Metronome LLC v. Dermaquest LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (Minnesota)
  • Defendant: Dermaquest, LLC (Delaware)
  • Plaintiff’s Counsel: Garibian Law Offices, P.C.
• Case Identification: 1:25-cv-00275, D. Del., 03/07/2025
• Venue Allegations: Venue is asserted based on Defendant having an established place of business in the District of Delaware and having committed alleged acts of infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical skincare products infringe a patent related to formulations containing specific concentrations of cannabis-derived compounds.
• Technical Context: The technology concerns the use of cannabinoids, such as THC and CBD, in topical preparations at concentrations purported to be therapeutically effective for dermatological conditions.
• Key Procedural History: The complaint does not mention any prior litigation, inter partes review proceedings, or licensing history related to the patent-in-suit.

Case Timeline

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

• Patent Identification: U.S. Patent No. 9,095,563, "Topical treatments incorporating Cannabis sp. derived botanical drug product," issued August 4, 2015.

The Invention Explained

• Problem Addressed: The patent asserts a need for topical formulations that use cannabis-derived compounds at concentrations exceeding the low levels found in products like commercial hemp oil, which are often legally restricted (Compl. Ex. 1, ’563 Patent, col. 1:49-55). The background suggests that prior art, such as U.S. Pat. No. 6,630,507, disclosed cannabinoids for other purposes but in amounts that did not exceed a mere detection limit for THC, failing to explore their potential in higher-concentration topical treatments (Compl. Ex. 1, ’563 Patent, col. 2:1-10).
• 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 explicitly "greater than 2 milligrams per kilogram" (Compl. Ex. 1, ’563 Patent, Abstract; col. 2:28-34). The patent describes various forms for this formulation, including creams, lotions, and ointments, intended for treating dermatological diseases (Compl. Ex. 1, ’563 Patent, col. 3:29-41).
• Technical Importance: The claimed invention sought to leverage the known anti-inflammatory and analgesic properties of cannabinoids by formulating them in topical products at concentrations above the commonly accepted legal limits for non-drug products (Compl. Ex. 1, ’563 Patent, col. 2:12-22).

Key Claims at a Glance

• The complaint asserts infringement of one or more claims, identified as the "Exemplary ’563 Patent Claims" in a referenced exhibit, without specifying claim numbers in the body of the complaint (Compl. ¶11). Independent Claim 1 is representative and includes the following essential elements:
  • A topical formulation "consisting essentially of":
  • an "extract of cannabis sativa or cannabis indicia";
  • and at least one component from a nine-member group (including capsaicin, hydrocortisone, and salicylic acid);
  • present in an amount of at least 0.1 wt %;
  • wherein the concentration of THC is greater than 2 mg/kg;
  • and wherein the formulation is obtained by dispersing the extract in a specific base type (e.g., a water-in-oil emulsion);
  • which base also "consisting essentially of" at least one component from the same nine-member group.
• The complaint states that Plaintiff incorporates by reference the claim charts of Exhibit 2, but does not foreclose asserting other claims (Compl. ¶11, ¶17).

III. The Accused Instrumentality

• Product Identification: The complaint accuses "Exemplary Defendant Products" which are identified in claim charts attached as Exhibit 2 (Compl. ¶11, ¶16). As Exhibit 2 was not filed with the complaint, the specific products are not identified in the available document.
• Functionality and Market Context: The complaint does not provide sufficient detail for analysis of the accused products' specific functionality. Based on the defendant's name (Dermaquest, LLC) and the nature of the patent, the products are presumably commercial topical skincare formulations.

IV. Analysis of Infringement Allegations

The complaint’s infringement allegations are detailed in claim charts provided as Exhibit 2, which is referenced by the complaint but not included in the public filing (Compl. ¶16, ¶17). The complaint asserts narratively 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 the charts, a detailed element-by-element analysis is not possible.

No probative visual evidence provided in complaint.

• Identified Points of Contention: Based on the language of the patent and the general nature of the allegations, the infringement analysis raises several questions.
  • Scope Questions: The use of the transitional phrase "consisting essentially of" in Claim 1 is highly restrictive. A central dispute may be whether the accused products contain unlisted ingredients (such as preservatives, fragrances, or other active agents common in cosmetics) that "materially affect the basic and novel characteristics of the claimed invention" and thereby fall outside the claim's scope (Compl. Ex. 1, ’563 Patent, col. 4:15-21).
  • Technical Questions: A significant technical question is whether the accused products meet the specific concentration threshold of "greater than 2 milligrams per kilogram" for THC, as required by Claim 1. Proving this will likely require chemical analysis of the accused products. Furthermore, Claim 1 requires that the formulation's base (e.g., the cream or lotion itself) also "consist essentially of" one of the nine specified active ingredients, a requirement that may not be met by standard cosmetic bases.

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

• Context and Importance: This term, which appears twice in Claim 1, governs the allowable ingredients in both the overall formulation and its base. Its construction will be dispositive for infringement, as it determines whether the presence of any unlisted ingredients in Defendant's products places them outside the claim scope. Practitioners may focus on this term because it is more limiting than "comprising" but less limiting than "consisting of."

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent specification provides a definition consistent with general patent law, stating the term "limits the scope of the claim to the materials specified... and... excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" (Compl. Ex. 1, ’563 Patent, col. 4:15-21). A plaintiff might argue that common excipients like water or standard emulsifiers do not materially affect the core therapeutic properties and are thus permissible.
  • Evidence for a Narrower Interpretation: A defendant could argue that many standard cosmetic ingredients, such as certain emollients, preservatives, or penetration enhancers, do materially affect the formulation's stability, skin feel, and delivery characteristics, which are basic properties of a topical cream, thus taking the product outside the scope of the claim.

• The Term: "extract of cannabis sativa or cannabis indicia"

• Context and Importance: This term defines the required source of the THC. Infringement depends on whether the defendant's product uses a substance that qualifies as such 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 various solvent extracts from different plant parts (Compl. Ex. 1, ’563 Patent, col. 7:1-12).
  • Evidence for a Narrower Interpretation: The patent distinguishes "botanical drug products" from "highly purified or chemically modified botanical substances," stating the latter are not considered botanical drug products (Compl. Ex. 1, ’563 Patent, col. 6:65-67). A defendant could argue its product uses a synthesized cannabinoid or a highly purified compound (e.g., >99% pure THC) that does not qualify as a botanical "extract" or "complex mixture" as contemplated by the patent.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement based on Defendant’s distribution of "product literature and website materials" that allegedly instruct end users to use the products in an infringing manner (Compl. ¶14). The allegation is tied to knowledge obtained "at least since being served by this Complaint," suggesting a theory of post-suit inducement (Compl. ¶15).
• Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. It pleads that service of the complaint constitutes "actual knowledge" of infringement, which could form the basis for a later claim of post-filing willfulness (Compl. ¶13).

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

• A core issue will be one of claim scope: can the restrictive "consisting essentially of" language of Claim 1, which applies to both the entire formulation and its underlying base, be interpreted to read on a commercial cosmetic product that likely contains numerous conventional ingredients not expressly listed in the claim?
• A key evidentiary question will be one of composition and concentration: does the plaintiff possess evidence, such as third-party lab testing, demonstrating that the accused products contain an "extract of cannabis" with a THC concentration that definitively exceeds the 2 mg/kg threshold recited in the patent?
• The case may also turn on a question of construction: does the defendant's source of cannabinoids qualify as an "extract of cannabis" as that term is used in the patent, or is it a "highly purified or chemically modified" substance that falls outside the patent's definition of a "botanical drug product"?