DCT
2:25-cv-00942
Axcess Global Sciences LLC v. Hard Eight Nutrition LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences, LLC (Utah)
- Defendant: Hard Eight Nutrition, LLC dba Bulk Supplements (Nevada)
- Plaintiff’s Counsel: Spencer Fane LLP; Workman Nydegger
- Case Identification: 2:25-cv-00942, D. Nev., 05/29/2025
- Venue Allegations: Venue is alleged to be proper in the District of Nevada as Defendant resides, is incorporated, maintains its registered agent, and has its principal place of business within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Beta-Hydroxybutyrate (BHB) powder supplements infringe six patents related to non-racemic formulations of BHB compounds specifically enriched with either the R- or S-enantiomer.
- Technical Context: The technology relates to exogenous ketone supplements used to induce or sustain a state of nutritional ketosis, a significant sector of the dietary and wellness market.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with written notice of infringement on or about March 10, 2025, and May 5, 2025, establishing a basis for pre-suit knowledge and claims of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2017-11-22 | Earliest Priority Date (’876, ’129, ’131 Patents) |
| 2017-12-19 | Earliest Priority Date (’243, ’128, ’130 Patents) |
| 2019-04-02 | U.S. Patent No. 10,245,243 Issues |
| 2020-03-17 | U.S. Patent No. 10,588,876 Issues |
| 2020-03-24 | U.S. Patent Nos. 10,596,128, 10,596,129, 10,596,130, and 10,596,131 Issue |
| 2024-02-13 | Plaintiff alleges testing of Accused Product (S-enantiomer enriched lot) |
| 2024-09-13 | Plaintiff alleges testing of Accused Product (R-enantiomer enriched lot) |
| 2025-03-10 | Plaintiff alleges it sent written notice of infringement to Defendant |
| 2025-05-05 | Plaintiff alleges it sent a second written notice of infringement to Defendant |
| 2025-05-29 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,245,243 - "Non-Racemic Beta-Hydroxybutyrate Compounds and Compositions Enriched With The S-Enantiomer And Methods Of Use"
The Invention Explained
- Problem Addressed: The patent’s background describes the difficulty for individuals to transition into and sustain a state of nutritional ketosis, noting that the process can be physically demanding and accompanied by uncomfortable side effects, commonly referred to as the "low-carb flu" (’243 Patent, col. 2:4-27).
- The Patented Solution: The invention is a non-racemic mixture of beta-hydroxybutyrate (BHB) that is enriched with the S-enantiomer, which is not the form of BHB endogenously produced by mammals (’243 Patent, Abstract). By providing more of the S-enantiomer relative to the natural R-enantiomer, the composition aims to provide a "more controlled and sustained ketogenic effect" compared to compositions that are racemic (50/50 mix) or enriched only with the R-enantiomer (’243 Patent, col. 3:15-25).
- Technical Importance: This approach seeks to provide the metabolic benefits of ketosis while modulating the physiological response to provide a more stable and prolonged effect than other available supplements (’243 Patent, col. 2:4-9).
Key Claims at a Glance
- The complaint asserts Claim 22 as a representative claim (Compl. ¶21).
- Essential elements of independent Claim 22 include:
- A composition for administering ketone bodies or ketone body precursors to a subject:
- a dietetically or pharmaceutically acceptable carrier selected from a specified group including a food supplement; and
- S-beta-hydroxybutyrate or a non-racemic mixture of S-beta-hydroxybutyrate and R-beta-hydroxybutyrate;
- wherein the composition comprises from about 52% to 100% by enantiomeric equivalents of the S-beta-hydroxybutyrate and 0% to 48% by enantiomeric equivalents of the R-beta-hydroxybutyrate.
U.S. Patent No. 10,588,876 - "Non-Racemic Beta-Hydroxybutyrate Compounds and Compositions Enriched With The R-Enantiomer And Methods Of Use"
The Invention Explained
- Problem Addressed: Similar to the ’243 Patent, this patent addresses the challenges individuals face in achieving and maintaining nutritional ketosis (’876 Patent, col. 2:4-32).
- The Patented Solution: The invention is a method for increasing ketone body levels by administering a non-racemic BHB mixture that is enriched with the R-enantiomer (the form naturally produced by the body) but still contains a significant percentage of the S-enantiomer (’876 Patent, col. 3:5-11). This composition is intended to provide a "greater and/or faster ketogenic effect" than a racemic mixture by supplying more of the immediately usable R-enantiomer, while the S-enantiomer component provides modulating effects (’876 Patent, col. 3:12-24).
- Technical Importance: This method aims to accelerate the onset of ketosis by prioritizing the body's endogenous BHB form, while still including the S-enantiomer to provide alternative metabolic benefits not found in R-only supplements (’876 Patent, col. 5:1-12).
Key Claims at a Glance
- The complaint asserts Claim 1 as a representative claim (Compl. ¶35).
- Essential elements of independent Claim 1 include:
- A method for increasing ketone body level in a subject, comprising administering a composition comprising:
- a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate that is enriched with the R-beta-hydroxybutyrate relative to the S-beta-hydroxybutyrate;
- wherein the non-racemic mixture contains up to 89% by enantiomeric equivalents of the R-beta-hydroxybutyrate and at least 11% by enantiomeric equivalents of the S-beta-hydroxybutyrate;
- with the proviso that the non-racemic mixture contains no more than 88% by enantiomeric equivalents of mono-ester of R-1,3-butanediol and R-beta-hydroxybutyrate.
U.S. Patent No. 10,596,128 - "Non-Racemic Beta-Hydroxybutyrate Compounds And Compositions Enriched With The S-Enantiomer And Methods Of Use"
- Patent Identification: U.S. Patent No. 10,596,128, issued March 24, 2020 (Compl. ¶46).
- Technology Synopsis: The patent claims a method for increasing ketone levels by administering a non-racemic BHB composition enriched with the S-enantiomer. The claimed composition must contain less than 100% S-enantiomer and greater than 0% R-enantiomer, distinguishing it from a pure S-enantiomer formulation (’128 Patent, col. 14:1-10).
- Asserted Claims: Claim 1 is asserted as representative (Compl. ¶50).
- Accused Features: Defendant's BHB powder is accused of infringement based on test results of a product lot showing enrichment with the S-enantiomer (Compl. ¶¶48, 53).
U.S. Patent No. 10,596,129 - "Non-Racemic Beta-Hydroxybutyrate Compounds And Compositions Enriched With The R-Enantiomer And Methods Of Use"
- Patent Identification: U.S. Patent No. 10,596,129, issued March 24, 2020 (Compl. ¶61).
- Technology Synopsis: The patent claims a composition comprising a non-racemic BHB mixture with specific ratios enriched with the R-enantiomer (52% to 89% R-BHB and 48% to 11% S-BHB). The claim further requires the composition to be provided in one of several specified forms, including a powder or food supplement (’129 Patent, col. 15:15-32).
- Asserted Claims: Claim 1 is asserted as representative (Compl. ¶65).
- Accused Features: Defendant's BHB powder is accused of infringement based on test results of a product lot showing enrichment with the R-enantiomer within the claimed ranges (Compl. ¶¶63, 68).
U.S. Patent No. 10,596,130 - "Non-Racemic Beta-Hydroxybutyrate Compounds And Compositions Enriched With The S-Enantiomer And Methods Of Use"
- Patent Identification: U.S. Patent No. 10,596,130, issued March 24, 2020 (Compl. ¶76).
- Technology Synopsis: The patent claims a composition comprising a non-racemic mixture of BHB salt that is enriched with the S-enantiomer. A key limitation is a proviso that the S-beta-hydroxybutyrate salt is not calcium S-beta-hydroxybutyrate, thereby carving out certain formulations (’130 Patent, col. 15:20-31).
- Asserted Claims: Claim 1 is asserted as representative (Compl. ¶80).
- Accused Features: Defendant’s product, identified as a "Sodium BHB" powder, is accused of infringement based on test results of a lot showing S-enantiomer enrichment (Compl. ¶¶78, 83).
U.S. Patent No. 10,596,131 - "Non-Racemic Beta-Hydroxybutyrate Compounds And Compositions Enriched With The R-Enantiomer And Methods Of Use"
- Patent Identification: U.S. Patent No. 10,596,131, issued March 24, 2020 (Compl. ¶90).
- Technology Synopsis: The patent claims a composition with a specific R-enriched BHB ratio (more than 50% and up to 89% R-BHB; less than 50% and at least 11% S-BHB). Like the ’129 Patent, it requires the composition to be provided in a specified form, such as a powder (’131 Patent, col. 16:1-21).
- Asserted Claims: Claim 1 is asserted as representative (Compl. ¶94).
- Accused Features: Defendant's BHB powder is accused of infringement based on test results of a product lot showing enrichment with the R-enantiomer within the claimed ranges (Compl. ¶¶92, 97).
III. The Accused Instrumentality
Product Identification
The accused product is the "BHB Beta-hydroxybutyrate (Sodium) Powder" distributed by Defendant under its "Bulk Supplements" brand name (Compl. ¶3). The complaint presents a product image showing packaging for "SODIUM BHB BETA-HYDROXYBUTYRATE POWDER" (Compl. p. 2).
Functionality and Market Context
The product is a dietary supplement powder intended for human consumption to provide exogenous BHB, which aids the body in transitioning into nutritional ketosis (Compl. ¶¶5, 8). The complaint alleges that testing of different lots of this single product revealed significant variability in its chemical composition. One tested lot allegedly contained a mixture enriched with the S-enantiomer of BHB (S-85.3% and R-14.7%), while another lot allegedly contained a mixture enriched with the R-enantiomer (R-54.51% and S-45.49%) (Compl. ¶¶11-12).
IV. Analysis of Infringement Allegations
U.S. Patent No. 10,245,243 Infringement Allegations
| Claim Element (from Independent Claim 22) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for administering ketone bodies or ketone body precursors to a subject: | Defendant sells its Sodium BHB powder, a composition for human consumption intended to elevate ketone body levels. | ¶¶3, 22 | col. 16:13-15 |
| a dietetically or pharmaceutically acceptable carrier selected from the group consisting of ... food supplement... | The Accused Product is sold as a powder and marketed as a food supplement. | ¶¶22, 23 | col. 16:16-20 |
| S-beta-hydroxybutyrate or a non-racemic mixture of S-beta-hydroxybutyrate and R-beta-hydroxybutyrate, | The complaint provides test results showing one lot of the Accused Product contains a non-racemic mixture of S- and R-beta-hydroxybutyrate. A Certificate of Analysis is provided as evidence (Compl. p. 9). | ¶¶11, 23 | col. 16:21-22 |
| wherein the composition comprises from about 52% to 100% by enantiomeric equivalents of the S-beta-hydroxybutyrate and 0% to 48% by enantiomeric equivalents of the R-beta-hydroxybutyrate. | The test results for one lot allegedly show 85.3% S-enantiomer and 14.7% R-enantiomer, falling within the claimed percentage ranges. | ¶¶11, 23 | col. 16:23-27 |
U.S. Patent No. 10,588,876 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for increasing ketone body level in a subject, comprising administering to a subject in need thereof a composition comprising: | Defendant provides instructions for its customers to administer the Accused Product, a composition intended to increase ketone levels. | ¶¶34, 36 | col. 14:48-52 |
| a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate that is enriched with the R-beta-hydroxybutyrate relative to the S-beta-hydroxybutyrate, | The complaint provides test results showing a second lot of the Accused Product contains a non-racemic mixture enriched with the R-enantiomer (54.51%). A Certificate of Analysis is provided as evidence (Compl. p. 13). | ¶¶12, 38 | col. 14:53-56 |
| wherein the non-racemic mixture contains up to 89% by enantiomeric equivalents of the R-beta-hydroxybutyrate and at least 11% by enantiomeric equivalents of the S-beta-hydroxybutyrate... | Test results for the second lot allegedly show 54.51% R-enantiomer and 45.49% S-enantiomer, falling within the claimed percentage ranges. | ¶¶12, 38 | col. 14:57-60 |
| with the proviso that the non-racemic mixture contains no more than 88% by enantiomeric equivalents of mono-ester of R-1,3-butanediol and R-beta-hydroxybutyrate. | The Accused Product is identified as a "Sodium BHB" powder, suggesting it is a salt and not the specific mono-ester recited in the proviso. | ¶3 | col. 14:61-64 |
Identified Points of Contention
- Factual Questions: The complaint's central allegation relies on test results from two different product lots showing opposite enantiomeric enrichment. This raises the question of whether Defendant's manufacturing process is inconsistent, and whether any single batch of product can simultaneously infringe patents requiring S-enrichment (e.g., ’243 Patent) and patents requiring R-enrichment (e.g., ’876 Patent). The case may turn on evidence regarding Defendant's manufacturing consistency and quality control.
- Scope Questions: It is an open question whether infringement is systemic across all products sold, or sporadic and dependent on the specific batch a consumer receives. This could significantly impact the scope of any potential infringement finding and the calculation of damages.
- Negative Limitation: For claims including a proviso (e.g., Claim 1 of the ’876 Patent), the complaint relies on the product's identification as "Sodium BHB" to suggest the absence of the excluded mono-ester. The degree to which Plaintiff must affirmatively prove this negative limitation may become a point of contention.
V. Key Claim Terms for Construction
- The Term: "non-racemic mixture"
- Context and Importance: This term is fundamental to all asserted patents, as it distinguishes the inventions from racemic (50/50) mixtures. The dispute will likely center on whether the specific tested ratios (e.g., R-54.51% / S-45.49%) constitute a legally significant "non-racemic mixture" or could be characterized by a defendant as incidental manufacturing variance from a targeted racemic mixture.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patents define compositions by specific percentage ranges that are, by definition, not 50/50 (e.g., "from 52% to 99% by enantiomeric equivalents of the S-beta-hydroxybutyrate enantiomer" in the ’243 Patent, Abstract). This language may support an interpretation where any mixture falling within those explicit ranges is "non-racemic" for the purposes of the patent.
- Evidence for a Narrower Interpretation: The specifications repeatedly tie the non-racemic nature to achieving a specific technical goal, such as a "more controlled and sustained" effect (’243 Patent, col. 3:19-20) or a "greater and/or faster" effect (’876 Patent, col. 3:15-16). A defendant might argue that to be "non-racemic" in the context of the patent, a mixture must deviate from 50/50 enough to achieve such a technical advantage, not just exhibit minor statistical variance.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant instructs its customers on how to use the accused products for human consumption through its product packaging, supplement facts, and usage instructions (Compl. ¶¶25, 40). The complaint also makes allegations of contributory infringement (Compl. ¶¶26, 41).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported actual notice of infringement received via written correspondence on or about March 10, 2025 and May 5, 2025, prior to the filing of the suit (Compl. ¶¶13, 27, 42).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof and product consistency: given that the complaint provides evidence of lot-to-lot variability with opposite enantiomeric enrichment, a key question for the court will be whether infringement is systemic across the accused product line or is merely sporadic and batch-dependent. This determination will be central to establishing the scope of liability and damages.
- The case may also present a question of infringement by happenstance: does a manufacturer whose process may target a racemic (50/50) mixture, but which results in non-racemic batches due to normal variance, infringe patents that claim specific non-racemic ranges? This will require the court to consider the line between incidental product characteristics and infringing activity.