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Catalyst Pharma v. Inventia Healthcare: Amifampridine Patent Dismissal | PatSnap
Patent Litigation

Catalyst Pharma & SERB SA v. Inventia Healthcare: Voluntarily Dismissed in 18 Days

Catalyst Pharmaceuticals and SERB SA filed a six-patent infringement action in Delaware against Inventia Healthcare over Amifampridine Tablets 10mg. The plaintiffs voluntarily dismissed all claims without prejudice just 18 days after filing, before the defendant had entered any appearance of record.

Resolution time
18days
From filing to voluntary dismissal — exceptionally short for a pharmaceutical patent case
Patents asserted
6
US11268128B2 and 5 further patents asserted covering Amifampridine Tablets 10mg
Outcome
Voluntary dismissal
All claims dismissed without prejudice under Fed. R. Civ. P. 41(a)(1)(A)(i); public record is silent on specific terms
Cost ruling
Not recorded
No costs or fees ruling appears in the available public record
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Six-patent Amifampridine action dropped in under three weeks

On 20 November 2023, Catalyst Pharmaceuticals, Inc. and SERB SA filed suit in the Delaware District Court against Inventia Healthcare Limited, asserting six U.S. patents — US11268128B2, US11274332B2, US11274331B2, US10626088B2, US10793893B2, and US11060128B2 — covering Amifampridine Tablets 10mg, a treatment associated with Lambert-Eaton Myasthenic Syndrome. Plaintiffs were represented by Gibbons PC; no defendant agent or law firm appears in the available record.

The recorded Basis of Termination is Voluntary dismissal. The docket order states that the plaintiffs, pursuant to Fed. R. Civ. P. 41(a)(1)(A)(i), voluntarily dismissed all claims asserted against the defendant without prejudice. The specific terms underlying the dismissal are not disclosed in the available record.

The 18-day duration — from filing to dismissal — is exceptionally short, even by the standards of ANDA-related pharmaceutical patent litigation. A Rule 41(a)(1)(A)(i) dismissal is filed unilaterally by the plaintiff before the defendant has served an answer or a motion for summary judgment, which is consistent with the absence of any defendant filing in the record. What, if anything, was agreed or communicated between the parties prior to this dismissal is not disclosed in the available public record.

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Case at a glance
CourtDelaware District Court
JudgeJennifer Choe-Groves
FiledNovember 20, 2023
ClosedDecember 8, 2023
Duration18 days
OutcomeVoluntary dismissal
Verdict causeInfringement Action
BasisVoluntary dismissal
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Voluntary dismissal in 18 days

From filing to voluntary dismissal — exceptionally short for a pharmaceutical patent case

Case timeline: Complaint filed NOV 20 2023 — 18 days total Horizontal timeline showing the three key events in Catalyst Pharmaceuticals, Inc. v Inventia Healthcare Limited from filing to resolution. Source: PACER, Delaware District Court. NOV 20 2023 Complaint filed Pre-trial proceedings DEC 8 2023 Voluntary dismissal 18 DAYS TOTAL
Patent at issue

US11268128B2 and five further patents — Amifampridine Tablets 10mg

Publication No.US11268128B2
Application No.US17/503190
Patent details
ProductAmifampridine Tablets 10mg compositions and methods (US11268128B2)
Cited in actionNovember 20, 2023

Publication No.US11274332B2
Application No.US17/503148
Patent details
ProductAmifampridine Tablets 10mg compositions and methods (US11274332B2)
Cited in actionNovember 20, 2023

Publication No.US11274331B2
Application No.US17/503092
Patent details
ProductAmifampridine Tablets 10mg compositions and methods (US11274331B2)
Cited in actionNovember 20, 2023

Publication No.US10626088B2
Application No.US15/695043
Patent details
ProductAmifampridine phosphate salt compositions and related methods (US10626088B2)
Cited in actionNovember 20, 2023

Publication No.US10793893B2
Application No.US14/128672
Patent details
ProductAmifampridine active pharmaceutical ingredient and synthesis methods (US10793893B2)
Cited in actionNovember 20, 2023

Publication No.US11060128B2
Application No.US17/009250
Patent details
ProductAmifampridine Tablets 10mg formulation and dosing methods (US11060128B2)
Cited in actionNovember 20, 2023
Technical brief · sourced from PatSnap patent database
Patent figurePatent figure
Representative claim (1 of 1 independent)
1. A method of treating a human patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS) in need of treatment thereof comprising administering a total daily dose of 3,4-diaminopyridine (3,4-DAP), or an equivalent amount of a pharmaceutically acceptable salt thereof, to the patient, wherein the patient has at least one N-acetyl transferase 2 (NAT2) fast allele, and the total daily dose is about 30 mg to about 240 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt thereof, optionally provided as a series of divided doses, or wherein the patient has two NAT2 slow alleles, each NAT2 s…
Technical background
CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Nos.: 61/503,553, filed Jun. 30, 2011; and 61/553,045, filed Oct. 28, 2011; the disclosure of each of which is incorporated herein by reference in its entirety. FIELD Provided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, method…
Patent family
21 family members across 3 jurisdictions (CA, US, WO)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US11268128B2 and the Amifampridine patent estate?

Any pharmaceutical manufacturer, generic drug company, or ANDA filer with Amifampridine Tablets 10mg in development or commercialisation should treat this six-patent portfolio as an active enforcement risk. The without-prejudice dismissal against Inventia confirms that the patent holders are willing to litigate and have preserved all rights. A comprehensive FTO is material before progressing any Amifampridine product toward ANDA submission or US market entry.

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Official verdict

Official order — verbatim text

PLEASE TAKE NOTICE that Plaintiffs Catalyst Pharmaceuticals, Inc. and SERB SA, pursuant to Fed. R. Civ. P. 41(a)(1)(A)(i), hereby voluntarily dismiss all claims asserted against Defendant (D.I. 1) in this action, without prejudice.
Source: PACER Docket, Case 1:23-cv-01331, Delaware District Court

The dismissal notice invokes Rule 41(a)(1)(A)(i) — the unilateral plaintiff mechanism available before any defendant answer is filed — and expressly specifies 'without prejudice.' This means the proceeding ends without any adjudication of infringement, validity, or claim scope. The six asserted patents are unaffected by the dismissal and remain enforceable on their face.

PACER case 1:23-cv-01331 · Public docket record Explore in Eureka ↗
Dismissal terms

Voluntarily dismissed: what the Rule 41 exit means for both parties

Legal mechanism

Rule 41(a)(1)(A)(i): unilateral plaintiff dismissal before answer

Fed. R. Civ. P. 41(a)(1)(A)(i) permits a plaintiff to dismiss an action without a court order, as of right, before the defendant has served an answer or a motion for summary judgment. Because no defendant filings appear in the record here, this right was available to the plaintiffs. The dismissal is self-executing upon filing of the notice.

No court order required
With or without prejudice?

Dismissed without prejudice — but public record is silent on why

The notice expressly states 'without prejudice,' meaning the plaintiffs are not barred from refiling the same claims against Inventia on the same six patents. Whether the parties reached any collateral understanding is not disclosed in the available public record. The distinction matters: a with-prejudice dismissal would extinguish the claims permanently; without prejudice preserves the plaintiffs' option to refile.

Refiling remains possible
Defendant outcome

Inventia exits without a merits ruling — but exposure persists

Inventia Healthcare obtained no judgment on the merits and faces no estoppel from this proceeding. However, because the dismissal is without prejudice, the six asserted patents remain enforceable and Inventia could face a refiled action. No costs or fees ruling was entered, and the specific terms of any resolution are not disclosed in the available record.

No merits adjudication
Commercial implications

Six patents remain live enforcement tools in Amifampridine market

The voluntary without-prejudice dismissal leaves all six asserted patents — spanning multiple application families — fully enforceable. Any manufacturer seeking to commercialise Amifampridine Tablets 10mg in the US market should treat this outcome as an open enforcement posture. The compressed 18-day timeline suggests this litigation chapter is not necessarily closed for Inventia or others in this product space.

Patents remain enforceable
Legal analysis based on PACER docket records for case 1:23-cv-01331 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffCatalyst Pharmaceuticals, Inc.Company/Search in Eureka ↗
Co-PlaintiffSerb, SACompanySearch in Eureka ↗
DefendantInventia Healthcare LimitedCompany/Search in Eureka ↗
Plaintiff counselChristopher ViceconteAttorneyCounsel for Catalyst Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting Catalyst Pharmaceuticals, Inc.Search in Eureka ↗
Presiding judgeJudge Jennifer Choe-GrovesJudgeDelaware District CourtSearch in Eureka ↗
R&D signals

R&D signals in the Amifampridine and rare disease pharmaceutical IP space

Forward-looking patent and R&D intelligence derived from the Catalyst Pharma and SERB SA six-patent Amifampridine portfolio — signals for product developers and IP strategists.

Patent portfolio

Catalyst Pharma's Amifampridine filing activity across application families

Catalyst Pharmaceuticals and SERB SA have built a six-granted-patent estate across multiple application families for Amifampridine Tablets 10mg. Tracking continuation and divisional filings from the US14/128672, US15/695043, US17/009250, and US17/503xxx families will reveal whether additional protection layers are being added — a key signal for any ANDA filer or competing developer.

Multi-family patent estate
Technology landscape

Amifampridine formulation patent filing trends in the US

Amifampridine and its phosphate salt form have attracted growing patent activity around formulation stability, dosing methods, and active ingredient synthesis. Mapping filing trends across IPC classes relevant to pyridine derivative pharmaceuticals can identify where innovation is converging and where white space may exist for next-generation formulations.

Rare disease pharma IP trends
Competitor IP posture

Inventia Healthcare's patent and product development profile

Inventia Healthcare Limited is a named defendant in this action with no filed response in the available record. Analysing Inventia's own patent filing activity, ANDA history, and product pipeline in the rare disease and neurology pharmaceutical space can provide competitive intelligence on their development direction and defensive IP capability.

Generic pharma IP posture
White space opportunity

Adjacent R&D opportunities near Amifampridine delivery and dosing

The existing patent estate concentrates on tablet composition, phosphate salt forms, and dosing methods for Amifampridine 10mg. Adjacent white space may exist in modified-release delivery systems, paediatric formulations, or combination therapy approaches — areas that may not be blocked by the current six-patent portfolio and could offer independent development pathways.

Formulation white space
Related litigation

Similar pharmaceutical patent cases in Delaware District Court

Explore comparable Amifampridine and ANDA-related patent infringement actions filed in the Delaware District Court, including cases involving voluntary dismissal and multi-patent pharmaceutical portfolios.

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Catalyst Pharmaceuticals, Inc. patent enforcement history, Delaware District Court case history, Catalyst Pharmaceuticals, Inc.'s full IP portfolio, and comparable case analysis
Amifampridine ANDA casesCatalyst Pharma v. other defendantsDelaware pharma Rule 41 dismissalsSERB SA patent enforcement
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Strategic implications

What this case signals for the Amifampridine pharmaceutical IP landscape

A six-patent filing dropped in 18 days raises clear signals about enforcement posture and ANDA market dynamics for Amifampridine.

Without-prejudice dismissals are not clean exits — monitor for refiling

Plaintiffs preserving their right to refile against Inventia — or other ANDA filers — is the operative risk here. All six patents remain in force. Companies active in the Amifampridine Tablets 10mg space should monitor Catalyst and SERB SA's enforcement activity across related proceedings and ANDA dockets.

Speed of dismissal signals pre-suit resolution or strategic repositioning

An 18-day lifecycle before any defendant response is filed consistently suggests either a pre-suit resolution, a strategic decision to refile in a different venue, or a change in enforcement strategy. The public record discloses none of these; parties should treat the underlying rationale as unknown but commercially significant.

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Unlock detailed enforcement risk analysis for Amifampridine patents in the Delaware District Court pharmaceutical IP landscape.
Patent family mappingANDA refiling riskCo-plaintiff rights structure
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Frequently asked questions

Catalyst v Inventia — key questions answered

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Monitor Amifampridine patent enforcement before your next ANDA decision

All six patents asserted in this action remain live after the without-prejudice dismissal. Use PatSnap Eureka to run a full FTO against the Catalyst and SERB SA Amifampridine portfolio and set alerts for refiling or continuation activity.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

Nothing on this page constitutes legal advice or a legal opinion on the validity, infringement, enforceability, or scope of any patent or case, and no attorney‑client relationship is created by its use. Any description of an outcome (such as a dismissal, settlement, or consent judgment) is a general summary, not a legal determination. All patents, trademarks, and company or law‑firm names are the property of their respective owners. PatSnap makes no warranty as to the accuracy or completeness of this content and disclaims, to the fullest extent permitted by law, all liability for reliance on it. For advice on a specific matter, consult qualified legal counsel.

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