Metronome LLC v. Irwin Naturals

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (New Mexico)
  • Defendant: FitLife Brands, Inc. (Nevada)
  • Plaintiff’s Counsel: Private Wealth Law, Inc.
• Case Identification: 2:25-cv-02471, D. Nev., 01/27/2026
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is incorporated in Nevada, has an established place of business in the District of Nevada, and has allegedly committed acts of patent infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s unspecified topical products infringe a patent related to topical treatments incorporating cannabis-derived botanical products with specific concentrations of cannabinoids.
• Technical Context: The technology lies at the intersection of pharmaceuticals and cosmetics, concerning topical formulations that use cannabis extracts for treating dermatological conditions.
• Key Procedural History: The complaint is a First Amended Complaint. No other procedural history, such as prior litigation or administrative proceedings involving the patent-in-suit, is mentioned.

Case Timeline

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 (’736 Patent). Compl. ¶¶7-8

The Invention Explained

• Problem Addressed: The patent background notes a need for topical formulations using cannabis-derived products for dermatological treatment, distinguishing its approach from prior art focused on systemic administration or neuroprotective uses. ’736 Patent, col. 2:5-28 It suggests that prior compositions did not disclose topical formulations with tetrahydrocannabinol (THC) in amounts exceeding the compound's detection limit. ’736 Patent, col. 2:15-17
• The Patented Solution: The invention is a topical formulation containing a Cannabis-derived botanical drug product, such as an extract, where the concentration of THC and/or cannabidiol (CBD) is specifically greater than 2 milligrams per kilogram (2 ppm). ’736 Patent, Abstract The specification describes this concentration as exceeding commonly applied maximum levels for products like hemp oil, aiming to provide "unexpected and highly beneficial treatments" for various dermatological diseases. ’736 Patent, col. 2:25-28 These formulations can take various forms, including creams, lotions, and ointments. ’736 Patent, col. 10:33-39
• Technical Importance: The technology sought to harness the therapeutic potential of cannabinoids for skin conditions by using them topically at concentrations that may have been previously discouraged or legally restricted in some commercial contexts. ’736 Patent, col. 1:50-61

Key Claims at a Glance

• The complaint asserts infringement of "exemplary claims" identified in an unattached exhibit, but does not specify claim numbers in the body of the complaint. Compl. ¶¶8, 10 Independent claim 1 is representative of the invention.
• Essential elements of Independent Claim 1 include:
  • A topical formulation, consisting essentially of:
  • an extract of Cannabis sativa or Cannabis indica;
  • at least one compound selected from menthol, resorcinol, and phenol, present at a concentration of at least 0.1% by weight;
  • a concentration of at least one of THC or CBD that is greater than 2 milligrams per kilogram; and
  • the formulation being an emulsion or base (e.g., water-in-oil emulsion, oil-in-water emulsion). ’736 Patent, col. 16:1-17
• The complaint states that Defendant infringes "one or more claims," suggesting the right to assert additional dependent or independent claims is reserved. Compl. ¶10

III. The Accused Instrumentality

Product Identification

The complaint does not identify any accused products by name. It refers generally to "Exemplary Defendant Products" that are allegedly detailed in "charts incorporated into this Count." Compl. ¶¶7, 10 These charts, referenced as Exhibit 2, were not attached to the complaint provided for analysis. Compl. ¶16

Functionality and Market Context

The complaint does not provide sufficient detail for analysis of the accused products' specific functionality, ingredients, or market context, as this information is allegedly contained within the unattached Exhibit 2. Compl. ¶15

IV. Analysis of Infringement Allegations

The complaint references claim charts in an unattached Exhibit 2 to support its infringement allegations but does not provide them. Compl. ¶15 The narrative infringement theory alleges that Defendant’s "Exemplary Defendant Products" practice the technology claimed by the ’736 Patent and "satisfy all elements of the Exemplary ’736 Patent Claims." Compl. ¶15 The complaint alleges direct infringement through the making, using, selling, and importing of these products, including through internal testing by employees. Compl. ¶¶10-11 No probative visual evidence provided in complaint.

Identified Points of Contention

• Scope Questions: A central dispute may arise over the claim term "consisting essentially of." The question will be whether the accused products contain other active ingredients that materially alter the basic and novel characteristics of the claimed formulation, potentially placing them outside the scope of the claims. ’736 Patent, col. 4:25-31
• Technical Questions: The infringement analysis will depend on factual evidence. Key questions include:
  • What evidence does the complaint provide that the accused products contain an "extract of Cannabis sativa or Cannabis indica" as opposed to, for example, synthetic cannabinoids?
  • How can Plaintiff prove that the concentration of THC or CBD in the accused final products is "greater than 2 milligrams per kilogram" as required by the claim?
  • Do the accused products contain menthol, resorcinol, or phenol at the claimed concentration of at least 0.1 wt%?

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

• Context and Importance: This transitional phrase is narrower than "comprising" and limits the invention to the specified elements and any others that do not materially affect its "basic and novel characteristics." The case may turn on whether any additional active ingredients in Defendant's products are found to materially alter the formulation's properties, which could be a basis for a non-infringement defense.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that common excipients (e.g., stabilizers, fragrances, preservatives) do not materially affect the fundamental therapeutic properties of the claimed cannabinoid formulation and thus fall within the claim's scope.
  • Evidence for a Narrower Interpretation: The patent specification explicitly defines the term, stating it "excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention." ’736 Patent, col. 4:25-31 A party could argue that any additional pharmacologically active ingredient, such as a different anti-inflammatory agent, would materially affect the invention's characteristics.

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

• Context and Importance: Infringement is predicated on the presence of this specific ingredient. The construction of "extract" will determine whether the claims cover products made with synthetic cannabinoids or ingredients derived from processes that differ from those described in the patent.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification defines "Cannabis derived biological drug product" broadly to include oils pressed from seeds, powders from various plant parts, and extracts prepared using various methods, which may support a broad definition of "extract." ’736 Patent, col. 7:14-25
  • Evidence for a Narrower Interpretation: A party could argue for a narrower definition tied to the specific extraction methods mentioned in the patent, such as solvent extraction or CO2 extraction, to distinguish the accused product's composition. ’736 Patent, col. 6:30-46

VI. Other Allegations

Indirect Infringement

The complaint alleges inducement, asserting that Defendant distributes "product literature and website materials" that instruct and encourage end users to use the accused products in an infringing manner. Compl. ¶13 It further alleges that Defendant has had knowledge of infringement at least since being served with the complaint and has continued to induce infringement. Compl. ¶14

Willful Infringement

The complaint does not use the term "willful," but it alleges "Actual Knowledge of Infringement" arising from the service of the complaint. Compl. ¶12 It further alleges that Defendant continued its infringing activities "Despite such actual knowledge," which provides a basis for alleging post-filing willfulness. Compl. ¶13 No allegations of pre-suit knowledge are made.

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

• A primary issue will be one of evidentiary proof of composition: can the Plaintiff, through discovery and expert testing, demonstrate that the accused products meet every quantitative and qualitative limitation of an asserted claim, specifically the presence and concentration of the claimed cannabinoids and other required compounds (e.g., menthol)?
• A key legal question will be one of claim scope: will the phrase "consisting essentially of" be construed to exclude Defendant's products if they are found to contain additional active ingredients not explicitly recited in the claims?
• A threshold procedural question will be one of pleading sufficiency: does the complaint's failure to identify specific accused products or provide its referenced evidentiary exhibits meet the pleading standards of Federal Rules of Civil Procedure 8 and 12, or will it be subject to an early motion to dismiss?