Amicus Therapeutics v. Aurobindo Pharma: Migalastat ANDA Litigation Ends in Consent Judgment
Amicus Therapeutics filed suit in the Delaware District Court against Aurobindo Pharma after Aurobindo submitted an ANDA seeking FDA approval for generic migalastat — a treatment for Fabry disease. After 1,141 days, the parties resolved the dispute via consent judgment and permanent injunction, with Aurobindo acknowledging patent validity and infringement, backed by a separate undisclosed license agreement.
Hatch-Waxman battle over Fabry disease drug migalastat ends in Aurobindo acknowledgment
Amicus Therapeutics US, LLC filed suit in the District of Delaware on 7 November 2022, asserting 23 United States patents against Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc. The action arose from Aurobindo’s submission of ANDA No. 217786 to the FDA seeking approval to commercially manufacture and sell generic migalastat — marketed by Amicus as Galafold — for treatment of Fabry disease. Amicus alleged infringement under 35 U.S.C. § 271(e)(2), the statutory mechanism that treats ANDA filing itself as an act of infringement, and sought a permanent injunction to block Aurobindo’s generic entry.
The case closed on 22 December 2025 via a consent judgment and permanent injunction entered by Judge Christopher J. Burke. Under the judgment, Aurobindo explicitly acknowledged Amicus’s ownership and standing to sue, acknowledged the asserted patents to be valid and enforceable, and acknowledged infringement under § 271(e)(2). Aurobindo and its successors are permanently enjoined from commercialising any generic migalastat product covered by the ANDA outside of a license from Amicus. All claims were dismissed without prejudice, and the parties simultaneously executed a separate — and non-public — license agreement governing the terms under which Aurobindo may eventually enter the market.
The 1,141-day duration is consistent with contested Hatch-Waxman proceedings but the outcome is commercially significant: Aurobindo’s formal acknowledgment of validity and infringement is unusually strong language in a settlement, and the consent judgment functions as a ‘consent decree’ under 21 U.S.C. § 355(j)(5)(B)(iii), meaning it can trigger or structure FDA final-approval timing for Aurobindo’s ANDA. The specific commercial terms of the license — including any authorised generic provisions or royalty structure — remain confidential, leaving the practical timeline for any Aurobindo generic launch publicly unknown.
Filing to Consent Judgment in 1141 days
1,141 days — over three years of Hatch-Waxman litigation before settlement
Consent judgment with permanent injunction: what the resolution means for both parties
Consent judgment is more than a typical settlement — Aurobindo admitted validity
Unlike a standard voluntary dismissal, a consent judgment is a court order carrying the force of law. Here, Aurobindo formally acknowledged that Amicus’s 23 asserted patents are valid and enforceable, and that Aurobindo infringed them under § 271(e)(2). This admission is embedded in the public court record and is enforceable as a judicial decree — a significantly stronger outcome for Amicus than a confidential stipulation to dismiss.
Consent decree — binding admissionAmicus secures permanent injunction and public acknowledgment of patent strength
Amicus obtained a permanent injunction blocking Aurobindo from commercialising generic migalastat outside a license. Aurobindo’s public acknowledgment of validity across 23 patents substantially raises the litigation bar for any future ANDA challenger contemplating a Paragraph IV certification against Galafold. The accompanying license agreement — while confidential — likely provides Amicus control over when and how Aurobindo enters the market, preserving Galafold’s commercial exclusivity on Amicus’s terms.
Patent exclusivity maintainedAurobindo’s market entry now governed by undisclosed license, not litigation outcome
Aurobindo avoided a potentially adverse trial judgment by settling, but at the cost of formally conceding validity and infringement in a public court record. Any future market entry for Aurobindo’s generic migalastat depends entirely on the terms of the private license agreement with Amicus. The consent decree also structures the FDA’s ability to grant final ANDA approval, meaning the launch date is now a commercial negotiation rather than a regulatory milestone Aurobindo controls independently.
Market entry contingent on license23-patent portfolio creates high barrier for next ANDA filer targeting migalastat
With 23 patents acknowledged valid and enforceable — spanning methods of treatment in renal-impaired and pregnant Fabry patients — any subsequent generic manufacturer filing a Paragraph IV ANDA for migalastat faces a formidable litigation landscape. The consent judgment’s public admission of validity is persuasive, if not binding, against other defendants. Competing generic filers should expect aggressive enforcement and will need robust invalidity and non-infringement positions across a large, overlapping patent family.
High barrier to generic competitionFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Amicus Therapeutics US, LLC | Company | Rare disease biopharmaceutical company — holder of 23 migalastat patents covering Fabry disease treatmentSearch in Eureka ↗ |
| Defendant | Aurobindo Pharma, Ltd. | Company | Indian generic pharmaceutical manufacturer seeking FDA approval for generic migalastat via ANDA No. 217786Search in Eureka ↗ |
| Plaintiff counsel | Anna Whitacre | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Chad S.C. Stover | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Christina M. Baugh | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | John W. Cox | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Joshua E. Ney | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Joshua M. Kalb | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Lauren Baker | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Mark C. Nelson | Attorney | Counsel for Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Plaintiff law firm | Barnes & Thornburg, LLP | Law Firm | Representing Amicus Therapeutics US, LLCSearch in Eureka ↗ |
| Defendant counsel | Michael P. Hogan | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | R. Touhey Myer | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | Timothy H. Kratz | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | Kratz & Barry LLP | Law Firm | Representing Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge Christopher J. Burke | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consent judgment’s phrasing is unusually explicit for a settlement instrument: Aurobindo did not merely agree to be enjoined — it affirmatively acknowledged that Amicus’s patents ‘are valid and enforceable’ and that it ‘has infringed’ them under § 271(e)(2). This language exceeds what is typically required to resolve Hatch-Waxman litigation by agreement and signals that Amicus negotiated hard for public record protection. The without-prejudice dismissal of all claims, coupled with the permanent injunction and the court’s retained enforcement jurisdiction, means the case is legally closed but the parties remain bound by a judicially supervised framework enforceable in the same Delaware court.
US11633388, US11833164, US12042490 — migalastat treatment methods for Fabry disease
The three patents named in the consent judgment — US11633388, US11833164, and US12042490 — are part of a broader portfolio of 23 patents asserted in this action, all directed to methods of treating Fabry disease using migalastat, a pharmacological chaperone that stabilises mutant forms of the enzyme alpha-galactosidase A. The asserted patents address specific clinical contexts including treatment of patients with renal impairment and pregnant patients with Fabry disease, reflecting Amicus’s strategy of patenting method-of-treatment claims tied to clinical subpopulations identified through post-approval study. The applications were filed across 2020–2022, suggesting a deliberate lifecycle management programme timed ahead of anticipated generic competition.
Migalastat (marketed as Galafold) is the first oral treatment approved for Fabry disease in patients with amenable GLA mutations, representing a significant commercial asset for Amicus in a rare disease market with limited competition. The 23-patent portfolio creates a defensive perimeter that generic manufacturers must navigate patent-by-patent, significantly increasing ANDA litigation costs and uncertainty. For competing biopharmaceutical companies and generic manufacturers, the consent judgment confirms that Amicus’s method-of-treatment claims survived adversarial scrutiny sufficiently to compel a formal acknowledgment of validity — a signal that these patents present genuine infringement risk rather than merely nuisance value.
Should you run an FTO against the Amicus Therapeutics migalastat patent portfolio?
Any pharmaceutical company considering an ANDA filing for generic migalastat, or developing a next-generation pharmacological chaperone for Fabry disease, should conduct a thorough freedom-to-operate analysis against Amicus’s now-validated 23-patent portfolio. The patents cover not only the core treatment method but specifically claim administration in clinically distinct subpopulations — renal-impaired patients and pregnant patients — meaning a product indistinguishable from Galafold in composition may still infringe one or more method claims depending on its labelling and indicated uses.
PatSnap Eureka’s FTO Search Agent can map the full Amicus migalastat patent family, identify claim scope across all 23 asserted patents, flag expiry dates, and surface any continuation or divisional applications still pending that could extend the enforcement window. For R&D teams developing GLA-targeting therapies or Fabry disease treatments via alternative mechanisms, Eureka can identify design-around opportunities and benchmark the claim landscape against your specific product profile — reducing the risk of an expensive Hatch-Waxman dispute before ANDA preparation begins.
Run a freedom-to-operate analysis on US11278539B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman ANDA cases involving rare disease and migalastat patents
Other Hatch-Waxman ANDA litigations in the District of Delaware involving rare disease pharmacological chaperone patents and multi-patent enforcement portfolios.
What this case signals for the rare disease pharmaceutical IP landscape
A 23-patent enforcement campaign ending in a validity-acknowledgment consent decree sets a high-water mark for Hatch-Waxman portfolio defence strategy.
Large patent families create compounding litigation risk for ANDA filers
Amicus’s assertion of 23 patents — covering diverse methods of treating distinct patient subpopulations — required Aurobindo to mount invalidity and non-infringement defences across a sprawling claim landscape. Generic manufacturers evaluating Paragraph IV filings against mature rare disease drugs should model the cost and risk of multi-patent litigation before filing, particularly where the innovator has systematically patented method-of-treatment variations.
Consent decrees carry strategic weight beyond the settling defendant
Because Aurobindo’s acknowledgment of validity is now part of the public court record, Amicus can reference it in future litigation against other ANDA filers. While not technically binding on third parties, a judicial record of an accused infringer conceding validity creates reputational and practical pressure on subsequent challengers and may influence litigation strategy and settlement leverage in follow-on ANDA disputes.
Amicus v Aurobindo — key questions answered
Under the consent judgment entered 22 December 2025, Aurobindo acknowledged that Amicus’s asserted patents are valid and enforceable, and that Aurobindo infringed them under 35 U.S.C. § 271(e)(2) by submitting ANDA No. 217786 to the FDA. Aurobindo also acknowledged Amicus’s ownership and standing to sue. This admission is part of the public court record.
Amicus asserted 23 United States patents covering methods of treating Fabry disease with migalastat, including methods specific to patients with renal impairment and pregnant patients. The consent judgment specifically names US11633388, US11833164, and US12042490 as the ‘Asserted Patents,’ though the full complaint involved the broader portfolio listed in the case record.
Aurobindo is permanently enjoined from commercialising generic migalastat covered by ANDA No. 217786 except pursuant to a license granted by Amicus. The parties simultaneously executed a separate — and non-public — license agreement that likely governs when and under what conditions Aurobindo may actually enter the market. The consent decree also functions under 21 U.S.C. § 355(j)(5)(B)(iii) to structure FDA final-approval timing for Aurobindo’s ANDA.
In Hatch-Waxman consent judgments, dismissal without prejudice alongside a permanent injunction is a standard structure. The injunction provides the operative enforcement mechanism, while without-prejudice dismissal preserves procedural flexibility — for example, allowing Amicus to return to court if the license agreement is breached or disputed. The court also explicitly retained jurisdiction to enforce both the consent judgment and the license agreement.
The public acknowledgment of validity across a large patent portfolio raises the litigation bar significantly for subsequent ANDA filers. While Aurobindo’s admission is not legally binding on third parties, it creates a persuasive public record that Amicus’s patents withstood adversarial challenge. Any next ANDA filer should anticipate vigorous enforcement, the need for robust invalidity positions across 23 patents, and significant Hatch-Waxman litigation costs in Delaware.
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