Metronome LLC v. Well Theory LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: The Well Theory, LLC (DE)
  • Plaintiff’s Counsel: Garibian Law Offices, P.C.; Rabicoff Law LLC
• Case Identification: 1:25-cv-00286, D. Del., 03/10/2025
• Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is incorporated in Delaware, has 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 products infringe a patent related to formulations containing specific concentrations of cannabis-derived compounds for treating dermatological conditions.
• Technical Context: The technology concerns the use of cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), in topical preparations at concentrations purported to be effective for therapeutic use on the skin.
• Key Procedural History: No prior litigation, licensing history, or other significant procedural events are mentioned in the complaint.

Case Timeline

Date	Event
2013-09-26	'563 Patent Priority Date
2015-08-04	'563 Patent Issue Date
2025-03-10	Complaint Filing Date

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

U.S. Patent No. 9,095,563 - Topical treatments incorporating Cannabis sp. derived botanical drug product

• Patent Identification: U.S. Patent No. 9,095,563, issued August 4, 2015.

The Invention Explained

• Problem Addressed: The patent asserts a need for topical cannabis formulations for dermatological diseases that go beyond prior art, which it characterizes as focused on neuroprotective uses with minimal THC content. The patent identifies a need for formulations with concentrations of cannabinoids that exceed the "commonly applied maximum levels" found in products like hemp oil, in order to provide "unexpected and highly beneficial treatments" ('563 Patent, col. 2:12-22).
• The Patented Solution: The invention is a topical formulation containing a "Cannabis derived botanical drug product" where the concentration of key cannabinoids (THC or CBD) is specifically greater than 2 milligrams per kilogram (2 ppm) ('563 Patent, Abstract). The patent describes this botanical product as being derived from Cannabis indica or sativa species and can take many forms, including oils, powders, and various extracts, which are then incorporated into bases like lotions, creams, or salves to treat skin conditions ('563 Patent, col. 1:12-17; col. 7:1-17).
• Technical Importance: The claimed invention seeks to leverage the known anti-inflammatory and analgesic properties of cannabinoids by applying them topically at specific, higher-than-trace concentrations for dermatological use ('563 Patent, col. 1:40-44).

Key Claims at a Glance

• The complaint asserts infringement of one or more claims of the ’563 Patent, referring to "Exemplary '563 Patent Claims" in its incorporated charts, but does not specify claim numbers in the body of the complaint (Compl. ¶11). Claim 1 is the first independent claim.
• Independent Claim 1 Elements:
  • A topical formulation consisting essentially of:
  • an extract of cannabis sativa or cannabis indicia;
  • at least one component selected from a specified group including capsaicin, benzocaine, lidocaine, and others;
  • said component present in an amount of at least 0.1 wt %;
  • wherein the concentration of tetrahydrocannabinol (THC) is greater than 2 milligrams per kilogram;
  • and wherein the formulation is obtained by dispersing the extract in a base (e.g., water-in-oil emulsion, oil-in-water emulsion, etc.) that itself consists essentially of at least one component from the same specified group.
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

• The complaint does not name any specific accused products. It refers generally to "Exemplary Defendant Products" that are identified in charts incorporated as Exhibit 2 (Compl. ¶11). This exhibit was not publicly available with the complaint.

Functionality and Market Context

• The complaint does not provide sufficient detail for analysis of the accused products' functionality or market context, other than to allege they are made, used, or sold by Defendant The Well Theory, LLC (Compl. ¶¶ 3, 11).

IV. Analysis of Infringement Allegations

The complaint references claim charts in an attached Exhibit 2 to support its infringement allegations but does not provide the exhibit itself or a narrative summary of the infringement theory in the body of the pleading (Compl. ¶¶ 16-17). The complaint alleges that the "Exemplary Defendant Products practice the technology claimed by the '563 Patent" and "satisfy all elements of the Exemplary '563 Patent Claims" (Compl. ¶16). Without access to the charts or more detailed allegations, a direct comparison of product features to claim elements is not possible.

No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Evidentiary Question: A central issue will be whether the Plaintiff can produce evidence, likely through chemical analysis, demonstrating that the accused products contain an "extract of cannabis sativa or cannabis indicia" and that the concentration of THC is "greater than 2 milligrams per kilogram" as required by Claim 1.
  • Scope Question: Claim 1 uses the transitional phrase "consisting essentially of." The patent defines this phrase to exclude materials that "materially affect the basic and novel characteristics of the claimed invention" ('563 Patent, col. 4:15-20). A key dispute may arise over whether any unlisted ingredients in the accused products materially alter their characteristics in a way that avoids infringement.
  • Technical Question: Infringement of Claim 1 requires that the accused formulation contain "at least one component" from a specific list (e.g., capsaicin, benzocaine) at a concentration of "at least 0.1 wt %." The plaintiff will need to prove the presence and concentration of such a component in the accused products.

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

  • Context and Importance: This term appears in Claim 1 and governs the entire composition. Its construction will be critical because it is more limiting than "comprising" but less limiting than "consisting of." Practitioners may focus on this term because if Defendant’s products contain additional active ingredients not recited in the claim, the case could turn on whether those ingredients "materially affect" the invention's properties, thereby taking the product outside the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue that many common excipients or stabilizers do not materially affect the "basic and novel" anti-inflammatory or analgesic characteristics of the cannabis extract, and thus their presence does not defeat infringement.
    • Evidence for a Narrower Interpretation: The patent explicitly defines the term: "this transitional phrase excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" ('563 Patent, col. 4:17-20). A party could argue that any additional pharmacologically active ingredient, by its nature, materially affects the product's characteristics.

• The Term: "Cannabis derived botanical drug product"

  • Context and Importance: This term is central to the invention, but the complaint accuses "products" of infringement while the patent claims a "formulation" containing this specific ingredient. Practitioners may focus on this term to dispute whether the accused products contain what the patent defines as a "botanical drug product."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent provides a very broad definition, stating the term is prepared from Cannabis varieties and includes "oils pressed from the seeds; powders...; extracts...; hemp oil; hashish oil; hashish; and fractions of extracts or oils" ('563 Patent, col. 7:1-12). This supports a wide range of materials.
    • Evidence for a Narrower Interpretation: The patent also notes that "Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use," and distinguishes them from "highly purified or chemically modified botanical substances" ('563 Patent, col. 6:63-68). A defendant could argue that its product, if it uses a highly purified cannabinoid isolate (e.g., 99% pure THC), does not qualify as a "complex mixture" and thus is not a "botanical drug product" as characterized by the patent.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendant distributes "product literature and website materials inducing end users and others to use its products in the customary and intended manner that infringes the '563 Patent" (Compl. ¶14).
• Willful Infringement: The complaint alleges Defendant has had "actual knowledge" of infringement since the service of the complaint and that its continued infringement is therefore willful (Compl. ¶¶ 13-14). This frames the willfulness claim as arising from post-suit conduct.

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

1. A primary issue will be one of claim scope: can the limiting phrase "consisting essentially of" be overcome? The case will likely require a factual determination of whether any unlisted ingredients in the accused products "materially affect" the basic and novel characteristics of the claimed formulation.
2. A second core issue will be evidentiary proof: can the Plaintiff demonstrate through testing that the accused products meet the quantitative limitations of the asserted claims, specifically a THC concentration "greater than 2 milligrams per kilogram" and the presence of a second listed component at "at least 0.1 wt %"?
3. The case may also hinge on a definitional question: does the accused product's cannabis-derived ingredient meet the patent's definition of a "botanical drug product," particularly if it is a highly purified isolate rather than the "complex mixture" described in the patent's specification?