Metronome LLC v. Happy Hemp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Happy Hemp (CO)
  • Plaintiff’s Counsel: Rabicoff Law LLC
• Case Identification: 1:25-cv-00625, D. Colo., 02/26/2025
• Venue Allegations: Venue is alleged to be proper in the District of Colorado because Defendant maintains an established place of business in the district, has committed alleged acts of infringement in the district, and Plaintiff has suffered harm there.
• Core Dispute: Plaintiff alleges that Defendant’s topical hemp products infringe a patent related to cannabis-based topical formulations for treating dermatological conditions.
• Technical Context: The technology concerns topical therapeutic formulations that use specific concentrations of cannabinoids, such as THC and CBD, derived from cannabis plants.
• Key Procedural History: The patent-in-suit claims priority back to a 2013 provisional application and is a continuation of several prior applications. This extended prosecution history may be relevant to claim construction and the scope of the claims. No other procedural events are mentioned in the complaint.

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 using cannabis-derived products for treating dermatological diseases, noting that prior art focused on systemic administration or different therapeutic uses like neuroprotection. (’736 Patent, col. 2:1-17). It further identifies a need for formulations with cannabinoid concentrations that exceed the low levels found in products like hemp oil, which are legally restricted in many jurisdictions. (’736 Patent, col. 2:18-28).
• The Patented Solution: The invention is a topical formulation comprising a "Cannabis derived botanical drug product" where the concentration of tetrahydrocannabinol (THC), cannabidiol (CBD), or both is specifically greater than 2 milligrams per kilogram (mg/kg). (’736 Patent, Abstract; col. 2:51-56). The claimed formulations are dispersed in specific bases (e.g., emulsions or waxes) and also include other active agents like menthol, resorcinol, or phenol to treat skin conditions. (’736 Patent, col. 16:1-17).
• Technical Importance: The technology proposes using higher-than-typical concentrations of cannabinoids topically to leverage their known pharmacological activities (e.g., anti-inflammatory, analgesic) for direct dermatological application. (’736 Patent, col. 1:45-50).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" and "exemplary claims" without specifying claim numbers, but incorporates by reference unattached claim charts. (Compl. ¶11, 16). Independent claim 1 is the broadest independent 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 % in the topical formulation;
  • 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 of Cannabis sativa or Cannabis indica in a water-in-oil emulsion, an oil-in-water emulsion, a wax-in-oil base, or an oil-in-wax base.
• The complaint notes that infringement is alleged for the "Exemplary '736 Patent Claims" identified in the charts, suggesting other claims may be asserted. (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

The complaint does not name specific products in its main body, instead referring to "Exemplary Defendant Products" that are identified in claim charts attached as Exhibit 2. (Compl. ¶11). This exhibit was not filed with the complaint.

Functionality and Market Context

The complaint alleges that Defendant makes, uses, sells, and imports products that practice the technology claimed by the ’736 Patent. (Compl. ¶11). Given the defendant's name, "Happy Hemp," the products are presumably topical formulations containing hemp-derived ingredients. The complaint does not provide sufficient detail for analysis of the accused products' specific functionality or market positioning. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Defendant directly infringes the ’736 Patent but does not provide the claim charts (Exhibit 2) that purportedly detail this infringement. (Compl. ¶11, 16-17). The complaint states that these charts compare the asserted claims to the accused products and demonstrate that the products "satisfy all elements" of the claims. (Compl. ¶16). Without the charts, a detailed element-by-element analysis is not possible based on the complaint alone. The core of the infringement allegation is that Defendant's topical products are formulations containing a cannabis extract with specific concentrations of THC/CBD and other active ingredients as recited in the asserted claims. (Compl. ¶11, 16).

• Identified Points of Contention:
  • Compositional Questions: The central factual dispute will likely concern the precise chemical composition of the accused products. The plaintiff will need to present evidence, presumably through chemical testing, that the products contain (1) an "extract of Cannabis sativa or Cannabis indica," (2) THC or CBD at a concentration "greater than 2 milligrams per kilogram," and (3) for infringement of claim 1, at least 0.1 wt % of "menthol, resorcinol, or phenol."
  • Scope Questions: The use of the transitional phrase "consisting essentially of" in claim 1 raises the question of whether any unlisted ingredients in the accused products "materially affect the basic and novel characteristics" of the invention. Defendant may argue that additional components in its formulations, if present, place the products outside the scope of the claim.
  • Technical Questions: A key question will be whether the cannabinoid component in the accused products meets the patent's definition of an "extract." The patent distinguishes a "botanical drug product" from "highly purified or chemically modified botanical substances." (’736 Patent, col. 7:11-13). If Defendant's products use a highly purified CBD isolate or a synthetic cannabinoid, it may argue that this does not constitute an "extract" as required by claim 1.

V. Key Claim Terms for Construction

"consisting essentially of"

• Context and Importance: This term is a legal term of art that is narrower than "comprising" but broader than "consisting of." Its construction is critical because it will determine whether the presence of unlisted ingredients in Defendant’s products allows them to avoid infringement. Practitioners may focus on this term because the accused products, as consumer goods, may contain various excipients, fragrances, or preservatives not listed in the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent lists numerous other potential ingredients that can be added to formulations in other embodiments, such as steroids, antibiotics, and analgesics. (’736 Patent, col. 8:8-col. 10:29). A party could argue these examples show that the "basic and novel characteristics" are tolerant of many additional components.
  • Evidence for a Narrower Interpretation: The patent does not explicitly define the "basic and novel characteristics" of the invention. A party could argue that this characteristic is simply the topical application of a cannabis extract with >2 mg/kg of cannabinoids and a limited set of co-ingredients, and that any other pharmacologically active ingredient would be a material alteration.

"extract of Cannabis sativa or Cannabis indica"

• Context and Importance: The infringement reading depends entirely on the accused product containing an "extract." The source and processing of the cannabinoids in Defendant's "Happy Hemp" products will be a central issue. If the products use, for example, a synthetic cannabinoid or a crystalline CBD isolate, a dispute will arise over whether that component qualifies as an "extract."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification defines a "Cannabis derived biological drug product" broadly to include oils pressed from seeds, powders, and extracts prepared using various methods like solvent or CO2 extraction. (’736 Patent, col. 7:14-25).
  • Evidence for a Narrower Interpretation: The specification explicitly states that "highly purified or chemically modified botanical substances are not considered botanical drug products." (’736 Patent, col. 7:11-13). A defendant could argue this language was intended to exclude components like pure CBD isolate from the scope of an "extract."

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendant distributes "product literature and website materials" that direct end users to use the products in a manner that infringes the ’736 Patent. (Compl. ¶14).
• Willful Infringement: The complaint alleges that Defendant has had "actual knowledge" of infringement since at least the service of the complaint and its attached (but unfiled) claim charts. (Compl. ¶13). The claim for inducement is likewise based on knowledge from the date of service forward. (Compl. ¶15). No allegations of pre-suit knowledge are made.

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

1. A central issue will be one of compositional proof: Can Plaintiff provide sufficient evidentiary testing to demonstrate that Defendant’s products meet the quantitative thresholds of claim 1, specifically a cannabinoid concentration "greater than 2 milligrams per kilogram" and the presence of at least 0.1 wt% of menthol, resorcinol, or phenol?

2. The case will likely involve a key question of definitional scope: Does the cannabinoid source in the accused "Happy Hemp" products qualify as an "extract of Cannabis sativa or Cannabis indica," or is it a purified isolate or synthetic equivalent that falls outside the patent's definition, which excludes "highly purified" substances?

3. A significant legal battle may hinge on the term "consisting essentially of": Do the accused products contain other ingredients not recited in the claim that "materially affect" the invention's characteristics, thereby placing them outside the claim's scope? The court's interpretation of this phrase will be critical to the infringement outcome.