DCT

2:25-cv-02471

Metronome LLC v. Irwin Naturals

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-02471, D. Nev., 12/12/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Nevada because Defendant is incorporated in Nevada, has an established place of business in the district, and has committed acts of infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s topical products infringe a patent related to formulations incorporating specific concentrations of cannabis-derived compounds for treating dermatological conditions.
  • Technical Context: The technology concerns the use of botanical drug products derived from Cannabis sativa or indica, specifically in topical preparations like creams and lotions for therapeutic use.
  • Key Procedural History: The complaint does not reference any prior litigation, licensing history, or post-grant proceedings involving the patent-in-suit.

Case Timeline

Date Event
2013-09-26 ’736 Patent Priority Date
2020-05-19 ’736 Patent Issue Date
2025-12-12 Complaint Filing Date

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

U.S. Patent No. 10,653,736 - "Topical treatments incorporating cannabis sp. derived botanical drug product"

  • Patent Identification: U.S. Patent No. 10,653,736, "Topical treatments incorporating cannabis sp. derived botanical drug product," issued May 19, 2020 (the "’736 Patent").

The Invention Explained

  • Problem Addressed: The patent background describes a need for topical cannabis-based formulations that utilize concentrations of active compounds like tetrahydrocannabinol (THC) and cannabidiol (CBD) that exceed the low levels found in legal non-drug products such as hemp oil, in order to treat dermatological and other diseases ( Compl. ¶¶7-8; ’736 Patent, col. 2:18-28).
  • The Patented Solution: The invention is a topical formulation containing a Cannabis-derived botanical drug product where the concentration of THC, CBD, or both is greater than two milligrams per kilogram. This formulation is intended to provide therapeutic benefits for skin conditions by delivering higher, targeted doses of these cannabinoids directly to the affected area (’736 Patent, Abstract; col. 2:50-55). The patent discloses various forms for the formulation, including creams, lotions, and ointments (’736 Patent, col. 3:40-42).
  • Technical Importance: The claimed invention sought to leverage the pharmacological activities of cannabinoids for topical dermatological treatments, distinct from their more widely known systemic, neuroprotective, or psychoactive applications (’736 Patent, col. 2:18-24).

Key Claims at a Glance

  • The complaint asserts infringement of "Exemplary '736 Patent Claims" identified in an exhibit not attached to the publicly filed complaint (Compl. ¶10). The patent contains one independent claim, Claim 1.
  • The essential elements of independent Claim 1 are:
    • A topical formulation,
    • consisting essentially of:
      • an extract of Cannabis sativa or Cannabis indica;
      • at least one compound selected from the group consisting of menthol, resorcinol, and phenol, present in an amount of at least 0.1 wt %;
    • wherein a concentration of at least one component selected from the group consisting of tetrahydrocannabinol and cannabidiol in the topical formulation is greater than 2 milligrams per kilogram, and
    • wherein the topical formulation is obtained by dispersing the extract in a water-in-oil emulsion, an oil-in-water emulsion, a wax-in-oil base, or an oil-in-wax base.

III. The Accused Instrumentality

Product Identification

  • The complaint identifies the accused instrumentalities as the "Exemplary Defendant Products" (Compl. ¶10).

Functionality and Market Context

  • The complaint does not name or describe any specific accused products. It alleges that the products are identified in charts that were incorporated by reference but not publicly filed with the complaint (Compl. ¶¶10, 15). The complaint does not provide sufficient detail for analysis of the functionality or market context of the accused products.

IV. Analysis of Infringement Allegations

The complaint alleges that infringement is detailed in claim charts provided in Exhibit 2 (Compl. ¶¶15-16). As this exhibit was not filed with the complaint, a claim chart summary cannot be constructed. The complaint’s narrative infringement theory is limited to the conclusory statement that "the Exemplary Defendant Products practice the technology claimed by the '736 Patent" and "satisfy all elements of the Exemplary '736 Patent Claims" (Compl. ¶¶11-12).

No probative visual evidence provided in complaint.

  • Identified Points of Contention: Based on the language of independent Claim 1 and the limited allegations, the infringement analysis raises several questions:
    • Scope Questions: Claim 1 uses the transitional phrase "consisting essentially of." A central question will be whether the accused products contain additional active or inactive ingredients that "materially affect the basic and novel characteristics of the claimed invention" (’736 Patent, col. 4:25-30), which could be a basis for a non-infringement argument.
    • Technical Questions: A key factual question will be whether the accused products contain a Cannabis sativa or indica "extract" with a THC or CBD concentration "greater than 2 milligrams per kilogram" as required by the claim. This will likely depend on documentary evidence and chemical analysis of the accused products obtained during discovery. Another question is whether the accused products meet the limitation requiring the extract to be dispersed in one of the four specified emulsion or base types.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of"

    • Context and Importance: This term sets the scope of the claimed formulation. Its construction is critical because if Defendant's products include other active ingredients not listed in the claim (e.g., other analgesics, anti-inflammatory agents), the infringement analysis will turn on whether those additional components materially alter the invention's fundamental characteristics.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides its own definition, stating the phrase "excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" (’736 Patent, col. 4:28-30). A party could argue this allows for the presence of many common topical ingredients (e.g., moisturizers, preservatives) that do not affect the core therapeutic function of the specified cannabinoids.
      • Evidence for a Narrower Interpretation: A party could argue that the "basic and novel characteristic" is the specific therapeutic effect derived only from the combination of the cannabis extract and the limited list of additional compounds (menthol, resorcinol, phenol). The presence of any other therapeutically active ingredient could be argued to materially alter this characteristic, thereby placing the product outside the claim scope.

  • The Term: "extract of Cannabis sativa or Cannabis indica"

    • Context and Importance: The definition of "extract" is central to determining if the accused products meet this limitation. Practitioners may focus on this term because the source and processing of the cannabinoid material (e.g., full-spectrum extract vs. isolated CBD/THC vs. synthetic cannabinoids) could be a point of dispute.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines the broader term "Cannabis derived biological drug product" to include a wide variety of preparations, such as oils pressed from seeds, powders, and extracts prepared using solvents, water, or CO2 (’736 Patent, col. 7:14-25). This broad definition could support an argument that many forms of cannabis-derived material qualify as an "extract."
      • Evidence for a Narrower Interpretation: The patent distinguishes between different cannabis products like "hemp oil," "hashish oil," and "hashish" (’736 Patent, col. 5:26, col. 6:11, col. 6:46). An argument could be made that the term "extract" as used in the claim implies a specific type of preparation, potentially excluding others like simple pressed hemp oil that might contain only trace amounts of cannabinoids.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induces infringement by distributing "product literature and website materials inducing end users and others to use its products in the customary and intended manner that infringes the '736 Patent" (Compl. ¶¶13-14).
  • Willful Infringement: The complaint alleges that Defendant has actual knowledge of its infringement at least from the service of the complaint and that its continued infringement is willful (Compl. ¶¶12-13). This appears to be a claim for post-filing willfulness.

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

The resolution of this case will likely depend on the answers to three central questions that are left open by the complaint's lack of specificity.

  1. A primary issue is one of factual pleading and proof: What specific products are accused of infringement, what are their precise formulations, and how does Plaintiff allege they meet each element of the asserted claims? The absence of the referenced claim charts in the public filing leaves the core of the infringement allegation unspecified.
  2. A key question of claim scope will be: What is the boundary of the phrase "consisting essentially of" in the context of a topical formulation? The court's construction of this term may determine whether the presence of additional active ingredients in Defendant's products provides a viable path to non-infringement.
  3. A dispositive evidentiary question will be one of quantitative analysis: Do the accused products, through reliable testing, demonstrate a concentration of THC or CBD "greater than 2 milligrams per kilogram" as strictly required by the claim language?