Metronome LLC v. Bioserene Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Bioserene, Inc. (FL)
  • Plaintiff’s Counsel: Beusse Sanks, PLLC; Rabicoff Law LLC
• Case Identification: 2:25-cv-14255, S.D. Fla., 07/16/2025
• Venue Allegations: Venue is asserted on the basis that Defendant has an established place of business in the Southern District of Florida and has allegedly committed acts of patent infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical botanical products infringe a patent related to formulations containing specific concentrations of cannabis-derived compounds.
• Technical Context: The technology concerns topical pharmaceutical and cosmetic formulations that incorporate specific cannabis compounds, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), for treating dermatological diseases.
• 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.

Case Timeline

Date	Event
2013-09-26	Priority Date for U.S. Patent No. 10,653,736
2020-05-19	U.S. Patent No. 10,653,736 Issued
2025-07-16	Complaint Filed

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

U.S. Patent No. 10,653,736 - “Topical treatments incorporating cannabis sp. derived botanical drug product”

• Patent Identification: 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 background describes a need for topical formulations that utilize the pharmacological properties of cannabis-derived compounds at concentrations that exceed the low, legally-defined levels found in products like commercial hemp oil (’736 Patent, col. 2:18-28). The patent notes that prior art focused on systemic administration or use as neuroprotectants, without disclosing topical compositions with THC levels above a detection limit ('736 Patent, col. 2:5-17).
• The Patented Solution: The invention is a topical formulation comprising a cannabis-derived botanical drug product, such as an extract, where the concentration of THC, CBD, or both is specifically greater than 2 milligrams per kilogram ('736 Patent, Abstract; col. 2:31-36). The patent describes various forms for the formulation, including lotions, creams, and ointments, and specifies that the "Cannabis derived biological drug product" can be prepared from Cannabis indica or sativa through various extraction methods ('736 Patent, col. 7:14-30).
• Technical Importance: The invention aims to provide a treatment for dermatological diseases, such as psoriasis, by leveraging the anti-inflammatory and analgesic properties of cannabinoids in a direct, topically-applied manner ('736 Patent, col. 1:19-22, col. 13:24-35).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" of the ’736 Patent, referring to them as the "Exemplary '736 Patent Claims" (Compl. ¶11).
• Independent Claim 1:
  • 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 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 does not specify which, if any, dependent claims are asserted, but generally alleges infringement of the patent (Compl. ¶11).

III. The Accused Instrumentality

Product Identification

• The complaint does not name specific accused products in its main body. It refers to "Exemplary Defendant Products" that are identified in claim charts attached as Exhibit 2 (Compl. ¶11, ¶16). This exhibit was not provided.

Functionality and Market Context

• The complaint alleges that the unspecified "Exemplary Defendant Products" are topical products that "practice the technology claimed by the '736 Patent" (Compl. ¶16). The complaint further alleges that Defendant makes, uses, sells, and imports these products within the United States (Compl. ¶11). The complaint does not provide sufficient detail for analysis of the products' specific functionality or market positioning.

IV. Analysis of Infringement Allegations

The complaint references, but does not include, "Exhibit 2," which it states contains "charts comparing the Exemplary '736 Patent Claims to the Exemplary Defendant Products" (Compl. ¶16). The complaint’s narrative theory of infringement is that these unspecified products "satisfy all elements of the Exemplary '736 Patent Claims" (Compl. ¶16). Lacking the specific factual mappings from the referenced exhibit, the infringement theory relies on the conclusory allegation that the accused products contain all the elements of at least one claim. No probative visual evidence provided in complaint.

Identified Points of Contention

• Compositional Questions: A central factual dispute will likely concern the precise chemical composition of the accused products. The plaintiff will need to present evidence, presumably from chemical analysis, demonstrating that the products contain: (1) an extract of Cannabis sativa or indica; (2) menthol, resorcinol, or phenol at ≥0.1 wt %; and (3) THC and/or CBD at a concentration >2 mg/kg, as required by claim 1.
• Scope Questions: The use of the transitional phrase "consisting essentially of" in claim 1 raises the question of whether the accused products contain other ingredients that "materially affect the basic and novel characteristics of the claimed invention" ('736 Patent, col. 4:25-31). The presence of other active pharmaceutical ingredients in the accused products could become a basis for a non-infringement argument.

V. Key Claim Terms for Construction

"consisting essentially of"

• Context and Importance: This transitional phrase, which appears in independent claim 1, is a term of art that is narrower than "comprising" but broader than "consisting of." Its construction will be critical to determining the scope of the claim. Practitioners may focus on this term because if the accused products contain additional, unlisted ingredients, the infringement analysis will hinge on whether those ingredients "materially affect the basic and novel characteristics" of the invention.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that the "basic and novel characteristic" is simply the delivery of a specific concentration of cannabinoids topically, and thus many other common cosmetic or pharmaceutical ingredients would not be material.
  • Evidence for a Narrower Interpretation: The patent itself explicitly defines the term, stating that it "limits the scope of the claim" and "excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" ('736 Patent, col. 4:25-31). A party could argue that the "basic and novel characteristic" is the specific combination of the cannabis extract with the phenol/menthol/resorcinol group, and the addition of any other active ingredient would be a material alteration.

"a Cannabis derived botanical drug product"

• Context and Importance: This term, recited in the patent title and throughout the specification, is defined in the patent as the core component of the formulation. The breadth of this definition will be important for establishing the scope of accused materials.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification provides a broad definition, stating the term is "prepared form varieties of Cannabis indica and sativia" and includes "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 language suggests the term covers a wide range of cannabis-derived materials.
  • Evidence for a Narrower Interpretation: A party might argue that the context of treating dermatological diseases implies the term should be limited to preparations suitable for pharmaceutical use, potentially excluding cruder forms like "hashish" if used in a non-pharmaceutical context. The patent’s distinction from products like "Canadian hemp seed oil" with low THC levels could also be used to argue for a narrower scope limited to high-potency extracts ('736 Patent, col. 1:56-61).

VI. Other Allegations

Indirect Infringement

• The complaint alleges induced infringement, stating that Defendant distributes "product literature and website materials inducing end users and others to use its products in the customary and intended manner that infringes" the ’736 Patent (Compl. ¶14). The specific content of this literature is not detailed in the complaint but is referenced as being part of Exhibit 2 (Compl. ¶14).

Willful Infringement

• The complaint does not use the term "willful." However, it alleges that Defendant has had "actual knowledge of infringement" since the service of the complaint and has "continued to make, use, test, sell, offer for sale, market, and/or import" the accused products thereafter (Compl. ¶13-14). These allegations may form the basis for a claim of post-filing willful infringement and a request for enhanced damages under 35 U.S.C. § 284.

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

This dispute, as framed by the complaint, appears to center on fundamental questions of claim scope and evidence. The key issues for the court will likely be:

1. A question of claim scope: How will the court construe the phrase "consisting essentially of"? The outcome will determine whether the presence of any additional active ingredients in Defendant's products can defeat Plaintiff's infringement claim.

2. An evidentiary question of composition: Assuming the claim scope is resolved, can Plaintiff produce sufficient evidence, likely through expert testing and analysis, to prove that Defendant’s products contain the precise combination of ingredients (a cannabis extract, a phenol-group compound, and a specific concentration of cannabinoids) required to meet all limitations of the asserted claims?