to Arbutus
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`and Genevant. Arbutus and Genevant have no choice but to defend their proprietary and
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`patented technology and seek fair and reasonable compensation for the value of their
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`innovation.27
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`COUNT 1: INFRINGEMENT OF U.S. PATENT NO. 8,058,069
`
`65.
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`66.
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`Paragraphs 1 through 64 are incorporated by reference as if fully set forth herein.
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`The United States Patent and Trademark Office duly and legally issued the ’069
`
`Patent to one of Arbutus’s predecessor companies on November 15, 2011. The ’069 Patent is
`
`titled “Novel Lipid Formulations for Nucleic Acid Delivery.”
`
`67.
`
`68.
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`Arbutus owns, and at all relevant times has owned, the ’069 Patent.
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`Genevant holds, and at all relevant times has held, a license to Exclusive Rights in
`
`the ’069 Patent for certain fields of use, which include the Accused Product. Genevant has the
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`right to sue and seek damages for the infringement alleged herein.
`
`69.
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`Claims of the ’069 Patent cover, among other things, nucleic acid-lipid particles
`
`and compositions thereof.
`
`
`27 The allegations herein are exemplary and without prejudice to Arbutus and Genevant’s
`infringement contentions. In providing these allegations, Arbutus and Genevant do not convey
`or imply any particular claim constructions or the precise scope of the claims. Arbutus and
`Genevant’s claim construction contentions regarding the meaning and scope of the claim terms
`will be provided under the Court’s scheduling order and this District’s Local Rules.
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`23
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`Case 1:22-cv-00252-UNA Document 1 Filed 02/28/22 Page 24 of 51 PageID #: 24Case 1:22-cv-00252-MSG Document 133-5 Filed 09/27/23 Page 4 of 19 PageID #: 1796
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`70. Moderna has directly infringed and continues to directly infringe claims of the
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`’069 Patent under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or using within
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`the United States, or importing into the United States, the Accused Product incorporating
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`Arbutus’s patented LNP delivery technology covered by the ’069 Patent, without authority or
`
`license to do so, during the term of the ’069 Patent.
`
`71. Moderna actively, knowingly, and intentionally has induced, and continues to
`
`induce, infringement of one or more claims of the ’069 Patent under 35 U.S.C. § 271(b) by
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`encouraging others to make and use the Accused Product in the United States in a manner
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`specifically intended to infringe the ’069 Patent.
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`72. Moderna has contributed, and continues to contribute, to the infringement of one
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`or more claims of the ’069 Patent by others under 35 U.S.C. § 271(c) by offering to sell and
`
`selling within the United States, or importing into the United States, a component of a patented
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`manufacture, combination or composition, constituting a material part of the invention of the
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`’069 Patent, knowing the same to be especially made or especially adapted for use in the
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`infringement of the ’069 Patent and not a staple article or commodity of commerce suitable for
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`substantial non-infringing use.
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`73.
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`For example, Claim 1 of the ’069 Patent recites a “nucleic acid-lipid particle
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`comprising: (a) a nucleic acid; (b) a cationic lipid comprising from 50 mol % to 65 mol % of the
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`total lipid present in the particle; (c) a non-cationic lipid comprising a mixture of a phospholipid
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`and cholesterol or a derivative thereof, wherein the phospholipid comprises from 4 mol % to 10
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`mol % of the total lipid present in the particle and the cholesterol or derivative thereof comprises
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`from 30 mol % to 40 mol % of the total lipid present in the particle; and (d) a conjugated lipid
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`24
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`that inhibits aggregation of particles comprising from 0.5 mol % to 2 mol % of the total lipid
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`present in the particle.”
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`74.
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`The Accused Product is a pharmaceutical composition of nucleic acid-lipid
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`particles. The nucleic acid in the Asserted Product is an mRNA which encodes the COVID-19
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`spike protein.
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`75.
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`The Accused Product comprises nucleic acid-lipid particles comprising the
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`following lipids: an ionizable cationic lipid (SM-102); a phospholipid (DSPC); cholesterol; and a
`
`conjugated lipid that inhibits aggregation of particles (a PEG-lipid conjugate).
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`76.
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`On information and belief, as indicated in the Moderna/NIH preprint and in
`
`International Patent Publication WO 2021/159130, the Accused Product comprises nucleic acid-
`
`lipid particles comprising the following lipids in the following ratio of the total lipid present in
`
`the particle: 50 mol % of an ionizable cationic lipid; 10 mol % of a phospholipid; 38.5 mol % of
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`cholesterol; and 1.5 mol % of a conjugated lipid that inhibits aggregation of particles.
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`77. Moderna has known of the ’069 Patent since before it commenced the infringing
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`conduct or has been willfully blind to its existence and contents since then. Moderna has long
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`been aware of, and has actively monitored Arbutus’s patent estate, including the ’069 Patent.28
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`Moderna secured unauthorized limited sublicenses to Arbutus’s LNP-related patents through
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`Acuitas; Moderna later sought to invalidate three of Arbutus’s LNP-related patents, including the
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`’069 Patent, through inter partes review; and Moderna has repeatedly made public
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`representations regarding Arbutus’s LNP technology and patents.29 Despite such knowledge,
`
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`28 See, e.g., Moderna Mot. at 4-5, Dkt. No. 18, Moderna TX, Inc. v. Arbutus Biopharma Corp.
`(Fed. Cir. No. 2020-2329).
`29 See, e.g., Moderna Mot. at 5, Dkt. No. 18, Moderna TX, Inc. v. Arbutus Biopharma Corp.
`(Fed. Cir. No. 2020-2329); Press Release, Moderna, Statement from Moderna on Patent Trial
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`25
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`Case 1:22-cv-00252-UNA Document 1 Filed 02/28/22 Page 28 of 51 PageID #: 28Case 1:22-cv-00252-MSG Document 133-5 Filed 09/27/23 Page 6 of 19 PageID #: 1798
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`COUNT 2: INFRINGEMENT OF U.S. PATENT NO. 8,492,359
`
`84.
`
`85.
`
`Paragraphs 1 through 83 are incorporated by reference as if fully set forth herein.
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`The United States Patent and Trademark Office duly and legally issued the ’359
`
`Patent to one of Arbutus’s predecessor companies on July 23, 2013. The ’359 Patent is titled
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`“Lipid Formulations for Nucleic Acid Delivery.”
`
`86.
`
`87.
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`Arbutus owns, and at all relevant times has owned, the ’359 Patent.
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`Genevant holds, and at all relevant times has held, a license to Exclusive Rights in
`
`the ’359 Patent for certain fields of use, which include the Accused Product. Genevant has the
`
`right to sue and seek damages for the infringement alleged herein.
`
`88.
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`Claims of the ’359 Patent cover, among other things, nucleic acid-lipid particles
`
`and compositions thereof.
`
`89. Moderna has directly infringed and continues to directly infringe claims of the
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`’359 Patent under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or using within
`
`the United States, or importing into the United States, the Accused Product incorporating
`
`Arbutus’s patented LNP delivery technology covered by the ’359 Patent, without authority or
`
`license to do so, during the term of the ’359 Patent.
`
`90. Moderna actively, knowingly, and intentionally has induced, and continues to
`
`induce, infringement of one or more claims of the ’359 Patent under 35 U.S.C. § 271(b) by
`
`actively encouraging others to make and use the Accused Product in the United States in a
`
`manner specifically intended to infringe the ’359 Patent.
`
`91. Moderna has contributed, and continues to contribute to the infringement of one
`
`or more claims of the ’359 Patent by others under 35 U.S.C. § 271(c) by offering to sell and
`
`selling within the United States, or importing into the United States, a component of a patented
`
`manufacture, combination or composition, constituting a material part of the invention of the
`
`28
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`Case 1:22-cv-00252-UNA Document 1 Filed 02/28/22 Page 29 of 51 PageID #: 29Case 1:22-cv-00252-MSG Document 133-5 Filed 09/27/23 Page 7 of 19 PageID #: 1799
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`’359 Patent, knowing the same to be especially made or especially adapted for use in the
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`infringement of the ’359 Patent and not a staple article or commodity of commerce suitable for
`
`substantial non-infringing use.
`
`92.
`
`For example, Claim 1 of the ’359 Patent recites a “nucleic acid-lipid particle
`
`comprising: (a) a nucleic acid; (b) a cationic lipid comprising from 50 mol % to 65 mol % of the
`
`total lipid present in the particle; (c) a non-cationic lipid comprising a mixture of a phospholipid
`
`and cholesterol or a derivative thereof, wherein the phospholipid comprises from 3 mol % to 15
`
`mol % of the total lipid present in the particle and the cholesterol or derivative thereof comprises
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`from 30 mol % to 40 mol % of the total lipid present in the particle; and (d) a conjugated lipid
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`that inhibits aggregation of particles comprising from 0.5 mol % to 2 mol % of the total lipid
`
`present in the particle.”
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`93.
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`The Accused Product is a pharmaceutical composition of nucleic acid-lipid
`
`particles. The nucleic acid in the Accused Product is an mRNA which encodes the COVID-19
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`spike protein.
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`94.
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`The Accused Product comprises nucleic acid-lipid particles comprising the
`
`following lipids: an ionizable cationic lipid (SM-102); a phospholipid (DSPC); cholesterol; and a
`
`conjugated lipid that inhibits aggregation of particles (a PEG-lipid conjugate).
`
`95.
`
`On information and belief, as indicated in the Moderna/NIH preprint and in
`
`International Patent Publication WO 2021/159130, the Accused Product comprises nucleic acid-
`
`lipid particles comprising the following lipids in the following ratio of the total lipid present in
`
`the particle: 50 mol % of an ionizable cationic lipid; 10 mol % of a phospholipid; 38.5 mol % of
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`cholesterol; and 1.5 mol % of a conjugated lipid that inhibits aggregation of particles.
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`29
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`102. This is an exceptional case. Genevant and Arbutus are entitled to attorneys’ fees
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`and costs under 35 U.S.C. § 285 as a result of Moderna’s infringement of the ’359 Patent.
`
`COUNT 3: INFRINGEMENT OF U.S. PATENT NO. 8,822,668
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`103. Paragraphs 1 through 102 are incorporated by reference as if fully set forth herein.
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`104. The United States Patent and Trademark Office duly and legally issued the ’668
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`Patent to one of Arbutus’s predecessor companies on September 2, 2014. The ’668 Patent is
`
`titled “Lipid Formulations for Nucleic Acid Delivery.”
`
`105. Arbutus owns, and at all relevant times has owned, the ’668 Patent.
`
`106. Genevant holds, and at all relevant times has held, a license to Exclusive Rights in
`
`the ’668 Patent for certain fields of use, which include the Accused Product. Genevant has the
`
`right to sue and seek damages for the infringement alleged herein.
`
`107. Claims of the ’668 Patent cover, among other things, nucleic acid-lipid particles
`
`and compositions thereof and methods of using them.
`
`108. Moderna has directly infringed and continues to directly infringe claims of the
`
`’668 Patent under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or using within
`
`the United States, or importing into the United States, the Accused Product incorporating
`
`Arbutus’s patented LNP delivery technology covered by the ’668 Patent, without authority or
`
`license to do so, during the term of the ’668 Patent.
`
`109. Moderna actively, knowingly, and intentionally has induced, and continues to
`
`induce, infringement of one or more claims of the ’668 Patent under 35 U.S.C. § 271(b) by
`
`actively encouraging others to make and use the Accused Product in the United States in a
`
`manner specifically intended to infringe the ’668 Patent.
`
`110. Moderna has contributed, and continues to contribute, to the infringement of one
`
`or more claims of the ’668 Patent by others under 35 U.S.C. § 271(c) by offering to sell and
`
`32
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`selling within the United States, or importing into the United States, a component of a patented
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`manufacture, combination or composition, constituting a material part of the invention of the
`
`’668 Patent, knowing the same to be especially made or especially adapted for use in the
`
`infringement of the ’668 Patent and not a staple article or commodity of commerce suitable for
`
`substantial non-infringing use.
`
`111. For example, Claim 1 of the ’668 Patent recites a “nucleic acid-lipid particle
`
`comprising: (a) a nucleic acid; (b) a cationic lipid comprising from 50 mol % to 65 mol % of the
`
`total lipid present in the particle; (c) a non-cationic lipid comprising up to 49.5 mol % of the total
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`lipid present in the particle and comprising a mixture of a phospholipid and cholesterol or a
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`derivative thereof, wherein the cholesterol or derivative thereof comprises from 30 mol % to 40
`
`mol % of the total lipid present in the particle; and (d) a conjugated lipid that inhibits aggregation
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`of particles comprising from 0.5 mol % to 2 mol % of the total lipid present in the particle.”
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`112. The Accused Product is a pharmaceutical composition of nucleic acid-lipid
`
`particles. The nucleic acid in the Accused Product is an mRNA which encodes the COVID-19
`
`spike protein.
`
`113. The Accused Product comprises nucleic acid-lipid particles comprising the
`
`following lipids: an ionizable cationic lipid (SM-102); a non-cationic lipid comprising a mixture
`
`of a phospholipid and cholesterol; and a conjugated lipid that inhibits aggregation of particles (a
`
`PEG-lipid conjugate).
`
`114.
`
` On information and belief, as indicated in the Moderna/NIH preprint and in
`
`International Patent Publication WO 2021/159130, the Accused Product comprises nucleic acid-
`
`lipid particles comprising the following lipids in the following ratio of the total lipid present in
`
`33
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`people to have the Accused Product administered to them within the United States. At all times
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`after Moderna knew or should have known that the Accused Product constituted a material part
`
`of the invention of the ’668 Patent, it contracted with others to manufacture the Accused Product,
`
`both in the United States and abroad, knowing healthcare professionals would directly infringe
`
`one or more claims of the ’668 Patent by administering the Accused Product in the United States.
`
`121. Arbutus and Genevant are entitled to a judgment that Moderna infringes the
`
`claims of the ’668 Patent by engaging in the manufacture, use, sale, or offer for sale of the
`
`Accused Product within the United States, and/or the importation of the Accused Product into
`
`the United States, and/or by actively inducing others to do the same, and/or by contributing to the
`
`same.
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`122. Moderna’s infringement has damaged and continues to damage Genevant and
`
`Arbutus in an amount yet to be determined, of at least a reasonable royalty.
`
`123. Moderna has undertaken its infringing actions despite knowing that such actions
`
`infringe one or more claims of the ’668 Patent. As such, Moderna has and continues to willfully
`
`infringe one or more claims of the ’668 Patent.
`
`124. This is an exceptional case. Genevant and Arbutus are entitled to attorneys’ fees
`
`and costs under 35 U.S.C. § 285 as a result of Moderna’s infringement of the ’668 Patent.
`
`COUNT 4: INFRINGEMENT OF U.S. PATENT NO. 9,364,435
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`125. Paragraphs 1 through 124 are incorporated by reference as if fully set forth herein.
`
`126. The United States Patent and Trademark Office duly and legally issued the ’435
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`Patent to one of Arbutus’s predecessor companies on June 14, 2016. The ’435 Patent is titled
`
`“Lipid Formulations for Nucleic Acid Delivery.”
`
`127. Arbutus owns, and at all relevant times has owned, the ’435 Patent.
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`36
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`128. Genevant holds, and at all relevant times has held, a license to Exclusive Rights in
`
`the ’435 Patent for certain fields of use, which include the Accused Product. Genevant has the
`
`right to sue and seek damages for the infringement alleged herein.
`
`129. Claims of the ’435 Patent cover, among other things, nucleic acid-lipid particles
`
`and compositions thereof and methods of using them.
`
`130. Moderna has directly infringed and continues to directly infringe claims of the
`
`’435 Patent under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or using within
`
`the United States, or importing into the United States, the Accused Product incorporating
`
`Arbutus’s patented LNP delivery technology covered by the ’435 Patent, without authority or
`
`license to do so, during the term of the ’435 Patent.
`
`131. Moderna actively, knowingly, and intentionally has induced, and continues to
`
`induce, infringement of one or more claims of the ’435 Patent under 35 U.S.C. § 271(b) by
`
`actively encouraging others to make and use the Accused Product in the United States in a
`
`manner specifically intended to infringe the ’435 Patent.
`
`132. Moderna has contributed, and continues to contribute, to the infringement of one
`
`or more claims of the ’435 Patent by others under 35 U.S.C. § 271(c) by offering to sell and
`
`selling within the United States, or importing into the United States, a component of a patented
`
`manufacture, combination or composition, constituting a material part of the invention of the
`
`’435 Patent, knowing the same to be especially made or especially adapted for use in the
`
`infringement of the ’435 Patent and not a staple article or commodity of commerce suitable for
`
`substantial non-infringing use.
`
`133. The Accused Product infringes at least Claim 7 of the ’435 Patent.
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`people to have the Accused Product administered to them within the United States. At all times
`
`after Moderna knew or should have known that the Accused Product constituted a material part
`
`of the invention of the ’435 Patent, it contracted with others to manufacture the Accused Product,
`
`both in the United States and abroad, knowing healthcare professionals would directly infringe
`
`one or more claims of the ’435 Patent by administering the Accused Product in the United States.
`
`145. Arbutus and Genevant are entitled to a judgment that Moderna infringes the
`
`claims of the ’435 Patent by engaging in the manufacture, use, sale, or offer for sale of the
`
`Accused Product within the United States, and/or the importation of the Accused Product into
`
`the United States, and/or by actively inducing others to do the same, and/or by contributing to the
`
`same.
`
`146. Moderna’s infringement has damaged and continues to damage Genevant and
`
`Arbutus in an amount yet to be determined, of at least a reasonable royalty.
`
`147. Moderna has undertaken its infringing actions despite knowing that such actions
`
`infringed one or more claims of the ’435 Patent. As such, Moderna has and continues to
`
`willfully infringe one or more claims of the ’435 Patent.
`
`148. This is an exceptional case. Genevant and Arbutus are entitled to attorneys’ fees
`
`and costs under 35 U.S.C. § 285 as a result of Moderna’s infringement of the ’435 Patent.
`
`COUNT 5: INFRINGEMENT OF U.S. PATENT NO. 9,504,651
`
`149. Paragraphs 1 through 148 are incorporated by reference as if fully set forth herein.
`
`150. The United States Patent and Trademark Office duly and legally issued the ’651
`
`Patent to one of Arbutus’s predecessor companies on November 29, 2016. The ’651 Patent is
`
`titled “Lipid Compositions for Nucleic Acid Delivery.”
`
`151. Arbutus owns, and at all relevant times has owned, the ’651 Patent.
`
`41
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`152. Genevant holds, and at all relevant times has held, a license to Exclusive Rights in
`
`the ’651 Patent for certain fields of use, which include the Accused Product. Genevant has the
`
`right to sue and seek damages for the infringement alleged herein.
`
`153. Claims of the ’651 Patent cover, among other things, lipid vesicle formulations
`
`comprising mRNA.
`
`154. Moderna has directly infringed and continues to directly infringe the claims of the
`
`’651 Patent under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or using within
`
`the United States, or importing into the United States, the Accused Product, incorporating
`
`Arbutus’s patented LNP delivery technology covered by the ’651 Patent, without authority or
`
`license to do so, during the term of the ’651 Patent.
`
`155. Moderna actively, knowingly, and intentionally has induced, and continues to
`
`induce, infringement of one or more claims of the ’651 Patent under 35 U.S.C. § 271(b) by
`
`actively encouraging others to make and use the Accused Product in the United States in a
`
`manner specifically intended to infringe the ’651 Patent.
`
`156. Moderna has contributed, and continues to contribute, to the infringement of one
`
`or more claims of the ’651 Patent by others under 35 U.S.C. § 271(c) by offering to sell and
`
`selling within the United States, or importing into the United States, a component of a patented
`
`manufacture, combination or composition, constituting a material part of the invention of the
`
`’651 Patent, knowing the same to be especially made or especially adapted for use in the
`
`infringement of the ’651 Patent and not a staple article or commodity of commerce suitable for
`
`substantial non-infringing use.
`
`157. For example, Claim 1 of the ’651 Patent recites a “lipid vesicle formulation
`
`comprising: (a) a plurality of lipid vesicles, wherein each lipid vesicle comprises: a cationic
`
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`lipid; an amphipathic lipid; and a polyethyleneglycol (PEG)-lipid; and (b) messenger RNA
`
`(mRNA), wherein at least 70% of the mRNA in the formulation is fully encapsulated in the lipid
`
`vesicles.” Claim 9 of the ’651 Patent further requires “[t]he lipid vesicle formulation of claim 1,
`
`wherein each lipid vesicle is a lipid-nucleic acid particle.”
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`158. The Accused Product is a lipid vesicle formulation comprising mRNA and lipid
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`vesicles. The mRNA in the Accused Product encodes the COVID-19 spike protein.
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`159. The Accused Product comprises a lipid vesicle comprising the following lipids:
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`an ionizable cationic lipid (SM-102); an amphipathic lipid (DSPC); and a PEG-lipid.
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`160.
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` Upon information and belief, in connection with the Accused Product, Moderna
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`makes a lipid vesicle formulation wherein at least 70% of the mRNA in the formulation is fully
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`encapsulated in the lipid vesicles.
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`161. On information and belief, Moderna has known of the ’651 Patent since before it
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`commenced the infringing conduct or has been willfully blind to its existence and contents since
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`then. Moderna has long been aware of and actively monitored Arbutus’s patent estate.
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`Moderna secured unauthorized limited sublicenses to Arbutus’s LNP-related patents through
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`Acuitas; Moderna later sought to invalidate three of Arbutus’s LNP-related patents through inter
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`partes review, and Moderna has repeatedly made public statements regarding Arbutus’s LNP
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`technology and patents. Despite such knowledge, Moderna nonetheless has engaged in the
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`manufacture, offer for sale, sale or use of the Accused Product within the United States, and/or
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`the importation of the Accused Product into the United States, in violation of Plaintiffs’ patent
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`rights.
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`162. Moderna actively and knowingly has infringed the ’651 Patent and actively and
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`knowingly induced infringement of the ’651 Patent by others. After Moderna knew or should
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`have known that the Accused Product infringed, it applied for and obtained EUA and then full
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`approval from the FDA to market and sell the Accused Product in the United States, with the
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`specific intent to induce customers to purchase the Accused Product and for people to have the
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`Accused Product administered to them within the United States. At all times after Moderna
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`knew or should have known that the Accused Product infringed, it contracted with multiple
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`companies to manufacture the Accused Product, both in the United States and abroad, with the
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`specific intent to induce those companies to make its infringing product. Upon information and
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`belief, Moderna actively markets the Accused Product to governments and other entities with the
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`intent for healthcare professionals to administer the Accused Product to millions and potentially
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`billions of people as a means of protection against SARS-CoV-2 infection.
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`163. Moderna actively and knowingly contributes to the infringement of healthcare
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`professionals in the United States who administer or otherwise use the Accused Product in the
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`United States. After Moderna knew or should have known that the Accused Product constituted
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`a material part of the invention of the ’651 Patent, knowing the same to be especially made or
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`especially adapted for use in the infringement of the ’651 Patent and not a staple article or
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`commodity of commerce suitable for substantial non-infringing use, it pursued and obtained
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`EUA and then full approval from the FDA to market and sell the Accused Product in the United
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`States with the specific intent to induce customers to purchase the Accused Product and for
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`people to have the Accused Product administered to them within the United States. At all times
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`after Moderna knew or should have known that the Accused Product constituted a material part
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`of the invention of the ’651 Patent, it contracted with others to manufacture the Accused Product,
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`both in the United States and abroad, knowing healthcare professionals would directly infringe
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`one or more claims of the ’651 Patent by administering the Accused Product in the United States.
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`164. Arbutus and Genevant are entitled to a judgment that Moderna infringes the
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`claims of the ’651 Patent by engaging in the manufacture, use, sale, or offer for sale of the
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`Accused Product within the United States, and/or the importation of Moderna’s COVID-19
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`vaccine into the United States, and/or by actively inducing others to do the same, and/or by
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`contributing to the same.
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`165. Moderna’s infringement has damaged and continues to damage Genevant and
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`Arbutus in an amount yet to be determined, of at least a reasonable royalty.
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`166. Moderna has undertaken their infringing actions despite knowing that such
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`actions infringed one or more claims of the ’651 Patent. As such, Moderna has and continues to
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`willfully infringe one or more claims of the ’651 Patent.
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`167. This is an exceptional case. Genevant and Arbutus are entitled to attorneys’ fees
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`and costs under 35 U.S.C. § 285 as a result of Moderna’s infringement of the ’651 Patent.
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`COUNT 6: INFRINGEMENT OF U.S. PATENT NO. 11,141,378
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`168. Paragraphs 1 through 167 are incorporated by reference as if fully set forth herein.
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`169. The United States Patent and Trademark Office duly and legally issued the ’378
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`Patent to Arbutus on October 12, 2021. The ’378 Patent is titled “Lipid Formulations for
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`Nucleic Acid Delivery.”
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`170. Arbutus owns, and at all relevant times has owned, the ’378 Patent.
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`171. Genevant holds, and at all relevant times has held, a license to Exclusive Rights in
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`the ’378 Patent for certain fields of use, which include the Accused Product. Genevant has the
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`right to sue and seek damages for the infringement alleged herein.
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`172. Claims of the ’378 Patent cover, among other things, nucleic acid-lipid particles
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`and compositions thereof.
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`173. Moderna has directly infringed and continues to directly infringe claims of the
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`’378 Patent under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or using within
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`the United States, or importing into the United States, the Accused Product incorporating
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`Arbutus’s patented LNP delivery technology covered by the ’378 Patent, without authority or
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`license to do so, during the term of the ’378 Patent.
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`174. Moderna actively, knowingly, and intentionally has induced, and continues to
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`induce, infringement of one or more claims of the ’378 Patent under 35 U.S.C. § 271(b) by
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`actively encouraging others to make and use the Accused Product in the United States in a
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`manner specifically intended to infringe the ’378 Patent.
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`175. Moderna has and continues to contribute to the infringement of one or more
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`claims of the ’378 Patent by others under 35 U.S.C. § 271(c) by offering to sell and selling
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`within the United States, or importing into the United States, a component of a patented
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`manufacture, combination or composition, constituting a material part of the invention of the
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`’378 Paten