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Amicus Therapeutics v. Aurobindo Pharma – Migalastat Patent Consent Judgment | PatSnap
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Case ID1:24-cv-01331
FiledDec 2024
ClosedDec 2025
Patent Litigation

Amicus Therapeutics v. Aurobindo Pharma: Migalastat Patent Consent Judgment

Amicus Therapeutics filed suit in the District of Delaware against Aurobindo Pharma over three patents covering migalastat (GALAFOLD), a treatment for Fabry disease. The case resolved after 381 days via a consent judgment, permanent injunction, and a separate license agreement — with Aurobindo acknowledging patent validity and infringement.

Resolution time
381days
381 days from filing to consent judgment — faster than the median Hatch-Waxman trial in Delaware
Patents asserted
3
US12042489B2, US12109205B2, and US12042490B2 — three migalastat (Fabry disease treatment) patents asserted
Outcome
Consent Judgment
Consent judgment with permanent injunction and separate license agreement; claims dismissed without prejudice
Cost ruling
Own costs
Each party bears its own attorneys’ fees and costs per consent judgment paragraph 7
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

ANDA Infringement Action Ends in Consent Judgment Favouring Amicus

On 6 December 2024, Amicus Therapeutics US, LLC filed suit in the District of Delaware against Aurobindo Pharma Ltd. under 35 U.S.C. § 271(e)(2), alleging that Aurobindo’s submission of ANDA No. 217786 — seeking FDA approval to commercialise generic 123 mg free base migalastat capsules — infringed three patents protecting its branded GALAFOLD product. The asserted patents are US12042489B2, US12109205B2, and US12042490B2, all covering aspects of migalastat formulations and their therapeutic use in Fabry disease.

The matter closed on 22 December 2025 via an unopposed consent judgment and permanent injunction. Under the judgment, Aurobindo acknowledged validity and enforceability of all three asserted patents, admitted infringement under § 271(e)(2), and accepted a permanent injunction barring commercial manufacture, sale, importation, or distribution of generic migalastat covered by ANDA No. 217786 — unless expressly licensed by Amicus. A contemporaneous, separately executed License Agreement governs any future authorised entry, the specific terms of which are not public record.

A resolution in just 381 days — before any substantive merits briefing appears on the public docket — is consistent with Hatch-Waxman cases that settle early once ANDA filers assess litigation risk against a multi-patent portfolio. The public record does not disclose the commercial terms of the license, including any market entry date or royalty structure, leaving open the question of when, if ever, generic migalastat may reach patients under the Aurobindo arrangement. The court retained jurisdiction to enforce both the consent judgment and the License Agreement.

Case at a glance
Case no.1:24-cv-01331
CourtDelaware
JudgeChristopher J. Burke
FiledDecember 6, 2024
ClosedDecember 22, 2025
Duration381 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 381 days

381 days from filing to consent judgment — faster than the median Hatch-Waxman trial in Delaware

Case timeline: Complaint filed DEC 6 2024, JUN–JUL — 381 days total Horizontal timeline showing the three key events in Amicus Therapeutics US, LLC v Aurobindo Pharma, Ltd. from filing to resolution. Source: PACER, Delaware District Court. DEC 6 2024 Complaint filed Pre-trial proceedings DEC 22 2025 Consent Judgment 381 DAYS TOTAL
Settlement terms

Consent judgment and permanent injunction: what the resolution means for both parties

Legal mechanism

Consent judgment is more than a settlement — it binds Aurobindo permanently

A consent judgment under Hatch-Waxman carries significant weight beyond a typical settlement. Aurobindo formally acknowledged patent validity, enforceability, and infringement under 35 U.S.C. § 271(e)(2). The court entered a permanent injunction, not merely a contractual undertaking. This means violation could constitute civil contempt, and the admissions on validity may have downstream implications in any related ANDA litigation involving the same patents.

Consent judgment + permanent injunction
Patent holder outcome

Amicus secures injunction and validity concession without going to trial

The outcome is strategically strong for Amicus. Aurobindo’s formal acknowledgment that the three asserted patents are valid and enforceable creates a public record that may deter or disadvantage other ANDA filers facing the same patents. The permanent injunction ensures Aurobindo cannot launch generic migalastat outside the License Agreement. The terms of the license — including any authorised generic launch date — remain confidential, preserving Amicus’s commercial flexibility.

Strong patent holder position
Generic challenger outcome

Aurobindo is enjoined but retains a licensed path to market

While Aurobindo accepted an injunction and acknowledged infringement, it also secured a License Agreement that presumably grants a future right to market generic migalastat at some agreed date. The consent judgment notes that final FDA approval of ANDA No. 217786 may be granted as of the judgment date — a provision with regulatory significance under 21 U.S.C. § 355(j)(5)(B)(iii). Aurobindo therefore preserves an eventual commercial opportunity, though the specific launch window is not disclosed.

Injunction with licensed entry path
Commercial implications

GALAFOLD patent wall strengthened ahead of likely further ANDA challenges

A consent judgment acknowledging validity of three migalastat patents sends a clear signal to other potential generic entrants. Any subsequent ANDA filer seeking to challenge the same patents faces the reputational weight of Aurobindo’s admissions, even if those admissions are not legally binding on third parties. Companies holding ANDA positions or monitoring generic migalastat entry should track the License Agreement’s undisclosed launch date as the operative market-entry trigger for this compound.

Strengthened exclusivity signal
Legal analysis based on PACER docket records for case 1:24-cv-01331 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAmicus Therapeutics US, LLCCompanyRare-disease biopharmaceutical company — holder of GALAFOLD (migalastat) patents for Fabry diseaseSearch in Eureka ↗
DefendantAurobindo Pharma, Ltd.CompanyIndian generic pharmaceutical manufacturer seeking FDA ANDA approval for generic migalastat capsulesSearch in Eureka ↗
Plaintiff counselCameron Paul ClarkAttorneyCounsel for Amicus Therapeutics US, LLCSearch in Eureka ↗
Plaintiff counselChad S.C. StoverAttorneyCounsel for Amicus Therapeutics US, LLCSearch in Eureka ↗
Plaintiff counselKaren JacobsAttorneyCounsel for Amicus Therapeutics US, LLCSearch in Eureka ↗
Plaintiff counselMegan Elizabeth DellingerAttorneyCounsel for Amicus Therapeutics US, LLCSearch in Eureka ↗
Plaintiff law firmBarnes & Thornburg LLPLaw FirmRepresenting Amicus Therapeutics US, LLCSearch in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting Amicus Therapeutics US, LLCSearch in Eureka ↗
Presiding judgeJudge Christopher J. BurkeJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“This matter is before the Court on the unopposed motion of Plaintiffs Amicus Therapeutics US, LLC and Amicus Therapeutics, Inc. (collectively “Amicus”) and Defendants Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc. (collectively “Aurobindo”). WHEREAS, Amicus owns U.S. Patent Nos. 11,633,388; 11,833,164; and 12,042,490 (“the Asserted Patents”); WHEREAS, Aurobindo submitted Abbreviated New Drug Application No. 217786 (“Aurobindo’s ANDA”) to the FDA under 21 U.S.C. § 355(j) seeking to obtain approval to commercially manufacture and sell generic migalastat for treatment of Fabry disease; WHEREAS, in this Action, Amicus alleges that Aurobindo infringed one or more claims of the Asserted Patents under 35 U.S.C. § 271(e)(2) by virtue of Aurobindo’s submission of Aurobindo’s ANDA to the FDA; WHEREAS, in this Action, Amicus alleges that it would be irreparably harmed if Aurobindo were not enjoined from infringing or actively inducing or contributing to infringement of one or more claims of the Asserted Patents; WHEREAS, in this Action, Amicus requested that this Court enter a permanent injunction enjoining Aurobindo from infringing the Asserted Patents; WHEREAS, in this Action, Aurobindo has denied that the Asserted Patents are valid, enforceable, and infringed by the product described in Aurobindo’s ANDA; WHEREAS, Amicus and Aurobindo have reached an agreement to finally settle the Litigation as set forth in this Consent Judgment and Permanent Injunction as to Aurobindo and a separate License Agreement (“License Agreement”) which is contemporaneously and separately being executed; WHEREAS, final settlement of this Action will help Amicus and Aurobindo avoid the substantial uncertainty and risks involved with prolonged litigation; WHEREAS, final settlement of this Action will permit Amicus and Aurobindo to save litigation costs, as well as adhere to the judicially recognized mandate that encourages the settlement of litigation whenever possible; WHEREAS, final settlement of the Action serves the public interest by saving judicial resources and avoiding the risks to each of Amicus and Aurobindo associated with infringement; and WHEREAS, Amicus and Aurobindo each consent to personal jurisdiction in Delaware for purposes of enforcing the License Agreement; IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows: 1. The Court has jurisdiction over Amicus and Aurobindo and the subject matter of this litigation.Aurobindo acknowledges Amicus’s ownership and standing to sue for infringement of the Asserted Patents. 3. Aurobindo acknowledges that the Asserted Patents are valid and enforceable, as described more fully and subject to the restrictions contained in the License Agreement.Aurobindo acknowledges that it has infringed the Asserted Patents under 35 U.S.C. § 271(e)(2) and that Amicus did not authorize the manufacture, use, sale, offer for sale, importation and distribution of the product described in Aurobindo’s ANDA. 5. Aurobindo and its successors, assigns, and affiliates, and partners or joint-venturers with are permanently enjoined as of the date hereof from infringing the asserted patents by the commercial manufacture, use, offer to sell, sale, importation, or distribution of any generic migalastat products that are the subject of Aurobindo’s ANDA that is not pursuant to a license granted by Amicus or otherwise exempt from infringement under 35 U.S.C. § 271(e)(1), and from inducing others to infringe or contributing to the infringement of the asserted patents by inducing others to manufacture, use, offer to sell, sale, import, or distribute or contributing to others’ manufacture, use, offer for sale, sale, importation, or distribution of any generic migalastat products that are the subject of Aurobindo’s ANDA that is not pursuant to a license granted by Amicus or otherwise exempt from infringement under 35 U.S.C. § 271(e)(1). 6. All claims in this Action are hereby dismissed without prejudice. 7. Each party shall bear its own costs and attorneys’ fees. 8. This Court shall retain jurisdiction over Aurobindo and Amicus for the purpose of enforcing the terms of this Consent Judgment and Permanent Injunction and over any matters related to or arising from the interpretation or enforcement of the License Agreement or any legal or equitable claim concerning the License Agreement by any third party. 9. This Consent Judgment constitutes a “consent decree” pursuant to 21 U.S.C. § 355(j)(5)(B)(iii)(I)(bb), such that Final Approval of Aurobindo’s Abbreviated New Drug Application No. 217786 under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) may be granted on the date that this Consent Judgment is entered.”
Source: PACER Docket, Case 1:24-cv-01331, Delaware District Court

The consent judgment is notable for the breadth of Aurobindo’s concessions: explicit acknowledgment of patent validity, enforceability, and infringement — not merely an agreement to be bound by an injunction. The dismissal of all claims without prejudice, combined with a retained-jurisdiction clause, means the court can act swiftly on any future breach of the License Agreement or injunction without requiring a new filing. The without-prejudice dismissal does not signal weakness in Amicus’s claims; it is standard Hatch-Waxman practice where the license governs ongoing obligations.

PACER case 1:24-cv-01331 · Public docket record Explore in Eureka ↗
Patent at issue

US12042489B2, US12109205B2 & US12042490B2 — Migalastat Formulations for Fabry Disease

Publication No.US12042489B2
Application No.US18/326279
Patent details
ProductMigalastat formulation and composition for Fabry disease (application US18/326279)
Cited in actionDecember 6, 2024

Publication No.US12109205B2
Application No.US17/078840
Patent details
ProductMigalastat therapeutic use and dosing methods for Fabry disease (application US17/078840)
Cited in actionDecember 6, 2024

Publication No.US12042490B2
Application No.US18/326281
Patent details
ProductMigalastat formulation and composition variant for Fabry disease (application US18/326281)
Cited in actionDecember 6, 2024

The three asserted patents — US12042489B2, US12109205B2, and US12042490B2 — protect aspects of migalastat, a pharmacological chaperone therapy approved as GALAFOLD for Fabry disease, a rare lysosomal storage disorder. The patents span formulation and method-of-use claims tied to 123 mg free base migalastat capsules. Their application numbers (US18/326279, US17/078840, and US18/326281) suggest continuation and divisional filing strategies, consistent with an evergreening approach designed to extend exclusivity beyond any single foundational patent.

For the Fabry disease treatment market — a segment with limited approved therapies and a small but high-value patient population — overlapping patents on the same active compound create a formidable barrier to generic entry. The consent judgment’s validation of all three patents reinforces Amicus’s exclusivity position. Any competitor considering an ANDA for migalastat must now design around or challenge this three-patent cluster, and the public record of Aurobindo’s validity concession raises the reputational stakes for any such challenge.

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

Should you run an FTO against the GALAFOLD migalastat patent portfolio?

Any company developing, manufacturing, or seeking to commercialise generic migalastat capsules — or investigating pharmacological chaperone therapies for lysosomal storage disorders more broadly — should conduct freedom-to-operate analysis against this three-patent cluster before submitting an ANDA or investing in formulation development. The consent judgment has reinforced the validity of all three patents on the public record, and the court retains jurisdiction for expedited enforcement.

PatSnap Eureka’s FTO Search Agent enables rapid landscaping of the migalastat patent family, identification of related continuations and divisionals, and claim-level analysis of the coverage of US12042489B2, US12109205B2, and US12042490B2. R&D and regulatory teams can use Eureka to map claim scope against proposed ANDA formulations and flag overlap before committing development resources, reducing the risk of replicating Aurobindo’s litigation exposure.

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Related litigation

Similar Hatch-Waxman ANDA Infringement Cases in Delaware District Court

Cases involving ANDA-based patent infringement over rare-disease or small-molecule formulation patents litigated in Delaware District Court with comparable consent judgment or early settlement resolutions.

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Strategic implications

What this case signals for the rare-disease generics IP landscape

Early consent judgments in Hatch-Waxman cases often reveal the relative strength of a branded company’s patent portfolio and its willingness to license on undisclosed terms.

Multi-patent portfolios accelerate Hatch-Waxman settlements

Amicus asserted three patents simultaneously, consistent with a layered IP strategy that raises the litigation risk and cost for any single ANDA filer. When a patent holder holds overlapping composition, formulation, and method-of-use patents on the same active, early settlement before claim construction becomes the rational path for a generic challenger of moderate scale.

Validity concessions in consent judgments have broad defensive value

Aurobindo’s formal acknowledgment of validity and enforceability is entered on the public court docket and cited in the FDA’s consent decree register. While not collateral estoppel against other ANDA filers, it creates reputational and practical weight. IP counsel advising subsequent ANDA applicants on these patents should account for the public record of this concession when assessing challenge viability.

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Full strategic analysis in PatSnap Eureka
Unlock gated insights on the migalastat IP landscape, generic entry timing signals, and Hatch-Waxman strategy at Delaware District Court.
License Agreement strategyANDA No. 217786 statusMigalastat patent expiry map
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Frequently asked questions

Amicus v Aurobindo — key questions answered

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Track new ANDA filings, continuation patent publications, and enforcement activity across the GALAFOLD migalastat portfolio with PatSnap Eureka. Run FTO analysis before committing development resources to Fabry disease generic entry.

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