DCT

1:22-cv-00335

Alnylam Pharma Inc v. Moderna Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00335, D. Del., 03/17/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because all Defendant entities are incorporated in Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s COVID-19 Vaccine (SPIKEVAX®), which contains the cationic lipid SM-102, infringes a patent covering a class of biodegradable lipids for forming lipid nanoparticles (LNPs) to deliver RNA-based active agents.
  • Technical Context: The technology involves specialized lipid molecules that form nanoparticles to encapsulate, protect, and deliver fragile messenger RNA (mRNA) into human cells, a foundational component of modern mRNA vaccines.
  • Key Procedural History: The complaint alleges that in 2014, the parties entered into a confidentiality agreement and held discussions regarding a potential license to Plaintiff's LNP technology, which included the patent family from which the patent-in-suit later issued. The discussions allegedly ended without a license agreement. Plaintiff explicitly states it does not seek injunctive relief.

Case Timeline

Date Event
2011-12-07 '933 Patent Priority Date
2014-02-07 Alnylam and Moderna enter Mutual Confidentiality Agreement
2014-04-28 Alnylam presents its LNP technology to Moderna
2014-09-30 Alleged end of licensing discussions between parties
2020-01-13 Moderna finalizes mRNA sequence for vaccine candidate
2020-02-07 First clinical batch of Moderna vaccine with SM-102 completed
2020-03-16 First patient dosed in Phase 1 clinical study
2020-04-27 Moderna files Investigational New Drug (IND) application for vaccine
2020-05-12 FDA grants Fast Track status to Moderna's vaccine candidate
2020-11-30 Moderna announces Phase 3 trial results for vaccine with SM-102
2020-12-18 FDA grants Emergency Use Authorization for Moderna's COVID-19 Vaccine
2022-01-31 FDA grants full approval for SPIKEVAX®
2022-02-15 U.S. Patent No. 11,246,933 issues
2022-03-17 Complaint for Patent Infringement filed

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

U.S. Patent No. 11,246,933 - "Biodegradable Lipids for the Delivery of Active Agents"

The Invention Explained

  • Problem Addressed: The patent’s background section describes the long-standing challenge of delivering therapeutic nucleic acids, such as RNA, into cells. These molecules are fragile and easily degraded by enzymes in the body, and early delivery systems using cationic lipids were often associated with significant toxicity at effective doses (Compl. ¶17; ’933 Patent, col. 1:30-55).
  • The Patented Solution: The invention is a novel class of cationic lipids designed with specific biodegradable groups (such as ester groups) integrated into their chemical structure (’933 Patent, Abstract). These groups are designed to be stable enough to protect the RNA payload until it reaches the target cell but can then be broken down (hydrolyzed) by the body's natural processes. This biodegradability is intended to allow the lipid components to be metabolized and eliminated, thereby reducing the toxicity associated with prior delivery technologies (’933 Patent, col. 2:1-4).
  • Technical Importance: The development of lipids that are both effective at delivery and biodegradable was a key step in making RNA-based therapeutics, including mRNA vaccines, safe and viable for widespread human use (Compl. ¶21).

Key Claims at a Glance

  • The complaint asserts independent claim 18 and dependent claims 20-22 and 24-27 (’933 Patent, col. 538:13-38; Compl. ¶44).
  • Independent Claim 18 recites a cationic lipid with the following essential elements:
    • A primary group comprising a head group (with an optional amine) and a central moiety (a carbon or nitrogen atom).
    • Two biodegradable hydrophobic tails bonded to the central moiety.
    • Each tail has a specific formula including a biodegradable group, defined as -OC(O)- or -C(O)O- (an ester group).
    • At least one tail has a defined structure with a branched alkyl terminal chain where branching occurs at the alpha (α) position relative to the biodegradable group, and the tail meets specific carbon chain length and total carbon count requirements (21 to 26 atoms).
    • In at least one tail, the biodegradable group is separated from the end of the tail by a specific distance (6 to 12 carbon atoms).
    • The lipid as a whole has a pKa value between approximately 4 and 11 and a logP value of at least 10.1.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Moderna's COVID-19 Vaccine, sold under the tradename SPIKEVAX®, and specifically the cationic lipid SM-102 used within that vaccine (Compl. ¶¶2, 38, 45).

Functionality and Market Context

SM-102 is a key component of the lipid nanoparticle (LNP) delivery system in Moderna's vaccine (Compl. ¶2). Its function is to form a protective particle that encapsulates the vaccine's mRNA active ingredient, protecting it from degradation and facilitating its entry into human cells (Compl. ¶40). The complaint alleges that the biodegradability of the lipid system is essential to the vaccine's safety and efficacy and that Moderna has publicly touted this feature as a "big competitive advantage" (Compl. ¶¶41, 43).

IV. Analysis of Infringement Allegations

The complaint alleges that the SM-102 lipid meets every limitation of at least claim 18 of the ’933 Patent (Compl. ¶44). The complaint provides a two-dimensional chemical structure diagram of the accused SM-102 lipid (Compl. ¶46). The following table summarizes how the features of SM-102, based on its provided structure and the complaint's allegations, may map to the elements of claim 18.

’933 Patent Infringement Allegations

Claim Element (from Independent Claim 18) Alleged Infringing Functionality Complaint Citation Patent Citation
A cationic lipid comprising a primary group and two biodegradable hydrophobic tails, wherein 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; The complaint alleges SM-102 is a cationic lipid whose structure includes a head group containing a tertiary amine and a central moiety to which the other components are bonded. ¶¶44, 46 col. 15:30-33
the central moiety is a central carbon or nitrogen atom; The complaint alleges the central moiety of SM-102 is a nitrogen atom. ¶¶44, 46 col. 15:32-33
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-; The complaint alleges SM-102 has two hydrophobic tails, each containing a biodegradable ester group (-C(O)O-). ¶¶44, 46 col. 32:16-19
for at least one biodegradable hydrophobic tail, the terminal hydrophobic chain...is a branched alkyl, where the branching occurs at the α-position...and the biodegradable hydrophobic tail has the formula -R¹²-M¹-R¹³, where R¹² is a C₄-C₁₄ alkylene...M¹ is the biodegradable group, R¹³ is a branched C₁₀-C₂₀ alkyl, and the total carbon atom content of the tail...is 21 to 26; The complaint alleges that the chemical structure of the tails of SM-102 satisfies the specific branching, formula, chain length, and total carbon count requirements. ¶¶44, 46 col. 538:19-29
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 The complaint alleges that in the structure of SM-102, the ester group in at least one tail is separated from the end of the tail by a number of carbon atoms that falls within the claimed range. ¶¶44, 46 col. 538:30-33
the lipid has a pKa in the range of about 4 to about 11 and a logP of at least 10.1. The complaint alleges that the SM-102 lipid possesses the claimed pKa and logP properties. ¶44 col. 23:40-45

Identified Points of Contention

  • Structural Questions: The core of the infringement dispute will involve a highly technical, element-by-element comparison of the SM-102 chemical structure against the specific structural and numerical limitations of claim 18. This raises questions such as: Do the carbon chains in SM-102's tails precisely match the "C₄-C₁₄ alkylene" and "branched C₁₀-C₂₀ alkyl" requirements? Does the total carbon count of the tail fall within the narrow "21 to 26" atom range? Does the branching of the alkyl chain occur at the precise "α-position" relative to the ester group as defined in the patent?
  • Property Questions: The claim requires specific physicochemical properties (pKa and logP). This raises the question of what evidence will be presented to verify the actual pKa and logP values of the SM-102 lipid and whether those values fall within the claimed ranges of "about 4 to about 11" and "at least 10.1," respectively. The interpretation of the word "about" may also become a point of contention.

V. Key Claim Terms for Construction

The Term: "biodegradable group"

  • Context and Importance: This term is central to the patent's inventive concept of creating lipids that can be safely cleared from the body. The definition is critical because infringement hinges on whether the ester linkages (-C(O)O-) in the accused SM-102 lipid qualify as the claimed "biodegradable group."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 18 itself provides an express definition, stating "the biodegradable group is -OC(O)- or -C(O)O-" (’933 Patent, col. 538:21-22). A party may argue that this explicit definition is controlling and that any chemical structure meeting this formula is sufficient.
    • Evidence for a Narrower Interpretation: The specification describes the functional purpose of this group, stating that it includes bonds that "undergo bond breaking reactions in a biological environment" and that the lipids are designed to be "metabolized by the body" to reduce toxicity (’933 Patent, col. 411:34-40). A party could argue that these functional properties should be used to narrow the term's scope, potentially requiring a certain rate or type of biodegradation in vivo.

The Term: "α-position relative to the biodegradable group"

  • Context and Importance: This term dictates a very specific point of chemical branching in at least one of the lipid tails, a key structural limitation of claim 18. Whether the SM-102 structure meets this limitation is a direct question of infringement. Practitioners may focus on this term because its interpretation requires a precise chemical analysis of the bond locations within the accused molecule.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that standard chemical nomenclature should apply, defining the "α-position" simply as the first carbon atom attached to the relevant functional group (the ester's carbonyl or oxygen).
    • Evidence for a Narrower Interpretation: The patent's detailed description and numerous chemical drawings of exemplary embodiments may be used to argue for a more specific structural context (’933 Patent, e.g., col. 18-24). If the examples consistently show a particular type of α-position branching, a party could argue that this context limits the claim term to those specific configurations.

VI. Other Allegations

Indirect Infringement

The complaint alleges active inducement under 35 U.S.C. § 271(b), stating that the Defendant entities act in concert and intend for each other, as well as distributors and end-users, to directly infringe by making, using, and selling the COVID-19 vaccine containing the SM-102 lipid (Compl. ¶52).

Willful Infringement

While not pleaded as a separate cause of action, the complaint alleges facts that may be used to support a claim for willful infringement. It alleges that Moderna has known of the '933 Patent since its issue date of February 15, 2022 (Compl. ¶49). It also alleges that Moderna was aware of the pending patent applications from which the '933 Patent would issue as early as 2014, when the parties allegedly engaged in licensing discussions and Alnylam disclosed its confidential LNP technology (Compl. ¶¶27-30).

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

  • A core issue will be one of structural mapping: Does the accused SM-102 lipid, as a matter of chemical fact, satisfy every specific structural and numerical limitation of claim 18, including the precise carbon counts, chain lengths, and the "α-position" of the branching in its hydrophobic tails?
  • A second central question will be one of property verification: What is the factual evidence for the physicochemical properties (pKa and logP) of the SM-102 lipid, and how will the parties and the court interpret the claimed ranges, particularly the term "about"?
  • Finally, a key issue related to damages will be the relevance of the alleged history: Given the 2014 licensing discussions and allegations of confidential disclosure, a significant question for determining a reasonable royalty will be what knowledge and intent can be established and at what point in time.