Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 1 of 28 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ALNYLAM PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`MODERNA, INC., MODERNATX, INC.,
`and MODERNA US, INC.,
`
`Defendants.
`
`
`
`
`
`
`
`
`Civil Action No. __
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`
`
`JURY TRIAL DEMANDED
`
`)
`)
`)
`)
`)
`)
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`)
`)
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`
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`Plaintiff Alnylam Pharmaceuticals, Inc. (“Alnylam”), by its attorneys, alleges as follows
`
`for its Complaint for Patent Infringement against Moderna, Inc., ModernaTX, Inc., and Moderna
`
`US, Inc. (collectively, “Moderna”).
`
`NATURE OF THE ACTION
`
`1.
`
`Alnylam is a pioneering RNA therapeutics company based in Cambridge,
`
`Massachusetts. Over a decade ago, Alnylam invented a breakthrough class of protonatable
`
`biodegradable lipids used to form lipid particles that carry and safely deliver in the body RNA-
`
`based therapeutics or vaccines (the “Alnylam Lipid Particle Technology”). The Alnylam Lipid
`
`Particle Technology is foundational to the success of the recently-developed messenger RNA
`
`(“mRNA”) based COVID vaccines. The United States Patent Office repeatedly recognized
`
`Alnylam’s inventive work, including by issuing United States Patent Nos. 11,590,229 (the “’229
`
`Patent), 11,633,479 (the “’479 Patent”), 11,633,480 (the “’480 Patent”) (collectively, the “Patents-
`
`in-Suit”), which are three of the patents that protect the Alnylam Lipid Particle Technology.
`
`(Exhibits 1, 2, and 3.) The ’229 Patent issued from U.S. Application No. 17/651,029 (the “’029
`
`Application”). (Exhibit 1.) The ’479 Patent issued from U.S. Application No. 17/651,017 (the
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`
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`1
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`“’017 Application”). (Exhibit 2.) The ’480 Patent issued from U.S. Application No. 17/651,023
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`(the “’023 Application”). (Exhibit 3.)
`
`2.
`
` Moderna infringes Alnylam’s ’479 Patent and ’480 Patent through the use of SM-
`
`102, 1 a protonatable biodegradable lipid formulated into lipid particles that protect and deliver the
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`vaccine’s mRNA. Similarly, Moderna infringes Alnylam’s ’229 Patent through the use of
`
`Alnylam’s patented lipid particles that protect and deliver Moderna’s COVID-19 Vaccine’s
`
`mRNA. The “Moderna’s Infringing Lipid Particles” comprise four lipids: SM-102, polyethylene
`
`glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-
`
`phosphocholine [DSPC].
`
`3.
`
`Moderna has been aware of the Alnylam Lipid Particle Technology since at least
`
`early 2014, when Alnylam and Moderna entered into a business discussion regarding a license to
`
`Alnylam technology including the Alnylam Lipid Particle Technology. Alnylam brings this action
`
`to recover monetary compensation for Moderna’s unlicensed use of Alnylam’s Patents-in-Suit.
`
`Alnylam does not seek injunctive relief under 35 U.S.C. § 283 against such use.
`
`THE PARTIES
`
`4.
`
`Plaintiff Alnylam is a corporation organized under the laws of the State of Delaware
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`with a principal place of business at 675 West Kendall Street, Henri A. Termeer Square,
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`Cambridge, Massachusetts 02142. Founded in 2002, Alnylam is a groundbreaking life science
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`company that has worked to harness the potential of RNA interference (“RNAi”) therapeutics to
`
`transform the lives of people living with diseases that have limited or inadequate treatment options.
`
`Utilizing an earlier version of in licensed Lipid Particle Technology, in 2018 Alnylam delivered
`
`
`
`8-{(2-hydroxyethyl)[6-oxo-6-
`
` 1
`
`
`
`
`
`9-heptadecanyl
`is
`name
`chemical
`SM-102’s
`
`(undecyloxy)hexyl]amino}octanoate. (Exhibit 25 at 3.)
`2
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`

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`the world’s first approved RNAi therapeutic, ONPATTRO® (patisiran). ONPATTRO® is currently
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`approved for the treatment of polyneuropathy caused by an illness called hereditary ATTR
`
`(hATTR) amyloidosis. Alnylam has developed an additional delivery modality termed GalNAc
`
`Delivery, which is utilized in three marketed products, GIVLAARI® (givosiran), approved in
`
`2019, and OXLUMO® (lumasiran), approved in 2020, both marketed by Alnylam and
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`LEQVIO®(inclisiran), approved in 2021, developed initially by Alnylam and licensed to Novartis.
`
`5.
`
`Alnylam has a long history of licensing or offering to license to third parties its
`
`intellectual property, including the Alnylam Lipid Particle Technology and the GalNAc
`
`Technology.
`
`6.
`
`Upon information and belief, Defendant Moderna, Inc. is a company organized
`
`under the laws of the State of Delaware with a principal place of business at 200 Technology
`
`Square, Cambridge, Massachusetts 02139. Upon information and belief, Defendant Moderna, Inc.
`
`was previously known as Moderna Therapeutics, Inc. Upon information and belief, Defendant
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`Moderna, Inc. is the parent company of the other Defendants and recognizes the revenue from
`
`sales of Moderna’s COVID-19 vaccine. (Exhibit 4 at 98-100; Exhibit 5 at 97, 120, 128.)
`
`7.
`
`Upon information and belief, Defendant ModernaTX, Inc. is a company organized
`
`under the laws of the State of Delaware with a principal place of business at 200 Technology
`
`Square, Cambridge, Massachusetts 02139. Upon information and belief, Defendant ModernaTX,
`
`Inc. is a wholly owned subsidiary of Defendant Moderna, Inc. The FDA granted the Biologic
`
`License Approval (“BLA”) for SPIKEVAX® 2 to Defendant ModernaTX, Inc. (Exhibit 6).
`
`Defendant ModernaTX, Inc. is listed as the entity to contact in the prescribing information for
`
`
`
` Moderna’s mRNA COVID-19 Vaccine is approved under the tradename SPIKEVAX®.
`3
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` 2
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`
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`SPIKEVAX®. (Exhibit 7 at 71-72.) According to the prescribing information, SPIKEVAX® is a
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`trademark of Defendant ModernaTX, Inc. (Id. at 9).
`
`8.
`
`Upon information and belief, Defendant Moderna US, Inc. is a company organized
`
`under the laws of the State of Delaware with a principal place of business at 200 Technology
`
`Square, Cambridge, Massachusetts 02139. Upon information and belief, Defendant Moderna US,
`
`Inc. is a wholly-owned subsidiary of Defendant Moderna, Inc. Defendant Moderna US, Inc. is
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`listed in the prescribing information as the entity manufacturing SPIKEVAX®. (Exhibit 7 at 71-
`
`72.)
`
`9.
`
`On information and belief, Defendants Moderna Inc., ModernaTX, and Moderna
`
`US, Inc. are agents of each other and/or work in concert with each other with respect to the
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`development, regulatory approval, marketing, manufacturing, sales, offers for sale, and
`
`distribution of Moderna’s COVID-19 Vaccine which contains Moderna’s Infringing Lipid
`
`Particles. One of the lipids in Moderna’s Infringing Lipid Particles is SM-102.
`
`JURISDICTION AND VENUE
`
`10.
`
`This is an action for patent infringement arising under the patent laws of the United
`
`States, 35 U.S.C. § 1, et seq.
`
`11.
`
`This Court has jurisdiction under 28 U.S.C. §§ 1331 and 1338(a) because this is a
`
`civil action arising under the Patent Act.
`
`12.
`
`This Court has personal jurisdiction over Defendant Moderna, Inc., Defendant
`
`ModernaTX, Inc., and Defendant Moderna US, Inc. because all three are Delaware corporations.
`
`13.
`
`This Court also has jurisdiction over Defendant Moderna, Inc. because, upon
`
`information and belief, it directly or indirectly makes, uses, offers for sale, and/or sells its COVID-
`
`
`
`
`
`4
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`

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`
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`19 Vaccine, containing Moderna’s Infringing Lipid Particles, which include SM-102, throughout
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`the United States, including in this judicial district.
`
`14.
`
`This Court also has jurisdiction over Defendant ModernaTX, Inc. because, upon
`
`information and belief, it directly or indirectly makes, uses, offers for sale, and/or sells its COVID-
`
`19 Vaccine, containing Moderna’s Infringing Lipid Particles, which include SM-102, throughout
`
`the United States, including in this judicial district.
`
`15.
`
`This Court also has jurisdiction over Defendant Moderna US, Inc. because, upon
`
`information and belief, it directly or indirectly makes, uses, offers for sale, and/or sells its COVID-
`
`19 Vaccine, containing Moderna’s Infringing Lipid Particles, which including SM-102,
`
`throughout the United States, including in this judicial district.
`
`16.
`
`Venue is proper in this Court under 28 U.S.C. § 1400(b) because Defendant
`
`Moderna, Inc., Defendant ModernaTX, Inc., and Defendant Moderna US, Inc. are Delaware
`
`corporations.
`
`A.
`
`17.
`
`BACKGROUND
`
`RNA THERAPEUTICS
`
`The promise of RNA-based therapeutics (including RNAi and mRNA) has long
`
`been known, but scientists have struggled for decades to translate the promise into successful
`
`human therapeutics. The main challenge scientists around the world struggled with was how to
`
`deliver the fragile, negatively charged RNA into the body’s cells in a safe, effective, and non-toxic
`
`way. (Exhibit 8 at 1-2.)
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`5
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`18.
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`One approach was to develop a lipid3 system for use with RNA-based therapeutics.
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`These lipids would form a lipid particle. The lipid particles would encapsulate and protect the
`
`fragile RNA upon administration to the body so the RNA could be delivered to the cells where the
`
`RNA would provide its therapeutic effect. Because the RNA is negatively charged, certain of the
`
`lipids in the lipid particle had to be protonatable to create the protective bubble around the RNA.
`
`Protonatable lipids do not exist in nature, and therefore had to be synthesized. There were toxicity
`
`issues with early attempts to use them in therapeutics due to the high dose of lipid particle needed
`
`to be effective.
`
`19.
`
`To harness the full promise and power of lipid particles to deliver revolutionary
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`RNA therapies, scientists needed to develop a more potent lipid particle system that could safely
`
`and effectively deliver the RNA to the target cells, and then be metabolized and eliminated from
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`the body.
`
`20.
`
`Alnylam overcame some of the issues associated with earlier versions of lipid
`
`particles using an in-licensed lipid particle system containing the protonatable lipid compound
`
`known as MC3, a highly potent molecule. With MC3, Alnylam developed ONPATTRO®. MC3,
`
`while safe and effective, is more stable in the body and thus has a relatively long half-life. Alnylam
`
`recognized the need for further improvements in lipid particle technology and internally embarked
`
`on a research program to develop a new class of lipids with improved properties.
`
`
`
` 3
`
`
`
`
`
` A lipid is a molecule that is minimally soluble in water while soluble in nonpolar solvents.
`Examples include macro biomolecules such as fats, oils, certain vitamins, and hormones.
`6
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`
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`B.
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`ALNYLAM’S BREAKTHROUGH BIODEGRADABLE LIPID PARTICLE TECHNOLOGY
`FOR DELIVERY OF RNA TO CELLS
`
`21.
`
`Over a decade ago, Alnylam scientists solved these pressing issues by inventing a
`
`new class of non-natural lipid particles comprising a protonatable lipid with biodegradable groups
`
`(i.e., the Alnylam Lipid Particle Technology). Lipid particles with these biodegradable groups
`
`protect the RNA until delivery to inside the cell, and then are metabolized and eliminated from the
`
`body ensuring no dose-limiting toxicity. Alnylam’s seminal work to create these novel
`
`biodegradable lipid particles has been employed in potential RNA therapeutics in development
`
`and now mRNA-based vaccines.
`
`C.
`
`22.
`
`THE PATENTS-IN-SUIT
`
`Alnylam filed a series of provisional and utility patent applications on its novel
`
`protonatable biodegradable lipids. Utility applications disclosing these novel protonatable
`
`biodegradable lipids published on February 2, 2012 and August 1, 2013. At least forty-nine patents
`
`world-wide have issued to Alnylam based on these groundbreaking inventions described in its
`
`provisional and utility patent applications.
`
`23.
`
`On February 28, 2023, The United States Patent & Trademark Office issued the
`
`’229 Patent, entitled “Biodegradable Lipids for the Delivery of Active Agents.” The ’229 Patent
`
`issued to Alnylam as assignee of the inventors.
`
`24.
`
`The ’229 Patent claims a class of lipid particles and vaccines containing a
`
`protonatable lipid compound, distearoylphosphatidylcholine (DSPC), cholesterol, and a PEG-
`
`modified lipid for use in delivering a nucleic acid, including mRNA, and a method of delivering
`
`the same.
`
`25.
`
`Independent claim 1 of the ’229 Patent is representative and recites:
`
`
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`7
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`lipid particle and a
`A pharmaceutical composition comprising a
`pharmaceutically acceptable diluent, excipient, or carrier, wherein the lipid particle
`comprises:
`
`
`(i) a nucleic acid,
`
`(ii) 35-65 mol% of a protonatable lipid compound,
`
`(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC),
`
`(iv) 15-45 mol% cholesterol, and
`
`(v) 0.5-10 mol% of 1-(monomethoxy-polyethylene glycol)-2,3-dimyristoyl
`glycerol (PEG-DMG),
`
`
`
`
`
`
`wherein the mol% is based on 100% total moles of lipids in the lipid particle,
`
`wherein:
`
`the protonatable lipid compound comprises a head group, hydrophobic tails,
`and a central moiety to which the head group and the hydrophobic tails are directly
`bonded, wherein:
`
`the central moiety is a nitrogen atom;
`
`the hydrophobic tails consist of two hydrophobic tails;
`
`each of the two hydrophobic tails independently consists of a first
`hydrophobic chain, an ester group, and a second hydrophobic chain, wherein the
`first and second hydrophobic chains are aliphatic and linked by the ester group, and
`the first hydrophobic chain is bonded directly to the central moiety, wherein each
`ester group is -C(O)O-:
`
`each hydrophobic tail has a total carbon atom content from 17 to 26 carbon
`atoms; and
`
`one of the hydrophobic tails has (a) the formula -R12-M1-R13, wherein R12
`is a C4-C14 alkyl group, M1 is -C(O)O-, and R13 is a C10-C20 branched alkyl group,
`(b) a chain length for formula -R12-M1-R13 of 18 to 20 atoms, and (c) a total carbon
`atom content of 21 to 26 carbon atoms.
`
`
`(Exhibit 1 at Claim 1.)
`
`
`26.
`
`Independent claim 11 of the ’229 Patent is representative of the method of delivery
`
`claims and recites:
`
`
`
`
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`8
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`A method for delivering a nucleic acid, comprising administering to a
`subject a pharmaceutical composition comprising a lipid particle and a
`pharmaceutically acceptable diluent, excipient, or carrier, wherein the lipid particle
`comprises:
`
`
`(i) a nucleic acid,
`
`(ii) 35-65 mol% of a protonatable lipid compound,
`
`(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC),
`
`(iv) 15-45 mol% cholesterol, and
`
`(v) 0.5-10 mol% of 1-(monomethoxy-polyethylene glycol)-2,3-dimyristoyl
`glycerol (PEG-DMG),
`
`
`
`
`
`
`wherein the mol% is based on 100% total moles of lipids in the lipid particle,
`
`wherein:
`
`the protonatable lipid compound comprises a head group, hydrophobic tails,
`and a central moiety to which the head group and the hydrophobic tails are directly
`bonded, wherein:
`
`the central moiety is a nitrogen atom;
`
`the hydrophobic tails consist of two hydrophobic tails;
`
`each of the two hydrophobic tails independently consists of a first
`hydrophobic chain, an ester group, and a second hydrophobic chain, wherein the
`first and second hydrophobic chains are aliphatic and linked by the ester group, and
`the first hydrophobic chain is bonded directly to the central moiety, wherein each
`ester group is -C(O)O-;
`
`each hydrophobic tail has a total carbon atom content from 17 to 26 carbon
`atoms; and
`
`one of the hydrophobic tails has (a) the formula -R12-M1-R13, wherein R12
`is a C4-C14 alkyl group, M1 is -C(O)O-, and R13 is a C10-C20 branched alkyl group,
`(b) a chain length for formula -R12-M1-R13 of 18 to 20 atoms, and (c) a total carbon
`atom content of 21 to 26 carbon atoms.
`
`
`(Exhibit 1 at Claim 11.)
`
`
`
`
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`9
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`27.
`
`Independent claim 21 of the ’229 Patent is representative of the vaccine claims and
`
`recites:
`
`A vaccine comprising a lipid particle and a pharmaceutically acceptable
`diluent, excipient, or carrier, wherein the lipid particle comprises:
`
`
`(i) a nucleic acid, wherein the nucleic acid comprises RNA,
`
`(ii) 35-65 mol% of a protonatable lipid compound,
`
`(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC),
`
`(iv) 15-45 mol% cholesterol, and
`
`(v) 0.5-10 mol% of 1-(monomethoxy-polyethylene glycol)-2,3-dimyristoyl
`glycerol (PEG-DMG),
`
`wherein the mol% is based on 100% total moles of lipids in the lipid particle,
`
`wherein:
`
`the protonatable lipid compound comprises a head group, hydrophobic tails,
`and a central moiety to which the head group and the hydrophobic tails are directly
`bonded, wherein:
`
`the central moiety is a nitrogen atom;
`
`the hydrophobic tails consist of two hydrophobic tails;
`
`each of the two hydrophobic tails independently consists of a first
`hydrophobic chain, an ester group, and a second hydrophobic chain, wherein the
`first and second hydrophobic chains are aliphatic and linked by the ester group, and
`the first hydrophobic chain is bonded directly to the central moiety, wherein each
`ester group is -C(O)O-:
`
`each hydrophobic tail has a total carbon atom content from 17 to 26 carbon
`atoms; and
`
`one of the hydrophobic tails has the formula
`
`
`, wherein:
`
`10
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`R13 is a C13-C17 branched alkyl; and
`
`the chain length of the hydrophobic tail is from 18 to 20 atoms.
`
`
`(Exhibit 1 at Claim 21.)
`
`
`28.
`
`The ’229 Patent has been owned by Alnylam at all times, is fully maintained, and
`
`is valid and enforceable.
`
`29.
`
`On April 25, 2023, The United States Patent & Trademark Office issued the ’479
`
`Patent, entitled “Biodegradable Lipids for the Delivery of Active Agents.” The ’479 Patent issued
`
`to Alnylam as assignee of the inventors.
`
`30.
`
`The ’479 Patent claims a lipid compound and a method of delivering a nucleic acid
`
`comprising administering lipid particles that can deliver lipid compounds along with an active
`
`agent, including mRNA. Each lipid compound contains one or more protonatable group.
`
`31.
`
`Independent claim 1 of the ’479 Patent recites:
`
`A lipid compound, comprising a head group, two hydrophobic tails, and a central moiety
`to which the head group and the two hydrophobic tails are directly bonded, wherein:
`
`the central moiety is a nitrogen atom;
`
`each of the two hydrophobic tails independently consists of an aliphatic group interrupted
`by an ester group; and
`
`at least one of the hydrophobic tails has the formula -R12-M1-R13, wherein:
`
`R12 is a C4-C14 alkyl group,
`
`M1 is an ester group, and
`
`R13 is a C10-C20 alkyl group that is branched at the α-position relative to M1;
`
`the chain length of formula -R12-M1-R13 is from 17 to 24 atoms;
`
`the total carbon atom content of the at least one hydrophobic tail is 21 to 26
`carbon atoms; and
`
`
`
`
`
`11
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`
`
`wherein the lipid compound contains a protonatable group such that the lipid
`compound is positively charged at a pH at or below pH 7.4.
`
`(Exhibit 2 at Claim 1)
`
`32.
`
`Dependent claim 5 of the ’479 Patent recites:
`
`The lipid compound of claim 1, wherein the ester group in each hydrophobic tail is
`-C(O)O-.
`
`(Exhibit 2 at Claim 5)
`
`33.
`
`Dependent claim 6 of the ’479 Patent is representative and recites:
`
`The lipid compound of claim 5, wherein the at least one hydrophobic tail has the formula:
`
`
`where R13 is branched at the α-position relative to the -C(O)O- group, and
`where R13 is a C13-Cl7 alkyl and the maximum length of R13 is 11 carbon atoms.
`
`(Exhibit 2 at Claim 6)
`
`34.
`
`Independent claim 13 of the ’479 Patent recites:
`
`A method for delivering a nucleic acid comprising administering to a subject a lipid
`particle comprising a nucleic acid, a lipid compound, a neutral lipid, a PEG-lipid, and a sterol,
`wherein:
`
`the lipid compound comprises a head group, two hydrophobic tails, and a central moiety
`
`to which the head group and the two hydrophobic tails are directly bonded, wherein:
`
`
`
`the central moiety is a nitrogen atom;
`
`each of the two hydrophobic tails independently consists of an aliphatic group interrupted
`by an ester group; and
`
`at least one of the hydrophobic tails has the formula -R12-M1-R13, wherein:
`
`R12 is a C4-C14 alkyl group,
`
`M1 is an ester group, and
`
`R13 is a C10-C20 alkyl group that is branched at the α-position relative to M1;
`
`the chain length of formula -R12-M1-R13 is from 17 to 24 atoms; and
`12
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`Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 13 of 28 PageID #: 13
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`
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`the total carbon atom content of the at least one hydrophobic tail is 21 to 26
`carbon atoms; and
`
`wherein the lipid compound contains a protonatable group such that the lipid
`compound is positively charged at a pH at or below pH 7.4.
`
`
`(Exhibit 2 at Claim 13).
`
`35.
`
`Dependent claim 14, which depends from claim 13, of the ’479 Patent recites:
`
`
`
`
`
`The method of claim 13, wherein the nucleic acid comprises RNA.
`
`36.
`
`Dependent claim 15, which depends from claim 14 ,of the ’479 Patent recites:
`
`The method of claim 14, wherein the ester group in each hydrophobic tail is -C(O)O-.
`
`37.
`
`Dependent claim 16, which depends from claim 15, of the ’479 Patent is
`
`representative and recites:
`
`The method of claim 15, wherein the at least one hydrophobic tail has the formula:
`
`
`
`
`
`
`
`
`
`where R13 is branched at the α-position relative to the -C(O)O- group, and
`
`where R13 is a C13-Cl7 alkyl and the maximum length of R13 is 11 carbon atoms.
`
`38.
`
`The ’479 Patent has been owned by Alnylam at all times, is fully maintained, and
`
`is valid and enforceable.
`
`39.
`
`On April 25, 2023, The United States Patent & Trademark Office issued the ’480
`
`Patent, entitled “Biodegradable Lipids for the Delivery of Active Agents.” The ’480 Patent issued
`
`to Alnylam as assignee of the inventors.
`
`40.
`
`The ’480 Patent claims a lipid particle for delivery of an active agent, including
`
`mRNA, containing a protonatable lipid compound, distearoylphosphatidylcholine (DSPC),
`
`
`
`
`
`13
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`

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`
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`cholesterol, and a PEG-modified lipid. Each protonatable lipid compound contains a head group,
`
`hydrophobic tails, and a central moiety to which the head group and the two hydrophobic tails are
`
`directly bonded.
`
`41.
`
`Independent claim 5 of the ’480 Patent is representative of the lipid particle
`
`composition claims and recites:
`
`A lipid particle comprising:
`
`(i) a nucleic acid,
`
`(ii) 35-65 mol % of a protonatable lipid compound,
`
`(iii) 3-12 mol % distearoylphosphatidylcholine (DSPC),
`
`(iv) 15-45 mol % cholesterol, and
`
`(v) 0.5-10 mol % of a PEG-modified lipid, wherein the PEG-modified
`lipid is 1-(monomethoxy-polyethylene glycol)-2,3-dimyristoyl glycerol (PEG-
`DMG),
`
`wherein the mol% is based on 100% total moles of lipids in the lipid particle,
`
`wherein the protonatable lipid compound comprises a head group, hydrophobic
`tails, and a central moiety to which the head group and the two hydrophobic tails are
`directly bonded, wherein:
`
`the central moiety is a nitrogen atom;
`
`the hydrophobic tails consist of two hydrophobic tails;
`
`each of the two hydrophobic tails independently consists of a first hydrophobic
`
`chain, an ester group, and a second hydrophobic chain, wherein the first and second
`hydrophobic chains are aliphatic and linked by the ester group, and the first hydrophobic
`chain is bonded directly to the central moiety, wherein each ester group is -C(O)O-;
`
`wherein each hydrophobic tail has a total carbon atom content from 17 to 26
`carbon atoms; and
`
`wherein one hydrophobic tail has the formula:
`
`
`
`
`
`14
`
`

`

`Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 15 of 28 PageID #: 15
`
`
`
`
`, wherein
`
`R13 is a Cl3-Cl7 branched alkyl; and
`
`the chain length of the one hydrophobic tail is from 18 to 20 atoms.
`
`(Exhibit 3 at Claim 5.)
`
`
`42.
`
`The ’480 Patent has been owned by Alnylam at all times, is fully maintained, and
`
`is valid and enforceable.
`
`D.
`
`ALNYLAM PRESENTED CONFIDENTIAL
`INFORMATION REGARDING
`PATENTED LIPID PARTICLE TECHNOLOGY TO MODERNA IN 2014
`
`ITS
`
`43.
`
`In late-2013 or 2014, Alnylam and Moderna began discussions about a potential
`
`license to some of Alnylam’s intellectual property along with a potential business relationship or
`
`a collaboration. Among the Alnylam intellectual property under consideration for license were the
`
`pending Alnylam Lipid Particle Technology patent applications and all patents that would issue
`
`from such applications. On February 7, 2014, Moderna and Alnylam entered into a Mutual
`
`Confidentiality Agreement (the “Agreement”), allowing Alnylam and Moderna to share
`
`confidential information “for the purpose of enabling the other party to evaluate the feasibility or
`
`desirability of such business or research relationship.” (Exhibit 9, § 1.) The Agreement stated that
`
`recipients of confidential information “shall not use or exploit such Confidential Information for
`
`its own benefit or the benefit of another without the prior written consent of the Disclosing Party.”
`
`(Id. § 3.)
`
`44.
`
`Pursuant to this Agreement, on or about April 28, 2014, Alnylam met with Moderna
`
`to disclose and discuss the Alnylam Lipid Particle Technology. Attendees from Moderna included
`
`Stephen Hoge (then Senior VP of Corporate Development), Said Francis (then Director of
`
`
`
`
`
`15
`
`

`

`Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 16 of 28 PageID #: 16
`
`
`
`Business Development), Matt Stanton (then VP of Chemistry), and Örn Almarsson (then Senior
`
`VP of Formulation and Delivery Technology).
`
`45.
`
`In the April 28, 2014 meeting, Alnylam presented a detailed PowerPoint disclosing
`
`Alnylam Lipid Particle Technology and how those lipid particles could be used for developing
`
`RNA-based pharmaceuticals. Alnylam further disclosed valuable rodent and non-human primate
`
`pharmacology experiments that showed superior in vivo elimination of its biodegradable lipid
`
`particles, while also showing superior potency.
`
`46.
`
`The discussions between Moderna and Alnylam continued through at least
`
`September 30, 2014. The discussions ended without Moderna agreeing to take a license to
`
`Alnylam’s patents, patent applications, or trade secrets embodied in the Confidential Information
`
`on the Alnylam Lipid Particle Technology.
`
`47.
`
`Upon information and belief, as of 2014, Moderna did not possess a protonatable
`
`lipid with biodegradable groups sufficient to form a lipid particle with desirable properties to
`
`deliver RNA materials for use in therapeutics and vaccines. Upon information and belief, Moderna
`
`did not make the infringing SM-102 – a protonatable lipid with biodegradable groups that uses the
`
`Alnylam Lipid Particle Technology – until sometime in 2015 for use in non-COVID vaccines
`
`Moderna was developing. (See Exhibit 10 at 8.)
`
`E. MODERNA’S COVID-19 VACCINE
`
`48.
`
`Upon information and belief, in either December 2019 or January 2020, Moderna
`
`began work on developing and formulating a vaccine for the prevention of the novel coronavirus
`
`(SARS-CoV-2). Despite lacking a license to the Alnylam Lipid Particle Technology, as part of
`
`that development and formulation, Moderna developed its COVID-19 Vaccine using Moderna’s
`
`Infringing Lipid Particles.
`
`
`
`
`
`16
`
`

`

`Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 17 of 28 PageID #: 17
`
`
`
`
`49.
`
`Upon information and belief, Moderna, working in conjunction with researchers
`
`from the NIH, finalized the mRNA sequence on January 13, 2020, for use as a potential vaccine
`
`against SARS-CoV-2. (See Exhibit 11 at 3.)
`
`50.
`
`Upon information and belief, the first clinical batch of Modena’s vaccine candidate
`
`incorporating Moderna’s Infringing Lipid Particles was completed on February 7, 2020. The first
`
`patient in Moderna’s Phase 1 clinical study received a dose on March 16, 2020. (See Exhibit 12 at
`
`1.)
`
`51.
`
`Upon information and belief, Moderna filed its IND for its COVID-19 vaccine
`
`candidate incorporating Moderna’s Infringing Lipid Particles on April 27, 2020. (See Exhibit 12
`
`at 1.) On May 12, 2020, the FDA granted Fast Track status to Moderna’s vaccine candidate. (See
`
`Exhibit 13 at 1.)
`
`52.
`
`On November 30, 2020, Moderna announced the results of its Phase 3 trial of its
`
`vaccine candidate incorporating Moderna’s Infringing Lipid Particles. (See Exhibit 14 at 1.) It
`
`announced on the same day that it would submit its Emergency Use Authorization to the FDA.
`
`(See id.)
`
`53.
`
`On December 18, 2020, the FDA granted an Emergency Use Authorization (EUA)
`
`to Moderna’s COVID-19 Vaccine incorporating Moderna’s Infringing Lipid Particles, under the
`
`tradename “Moderna COVID-19 Vaccine,” allowing commercial sales of its Covid-19 vaccine to
`
`commence. (See Exhibit 15 at 1.) Upon information and belief, every dose of Defendants’ COVID-
`
`19 Vaccine sold pursuant to this Emergency Use Authorization contains the infringing lipid
`
`particles. According to the EUA approximately 30,000 individuals had received at least one dose
`
`of Moderna COVID-19 Vaccine during clinical trials and millions of doses have been distributed
`
`since the EUA.
`
`
`
`
`
`17
`
`

`

`Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 18 of 28 PageID #: 18
`
`
`
`
`54.
`
`On January 31, 2022, Moderna announced that it received FDA approval for its
`
`COVID-19 Vaccine, under the tradename SPIKEVAX®. (See Exhibit 15 at 2).
`
`55.
`
`On February 25, 2022, Moderna stated that it recognized $17.7 billion dollars in
`
`revenue in 2021 from sales of 807 million doses of its COVID-19 Vaccine. (Exhibit 4 at 100.)
`
`Moderna stated that it recognized $18,435,000,000 in revenue in 2022 globally from sales of its
`
`COVID-19 Vaccine, and $4,405,000,000 in revenue from U.S. COVID-19 Vaccine sales. (Exhibit
`
`5 at 128). Moderna reported that it expected at least $5.0 billion in revenue from COVID-19s
`
`delivered in 2023.
`
`56.
`
`Upon information and belief, on June 17, 2022, the FDA approved Moderna’s
`
`COVID-19 Vaccine under the tradename SPIKEVAX® for ages 12 years and older (Primary Series
`
`– “Light Blue Border”), for ages 6 to 11 years (Primary Series – “Teal Border” and Primary Series
`
`“Booster Doses Only” – “Purple Border”), and for ages 6 months to 5 years (Primary Series –
`
`“Magenta Border”). (Exhibit 15 at n.13.) Upon information and belief, on August 31, 2022, the
`
`FDA approved Moderna’s COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
`
`(“Bivalent”) for individuals 18 and older (Bivalent – “Gray Border”). (Exhibit 15 at n.14) Upon
`
`information and belief, on October 12, 2022, the FDA approved Moderna’s COVID-19 Vaccine,
`
`Bivalent for individuals 12 through 17 years of age and 6 through 11 years of age. (Exhibit 15 at
`
`n. 14.) Upon information and belief, on December 8, 2022, the FDA revised and reissued the
`
`October 12, 2022 letter of authorization to authorize the use of Moderna’s COVID-19 Vaccine,
`
`Bivalent for individuals 6 months through 5 years of age (Bivalent – “Yellow Border”). (New
`
`Exhibit 15 at 1, n. 18;
`
`57.
`
`Upon information and belief, on April 18, 2023 the FDA amended the EUA,
`
`rescinding its authorization for use of monovalent SPIKEVAX® in the United States (Exhibit 16,
`
`
`
`
`
`18
`
`

`

`Case 1:23-cv-00580-UNA Document 1 Filed 05/26/23 Page 19 of 28 PageID #: 19
`
`
`
`FDA announcement). The amendment authorized the use of Moderna’s COVID-19 Vaccine,
`
`Bivalent (Original and Omicron BA.4/BA.5) (“Bivalent”) (“Gray Border”) for all doses
`
`administered to all individuals 6 months of age or older (Exhibit 15 at 1). Moderna’s COVID-19
`
`Vaccine, Bivalent contains the infringing lipid particles made with Defendants’ Infringing lipid
`
`particles. (Exhibit 15 at 20).
`
`58.
`
`Upon information and belief, Moderna has manufactured doses of its COVID-19
`
`Vaccine in the United States and has shipped those doses to o