DCT

1:22-cv-00925

Alnylam Pharma Inc v. Moderna Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00925, D. Del., 07/12/2022
  • Venue Allegations: Venue is asserted in the District of Delaware on the basis that all defendant entities are organized under the laws of the State of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s SPIKEVAX® COVID-19 Vaccine infringes a patent directed to a class of biodegradable cationic lipids used to form lipid nanoparticles (LNPs) for delivering nucleic acids.
  • Technical Context: The technology involves specialized lipid nanoparticles (LNPs) designed to safely and effectively encapsulate and deliver fragile RNA-based therapeutics, such as mRNA vaccines, into the body's cells while minimizing toxicity.
  • Key Procedural History: The complaint alleges that the parties engaged in business discussions regarding a potential license to the asserted technology, including entering a Mutual Confidentiality Agreement, in early 2014. The complaint notes that Plaintiff Alnylam does not seek injunctive relief. Plaintiff also alleges it notified Defendant of the published application corresponding to the patent-in-suit prior to its issuance.

Case Timeline

Date Event
2011-12-07 U.S. Patent No. 11,382,979 Priority Date
2012-02-02 Publication of a utility patent application disclosing the technology
2013-08-01 Publication of a utility patent application disclosing the technology
2014-02-07 Alnylam and Moderna enter into a Mutual Confidentiality Agreement
2014-04-28 Alnylam and Moderna meet to discuss Alnylam's LNP Technology
2014-09-30 Licensing discussions between Alnylam and Moderna concluded without an agreement
2019-12-01 Moderna allegedly begins development of its COVID-19 vaccine
2020-01-13 Moderna finalizes the mRNA sequence for its vaccine candidate
2020-02-07 First clinical batch of Moderna's vaccine candidate is completed
2020-03-16 First patient in Phase 1 clinical study is dosed
2020-04-27 Moderna files its Investigational New Drug (IND) application
2020-05-12 FDA grants Fast Track status to Moderna's vaccine candidate
2020-11-30 Moderna submits its Emergency Use Authorization (EUA) application to the FDA
2020-12-18 FDA grants EUA for Moderna's COVID-19 Vaccine
2022-01-31 Moderna receives full FDA approval for its vaccine, under the tradename SPIKEVAX®
2022-06-23 Alnylam notifies Moderna of the published patent application for the '979 Patent
2022-07-12 U.S. Patent No. 11382979 Issues
2022-07-12 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

  • Patent Identification: U.S. Patent No. 11,382,979 (“Biodegradable Lipids for the Delivery of Active Agents”), issued July 12, 2022 (the “’979 Patent”).

The Invention Explained

  • Problem Addressed: The patent addresses the long-standing challenge of delivering fragile therapeutic agents like RNA into target cells. Such delivery requires a carrier system, but early lipid-based systems suffered from toxicity, especially at the high doses needed for efficacy ('979 Patent, col. 1:26-2:17; Compl. ¶18).
  • The Patented Solution: The invention is a class of novel, synthetic cationic lipids containing biodegradable groups, such as ester groups. These lipids are formulated into lipid nanoparticles (LNPs) that encapsulate a nucleic acid (e.g., mRNA). The LNP protects the nucleic acid until it reaches the target cell, and the biodegradable nature of the lipid allows it to be safely metabolized and cleared from the body, thereby reducing toxicity ('979 Patent, Abstract; Compl. ¶21). The patent's specification explains that these lipids have one or more biodegradable groups located in the lipid moiety, which allows for faster elimination from the body following delivery of the active agent ('979 Patent, col. 2:1-9).
  • Technical Importance: The development of biodegradable lipids was a key step in making LNP delivery systems safe and effective enough for widespread human therapeutic use, including for mRNA vaccines (Compl. ¶1).

Key Claims at a Glance

  • The complaint asserts infringement of at least claims 1-3, 5-14, 18-20, and 22-30 (Compl. ¶47). The independent claims are 1 (a composition claim) and 18 (a method claim).
  • Independent Claim 1 (Composition):
    • A lipid particle comprising: (i) a nucleic acid; (ii) 35-65 mol% of a cationic lipid; (iii) 3-12 mol% distearoylphosphatidylcholine (DSPC); (iv) 15-45 mol% cholesterol; and (v) 0.5-10 mol% of a PEG-modified lipid.
    • The cationic lipid itself must comprise a head group, two hydrophobic tails, and a central moiety (carbon or nitrogen atom).
    • Each hydrophobic tail must have an ester group.
    • At least one hydrophobic tail must have specific structural characteristics, including a terminal branched alkyl chain with branching at the α-position relative to the ester group, a defined chemical formula, a total carbon atom content of 21 to 26, and a specified distance between the ester group and the tail's terminus.
  • Independent Claim 18 (Method):
    • A method for preparing a lipid particle mixture by mixing a first solution (organic solvent and lipids) with a second solution (nucleic acid and water).
    • The resulting lipid particle must comprise the same components and molar percentages as recited in claim 1.
    • The cationic lipid in the particle must meet the same structural requirements as recited in claim 1.
  • The complaint states that its identification of infringed claims is not intended to be limiting (Compl. ¶52).

III. The Accused Instrumentality

Product Identification

  • Defendant's mRNA COVID-19 Vaccine, marketed under the tradename SPIKEVAX® (Compl. ¶¶2, 39).

Functionality and Market Context

  • The accused product is an mRNA vaccine that uses a lipid nanoparticle (LNP) formulation to deliver its active ingredient (mRNA) into human cells (Compl. ¶2). The complaint alleges this LNP formulation is essential to the vaccine's efficacy and safety (Compl. ¶43).
  • The complaint alleges the LNP is composed of four specific lipids: the cationic lipid SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC] (Compl. ¶¶2, 48).
  • The complaint cites Defendant's public statements that its lipid system "is biodegradable, so it's a big competitive advantage for us" (Compl. ¶46). It also cites revenue of $17.7 billion in 2021 from sales of 807 million doses of the vaccine (Compl. ¶40).

IV. Analysis of Infringement Allegations

’979 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A lipid particle comprising: (i) a nucleic acid The SPIKEVAX® vaccine is a lipid particle containing mRNA as its active agent. ¶2 col. 493:43
(ii) 35-65 mol% of a cationic lipid The vaccine allegedly contains 50 mol% of the ionizable cationic lipid SM-102. ¶49 col. 493:44
(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC) The vaccine allegedly contains 10 mol% of a neutral lipid, identified as DSPC. ¶¶48, 49 col. 493:45
(iv) 15-45 mol% cholesterol The vaccine allegedly contains 38.5 mol% of cholesterol. ¶¶48, 49 col. 493:46
(v) 0.5-10 mol% of a PEG-modified lipid The vaccine allegedly contains 1.5 mol% of a PEGylated lipid (PEG 2000 DMG). ¶¶48, 49 col. 493:47-48
the cationic lipid comprises a head group, two hydrophobic tails, and a central moiety ... wherein (a) the central moiety is a central carbon or nitrogen atom The accused cationic lipid, SM-102, allegedly has a structure with a central nitrogen atom. The complaint provides a visual of this chemical structure. ¶50 col. 493:49-54
(b) each hydrophobic tail independently has the formula -(hydrophobic chain)-(ester group)-(hydrophobic chain)... The alleged structure of SM-102 contains two ester groups, each flanked by hydrocarbon chains, which the complaint alleges meets this limitation. ¶50 col. 493:55-58
(c) for at least one hydrophobic tail, (I) the terminal hydrophobic chain...is a branched alkyl, where the branching occurs at the α-position relative to the ester group The alleged structure of SM-102 contains a branched heptadecanyl group, which the complaint alleges meets the requirements for a branched alkyl tail. ¶50 col. 493:59-62

Identified Points of Contention

  • Scope Questions: A central dispute may arise over whether Moderna's specific lipid, SM-102, falls within the scope of the general chemical structures claimed in the ’979 Patent. This will require a detailed comparison of the SM-102 structure, as depicted in the complaint (Compl. ¶50), against each specific limitation of the Markush group defining the "cationic lipid" in Claim 1. For example, the court may need to determine if the specific side chains and branching in SM-102 meet the definitions of "branched alkyl" or the carbon counts required by the claim.
  • Technical Questions: The complaint's allegations regarding the precise molar ratios of the lipid components in the final vaccine product are made "upon information and belief" and cite an external exhibit (Compl. ¶49). A key factual question for the court will be what evidence exists to confirm that the commercially manufactured SPIKEVAX® product consistently contains these exact compositional ratios as required by the claims.

V. Key Claim Terms for Construction

  • The Term: "cationic lipid"

  • Context and Importance: This term is the core of the invention. The complaint alleges SM-102 is the infringing "cationic lipid" (Compl. ¶49). However, such lipids are often described in the field as "ionizable," meaning they are neutral at physiological pH but become positively charged (cationic) in the acidic environment of an endosome. The construction of "cationic lipid" will be critical to determining if it is broad enough to read on an ionizable lipid like SM-102.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses that the pKa of the lipid (the pH at which it becomes charged) can be modulated, and provides a range of preferred pKa values (e.g., from about 4 to about 7) ('979 Patent, col. 23:44-53). This may support an interpretation that the term includes lipids that are not permanently charged but become cationic under specific, biologically relevant conditions.
    • Evidence for a Narrower Interpretation: The patent defines the term as a lipid that "is preferably cationic at physiological pH" ('979 Patent, col. 379:10-13). A defendant could argue that this language, combined with the plain meaning of "cationic," requires the lipid to be positively charged at the body's normal pH, potentially excluding ionizable lipids that are neutral in the bloodstream.

  • The Term: "hydrophobic tail"

  • Context and Importance: Claim 1 defines the structure of the cationic lipid by reference to a "central moiety" and two "hydrophobic tails." How the SM-102 molecule is conceptually divided into these constituent parts will determine whether it meets the claim's structural limitations.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent provides numerous examples of chemical structures that fall within the scope of the invention, which could be used to argue for a flexible interpretation of how a molecule can be parsed into the claimed structural components ('979 Patent, cols. 37-372).
    • Evidence for a Narrower Interpretation: The patent includes a diagram explicitly breaking a representative lipid into a "Head Group," "Central Moiety," and two "Hydrophobic Groups" ('979 Patent, col. 37:10-28). A party could argue that this specific depiction limits how the term should be construed and applied to an accused structure like SM-102.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, stating that the Defendant entities work in concert and intend for distributors and end-users to use the infringing vaccine (Compl. ¶¶9, 56). The factual basis alleged is that Defendants' actions in manufacturing, marketing, and selling the vaccine cause others to directly infringe the patent with knowledge and specific intent (Compl. ¶56).
  • Willful Infringement: The complaint does not explicitly plead "willful infringement." However, it alleges facts that could support a later claim for enhanced damages. It alleges that Moderna had knowledge of Alnylam's LNP technology through licensing discussions as early as 2014 (Compl. ¶¶3, 28-31) and that Alnylam provided notice of the published patent application—containing claims identical to the issued patent—on June 23, 2022, weeks before the patent issued and the lawsuit was filed (Compl. ¶53).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of chemical scope and claim construction: can the term "cationic lipid," as defined and used in the ’979 Patent, be construed to cover Moderna's specific "ionizable" lipid, SM-102? The outcome will depend on whether the court adopts a broader definition inclusive of lipids that become cationic in specific environments or a narrower one requiring a positive charge at physiological pH.
  • A second central question will be one of evidentiary proof: what factual evidence will demonstrate that the final, mass-produced SPIKEVAX® vaccine contains the specific lipid composition—particularly the molar percentages and the precise chemical structure of the cationic lipid—required by the asserted claims?
  • Finally, the case may turn on the legal and factual implications of the parties' pre-suit history: how will the 2014 licensing discussions and Alnylam's alleged disclosure of its technology affect the analysis of infringement, particularly regarding any potential claims for enhanced damages based on pre-suit knowledge?