Metronome LLC v. Purekana LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Purekana, LLC (DE)
  • Plaintiff’s Counsel: Garibian Law Offices, P.C.; Rabicoff Law LLC
• Case Identification: 1:25-cv-00284, D. Del., 03/10/2025
• Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant has an established place of business in the district and has committed acts of patent infringement there.
• Core Dispute: Plaintiff alleges that Defendant’s topical botanical products infringe a patent related to topical treatments incorporating cannabis-derived compounds at specific concentrations.
• Technical Context: The technology relates to dermatological formulations, specifically topical creams, lotions, and ointments that utilize extracts from the Cannabis plant for therapeutic purposes.
• 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 (Issued May 19, 2020)

The Invention Explained

• Problem Addressed: The patent describes a need for new topical treatments for dermatological diseases that utilize the pharmacological activities of cannabis-derived compounds. It notes that prior art focus was on systemic administration or on topical products with only trace amounts of cannabinoids, such as hemp oil. (’736 Patent, col. 1:50-col. 2:28).
• The Patented Solution: The invention is a topical formulation containing a "Cannabis derived botanical drug product" where the concentration of tetrahydrocannabinol (THC), cannabidiol (CBD), or both is greater than 2 milligrams per kilogram. This formulation is intended to provide "unexpected and highly beneficial treatments" for skin conditions like psoriasis. (’736 Patent, Abstract; col. 2:25-28, 42-47).
• Technical Importance: The patent suggests that using cannabinoids in topical formulations at concentrations exceeding the typical legal limits for foodstuffs or hemp oil unlocks unforeseen therapeutic potential for dermatological diseases. (’736 Patent, col. 2:18-28).

Key Claims at a Glance

• The complaint asserts "one or more claims" of the ’736 Patent, referencing an "Exemplary '736 Patent Claims" list in an exhibit not attached to the publicly filed complaint (Compl. ¶11). The patent’s sole independent claim is Claim 1.
• Independent Claim 1 requires:
  • 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 %;
  • a concentration of at least one of THC or CBD greater than 2 mg/kg; and
  • the formulation is dispersed in a specific base (e.g., a water-in-oil emulsion, oil-in-water emulsion, etc.).
• The complaint’s reference to "one or more claims" suggests the right to assert dependent claims is reserved (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

The complaint does not name any specific accused products, referring only to "Exemplary Defendant Products" identified in charts within an external Exhibit 2, which was not filed with the complaint (Compl. ¶11, ¶16).

Functionality and Market Context

The complaint provides no specific details regarding the formulation, ingredients, or function of the accused products. All allegations of infringing functionality are incorporated by reference to the un-filed Exhibit 2 (Compl. ¶17). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the "Exemplary Defendant Products" directly infringe the ’736 Patent and states that claim charts demonstrating this are provided in Exhibit 2 (Compl. ¶11, ¶16). As Exhibit 2 was not included with the filed complaint, a detailed element-by-element analysis is not possible based on the provided documents. The complaint’s narrative theory is that the accused products "practice the technology claimed by the '736 Patent" and "satisfy all elements of the Exemplary '736 Patent Claims" (Compl. ¶16).

Identified Points of Contention

• Evidentiary Question: A central issue will be whether Plaintiff can produce sufficient evidence, such as through chemical analysis of the accused products, to demonstrate the presence of every component required by Claim 1 (an "extract," specific concentrations of THC/CBD, and 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 active ingredients in the accused products "materially affect the basic and novel characteristics of the claimed invention" (’736 Patent, col. 4:25-30). If so, the products may fall outside the claim's scope.

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

• Context and Importance: This transitional phrase limits the scope of the claim to the specified ingredients and those that do not materially affect the invention's "basic and novel characteristics." The infringement analysis will depend heavily on how those characteristics are defined and whether any additional ingredients in Defendant’s products are found to materially alter them.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent does not explicitly define the "basic and novel characteristics." A party could argue they relate broadly to the topical delivery of a cannabis extract at a therapeutic concentration (>2 mg/kg) for treating a dermatological condition (’736 Patent, col. 2:18-28).
  • Evidence for a Narrower Interpretation: A party could argue the characteristics are tied to the specific combination of the cannabis extract and the additional active agents (menthol, resorcinol, phenol). The patent itself discloses numerous other potential active ingredients for different embodiments, which could be argued to represent material additions if found in an accused product but not recited in Claim 1 (’736 Patent, col. 7:42-col. 10:29).

The Term: "extract of Cannabis sativa or Cannabis indica"

• Context and Importance: Claim 1 requires an "extract," not just isolated cannabinoid compounds. The method of production and final composition of the cannabis-derived component in the accused products will be critical to determining infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification defines the broader term "Cannabis derived biological drug product" to include oils pressed from seeds, powders, and various types of extracts prepared using solvents, which could support a more expansive view of what qualifies (’736 Patent, col. 7:13-26).
  • Evidence for a Narrower Interpretation: Claim 1 specifically recites an "extract," which is narrower than the general term used in the specification. A party could argue that this term requires a product of a direct extraction process from plant material, as distinct from a formulation using highly purified or synthetically derived THC or CBD compounds that may not meet the definition of a botanical "extract."

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement, stating that Defendant distributes "product literature and website materials" that instruct end-users on an infringing use of the products (Compl. ¶14). Knowledge for inducement is alleged to exist "at least since being served by this Complaint" (Compl. ¶15).

Willful Infringement

The complaint alleges that service of the complaint and its associated (but un-filed) claim charts provides Defendant with "actual knowledge of infringement" (Compl. ¶13). It further alleges that Defendant’s continued infringing activities despite this knowledge constitute willful infringement (Compl. ¶14).

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

1. Evidentiary Sufficiency: As the complaint lacks specific factual allegations, a primary question will be whether the Plaintiff can produce sufficient evidence to prove that Defendant’s unnamed products contain the precise combination of chemical components and concentrations required by the asserted claims.

2. Claim Scope ("Consisting Essentially Of"): A central legal issue will be the scope of the "consisting essentially of" limitation. The case may turn on whether the accused products contain additional active ingredients and, if so, whether those ingredients "materially affect" the basic and novel characteristics of the patented formulation, thereby placing them outside the claim’s scope.

3. Definitional Scope ("Extract"): A key technical and legal question will be one of definitional scope: can the term "extract," as used in Claim 1, be construed to cover the specific cannabis-derived component used in the accused products, or will evidence show it to be a purified or isolated compound that falls outside the boundaries of that term?