DCT
1:25-cv-04026
University Of South Florida Board Of Trustees v. Hi Tech Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: University of South Florida Board of Trustees (Florida), University of South Florida Research Foundation, Inc. (Florida), and Axcess Global Sciences, LLC (Utah)
- Defendant: Hi-Tech Pharmaceuticals, Inc. (Georgia) and BPI Sports LLC (Florida)
- Plaintiff’s Counsel: Kent & Risley LLC
- Case Identification: 1:25-cv-04026, N.D. Ga., 07/21/2025
- Venue Allegations: Venue is alleged to be proper in the Northern District of Georgia because Defendant Hi-Tech Pharmaceuticals is a Georgia corporation with its principal place of business in the district, and its wholly-owned subsidiary, Defendant BPI Sports, also maintains a regular and established place of business within the district.
- Core Dispute: Plaintiffs allege that Defendants’ ketogenic dietary supplement products infringe a patent related to compositions for inducing ketosis.
- Technical Context: The technology concerns chemical compositions, specifically dietary supplements, designed to elevate blood ketone levels to achieve a state of nutritional ketosis for purposes such as weight loss and metabolic health.
- Key Procedural History: The complaint alleges that Plaintiffs provided Defendants with actual notice of infringement on or about February 10, 2025, approximately five months prior to filing the lawsuit. The asserted patent is subject to a terminal disclaimer.
Case Timeline
| Date | Event |
|---|---|
| 2013-03-19 | Earliest Priority Date Claimed by ’462 Patent |
| 2020-05-12 | U.S. Patent No. 10,646,462 Issues |
| 2025-02-10 | Alleged Date of Actual Notice of Infringement to Defendants |
| 2025-07-21 | 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, "Compositions and Methods for Producing Elevated and Sustained Ketosis," issued May 12, 2020.
The Invention Explained
- Problem Addressed: The patent describes the difficulty, physiological discomfort (e.g., "low carb flu"), and slow progress associated with inducing a state of nutritional ketosis through traditional methods like strict dieting and fasting (’462 Patent, col. 4:45-54; col. 5:1-11).
- The Patented Solution: The invention is a composition that combines at least two different beta-hydroxybutyrate (BHB) mineral salts with at least one medium chain fatty acid (or an ester thereof, such as medium chain triglycerides, or MCTs) to rapidly and sustainably elevate blood ketone levels (’462 Patent, Abstract; col. 6:35-40). This combination is presented as a more effective method for achieving ketosis than using either BHB salts or MCTs alone (’462 Patent, col. 13:15-30).
- Technical Importance: The technology provides a supplemental pathway to achieve the therapeutic and performance benefits of ketosis without requiring the extreme dietary restrictions that are a barrier for many individuals (’462 Patent, col. 6:10-21).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 4 (Compl. ¶¶ 27-28).
- Independent Claim 1 recites a composition with three primary elements:
- A composition for a specified purpose (inducing ketosis, suppressing appetite, or promoting weight loss) in "therapeutically effective amounts."
- The composition must contain "at least one medium chain fatty acid or ester thereof."
- The composition must also contain "a beta-hydroxybutyrate monomer salt mixture" comprising at least two salts from a specified list that includes sodium, potassium, calcium, and magnesium BHB.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the "Keto Lean" supplement, sold by Defendant Hi-Tech Pharma, and the "Keto Weight Loss" supplement, sold by Defendant BPI Sports (Compl. ¶¶ 1, 17).
Functionality and Market Context
- The accused products are oral dietary supplements marketed to consumers pursuing a ketogenic lifestyle (Compl. ¶¶ 18, 20). The complaint alleges these products are designed to accelerate ketosis and support weight loss by providing exogenous ketones and other ingredients (Compl. ¶¶ 18, 20).
- The complaint presents the "Supplement Facts" panel for "Keto Lean," which lists a "Keto Lean™ BHB Ketosis Complex" containing Calcium, Magnesium, Potassium, and Sodium Beta-hydroxybutyrate, as well as a "Keto Lean Weight Loss Blend" containing "Medium Chain Triglycerides" (Compl. ¶17, p. 7).
- Similarly, the "Supplement Facts" panel for "Keto Weight Loss" is provided, which lists a proprietary blend including "Medium Chain Triglycerides (MCTs)" and "BETA-HYDROXYBUTYRATE (BHB) (as salt form)," specifically listing Calcium, Magnesium, and Sodium Beta-Hydroxybutyrate (Compl. p. 8). The complaint's image of the "Keto Lean" supplement facts panel lists ingredients corresponding to elements of the asserted claims (Compl. p. 7).
IV. Analysis of Infringement Allegations
’462 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | 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 Accused Products are marketed as ketogenic supplements for accelerating ketosis and promoting weight loss. For example, "Keto Lean" is described as for "ACCELERATES KETOSIS," and "Keto Weight Loss" is marketed to "SUPPORT WEIGHT LOSS." | ¶¶ 17, 18, 20 | col. 20:10-13 |
| at least one medium chain fatty acid or ester thereof; | The "Supplement Facts" panels for both Accused Products explicitly list "Medium Chain Triglycerides" as an ingredient. | ¶¶ 17, 19, 21 | col. 6:37-38 |
| a beta-hydroxybutyrate monomer salt mixture comprising a plurality of beta-hydroxybutyrate monomer salts with at least two beta-hydroxybutyrate monomer salts selected from the group consisting of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate... and citrulline beta-hydroxybutyrate. | The "Keto Lean" product label identifies a "BHB Ketosis Complex" containing Calcium Beta-hydroxybutyrate, Magnesium Beta-hydroxybutyrate, Potassium Beta-hydroxybutyrate, and Sodium Beta-hydroxybutyrate. The "Keto Weight Loss" product label identifies Calcium, Magnesium, and Sodium Beta-Hydroxybutyrate. Both compositions contain more than the two required salts from the claimed group. | ¶¶ 17, 19, 21 | col. 20:17-24 |
Identified Points of Contention
- Scope Questions: A central dispute may concern the claim term "therapeutically effective amounts." The question for the court will be how to construe this term and whether the dosages provided in the Accused Products meet that definition. The complaint relies on the products' labels and marketing claims but does not provide scientific data on their efficacy.
- Technical Questions: What evidence will Plaintiffs present to demonstrate that the specific formulations of the Accused Products actually perform the function of "inducing ketosis, suppressing appetite, or promoting weight loss" in a mammal, as required by the claim's preamble? Infringement analysis will depend on factual evidence of the products' effects, not just their stated ingredients and marketing purpose.
V. Key Claim Terms for Construction
- The Term: "therapeutically effective amounts"
- Context and Importance: This term, appearing in the preamble of claim 1, is crucial because infringement hinges on whether the quantity of the active ingredients in the Accused Products is sufficient to achieve the claimed therapeutic effect. Practitioners may focus on this term because its potential ambiguity could be a basis for a non-infringement or invalidity defense, arguing it is either not met or indefinite.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests flexibility, stating that a "therapeutically effective amount" is determined by factors like the "age, sex, and weight of the individual" and that "one of skill in the art can readily determine appropriate single dose sizes" (’462 Patent, col. 12:32-35, 12:53-56). This could support a reading that is not tied to a specific dosage.
- Evidence for a Narrower Interpretation: The patent's detailed examples describe compositions with specific, relatively high dosages, such as approximately 18 grams of BHB salts (’462 Patent, col. 13:51-53, Table 1). A party could argue that "therapeutically effective" should be construed in light of these concrete examples, potentially setting a higher threshold than what is present in the Accused Products.
VI. Other Allegations
Willful Infringement
- The complaint alleges that Defendants have willfully infringed the ’462 Patent (Compl. ¶35). The basis for this allegation is the assertion that Defendants received "actual notice of their infringement from the Plaintiff on or about February 10, 2025," establishing knowledge of the patent and the alleged infringement prior to the lawsuit's filing (Compl. ¶34).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "therapeutically effective amounts," which the patent suggests is context-dependent, be construed to cover the specific ingredient quantities found in the Defendants' commercial dietary supplements? The resolution of this claim construction question will be critical to the infringement analysis.
- A key evidentiary question will be one of functional proof: beyond showing that the accused supplements contain the claimed ingredients, what scientific evidence will be required to prove that these compositions actually cause the claimed physiological outcomes of "inducing ketosis, suppressing appetite, or promoting weight loss" in a mammal? The case will likely turn on expert testimony and clinical data regarding the products' real-world effects.