Metronome LLC v. Floyd's Of Leadville

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Floyd's of Leadville (CO)
  • Plaintiff’s Counsel: Rabicoff Law LLC
• Case Identification: 1:25-cv-00624, D. Colo., 02/26/2025
• Venue Allegations: Venue is asserted based on Defendant having an established place of business in the District of Colorado and having allegedly committed acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical products containing cannabis-derived compounds infringe a patent related to topical treatments for dermatological conditions.
• Technical Context: The technology relates to pharmaceutical and cosmetic formulations that use specific concentrations of cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), for topical application.
• Key Procedural History: The complaint does not reference any prior litigation, inter partes review (IPR) proceedings, or licensing history related to the patent-in-suit. The claim for willful infringement is based on knowledge of the patent gained from the filing of the instant complaint.

Case Timeline

Date	Event
2013-09-26	U.S. Patent No. 9,095,563 Priority Date (Provisional App.)
2015-08-04	U.S. Patent No. 9,095,563 Issued
2025-02-26	Complaint Filed

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

U.S. Patent No. 9,095,563 - Topical treatments incorporating Cannabis sp. derived botanical drug product

The Invention Explained

• Problem Addressed: The patent describes a need for new topical treatments for dermatological diseases that utilize the pharmacological properties of cannabis-derived compounds. It distinguishes itself from prior art focused on neuroprotective uses and from products limited by low THC concentrations, such as hemp oil, which may not provide the same therapeutic benefits ('563 Patent, col. 2:11-23).
• The Patented Solution: The invention is a topical formulation that includes a "Cannabis derived botanical drug product" where the concentration of key cannabinoids (THC, CBD, or both) is explicitly greater than 2 milligrams per kilogram (mg/kg) ('563 Patent, Abstract; col. 2:24-34). The patent discloses that this specific concentration threshold allows for "unexpected and highly beneficial treatments for a wide variety of diseases" beyond what was previously known, particularly for topical applications ('563 Patent, col. 2:20-23). The invention can be embodied in various forms, such as lotions, creams, and ointments ('563 Patent, col. 3:30-66).
• Technical Importance: The invention purports to provide a legal and technical framework for creating effective topical dermatological treatments by defining a minimum therapeutic concentration of cannabinoids, distinguishing them from hemp-based consumer products that are legally required to have very low or non-detectable THC levels ('563 Patent, col. 1:50-56; col. 2:15-23).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims," referring to them as the "Exemplary '563 Patent Claims," but does not specify which claims are asserted (Compl. ¶11). The patent contains three independent claims: 1, 11, and 21.
• Independent Claim 1:
  • A topical formulation consisting essentially of an extract of cannabis sativa or cannabis indicia
  • and at least one component selected from a specified group (including capsaicin, benzocaine, lidocaine, etc.)
  • present in an amount of at least 0.1 wt % in the topical formulation,
  • wherein the concentration of tetrahydrocannabinol in the topical formulation is greater than 2 milligrams per kilogram,
  • said topical formulation obtained by dispersing the extract in a specific base (e.g., a water-in-oil emulsion).
• The complaint reserves the right to assert infringement literally or under the doctrine of equivalents (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

The complaint does not identify any specific accused products by name. It refers generally to "Exemplary Defendant Products" that are identified in claim charts attached as Exhibit 2 (Compl. ¶11, ¶16). This exhibit was not provided with the complaint document.

Functionality and Market Context

The complaint alleges that Defendant makes, uses, sells, and imports products that infringe the '563 Patent (Compl. ¶11). The complaint does not provide sufficient detail for analysis of the specific formulation, features, or market context of the accused products. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint incorporates by reference claim charts contained in an external "Exhibit 2," which was not included with the filed complaint (Compl. ¶17). The complaint itself contains only conclusory allegations that the "Exemplary Defendant Products practice the technology claimed by the '563 Patent" and "satisfy all elements of the Exemplary '563 Patent Claims" (Compl. ¶16). Without access to the referenced claim charts or more detailed allegations in the body of the complaint, a tabular analysis of the infringement theory is not possible.

• Identified Points of Contention:
  • Evidentiary Question: A primary question will be whether Plaintiff can produce evidence, such as laboratory testing, to demonstrate that Defendant's products contain (1) an "extract of cannabis sativa or cannabis indicia," (2) one of the other required active ingredients (e.g., lidocaine, methyl salicylate), and (3) a THC and/or CBD concentration that exceeds the 2 mg/kg threshold as claimed ('563 Patent, col. 17:11-21).
  • Scope Questions: The independent claims use the transitional phrase "consisting essentially of." This raises the question of whether Defendant's products contain any unlisted ingredients that "materially affect the basic and novel characteristics" of the claimed invention, which the patent suggests is the topical treatment of dermatological diseases ('563 Patent, col. 4:13-20). The presence of other active or functional ingredients in the accused products could become a central point of dispute regarding the scope of the claims.

V. Key Claim Terms for Construction

• 1. The Term: "consisting essentially of" ('563 Patent, col. 17:11)

  • Context and Importance: This transitional phrase is a legal term of art that restricts the claim to the specified elements and any others that do not materially affect the "basic and novel characteristics" of the invention. Its construction will be critical in determining whether additional ingredients in the accused products, not listed in the claim, are sufficient to avoid infringement. Practitioners may focus on this term because the accused topical products could contain various stabilizers, fragrances, or even other active ingredients common in the cosmetics industry.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that only ingredients that interfere with the claimed therapeutic effect on dermatological conditions would be material. The patent's focus is on the concentration of THC/CBD for therapeutic effect, suggesting other common topical ingredients may be non-material ('563 Patent, col. 2:11-23).
    • Evidence for a Narrower Interpretation: The patent itself defines the term, stating it "limits the scope of the claim to the materials specified" and excludes those that "materially affect the basic and novel characteristics of the claimed invention" ('563 Patent, col. 4:13-20). A party could argue that any additional active pharmaceutical ingredient, by its nature, materially affects the product's characteristics, thereby placing it outside the claim scope.

• 2. The Term: "Cannabis derived botanical drug product" ('563 Patent, col. 2:45-46)

  • Context and Importance: This term defines the source and nature of the primary active ingredient. The dispute may turn on whether the specific cannabinoid source used by the Defendant falls within the patent's definition.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent provides a broad definition, including "oils pressed from the seeds; powders...; extracts...; hemp oil; hashish oil; hashish; and fractions of extracts or oils" ('563 Patent, col. 7:2-12). This inclusive list could support a broad reading covering many forms of cannabis derivatives.
    • Evidence for a Narrower Interpretation: The definition is qualified with the phrase "provided that at least one of THC and CBD is present in the Cannabis derived botanical drug product" ('563 Patent, col. 7:14-17). Furthermore, the patent repeatedly distinguishes its invention from low-THC "hemp oil" ('563 Patent, col. 1:38-40, col. 2:18-20), which could support an interpretation that excludes certain federally legal hemp derivatives, even if they meet the concentration threshold through fortification.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant distributes "product literature and website materials" that instruct and encourage end users to use the accused products in an infringing manner (Compl. ¶14).
• Willful Infringement: The basis for willfulness is alleged to have begun "at least since being served by this Complaint and corresponding claim charts" (Compl. ¶15). This is an allegation of post-suit willfulness, asserting that any continued infringement after receiving notice via the lawsuit is deliberate and egregious.

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

• A central issue will be one of claim scope: can a formulation "consisting essentially of" the claimed ingredients read on a commercial product that may contain numerous other cosmetic or therapeutic agents? The case will likely require a judicial determination of which, if any, unlisted ingredients "materially affect" the invention's properties.
• A key evidentiary question will be whether the Plaintiff can prove, through chemical analysis, that the Defendant's products meet the explicit quantitative limitations of the asserted claims—specifically, the concentration threshold of "greater than 2 milligrams per kilogram" for THC and/or CBD.
• Finally, the dispute may involve a definitional question regarding the accused ingredient source: does the specific cannabis derivative used in the Defendant's products qualify as the claimed "extract of cannabis sativa or cannabis indicia" as defined and distinguished from other materials within the patent?