Case 1:22-cv-00924-UNA Document 1 Filed 07/12/22 Page 1 of 19 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ALNYLAM PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`)
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`COMPLAINT FOR PATENT INFRINGEMENT
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`C.A. No. __________________
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`JURY TRIAL DEMANDED
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`
`PFIZER INC., PHARMACIA & UPJOHN
`CO. LLC, BIONTECH SE, and BIONTECH
`MANUFACTURING GMBH,
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`
`
`Defendants.
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`
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`Plaintiff Alnylam Pharmaceuticals, Inc. (“Alnylam”), by its attorneys, alleges as follows
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`for its Complaint for Patent Infringement against Defendants Pfizer Inc. and Pharmacia & Upjohn
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`Co. LLC (collectively, “Pfizer”) and BioNTech SE and BioNTech Manufacturing GmbH
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`(collectively, “BioNTech”) (Pfizer and BioNTech collectively, “Defendants”).
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`NATURE OF THE ACTION
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`1.
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`Alnylam is a pioneering RNA therapeutics company based in Cambridge,
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`Massachusetts. Over a decade ago, Alnylam invented a breakthrough class of cationic
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`biodegradable lipids used to form lipid nanoparticles (“LNP”) that carry and safely deliver in the
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`body RNA-based therapeutics or vaccines (the “Alnylam LNP Technology”). The Alnylam LNP
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`Technology is foundational to the success of the recently-developed messenger RNA (“mRNA”)
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`based COVID vaccines. The United States Patent Office repeatedly recognized Alnylam’s
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`inventive work, including by issuing United States Patent No. 11,382,979 (the “’979 Patent”),
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`1
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`which is one of several patents that protects the Alnylam LNP Technology.1 (Exhibit 1.) The
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`’979 Patent issued from U.S. Application No. 17/644,907 (the “’907 Application). (Exhibit 1.)
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`2.
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` Defendants infringe Alnylam’s ’979 Patent through the use of Alnylam’s patented
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`LNPs that protect and deliver Defendants’ COVID-19 Vaccine’s mRNA. The “Defendants’
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`Infringing LNPs” comprise four lipids: ALC-0315 2 (a cationic biodegradable lipid), 2-
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`(polyethylene glycol 2000)-N,N-ditetradecylacetamide (a PEG-modified lipid), 1,2-distearoyl-sn-
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`glycero-3-phosphocholine (DSPC), and cholesterol.
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`3.
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`Alnylam brings this action to recover monetary compensation for Defendants’
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`unlicensed use of Alnylam’s ’979 Patent. Alnylam does not seek injunctive relief under 35 U.S.C.
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`§ 283 against such use.
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`THE PARTIES
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`4.
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`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
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`transform the lives of people living with diseases that have limited or inadequate treatment options.
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`Utilizing an earlier version of in-licensed LNP Technology, in 2018 Alnylam delivered the world’s
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`first approved RNAi therapeutic, ONPATTRO® (patisiran). ONPATTRO® is currently approved
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`for the treatment of polyneuropathy caused by an illness called hereditary ATTR (hATTR)
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`amyloidosis. Alnylam has developed an additional delivery modality distinct from LNP
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`1 The United States Patent Office also issued United States Patent No. 11,246,933 (the “’933
`Patent”) to Alnylam. (Exhibit 34.) The ’933 Patent protects other aspects of Alnylam LNP
`Technology.
`2
` ALC-0315’s chemical name
`hexyldecanoate). (Exhibit 5 at 22.)
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`is
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`((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-
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`2
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`Technology, termed GalNAc Delivery, which is utilized in three marketed products, GIVLAARI®
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`(givosiran), approved in 2019, and OXLUMO® (lumasiran), approved in 2020, both marketed by
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`Alnylam and LEQVIO® (inclisiran), approved in 2021, developed initially by Alnylam and
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`licensed to Novartis.
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`5.
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`Alnylam has a long history of licensing or offering to license to third parties its
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`intellectual property, including the Alnylam LNP Technology and the GalNAc Technology.
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`6.
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`Upon information and belief, Defendant Pfizer Inc. is a company organized and
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`existing under the laws of the State of Delaware with its principal place of business at 235 East
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`42nd Street, New York, New York 10017. The Biologic License Approval (“BLA”) Approval for
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`COMIRANTY® is addressed to Pfizer Inc., 235 East 42nd Street, New York, NY 10017. (Exhibit
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`3 at 1.) Upon information and belief, all regulatory correspondence regarding Defendants’
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`COVID-19 Vaccine is sent to Pfizer Inc.’s principal place of business. (Exhibit 3 at 1.) The
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`prescribing information for COMIRNATY®3 states it is “[m]anufactured by Pfizer Inc.” (Exhibit
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`4 at 20.) Upon information and belief, Defendant Pfizer Inc. maintains one or more facilities,
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`including in Kalamazoo, Michigan, under the name PfizerCentre One, as a subsidiary of Pfizer
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`Inc. and/or Defendant Pfizer Inc. is doing business as PfizerCentre One at one or more facilities,
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`including in Kalamazoo, Michigan. Upon information and belief, Pfizer Laboratories, a division
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`of Defendant Pfizer Inc., prepared the package insert for COMIRNATY® that was accepted by the
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`FDA. (Exhibit 7 at 19.) Upon information and belief, Defendant Pfizer Inc. recognizes the revenue
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`from sales of Defendants’ COVID-19 Vaccine. (Exhibit 6 at 1, 4, 5, 14, 27, 29, 33-36.)
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`7.
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`Upon information and belief, Defendant Pharmacia & Upjohn Co. LLC is a
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`company organized and existing under the laws of the State of Delaware with its principal place
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`3 Defendants’ mRNA COVID-19 Vaccine is approved under the tradename COMIRNATY®.
`3
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`of business at 100 Route 206 N, Peapack, New Jersey, 07977. Upon information and belief,
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`Defendant Pharmacia & Upjohn Co. LLC is a wholly-owned subsidiary of Defendant Pfizer Inc.
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`The BLA Approval Letter for COMIRNATY® states that, “[t]he final formulated product will be
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`manufactured, filled, labeled and packaged . . . at Pharmacia & Upjohn Company LLC, 7000
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`Portage Road, Kalamazoo, Michigan.” (Exhibit 3 at 1.)
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`8.
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`Upon information and belief, Defendant BioNTech SE is a company organized and
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`existing under the laws of Germany, with its principal place of business located at An der
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`Goldgrube 12 Mainz, 55131 Germany. Its shares are traded in the United States on the NASDAQ
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`under the symbol BNTX.
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`9.
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`Upon information and belief, Defendant BioNTech Manufacturing GmbH, is a
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`company organized and existing under the laws of Germany, with its principal place of business
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`located at An der Goldgrube 12 Mainz, 55131 Germany. Upon information and belief, Defendant
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`BioNTech Manufacturing GmbH is 100 % controlled by Defendant BioNTech SE. (Exhibit 27 at
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`F-29.) The prescribing information for COMIRANTY® states it is “[m]anufactured for BioNTech
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`Manufacturing GmbH” but is “[m]anufactured by Pfizer Inc.” (Exhibit 4 at 20.) The BLA
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`Approval for COMIRANTY® states that the FDA is “issuing Department of Health and Human
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`Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany.” (Exhibit
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`3 at 1.)
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`10.
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`On information and belief, Defendants Pfizer Inc., Pharmacia & Upjohn Co. LLC,
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`BioNTech SE, and BioNTech Manufacturing GmbH are agents of each other and/or work in
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`concert with each other with respect to the development, regulatory approval, marketing, making,
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`sales, offers for sale, import and export, and distribution of Defendants’ COVID-19 Vaccine
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`containing LNPs made with Defendants’ Infringing LNPs.
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`4
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`JURISDICTION AND VENUE
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`11.
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`This is an action for patent infringement arising under the patent laws of the United
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`States, 35 U.S.C. § 1, et seq.
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`12.
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`This Court has jurisdiction under 28 U.S.C. §§ 1331 and 1338(a) because this is a
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`civil action arising under the Patent Act.
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`13.
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`This Court has personal jurisdiction over Defendant Pfizer Inc. because it is a
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`Delaware corporation.
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`14.
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`This Court also has jurisdiction over Defendant Pfizer Inc. because, upon
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`information and belief, it directly or indirectly makes, uses, offers for sale, and/or sells Defendants’
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`COVID-19 Vaccine, containing LNPs made with Defendants’ Infringing LNPs, throughout the
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`United States, including in this judicial district.
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`15.
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`This Court has personal jurisdiction over Defendant Pharmacia & Upjohn Co. LLC
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`because it is a Delaware corporation.
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`16.
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`This Court also has jurisdiction over Defendant Pharmacia & Upjohn Co. LLC
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`because, upon information and belief, it directly or indirectly makes, uses, offers for sale, and/or
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`sells Defendants’ COVID-19 Vaccine, comprising Defendants’ Infringing LNPs, throughout the
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`United States, including in this judicial district.
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`17.
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`This Court has jurisdiction over Defendant BioNTech SE, upon information and
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`belief, because it directly or indirectly manufactures, uses, offers for sale, and/or sells Defendants’
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`COVID-19 Vaccine, containing Defendants’ Infringing LNPs, throughout the United States,
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`including in this judicial district. Further, BioNTech SE has consented to the personal jurisdiction
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`of the Court by appearing in a litigation filed by Alnylam against Pfizer in this judicial district and
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`filing a Counterclaim against Alnylam for a Declaratory Judgment of noninfringement and
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`5
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`invalidity, and thus has demonstrated a willingness to engage in litigation with respect to
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`Defendants’ COVID-19 Vaccine in this forum. See Alnylam Pharmaceuticals Inc. v. Pfizer Inc.,
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`C.A. No. 22-336-CFC (D. Del.), D.I. 13.
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`18.
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`This Court has jurisdiction over Defendant BioNTech Manufacturing GmbH, upon
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`information and belief, because it directly or indirectly, manufactures, uses, offers for sale, and/or
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`sells Defendants’ COVID-19 Vaccine, containing Defendants’ Infringing LNPs, throughout the
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`United States, including in this judicial district. Further, BioNTech SE has consented to the
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`personal jurisdiction of the Court by appearing in a litigation filed by Alnylam against Pfizer in
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`this judicial district and filing a Counterclaim against Alnylam for a Declaratory Judgment of
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`noninfringement and invalidity and thus has demonstrated a willingness to engage in litigation
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`with respect to Defendants’ COVID-19 Vaccine in this forum. See Alnylam Pharmaceuticals Inc.
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`v. Pfizer Inc., C.A. No. 22-336-CFC (D. Del.), D.I. 13.
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`19.
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`Venue is proper with respect to Defendant Pfizer in this Court under 28 U.S.C. §
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`1400(b) because Defendant Pfizer Inc. is a Delaware corporation.
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`20.
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`Venue is proper with respect to Defendant Pharmacia & Upjohn Co. LLC in this
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`Court under 28 U.S.C. § 1400(b) because Defendant Pharmacia & Upjohn Co. LLC is a Delaware
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`corporation.
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`21.
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`Venue is proper with respect to Defendant BioNTech SE and Defendant BioNTech
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`Manufacturing GmbH in this Court under 28 U.S.C. § 1391(c)(3) because Defendant BioNTech
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`SE and Defendant BioNTech Manufacturing GmbH are not residents of the United States.
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`BACKGROUND
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`RNA THERAPEUTICS
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`The promise of RNA-based therapeutics (including RNAi and mRNA) has long
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`A.
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`22.
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`been known, but scientists have struggled for decades to translate the promise into successful
`6
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`human therapeutics. The main challenge scientists around the world struggled with was how to
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`deliver the fragile, negatively charged RNA into the body’s cells in a safe, effective, and non-toxic
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`way. (Exhibit 8 at 1-2.)
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`23.
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`One approach was to develop a lipid4 system for use with RNA-based therapeutics.
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`These lipids would form a nanoparticle, called a Lipid Nanoparticle or LNP. The LNP would
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`encapsulate and protect the fragile RNA upon administration to the body so the RNA could be
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`delivered to the cells where the RNA would provide its therapeutic effect. Because the RNA is
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`negatively charged, certain of the lipids in the LNP had to be positively charged (cationic) to create
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`the protective bubble around the RNA. Cationic lipids do not exist in nature, and therefore had to
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`be synthesized. There were toxicity issues with early attempts to use them in therapeutics due to
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`the high dose of LNP needed to be effective.
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`24.
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`To harness the full promise and power of LNPs to deliver revolutionary RNA
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`therapies, scientists needed to develop a more potent LNP system that could safely and effectively
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`deliver the RNA to the target cells, and then be metabolized and eliminated from the body.
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`25.
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`Alnylam overcame some of the issues associated with earlier versions of LNPs
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`using an in-licensed LNP system containing the cationic lipid compound known as MC3, a highly
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`potent molecule. With MC3, Alnylam developed ONPATTRO®. MC3, while safe and effective,
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`is more stable in the body and thus has a relatively long half-life. Alnylam recognized the need
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`for further improvements in LNP technology and internally embarked on a research program to
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`develop a new class of lipids with improved properties.
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`4 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.
`7
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`B.
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`ALNYLAM’S BREAKTHROUGH BIODEGRADABLE LNP TECHNOLOGY FOR
`DELIVERY OF RNA TO CELLS
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`26.
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`Over a decade ago, Alnylam scientists solved these pressing issues by inventing a
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`new class of non-natural LNPs comprising a cationic lipid with biodegradable groups (i.e., the
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`Alnylam LNP Technology). LNPs with these biodegradable groups protect the RNA until delivery
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`to inside the cell, and then are metabolized and eliminated from the body ensuring no dose-limiting
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`toxicity. Alnylam’s seminal work to create these novel biodegradable LNPs has been employed
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`in potential RNA therapeutics in development and now mRNA-based vaccines.
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`C.
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`27.
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`THE PATENT-IN-SUIT
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`Alnylam filed a series of provisional and utility patent applications on its novel
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`cationic biodegradable lipids. Utility applications disclosing these novel cationic biodegradable
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`lipids published on February 2, 2012 and August 1, 2013. Twenty-three patents world-wide have
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`issued to Alnylam based on these groundbreaking inventions described in its provisional and utility
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`patent applications.
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`28.
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`On July 12, 2022, The United States Patent & Trademark Office issued the ’979
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`Patent, entitled “Biodegradable Lipids for the Delivery of Active Agents.” The ’979 Patent issued
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`to Alnylam as assignee of the named inventors Martin Maier, Muthusamy Jayaraman, Akin Akinc,
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`Shigeo Matsuda, Pachamuthu Kandasamy, Kallanthottathil G. Rajeev, and Muthiah Manoharan.
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`29.
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`The ’979 Patent claims a class of LNPs containing cationic biodegradable lipids,
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`distearoylphosphatidylcholine (DSPC), cholesterol, and a PEG-modified lipid for use in delivering
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`a nucleic acid, including mRNA.
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`30.
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`Independent claim 1 of the ’979 Patent is representative of the LNP composition
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`claims and recites:
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`A lipid particle comprising:
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`8
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`(i) a nucleic acid,
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`(ii) 35-65 mol% of a cationic lipid,
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`(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC),
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`(iv) 15-45 mol% cholesterol, and
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`(v) 0.5-10 mol% of a PEG-modified lipid,
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`
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`wherein the mol% is based on 100% total moles of lipids in the lipid particle; and
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`the cationic lipid 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
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`
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`(a) the central moiety is a central carbon or nitrogen atom;
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`(b) each hydrophobic tail independently has the formula -(hydrophobic chain)-
`(ester group)-(hydrophobic chain), wherein the ester group is -OC(O)- or -C(O)O-;
`and
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`(c) for at least one hydrophobic tail,
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`(I) the terminal hydrophobic chain in the hydrophobic tail is a branched
`alkyl, where the branching occurs at the α-position relative to the ester
`group;
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`(II) the hydrophobic tail has the formula -R12-M1-R13, wherein R12 is a C4-
`C14 alkylene or C4-C14 alkenylene, M1 is the ester group, and R13 is a
`branched C10-C20 alkyl;
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`(III) the total carbon atom content of the tail -R12-M1-R13 is 21 to 26; and
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`
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`(IV) the ester group is separated from a terminus of the hydrophobic tail by
`from 6 to 12 carbon atoms.
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`(Exhibit 1 at 493:41-494:42.)
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`31.
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`Independent claim 18 of the ’979 Patent is representative of the method of
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`manufacture claims and recites:
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`A method for preparing a lipid particle mixture comprising mixing a first solution
`comprising an organic solvent, a cationic lipid, distearoylphosphatidylcholine (DSPC),
`cholesterol, and a PEG-modified lipid, with a second solution comprising a nucleic acid
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`and water to form a mixture containing lipid particles, wherein each lipid particle
`comprises
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`(i) the nucleic acid,
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`(ii) 35-65 mol% of the cationic lipid,
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`(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC),
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`(iv) 15-45 mol% cholesterol, and
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`(v) 0.5-10 mol% of the PEG-modified lipid, and
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`wherein the mol% is based on 100% total moles of lipids in the lipid particle, and
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`the cationic lipid 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
`
`(a) the central moiety is a central carbon or nitrogen atom;
`
`(b) each hydrophobic tail independently has the formula -(hydrophobic chain)-
`(ester group)-(hydrophobic chain), wherein the ester group is -OC(O)- or -C(O)O-;
`and
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`(c) for at least one hydrophobic tail,
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`(I) the terminal hydrophobic chain in the hydrophobic tail is a branched
`alkyl, where the branching occurs at the α-position relative to the ester
`group;
`
`(II) the hydrophobic tail has the formula -R12-M1-R13, wherein R12 is a C4-
`C14 alkylene or C4-C14 alkenylene, M1 is the ester group, R13 is a branched
`C10-C20 alkyl;
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`(III) the total carbon atom content of the tail -R12-M1-R13 is 21 to 26; and
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`(IV) the ester group is separated from a terminus of the hydrophobic tail by
`from 6 to 12 carbon atoms.
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`(Exhibit 1 at 495:42-496:19.)
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`32.
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`The ’979 Patent has been owned by Alnylam at all times, is fully maintained, and
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`is valid and enforceable.
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`D.
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`33.
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`DEFENDANTS’ COVID-19 VACCINE
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`On March 17, 2020, Defendants Pfizer Inc. and BioNTech SE announced a plan to
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`jointly develop a COVID-19 vaccine. (Exhibit 9 at 2.) A redacted copy of the Collaboration
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`Agreement by and between Pfizer Inc. and BioNTech, dated March 17, 2020, is publicly available.
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`(Exhibit 10.) Under the Collaboration Agreement, Defendant Pfizer Inc. has the sole right in the
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`United States to “market, promote, distribute, offer for sale, sell, have sold, import, have imported,
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`export, have exported or otherwise commercialize” Defendants’ COVID-19 Vaccine. (Exhibit 10,
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`§1.25 (defining “Commercialize”); §1.6 (defining “BioNTech Commercialization Territory”);
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`§1.88 (defining “Pfizer Commercialization Territory”).) Under the Collaboration Agreement,
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`Defendant Pfizer Inc. has the right in the United States to “make, produce, manufacture, process,
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`fill, finish, package, label, perform quality assurance testing, release, ship or store, and for the
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`purposes of further manufacturing, distribute, import or export” Defendants’ COVID-19 Vaccine
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`or “any component thereof.” (Id., §1.75 (defining “Manufacture”); §3.2 (“Licenses for
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`Commercial Manufacturing”).)
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`34.
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`On April 9, 2020, Defendants provided additional details about this collaboration,
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`including that “BioNTech will contribute multiple mRNA vaccine candidates as part of its
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`BNT162 COVID-19 vaccine program” and that “Pfizer will contribute its leading global vaccine
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`clinical research and development, regulatory, manufacturing and distribution infrastructure and
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`capabilities.” (Exhibit 9 at 1.)
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`35.
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`On April 22, 2020, Defendants announced their first clinical trial in Germany of
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`four mRNA vaccine candidates. (Exhibit 11 at 1.) Each vaccine candidate used an LNP to deliver
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`the mRNA. (Id.)
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`36.
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`On May 5, 2020, Defendants announced that the first doses of Defendants’ four
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`vaccine candidates were administered to individuals in the United States as part of Defendants’
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`Phase 1/2 clinical trial. (Exhibit 12 at 1.) Defendants stated that “Pfizer plans to activate its
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`extensive manufacturing network and invest at risk in an effort to produce an approved COVID-
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`19 vaccine as quickly as possible for those most in need around the world . . . . Pfizer-owned sites
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`in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium, have been
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`identified as manufacturing centers for COVID-19 vaccine production, with more sites to be
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`selected.” (Id. at 2.)
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`37.
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`On July 13, 2020, Defendants announced that the FDA granted Fast Track
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`Designations to two of Defendants’ candidate vaccines. (Exhibit 13 at 1.) Peter Honig, Pfizer’s
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`Senior Vice President, Global Regulatory Affairs, commented “[w]e look forward to continue
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`working closely with the FDA throughout the clinical development of this program, Project
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`Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.” (Id. at 1-2.)
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`38.
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`On July 27, 2020, Defendants announced that they had advanced the “nucleoside-
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`modified messenger RNA (modRNA) candidate BNT162b2,5 which encodes an optimized SARS-
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`CoV-2 full-length spike glycoprotein, at a 30µg dose level in a 2 dose regimen into Phase 2/3
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`Study.” (Exhibit 14 at 1.) Upon information and belief, the vaccine that Defendants selected
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`contains Defendants’ Infringing LNPs.
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`39.
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`On November 18, 2020, Defendants announced that their Phase 3 clinical trial met
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`all primary efficacy endpoints. (Exhibit 15 at 1.) Defendants stated that “[f]our of Pfizer’s
`
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`5 Upon information and belief, BNT162b2 was the code name for Defendants’ mRNA COVID-19
`Vaccine during clinical trials. (Exhibit 5 at 21.)
`12
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`facilities are part of the manufacturing and supply chain; St. Louis, MO; Andover, MA; and
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`Kalamazoo, MI in the U.S.; and Puurs in Belgium.” (Id. at 2.)
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`40.
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`On December 11, 2020, the FDA authorized Defendants’ BNT162b2 candidate
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`with the infringing LNPs made from Defendnats’ Infringing LNPs (Defendants’ COVID-19
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`Vaccine) for emergency use against COVID-19 in individuals 16 years of age or older. (Exhibit
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`16 at 1.) Upon information and belief, every dose of Defendants’ COVID-19 Vaccine sold
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`pursuant to this emergency use authorization contains the infringing LNPs. Albert Bourla,
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`Chairman and Chief Executive Officer of Pfizer said, “[a]s a U.S. company, today’s news brings
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`great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has
`
`the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make
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`the impossible possible, steadfast in our belief that science will win.” (Exhibit 16 at 1-2.)
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`41.
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`On May 11, 2021, the FDA authorized Defendants’ COVID-19 Vaccine for
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`emergency use against COVID-19 in children ages twelve to fifteen. (Exhibit 17 at 1.) Upon
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`information and belief, every dose of Defendants’ COVID-19 Vaccine sold pursuant to this
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`emergency use authorization contains the infringing LNPs made with Defendants’ Infringing
`
`LNPs.
`
`42.
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`On August 23, 2021, the FDA approved Defendants’ COVID-19 Vaccine under the
`
`tradename COMIRNATY® for use in individuals sixteen and over. (Exhibit 18 at 1.) Upon
`
`information and belief, every dose of Defendants’ COVID-19 Vaccine sold under the tradename
`
`COMIRNATY® contains the infringing LNPs made with Defendants’ Infringing LNPs.
`
`43.
`
`On October 29, 2021, the FDA authorized Defendants’ COVID-19 Vaccine for
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`emergency use against COVID-19 in children ages five to eleven. (Exhibit 19 at 1.) Upon
`
`information and belief, every dose of Defendants’ COVID-19 Vaccine sold pursuant to this
`
`
`
`
`
`13
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`Case 1:22-cv-00924-UNA Document 1 Filed 07/12/22 Page 14 of 19 PageID #: 14
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`emergency use authorization contains the infringing LNPs made with Defendants’ Infringing
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`LNPs.
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`44.
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`Upon information and belief, on December 16, 2021, the FDA approved a new
`
`formulation of Defendants’ COVID-19 Vaccine under the tradename COMIRNATY® (gray cap)
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`in individuals sixteen and over. (Exhibit 22 at 1, Exhibit 23; see also Exhibit 4 at 1.) Upon
`
`information and belief, Defendants continue to market their prior COVID-19 Vaccine formulation
`
`under the tradename COMIRNATY® (purple cap) for use in individuals sixteen and over. (Exhibit
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`24 at 1.) Upon information and belief, every dose of Defendants’ COVID-19 Vaccine sold under
`
`the tradename COMIRNATY® (gray cap and purple cap)6 contains the infringing LNPs made with
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`Defendants’ Infringing LNPs.
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`45.
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`On February 8, 2022, Defendant Pfizer Inc. stated that it expected 2022 worldwide
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`revenue of $32,000,000,000 for Defendants’ COVID-19 Vaccine. (Exhibit 6 at 29.) Defendant
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`Pfizer Inc.’s reported revenues suggest that U.S. sales in 2021 accounted for approximately 21%
`
`of the sales of Defendants’ COVID-19 Vaccine in 2021. (Id. at 35.)
`
`46.
`
`Upon information and belief, Pfizer has manufactured doses of Defendants’
`
`COVID-19 Vaccine in the United States that it has shipped to other countries, including Mexico
`
`and Canada. (Exhibit 28) Upon information and belief, Pfizer exported those U.S.-made doses
`
`pursuant to agreements with the governments of Mexico and Canada. (Exhibits 29, 30.) An
`
`official from the Canadian government confirmed shipments of Defendants’ COVID-19 vaccine
`
`from Kalamazoo, Michigan to Canada. (Exhibit 31.) A White House COVID-19 advisor
`
`confirmed that Pfizer shipped U.S.-made doses of Defendants’ COVID-19 Vaccine to Mexico and
`
`
`6 The prescribing information for both versions state that Defendant Pfizer Inc. manufactures
`Defendants’ COVID-19 Vaccine. (Compare Exhibit 4 at 20 with Exhibit 24 at 22.)
`14
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`Case 1:22-cv-00924-UNA Document 1 Filed 07/12/22 Page 15 of 19 PageID #: 15
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`Canada. (Exhibit 31.) Upon information and belief, Pfizer has an agreement with the Canadian
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`government to provide Defendants’ COVID-19 Vaccine through at least 2024, including “[u]p to
`
`65 million for 2022, up to 60 million in 2023 and up to 60 million in 2024.” (Exhibit 30.)
`
`E.
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`ALNYLAM’S PATENTED LNP TECHNOLOGY IS ESSENTIAL TO DEFENDANTS’
`COVID-19 VACCINE
`
`47.
`
`The patented Alnylam LNP Technology is essential to the efficacy and safety of
`
`Defendants’ COVID-19 Vaccine. mRNA is very delicate and subject to rapid degradation by
`
`various enzymes upon administration. (Exhibit 8 at 2.) The large, negatively-charged mRNA
`
`strands also struggle to pass through the protective lipid membranes of cells. (Id.) Thus, to be
`
`effective, the mRNA strands require a delivery mechanism that can ensure that the mRNA strands
`
`are not degraded before delivery to the cell and can penetrate the cell. In addition, the LNP needs
`
`to be biodegradable, i.e., such that the LNPs are metabolized and eliminated after successful
`
`mRNA delivery to the cells, so as to enhance safety.
`
`48.
`
`Regarding these LNPs, Defendant Pfizer Inc.’s website states “[t]his tiny fat glob,
`
`known as a functional lipid, is actually one of four lipids that make up the lipid nanoparticles that
`
`go into the vaccine. Without these lipid nanoparticles, in fact, there could be no Pfizer-BioNTech
`
`mRNA vaccine. That’s because mRNA, which is the genetic material that teaches our cells to make
`
`the protein that will help our immune systems produce antibodies that helps to protect us from
`
`COVID-19, is incredibly delicate.” (Exhibit 20 (emphasis added) at 2.)
`
`DEFENDANTS’ INFRINGING ACTIVITIES
`
`49.
`
`On information and belief, Defendants and/or their end users employ in their
`
`COVID-19 Vaccine Defendants’ Infringing LNPs, which meets every limitation of at least claims
`
`1-4, 7, 9-20, 23, and 25-30 of the ’979 Patent.
`
`
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`15
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`Case 1:22-cv-00924-UNA Document 1 Filed 07/12/22 Page 16 of 19 PageID #: 16
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`50.
`
`The Prescribing Information for COMIRNATY® states that each dose contains “30
`
`mcg of a nucleoside-modified messenger RNA (mRNA)7 encoding the viral spike (S) glycoprotein
`
`of SARS-CoV-2.” (Exhibit 4 at 14). Upon information and belief, this document was prepared
`
`by Defendants and accepted by the FDA for distribution to providers of Defendants’ COVID-19
`
`Vaccine.
`
`51.
`
`The Prescribing Information for COMIRNATY® states that each dose contains the
`
`following
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`lipid mixture: “0.43 mg
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`((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-
`
`hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-
`
`distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol”. (Exhibit 4 at 15.) Upon
`
`information and belief, the lipids are in molar lipid ratio of 46.3:9.4:42.7:1.6 for the ionizable
`
`cationic lipid:neutral lipid:cholesterol:PEGylated lipid. (Exhibit 21 at 3.)
`
`52.
`
`Upon information and belief, 4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-
`
`hexyldecanoate) is known as ALC-0315. Upon information and belief, ALC-0315 has the
`
`chemical structure depicted just below:
`
`
`
`7 mRNA is a nucleic acid.
`
`
`
`
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`16
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`Case 1:22-cv-00924-UNA Document 1 Filed 07/12/22 Page 17 of 19 PageID #: 17
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`(Exhibit 21 at 8.)
`
`53.
`
`Upon information and belief, Defendants’ Infringing LNPs are in every dose of the
`
`COVID-19 Vaccine that Defendants have made, offered for sale, and sold, and will continue to do
`
`so. Upon information belief, Defendants’ Infringing LNPs are manufactured in a manner that uses
`
`the patented Alnylam methods.
`
`54.
`
`Attached as Exhibit 2 and incorporated herein is a preliminary claim chart
`
`describing Defendants’ infringement of claims 1-4, 7, 9-20, 23, and 25-30 of the ’979 Patent.
`
`Exhibits 4, 5, 21, 32, and 33 are supporting documents for the chart. The claim chart is not intended
`
`to limit Alnylam’s right to modify the chart or allege that other activities of Defendants infringe
`
`the identified claim or any other claims of the ’979 Patent or any other patents.
`
`55.
`
`Defendants have known of the ’979 Patent since at least as early as July 12, 2022,
`
`when the ’979 Patent issued. Alnylam notified Defendants of the published ’907 Application on
`
`June 23, 2022, which set forth the same claims as in the subsequently-issued ’979 Patent.
`
`FIRST CAUSE OF ACTION
`(Infringement of the ’979 Patent)
`Alnylam realleges and incorporates by reference the allegations contained in the
`
`56.
`
`foregoing paragraphs.
`
`57.
`
`On information and belief, Pfizer has infringed and will continue to infringe at least
`
`one of the asserted claims of the ’979 Patent, pursuant to 35 U.S.C. § 271(a), literally or under the
`
`doctrine of equivalents, by making, using, selling, or offering to sell within the United States or
`
`importing into the United States Defendants’ COVID-19 Vaccine containing Defendants’
`
`Infringing LNPs without authority.
`
`58.
`
`Defendants without authority have infringed and will continue to infringe at least
`
`one of the asserted claims of the ’979 Patent pursuant to 35 U.S.C. § 271(b) by actively inducing
`
`
`
`
`
`17
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`Case 1:22-cv-00924-UNA Document 1 Filed 07/12/22 Page 18 of 19 PageID #: 18
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`the making, using, selling, or offering for sale within the United States or importing into the United
`
`States Defendants’ COVID-19 Vaccine containing Defendants’ Infringing LNPs. Each Defendant
`
`intends that the other Defendant makes, uses, sells, offers to sell, distributes, exports, and/or
`
`imports Defendants’ COVID-19 Vacci