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IntraBio v. Tesseract Medical Research — N-Acetyl-L-Leucine Patent | PatSnap
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Case ID1:25-cv-00446
FiledApr 2025
ClosedAug 2025
Patent Litigation

IntraBio v. Tesseract Medical Research: Consent Judgment & Injunction in 113 Days

IntraBio Inc. asserted four patents covering its AQNEURSA® N-acetyl-L-leucine therapy against Tesseract Medical Research’s competing NALL product. The case resolved in just 113 days via a consent judgment in which Tesseract admitted patent validity, accepted an injunction across six states, and the claims were dismissed without prejudice.

Resolution time
113days
113 days — well below the median district court patent case duration of ~2.5 years
Patents asserted
4
US11471434B2, US12144792B2, US11660279B2, and US11400067B2 — four NALL therapeutic patents asserted
Outcome
Consent Judgment
Tesseract admitted patent validity; injunction entered; claims dismissed without prejudice
Cost ruling
No Costs Awarded
Stipulated order expressly excludes costs, disbursements, and attorneys’ fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Four NALL Patents, One Consent Judgment, and a Six-State Injunction

Filed on 10 April 2025 in the District of Delaware before Judge Jennifer L. Hall, IntraBio Inc. — the holder of FDA-approved AQNEURSA® (N-acetyl-L-leucine, or NALL) for Niemann-Pick disease type C — brought an infringement action against Tesseract Medical Research, LLC and affiliated entities over four U.S. patents: US11400067B2, US11471434B2, US11660279B2, and US12144792B2. The patents collectively cover NALL compositions, formulations, and methods of use. Tesseract was accused of making, marketing, selling, or distributing a competing NALL product in violation of those rights.

The litigation concluded on 1 August 2025 — just 113 days after filing — through a consent judgment and injunction stipulated by both parties. Critically, Tesseract admitted that the claims of all four asserted patents are valid and enforceable, a concession that is unusual and carries significant weight in any future enforcement. Tesseract and its affiliates, successors, and assigns are now permanently enjoined from commercialising the Tesseract NALL product in California, Colorado, Florida, Tennessee, South Carolina, and Connecticut, unless specifically authorised by IntraBio. All claims and counterclaims were dismissed without prejudice, with no costs awarded to either side.

A resolution inside four months, culminating in a validity admission and multi-state injunction, suggests IntraBio held a strong enforcement position from the outset — possibly supported by the commercial weight of an FDA-approved product and a freshly issued fourth patent (US12144792B2). The absence of a damages award and the without-prejudice dismissal leave open the possibility of future proceedings if Tesseract’s conduct expands beyond the injunction’s current geographic scope or product definition. The financial consideration exchanged between the parties — described only as ‘good cause and valuable consideration’ — is not disclosed in the public record.

Case at a glance
Case no.1:25-cv-00446
PlaintiffIntraBio Inc.
CourtDelaware
JudgeJennifer L. Hall
FiledApril 10, 2025
ClosedAugust 1, 2025
Duration113 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 113 days

113 days — well below the median district court patent case duration of ~2.5 years

Case timeline: Complaint filed APR 10 2025, JUN–JUL — 113 days total Horizontal timeline showing the three key events in IntraBio Inc. v Tesseract Medical Research, LLC from filing to resolution. Source: PACER, Delaware District Court. APR 10 2025 Complaint filed Pre-trial proceedings AUG 1 2025 Consent Judgment 113 DAYS TOTAL
Consent Judgment terms

Consent Judgment entered: what Tesseract’s admission and injunction mean

Legal mechanism

Consent judgment: a negotiated court order with teeth

A consent judgment is a binding court order entered by agreement of both parties. Unlike a settlement agreement that may remain private, a consent judgment is a public judicial decree enforceable by the court. Here, the Delaware District Court retains express jurisdiction to enforce or supervise compliance. This means IntraBio can return to court for contempt or enforcement proceedings without filing a new lawsuit if Tesseract violates the injunction.

Judicially enforceable order
Plaintiff outcome

IntraBio secures validity admission across all four patents

Tesseract expressly admitted that the claims of all four asserted patents are valid and enforceable — a concession that strengthens IntraBio’s position against any future challenger. The six-state injunction bars Tesseract and its affiliates from commercialising the competing NALL product in key markets without IntraBio’s authorisation. Claims were dismissed without prejudice, preserving IntraBio’s right to seek damages for past conduct should commercial terms later break down.

Validity confirmed by admission
Defendant outcome

Tesseract accepts injunction and concedes patent validity

Tesseract’s admission of validity forecloses the most common defensive weapon in patent litigation. The six-state injunction restricts Tesseract’s commercial operations in California, Colorado, Florida, Tennessee, South Carolina, and Connecticut. The without-prejudice dismissal means IntraBio retains the ability to reassert claims. Tesseract may still operate outside those six states unless the parties’ agreement — terms of which are not public — imposes broader restrictions.

Injunction in six states
Commercial implications

NALL market: IntraBio’s IP position materially strengthened

With a public validity admission and an active injunction on record, any future NALL competitor faces a higher bar. The admission cannot be used directly against third parties in litigation, but it signals that Tesseract — represented by counsel and presumably after due diligence — saw no viable invalidity defence. Companies developing or marketing NALL products for neurological indications should treat IntraBio’s four-patent portfolio as actively and aggressively enforced IP requiring careful FTO analysis.

Heightened competitor risk
Legal analysis based on PACER docket records for case 1:25-cv-00446 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffIntraBio Inc.CompanyRare-disease therapeutics company — holder of US11400067B2, US11471434B2, US11660279B2, and US12144792B2Search in Eureka ↗
DefendantTesseract Medical Research, LLCCompanyNutraceutical/supplement developer commercialising a competing N-acetyl-L-leucine (NALL) productSearch in Eureka ↗
Plaintiff counselAlfonso G. ChanAttorneyCounsel for IntraBio Inc.Search in Eureka ↗
Plaintiff counselDara M. KurlancheekAttorneyCounsel for IntraBio Inc.Search in Eureka ↗
Plaintiff counselKelly E. FarnanAttorneyCounsel for IntraBio Inc.Search in Eureka ↗
Plaintiff counselPaul A. AinsworthAttorneyCounsel for IntraBio Inc.Search in Eureka ↗
Plaintiff counselStephen E. BaskinAttorneyCounsel for IntraBio Inc.Search in Eureka ↗
Plaintiff law firmRichards Layton & Finger PALaw FirmRepresenting IntraBio Inc.Search in Eureka ↗
Defendant counselStamatios StamoulisAttorneyCounsel for Tesseract Medical Research, LLCSearch in Eureka ↗
Defendant law firmStamoulis & Weinblatt LLCLaw FirmRepresenting Tesseract Medical Research, LLCSearch in Eureka ↗
Presiding judgeJudge Jennifer L. HallJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“IntraBio Inc. and IntraBio Limited (“IntraBio” or “Plaintiffs”) and Defendants Tesseract Medical Research, LLC, Tesseract Medical Research MidCo, Inc., and Tesseract Holding, LLC (“Tesseract” or “Defendants”), parties in the above-captioned action, have resolved this litigation for good cause and valuable consideration recognized by IntraBio and Tesseract. Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in the action, as follows: IT IS this _____ day of ___________, 2025: ORDERED, ADJUDGED AND DECREED as follows: 1. This District Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties. 2. As used in this Consent Judgment, (i) the term “Tesseract Product” shall mean a levacetylleucine (n-acetyl-L-leucine (“NALL”)) product sold, offered for sale or distributed by Tesseract; (ii) the term “Asserted Patents” shall mean United States Patent Nos. U.S. Patent Nos. 11,400,067 (“the ’067 Patent”), 11,471,434 (“the ’434 Patent”), 11,660,279 (“the ’279 Patent”), and 12,144,792 (“the ’792 Patent”); and (iii) the term “Affiliate” shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Tesseract; for purposes of this definition, “control” means (a) ownership, directly or through one or more intermediaries, of (1) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (2) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the Board of Directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity. 3. Tesseract admits that the claims of the Asserted Patents are valid and enforceable. 4. Unless otherwise specifically authorized by IntraBio, Tesseract, including any of its Affiliates, successors and assigns, is enjoined from making, having made, marketing, selling, offering to sell, exporting, or distributing the Tesseract Product in violation of the state laws of California, Colorado, Florida, Tennessee, South Carolina, and Connecticut. 5. Compliance with this Consent Judgment may be enforced by IntraBio and its successors in interest, or assigns, as agreed by the parties. 6. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment. 7. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party.”
Source: PACER Docket, Case 1:25-cv-00446, Delaware District Court

The consent judgment is notable for three features beyond a standard settlement: (1) Tesseract’s express admission that all four asserted patent claims are valid and enforceable — a concession that survives the litigation and informs future enforcement; (2) a judicially entered injunction binding Tesseract’s affiliates, successors, and assigns across six U.S. states; and (3) the court’s retained jurisdiction for enforcement. The without-prejudice dismissal of all claims preserves IntraBio’s ability to seek damages in a future proceeding, making this outcome functionally asymmetric — IntraBio retains offensive optionality while Tesseract absorbs an immediate operational constraint.

PACER case 1:25-cv-00446 · Public docket record Explore in Eureka ↗
Patent at issue

US11400067B2, US11471434B2, US11660279B2, US12144792B2 — NALL Therapeutic Patents

Publication No.US11471434B2
Application No.US16/622785
Patent details
ProductN-acetyl-L-leucine formulations and methods of use for neurological disorders
Cited in actionApril 10, 2025

Publication No.US12144792B2
Application No.US16/324353
Patent details
ProductN-acetyl-L-leucine compositions for treating neurological disease
Cited in actionApril 10, 2025

Publication No.US11660279B2
Application No.US16/968919
Patent details
ProductN-acetyl-L-leucine therapeutic methods and dosing regimens
Cited in actionApril 10, 2025

Publication No.US11400067B2
Application No.US16/324301
Patent details
ProductN-acetyl-L-leucine compositions, formulations, and treatment methods
Cited in actionApril 10, 2025

The four asserted patents — US11400067B2, US11471434B2, US11660279B2, and US12144792B2 — form a coordinated portfolio covering N-acetyl-L-leucine (NALL) compositions, formulations, and therapeutic methods for neurological indications including Niemann-Pick disease type C. Filed across U.S. application numbers US16/324301, US16/622785, US16/968919, and US16/324353, the patents represent layered protection across product, formulation, and method-of-use dimensions. US12144792B2 is the most recently issued, suggesting IntraBio has been actively prosecuting continuation or related applications to maintain and extend coverage.

NALL’s emergence as a therapy for rare neurological diseases — culminating in FDA approval of AQNEURSA® — makes this patent estate commercially high-stakes. The breadth of four independently asserted patents, spanning multiple application families, creates a portfolio that is difficult to design around without touching at least one claim set. Any company developing or marketing a NALL-based product for neurological indications — whether as a pharmaceutical or supplement — should treat this portfolio as actively enforced IP. The consent judgment, including Tesseract’s validity admission, materially strengthens IntraBio’s enforcement position in any future dispute.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should you run an FTO against IntraBio’s NALL patent portfolio?

Any company developing, manufacturing, or distributing an N-acetyl-L-leucine product — whether as a prescription therapy, over-the-counter supplement, or nutraceutical — should conduct a freedom-to-operate analysis against IntraBio’s four-patent portfolio before entering U.S. markets. The consent judgment confirms these patents are asserted aggressively, and Tesseract’s validity admission eliminates the comfort of assuming the claims are vulnerable to early challenge. Product teams planning NALL launches in any U.S. state should treat this as a blocking IP risk.

PatSnap Eureka’s FTO Search Agent can map your NALL product’s technical features against the claim sets of US11400067B2, US11471434B2, US11660279B2, and US12144792B2 simultaneously. Eureka identifies claim-by-claim overlap, surfaces prior art that was not considered during prosecution, and flags continuation applications that may extend IntraBio’s coverage. R&D teams can use Eureka to identify design-around opportunities early — before product launch creates infringement exposure or litigation risk.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US11471434B2 to assess your product’s exposure

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Related litigation

Similar NALL and rare-disease therapeutic patent cases in Delaware

Cases involving NALL compositions, rare neurological disease therapeutics, and consent judgment outcomes in the Delaware District Court — explore comparable enforcement patterns.

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IntraBio Inc. patent enforcement history, Delaware case history, IntraBio Inc.’s full IP portfolio, and comparable case analysis
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Strategic implications

What this case signals for the NALL therapeutics IP landscape

A four-month enforcement action ending in a validity admission sets a clear precedent for IntraBio’s willingness and ability to protect its NALL patent estate.

Speed of resolution signals IntraBio’s strong opening position

A 113-day turnaround from filing to consent judgment — with no motions to dismiss, no IPR filings, and no validity fight — suggests Tesseract’s counsel assessed the four asserted patents as difficult to challenge. Companies holding competing NALL formulations or methods of use should not assume they can outlast IntraBio’s enforcement strategy in litigation.

Six-state injunction scope leaves geographic gaps worth monitoring

The injunction covers California, Colorado, Florida, Tennessee, South Carolina, and Connecticut — but is silent on other U.S. markets. Whether the underlying commercial terms impose broader restrictions is unknown from the public record. Competitors and counsel should monitor whether Tesseract resumes sales in uncovered states, which could trigger further enforcement action or a new filing.

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Frequently asked questions

IntraBio v Tesseract — key questions answered

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PatSnap Eureka

Monitor IntraBio’s NALL patent estate and enforcement activity

IntraBio’s four-patent NALL portfolio is actively enforced, with a consent judgment on record. Use PatSnap Eureka to track continuation filings, monitor new NALL patent applications, and run FTO analysis before launching any N-acetyl-L-leucine product.

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