Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 1 of 15 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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`
`
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`PFIZER INC. and PHARMACIA &
`UPJOHN CO. LLC,
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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
`
`Co. LLC (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 recognized Alnylam’s inventive work,
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`issuing United States Patent No. 11,246,933 (the “’933 Patent”) that protects the Alnylam LNP
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`Technology. (Exhibit 1.)
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`2.
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` Defendants’ mRNA COVID-19 uses a cationic biodegradable lipid covered by
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`’933 Patent. Specifically, Defendants infringe Alnylam’s ’933 Patent through the use of ALC-
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`1
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 2 of 15 PageID #: 2
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`0315,1 a cationic biodegradable lipid formulated into LNPs that protect and deliver the vaccine’s
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`mRNA. Alnylam brings this action to recover monetary compensation for Defendants’
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`unlicensed use of Alnylam’s ’933 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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`3.
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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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`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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`4.
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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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`5.
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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
`
`
`1
` ALC-0315’s chemical name
`hexyldecanoate). (Exhibit 5 at 22.)
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`
`
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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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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 3 of 15 PageID #: 3
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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®2 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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`6.
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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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`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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`7.
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`On information and belief, Defendants Pfizer Inc. and Pharmacia & Upjohn Co.
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`LLC are agents of each other and/or work in concert with each other with respect to the
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`2 Defendants’ mRNA COVID-19 Vaccine is approved under the tradename COMIRNATY®.
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`3
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 4 of 15 PageID #: 4
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`development, regulatory approval, marketing, making, sales, offers for sale, import and export,
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`and distribution of Defendants’ COVID-19 Vaccine containing ALC-0315.
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`JURISDICTION AND VENUE
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`8.
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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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`9.
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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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`10.
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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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`11.
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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 ALC-0315, throughout the United States, including in this judicial
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`district.
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`12.
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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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`13.
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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, containing ALC-0315, throughout the United States,
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`including in this judicial district.
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`14.
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`Venue is proper in this Court under 28 U.S.C. § 1400(b) because Defendant Pfizer
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`Inc. is a Delaware corporation.
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`15.
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`Venue is proper in this Court under 28 U.S.C. § 1400(b) because Defendant
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`Pharmacia & Upjohn Co. LLC is a Delaware corporation.
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`4
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 5 of 15 PageID #: 5
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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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`16.
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`been known, but scientists have struggled for decades to translate the promise into successful
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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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`17.
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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 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, the lipids had to be positively charged (cationic) to create the protective bubble
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`around the RNA. Cationic lipids do not exist in nature, and therefore had to be synthesized. There
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`were toxicity issues with early attempts to use them in therapeutics due to the high dose of LNP
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`needed to be effective.
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`18.
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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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`19.
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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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`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.
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`5
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 6 of 15 PageID #: 6
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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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`B.
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`ALNYLAM’S BREAKTHROUGH BIODEGRADABLE LNP TECHNOLOGY FOR
`DELIVERY OF RNA TO CELLS
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`20.
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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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`21.
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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-two 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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`22.
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`On February 15, 2022, The United States Patent & Trademark Office issued the
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`’933 Patent, entitled “Biodegradable Lipids for the Delivery of Active Agents.” The ’933 Patent
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`issued to Alnylam as assignee of the named inventors Martin Maier, Muthusamy Jayaraman, Akin
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`Akinc, Shigeo Matsuda, Pachamuthu Kandasamy, Kallanthottathil G. Rajeev, and Muthiah
`
`Manoharan.
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`23.
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`The ’933 Patent claims a class of cationic biodegradable lipids that can be used in
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`the formation of LNPs for the delivery of an active agent, including mRNA. Each cationic lipid
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`contains one or more biodegradable group.
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`6
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`24.
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`Independent claim 18 of the ’933 Patent is representative and recites:
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`A cationic lipid comprising a primary group and two biodegradable
`hydrophobic tails, wherein
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`the primary group comprises (i) a head group that optionally comprises
`a primary, secondary, or tertiary amine, and (ii) a central moiety to which the head
`group and the two biodegradable hydrophobic tails are directly bonded;
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`the central moiety is a central carbon or nitrogen atom;
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`each biodegradable hydrophobic tail independently has the formula -
`(hydrophobic chain)(biodegradable group )-(hydrophobic chain), wherein the
`biodegradable group is -OC(O)- or -C(O)O-;
`
`terminal
`the
`tail,
`least one biodegradable hydrophobic
`for at
`hydrophobic chain in the biodegradable hydrophobic tail is a branched alkyl, where
`the branching occurs at the α-position relative to the biodegradable group and the
`biodegradable hydrophobic tail has the formula -R12-M1-R13, where R12 is a C4-C14
`alkylene or C4-C14 alkenylene, M1 is the biodegradable group, R13 is a branched
`C10-C20 alkyl, and the total carbon atom content of the tail -R12-M1-R13 is 21 to 26;
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`in at least one hydrophobic tail, the biodegradable group is separated
`from a terminus of the hydrophobic tail by from 6 to 12 carbon atoms; and
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`the lipid has a pKa in the range of about 4 to about 11 and a logP of at
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`least 10.1.
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`(Exhibit 1 at 538:13-38.)
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`25.
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`The ’933 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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`26.
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`DEFENDANTS’ COVID-19 VACCINE
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`On March 17, 2020, Defendant Pfizer Inc. and BioNTech SE (“BioNTech”)
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`announced a plan to jointly develop a COVID-19 vaccine. (Exhibit 9 at 2.) A redacted copy of
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`the Collaboration Agreement by and between Pfizer Inc. and BioNTech, dated March 17, 2020, is
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`publicly available. (Exhibit 10.) Under the Collaboration Agreement, Defendant Pfizer Inc. has
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`the sole right in the United States to “market, promote, distribute, offer for sale, sell, have sold,
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`import, have imported, export, have exported or otherwise commercialize” Defendants’ COVID-
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`7
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`19 Vaccine. (Exhibit 10, §1.25 (defining “Commercialize”); §1.6 (defining “BioNTech
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`Commercialization Territory”); §1.88 (defining “Pfizer Commercialization Territory”).) Under
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`the Collaboration Agreement, Defendant Pfizer Inc. has the right in the United States to “make,
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`produce, manufacture, process, fill, finish, package, label, perform quality assurance testing,
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`release, ship or store, and for the purposes of further manufacturing, distribute, import or export”
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`Defendants’ COVID-19 Vaccine or “any component
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`thereof.”
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` (Id., §1.75 (defining
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`“Manufacture”); §3.2 (“Licenses for Commercial Manufacturing”).)
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`27.
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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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`28.
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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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`29.
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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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`8
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`30.
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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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`31.
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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 BNT162b2,4 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 the infringing ALC-0315 cationic lipid.
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`32.
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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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`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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`33.
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`On December 11, 2020, the FDA authorized Defendants’ BNT162b2 candidate
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`with the infringing ALC-0315 cationic LNP (Defendants’ COVID-19 Vaccine) for emergency use
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`against COVID-19 in individuals 16 years of age or older. (Exhibit 16 at 1.) Upon information
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`and belief, every dose of Defendants’ COVID-19 Vaccine sold pursuant to this emergency use
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`authorization contains the infringing ALC-0315 cationic lipid. Albert Bourla, Chairman and Chief
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`Executive Officer of Pfizer said, “As a U.S. company, today’s news brings great pride and
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`tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to
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`4 Upon information and belief, BNT162b2 was the code name for Defendants’ mRNA COVID-19
`Vaccine during clinical trials. (Exhibit 5 at 21.)
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`9
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`help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible
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`possible, steadfast in our belief that science will win.” (Exhibit 16 at 1-2.)
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`34.
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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 ALC-0315 cationic lipid.
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`35.
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`On August 23, 2021, the FDA approved Defendants’ COVID-19 Vaccine under the
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`tradename COMIRNATY® for use in individuals sixteen and over. (Exhibit 18 at 1.) Upon
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`information and belief, every dose of Defendants’ COVID-19 Vaccine sold under the tradename
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`COMIRNATY® contains the infringing ALC-0315 cationic lipid.
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`36.
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`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
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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 ALC-0315 cationic lipid.
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`37.
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`Upon information and belief, on December 16, 2021, the FDA approved a new
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`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
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`information and belief, Defendants continue to market their prior COVID-19 Vaccine formulation
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`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
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`10
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`the tradename COMIRNATY® (gray cap and purple cap) 5 contains the infringing ALC-0315
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`cationic lipid.
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`38.
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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%
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`of the sales of Defendants’ COVID-19 Vaccine in 2021. (Id. at 35.)
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`E.
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`ALNYLAM’S PATENTED LNP TECHNOLOGY IS ESSENTIAL TO DEFENDANTS’
`COVID-19 VACCINE
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`39.
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`The patented Alnylam LNP Technology is essential to the efficacy and safety of
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`Defendants’ COVID-19 Vaccine. mRNA is very delicate and subject to rapid degradation by
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`various enzymes upon administration. (Exhibit 8 at 2.) The large, negatively-charged mRNA
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`strands also struggle to pass through the protective lipid membranes of cells. (Id.) Thus, to be
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`effective, the mRNA strands require a delivery mechanism that can ensure that the mRNA strands
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`are not degraded before delivery to the cell and can penetrate the cell. In addition, the LNP needs
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`to be biodegradable, i.e., such that the LNPs are metabolized and eliminated after successful
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`mRNA delivery to the cells, so as to enhance safety.
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`40.
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`Regarding these LNPs, Defendant Pfizer Inc.’s website states “[t]his tiny fat glob,
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`known as a functional lipid, is actually one of four lipids that make up the lipid nanoparticles that
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`go into the vaccine. Without these lipid nanoparticles, in fact, there could be no Pfizer-BioNTech
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`mRNA vaccine. That’s because mRNA, which is the genetic material that teaches our cells to make
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`the protein that will help our immune systems produce antibodies that helps to protect us from
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`COVID-19, is incredibly delicate.” (Exhibit 20 (emphasis added) at 2.)
`
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`5 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.)
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`11
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`DEFENDANTS’ INFRINGING ACTIVITIES
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`41.
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`On information and belief, Defendants and/or their end users employ in their
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`COVID-19 Vaccine ALC-0315, which meets every limitation of at least claims 18, 19, 21, 22, and
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`24-27 of the ’933 Patent.
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`42.
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`The Prescribing Information for COMIRNATY® states that each dose contains ((4-
`
`hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate). (Exhibit 4 at 15.) Upon
`
`information and belief, this document was prepared by Defendants and accepted by the FDA for
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`distribution to providers of Defendants’ COVID-19 Vaccine. Upon information and belief, 4-
`
`hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) is known as ALC-0315.
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`43.
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`Upon information and belief, ALC-0315 has the chemical structure depicted just
`
`below:
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`
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`(Exhibit 21 at 8.)
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`44.
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`Upon information and belief, ALC-0315 is in every dose of the COVID-19 Vaccine
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`that Defendants have made, offered for sale, and sold, and will continue to do so.
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`45.
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`Attached as Exhibit 2 is a preliminary claim chart describing Defendants’
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`infringement of claims 18, 19, 21, 22, and 24-27 of the ’933 Patent. Exhibits 4, 5, 21, 25, and 26
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`12
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 13 of 15 PageID #: 13
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`are supporting documents for the chart. The claim chart is not intended to limit Alnylam’s right
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`to modify the chart or allege that other activities of Defendants infringe the identified claim or any
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`other claims of the ’933 Patent or any other patents.
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`46.
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`Defendants have known of the ’933 Patent since at least as early as February 15,
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`2022, when the ’933 Patent issued.
`
`FIRST CAUSE OF ACTION
`(Infringement of the ’933 Patent)
`
`47.
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`Alnylam realleges and incorporates by reference the allegations contained in the
`
`foregoing paragraphs.
`
`48.
`
`On information and belief, Defendants have infringed and will continue to infringe
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`at least one of the asserted claims of the ’933 Patent, pursuant to 35 U.S.C. § 271(a), literally or
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`under the doctrine of equivalents, by making, using, selling, or offering to sell within the United
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`States or importing into the United States Defendants’ COVID-19 Vaccine containing ALC-0315
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`without authority.
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`49.
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`Defendants without authority have infringed and will continue to infringe at least
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`one of the asserted claims of the ’933 Patent pursuant to 35 U.S.C. § 271(b) by actively inducing
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`the making, using, selling, or offering for sale within the United States or importing into the United
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`States Defendants’ COVID-19 Vaccine containing ALC-0315. Each Defendant intends that the
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`other Defendant makes, uses, sells, offers to sell, distributes, exports, and/or imports Defendants’
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`COVID-19 Vaccine and/or its components comprising the infringing ALC-0315 biodegradable
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`lipid with the knowledge and specific intent that the other Defendant will directly infringe
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`Alnylam’s ’933 Patent. Defendants further intend that each end user, distributor, importer and/or
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`exporter make, use, sell, offer to sell, distribute, export, and/or import Defendants’ COVID-19
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`Vaccine and/or its components comprising the infringing ALC-0315 biodegradable lipid with the
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 14 of 15 PageID #: 14
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`knowledge and specific intent that such end user, distributor, importer, and/or exporter end-users
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`directly infringe Alnylam’s ’933 Patent.
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`50.
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`Defendants’ infringement has damaged and will continue to damage Alnylam,
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`which is entitled to recover the damages resulting from Defendants’ wrongful acts in an amount
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`to be determined at trial, and in any event no less than a reasonable royalty.
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`PRAYER FOR RELIEF
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`WHEREFORE, Alnylam prays for a judgment in its favor and against Defendants and
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`respectfully requests the following relief:
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`A.
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`B.
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`C.
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`A judgment that Defendants directly infringe the ’933 Patent;
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`A judgment that Defendants induce infringement of the ’933 Patent;
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`Damages or other monetary relief, including post-judgment monetary relief and
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`pre- and post-judgment interest;
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`D.
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`E.
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`Costs and expenses in this action; and
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`An order awarding Alnylam any such other relief as the Court may deem just and
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`proper under the circumstances, except that Alnylam does not seek any form of injunctive relief.
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`JURY DEMAND
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`Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure, Alnylam hereby demands
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`a jury trial as to all issues so triable.
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`Case 1:22-cv-00336-UNA Document 1 Filed 03/17/22 Page 15 of 15 PageID #: 15
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`MCDERMOTT WILL & EMERY LLP
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`
`/s/ Ethan H. Townsend
`Ethan H. Townsend (#5813)
`The Nemours Building
`1007 North Orange Street, 10th Floor
`Wilmington, DE 19801
`(302) 485-3910
`ehtownsend@mwe.com
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`Attorneys for Alnylam Pharmaceuticals, Inc.
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`OF COUNSEL:
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`William G. Gaede, III
`MCDERMOTT WILL & EMERY LLP
`415 Mission Street, Suite 5600
`San Francisco, CA 94105
`(650) 815-7400
`
`Sarah Chapin Columbia
`Sarah J. Fischer
`MCDERMOTT WILL & EMERY LLP
`200 Clarendon Street, Floor 58
`Boston, MA 02116-5021
`(617) 535-4000
`
`Ian B. Brooks
`MCDERMOTT WILL & EMERY LLP
`500 N. Capitol Street NW
`Washington, DC 20003
`(202) 756-8000
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`Dated: March 17, 2022
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`15
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