Metronome LLC v. Smartscience Laboratories Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: SmartScience Laboratories, Inc. (FL)
  • Plaintiff’s Counsel: Beusse Sanks, PLLC; Rabicoff Law LLC
• Case Identification: 8:25-cv-01844, M.D. Fla., 07/16/2025
• Venue Allegations: Venue is alleged to be proper because Defendant maintains an established place of business in the Middle District of Florida, has committed alleged acts of infringement in the district, and has caused Plaintiff harm there.
• Core Dispute: Plaintiff alleges that Defendant’s topical products infringe a patent related to formulations containing specific concentrations of cannabis-derived compounds for treating dermatological conditions.
• Technical Context: The technology resides in the field of pharmaceutical and cosmeceutical formulations, specifically leveraging cannabis extracts for topical therapeutic applications.
• Key Procedural History: The patent-in-suit claims priority back to a 2013 provisional application through a chain of continuing applications, which may be relevant to assessing the scope of prior art and potential prosecution history estoppel. The complaint does not mention any prior litigation or administrative proceedings involving the patent.

Case Timeline

Date	Event
2013-09-26	U.S. Patent 10,653,736 Priority Date
2019-01-25	U.S. Patent 10,653,736 Application Date
2020-05-19	U.S. Patent 10,653,736 Issue Date
2025-07-16	Complaint Filing Date

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 asserts a need for new topical treatments for dermatological diseases, noting that prior development of cannabinoid-containing products had largely focused on systemic administration (e.g., for psychotropic or neuroprotective effects) rather than topical applications with specific, low-level concentrations of active ingredients like tetrahydrocannabinol (THC). (Compl. ¶9; ’736 Patent, col. 2:1-28).
• The Patented Solution: The invention is a topical formulation that includes a “Cannabis derived botanical drug product” where the concentration of THC, cannabidiol (CBD), or both is greater than 2 milligrams per kilogram (2 ppm). (’736 Patent, Abstract). The patent describes this formulation as providing "unexpected and highly beneficial treatments for a wide variety of diseases," including dermatological conditions like psoriasis. (’736 Patent, col. 2:26-28, col. 2:40-47). The patent’s FIG. 2 purports to show the result of treating a psoriasis-affected area, illustrating the claimed therapeutic effect. (’736 Patent, col. 2:42-47).
• Technical Importance: The invention claims to provide a therapeutic benefit by using specific concentrations of cannabinoids in a topical format, an approach the patent suggests was previously underexplored due to a focus on the systemic and psychoactive effects of such compounds. (’736 Patent, col. 2:18-28).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims," identified as "Exemplary '736 Patent Claims" in an incorporated exhibit not provided with the complaint. (Compl. ¶11). The patent contains a single independent claim, Claim 1.
• Independent 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 % 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.
• The complaint’s allegation of infringement of "one or more claims" suggests it may assert dependent claims in addition to the independent claim. (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

The complaint refers to "Exemplary Defendant Products" but identifies them only within claim charts in Exhibit 2, which was not publicly filed with the complaint. (Compl. ¶11).

Functionality and Market Context

The complaint alleges that the accused products "practice the technology claimed by the '736 Patent," implying they are topical formulations containing cannabis-derived compounds. (Compl. ¶16). The complaint does not provide specific details about the accused products' technical functionality, commercial importance, or market position.

IV. Analysis of Infringement Allegations

The complaint incorporates by reference claim charts (Exhibit 2) that allegedly detail the infringement theory, but this exhibit was not provided. The complaint’s narrative alleges that Defendant’s products satisfy all elements of the asserted claims. (Compl. ¶16-17). The core of the infringement allegation is that the Defendant makes, uses, and sells topical products that are formulations containing a cannabis extract with specific concentrations of THC and/or CBD, along with other specified ingredients, for use in treating skin conditions. (Compl. ¶11, ¶16). The complaint also alleges direct infringement occurs when Defendant’s employees "internally test and use" the accused products. (Compl. ¶12). A visual in the patent, FIG. 2, shows the improved appearance of skin affected by psoriasis after treatment, illustrating the type of therapeutic effect the patent claims and which plaintiff implicitly alleges the accused products provide. ('736 Patent, FIG. 2).

The complaint does not provide sufficient detail for a tabular analysis of infringement allegations.

Identified Points of Contention

• Scope Questions: Claim 1 uses the transitional phrase "consisting essentially of," which limits the claim to the listed elements and other components that do not materially affect its "basic and novel characteristics." (’736 Patent, col. 4:25-31). A central dispute may be whether unlisted ingredients in the accused products materially alter the formulation's therapeutic properties, thereby taking the products outside the claim's scope.
• Technical Questions: The infringement claim depends on at least two key factual questions requiring evidentiary proof: (1) Do the accused products contain a concentration of THC and/or CBD that is verifiably "greater than 2 milligrams per kilogram"? (2) Do the accused products contain "at least 0.1 wt %" of menthol, resorcinol, or phenol, as required by the claim?

V. Key Claim Terms for Construction

"consisting essentially of"

• Context and Importance: This transitional phrase governs the scope of the entire claim. Its construction will determine whether the presence of any unrecited ingredients in Defendant's products is sufficient to avoid infringement. Practitioners may focus on this term because it creates a potential non-infringement defense if additional components in the accused product are found to materially alter the invention's characteristics.
• Intrinsic Evidence for a Broader Interpretation: The specification discloses numerous embodiments where the core formulation is combined with other agents, such as steroids, antibiotics, or anti-acne agents. (’736 Patent, col. 3:1-20). A party could argue these examples show that the "basic and novel characteristics" relate only to the therapeutic effect of the cannabinoids, and that many other ingredients can be added without materially affecting them.
• Intrinsic Evidence for a Narrower Interpretation: The patent itself defines the phrase as excluding materials that "materially affect the basic and novel characteristics of the claimed invention." (’736 Patent, col. 4:25-31). A party could argue that in a topical formulation, any additional active ingredient, or even an excipient that significantly affects skin penetration or stability, necessarily has a material effect.

"an extract of Cannabis sativa or Cannabis indica"

• Context and Importance: The definition of the starting material is fundamental to the infringement analysis. The dispute may turn on what methods of preparation qualify as creating an "extract."
• Intrinsic Evidence for a Broader Interpretation: The patent broadly defines the "Cannabis derived biological drug product" to include oils pressed from seeds, powders, and extracts prepared using various methods including organic solvents, water, and carbon dioxide. (’736 Patent, col. 7:14-25). This suggests "extract" could be interpreted broadly to cover many types of cannabis-derived preparations.
• Intrinsic Evidence for a Narrower Interpretation: The patent also states that, "Most preferably, the term 'a Cannabis derived botanical drug product' refers to the compounds obtained from chemical extraction of Cannabis." (’736 Patent, col. 7:26-28). A party may argue that this "most preferred" definition, combined with the claim's use of the word "extract," narrows the term's scope to preparations derived from a chemical extraction process, potentially excluding those made by other means like simple pressing.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, asserting that Defendant provides "product literature and website materials" that instruct and encourage end users to use the accused products in a manner that infringes the ’736 Patent. (Compl. ¶14-15).
• Willful Infringement: The willfulness allegation appears to be based on post-suit conduct. The complaint alleges that Defendant gained "actual knowledge" of infringement upon service of the complaint and that its continued activities thereafter are willful. (Compl. ¶13-14).

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

• A primary issue will be one of evidentiary proof: can the plaintiff produce reliable chemical analysis to demonstrate that the accused products meet the specific quantitative limitations of Claim 1, namely a cannabinoid concentration "greater than 2 milligrams per kilogram" and the presence of at least 0.1 wt% of menthol, resorcinol, or phenol?
• The case will likely turn on a question of claim scope: how will the court interpret "consisting essentially of"? The outcome may depend on whether any unlisted ingredients in the accused products are found to "materially affect" the formulation's fundamental therapeutic properties, thus placing them outside the bounds of the claim.
• A third key question will be one of definitional interpretation: does the term "extract," as used in the claim and defined in the specification, encompass the specific method by which Defendant derives the cannabis-based components for its accused products?