DCT
1:22-cv-01529
University Of South Florida Board Of Trustees v. Northe Star Global LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiffs: University of South Florida Board of Trustees, University of South Florida Research Foundation, Inc. (Florida), and Axcess Global Sciences, LLC (Utah)
- Defendant: Northe Star Global, LLC (Delaware)
- Plaintiffs’ Counsel: Smith, Katzenstein, & Jenkins LLP; Potter Anderson & Corroon LLP
- Case Identification: 1:22-cv-01529, D. Del., 11/22/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware limited liability corporation and therefore resides in the district.
- Core Dispute: Plaintiffs allege that Defendant’s "NCT Powder" nutritional supplement infringes two patents related to compositions for inducing ketosis and maintaining electrolyte balance.
- Technical Context: The technology relates to exogenous ketone supplements designed to help consumers achieve the metabolic state of ketosis, which is associated with various health and performance benefits, without the strict dietary requirements typically needed.
- Key Procedural History: The complaint notes that Plaintiff Axcess Global Sciences, LLC is an exclusive licensee of the patent owned by the University of South Florida entities, establishing the basis for its standing to sue alongside the patent owner.
Case Timeline
| Date | Event |
|---|---|
| 2013-03-19 | U.S. Patent No. 10,646,462 Priority Date |
| 2016-03-11 | U.S. Patent No. 10,292,952 Priority Date |
| 2019-05-21 | U.S. Patent No. 10,292,952 Issued |
| 2020-05-12 | U.S. Patent No. 10,646,462 Issued |
| 2022-11-22 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,646,462 - "Compositions and Methods for Producing Elevated and Sustained Ketosis"
- Patent Identification: U.S. Patent No. 10,646,462, titled “Compositions and Methods for Producing Elevated and Sustained Ketosis,” issued on May 12, 2020.
The Invention Explained
- Problem Addressed: The patent identifies the significant physiological and emotional difficulties associated with transitioning into and sustaining a state of nutritional ketosis through diet alone, such as the "low carb flu" and the need for extreme dietary restriction (ʼ462 Patent, col. 5:1-11).
- The Patented Solution: The invention is a composition that combines at least one medium chain fatty acid (or an ester like MCT oil) with a mixture of beta-hydroxybutyrate (BHB) mineral salts. This combination is described as creating a synergistic effect that allows for a rapid and sustained elevation of blood ketones, thereby making it easier for a user to enter and maintain a state of ketosis (ʼ462 Patent, Abstract; col. 6:35-39).
- Technical Importance: This approach seeks to provide the metabolic benefits of ketosis to a broader population by creating a supplement that can induce ketosis quickly and mitigate the common negative side effects that deter individuals from adopting ketogenic diets (ʼ462 Patent, col. 6:10-16).
Key Claims at a Glance
- The complaint asserts dependent claim 4, which incorporates independent claim 1 (Compl. ¶15).
- Independent Claim 1 requires:
- A composition for inducing ketosis, suppressing appetite, or promoting weight loss in a mammal.
- Comprising "therapeutically effective amounts of" two components:
- At least one medium chain fatty acid or ester thereof.
- A beta-hydroxybutyrate (BHB) monomer salt mixture with at least two different BHB salts from a specified group (including sodium, potassium, calcium, and magnesium BHB).
- Dependent Claim 4 further specifies that the BHB salt mixture must comprise at least three salts from the group of sodium, potassium, calcium, or magnesium BHB (ʼ462 Patent, col. 20:34-39).
U.S. Patent No. 10,292,952 - "Mixed Salt Compositions for Maintaining or Restoring Electrolyte Balance While Producing Elevated and Sustained Ketosis"
- Patent Identification: U.S. Patent No. 10,292,952, titled “Mixed Salt Compositions for Maintaining or Restoring Electrolyte Balance While Producing Elevated and Sustained Ketosis,” issued on May 21, 2019.
The Invention Explained
- Problem Addressed: The patent describes how entering and maintaining a ketogenic state can disrupt the body's electrolyte balance due to diuretic effects and changes in insulin levels (ʼ952 Patent, col. 2:31-41). Furthermore, it notes that supplementing with a single type of BHB salt (e.g., sodium BHB) can worsen this problem by creating an unhealthy overload of one specific electrolyte ('952 Patent, col. 5:56-65).
- The Patented Solution: The invention is a mixed salt composition of BHB that uses a plurality of different cations (e.g., sodium, potassium, calcium, magnesium). This mixture is explicitly formulated to provide a "biologically balanced set of cationic electrolytes," thereby delivering the benefits of BHB for ketosis while simultaneously helping to maintain or restore proper electrolyte levels ('952 Patent, Abstract).
- Technical Importance: The invention aims to improve the safety and tolerability of exogenous ketone supplementation by directly addressing the secondary, but critical, problem of electrolyte imbalance that can be a significant barrier to sustaining ketosis ('952 Patent, col. 3:52-56).
Key Claims at a Glance
- The complaint asserts independent claim 19 (Compl. ¶27).
- Independent Claim 19 requires:
- A composition for maintaining or restoring electrolyte balance while promoting or sustaining ketosis.
- Comprising a BHB mixed salt formulated from multiple different cations and a single anion (BHB), where other anions are omitted.
- The cations are formulated to provide a "biologically balanced set of cationic electrolytes."
- The mixed salt comprises at least three salts selected from a group including sodium BHB, potassium BHB, calcium BHB, and magnesium BHB, with each being present in a concentration of 10-70% by weight.
- The composition is in a solid and/or powder form.
III. The Accused Instrumentality
Product Identification
- The accused products are Defendant's "NCT Powder" supplements (Compl. ¶9).
Functionality and Market Context
- The "NCT Powder" is a powdered nutritional supplement intended to be mixed with water. The complaint provides a visual of the product's "Supplement Facts" label, which lists a 6g proprietary "Ketogenic Blend" (Compl. ¶10, Figure). This blend is identified as containing "MCT Powder, Sodium Betahydroxybutyrate, Calcium Betahydroxybutyrate, Magnesium Betahydroxybutyrate" (Compl. ¶10, Figure). The product is marketed for purposes including weight management and cognitive support, with marketing materials stating, "By taking NCT, you will accelerate your path to the desired body weight" (Compl. ¶17).
IV. Analysis of Infringement Allegations
'462 Patent Infringement Allegations
| Claim Element (from Independent Claim 1, as narrowed by Claim 4) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for inducing ketosis, suppressing appetite, or promoting weight loss in a mammal, comprising therapeutically effective amounts of: | The NCT Powder is marketed as a "Weight management" technology that will "accelerate your path to the desired body weight." | ¶17 | col. 20:8-10 |
| at least one medium chain fatty acid or ester thereof; and | The accused product's "Supplement Facts" label explicitly lists "MCT Powder" as an ingredient in its "Ketogenic Blend." | ¶18 | col. 6:37-39 |
| a beta-hydroxybutyrate monomer salt mixture comprising... at least three of sodium beta-hydroxybutyrate, ... calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate. | The "Supplement Facts" label lists "Sodium Betahydroxybutyrate, Calcium Betahydroxybutyrate, Magnesium Betahydroxybutyrate" as ingredients, meeting the requirement for at least three specified salts. The referenced visual is a "Supplement Facts" label from the accused product's packaging. | ¶18 | col. 20:34-39 |
'952 Patent Infringement Allegations
| Claim Element (from Independent Claim 19) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for maintaining or restoring electrolyte balance while promoting or sustaining ketosis in a mammal... | The complaint alleges the product's purpose is to promote ketosis, and the inclusion of multiple mineral salts is alleged to address electrolyte balance. The product is marketed with claims of supporting a "healthy brain & heart." | ¶29, ¶30 | col. 15:1-4 |
| a beta-hydroxybutyrate mixed salt formulated from a plurality of different cations and a single anion, wherein the single anion is beta-hydroxybutyrate, and wherein other anions are omitted..., the cations being formulated so as to provide a biologically balanced set of cationic electrolytes... | The accused product's "Ketogenic Blend" contains BHB combined with three different cations (sodium, calcium, magnesium) and allegedly omits other anions. | ¶30 | col. 15:5-9 |
| the beta-hydroxybutyrate mixed salt comprising at least three salts selected from the group consisting of...sodium beta-hydroxybutyrate...calcium beta-hydroxybutyrate; and...magnesium beta-hydroxybutyrate, | The product's "Supplement Facts" label lists Sodium Betahydroxybutyrate, Calcium Betahydroxybutyrate, and Magnesium Betahydroxybutyrate, meeting the "at least three" requirement. The referenced visual is a "Supplement Facts" label showing these ingredients. | ¶31 | col. 15:11-17 |
| wherein the beta-hydroxybutyrate mixed salt is in solid and/or powder form. | The accused product is sold and marketed as "NCT Powder" and described as a powder to be mixed with water. | ¶32 | col. 15:19-20 |
- Identified Points of Contention:
- Scope Questions: A central dispute for the '462 Patent may be whether the 6g "Ketogenic Blend" in the accused product constitutes "therapeutically effective amounts" as required by the claim. For the '952 Patent, a core question is whether the specific mixture of sodium, calcium, and magnesium BHB salts (notably, without potassium BHB) provides a "biologically balanced set of cationic electrolytes," a key functional limitation of the asserted claim.
- Technical Questions: What evidence will be presented to establish that the accused product's formulation achieves the claimed therapeutic and balancing effects? The analysis will likely turn on expert interpretation of the product's quantitative composition in light of the patent specifications and the state of the art in nutritional science.
V. Key Claim Terms for Construction
The Term: "therapeutically effective amounts" (’462 Patent, Claim 1)
- Context and Importance: This term is crucial because infringement depends on whether the quantity of active ingredients in the accused product is sufficient to achieve the claimed purpose (e.g., inducing ketosis). The defendant may argue its formulation provides only nutritional support, not a "therapeutic" dose in the patented sense.
- Evidence for a Broader Interpretation: The patent does not define a strict numerical threshold for the term. A plaintiff may argue that any amount sufficient to contribute to the elevation of blood ketones, as the product is designed to do, is "effective." (ʼ462 Patent, col. 20:8-10).
- Evidence for a Narrower Interpretation: The specification provides examples with specific dosages, such as a single dose containing approximately 18g of BHB salts ('462 Patent, Table 1). A defendant may argue that "therapeutically effective" should be construed to require amounts consistent with these examples, which are higher than the 6g total "Ketogenic Blend" listed on the accused product's label.
The Term: "biologically balanced set of cationic electrolytes" (’952 Patent, Claim 19)
- Context and Importance: This term captures the core inventive concept of the '952 Patent. The infringement analysis will hinge on whether the accused product's specific blend of sodium, calcium, and magnesium salts meets this functional requirement.
- Evidence for a Broader Interpretation: The patent’s brief summary suggests the goal is to promote ketosis "without delivering too much total electrolyte... or too much of a particular electrolyte" ('952 Patent, col. 3:62-65). A plaintiff could argue that any multi-cation formula that avoids the harms of a single-cation formula meets this test.
- Evidence for a Narrower Interpretation: The detailed description provides more specific guidance, suggesting that preferred embodiments have molar ratios of sodium-to-potassium and calcium-to-magnesium that are "no greater than 1" ('952 Patent, col. 7:42-54). A defendant will likely argue that a composition lacking potassium BHB entirely cannot be "biologically balanced" in the manner contemplated and explicitly preferred by the patent.
VI. Other Allegations
- Willful Infringement: The complaint alleges that the Defendant had "actual notice" of its infringement of both the '462 and '952 patents (Compl. ¶20, ¶34). It further alleges that Defendant's infringement of the '462 Patent was willful (Compl. ¶21). The allegations are based on knowledge of the patents, which could support a claim for enhanced damages if infringement is found.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional definition: Does the accused "NCT Powder," which contains a 6g "Ketogenic Blend," provide "therapeutically effective amounts" of its active ingredients as required by the '462 Patent? This question will likely require the court to construe the claim term and evaluate expert evidence on the product's physiological effects at the dose provided.
- A second central question will be one of technical scope: Can the accused product's mixture of sodium, calcium, and magnesium BHB salts be considered a "biologically balanced set of cationic electrolytes" under the '952 Patent, particularly given the patent's emphasis on sodium-to-potassium ratios and the product's omission of a potassium salt? The outcome may depend on whether this claim limitation is interpreted as a broad goal or as requiring adherence to the more specific ratios disclosed in the patent's specification.