Axcess Global Sciences LLC v. BUDDIBOX LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Axcess Global Sciences, LLC (Utah)
  • Defendant: Buddibox LLC dba eSHOP DIRECT dba WW Supplements dba Total Vitamins (Georgia) and Hadis Nuhanovic (Georgia)
  • Plaintiff’s Counsel: Kent & Risley LLC; Workman | Nydegger
• Case Identification: 1:23-cv-06029, N.D. Ga., 12/29/2023
• Venue Allegations: Venue is alleged to be proper in the Northern District of Georgia because both defendants reside in the district, maintain a regular and established place of business there, and have committed a substantial portion of the alleged infringements from within the district.
• Core Dispute: Plaintiff alleges that Defendants’ extensive line of ketogenic dietary supplements infringes three patents related to specific formulations of beta-hydroxybutyrate (BHB) mixed salts.
• Technical Context: The lawsuit concerns the popular and competitive market for exogenous ketone supplements, which are designed to help users achieve or sustain a state of nutritional ketosis for purposes such as weight loss and athletic performance.
• Key Procedural History: The complaint alleges that the individual defendant, Hadis Nuhanovic, was previously indicted for, and pled guilty to, federal crimes related to selling counterfeit products and other fraudulent schemes, and that the conduct alleged in this lawsuit began while he was under criminal investigation.

Case Timeline

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

U.S. Patent No. 11,241,403 - "Beta-hydroxybutyrate mixed salt compositions and methods of use"

• Patent Identification: U.S. Patent No. 11241403, titled "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued on February 8, 2022.

The Invention Explained

• Problem Addressed: The patent describes the difficulty for individuals to transition into and maintain a state of nutritional ketosis, a process often accompanied by uncomfortable side effects like fatigue and headaches (the "low-carb flu") and potentially harmful electrolyte imbalances (’952 Patent, col. 2:3-56).
• The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) salts that can be ingested to raise blood ketone levels exogenously. The composition is formulated to provide a "biologically balanced set of cationic electrolytes" to mitigate the imbalances associated with ketosis (’952 Patent, col. 3:58-65). The specific composition of the ’403 Patent requires a plurality of BHB salts—including at least one salt from a calcium/magnesium group and at least one other salt from a broader group—and is explicitly "free of medium chain fatty acids" (MCTs) (’403 Patent, Claim 1).
• Technical Importance: This approach aims to provide the benefits of elevated ketone levels without requiring a strictly maintained ketogenic diet, while simultaneously supplying key electrolytes to counteract the common negative side effects of the metabolic shift (’952 Patent, col. 5:28-36).

Key Claims at a Glance

• The complaint asserts representative independent claim 1 (Compl. ¶66).
• The essential elements of claim 1 are:
  • A composition for increasing ketone level in a subject.
  • Comprising a plurality of beta-hydroxybutyrate salts.
  • The plurality includes at least one salt selected from calcium BHB and magnesium BHB.
  • The plurality also includes at least one other salt selected from sodium BHB, potassium BHB, calcium BHB, magnesium BHB, and amino acid salts of BHB.
  • The BHB salts comprise at least 20% by total weight of calcium BHB and/or magnesium BHB.
  • The composition is in solid and/or powder form.
  • The composition is free of medium chain fatty acids (MCTs) having 6 to 12 carbons.
• The complaint does not explicitly reserve the right to assert dependent claims, but this remains a possibility.

U.S. Patent No. 11,020,362 - "Beta-hydroxybutyrate mixed salt compositions and methods of use"

• Patent Identification: U.S. Patent No. 11020362, titled “Beta-hydroxybutyrate mixed salt compositions and methods of use,” issued on June 1, 2021.

The Invention Explained

• Problem Addressed: The patent addresses the same challenges of entering and sustaining ketosis and the associated electrolyte imbalances described in the related ’403 Patent (’952 Patent, col. 2:3-56).
• The Patented Solution: This invention provides a similar solution based on a mixed-salt BHB composition. The distinguishing feature of the ’362 Patent is its requirement for a composition comprising at least three distinct BHB salts selected from the group of sodium, potassium, calcium, and magnesium. Like the ’403 Patent, it also explicitly requires the composition to be "free of medium chain fatty acids" (’362 Patent, Claim 1).
• Technical Importance: By specifying a combination of at least three mineral salts, the formulation seeks to provide a broader spectrum of electrolytes to support the body during the metabolic shift to ketosis, separate from any effects of MCTs (’952 Patent, col. 5:28-36).

Key Claims at a Glance

• The complaint asserts representative independent claim 1 (Compl. ¶84).
• The essential elements of claim 1 are:
  • A composition for increasing blood ketone level in a subject.
  • Comprising at least three BHB salts selected from: sodium BHB, potassium BHB, calcium BHB, and magnesium BHB.
  • The composition is in solid and/or powder form.
  • The composition is free of medium chain fatty acids having 6 to 12 carbons.
• The complaint does not explicitly reserve the right to assert dependent claims, but this remains a possibility.

U.S. Patent No. 10,292,952 - "Mixed Salt Compositions for Maintaining or Restoring Electrolyte Balance while Producing Elevated and Sustained Ketosis"

• Patent Identification: U.S. Patent No. 10292952, "Mixed Salt Compositions for Maintaining or Restoring Electrolyte Balance while Producing Elevated and Sustained Ketosis," issued May 21, 2019.
• Technology Synopsis: This patent, the parent of the other two asserted patents, discloses compositions of mixed BHB salts designed to induce ketosis while restoring or maintaining electrolyte balance (’952 Patent, Abstract). Unlike the asserted claims of the ’403 and ’362 Patents, which require compositions to be "free of" MCTs, asserted dependent claim 22 of the ’952 Patent explicitly adds MCTs to the claimed BHB salt composition, providing a dual-source approach to ketone production (’952 Patent, Claim 22).
• Asserted Claims: Representative independent claim 19 and dependent claim 22 (Compl. ¶100).
• Accused Features: The complaint alleges that Defendants' "MCT Infringing Products" (e.g., "Fitness Keto") infringe by including a blend of BHB salts (Calcium, Magnesium, and Sodium) along with "MCT Powder" (Compl. ¶¶98-99, 107).

III. The Accused Instrumentality

Product Identification

The complaint accuses over 50 differently branded ketogenic dietary supplements, collectively referred to as the "Accused Products" (Compl. ¶5). These are divided into "Non-MCT Infringing Products" (e.g., Keto Platinum) and "MCT Infringing Products" (e.g., Fitness Keto) (Compl. ¶5, 65, 99).

Functionality and Market Context

• The Accused Products are oral supplements provided in capsule form containing a powder (Compl. ¶72). Their labels identify a "Proprietary Blend" of BHB salts, including Magnesium BHB, Calcium BHB, and Sodium BHB (Compl. ¶¶65, 83). The MCT Infringing Products additionally list "MCT Powder" as an ingredient (Compl. ¶99). The "Supplement Facts" label for the representative "Keto Platinum" product is provided as visual evidence in the complaint (Compl. ¶65).
• The complaint alleges that these products are central to Defendants' business, which it characterizes as being built on infringing Plaintiff's intellectual property and that of third parties (Compl. ¶¶4, 23). It further alleges Defendants engage in false advertising, including unauthorized use of Plaintiff's "goBHB®" trademark and false affiliations with the television program Shark Tank (Compl. ¶¶30, 33).

IV. Analysis of Infringement Allegations

'403 Patent Infringement Allegations

'362 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: A central point of contention may be the negative limitation "free of medium chain fatty acids." The parties may dispute whether this requires absolute absence or merely absence below a certain functional or detectable threshold. The complaint's reliance on a lab report showing "None Detected" suggests Plaintiff's position is a strict one (Compl. ¶71).
• Technical Questions: The infringement case for the entire line of over 50 products appears to be extrapolated from evidence related to a few representative products (e.g., "Keto Platinum" and "Fitness Keto"). A key question is whether the evidence for these exemplars, including product labels and third-party lab reports, will be sufficient to prove the composition of all accused products, or if Defendants will be able to demonstrate meaningful compositional differences across their product line.

V. Key Claim Terms for Construction

For U.S. Patent Nos. 11241403 & 11020362

• The Term: "free of medium chain fatty acids"
• Context and Importance: This negative limitation is the primary feature distinguishing the asserted claims of the ’403 and ’362 Patents from those of the ’952 Patent and from other ketogenic supplements that combine BHB salts with MCTs. The construction of "free of" will likely determine whether a wide range of products that do not intentionally add MCTs fall within the scope of these claims.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (e.g., not intentionally added): A defendant may argue that in the context of dietary supplements, "free of" is commonly understood to mean the ingredient is not added as part of the formulation, which might not preclude the presence of trace or incidental amounts. The patents do not appear to provide an explicit definition of the term.
  • Evidence for a Narrower Interpretation (e.g., absolute or near-absolute absence): Plaintiff will likely argue that the plain and ordinary meaning is simply "without." The negative recitation in the claim body, without any qualification (e.g., "substantially free of"), suggests an intent to create a clear line. The patent distinguishes itself from prior art that combines BHB with MCTs, supporting the view that the invention is the composition without MCTs (’952 Patent, col. 6:40-54).

VI. Other Allegations

Indirect Infringement

The complaint alleges inducement by asserting that Defendants have actual knowledge of the patents and encourage infringement by selling the products to end-users (Compl. ¶¶75, 91, 108). Knowledge is alleged to be based on Defendants' practice of copying marketing statements from third-party sellers of licensed products, where those statements explicitly refer to "patented goBHB™" (Compl. ¶31).

Willful Infringement

The complaint makes a detailed case for willfulness. It alleges that Defendants knew or should have known they were infringing because they copied marketing language that explicitly mentioned the patented nature of the formulas (Compl. ¶¶31-32). The allegations are significantly strengthened by references to the individual defendant's prior criminal conviction for selling counterfeit goods, which the complaint frames as a similar pattern of misconduct (Compl. ¶¶14-16).

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

• A core issue will be one of evidentiary sufficiency: Can the Plaintiff's evidence, which relies on product labels and lab reports for a few representative products, successfully establish the precise chemical composition of all 50+ accused supplements? The defense may turn on creating factual disputes about the composition of individual products not specifically tested.
• A second key question will be one of definitional scope: How will the court construe the negative limitation "free of medium chain fatty acids"? Whether this term means an absolute absence or allows for trace amounts could be dispositive for the infringement analysis of the ’403 and ’362 Patents.
• Finally, the case presents an unusually strong question of intent: Given the detailed allegations of copying patented formulas and the individual defendant's documented criminal history involving counterfeit products, a central focus will likely be on whether the alleged infringement rises to the level of "egregious" misconduct that would justify a finding of willfulness and an award of enhanced damages.