Metronome LLC v. Bioserene Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Bioserene, Inc. (FL)
  • Plaintiff’s Counsel: Beusse Sanks, PLLC; Rabicoff Law LLC
• Case Identification: 1:25-cv-23170, S.D. Fla., 07/16/2025
• Venue Allegations: Venue is alleged to be proper based on Defendant having an established place of business in the district and committing acts of infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical botanical products infringe a patent related to formulations containing specific concentrations of cannabis-derived compounds.
• Technical Context: The technology relates to pharmaceutical and cosmetic topical formulations, such as lotions and creams, that incorporate cannabinoids like tetrahydrocannabinol (THC) and cannabidiol (CBD) for treating dermatological conditions.
• Key Procedural History: The complaint does not mention any prior litigation, licensing history, or administrative proceedings related to the patent-in-suit.

Case Timeline

Date	Event
2013-09-26	Priority Date ('736 Patent)
2020-05-19	Issue Date ('736 Patent)
2025-07-16	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 Invention Explained

• Problem Addressed: The patent describes a need for new topical treatments that utilize the pharmacological properties of cannabinoids beyond their use as antioxidants or neuroprotectants, particularly in concentrations exceeding the low, legally-defined limits for products like hemp oil (’736 Patent, col. 2:18-28). The background notes that while cannabinoids have diverse reported activities, their medical use has been discouraged, and existing products often have THC levels below detection limits or within very low legal thresholds (e.g., 4-10 ppm) (’736 Patent, col. 2:50-62).
• The Patented Solution: The invention provides topical formulations comprising a "Cannabis derived botanical drug product" where the concentration of THC, CBD, or both is specifically greater than 2 milligrams per kilogram (mg/kg) (’736 Patent, col. 2:31-36). The patent explains that these formulations can take various forms, including lotions, creams, and ointments, and can be used to treat dermatological diseases like psoriasis (’736 Patent, col. 2:41-47).
• Technical Importance: The invention purports to provide effective dermatological treatments by using cannabinoid concentrations that exceed the common industrial and foodstuff limits, harnessing therapeutic benefits that were previously unexplored in topical applications due to regulatory constraints (’736 Patent, col. 2:22-28).

Key Claims at a Glance

• The complaint asserts "one or more claims" without specifying which ones (Compl. ¶11). The patent contains one independent claim, Claim 1.
• Independent Claim 1: The essential elements 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.
• The complaint does not explicitly reserve the right to assert dependent claims but refers generally to infringement of the "’736 Patent" (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

• The complaint does not identify any specific products by name, referring only to "Exemplary Defendant Products" (Compl. ¶11).

Functionality and Market Context

• The complaint alleges that the accused products "practice the technology claimed by the '736 Patent" but provides no specific details about their formulation, ingredients, or function (Compl. ¶16). It states that Defendant makes, uses, sells, and markets these products in the United States (Compl. ¶11, ¶14). The complaint also alleges Defendant distributes "product literature and website materials" to end users (Compl. ¶14). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the infringement theory is detailed in claim charts attached as Exhibit 2 (Compl. ¶16). As this exhibit was not provided with the complaint, a detailed element-by-element analysis is not possible.

The narrative infringement theory is that Defendant's "Exemplary Defendant Products" directly infringe one or more claims of the ’736 Patent because they "satisfy all elements of the Exemplary '736 Patent Claims" (Compl. ¶16). The complaint alleges infringement by making, using, testing, selling, and importing the accused products (Compl. ¶11, ¶12). The complaint does not provide specific factual allegations in the body of the complaint mapping claim elements to features of the accused products.

• Identified Points of Contention:
  • Scope Questions: A central question will be whether the accused products meet the negative limitation implied by the "consisting essentially of" language in Claim 1, which excludes other ingredients that would materially affect the basic and novel properties of the invention. The composition of the accused products will be critical.
  • Technical Questions: A key factual question will be whether the accused products contain an "extract of Cannabis sativa or Cannabis indica" and whether the concentrations of THC and/or CBD are verifiably "greater than 2 milligrams per kilogram" as required by the claim (’736 Patent, col. 16:11-14). Another factual dispute may arise over whether the accused products contain at least 0.1 wt % of menthol, resorcinol, or phenol, and are formulated as one of the specific emulsion or base types recited in the claim (’736 Patent, col. 16:7-10, 16:15-18).

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

  • Context and Importance: This transitional phrase appears in the preamble of Claim 1 and governs the entire composition. Its construction is critical because it limits the scope of the claim to the listed ingredients (the extract, the specified compound, and the emulsion/base) and unlisted ingredients that do not materially affect the "basic and novel characteristics" of the invention. Practitioners may focus on this term because the case could turn on whether any additional components in Defendant's products (e.g., other active ingredients, preservatives, fragrances) are found to materially alter the formulation's properties.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not explicitly define the "basic and novel characteristics." A party might argue this refers only to the core function of delivering a specific dose (>2 mg/kg) of cannabinoids in a topical base, allowing for a wide range of other conventional cosmetic or pharmaceutical ingredients.
    • Evidence for a Narrower Interpretation: The specification distinguishes the invention from prior art based on the specific use of cannabinoids for dermatological treatment at concentrations higher than those in products like hemp oil (’736 Patent, col. 2:18-28). A party could argue that any additional active ingredient that provides a separate, material therapeutic effect (e.g., a different anti-inflammatory agent) would materially alter the invention's characteristics, thereby placing a product containing it outside the claim's scope. The patent’s detailed description of adding other specific agents like steroids or antibiotics in separate embodiments may suggest these are not part of the "basic" invention of Claim 1 (’736 Patent, col. 3:1-12, col. 8:36-56).

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

  • Context and Importance: This term defines the source of the active cannabinoid ingredients. The nature and method of producing the "extract" could be a point of dispute. Infringement will depend on whether Defendant's cannabinoid source qualifies as an "extract" as understood in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent defines "Cannabis derived biological drug product" very broadly to include oils, powders, and extracts prepared using various methods, including organic solvents, water, and carbon dioxide extraction (’736 Patent, col. 7:14-26). This broad definition could support an interpretation that covers nearly any processed material derived from the cannabis plant containing cannabinoids.
    • Evidence for a Narrower Interpretation: A party might argue that the term "extract" implies a specific level of processing or purification that distinguishes it from, for example, simple pressed hemp oil or synthetically derived cannabinoids. The patent distinguishes between "oils pressed from the seeds" and "extracts prepared from the various parts" (’736 Patent, col. 7:16-19), suggesting "extract" may not cover all possible cannabis-derived oils.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that since the filing of the complaint, Defendant has acted with knowledge by selling its products to customers and distributing "product literature and website materials" that instruct end users on how to use the products in an infringing manner (Compl. ¶14, ¶15).
• Willful Infringement: The willfulness allegation is based on post-suit conduct. The complaint alleges that Defendant gained "Actual Knowledge of Infringement" upon service of the complaint and that its continued infringement thereafter is willful (Compl. ¶13, ¶14).

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

The resolution of this case will likely depend on the answers to two primary questions:

1. A core issue will be one of claim scope: can the phrase "consisting essentially of" be interpreted to read on Defendant's products if they contain additional active or functional ingredients beyond the cannabis extract and the limited set of other compounds recited in Claim 1? The presence of other common cosmetic or therapeutic agents in the accused products could be dispositive.

2. A key evidentiary question will be one of factual compliance: does the evidence show that the accused products are in fact formulated with "an extract" of cannabis (as opposed to, for example, synthetic cannabinoids) and, crucially, that the concentration of THC and/or CBD meets the "greater than 2 milligrams per kilogram" threshold required by the patent?