Metronome LLC v. Abacus Health Products Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Abacus Health Products, Inc. (DE)
  • Plaintiff’s Counsel: Garibian Law Offices, P.C.; Rabicoff Law LLC
• Case Identification: 1:25-cv-00274, D. Del., 03/07/2025
• Venue Allegations: Venue is asserted based on Defendant having an established place of business in the District of Delaware.
• Core Dispute: Plaintiff alleges that Defendant’s topical botanical products infringe a patent related to formulations incorporating specific concentrations of cannabis-derived compounds.
• Technical Context: The lawsuit concerns the field of topical dermatological treatments, specifically formulations that utilize cannabinoids like tetrahydrocannabinol (THC) and cannabidiol (CBD) for therapeutic effects.
• Key Procedural History: The complaint does not mention any prior litigation, inter partes review (IPR) proceedings, or specific licensing history related to the patent-in-suit. The allegations of willful and induced infringement are based on knowledge allegedly established by the filing of this complaint.

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 formulations using cannabis-derived products for treating dermatological diseases (’736 Patent, col. 2:18-22). It notes that prior art focus was on systemic administration or neuroprotective uses, and that legal limits on THC and CBD concentrations in products like hemp oil had constrained the development of topical treatments that could leverage the "diverse pharmacologic activities" of these compounds at higher concentrations (’736 Patent, col. 1:50-59; col. 2:18-28).
• The Patented Solution: The invention is a topical formulation that includes a "Cannabis derived botanical drug product" where the concentration of either tetrahydrocannabinol (THC) or cannabidiol (CBD) is specified to be "greater than 2 milligrams per kilogram" (’736 Patent, Abstract; col. 2:31-37). This approach is intended to provide "unexpected and highly beneficial treatments" for a variety of skin diseases, such as the plaque psoriasis depicted in the patent’s figures (’736 Patent, col. 2:25-28, 41-47).
• Technical Importance: The claimed invention sought to leverage cannabinoids for topical dermatological applications at concentrations exceeding then-common legal or commercial limits, moving beyond their known psychotropic or antioxidant properties to address skin conditions directly (’736 Patent, col. 2:18-28).

Key Claims at a Glance

• The complaint asserts "one or more claims," including unspecified "Exemplary '736 Patent Claims" (Compl. ¶11). Independent claim 1 is representative:
• Claim 1 Elements:
  • 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 %;
  • wherein a concentration of at least one component selected from the group consisting of tetrahydrocannabinol and cannabidiol is greater than 2 milligrams per kilogram; and
  • wherein the 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.
• The complaint states that Plaintiff may assert other claims, including dependent claims, at a later time (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

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

Functionality and Market Context

The complaint does not provide specific names or technical details for the accused products. It alleges that these products are made, used, sold, or imported by the Defendant and that they "practice the technology claimed by the '736 Patent" (Compl. ¶11, 16). The complaint references claim charts in an external exhibit, which are not included in the filed document, for a comparison of the accused products to the patent claims (Compl. ¶16). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint incorporates its infringement allegations by reference to claim charts in Exhibit 2, which was not provided with the complaint document (Compl. ¶16-17). The narrative infringement theory is that the "Exemplary Defendant Products" practice the claimed technology and "satisfy all elements of the Exemplary '736 Patent Claims" (Compl. ¶16). Without the charts, a detailed element-by-element analysis is not possible based on the complaint alone.

Identified Points of Contention

• Scope Questions: Claim 1 uses the transitional phrase "consisting essentially of," which limits the claim to the specified ingredients and any others that do not materially affect the "basic and novel characteristics" of the invention (’736 Patent, col. 3:25-30). A central dispute may be whether any additional ingredients in Defendant's products materially alter the formulation's properties, thereby placing them outside the claim's scope.
• Technical Questions: A key factual question will be whether the accused products contain the claimed concentration of THC and/or CBD—"greater than 2 milligrams per kilogram" (’736 Patent, col. 16:11-14). Proving this element will likely require discovery and scientific testing of the accused products. Another question is whether the accused products contain an "extract of Cannabis sativa or Cannabis indica" as opposed to, for example, a synthetically derived or highly purified cannabinoid, which may fall outside the patent's definition of a "botanical drug product" (’736 Patent, col. 7:10-13).

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

  • Context and Importance: This transitional phrase, used in independent claim 1, defines the boundary of the invention. Its construction will determine whether unlisted ingredients in the accused products are permissible. Practitioners may focus on this term because it creates a potential non-infringement defense if an accused product contains additional components that "materially affect" the invention's key characteristics.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term is generally understood in patent law to permit the presence of unrecited elements that are not material.
    • Evidence for a Narrower Interpretation: The specification explicitly defines the term to "exclude[] those materials or stages that materially affect the basic and novel characteristics of the claimed invention" (’736 Patent, col. 3:28-30). The scope will therefore depend on how the court defines those "basic and novel characteristics" based on the patent's teachings.

• The Term: "a Cannabis derived botanical drug product"

  • Context and Importance: This term, recited in the patent's summary and embodiments, is foundational to the claimed subject matter (’736 Patent, col. 2:32-33). The patent contrasts this term with other types of substances. Its definition is critical because if Defendant's products use cannabinoids sourced or processed in a way that falls outside this definition, they may not infringe.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent states the term includes materials from Cannabis indica and sativa, and covers "oils pressed from the seeds; powders...; extracts..., hemp oil; hashish oil; hashish; and fractions of extracts or oils" (’736 Patent, col. 7:14-25). This suggests a wide variety of preparations are included.
    • Evidence for a Narrower Interpretation: The specification explicitly states that "highly purified or chemically modified botanical substances are not considered botanical drug products" (’736 Patent, col. 7:11-13). This language could be used to argue that products containing isolated, synthetic, or heavily processed cannabinoids (e.g., CBD isolate) do not meet this limitation.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendant induces infringement by selling the accused products and distributing "product literature and website materials" that instruct customers on how to use the products in an infringing manner (Compl. ¶14-15). The knowledge element is alleged to be met "at least since being served by this Complaint" (Compl. ¶15).
• Willful Infringement: Willfulness is alleged based on Defendant’s continuation of infringing activities after receiving "actual knowledge" of the ’736 Patent via the service of the complaint (Compl. ¶13-14). This asserts a theory of post-filing willfulness.

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

This case appears to hinge on three central questions that will require judicial interpretation and factual discovery:

1. A definitional question: Do the accused products utilize an "extract of Cannabis sativa or Cannabis indica," as required by the claims, or do they contain cannabinoids (e.g., highly purified CBD isolate) that fall under the patent's explicit exclusion of "highly purified or chemically modified botanical substances"?
2. A scope question: Given the "consisting essentially of" claim language, what are the "basic and novel characteristics" of the patented formulation, and do any unlisted ingredients in the accused products materially affect those characteristics, thereby placing the products outside the claim scope?
3. An evidentiary question: Can the Plaintiff demonstrate through testing that Defendant’s products contain a concentration of THC or CBD "greater than 2 milligrams per kilogram," a specific quantitative threshold required for infringement of the asserted claims?