DCT

1:22-cv-00924

Alnylam Pharma Inc v. Pfizer Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00924, D. Del., 07/12/2022
  • Venue Allegations: Venue is alleged to be proper for the U.S.-based Defendants as they are Delaware corporations, and for the German-based Defendants as they are not residents of the United States.
  • Core Dispute: Plaintiff alleges that Defendants’ COMIRNATY® COVID-19 Vaccine, which uses lipid nanoparticles (LNPs), infringes a patent related to specific biodegradable cationic lipids for delivering RNA-based active agents, and seeks monetary damages but not injunctive relief.
  • Technical Context: The technology concerns the design of lipid nanoparticles, a critical delivery vehicle for fragile therapeutic molecules like mRNA, engineered to be biodegradable to enhance safety and efficacy.
  • Key Procedural History: The patent-in-suit was issued on the same day the complaint was filed. The complaint notes that Plaintiff notified Defendants of the patent’s antecedent published application approximately three weeks prior to filing suit.

Case Timeline

Date Event
2011-12-07 Earliest Priority Date for ’979 Patent
2020-03-17 Defendants announce joint COVID-19 vaccine development plan
2020-07-27 BNT162b2 candidate advanced to Phase 2/3 study
2020-12-11 FDA grants Emergency Use Authorization for COVID-19 vaccine
2021-08-23 FDA grants full approval for COMIRNATY® vaccine
2022-06-23 Plaintiff notifies Defendants of published application for the ’979 Patent
2022-07-12 U.S. Patent No. 11,382,979 issues
2022-07-12 Complaint filed

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

U.S. Patent No. 11,382,979 - "Biodegradable Lipids for the Delivery of Active Agents"

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

The Invention Explained

  • Problem Addressed: The patent addresses the longstanding challenge of safely and effectively delivering fragile, negatively charged RNA therapeutics (such as mRNA) into human cells (Compl. ¶22). Early delivery systems using lipid nanoparticles (LNPs) suffered from toxicity, and subsequent improvements still involved lipids with long biological half-lives, creating a need for further optimization (Compl. ¶23-25; ’979 Patent, col. 2:48-56).
  • The Patented Solution: The invention describes a class of novel, synthetic cationic lipids designed with specific biodegradable groups, such as ester linkages, within their chemical structure. These lipids are formulated into LNPs that encapsulate an RNA-based active agent (’979 Patent, Abstract). The biodegradable nature allows the lipids to be metabolized and cleared from the body after delivering their payload, which is intended to reduce toxicity and improve the therapeutic window (Compl. ¶26; ’979 Patent, col. 34:33-40). The core structure of the lipid is defined by a head group, a central moiety, and two specifically configured hydrophobic tails (’979 Patent, col. 37:1-4).
  • Technical Importance: The development of biodegradable LNPs was a key step in enabling the safe and effective administration of RNA-based therapies, including mRNA vaccines, by balancing the need for a stable delivery vehicle with the requirement for eventual clearance from the body to avoid toxicity (Compl. ¶26).

Key Claims at a Glance

  • The complaint identifies independent claims 1 (a lipid particle composition) and 18 (a method of preparing the particle) as representative of the asserted claims (Compl. ¶30, 31).
  • Independent Claim 1 recites a lipid particle with five components and defines the structure of the key cationic lipid. Its essential elements include:
    • A nucleic acid.
    • Specific molar percentages of four lipid types: a cationic lipid (35-65%), DSPC (3-12%), cholesterol (15-45%), and a PEG-modified lipid (0.5-10%).
    • A cationic lipid comprising a head group, two hydrophobic tails, and a central moiety.
    • A specific chemical structure for at least one hydrophobic tail, defined by its formula, branching at a particular position, total carbon atom count (21 to 26), and the position of its ester group.
  • Independent Claim 18 recites a method for preparing the lipid particle of claim 1 by mixing a lipid-containing organic solution with an aqueous nucleic acid solution (Compl. ¶31).
  • The complaint alleges infringement of a broader set of claims (1-4, 7, 9-20, 23, and 25-30) and notes that its infringement contentions are not limited to the initially identified claims (Compl. ¶49, 54).

III. The Accused Instrumentality

Product Identification

  • The Pfizer-BioNTech COVID-19 Vaccine, marketed under the tradename COMIRNATY® (Compl. ¶3, 42).

Functionality and Market Context

  • The accused product is an mRNA vaccine that uses a lipid nanoparticle (LNP) delivery system to introduce genetic material (mRNA) encoding the SARS-CoV-2 spike protein into the body’s cells, prompting an immune response (Compl. ¶50). The complaint alleges the LNP is essential for protecting the fragile mRNA and facilitating its cellular uptake (Compl. ¶47).
  • The complaint asserts that the LNP in the COMIRNATY® vaccine contains four lipids: the cationic lipid ALC-0315, a PEG-modified lipid, DSPC, and cholesterol (Compl. ¶2, 51). The chemical structure of the accused cationic lipid, ALC-0315, is depicted in the complaint. This figure shows the molecule's head group, ester linkages, and two hydrophobic tails (Compl. ¶52).
  • The complaint emphasizes the commercial success of the vaccine, citing expectations of tens of billions of dollars in annual worldwide revenue (Compl. ¶45).

IV. Analysis of Infringement Allegations

The complaint alleges that the COMIRNATY® vaccine’s LNP formulation infringes the ’979 patent. While the complaint references a preliminary claim chart in an exhibit that was not provided with the filing, the body of the complaint contains the core allegations mapping the accused product to the elements of representative claim 1.

’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 COMIRNATY® vaccine contains "30 mcg of a nucleoside-modified messenger RNA (mRNA)," which is a nucleic acid. ¶50 col. 493:43
(ii) 35-65 mol% of a cationic lipid, The vaccine allegedly contains the cationic lipid ALC-0315 at a molar lipid ratio of 46.3%. ¶51 col. 493:44-45
(iii) 3-12 mol% distearoylphosphatidylcholine (DSPC), The vaccine allegedly contains DSPC (a neutral lipid) at a molar lipid ratio of 9.4%. ¶51 col. 493:46-47
(iv) 15-45 mol% cholesterol, and The vaccine allegedly contains cholesterol at a molar lipid ratio of 42.7%. ¶51 col. 493:48-49
(v) 0.5-10 mol% of a PEG-modified lipid, The vaccine allegedly contains a PEGylated lipid at a molar lipid ratio of 1.6%. ¶51 col. 493:50-51
the cationic lipid comprises a head group, two hydrophobic tails, and a central moiety... wherein... for at least one hydrophobic tail, (I) the terminal hydrophobic chain... is a branched alkyl... (II) the hydrophobic tail has the formula -R¹²-M¹-R¹³... (III) the total carbon atom content of the tail... is 21 to 26; and (IV) the ester group is separated from a terminus... by from 6 to 12 carbon atoms. The complaint alleges that the cationic lipid in the vaccine is ALC-0315 and provides its chemical structure, asserting that this lipid meets the specific structural limitations of the claim. ¶52 col. 493:56-494:42
  • Identified Points of Contention:
    • Scope Questions: The dispute may center on whether the specific chemical structure of ALC-0315 falls within the precise definition of "cationic lipid" recited in the claims. The analysis will require a detailed comparison of ALC-0315's structure against claim limitations such as the total carbon atom count in the hydrophobic tail (claimed as 21 to 26) and the exact location of the branching relative to the ester group.
    • Technical Questions: A factual question is whether the molar percentages of the lipids in the commercially produced COMIRNATY® vaccine consistently fall within the ranges required by the claim (e.g., 35-65% cationic lipid). The allegation of a 46.3% ratio for the cationic lipid is based on "information and belief" (Compl. ¶51), raising the question of what evidence will support this specific value across manufactured lots.

V. Key Claim Terms for Construction

  • The Term: "cationic lipid"

  • Context and Importance: The definition of this term is the crux of the infringement case. Infringement will depend entirely on whether the accused ALC-0315 compound is encompassed by the claim's multi-part structural definition of a "cationic lipid." Practitioners may focus on this term because the claims provide a detailed, limiting definition that may be narrower than the broader disclosures in the specification.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides extensive lists and Markush groups defining numerous possible head groups, central moieties, and hydrophobic tails, suggesting the inventors contemplated a wide genus of compounds (’979 Patent, col. 3-6, col. 37:34-40:65).
    • Evidence for a Narrower Interpretation: The independent claims import a very specific set of structural limitations into the definition (e.g., branched alkyl at the α-position, total carbon count of 21-26, etc.) (’979 Patent, col. 494:27-42). Defendants could argue these limitations operate as a specific definition that excludes any lipids, even those in the specification's examples, that do not meet every recited structural requirement.

  • The Term: "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"

  • Context and Importance: This limitation defines a precise structural feature of the claimed lipid. Whether the ALC-0315 lipid infringes will depend on a chemical analysis of its structure to determine if it has the required type and location of branching.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes many different types of hydrophobic tails, including a wide array of branched structures, potentially supporting an interpretation that is not overly rigid (’979 Patent, Table 1C).
    • Evidence for a Narrower Interpretation: The claim language is highly specific, tying the "branched alkyl" not just to a location ("terminal") but also to a specific chemical position ("α-position relative to the ester group"). This precision may be argued to exclude structures where branching occurs at other positions or where the terminal chain is not a branched alkyl.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendants act in concert with the knowledge and specific intent that other Defendants, distributors, and end users will directly infringe by making, using, and selling the COMIRNATY® vaccine (Compl. ¶58).
  • Willful Infringement: The complaint does not use the term "willful," but it lays a foundation for a potential future claim by alleging Defendants had knowledge of the patent as of its issue date, July 12, 2022, and were notified of the pre-issuance published application on June 23, 2022 (Compl. ¶55). This allegation of pre-suit knowledge may be used later to support a claim for enhanced damages based on post-filing conduct.

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

  • A core issue will be one of structural identity: Does the specific chemical structure of the ALC-0315 lipid, as used in the accused COMIRNATY® vaccine, meet every precise limitation required by the asserted claims, particularly with respect to the carbon count, branching, and positioning of the ester group in the hydrophobic tails?
  • A key evidentiary question will be one of compositional conformity: Can the Plaintiff demonstrate through discovery that the commercial-scale manufacturing of the COMIRNATY® vaccine consistently produces lipid nanoparticles with molar percentage ratios of its four lipid components that fall within the specific ranges recited in the asserted claims?