Metronome LLC v. Sunflora Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (Minnesota)
  • Defendant: Sunflora, Inc. (Florida)
  • Plaintiff’s Counsel: Beusse Sanks, PLLC; Rabicoff Law LLC
• Case Identification: 8:25-cv-01846, M.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 alleged acts of infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical cannabis products infringe a patent related to formulations containing specific concentrations of cannabinoids for treating dermatological conditions.
• Technical Context: The technology involves topical preparations, such as creams and lotions, that incorporate cannabis-derived extracts with specified minimum concentrations of active ingredients like tetrahydrocannabinol (THC) and cannabidiol (CBD).
• Key Procedural History: The complaint does not mention prior litigation or post-grant proceedings. The asserted patent claims priority to a chain of applications originating with a provisional application filed in 2013, which may be relevant to assessing prior art.

Case Timeline

Date	Event
2013-09-26	'736 Patent Priority Date
2019-01-25	'736 Patent Application Filing Date
2020-05-19	'736 Patent Issue Date
2025-07-16	Complaint Filing Date

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

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

The Invention Explained

• Problem Addressed: The patent identifies a need for topical formulations that utilize the therapeutic potential of cannabis-derived compounds for dermatological diseases, noting that prior art had largely focused on systemic administration or on topical products with only trace amounts of active cannabinoids like THC ('736 Patent, col. 2:5-28).
• The Patented Solution: The invention provides a topical formulation comprising a “Cannabis derived botanical drug product” where the concentration of tetrahydrocannabinol (THC), cannabidiol (CBD), or both, is greater than 2 milligrams per kilogram (2 ppm) ('736 Patent, Abstract). The specification describes combining these cannabis extracts with other active ingredients and dispersing them in various bases (e.g., lotions, creams) to treat skin conditions like psoriasis ('736 Patent, col. 2:31-39, Figs. 1-2).
• Technical Importance: The claimed approach sought to deliver therapeutically effective amounts of cannabinoids directly to the skin, bypassing the psychotropic effects of systemic delivery and exceeding the low, often non-therapeutic, cannabinoid levels found in products like commercial hemp oil ('736 Patent, col. 1:52-62).

Key Claims at a Glance

The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶11). The first independent claim, Claim 1, is a representative composition claim.

• Independent Claim 1:
  • 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 of tetrahydrocannabinol (THC) and cannabidiol (CBD) is greater than 2 milligrams per kilogram; and
  • wherein the 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 "one or more claims" of the patent (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

• The complaint accuses "Exemplary Defendant Products" (Compl. ¶11).

Functionality and Market Context

• The complaint does not name specific accused products or describe their functionality. Instead, it incorporates by reference charts from an unprovided "Exhibit 2" that allegedly identify the products and compare them to the patent claims (Compl. ¶¶ 11, 16). The complaint alleges these products are made, used, sold, and imported by the Defendant (Compl. ¶11). The complaint does not provide sufficient detail for analysis of the accused instrumentality's specific features or market position.

IV. Analysis of Infringement Allegations

The complaint alleges infringement but relies on claim charts in an unprovided "Exhibit 2" to detail its theory (Compl. ¶¶ 16, 17). The narrative alleges that Defendant's "Exemplary Defendant Products" practice the technology claimed in the ’736 Patent and that these products satisfy all elements of the asserted claims (Compl. ¶16). Without the specific product details and claim charts, a direct comparison is not possible.

No probative visual evidence provided in complaint.

Identified Points of Contention

Based on the language of representative Claim 1 and the general nature of the allegations, the infringement analysis raises several questions:

• Compositional Questions: Do the accused products contain an "extract of Cannabis sativa or Cannabis indica," as opposed to synthetic cannabinoids or isolates? Do they also contain at least 0.1 wt % of menthol, resorcinol, or phenol, as strictly required by Claim 1?
• Scope Questions: The claim uses the transitional phrase "consisting essentially of." A central question will be whether the accused products contain other unlisted ingredients that "materially affect the basic and novel characteristics" of the claimed formulation, which could be a route to non-infringement ('736 Patent, col. 4:25-32).
• Structural Questions: Are the accused products formulated as one of the four specific base types required by Claim 1 (e.g., a water-in-oil emulsion), and what evidence does the plaintiff possess to prove this structure?

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

• Context and Importance: This transitional phrase appears at the beginning of Claim 1 and is a term of art in patent law. Its construction is critical because it is more limiting than "comprising" but less limiting than "consisting of." The infringement analysis will depend on whether any additional, unlisted ingredients in Defendant's products are deemed to materially alter the invention's fundamental characteristics.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that many common topical excipients (e.g., certain preservatives, fragrances) do not materially affect the "basic and novel characteristics" of the invention—namely, the topical delivery of a specific concentration of cannabinoids—and thus their presence in an accused product does not preclude infringement ('736 Patent, col. 4:25-32).
  • Evidence for a Narrower Interpretation: A party could argue that the "basic and novel characteristics" are narrowly defined by the patent's focus on treating specific dermatological diseases like psoriasis ('736 Patent, col. 13:35). Therefore, any additional active ingredient not recited in the claim that also affects skin conditions could be argued to materially alter the invention's character.

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

• Context and Importance: This term defines the source of the active cannabinoids. The case may turn on whether Defendant’s products use a substance that falls within the patent’s definition of an "extract," or if they use, for example, synthetically derived cannabinoids or highly purified isolates that might be argued to fall outside the scope of the term.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification defines a "Cannabis derived biological drug product" broadly to include oils, powders, and various types of extracts prepared using organic solvents, water, or CO2 ('736 Patent, col. 7:14-27). This language could support a broad definition of "extract."
  • Evidence for a Narrower Interpretation: The patent distinguishes between different cannabis-derived products, such as "hemp oil," "hashish oil," and "hashish" ('736 Patent, col. 7:24-26). A defendant might argue that the term "extract" as used in the claim refers to a specific subset of these preparations and does not cover, for example, a simple pressed oil or a purified resin.

VI. Other Allegations

Indirect Infringement

• The complaint alleges induced infringement, stating that Defendant sells the accused products to customers and distributes "product literature and website materials" that direct end users to use the products in a manner that infringes the ’736 Patent (Compl. ¶¶ 14, 15).

Willful Infringement

• The complaint does not use the word "willful," but it alleges that Defendant has "Actual Knowledge of Infringement" from the date of service of the complaint and has continued its allegedly infringing activities despite this knowledge (Compl. ¶¶ 13, 14). This forms a basis for post-suit willfulness and a request for enhanced damages under 35 U.S.C. § 284.

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

• A key evidentiary question will be one of compositional identity: once discovery commences, will the accused products be shown to contain the precise combination of ingredients mandated by the asserted claims? Specifically, the case may hinge on proving the presence of not only a cannabis extract with >2ppm of THC/CBD, but also one of the three co-agents (menthol, resorcinol, or phenol) in one of the four specified base types.
• A core issue will be one of definitional scope: the dispute may turn on the construction of "consisting essentially of." The court’s interpretation will determine whether the presence of other active or inactive ingredients in Defendant's formulations is sufficient to place them outside the bounds of the patent claims.
• A third pivotal question relates to infringement evidence: given that the complaint relies entirely on an unprovided exhibit for its technical infringement theory, the viability of the case will depend on the quality and admissibility of the evidence Plaintiff eventually produces to substantiate the conclusory allegations made in the pleading.