Metronome LLC v. Sunset Novelties USA LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Sunset Novelties USA LLC (FL)
  • Plaintiff’s Counsel: Beusse Sanks, PLLC; Rabicoff Law LLC
• Case Identification: 0:25-cv-61440, 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, committing alleged acts of infringement in the district, and causing harm to the Plaintiff in the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical products infringe a patent related to formulations containing cannabis-derived botanical drug products.
• Technical Context: The technology concerns topical pharmaceutical and cosmetic formulations, specifically those incorporating cannabinoids like tetrahydrocannabinol (THC) and cannabidiol (CBD) for treating dermatological conditions.
• Key Procedural History: The patent-in-suit claims priority back to a 2013 provisional application and is part of a chain of continuation applications, which may be relevant for determining the effective filing date and the scope of prior art. The complaint does not mention any prior litigation or administrative proceedings involving the patent.

Case Timeline

Date	Event
2013-09-26	Priority Date for U.S. Patent No. 10,653,736
2020-05-19	U.S. Patent No. 10,653,736 Issued
2025-07-16	Complaint Filed

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).

U.S. Patent No. 10,653,736 - "Topical treatments incorporating cannabis sp. derived botanical drug product"

The Invention Explained

• Problem Addressed: The patent describes a need for topical treatments that utilize the pharmacological properties of cannabis beyond its use as a neuroprotectant and at concentrations higher than those typically permitted in commercial products like hemp oil, which often have strict limits on THC content (e.g., <10 ppm) (’736 Patent, col. 2:5-28).
• The Patented Solution: The invention is a topical formulation containing a "Cannabis derived botanical drug product" where the concentration of THC, CBD, or both is greater than 2 milligrams per kilogram (’736 Patent, Abstract; col. 2:50-65). The patent describes various forms for the formulation, such as creams, lotions, and ointments, and discloses their use for treating dermatological diseases like psoriasis, as illustrated in its figures (’736 Patent, col. 2:41-48, Fig. 1-2).
• Technical Importance: The patent asserts that using cannabinoids at these specified higher concentrations in topical form can provide "unexpected and highly beneficial treatments for a wide variety of diseases" beyond what was previously known or practiced (’736 Patent, col. 2:25-28).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶11). Independent claim 1 is representative:
• 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 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 alleges infringement of "one or more claims" (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

• The complaint refers to "Exemplary Defendant Products" but does not name any specific products in the body of the complaint (Compl. ¶11).

Functionality and Market Context

• The complaint does not provide sufficient detail for analysis of the accused products' functionality or market context. It states that the accused products are identified in charts within an attached "Exhibit 2," but this exhibit was not provided with the complaint document (Compl. ¶¶11, 14, 16). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain specific infringement allegations or claim charts. It incorporates by reference an external "Exhibit 2" that allegedly contains charts comparing the asserted claims to the "Exemplary Defendant Products" (Compl. ¶16-17). As this exhibit is not provided, a detailed element-by-element analysis is not possible based on the complaint alone.

The narrative infringement theory is that the Defendant’s products "practice the technology claimed by the ’736 Patent" and "satisfy all elements of the Exemplary ’736 Patent Claims" (Compl. ¶16).

• Identified Points of Contention: The lack of specific factual allegations in the complaint makes it difficult to identify concrete disputes. However, based on the asserted claims, litigation will likely center on several key questions:
  • Evidentiary Questions: What is the precise chemical composition of the accused products? Do they contain an "extract of Cannabis sativa or Cannabis indica," and are THC and/or CBD present at concentrations "greater than 2 milligrams per kilogram" as required by the claims?
  • Technical Questions: Is the base formulation of the accused products a "water-in-oil emulsion, an oil-in-water emulsion, a wax-in-oil base, or an oil-in-wax base" as recited in claim 1? Do the accused products contain any of the additional required compounds (menthol, resorcinol, phenol) at the claimed weight percentage?

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

• Context and Importance: This transitional phrase is a legal term of art that is narrower than "comprising" and broader than "consisting of." Its construction will be critical for determining whether unlisted ingredients in the accused products prevent a finding of infringement. Practitioners may focus on this term because infringement will depend on whether any additional components in the accused products "materially affect the basic and novel characteristics of the claimed invention" (’736 Patent, col. 3:25-30).

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent itself does not offer evidence for a broad reading; the term is inherently limiting. Parties arguing for a broader scope might point to the general purpose of treating dermatological diseases, suggesting that only ingredients affecting that specific function are material.
  • Evidence for a Narrower Interpretation: The patent specification explicitly defines the term, stating it "limits the scope of the claim" and "excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" (’736 Patent, col. 3:25-30). This definition provides strong support for a narrow interpretation, limiting the formulation to the recited elements and other non-material ingredients.

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

• Context and Importance: The source and nature of the active ingredient are central to the claim. The case may turn on whether the accused products use a substance that qualifies as an "extract" from the specified plant species, as opposed to synthetically derived cannabinoids or extracts from other cannabis varieties (e.g., Cannabis ruderalis).

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent describes a "Cannabis derived biological drug product" as being prepared from Cannabis indica and sativa and including oils, powders, and various types of extracts (’736 Patent, col. 7:14-25). This could support an interpretation covering a wide range of preparation methods.
  • Evidence for a Narrower Interpretation: A defendant might argue that "extract" implies a specific process of separating desired compounds from the plant matrix, as described in the patent’s discussion of solvent extraction, and does not cover products where, for example, purified or synthetic CBD/THC is added to a base. The patent discusses extracts prepared using "organic solvents, water extraction, alcohol extracts, and liquid carbon dioxide extracts" (’736 Patent, col. 7:20-22).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement "at least since being served by this Complaint" (Compl. ¶15). The alleged inducement is based on the distribution of "product literature and website materials" that instruct end users on an infringing use of the products (Compl. ¶14).
• Willful Infringement: The complaint alleges that Defendant has had "Actual Knowledge of Infringement" from the date of service of the complaint and that its continued infringement is therefore willful (Compl. ¶¶13-14). No allegations of pre-suit knowledge are made.

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

1. An Evidentiary Question of Composition: The central issue will be establishing the precise formulation of the accused products. The case cannot proceed without discovery into whether the products contain the claimed cannabinoids, at the claimed concentrations, from the claimed source, in one of the claimed emulsion or base types.

2. A Definitional Question of Scope: The dispute will likely involve a classic claim construction battle over the term "consisting essentially of." The outcome will depend on whether the accused products contain unlisted ingredients and, if so, whether those ingredients are deemed to "materially affect" the "basic and novel characteristics" of the topical formulation as defined in the patent.

3. A Question of Source: A key point of contention may be the meaning of "extract of Cannabis sativa or Cannabis indica." The litigation will have to resolve whether the active ingredients in the accused products are derived from a qualifying "extract" or from another source, such as chemical synthesis or different plant varieties, which could place them outside the literal scope of the claims.