Metronome LLC v. Biospectrum Hemp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: BioSpectrum Hemp (WI)
  • Plaintiff’s Counsel: Rabicoff Law LLC
• Case Identification: 3:25-cv-144, W.D. Wis., 02/26/2025
• Venue Allegations: Venue is alleged to be proper based on Defendant’s established place of business within the district, along with acts of infringement and resulting harm occurring in the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical hemp products infringe a patent related to formulations containing specific concentrations of cannabis-derived compounds.
• Technical Context: The technology is in the field of topical dermatological treatments using botanical products derived from Cannabis species.
• Key Procedural History: The patent-in-suit claims priority back to a 2013 provisional application. The complaint alleges that Defendant gained actual knowledge of the infringement upon service of the complaint, forming the basis for its indirect and potential willful infringement claims.

Case Timeline

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

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 topical formulations that utilize the pharmacological properties of cannabis-derived compounds for treating dermatological diseases, particularly formulations that contain concentrations of active ingredients like tetrahydrocannabinol (THC) that exceed the low levels typically permitted in commercial products such as hemp oil (’736 Patent, col. 2:18-28).
• The Patented Solution: The invention provides a topical formulation comprising a "Cannabis derived botanical drug product" where the concentration of THC, cannabidiol (CBD), or both is greater than 2 milligrams per kilogram (’736 Patent, Abstract). The detailed description explains that these formulations can take various forms, such as creams and lotions, and are intended for treating skin conditions like psoriasis (’736 Patent, col. 2:41-47).
• Technical Importance: The technology sought to create effective, higher-concentration topical dermatological treatments from cannabis extracts, moving beyond their use as simple nutritional supplements or low-potency oils (’736 Patent, col. 2:22-28).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims" without specifying them, instead referencing charts in an un-provided exhibit (Compl. ¶11, ¶16). The patent contains one independent claim, Claim 1.
• Independent Claim 1 recites the following essential elements:
  • 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 %;
  • a concentration of at least one of THC or CBD greater than 2 mg/kg; and
  • the formulation is one of four specific types: a water-in-oil emulsion, an oil-in-water emulsion, a wax-in-oil base, or an oil-in-wax base.
• The complaint’s reference to "one or more claims" suggests it may reserve the right to assert dependent claims (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

The complaint does not identify any accused products by name, referring to them only as "Exemplary Defendant Products" listed in an un-provided Exhibit 2 (Compl. ¶11, ¶16).

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 composition, function, or market position (Compl. ¶16). It is alleged that Defendant distributes "product literature and website materials" related to the products (Compl. ¶14).

IV. Analysis of Infringement Allegations

The complaint references claim-chart exhibits that were not provided with the pleading; therefore, the following is a summary of the narrative infringement theory.

The complaint alleges that Defendant directly infringes the ’736 Patent by making, using, selling, and/or importing the accused products (Compl. ¶11). The pleading asserts that these products "satisfy all elements of the Exemplary '736 Patent Claims," with detailed comparisons allegedly contained within the un-provided Exhibit 2 (Compl. ¶16-17). The complaint also contains a specific allegation of direct infringement through internal testing and use of the products by Defendant's employees (Compl. ¶12). The complaint incorporates the '736 patent as Exhibit 1, which includes a figure showing skin affected by psoriasis after application of a formulation according to the invention, intended to demonstrate the treatment's effect (Compl. ¶9; ’736 Patent, Fig. 2).

Identified Points of Contention

• Evidentiary Question: Because the complaint does not provide test results or specific product compositions, a central issue will be whether discovery confirms that the accused products contain all elements required by Claim 1: a cannabis "extract," one of the three specified additives (menthol, resorcinol, or phenol) at the required weight percentage, a cannabinoid concentration above 2 mg/kg, and a formulation base matching one of the four claimed types.
• Scope Questions: The use of the transitional phrase "consisting essentially of" in Claim 1 raises the question of whether the accused products contain additional ingredients that "materially affect the basic and novel characteristics of the claimed invention," which could be a route to non-infringement (’736 Patent, col. 5:25-31). The patent does not explicitly define these characteristics.

V. Key Claim Terms for Construction

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

• Context and Importance: The definition of "extract" is central, as it defines the required source of the active cannabinoids. The infringement analysis may turn on whether Defendant's ingredient source (e.g., a highly purified isolate or a synthetic cannabinoid) falls within the scope of this term.
• Intrinsic Evidence for a Broader Interpretation: The patent defines the "Cannabis derived biological drug product" broadly to include oils pressed from seeds and extracts prepared from various plant parts using multiple methods (’736 Patent, col. 7:14-26).
• Intrinsic Evidence for a Narrower Interpretation: The patent also quotes an FDA definition of "Botanical Drug Product" that excludes "highly purified or chemically modified botanical substances" (’736 Patent, col. 7:11-13). A defendant could argue its ingredient is such a substance and therefore not an "extract" as contemplated by the patent.

The Term: "consisting essentially of"

• Context and Importance: This term limits the claim to the listed ingredients and any others that do not materially affect the invention's "basic and novel characteristics." Practitioners may focus on this term because the presence of other active or functional ingredients in the accused product could form a basis for a non-infringement argument.
• Intrinsic Evidence for Interpretation: The patent provides the standard legal definition for the phrase but does not specify what the "basic and novel characteristics" are (’736 Patent, col. 5:25-31). The parties will likely dispute whether this refers narrowly to the specified concentrations of cannabinoids or more broadly to the overall therapeutic effect.

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement based on Defendant's sale of the accused products to customers, supported by "product literature and website materials" that allegedly instruct on an infringing use (Compl. ¶14-15). The specific content of these materials is not detailed in the complaint itself.

Willful Infringement

The complaint alleges that service of the complaint provides Defendant with "Actual Knowledge of Infringement" and that inducement has occurred "at least since being served by this Complaint" (Compl. ¶13, ¶15). This framing suggests a basis for seeking enhanced damages for any post-filing infringement, rather than alleging pre-suit willfulness.

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

• A central issue will be evidentiary and factual: Does the accused product, once its specific composition is revealed in discovery, meet every limitation of the asserted claim, particularly the conjunctive requirement of a cannabis extract, a specific secondary ingredient (menthol, resorcinol, or phenol) at a minimum concentration, a cannabinoid level above 2 mg/kg, and one of the four specified formulation bases?
• A key legal question will be one of claim scope: How will the court construe the phrase "consisting essentially of"? The outcome will depend on the court's definition of the invention's "basic and novel characteristics" and whether any additional ingredients in the accused product materially alter those characteristics.
• The case may also turn on a definitional question: Can the term "extract," as used in the patent, be interpreted to read on the specific cannabis-derived ingredient used by the defendant, or can the defendant show its ingredient is a "highly purified substance" that the patent's own language appears to exclude from its scope?