Metronome LLC v. Well Care Botanicals LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Well Care Botanicals LLC (NJ)
  • Plaintiff’s Counsel: GARIBIAN LAW OFFICES, P.C.; Rabicoff Law LLC
• Case Identification: 2:25-cv-01936, D.N.J., 03/18/2025
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant maintains an established place of business in the district and has committed the alleged acts of patent infringement there.
• Core Dispute: Plaintiff alleges that Defendant’s topical botanical products infringe a patent related to topical formulations containing specific concentrations of cannabis-derived compounds for treating dermatological conditions.
• Technical Context: The technology resides in the field of pharmaceutical and cosmetic formulations, specifically using extracts from the Cannabis plant for topical application to treat skin ailments.
• Key Procedural History: The complaint does not mention any prior litigation, inter partes review (IPR) proceedings, or licensing history related to the patent-in-suit.

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"

• Patent Identification: U.S. Patent No. 10,653,736, issued May 19, 2020.

The Invention Explained

• Problem Addressed: The patent identifies a need for topical formulations containing cannabis-derived compounds for treating dermatological diseases, noting that previous focus had been on systemic administration or uses as neuroprotectants. It states there was no prior disclosure of topical compositions with tetrahydrocannabinol (THC) in amounts exceeding simple detection limits ('736 Patent, col. 2:5-17).
• The Patented Solution: The invention is a topical formulation that includes a "Cannabis derived botanical drug product" where the concentration of either THC or cannabidiol (CBD) is specifically "greater than 2 milligrams per kilogram." ('736 Patent, Abstract; col. 2:31-39). The patent describes this solution as providing "unexpected and highly beneficial treatments for a wide variety of diseases," particularly dermatological ones like psoriasis, as depicted in Figure 2 ('736 Patent, col. 2:25-28, 42-47).
• Technical Importance: The claimed technology sought to leverage the pharmacological properties of cannabinoids for topical skin treatment at concentrations higher than what was typically permissible in commercial products like hemp oil, which faced strict legal limits on THC content ('736 Patent, col. 1:50-62).

Key Claims at a Glance

• The complaint asserts infringement of one or more claims of the ’736 Patent (Compl. ¶11). The sole independent claim is Claim 1.
• Independent Claim 1 requires:
  • A topical formulation "consisting essentially of" its listed components.
  • An "extract of Cannabis sativa or Cannabis indica."
  • "at least one compound selected from the group consisting of menthol, resorcinol, and phenol," present at a concentration of at least 0.1% by weight.
  • A concentration of at least one of tetrahydrocannabinol (THC) or cannabidiol (CBD) that is "greater than 2 milligrams per kilogram."
  • The formulation must be obtained by dispersing the extract in one of four specified bases: a water-in-oil emulsion, an oil-in-water emulsion, a wax-in-oil base, or an oil-in-wax base.
• The complaint’s general assertion of "one or more claims" reserves the right to assert dependent claims (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

The complaint refers to "Exemplary Defendant Products" that are identified in claim charts attached as Exhibit 2 (Compl. ¶11, ¶16). This exhibit was not filed with the complaint, so specific product names are not available for analysis.

Functionality and Market Context

The complaint alleges that the accused products are topical formulations that practice the technology claimed in the ’736 Patent (Compl. ¶16). These products are made, used, sold, or imported by the Defendant and are alleged to satisfy all elements of the asserted claims (Compl. ¶11, ¶16). The complaint alleges these products are sold to customers for end-use in a manner that infringes the patent (Compl. ¶15). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that infringement is detailed in claim charts attached as Exhibit 2, which was not publicly filed (Compl. ¶17). In lieu of a chart, the infringement theory is summarized below.

The complaint alleges that the "Exemplary Defendant Products" directly infringe the ’736 Patent because they are topical formulations that contain all the elements of at least Claim 1 (Compl. ¶11, ¶16). The narrative theory suggests that Defendant’s botanical products are topical creams, lotions, or similar formulations that are derived from Cannabis and contain concentrations of THC and/or CBD above the 2 mg/kg threshold, as well as the other specific components recited in the claim, and are formulated in one of the claimed base types (Compl. ¶11, ¶16; '736 Patent, Claim 1).

Identified Points of Contention

• Scope Questions: Claim 1 uses the transitional phrase "consisting essentially of." This raises the question of whether any unrecited ingredients in the accused products "materially affect the basic and novel characteristics of the claimed invention" ('736 Patent, col. 3:25-31). The presence of additional active or inactive ingredients in Defendant’s products could become a central point of dispute.
• Technical Questions: A primary factual question will be whether the accused products meet the quantitative limitations of Claim 1. The complaint does not provide evidence (such as laboratory analysis) demonstrating that the accused products contain THC or CBD at a concentration "greater than 2 milligrams per kilogram" or contain "at least 0.1 wt %" of menthol, resorcinol, or phenol.
• Technical Questions: An additional evidentiary question is whether the accused formulations are created using one of the four specific emulsion or base types required by Claim 1 (e.g., a "water-in-oil emulsion").

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

• Context and Importance: This term appears at the start of Claim 1 and governs the scope of the entire claim. Its construction will be critical for determining whether unlisted ingredients in Defendant's products place them outside the scope of the claims. Practitioners may focus on this term because it is more restrictive than "comprising," and the presence of other pharmacologically active agents or formulation-altering excipients in the accused products could be used to argue non-infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification does not provide language supporting a particularly broad reading; the term's scope is defined by its established meaning in patent law.
  • Evidence for a Narrower Interpretation: The specification provides an explicit definition consistent with Federal Circuit precedent, stating the phrase "excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" ('736 Patent, col. 3:25-31). This language will likely be used to argue that any additional ingredient with a therapeutic or significant structural effect on the formulation is excluded.

The Term: "Cannabis derived botanical drug product"

• Context and Importance: This term defines the required source and nature of the active ingredients. Its construction is important because the infringement analysis depends on whether Defendant's active ingredients qualify. A dispute could arise if Defendant's products use, for example, synthetic cannabinoids or highly processed extracts that Defendant may argue do not qualify as a "botanical drug product."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent provides a broad definition, including materials prepared from Cannabis indica and sativa, "which include oils pressed from the seeds; powders...; extracts prepared using organic solvents, water extraction, alcohol extracts, and liquid carbon dioxide extracts; hemp oil; hashish oil; hashish..." ('736 Patent, col. 7:14-24).
  • Evidence for a Narrower Interpretation: The patent explicitly states that "highly purified or chemically modified botanical substances are not considered botanical drug products" ('736 Patent, col. 7:11-13). This language could support an argument that if the cannabinoids in the accused product are isolated and highly purified, they fall outside the claim's scope.

VI. Other Allegations

Indirect Infringement

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

Willful Infringement

The complaint alleges knowledge of infringement based on the service of the complaint itself (Compl. ¶13). It asserts that any continued infringement by the Defendant after receiving the complaint and its attached (but unfiled) claim charts is willful and deliberate (Compl. ¶14-15).

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

1. A central 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 ingredients, and what evidence will be required to determine if those ingredients "materially affect" the formulation's claimed characteristics?

2. The case will likely turn on a key evidentiary question: can the Plaintiff produce sufficient technical evidence, such as third-party chemical analysis, to prove that Defendant’s products meet the specific, quantitative limitations of Claim 1, namely a cannabinoid concentration "greater than 2 milligrams per kilogram" and the presence of at least 0.1% by weight of menthol, resorcinol, or phenol?