USF Board of Trustees v. Hi-Tech Pharmaceuticals: Keto Supplement Patent Dispute
The University of South Florida Board of Trustees and co-plaintiffs asserted US10646462B2 — a patent covering ketone-based dietary supplement formulations — against Hi-Tech Pharmaceuticals’ Keto Lean and Keto Weight Loss products in Georgia’s Northern District. The case was voluntarily dismissed without prejudice in just 86 days, before any answer was filed.
A university patent assertion against a supplement maker ends before it begins
On July 21, 2025, the University of South Florida Board of Trustees, the USF Research Foundation, and licensee Axcess Global Sciences filed an infringement action in the Northern District of Georgia against Hi-Tech Pharmaceuticals, Inc., a Georgia-based dietary supplement company. The suit centred on US10646462B2, a patent covering ketone-based dietary supplement compositions, which plaintiffs alleged were infringed by Hi-Tech’s Keto Lean and Keto Weight Loss product lines.
The case closed on October 15, 2025 — just 86 days after filing — when plaintiffs filed a notice of voluntary dismissal without prejudice under Federal Rule of Civil Procedure 41(a)(1)(A)(i). Because Hi-Tech had not filed an answer or a motion for summary judgment, plaintiffs were entitled to dismiss as of right, requiring no court order or defendant consent. The without-prejudice designation means the claims are not extinguished and plaintiffs retain the right to refile.
The speed of resolution — and the absence of any substantive litigation activity on the record — suggests the parties may have reached an early understanding, or that plaintiffs elected to reassess their enforcement strategy before committing to full discovery. The public record does not disclose any settlement terms, licensing arrangement, or the specific trigger for dismissal, leaving the ultimate commercial outcome between the parties undisclosed.
Filing to Voluntary dismissal in 86 days
86 days — resolved before defendant filed an answer, faster than most district court patent cases
Voluntarily dismissed: what the Rule 41 notice means for both parties
Rule 41(a)(1)(A)(i): dismissal as of right, no court order needed
Under Fed. R. Civ. P. 41(a)(1)(A)(i), a plaintiff may dismiss an action without a court order by filing a notice before the defendant serves an answer or a motion for summary judgment. Hi-Tech had filed neither, so plaintiffs exercised this right unilaterally. The dismissal took effect upon filing — no judicial approval was required and no merits ruling was issued.
Procedural right — no merits adjudicatedThe public record confirms without prejudice — but silence on the reason matters
The notice explicitly states dismissal is without prejudice, meaning plaintiffs retain the right to refile the same claims. A with-prejudice dismissal would extinguish those claims permanently. Here, the public record does not disclose why plaintiffs chose to dismiss or whether any side agreement accompanies the notice. Practitioners should not assume a settlement or a concession — the record is simply silent on the underlying commercial rationale.
Claims survive — refiling remains possibleUSF and AGS preserve all enforcement options against Hi-Tech
Because the dismissal is without prejudice, USF Board of Trustees, USF Research Foundation, and Axcess Global Sciences retain full standing to refile infringement claims against Hi-Tech over the same Keto Lean and Keto Weight Loss products. The patent US10646462B2 remains in force. However, any future action would reset the litigation clock and could face heightened scrutiny of pre-suit diligence and notice obligations.
Patent intact — enforcement preservedHi-Tech faces no judgment — but the patent threat has not been extinguished
Hi-Tech Pharmaceuticals avoids any adverse ruling, damages exposure, or injunction from this action. However, without a declaratory judgment of non-infringement or invalidity, the company cannot rely on this dismissal as a shield against future suits over the same patent. Continued sale of Keto Lean and Keto Weight Loss products remains potentially subject to renewed assertion under US10646462B2.
No judgment — exposure persistsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | University of South Florida Board of Trustees | Individual | University technology transfer entities and licensee — holders of US10646462B2 covering ketone supplement formulationsSearch in Eureka ↗ |
| Defendant | Hi-Tech Pharmaceuticals, Inc. | Company | Hi-Tech Pharmaceuticals, Inc. — Georgia-based dietary supplement manufacturer of Keto Lean and Keto Weight Loss productsSearch in Eureka ↗ |
| Plaintiff counsel | Cortney Alexander | Attorney | Counsel for University of South Florida Board of TrusteesSearch in Eureka ↗ |
| Plaintiff counsel | Kathleen M. Wade | Attorney | Counsel for University of South Florida Board of TrusteesSearch in Eureka ↗ |
| Plaintiff counsel | Richard E. Fee | Attorney | Counsel for University of South Florida Board of TrusteesSearch in Eureka ↗ |
| Plaintiff law firm | Fee & Jeffries PA | Law Firm | Representing University of South Florida Board of TrusteesSearch in Eureka ↗ |
| Plaintiff law firm | Kent & Risley, LLC | Law Firm | Representing University of South Florida Board of TrusteesSearch in Eureka ↗ |
| Presiding judge | Judge Sarah E. Geraghty | Judge | Georgia Northern District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice recites the Rule 41(a)(1)(A)(i) standard with precision — confirming that no answer or summary judgment motion had been filed, and that the right to dismiss without court order was properly invoked. Critically, the notice designates the dismissal as without prejudice, preserving plaintiffs’ claims in their entirety. No merits analysis, claim construction, or validity ruling accompanies this termination. The phrasing is purely procedural and provides no signal as to the strength of the underlying infringement theory or Hi-Tech’s likely defences.
US10646462B2 — ketone-based dietary supplement compositions
US10646462B2, filed under application number US15/610668, covers compositions and methods relating to ketone-based dietary supplements — formulations designed to deliver exogenous ketones or ketogenic compounds for metabolic and weight management applications. The patent originates from University of South Florida research and was exclusively licensed to Axcess Global Sciences for commercial exploitation. Its grant places a university-originated claim squarely over a high-growth consumer supplement category.
The keto supplement market is crowded with branded formulations, making freedom-to-operate clearance a persistent challenge for product developers. A university-held patent in this space — backed by a structured enforcement partnership between the institution and a commercial licensee — presents elevated risk for competitors. Hi-Tech’s Keto Lean and Keto Weight Loss products were specifically named, but the patent’s claim scope may reach any ketone supplement formulation with overlapping composition or method elements, affecting a broad range of market participants.
Should your keto supplement clear US10646462B2 before launch?
Any company formulating, manufacturing, or distributing exogenous ketone or ketogenic dietary supplements in the US market should treat US10646462B2 as a live enforcement risk. The fact that Hi-Tech’s Keto Lean and Keto Weight Loss products were specifically targeted — and that the case was dismissed without prejudice, not settled with a licence — means the patent remains fully available for future assertion against any overlapping formulation.
PatSnap Eureka’s FTO Search Agent can map your supplement formulation against the claim language of US10646462B2, surface related university-licensed patents in the ketone and nutraceutical space, and flag prosecution history disclaimers that define claim boundaries. Use Eureka to run a targeted FTO before reformulating or launching any ketone-based product, not after receiving a complaint.
Run a freedom-to-operate analysis on US10646462B2 to assess your product’s exposure
Run FTO in Eureka →Similar ketone supplement patent infringement cases in US district courts
Explore related patent infringement disputes involving ketone and nutraceutical supplement formulations filed in US district courts, including the Northern District of Georgia.
What this case signals for the ketone supplement IP landscape
University-held supplement patents are increasingly enforced through targeted litigation — even early dismissals carry strategic weight.
Early voluntary dismissal does not mean the dispute is resolved
A Rule 41(a)(1)(A)(i) notice filed before any answer is a low-cost reset mechanism. Companies operating in the ketone supplement market should treat this dismissal as a pause, not a resolution. The patent remains active and enforceable, and the plaintiffs have preserved every enforcement option.
University IP portfolios in nutraceuticals are becoming more assertive
USF’s enforcement of a ketone formulation patent signals that academic institutions — often acting through licensees like Axcess Global Sciences — are treating supplement IP as commercially valuable territory. Competitors in the keto and exogenous ketone product categories should audit their formulations against university-originated patents.
Trustees v Hi-Tech — key questions answered
The case was voluntarily dismissed without prejudice on October 15, 2025, under Fed. R. Civ. P. 41(a)(1)(A)(i). Plaintiffs — USF Board of Trustees, USF Research Foundation, and Axcess Global Sciences — filed the notice before Hi-Tech served any answer or summary judgment motion. No merits ruling was issued and the patent remains enforceable.
The asserted patent is US10646462B2 (application US15/610668), a University of South Florida patent covering ketone-based dietary supplement compositions. The accused products are Hi-Tech Pharmaceuticals’ Keto Lean Supplement and Keto Weight Loss Supplement product lines.
Not necessarily. A without-prejudice dismissal means no merits determination was made and the plaintiffs retain the right to refile. Hi-Tech faces no adverse judgment, but the underlying patent threat from US10646462B2 is not extinguished. The public record does not disclose any settlement, licence, or concession by either party.
Yes. Because the dismissal was without prejudice under Rule 41(a)(1)(A)(i), the plaintiffs — USF Board of Trustees, USF Research Foundation, and Axcess Global Sciences — may refile infringement claims against Hi-Tech over the same patent and accused products. A second dismissal of the same claims would ordinarily be treated as an adjudication on the merits under Rule 41(a)(1)(B).
Plaintiffs were represented by counsel from Fee & Jeffries PA and Kent & Risley, LLC, including attorneys Cortney Alexander, Kathleen M. Wade, and Richard E. Fee. No defendant counsel is listed in the public record, consistent with Hi-Tech not having filed an answer before dismissal.
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