Metronome LLC v. Global Products Group LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Metronome LLC (MN)
  • Defendant: Global Products Group LLC (NJ)
  • Plaintiff’s Counsel: GARIBIAN LAW OFFICES, P.C.; Rabicoff Law LLC
• Case Identification: 2:25-cv-01935, D.N.J., 03/18/2025
• Venue Allegations: Venue is alleged to be proper based on the Defendant having an established place of business in the District of New Jersey and having committed acts of patent infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant’s topical products infringe a patent related to formulations containing specific concentrations of Cannabis-derived botanical products.
• Technical Context: The technology resides in the field of topical therapeutic formulations, specifically using extracts from the Cannabis plant for treating dermatological conditions.
• Key Procedural History: The complaint notes that Plaintiff is the assignee of the patent-in-suit. No other procedural events, such as prior litigation or administrative challenges to the patent, are mentioned.

Case Timeline

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

U.S. Patent No. 9,095,563 - Topical treatments incorporating Cannabis sp. derived botanical drug product

The Invention Explained

• Problem Addressed: The patent’s background section identifies a need for topical formulations that utilize Cannabis-derived products at concentrations exceeding the low levels typically permitted in commercial products like hemp oil (’563 Patent, col. 2:12-23). The patent distinguishes its approach from prior art focused on non-topical, neuroprotective uses that sought to minimize tetrahydrocannabinol (THC) content (’563 Patent, col. 2:1-11).
• The Patented Solution: The invention provides 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 (’563 Patent, Abstract; col. 2:26-34). The detailed description outlines various forms for the formulation, such as lotions, creams, and salves, and contemplates the inclusion of other therapeutic agents alongside the cannabis extract (’563 Patent, col. 3:28-65).
• Technical Importance: The technology proposes leveraging the "diverse pharmacologic activities" of cannabinoids at higher concentrations for topical treatment of skin diseases, a departure from prior uses that were constrained by legal and technical limits on THC content (’563 Patent, col. 2:14-23).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" of the ’563 Patent, referencing "Exemplary ’563 Patent Claims" in an exhibit not provided with the complaint (Compl. ¶11). Independent claim 1 is a representative claim.
• Independent Claim 1 elements:
  • A topical formulation consisting essentially of an extract of cannabis sativa or cannabis indicia and at least one other specified component (e.g., capsaicin, hydrocortisone).
  • The concentration of tetrahydrocannabinol in the formulation is greater than 2 milligrams per kilogram.
  • The formulation is obtained by dispersing the cannabis extract in a specific base (e.g., a water-in-oil emulsion) which itself consists essentially of one of the specified components.

III. The Accused Instrumentality

Product Identification

The complaint identifies the accused products as the "Exemplary Defendant Products" detailed in charts within Exhibit 2 (Compl. ¶11). This exhibit was not included with the publicly filed complaint.

Functionality and Market Context

The complaint does not provide sufficient detail for analysis of the accused products' specific functionality or market context. It makes the general allegation that the products "practice the technology claimed by the '563 Patent" and are made, used, sold, or imported by the Defendant (Compl. ¶11, ¶16).

IV. Analysis of Infringement Allegations

The complaint incorporates by reference claim charts from Exhibit 2 to support its infringement allegations, but this exhibit is not available for analysis (Compl. ¶17). The narrative theory presented in the complaint is that the unspecified "Exemplary Defendant Products" infringe one or more claims of the ’563 Patent, both literally and under the doctrine of equivalents (Compl. ¶11). The complaint alleges these products "satisfy all elements of the Exemplary '563 Patent Claims" (Compl. ¶16). No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Scope Questions: The use of the transitional phrase "consisting essentially of" in Claim 1 limits the formulation to the listed ingredients and any others that do not "materially affect the basic and novel characteristics" of the invention (’563 Patent, col. 4:13-21). A central dispute may be whether any unlisted ingredients in the accused products materially alter the formulation's properties, thereby avoiding infringement.
  • Technical Questions: A key factual question will be whether Plaintiff can prove that the accused products contain an "extract of cannabis sativa or cannabis indicia" and that the concentration of THC is definitively "greater than 2 milligrams per kilogram" as required by the claim (’563 Patent, col. 17:19-21). The source of the cannabinoid (e.g., botanical extract vs. synthetic) and the methodology for measuring its concentration will be critical evidentiary points.

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

  • Context and Importance: This term, which appears twice in Claim 1, is critical for defining the scope of the claimed composition. The infringement analysis will depend on whether any additional ingredients in the accused products are found to "materially affect the basic and novel characteristics" of the invention (’563 Patent, col. 4:17-21). Practitioners may focus on this term because it creates a potential non-infringement defense if the accused products contain other active or functional ingredients.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not offer significant evidence for a broad reading. The term itself is a legal term of art with a defined meaning that is narrower than "comprising."
    • Evidence for a Narrower Interpretation: The specification explicitly states that this term "limits the scope of the claim to the materials specified" and "excludes those materials or stages that materially affect the basic and novel characteristics of the claimed invention" (’563 Patent, col. 4:13-21). The defense may argue that the "basic and novel characteristic" is the specific therapeutic effect from the claimed combination, and any other active ingredient would materially affect it.

• The Term: "extract of cannabis sativa or cannabis indicia"

  • Context and Importance: The definition of "extract" is central to infringement, as the source of the cannabinoids in the accused product will be scrutinized. A defendant could argue its product uses a substance, such as a synthetic cannabinoid, that does not qualify as a botanical "extract."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification defines a related term, "Cannabis derived biological drug product," very broadly to include oils, powders, and various types of solvent extracts (’563 Patent, col. 7:1-12). A party could argue this broad definition should inform the meaning of "extract."
    • Evidence for a Narrower Interpretation: The specification also notes that "highly purified or chemically modified botanical substances are not considered botanical drug products" (’563 Patent, col. 6:65-67). A party could argue that if the accused product uses such a purified substance, it falls outside the scope of a botanical "extract" as contemplated by the patent.

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" (Compl. ¶14).
• Willful Infringement: The willfulness allegation is based on post-suit conduct. The complaint alleges that the service of the complaint itself provides "actual knowledge" and that Defendant's continued alleged infringement thereafter is willful (Compl. ¶13-14). No facts suggesting pre-suit knowledge are alleged.

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

1. A core issue will be one of definitional scope and evidence: Can the term "extract of cannabis sativa or cannabis indicia" be construed to cover the specific cannabinoid source used in the accused products, and can the Plaintiff provide sufficient evidence that the THC concentration in those products exceeds the claimed 2 mg/kg threshold?
2. A second key issue will be one of claim limitation: Do the accused formulations contain any unlisted ingredients that "materially affect the basic and novel characteristics" of the invention, thereby placing the products outside the scope of claims that use the transitional phrase "consisting essentially of"?
3. A threshold procedural question arises from the complaint's reliance on an unattached exhibit to identify the accused products and detail the infringement theory. This raises the possibility of a challenge to the sufficiency of the pleadings under federal rules.