DCT
2:23-cv-00480
Axcess Global Sciences v. Viro Supplement Labs
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences, LLC (Utah)
- Defendant: Viro Supplement Labs LLC (Wyoming / Utah) and Chad Daniel DeVore (Utah)
- Plaintiff’s Counsel: Workman Nydegger
- Case Identification: 2:23-cv-00480, D. Utah, 07/25/2023
- Venue Allegations: Venue is asserted based on Defendants residing in, maintaining a principal place of business in, and having committed a substantial portion of the alleged infringing acts within the District of Utah.
- Core Dispute: Plaintiff alleges that Defendant’s KetoScorch dietary supplements infringe patents related to specific mixed-salt formulations of Beta-Hydroxybutyrate (BHB).
- Technical Context: The technology concerns exogenous ketone supplements designed to help consumers achieve and maintain a state of nutritional ketosis by providing a biologically balanced mixture of electrolytes.
- Key Procedural History: The complaint alleges that Defendant Chad Daniel DeVore was previously involved with other companies, Nutricost and Ketond, which have license agreements with the Plaintiff for the asserted patents. This history is presented to support allegations of knowing and willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-11 | Priority Date for ’403 and ’362 Patents |
| 2019-02-01 | Accused Products first advertised, offered for sale, or sold (approximate) |
| 2021-06-01 | ’362 Patent Issued |
| 2022-02-08 | ’403 Patent Issued |
| 2023-07-25 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,241,403 - "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued February 8, 2022 (’403 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the difficulty of transitioning into and sustaining a ketogenic state, which often leads to an electrolyte imbalance and associated negative side effects (e.g., fatigue, muscle cramps) colloquially known as the "low-carb flu" (’403 Patent, col. 4:33-51). The patent notes that administering exogenous ketones as single-cation salts can exacerbate these imbalances by providing an excessive amount of one electrolyte, such as sodium or calcium (’403 Patent, col. 7:15-51).
- The Patented Solution: The invention is a composition of mixed beta-hydroxybutyrate (BHB) salts. By combining BHB with a plurality of different cations (e.g., sodium, potassium, calcium, magnesium), the composition is designed to deliver exogenous ketones to induce ketosis while simultaneously providing a "biologically balanced set of cationic electrolytes" (’403 Patent, Abstract). This formulation aims to avoid overloading the body with a single electrolyte and thereby mitigate the associated negative health effects (’403 Patent, col. 4:5-15).
- Technical Importance: This approach seeks to enable the administration of therapeutically effective doses of BHB without the detrimental health consequences of imbalanced electrolytes, making a ketogenic state more sustainable for the user (’403 Patent, col. 7:63-67).
Key Claims at a Glance
- The complaint asserts infringement of at least representative independent claim 1 (Compl. ¶58).
- Claim 1 Essential Elements:
- A composition for increasing ketone level in a subject, comprising:
- a plurality of beta-hydroxybutyrate salts comprised of: at least one salt from the group of calcium beta-hydroxybutyrate and magnesium beta-hydroxybutyrate; and at least one other salt from the group of sodium, potassium, calcium, or magnesium beta-hydroxybutyrate or amino acid salts of beta-hydroxybutyrate;
- wherein the salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate;
- wherein the composition is in solid and/or powder form; and
- wherein the composition is free of medium chain fatty acids (6-12 carbons) and glycerides or other esters thereof.
U.S. Patent No. 11,020,362 - "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued June 1, 2021 (’362 Patent)
The Invention Explained
- Problem Addressed: The patent identifies the same technical problem as the ’403 Patent: the physiological difficulty and electrolyte imbalances that can occur when entering and maintaining a state of ketosis (’362 Patent, col. 4:33-51).
- The Patented Solution: The patented solution is also a composition of mixed BHB salts intended to provide exogenous ketones along with a balanced profile of electrolytes. The formulation aims to support ketosis without the negative effects associated with high doses of single-cation salts (’362 Patent, Abstract; col. 4:5-15).
- Technical Importance: The invention provides a specific formulation of BHB salts that purports to make ketosis more tolerable and sustainable by addressing the common issue of electrolyte depletion (’362 Patent, col. 7:63-67).
Key Claims at a Glance
- The complaint asserts infringement of at least representative independent claim 1 (Compl. ¶71).
- Claim 1 Essential Elements:
- A composition for increasing ketone level in a subject, comprising:
- at least three beta-hydroxybutyrate salts selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate;
- wherein the composition is in solid and/or powder form; and
- wherein the composition is free of medium chain fatty acids (6-12 carbons) and glycerides or other esters thereof.
III. The Accused Instrumentality
Product Identification
- The accused products are the "KetoScorch" and "KetoScorch PM" dietary supplements (Compl. ¶4).
Functionality and Market Context
- The Accused Products are sold as capsules containing a powdered formula designed to induce or support a state of ketosis for weight loss (Compl. ¶¶4, 23). The complaint presents a "Supplement Facts" label for KetoScorch which lists a "Proprietary Ketosis Blend" consisting of Magnesium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, and Sodium Beta-Hydroxybutyrate (Compl. ¶59). The infringement allegations are based on the specific formulation of these BHB salts. The complaint includes marketing materials showing the products are advertised as containing "patented goBHB™" to "Burn Fat As Fuel With Ketone Technology" (Compl. ¶23). The complaint provides an image of the KetoScorch and KetoScorch PM bottles alongside the product's "Supplement Facts" label (Compl. ¶4).
IV. Analysis of Infringement Allegations
’403 Patent Infringement Allegations
The complaint alleges that the formulation of the Accused Products meets every limitation of at least claim 1 of the ’403 Patent. The complaint provides an image of the accused product's "Supplement Facts" label to support its allegations (Compl. ¶59).
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition... comprising: a plurality of beta-hydroxybutyrate salts comprised of: at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; and at least one other beta-hydroxybutyrate salt selected from: sodium beta-hydroxybutyrate... | The Accused Products' "Supplement Facts" label lists Magnesium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, and Sodium Beta-Hydroxybutyrate. | ¶59 | col. 7:8-14 |
| wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate, | The complaint alleges this limitation is met but does not provide a quantitative breakdown of the proprietary blend's ingredients to substantiate the specific weight percentage. | ¶59 | col. 8:15-29 |
| wherein the composition is in solid and/or powder form, | The Accused Products are sold as an encapsulated powder. | ¶59 (p. 31 text) | col. 11:5-8 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The complaint alleges the Accused Products do not contain medium-chain fatty acids, which is consistent with the provided ingredient list. | ¶60 | col. 16:7-11 |
- Identified Points of Contention:
- Evidentiary Question: A primary point of contention may be the "at least 20% by total weight" limitation. As the accused product contains a "Proprietary Ketosis Blend," the specific ratios of the BHB salts are not public. The key question is what evidence the Plaintiff will produce to demonstrate that the accused formulation meets this quantitative requirement of the claim.
’362 Patent Infringement Allegations
The complaint alleges that the Accused Products' formulation meets every limitation of at least claim 1 of the ’362 Patent, supported by an identical "Supplement Facts" label image (Compl. ¶72).
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition... comprising: at least three beta-hydroxybutyrate salts selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; | The "Supplement Facts" label for the Accused Products lists sodium, calcium, and magnesium beta-hydroxybutyrate, thereby meeting the "at least three" requirement. | ¶72 | col. 7:8-14 |
| wherein the composition is in solid and/or powder form, | The Accused Products are sold as an encapsulated powder. | ¶72 (p. 35 text) | col. 11:5-8 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The complaint alleges the Accused Products are free of these acids, and the provided ingredient list does not include them. | ¶73 | col. 15:47-50 |
- Identified Points of Contention:
- Technical Question: The infringement theory for the ’362 Patent appears more direct on its face than for the ’403 Patent, as it lacks a specific weight percentage limitation. The central question will be evidentiary: does the accused product, when tested, consistently contain the three specific BHB salts listed on its label?
V. Key Claim Terms for Construction
- The Term: "free of medium chain fatty acids" (’403 Patent, cl. 1; ’362 Patent, cl. 1)
- Context and Importance: This negative limitation creates a clear demarcation between the claimed invention and other ketogenic supplements that use medium-chain triglycerides (MCTs) as a ketone precursor. The construction of "free of" is critical, as the presence of even small amounts of MCTs could be argued to place the accused product outside the literal scope of the claims. Practitioners may focus on this term because it presents a bright-line, testable condition for non-infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (e.g., "functionally" free): A plaintiff might argue that the term should be construed to mean the absence of MCTs as a functionally significant, intentionally added ingredient, as opposed to requiring absolute purity. The specification discusses MCTs as an alternative ketone precursor, suggesting the purpose of the limitation is to distinguish the invention from formulations that rely on MCTs (’362 Patent, col. 6:21-34).
- Evidence for a Narrower Interpretation (e.g., "absolutely" free): A defendant would likely argue for the plain and ordinary meaning of "free of," which implies a complete absence. The claim language does not use qualifiers like "substantially free." A defendant could argue that any detectable amount of MCTs, whether from active ingredients or excipients, is sufficient to avoid infringement.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement, asserting that Defendants' marketing materials and user instructions encourage and direct customers to consume the Accused Products for their patented purpose of achieving ketosis (Compl. ¶¶ 62, 75). For example, marketing materials reproduced in the complaint state the product will "help[s] get the body into ketosis" (Compl. ¶60).
- Willful Infringement: Willfulness is alleged based on Defendants' purported knowledge of the Asserted Patents (Compl. ¶¶ 63, 76). The complaint alleges this knowledge stems from two sources: (1) Defendants' explicit advertisement of the Accused Products as containing "patented goBHB® ingredients" (Compl. ¶63); and (2) Defendant DeVore's alleged prior involvement with other companies (Nutricost and Ketond) that are licensees of the Asserted Patents (Compl. ¶¶ 16-17). The complaint includes an advertisement claiming "WEIGHT LOSS WITH PATENTED goBHB™" (Compl. ¶23).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: Can the Plaintiff demonstrate through chemical analysis that the Defendants' "Proprietary Ketosis Blend" not only contains the claimed combination of BHB salts, but for the ’403 Patent, also meets the specific "at least 20% by total weight" requirement?
- A key legal question will concern willfulness: Given the allegations of the principal's prior business dealings with the Plaintiff and the explicit use of "patented goBHB™" in advertising, the court will likely need to examine the extent of the Defendants' pre-suit knowledge of the patents to determine if any infringement was willful.
- The outcome of the case may also depend on claim construction: The interpretation of the term "free of medium chain fatty acids" will be critical. The dispute will likely center on whether this requires an absolute absence of such compounds, or if it means merely not being intentionally added as a functional ingredient.