DCT

1:22-cv-00336

Alnylam Pharma Inc v. Pfizer Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00336, D. Del., 03/17/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendants are Delaware corporations.
  • Core Dispute: Plaintiff alleges that Defendant’s COMIRNATY® COVID-19 vaccine infringes a patent related to a specific class of cationic biodegradable lipids used to form lipid nanoparticles (LNPs) for delivering mRNA.
  • Technical Context: The technology involves lipid nanoparticles, a critical delivery vehicle for fragile RNA-based therapeutics that protects the active agent (mRNA) and facilitates its entry into human cells.
  • Key Procedural History: The asserted patent issued approximately one month before the complaint was filed. The complaint states that Plaintiff has a history of licensing its LNP technology. Notably, Plaintiff states that it does not seek injunctive relief against Defendants' use of the technology.

Case Timeline

Date Event
2011-12-07 '933 Patent Priority Date
2020-03-17 Pfizer & BioNTech announce collaboration to develop COVID-19 vaccine
2020-05-05 First doses of vaccine candidates administered in U.S. clinical trial
2020-07-27 Candidate BNT162b2 advanced into Phase 2/3 Study
2020-12-11 FDA grants Emergency Use Authorization (EUA) for ages 16 and older
2021-05-11 FDA grants EUA for ages 12 to 15
2021-08-23 FDA approves vaccine (COMIRNATY®) for ages 16 and over
2021-10-29 FDA grants EUA for ages 5 to 11
2021-12-16 FDA approves new formulation of COMIRNATY®
2022-02-15 U.S. Patent No. 11,246,933 Issues
2022-03-17 Complaint Filed

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

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

Issued February 15, 2022.

The Invention Explained

  • Problem Addressed: The patent addresses the long-standing challenge of delivering therapeutic nucleic acids, such as mRNA, into the body (Compl. ¶16). These molecules are fragile and susceptible to degradation, and their negative charge makes cellular uptake difficult. Early delivery systems using cationic lipids suffered from toxicity issues, particularly at the high doses required for effectiveness (Compl. ¶17; ’933 Patent, col. 1:35-55).
  • The Patented Solution: The patent discloses a class of novel cationic lipids designed to form lipid nanoparticles (LNPs). The key innovation is the inclusion of one or more “biodegradable groups,” such as an ester linkage, within the structure of the lipid’s hydrophobic tails (’933 Patent, Abstract; Compl. ¶23). These groups allow the LNP to remain stable long enough to deliver its RNA payload into a cell, after which the lipid is metabolized by enzymes in the body and safely eliminated, mitigating the toxicity seen in earlier, more stable LNP systems (Compl. ¶20; ’933 Patent, col. 23:35-42).
  • Technical Importance: Developing a delivery vehicle that is both potent enough to protect and deliver RNA and safe enough to be metabolized and cleared from the body was a critical breakthrough for the field of RNA therapeutics (Compl. ¶18, 20).

Key Claims at a Glance

  • The complaint asserts independent claim 18 and dependent claims 19, 21, 22, and 24-27 (Compl. ¶41).
  • Independent Claim 18 recites a cationic lipid with the following essential elements:
    • A primary group and two biodegradable hydrophobic tails.
    • The primary group comprises a head group and a central moiety, where the central moiety is a central carbon or nitrogen atom.
    • Each biodegradable hydrophobic tail contains a biodegradable group, specifically an ester linkage (-OC(O)- or -C(O)O-).
    • At least one tail has a terminal hydrophobic chain that is a branched alkyl, a specific formula (-R¹²-M¹-R¹³), and a total carbon atom content of 21 to 26.
    • In at least one tail, the biodegradable group is separated from a terminus of the tail by 6 to 12 carbon atoms.
    • The lipid has a pKa in the range of about 4 to about 11 and a logP of at least 10.1.

III. The Accused Instrumentality

Product Identification

The accused product is the Pfizer-BioNTech COVID-19 Vaccine, marketed under the tradename COMIRNATY® (Compl. ¶6, 35). The complaint identifies the specific infringing component as the cationic lipid ALC-0315, which has the chemical name ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (Compl. ¶2, 42).

Functionality and Market Context

  • ALC-0315 is alleged to be a "functional lipid" that is essential to the vaccine's function (Compl. ¶40). It is a structural component of the lipid nanoparticles that encapsulate, protect, and deliver the vaccine's active messenger RNA (mRNA) ingredient to human cells (Compl. ¶39-40). The complaint includes a quote attributed to Defendant Pfizer’s website stating, "Without these lipid nanoparticles, in fact, there could be no Pfizer-BioNTech mRNA vaccine" (Compl. ¶40).
  • The complaint alleges the COMIRNATY® vaccine is a major commercial product, citing a projection of $32 billion in worldwide revenue for 2022 (Compl. ¶38).

IV. Analysis of Infringement Allegations

The complaint alleges that the ALC-0315 lipid used in every dose of the COMIRNATY® vaccine meets every limitation of at least claim 18 of the ’933 patent (Compl. ¶41, 44). The complaint provides the chemical structure of ALC-0315 as visual evidence for its allegations (Compl. ¶43). While the complaint refers to a preliminary claim chart in an exhibit that was not filed with the complaint, the core allegations can be summarized based on the provided structure.

'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 ALC-0315, identified by its chemical name and structure, is alleged to be a cationic lipid used in the COMIRNATY® vaccine (Compl. ¶42). The provided structure depicts a molecule with a central amine group and two identical tail structures (Compl. ¶43). ¶41-43 col. 538:13-15
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 central moiety is a central carbon or nitrogen atom; The depicted chemical structure for ALC-0315 shows a central nitrogen atom (a tertiary amine) that serves as the central moiety, bonded to a head group and two hydrophobic tails (Compl. ¶43). ¶43 col. 538:16-22
each biodegradable hydrophobic tail independently has the formula ... wherein the biodegradable group is -OC(O)- or -C(O)O-; The ALC-0315 structure shows that each of the two tails contains an ester linkage (-C(O)O-), which the patent defines as a biodegradable group (Compl. ¶43). ¶43 col. 538:23-26
for at least one biodegradable hydrophobic tail, the terminal hydrophobic chain ... is a branched alkyl, ... and the biodegradable hydrophobic tail has the formula -R¹²-M¹-R¹³, ... and the total carbon atom content of the tail ... is 21 to 26; The complaint alleges this limitation is met by the ALC-0315 structure, which contains two identical tails derived from 2-hexyldecanoate and a hexane linker. The combination of the branched 16-carbon chain and the 6-carbon linker results in a total carbon count of 22 for the tail, which falls within the claimed range of 21 to 26 (Compl. ¶41-43). ¶41-43 col. 538:27-34
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 In the ALC-0315 structure, the ester group (the biodegradable group) is connected to the central nitrogen atom via a hexane-diyl linker, which contains 6 carbons. This configuration appears to meet the requirement that the biodegradable group is separated from a terminus of the tail by 6 to 12 carbons (Compl. ¶41-43). ¶41-43 col. 538:35-37
the lipid has a pKa in the range of about 4 to about 11 and a logP of at least 10.1. The complaint makes a blanket allegation that ALC-0315 meets all limitations of claim 18, but does not provide specific data or evidence for the pKa or logP values of ALC-0315 (Compl. ¶41). ¶41 col. 538:38, 536:3-9

Identified Points of Contention

  • Evidentiary Question: The complaint does not provide factual support, such as test results, for the allegation that the ALC-0315 lipid has a pKa and logP within the specific numerical ranges required by the claim. A central issue for the court may be whether Plaintiff can produce evidence to substantiate this element of its infringement theory.
  • Scope Question: The infringement analysis will depend on the interpretation of the "biodegradable hydrophobic tail" and its constituent parts. The parties may dispute how to count the carbon atoms in the complex structure of ALC-0315 to determine if it meets the "21 to 26" total carbon atom limitation, or how to define "a terminus of the hydrophobic tail" for the "6 to 12 carbon atoms" separation limitation.

V. Key Claim Terms for Construction

The Term: "biodegradable hydrophobic tail"

  • Context and Importance: This term is at the heart of the invention and the infringement claim. The specific structural characteristics of the tail—including its total carbon count, branching, and the location of the biodegradable group—are defined in multiple limitations of claim 18. The construction of this term and its sub-elements will be critical for determining whether the precise chemical structure of ALC-0315 falls within the scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides extensive lists and tables of suitable hydrophobic groups, suggesting that the term is meant to encompass a wide variety of chemical structures beyond the specific examples (’933 Patent, Table 1C, cols. 44-58).
    • Evidence for a Narrower Interpretation: A defendant may argue that the term must be construed in light of the patent's stated goal of creating lipids that are rapidly metabolized and cleared from the body (’933 Patent, col. 23:35-42). This could be used to argue that only structures with certain degradation profiles, as demonstrated in the patent's examples, are covered.

The Term: "a terminus of the hydrophobic tail"

  • Context and Importance: Claim 18 requires the biodegradable group to be separated from "a terminus" of the tail by 6 to 12 carbons. The interpretation of this term is crucial. Practitioners may focus on this term because its meaning determines the point from which the 6-12 carbon separation is measured.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Plaintiff may argue that "a terminus" could refer to either end of the tail structure, providing flexibility. For example, it could be the end that attaches to the central moiety or the free, distal end of the hydrocarbon chain.
    • Evidence for a Narrower Interpretation: Defendant may argue that, based on the patent's diagrams and chemical context, "the terminus" refers only to the distal end of the tail, furthest from the central moiety. The patent's general structural diagram (e.g., Formula VIII, col. 16) illustrates a central group with two tails extending outwards, which could support an interpretation where the terminus is the outward-facing end.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis alleged is that Defendants work in concert to develop, manufacture, and commercialize the vaccine, and that each Defendant acts with knowledge and specific intent that the other Defendant and downstream end-users will directly infringe the ’933 Patent by making, using, or selling the vaccine containing the accused ALC-0315 lipid (Compl. ¶49).
  • Willful Infringement: The complaint alleges that Defendants have had knowledge of the ’933 Patent "since at least as early as February 15, 2022, when the '933 Patent issued" (Compl. ¶46). However, the complaint does not contain a formal count for willful infringement or an explicit prayer for enhanced damages.

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

  • A core issue will be one of claim construction and chemical analysis: can the complex chemical structure of the accused ALC-0315 lipid, specifically its "(hexane-6,1-diyl)bis(2-hexyldecanoate)" component, be mapped to the precise structural and numerical limitations of the "biodegradable hydrophobic tail" as defined in claim 18? The resolution will likely depend on dueling expert testimony interpreting chemical nomenclature and the patent's language.
  • A key evidentiary question will be one of proof of physical properties: can Alnylam produce sufficient experimental evidence to demonstrate that the accused ALC-0315 lipid possesses a pKa and a logP value falling within the specific ranges recited in claim 18? The complaint currently asserts this as fact without providing underlying data.
  • A final question relates to damages and intent: given that the patent issued after the accused vaccine was already widely distributed, the litigation will likely explore the timeline of Defendants' knowledge of the patent and its claims. The fact that Plaintiff is seeking only monetary compensation and not an injunction suggests the central dispute will be over the calculation of a reasonable royalty for past and future use of the allegedly patented technology.