Metronome LLC v. Hemponix Holdings LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Hemponix Holdings LLC (DE)
  • Plaintiff’s Counsel: Garibian Law Offices, P.C.; Rabicoff Law LLC
• Case Identification: 1:25-cv-00283, D. Del., 03/10/2025
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation that has an established place of business in the district and has allegedly committed acts of patent infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical cannabis products infringe a patent related to formulations containing specific concentrations of cannabinoids for treating dermatological conditions.
• Technical Context: The technology concerns pharmaceutical and cosmetic topical formulations derived from the cannabis plant, specifically focusing on concentrations of active compounds like tetrahydrocannabinol (THC) and cannabidiol (CBD).
• Key Procedural History: The complaint does not mention any prior litigation, inter partes review proceedings, or licensing history related to the patent-in-suit. The patent claims priority to a 2013 provisional application.

Case Timeline

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

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

The patent-in-suit is U.S. Patent No. 9,095,563, issued August 4, 2015 (the "'563' Patent").

The Invention Explained

• Problem Addressed: The patent identifies a need for topical cannabis formulations that contain concentrations of cannabinoids, such as THC, exceeding the low levels found in products like commercial hemp oil, which are often legally restricted ('563' Patent, col. 2:11-23). The background notes that prior art focused on systemic administration or used cannabinoids as antioxidants in amounts that did not promote psychoactive effects, failing to disclose topical compositions with higher THC levels for treating dermatological diseases ('563' Patent, col. 2:1-10).
• The Patented Solution: The invention is a topical preparation containing a "Cannabis derived botanical drug product" where the concentration of tetrahydrocannabinol (THC), cannabidiol (CBD), or both is greater than 2 milligrams per kilogram ('563' Patent, Abstract; col. 2:26-34). The formulation is intended for treating skin conditions, with the patent providing photographic figures illustrating the treatment of plaque psoriasis ('563' Patent, FIG. 1, FIG. 2).
• Technical Importance: The invention proposed using specific, higher concentrations of cannabinoids in topical applications to leverage their analgesic and anti-inflammatory properties for skin diseases, moving beyond the legally restricted or non-therapeutic levels common at the time ('563' Patent, col. 1:41-44; col. 2:11-17).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims," including "Exemplary '563' Patent Claims" identified in an exhibit, but does not specify claim numbers in the body of the complaint (Compl. ¶¶11, 16). Independent claims 1, 11, and 21 are representative of the patent's scope.
• Independent Claim 1:
  • A topical formulation consisting essentially of an extract of cannabis sativa or cannabis indicia
  • and at least one additional component from a specified group (e.g., capsaicin, benzocaine, hydrocortisone) present at ≥ 0.1 wt%
  • wherein the concentration of tetrahydrocannabinol (THC) is greater than 2 milligrams per kilogram
  • said formulation obtained by dispersing the cannabis extract in a specific base (e.g., a water-in-oil emulsion) that also consists essentially of one of the specified additional components.
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The complaint refers to "Exemplary Defendant Products" but does not name any specific accused product, method, or service (Compl. ¶11). These products are identified in claim charts attached as Exhibit 2 to the complaint, which were not available for this analysis (Compl. ¶16).

Functionality and Market Context

The complaint alleges that the accused products are topical formulations that "practice the technology claimed by the '563' Patent" (Compl. ¶16). It further alleges that the Defendant has made, used, offered to sell, and sold these products in the United States (Compl. ¶11). The complaint does not provide sufficient detail for analysis of the accused products' specific functionality or market positioning.

IV. Analysis of Infringement Allegations

The complaint alleges that the Defendant's "Exemplary Defendant Products" directly infringe the '563' Patent because they "satisfy all elements of the Exemplary '563' Patent Claims" (Compl. ¶16). The complaint incorporates claim charts by reference in its Exhibit 2, but this exhibit was not provided (Compl. ¶17). No probative visual evidence provided in complaint.

The narrative infringement theory asserts that Defendant directly infringes by making, using, and selling the accused topical products (Compl. ¶11). A specific allegation of direct infringement is also made based on the Defendant's employees "internally test[ing] and us[ing] these Exemplary Products" (Compl. ¶12).

Identified Points of Contention

• Evidentiary Questions: A central factual dispute will likely be whether the accused products actually contain the claimed ingredients at the specified concentrations. Key questions include:
  • What is the precise chemical composition of the accused products?
  • Does testing show the concentration of THC and/or CBD is "greater than 2 milligrams per kilogram" as required by the independent claims ('563' Patent, col. 17:19-21)?
  • Do the products contain at least one of the additional required components (e.g., hydrocortisone, salicylic acid) in an amount of "at least 0.1 wt %" ('563' Patent, col. 17:15-17)?
• Scope Questions: The use of the transitional phrase "consisting essentially of" in the claims raises a significant question of claim scope. The dispute may turn on whether the accused products contain unrecited ingredients and, if so, whether those ingredients "materially affect the basic and novel characteristics of the claimed invention" ('563' Patent, col. 4:13-20).

V. Key Claim Terms for Construction

"consisting essentially of"

• Context and Importance: This transitional phrase appears in independent claim 1 and is narrower than "comprising" but broader than "consisting of." Its construction will be critical for determining whether any unlisted ingredients in the Defendant’s products are permissible or take the product outside the scope of the claims. Practitioners may focus on this term because it directly controls the universe of accused compositions.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The phrase by its nature allows for the presence of unrecited elements, so long as they are not material. A party might argue that common excipients (e.g., preservatives, fragrances) do not materially affect the core therapeutic function.
  • Evidence for a Narrower Interpretation: The patent specification explicitly defines the term, stating it "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" ('563' Patent, col. 4:13-20). The "basic and novel" characteristic is arguably the topical treatment of dermatological disease using the specified cannabinoid concentration.

"an extract of cannabis sativa or cannabis indicia"

• Context and Importance: This term defines the primary active ingredient. The nature of the cannabis-derived substance in the accused products—whether it is a true extract, a purified oil, a synthetic cannabinoid, or another form—will be central to the infringement analysis.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent broadly defines the related term "Cannabis derived biological drug product" to 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; and fractions of extracts or oils" ('563' Patent, col. 7:1-12). This suggests a wide range of source materials could qualify.
  • Evidence for a Narrower Interpretation: The specification distinguishes "botanical drug products" from "highly purified or chemically modified botanical substances," stating the latter "are not considered botanical drug products" ('563' Patent, col. 6:65-67). This language could be used to argue that a highly processed or synthetic cannabinoid in an accused product would not meet the claim limitation.

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement, stating that since being served the complaint, the Defendant has knowingly and intentionally induced infringement by selling its products to customers for infringing uses (Compl. ¶15). The basis for inducement is also alleged to be the distribution of "product literature and website materials" that instruct end users on the infringing use (Compl. ¶14).

Willful Infringement

The complaint does not use the term "willful," but it alleges that service of the complaint constitutes "Actual Knowledge of Infringement" (Compl. ¶13). It further alleges that despite this knowledge, the Defendant "continues to make, use, test, sell, offer for sale, market, and/or import" the accused products (Compl. ¶14). The prayer for relief requests that the case be declared "exceptional" under 35 U.S.C. § 285, which is often tied to findings of willful infringement or litigation misconduct (Prayer ¶E.i).

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

1. A primary issue will be one of chemical evidence: Can the Plaintiff produce evidence, likely through discovery and expert testing, demonstrating that the Defendant's accused products contain not only an "extract of cannabis" but also the specific concentrations of THC or CBD (>2 mg/kg) and the secondary active ingredients (≥ 0.1 wt%) required by the claims?

2. A secondary issue will be one of claim scope: How will the court construe the term "consisting essentially of"? The case may turn on whether the accused products contain additional, un-claimed ingredients and, if so, whether those ingredients will be found to "materially affect the basic and novel characteristics" of the patented formulation, thereby allowing the Defendant to escape infringement.