DCT
2:24-cv-02230
Axcess Global Sciences LLC v. Lebed
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences LLC (Utah)
- Defendant: Alexander Lebed, George Gonchar, Michael Fridman, et al. (Pennsylvania)
- Plaintiff’s Counsel: Levan Stapleton Segal Cochran LLP; Workman Nydegger
- Case Identification: 2:24-cv-02230, E.D. Pa., 05/24/2024
- Venue Allegations: Venue is alleged to be proper as each defendant either resides in the Eastern District of Pennsylvania or engages in patent infringement from a principal place of business within the district, identified as a warehouse in Huntingdon Valley, PA.
- Core Dispute: Plaintiff alleges that Defendants’ "Keto 3000" supplement products, sold through a network of entities on eBay, infringe two patents related to beta-hydroxybutyrate (BHB) mixed salt compositions.
- Technical Context: The technology involves exogenous ketone supplements formulated with a specific blend of mineral salts to induce or sustain a state of nutritional ketosis while aiming to avoid the electrolyte imbalances that can accompany ketogenic diets and supplementation.
- Key Procedural History: The complaint alleges that the numerous individual and LLC defendants operate as a single enterprise, using a "complex web" of entities in a fraudulent attempt to mask their identities and shield themselves from liability. Plaintiff also notes it has previously engaged in enforcement actions against other online retailers.
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 |
| 2024-05-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,241,403
- Patent Identification: U.S. Patent No. 11,241,403, titled “Beta-hydroxybutyrate mixed salt compositions and methods of use,” issued February 8, 2022 (the “’403 Patent”). (Compl. ¶54).
The Invention Explained
- Problem Addressed: The patent describes the difficulty of transitioning into and maintaining a state of nutritional ketosis, which can be accompanied by adverse effects like the "low-carb flu" and electrolyte imbalances (Compl. ¶54; ’403 Patent, col. 2:16-52). Furthermore, administering exogenous ketones as a single type of salt (e.g., sodium BHB) can exacerbate these imbalances or create new health risks, such as hypertension from excessive sodium or soft tissue calcification from excessive calcium (’403 Patent, col. 7:17-48).
- The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) combined with a "biologically balanced set of cationic electrolytes" (’403 Patent, Abstract). By creating a mixed salt formulation with specific combinations of cations like sodium, potassium, calcium, and magnesium, the invention aims to deliver therapeutic levels of BHB to induce ketosis without providing an unhealthy quantity of any single electrolyte, thereby mitigating the associated negative side effects (’403 Patent, col. 3:20-31).
- Technical Importance: The technology sought to make exogenous ketone supplementation safer and more tolerable, thereby lowering the barrier for individuals to adopt and sustain a ketogenic lifestyle for therapeutic or wellness purposes (’403 Patent, col. 2:1-9).
Key Claims at a Glance
- The complaint asserts infringement of at least representative independent claim 1. (Compl. ¶59).
- The essential elements of Claim 1 are:
- A composition for increasing ketone level in a subject, 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 a group including sodium beta-hydroxybutyrate and potassium 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 (MCFAs) having 6 to 12 carbons and glycerides or other esters thereof.
- The complaint reserves the right to assert additional claims. (Compl. ¶59).
U.S. Patent No. 11,020,362
- Patent Identification: U.S. Patent No. 11,020,362, titled “Beta-hydroxybutyrate mixed salt compositions and methods of use,” issued June 1, 2021 (the “’362 Patent”). (Compl. ¶72).
The Invention Explained
- Problem Addressed: As a related patent sharing a common specification with the ’403 Patent, the ’362 Patent addresses the same technical problem of electrolyte imbalances and other adverse side effects associated with inducing and maintaining ketosis through diet and conventional supplementation (’362 Patent, col. 2:16-52).
- The Patented Solution: The ’362 Patent similarly discloses a BHB mixed salt composition formulated to provide a balanced set of electrolytes, allowing for the benefits of ketosis while limiting the health risks of consuming excessive amounts of a single mineral salt (’362 Patent, col. 3:20-31).
- Technical Importance: The technical importance is the same as that described for the ’403 Patent.
Key Claims at a Glance
- The complaint asserts infringement of at least representative independent claim 1. (Compl. ¶77).
- The essential elements of Claim 1 are:
- A composition for increasing blood 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 having 6 to 12 carbons and glycerides or other esters thereof.
- The complaint reserves the right to assert additional claims. (Compl. ¶77).
III. The Accused Instrumentality
Product Identification
- The accused products are supplements sold under the name "Keto 3000" (the "Accused Products"). (Compl. ¶40).
Functionality and Market Context
- The complaint alleges that although marketed under different brands and by different defendant LLCs, the Accused Products are all the same item, manufactured, marketed, and shipped by a single enterprise. (Compl. ¶41). This allegation is supported by photographic evidence showing different branded bottles with identically formatted lot numbers. (Compl. ¶32, p. 7). The complaint also cites shipping data showing that test purchases from different defendants were shipped from the same location in identical packaging. (Compl. ¶¶ 30-31). The Accused Products are sold as capsules containing a BHB salt powder and are marketed to support metabolic ketosis and weight loss. (Compl. ¶¶ 57, 60). The products are sold through nearly 400 listings on eBay.com. (Compl. ¶40).
IV. Analysis of Infringement Allegations
’403 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for increasing ketone level in a subject... | The product is advertised with claims such as "Metabolic Ketosis Support." | ¶60 | col. 15:40-41 |
| a plurality of beta-hydroxybutyrate salts comprised of: at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; | The product's "Supplement Facts" label, depicted in the complaint, lists both "Magnesium Beta-Hydroxybutyrate" and "Calcium Beta-Hydroxybutyrate." A photograph of this label is provided in the complaint. (Compl. p. 16). | ¶61 | col. 15:43-45 |
| and at least one other beta-hydroxybutyrate salt selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; magnesium beta-hydroxybutyrate; and amino acid salts of beta-hydroxybutyrate, | The "Supplement Facts" label also lists "Sodium Beta-Hydroxybutyrate." | ¶62 | col. 15:46-52 |
| wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate, | The label indicates a serving size contains 1000 mg of Magnesium BHB and 1000 mg of Calcium BHB out of a total 3000 mg of BHB salts. This combined 2000 mg constitutes 66.7% of the total BHB salt weight, exceeding the 20% requirement. | ¶63 | col. 15:53-56 |
| wherein the composition is in solid and/or powder form, | The product is provided in capsules containing a powder. The complaint includes a photograph showing the capsules opened to reveal the powder within. (Compl. p. 20). | ¶64 | col. 15:57-58 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The product's "OTHER INGREDIENTS" list (gelatin, vegetable magnesium stearate, and silicon dioxide) does not include any medium chain fatty acids, glycerides, or esters. | ¶65 | col. 15:59-62 |
’362 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for increasing blood ketone level in a subject... | The product marketing includes phrases like "Metabolic Ketosis Support," indicating its purpose is to affect ketone levels. | ¶78 | col. 15:37-38 |
| 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 lists three salts from the claimed group: Sodium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, and Magnesium Beta-Hydroxybutyrate. | ¶79 | col. 15:38-41 |
| wherein the composition is in solid and/or powder form, | The product consists of a powder contained within gelatin capsules. | ¶80 | col. 15:42-43 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The list of "OTHER INGREDIENTS" on the product label does not contain any substances matching the description of medium chain fatty acids, glycerides, or other esters. | p. 25, Fig. | col. 15:44-47 |
Identified Points of Contention
- Evidentiary Question: The infringement allegations for both patents rely heavily on the accuracy of the "Supplement Facts" label on the Accused Products. A primary point of contention will be whether the actual chemical composition of the "Keto 3000" product, as determined by independent analysis, matches what is stated on the label.
- Scope Question: The negative limitation "free of medium chain fatty acids" is present in the asserted claims of both patents. The case may raise the question of how to construe this term. For instance, does "free of" require absolute absence, or does it mean the substance is not present as an intentionally added, functional ingredient? The presence of even trace amounts, perhaps as manufacturing excipients, could become a point of dispute.
V. Key Claim Terms for Construction
Term from ’403 and ’362 Patents
- The Term: "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof"
- Context and Importance: This negative limitation is central to distinguishing the patented invention from other ketogenic supplements that actively include medium chain triglycerides (MCTs) as a ketone precursor. The infringement analysis hinges on whether the Accused Products meet this "free of" requirement. Practitioners may focus on this term because the definition of "free of" can be ambiguous—it could mean a complete absence, an amount below a certain detection threshold, or the absence of the substance as an active ingredient.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (supporting a finding of non-infringement if any amount is present): The patents do not provide an explicit definition quantifying "free of." A defendant could argue for a plain meaning interpretation where the presence of any detectable amount of the specified substances would place the product outside the claim's scope.
- Evidence for a Narrower Interpretation (supporting an infringement finding if amounts are negligible or non-functional): The specification discusses compositions that include MCTs as an additional source for ketone production (’403 Patent, col. 9:8-18). A plaintiff could argue that "free of" should be construed in this context to mean not including MCFAs as a functional, ketone-producing ingredient, as opposed to unavoidable, non-functional trace contaminants from the manufacturing process.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants induce infringement by their customers. (Compl. ¶¶ 67, 82). It claims Defendants have "actual knowledge" of the patents, basing this on the widespread marketing of Plaintiff's patented and marked products and on Plaintiff's prior enforcement actions against other online retailers. (Compl. ¶50).
- Willful Infringement: The complaint alleges that the infringement is willful and the case is exceptional. (Compl. ¶¶ 68, 83). The basis for this allegation is the same as for inducement, with the additional assertion that the "deliberate steps that the Defendants' have taken to mask their identities" demonstrate an awareness of their infringing activity and an attempt to avoid liability. (Compl. ¶50).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: Will independent chemical testing of the "Keto 3000" product confirm the composition and ingredient ratios presented on its "Supplement Facts" label, which forms the primary basis for the Plaintiff's infringement allegations?
- The case will also turn on a question of scienter: Can the Plaintiff establish that the Defendants, operating through an allegedly deliberate "complex web" of entities, possessed pre-suit knowledge of the patents-in-suit, sufficient to support the allegations of induced and willful infringement?
- A key legal question will be one of claim construction: How will the court define the scope of the negative limitation "free of medium chain fatty acids...," and will that construction encompass trace or incidental amounts of such substances that may be present in the Accused Products?