Metronome LLC v. Floyd's Of Leadville

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Valued Inc. f/k/a Floyd's of Leadville Inc. d/b/a Floyd's of Leadville (CO)
  • Plaintiff’s Counsel: Rabicoff Law LLC
• Case Identification: 1:25-cv-00624, D. Colo., 06/10/2025
• Venue Allegations: Plaintiff alleges venue is proper in the District of Colorado because Defendant has an established place of business in the District and has committed the alleged acts of infringement there.
• Core Dispute: Plaintiff alleges that Defendant’s unspecified topical products infringe a patent related to topical formulations containing specific concentrations of cannabis-derived compounds.
• Technical Context: The technology concerns topical preparations, such as creams and lotions, that incorporate botanical drug products derived from cannabis for treating dermatological conditions.
• Key Procedural History: The complaint does not mention any prior litigation, licensing history, or post-grant proceedings related to the patent-in-suit.

Case Timeline

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

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

• Patent Identification: U.S. Patent No. 9,095,563, "Topical treatments incorporating Cannabis sp. derived botanical drug product," issued August 4, 2015 (the "'563 Patent").

The Invention Explained

• Problem Addressed: The patent background describes a need for topical formulations that utilize cannabis-derived compounds at specific concentrations to treat dermatological and other diseases, distinguishing such formulations from prior art focused on neuroprotective uses or products with cannabinoid levels below certain legal thresholds ('563 Patent, col. 2:12-22).
• The Patented Solution: The invention provides a topical formulation containing a cannabis-derived botanical drug product where the concentration of tetrahydrocannabinol (THC), cannabidiol (CBD), or both, exceeds 2 milligrams per kilogram (mg/kg) ('563 Patent, Abstract; col. 2:27-34). The specification describes various forms for the formulation, including lotions, creams, and ointments, and explains that these concentrations can provide "unexpected and highly beneficial treatments" for various diseases ('563 Patent, col. 2:20-22).
• Technical Importance: The invention aims to leverage the known anti-inflammatory and analgesic properties of cannabinoids in a topical delivery system at concentrations purported to be therapeutically effective for skin conditions ('563 Patent, col. 1:41-44).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims" and "Exemplary '563 Patent Claims" but does not identify which specific claims are asserted (Compl. ¶¶11-12). Independent claim 1 is representative of the invention's core composition.
• 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 of active ingredients (e.g., capsaicin, benzocaine, hydrocortisone);
  • wherein the at least one component is present in an amount of at least 0.1 wt %;
  • wherein the concentration of tetrahydrocannabinol in the topical formulation is greater than 2 milligrams per kilogram;
  • and wherein the formulation is obtained by dispersing the extract in a specific type of base (e.g., water-in-oil emulsion, oil-in-wax base).
• The complaint does not explicitly reserve the right to assert dependent claims.

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 incorporated by reference from an exhibit that is not attached to the complaint (Compl. ¶11, ¶15).

Functionality and Market Context

The complaint does not provide sufficient detail for analysis of the functionality or market context of the accused products. It alleges only that Defendant makes, uses, sells, or imports infringing products (Compl. ¶11).

IV. Analysis of Infringement Allegations

The complaint alleges that "Exemplary Defendant Products" infringe "Exemplary '563 Patent Claims" and states that charts comparing the claims to the products are included in an "Exhibit 2" (Compl. ¶15). However, Exhibit 2 was not filed with the complaint. The pleading itself offers no specific factual allegations mapping claim elements to features of any accused product. The complaint therefore provides insufficient detail for a tabular analysis of the infringement allegations. The narrative infringement theory is limited to the conclusory statement that "the Exemplary Defendant Products practice the technology claimed by the '563 Patent" (Compl. ¶15).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

• Term: "consisting essentially of"

• Context and Importance: This transitional phrase is a term of art in patent law that is more limiting than "comprising" but less limiting than "consisting of." It permits the presence of unlisted ingredients that do not materially affect the basic and novel properties of the claimed invention. The construction of this term will be critical to determining whether any additional ingredients in Defendant's products—such as preservatives, fragrances, or other active compounds not listed in the claim—are sufficient to place the products outside the scope of the claims.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent itself uses the broader term "comprising" extensively when describing embodiments in the specification (e.g., '563 Patent, col. 2:45, "a topical formulation comprising a Cannabis derived botanical drug product"), which a party could argue suggests the patentees did not intend for the claims to be narrowly restricted.
  • Evidence for a Narrower Interpretation: The patentees explicitly chose "consisting essentially of" for the independent claims, a deliberate choice that distinguishes it from the specification's language. A party may argue this choice was intended to exclude other ingredients that have a therapeutic or functional effect, thereby narrowing the claim scope to only the listed components and immaterial additives.

• Term: "extract of cannabis sativa or cannabis indicia"

• Context and Importance: The definition of "extract" will determine what types of cannabis-derived materials fall within the claim scope. The dispute may center on the method of extraction (e.g., solvent extraction, CO2 extraction, pressing) and the resulting purity or composition of the material.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification defines the related term "Cannabis derived biological drug product" very broadly to include oils pressed from seeds, powders, and various types of extracts prepared using organic solvents, water, or liquid carbon dioxide ('563 Patent, col. 7:1-12). A party could argue "extract" should be read in light of this broad definition.
  • Evidence for a Narrower Interpretation: The term "extract" itself implies a process of separation or purification that goes beyond simply pressing seeds for oil (hemp oil) or grinding plant matter (powders). A party might argue that the term requires a specific type of chemical extraction process that yields a more concentrated product, as distinguished from other "biological drug products" listed in the specification.

VI. Other Allegations

• Indirect Infringement: The complaint does not contain any allegations of induced or contributory infringement.
• Willful Infringement: The complaint does not allege pre-suit knowledge. It alleges that the filing of the complaint itself provides "actual knowledge of infringement," forming the basis for ongoing infringement post-filing (Compl. ¶13-14). This suggests an argument for post-suit willfulness only.

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

• A central issue will be one of claim scope: how will the court construe the phrase "consisting essentially of"? The outcome will determine whether Defendant’s products, which may contain various unlisted active or inactive ingredients, fall within the patent's scope or are designed around it.
• A dispositive procedural question will be one of pleading sufficiency: does the complaint, which fails to identify any specific accused products or provide operative claim charts, meet the plausibility standard for patent infringement established by Twombly and Iqbal? The lack of factual detail may expose the complaint to a motion to dismiss for failure to state a claim.