Metronome LLC v. Axcentria Pharma LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (Minnesota)
  • Defendant: Axcentria Pharmaceuticals, LLC (Delaware)
  • Plaintiff’s Counsel: Silverman, McDonald & Friedman; Rabicoff Law LLC
• Case Identification: 1:25-cv-01185, D. Del., 09/24/2025
• Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is incorporated in Delaware and has committed acts of patent infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s pharmaceutical products infringe a patent related to topical treatments containing cannabis-derived compounds.
• Technical Context: The technology concerns topical formulations for treating dermatological diseases, specifically using botanical drug products derived from Cannabis species that contain specified concentrations of cannabinoids.
• 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”

The Invention Explained

• Problem Addressed: The patent background describes a need for new topical formulations that utilize the pharmacological activities of cannabis-derived compounds for treating dermatological diseases, distinct from their known uses as neuroprotectants and at concentrations exceeding the low levels found in products like commercial hemp oil (Compl. Ex. 1, ’736 Patent, col. 2:18-28).
• 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 greater than 2 milligrams per kilogram (’736 Patent, Abstract; col. 4:50-56). This formulation is intended for treating skin conditions, with the patent providing an illustration of skin affected by psoriasis before and after treatment as an example of its application (’736 Patent, FIG. 1-2; col. 2:41-46).
• Technical Importance: The specified concentration of cannabinoids was presented as a way to provide "unexpected and highly beneficial treatments for a wide variety of diseases" beyond what was achievable with existing low-concentration cannabis products (’736 Patent, col. 2:25-28).

Key Claims at a Glance

The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶11). Independent claim 1 is representative:

• 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 % in the topical formulation,
• wherein a concentration of at least one component selected from the group consisting of tetrahydrocannabinol and cannabidiol in the topical formulation is greater than 2 milligrams per kilogram, and
• wherein the topical formulation is obtained by dispersing the extract in a water-in-oil emulsion, an oil-in-water emulsion, a wax-in-oil base, or an oil-in-wax base.

III. The Accused Instrumentality

Product Identification

The complaint refers to the accused instrumentalities as the "Exemplary Defendant Products" (Compl. ¶11).

Functionality and Market Context

The complaint does not provide specific names, features, or functions of any accused products. It states that infringement allegations and product details are contained in claim charts attached as Exhibit 2 (Compl. ¶16), but this exhibit was not filed with the complaint. Therefore, the complaint itself does not provide sufficient detail for analysis of the accused instrumentality.

IV. Analysis of Infringement Allegations

The complaint incorporates by reference an external claim chart (Exhibit 2) that was not provided with the pleading (Compl. ¶17). The complaint’s narrative theory alleges that the "Exemplary Defendant Products practice the technology claimed by the '736 Patent" and "satisfy all elements of the Exemplary '736 Patent Claims" (Compl. ¶16). However, the complaint provides no specific factual allegations mapping any feature of an accused product to any specific limitation of a patent claim.

No probative visual evidence provided in complaint.

• Identified Points of Contention: Based on the patent language and the conclusory nature of the complaint's allegations, the dispute may raise several questions:
  • Scope Questions: Claim 1 uses the transitional phrase "consisting essentially of," which limits the claim to the listed ingredients and any others that do not materially affect the basic and novel properties of the invention. A central question may be whether the accused products contain other active ingredients and, if so, whether those ingredients materially alter the formulation's properties.
  • Technical Questions: A primary evidentiary question will be whether Defendant's products meet the specific compositional requirements of the claims. For example, does the accused product contain an "extract of Cannabis sativa or Cannabis indica," as opposed to synthetic or isolated cannabinoids? Further, does it meet the dual concentration thresholds of "> 2 mg/kg" for cannabinoids and "at least 0.1 wt %" for menthol, resorcinol, or phenol? The complaint provides no facts to support these points.

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

• Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." Its construction will define the scope of permissible unlisted ingredients in an infringing product. Practitioners may focus on this term because if the accused products contain additional active ingredients (e.g., other anti-inflammatory agents, analgesics), the dispute will turn on whether those ingredients "materially affect the basic and novel properties" of the claimed cannabis-based formulation.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent specification describes numerous embodiments that add other active compounds—such as hydrocortisone, antibiotics, and antifungal agents—to the basic formulation, suggesting these additions are separate, non-material enhancements rather than part of the core inventive concept (’736 Patent, col. 8:9-11, col. 8:36-38).
  • Evidence for a Narrower Interpretation: A party could argue that the "basic and novel properties" relate narrowly to the therapeutic effect derived only from the combination of the cannabis extract and the menthol/resorcinol/phenol group. Under this view, any other ingredient with a distinct therapeutic effect could be argued to materially alter the formulation's properties.

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

• Context and Importance: The definition of "extract" will be critical to determining infringement. The case may hinge on whether Defendant's products use a substance that qualifies as an "extract" from the plant, or if they instead use cannabinoids that are synthesized, isolated and purified, or derived in a manner that falls outside the ordinary meaning of an extract.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification defines the broader term "Cannabis derived biological drug product" to encompass a wide range of materials, including "oils pressed from the seeds," "powders," and extracts prepared using various methods like organic solvents or liquid carbon dioxide (’736 Patent, col. 7:14-24). A party may argue this broad disclosure informs the meaning of "extract."
  • Evidence for a Narrower Interpretation: The claim language itself is more specific than the specification's general definitions, using only the term "extract." A party may argue that this choice was a deliberate narrowing of scope and excludes other forms of cannabis-derived products, such as highly purified CBD isolate that no longer retains the characteristics of a botanical "extract."

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement based on conduct occurring "at least since being served by this Complaint" (Compl. ¶15). The alleged inducing acts include selling the accused products and distributing "product literature and website materials" that instruct end users on an infringing use (Compl. ¶14).

Willful Infringement

The complaint does not use the word "willful" but alleges "Actual Knowledge of Infringement" arises from the service of the complaint and its attached claim charts (Compl. ¶13). This forms a basis for potential enhanced damages for any infringement occurring after the complaint was filed. No pre-suit knowledge is alleged.

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

• A core issue will be one of evidentiary proof: As the complaint lacks specific factual allegations, the case will depend entirely on whether discovery reveals that the accused products actually contain the precise combination of ingredients at the specific concentrations required by claim 1—namely, a botanical Cannabis extract, a cannabinoid concentration over 2 mg/kg, a menthol/resorcinol/phenol concentration over 0.1 wt %, and an emulsion or wax base.
• A second key issue will be one of claim scope: The interpretation of "consisting essentially of" will be dispositive. The central question for the court will be defining the "basic and novel properties" of the invention to determine whether any additional active ingredients in the Defendant's products materially alter those properties and thereby place the products outside the patent's scope.
• A final question will concern the nature of the ingredient: The case may turn on a fine technical distinction regarding the term "extract." The court will have to determine whether the defendant's cannabinoid source qualifies as an "extract of Cannabis sativa or Cannabis indica," or if it is a substance (e.g., a synthetic cannabinoid or a purified isolate) that falls outside that definition.