DCT
2:24-cv-00082
Axcess Global Sciences LLC v. Vitalux Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences, LLC (Utah)
- Defendant: VitaLux, Inc. and VitalityGlow, Inc. (Wyoming)
- Plaintiff’s Counsel: Workman Nydegger; Crowley | Fleck
- Case Identification: 2:24-cv-00082, D. Wyo., 04/19/2024
- Venue Allegations: Venue is based on Defendants being incorporated in Wyoming, maintaining a principal place of business in the district, and having committed a substantial portion of the alleged infringements from within the district.
- Core Dispute: Plaintiff alleges that Defendant’s beta-hydroxybutyrate (BHB) dietary supplements infringe patents related to mixed-salt BHB compositions designed to induce ketosis.
- Technical Context: The technology concerns exogenous ketone supplements, a product category in the health and wellness market designed to help users achieve a metabolic state of ketosis for benefits such as weight loss and enhanced energy.
- Key Procedural History: The complaint alleges that in December 2023, Plaintiff notified Amazon of the infringement, leading to the removal of Defendants' products. Plaintiff further alleges that Defendants subsequently relisted the same products under new identifiers and misleading names, which may be relevant to the claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-11 | Priority Date for ’403 and ’362 Patents |
| 2021-06-01 | U.S. Patent No. 11,020,362 Issued |
| 2022-02-08 | U.S. Patent No. 11,241,403 Issued |
| 2023-12-12 | Accused Products removed from Amazon following infringement report |
| 2024-04-19 | 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"
The Invention Explained
- Problem Addressed: The patent’s background section describes the difficulty of transitioning into and maintaining a state of nutritional ketosis, noting that the process is often accompanied by adverse physiological effects, such as electrolyte imbalances, commonly known as the "low-carb flu" (’403 Patent, col. 4:8-56).
- The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) mixed salts designed to rapidly induce or sustain ketosis by providing an exogenous source of ketones. The composition is formulated to deliver a "biologically balanced set of cationic electrolytes," thereby mitigating the electrolyte imbalances that can occur when entering ketosis through diet alone (’403 Patent, Abstract; col. 4:57-64).
- Technical Importance: The technology aimed to make the benefits of a ketogenic state more accessible by providing a method to circumvent the often-unpleasant physiological transition period and its associated side effects (’403 Patent, col. 4:1-7).
Key Claims at a Glance
- The complaint asserts independent claim 1 and reserves the right to assert others (Compl. ¶14).
- Essential elements of Claim 1:
- A composition for increasing ketone level in a subject.
- Comprising a plurality of beta-hydroxybutyrate (BHB) salts.
- The plurality includes at least one BHB salt of calcium and/or magnesium.
- The plurality also includes at least one other BHB salt of sodium, potassium, calcium, magnesium, or an amino acid salt 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 (C6-C12) and their glycerides or other esters.
U.S. Patent No. 11,020,362 - "Beta-hydroxybutyrate mixed salt compositions and methods of use"
The Invention Explained
- Problem Addressed: As with the related ’403 Patent, the specification describes the significant barriers to achieving and sustaining ketosis, including the potential for hypoglycemia and electrolyte disruption during the metabolic transition (’362 Patent, col. 4:8-56).
- The Patented Solution: The patent describes exogenous ketone compositions that use a mix of BHB salts. This approach is intended to elevate blood ketone levels quickly while simultaneously providing a balanced mix of electrolytes to support the body during the transition into a ketogenic state (’362 Patent, Abstract; col. 4:57-64).
- Technical Importance: The invention provided a nutritional tool to help users initiate and maintain ketosis without the negative side effects often associated with strict ketogenic diets, thereby broadening its potential applicability (’362 Patent, col. 4:1-7).
Key Claims at a Glance
- The complaint asserts independent claim 1 and reserves the right to assert others (Compl. ¶14).
- Essential elements of Claim 1:
- A composition for increasing blood ketone level in a subject.
- Comprising at least three beta-hydroxybutyrate 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 (C6-C12) and their glycerides or other esters.
III. The Accused Instrumentality
Product Identification
- The complaint identifies several dietary supplements, including "Vitalena BHB Pills," "Maxibears BHB Gummies," and "Vitalena BHB Gummies" (collectively, "Accused Products") (Compl. ¶13). The complaint further alleges that products marketed by Defendants as "ACV Gummies" are, in fact, the same infringing BHB products sold under different labeling (Compl. ¶¶18-21).
Functionality and Market Context
- The Accused Products are sold as pills containing encapsulated powder and as solid gummies (Compl. ¶¶51, 66). They contain a "Proprietary Blend" of beta-hydroxybutyrate salts, including calcium BHB, magnesium BHB, and sodium BHB, and are marketed to support a ketogenic lifestyle (Compl. ¶¶13, 19, 49). The complaint provides visual evidence, such as a "Supplement Facts" label for the "Defendants' BHB Gummies," which lists the specific BHB salts in an 800mg proprietary blend (Compl. ¶19). The products are allegedly sold to consumers across the United States via Amazon.com (Compl. ¶16).
IV. Analysis of Infringement Allegations
’403 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| 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 are alleged to be compositions containing a blend of Calcium Beta-Hydroxybutyrate (BHB), Magnesium Beta-Hydroxybutyrate (BHB), and Sodium Beta-Hydroxybutyrate (BHB). | ¶49 | col. 16:1-12 |
| wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate, | The complaint alleges that the Accused Products' formulation meets this weight percentage limitation. | ¶50 | col. 16:13-16 |
| wherein the composition is in solid and/or powder form, | The Accused Products are sold as solid gummies and as pills containing encapsulated powder. | ¶51 | col. 16:17-18 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The ingredient lists for the Accused Products, as depicted in the complaint, do not list any medium chain fatty acids or their esters. An image of the ingredients label for "Defendants' BHB Gummies" is provided as evidence. (Compl. ¶19). | ¶52 | col. 16:19-22 |
’362 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| at least three beta-hydroxybutyrate salts selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; | The Accused Products are alleged to contain three salts from the specified list: Sodium BHB, Calcium BHB, and Magnesium BHB. The complaint provides an image of the "Supplement Facts" label for the accused pills listing these three ingredients. (Compl. ¶66). | ¶65 | col. 15:42-47 |
| wherein the composition is in solid and/or powder form, | The Accused Products are sold as solid gummies and as pills containing encapsulated powder. | ¶66 | col. 15:48-49 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The ingredient lists for the Accused Products allegedly do not include medium chain fatty acids or their esters. | ¶67 | col. 15:50-53 |
Identified Points of Contention
- Evidentiary Questions (’403 Patent): The complaint alleges the product meets the "at least 20% by total weight" limitation of claim 1, but the provided "Supplement Facts" labels list the active ingredients as part of a "Proprietary Blend" without disclosing the specific weight of each component (Compl. ¶¶19, 50). A central question will be what evidence, such as third-party lab testing, the Plaintiff will produce to substantiate this quantitative limitation.
- Scope Questions (’362 Patent): Claim 1 of the ’362 Patent requires "at least three beta-hydroxybutyrate salts selected from: sodium...; potassium...; calcium...; and magnesium..." (Compl. ¶63). The Accused Products allegedly contain sodium, calcium, and magnesium BHB, but the provided labels do not list potassium BHB (Compl. ¶66). This raises the question of whether a composition that includes only three of the four salts recited in the claim language meets this limitation, which will depend on the judicial construction of the phrase "selected from."
V. Key Claim Terms for Construction
"at least three beta-hydroxybutyrate salts selected from" (’362 Patent, Claim 1)
- Context and Importance: The resolution of the infringement allegation for the ’362 Patent may hinge on the construction of this phrase. The Accused Products' labels indicate the presence of sodium, calcium, and magnesium BHB, but not potassium BHB (Compl. ¶66). The question is whether the three salts in the accused product must be chosen from the four-member list recited in the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the patent's goal is to provide a "biologically balanced set of cationic electrolytes" (’362 Patent, Abstract) and that any combination of at least three common physiological electrolyte salts of BHB accomplishes this purpose, even if one from the exemplary list is absent.
- Evidence for a Narrower Interpretation: The plain language "selected from" often suggests that the members must be chosen from the recited group. The claim lists four specific salts, and the first exemplary embodiment in the patent specification includes all four (sodium, potassium, calcium, and magnesium BHB), which could suggest the listed salts are the intended components (’362 Patent, col. 13:14-24).
"free of medium chain fatty acids... and glycerides or other esters thereof" (’403 Patent, Claim 1; ’362 Patent, Claim 1)
- Context and Importance: This negative limitation is critical for distinguishing the invention from other ketogenic supplements that use medium-chain triglycerides (MCTs) as a primary ingredient. A dispute could arise over whether any of the non-BHB ingredients or excipients in the Accused Products, such as "Vegetable Magnesium Stearate" or "Carnauba Wax" (Compl. ¶6), fall under the chemical definition of a "glyceride or other ester" of a C6-C12 fatty acid.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., less restrictive for Plaintiff): The patent repeatedly contrasts the invention with compositions that use MCTs as a primary, independent source for ketone production (’362 Patent, col. 6:21-34). A party may argue the term should be construed in this context to mean free of functionally ketogenic fats, not necessarily free of any molecule that happens to contain an ester linkage, such as a minor excipient.
- Evidence for a Narrower Interpretation (i.e., more restrictive for Plaintiff): A party could argue for a strict, literal chemical definition. If any ingredient, even an excipient, is found to be or to contain an ester of a C6-C12 fatty acid, the composition would not be "free of" it, and thus would not infringe.
VI. Other Allegations
Indirect Infringement
- The complaint alleges that Defendants induced infringement by selling the Accused Products (Compl. ¶¶54, 69). The basis for inducement appears to be the act of selling the products for their intended use, which would allegedly lead consumers to directly infringe the method claims by consuming the supplement.
Willful Infringement
- The complaint alleges that Defendants' infringement was knowing and willful, justifying an exceptional case finding (Compl. ¶¶55, 70). This allegation is primarily based on the assertion that Defendants continued to infringe after receiving notice from the Plaintiff via an Amazon.com patent infringement report in December 2023, which resulted in the initial removal of the products (Compl. ¶16). The complaint provides visual evidence of products allegedly being relisted under new identifiers and misleading names, such as a product labeled "KETO+ACV GUMMIES" on the outside but containing a bottle with a "KETO BHB GUMMIES" label inside (Compl. ¶19).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope: for the ’362 patent, can the limitation "at least three... salts selected from" a list of four be satisfied by a product that contains only three of the four salts from that specific list, notably lacking potassium BHB?
- A key evidentiary question will be one of factual proof: for the ’403 patent, will the Plaintiff be able to produce sufficient evidence, likely from technical analysis, to prove that the Defendants' "Proprietary Blend" meets the "at least 20% by total weight" limitation for calcium and/or magnesium BHB?
- A third central question will concern culpability: do the allegations that Defendants relisted infringing products on Amazon under new names immediately after a takedown constitute the type of egregious conduct required to support a finding of willful infringement and make this an exceptional case?