DCT
4:19-cv-00130
Axcess Global Sciences LLC v. Forevergreen Intl LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences, LLC (Utah) and Pruvit Ventures, Inc. (Texas)
- Defendant: ForeverGreen International, LLC (Utah)
- Plaintiff’s Counsel: FERGUSON BRASWELL FRASER KUBASTA PC
- Case Identification: 4:19-cv-00130, E.D. Tex., 02/19/2019
- Venue Allegations: Plaintiffs allege venue is proper because Defendant has committed acts of infringement in the Eastern District of Texas and has a regular and established place of business in the judicial district.
- Core Dispute: Plaintiffs allege that Defendant’s nutritional supplement product, "KetonX," infringes two patents related to compositions and methods for inducing metabolic ketosis.
- Technical Context: The technology involves nutritional supplements combining beta-hydroxybutyrate (BHB) salts and medium-chain triglycerides (MCTs) to rapidly induce and sustain a state of ketosis, a metabolic state where the body primarily uses fat for energy instead of carbohydrates.
- Key Procedural History: The complaint alleges a complex commercial history between the parties. Defendant was previously a sublicensee of one of the patents-in-suit. In prior litigation between the parties (Case No. 4:15-cv-00571, E.D. Tex.), Defendant allegedly asserted the validity and enforceability of the patent it is now accused of infringing. Plaintiffs allege that Defendant's sublicense was terminated in February 2017, making any subsequent sales of products embodying the technology unauthorized. This history may be relevant to the issues of willfulness and patent validity.
Case Timeline
| Date | Event |
|---|---|
| 2013-03-19 | Earliest Priority Date for '420 and '577 Patents |
| 2013-09-04 | AGS obtains exclusive license from University of South Florida |
| 2014-12-31 | AGS grants non-exclusive sublicense to Pruvit |
| 2015-07-07 | AGS grants exclusive sublicense to ForeverGreen |
| 2015-08-24 | Prior litigation initiated by Pruvit against ForeverGreen and AGS |
| 2015-09-22 | U.S. Patent No. 9,138,420 issues |
| 2015-10-26 | ForeverGreen asserts '420 Patent infringement in prior litigation |
| 2016-04-26 | Prior litigation dismissed with prejudice |
| 2017-02-27 | AGS provides written notice terminating ForeverGreen's sublicense |
| 2017-06-13 | U.S. Patent No. 9,675,577 issues |
| 2018-05-01 | AGS grants exclusive sublicense for '420 and '577 Patents to Pruvit |
| 2019-02-19 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,138,420 - “Compositions and Methods for Producing Elevated and Sustained Ketosis”
- Patent Identification: U.S. Patent No. 9,138,420, Issued September 22, 2015. (Compl. ¶9).
The Invention Explained
- Problem Addressed: The patent describes the difficulty of transitioning into and maintaining a state of nutritional ketosis through diet alone. This process can be slow, require extreme dietary discipline, and cause uncomfortable side effects, such as lethargy and light-headedness, colloquially known as the "low carb flu" (’420 Patent, col. 4:41-54).
- The Patented Solution: The invention is a composition that combines at least one medium chain fatty acid (or an ester thereof, such as medium-chain triglycerides (MCT)) with a salt of beta-hydroxybutyrate (BHB). This formulation is designed to provide an oral supplement that can quickly and sustainably elevate blood ketone levels, thereby easing the metabolic transition into ketosis and bypassing the typical challenges of dietary restriction (’420 Patent, Abstract; col. 6:11-24).
- Technical Importance: The technology purports to allow individuals to achieve the therapeutic and performance benefits of ketosis without the significant physiological and emotional challenges associated with the required strict dietary changes (’420 Patent, col. 4:55-67).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶32-33).
- Essential elements of claim 1:
- A composition, comprising:
- at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams; and
- at least one beta-hydroxybutyrate compound in an amount between about 2 grams and about 50 grams, wherein the at least one beta-hydroxybutyrate compound is comprised of a beta-hydroxybutyrate salt.
- The complaint also asserts dependent claims 2-3, 5-6, 12-13, 29, 32-34, 36, and 39-41. (Compl. ¶38).
U.S. Patent No. 9,675,577 - “Compositions and Methods for Producing Elevated and Sustained Ketosis”
- Patent Identification: U.S. Patent No. 9,675,577, Issued June 13, 2017. (Compl. ¶11).
The Invention Explained
- Problem Addressed: As a continuation of the ’420 Patent, the ’577 Patent addresses the same technical problem: the significant barriers to achieving and sustaining nutritional ketosis via diet, including the time required and the associated negative side effects (’577 Patent, col. 4:45-67).
- The Patented Solution: The ’577 Patent claims a method for promoting or sustaining ketosis. The method involves administering to a mammal the combination of a medium chain fatty acid (or ester thereof) and a beta-hydroxybutyrate monomer salt, with both components provided in specific daily dosage ranges (’577 Patent, Abstract; col. 6:25-50). The underlying technology is the same synergistic combination as in the parent patent.
- Technical Importance: This patent extends protection from the composition itself to the act of using the composition for the specific purpose of inducing or maintaining a ketogenic state in a mammal (’577 Patent, col. 3:11-34).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶34-35).
- Essential elements of claim 1:
- A method of promoting or sustaining ketosis in a mammal, comprising:
- administering at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams per day for at least one day; and
- administering at least one beta-hydroxybutyrate compound, where the at least one beta-hydroxybutyrate compound is beta-hydroxybutyrate monomer salt in an amount between about 2 grams and about 50 grams per day for at least one day.
- The complaint also asserts dependent claims 2-4, 7-10, and 13-17. (Compl. ¶45).
III. The Accused Instrumentality
Product Identification
- "KetonX," manufactured and sold by Defendant ForeverGreen. (Compl. ¶28).
Functionality and Market Context
- The KetonX product is a nutritional supplement marketed as a "Proprietary Blend" containing "DL-3 Hydroxybutyric Acid" (in the form of calcium, potassium, sodium, and magnesium salts) and "Medium Chain Triglyceride" (from MCT oil). (Compl. ¶29). The product's "Supplement Facts" label, included as a visual in the complaint, lists these ingredients. (Compl. p. 8).
- Marketing materials reproduced in the complaint describe KetonX as a "bridge into ketosis" that "works in less than one hour" and contains "patented technology" including "exogenous ketones Beta-hydroxybutyrate (or BHB salts), and MCT oils". (Compl. ¶30, p. 9). One screenshot describes the product's role in a "smooth transition from a carb-dependant [sic] body to a fat-burning one." (Compl. p. 9).
- Plaintiffs allege that commissioned lab testing of KetonX found approximately 5.0174 g of MCT and 6.25 g of BHB per serving, amounts which fall within the ranges of the asserted claims. (Compl. ¶31).
IV. Analysis of Infringement Allegations
'420 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams | The KetonX product contains "Medium Chain Triglyceride (MCT oil)." Lab testing commissioned by Plaintiffs allegedly shows 5.0174 g of MCT per serving. | ¶29, ¶31, p. 8 | col. 20:39-41 |
| at least one beta-hydroxybutyrate compound in an amount between about 2 grams and about 50 grams, wherein the at least one beta-hydroxybutyrate compound is comprised of a beta-hydroxybutyrate salt | The KetonX product contains "DL-3 Hydroxybutyric Acid" as calcium, potassium, sodium, and magnesium salts. Lab testing allegedly shows 6.25 g of BHB per serving. | ¶29, ¶31, p. 8 | col. 20:42-46 |
'577 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| administering at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams per day for at least one day | Defendant sells KetonX, which allegedly contains ~5g of MCT per serving, and provides instructions and marketing encouraging its use as a "bridge" into ketosis, implying daily administration. A marketing screenshot states the product is designed for "the first four days of your new lifestyle." | ¶30, ¶31, p. 9 | col. 26:50-54 |
| administering at least one beta-hydroxybutyrate compound, where the at least one beta-hydroxybutyrate compound is beta-hydroxybutyrate monomer salt in an amount between about 2 grams and about 50 grams per day for at least one day | Defendant sells KetonX, which allegedly contains ~6.25g of BHB salts per serving, with marketing materials that promote its use to "transition into ketosis smoothly." The product's intended use, as described in a screenshot, is to "help the body become fat adapted and enter ketosis more quickly." | ¶30, ¶31, p. 9 | col. 26:55-61 |
Identified Points of Contention
- Factual Question: The infringement allegations rely heavily on the quantitative composition of the KetonX product. A primary point of contention will likely be the accuracy and admissibility of Plaintiffs' lab testing results. The defense may challenge these findings or present conflicting evidence regarding the product's formulation.
- Scope Questions: The asserted claims recite ingredient amounts using the term "about" (e.g., "about 5 grams"). The alleged MCT amount of 5.0174 g is just over this lower boundary. The litigation may involve a dispute over whether this amount falls within the scope of "about 5 grams" as used in the patent.
V. Key Claim Terms for Construction
The Term: "about"
- Context and Importance: This term qualifies the lower and upper bounds of the claimed weight ranges for both the MCT and BHB components in the asserted independent claims of both patents. Because Plaintiffs' lab testing alleges an MCT amount (5.0174 g) that is very close to a claimed boundary ("about 5 grams"), the construction of "about" is critical to the literal infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patents do not provide an explicit definition for "about." A party arguing for a broader scope may point to the specification's use of wide exemplary ranges (e.g., "between 2 grams and 50 grams") as indicating that the endpoints are not intended to be rigidly precise (’420 Patent, col. 6:47-54).
- Evidence for a Narrower Interpretation: A party arguing for a narrower scope may contend that in the context of chemical compositions, claim terms should be given precise meaning and that "about" should only cover minor variations attributable to measurement error.
The Term: "beta-hydroxybutyrate monomer salt" (’577 Patent, Claim 1)
- Context and Importance: The accused product is alleged to contain salts of "DL-3 Hydroxybutyric Acid," a racemic mixture. The infringement analysis for the ’577 Patent depends on whether this formulation meets the "beta-hydroxybutyrate monomer salt" limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides strong support for a broad reading, stating that the claimed salts "may contain the racemic DL-beta hydroxybutyrate or the single isomer R-beta hydroxybutyrate" (’577 Patent, col. 7:19-21). This language suggests the patentee explicitly contemplated the racemic form found in the accused product.
- Evidence for a Narrower Interpretation: A defendant could attempt to argue a subtle distinction based on the term "monomer," but the specification's express inclusion of the racemic form presents a significant hurdle to a narrow construction.
VI. Other Allegations
- Indirect Infringement: While not pleaded as a separate count, the allegations supporting infringement of the method claims in the ’577 Patent form the basis for a claim of induced infringement. The complaint alleges that Defendant's marketing materials and product instructions actively encourage and instruct consumers to use KetonX in a manner that performs the steps of the patented method. (Compl. ¶30, p. 9).
- Willful Infringement: The complaint makes strong allegations of willfulness. It asserts that Defendant was a former sublicensee of the ’420 Patent and had "indisputable and intimate knowledge of the patents-in-suit." (Compl. ¶1, 13). Crucially, the complaint alleges that in prior litigation, Defendant itself asserted the '420 Patent against a third party, stating it was "valid, enforceable, and was duly issued." (Compl. ¶20). This alleged pre-suit knowledge, combined with the formal termination of its sublicense, forms the basis for the willfulness claims. (Compl. ¶41, 48).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual composition: Can Plaintiffs prove through reliable and admissible evidence that the accused KetonX product contains medium-chain triglycerides and beta-hydroxybutyrate salts in the specific quantitative ranges required by the asserted claims?
- A key question of law and equity will concern estoppel and willfulness: To what degree, if any, does Defendant's alleged prior conduct—acting as a sublicensee and previously asserting the '420 patent's validity in court—preclude it from now challenging the patent's validity and expose it to a finding of willful infringement and potential enhanced damages?
- The case may also turn on a question of claim construction: How will the court interpret the term "about" as it modifies the numerical ranges in the claims, and could this interpretation create a viable non-infringement defense if the accused product's composition is found to be at or near a claimed boundary?