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Allergan & AbbVie v. Macleods — Milnacipran ANDA Patent Dispute | PatSnap
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Case ID1:24-cv-00847
FiledJul 2024
ClosedJan 2025
Patent Litigation

Allergan & AbbVie v. Macleods: SAVELLA® Patent Upheld in 175-Day ANDA Dispute

Allergan Pharmaceuticals International and AbbVie Inc. asserted US Patent No. 7,994,220 covering SAVELLA® (milnacipran hydrochloride) tablets against Macleods’ ANDA No. 210944. Macleods admitted validity, enforceability, and infringement — resulting in a consent order and permanent injunction blocking generic entry for the life of the patent.

Resolution time
175days
175-day resolution — faster than median Hatch-Waxman district court litigation
Patents asserted
1
US7994220 — SAVELLA® milnacipran hydrochloride tablets (12.5 mg–100 mg), fibromyalgia SNRI
Outcome
Case Dismissed
Macleods admitted infringement; permanent injunction entered for life of the ‘220 patent
Cost ruling
Costs Waived
Both parties expressly waived appeal rights; no cost ruling recorded in the public docket
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

SAVELLA® ANDA blocked: Macleods concedes on all key patent questions

Filed on 19 July 2024 in the District of Delaware before Judge Maryellen Noreika, this Hatch-Waxman action saw Allergan Pharmaceuticals International Limited and AbbVie Inc. assert US Patent No. 7,994,220 against Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. The ‘220 patent covers milnacipran hydrochloride tablet formulations sold under the brand name SAVELLA®, indicated for fibromyalgia management, in 12.5 mg, 25 mg, 50 mg, and 100 mg strengths.

The case resolved on 10 January 2025 — just 175 days after filing — through a stipulated consent order. Critically, Macleods admitted that the ‘220 patent is valid, enforceable, and would be infringed by the commercial manufacture, use, or sale of its ANDA No. 210944 products. The court permanently enjoined Macleods from making, using, selling, or importing the generic tablets for the remaining life of the patent, including any extensions and pediatric exclusivities, absent a licence from plaintiffs.

The speed of resolution — under six months — is consistent with a defendant that assessed the strength of the patent position and chose to avoid prolonged litigation costs rather than mount an invalidity challenge. The public record does not disclose any licence or commercial side agreement between the parties, though the order expressly preserves both parties’ rights in any future dispute involving the ‘220 patent and a different product. The possibility of a confidential licensing arrangement cannot be excluded but remains unconfirmed.

Case at a glance
Case no.1:24-cv-00847
CourtDelaware
JudgeMaryellen Noreika
FiledJuly 19, 2024
ClosedJanuary 10, 2025
Duration175 days
OutcomeCase Dismissed
Verdict causeInfringement Action
BasisCase Dismissed
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 Case Dismissed in 175 days

175-day resolution — faster than median Hatch-Waxman district court litigation

Case timeline: Complaint filed JUL 19 2024, OCT–NOV — 175 days total Horizontal timeline showing the three key events in ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd. v Macleods Pharmaceuticals from filing to resolution. Source: PACER, Delaware District Court. JUL 19 2024 Complaint filed Pre-trial proceedings JAN 10 2025 Case Dismissed 175 DAYS TOTAL
Dismissal terms

Consent order and injunction: what the stipulated resolution means for both parties

Legal mechanism

Stipulated consent order — infringement admitted under 35 U.S.C. § 271(e)(2)(A)

Under the Hatch-Waxman framework, filing an ANDA referencing a patented drug constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A). Here, Macleods went further than the statute requires by expressly admitting validity and enforceability of the ‘220 patent — a concession that typically signals an inability to mount a credible invalidity or non-infringement defence. The parties jointly petitioned the court to enter a consent order, which carries the same enforceability as a contested judgment.

Hatch-Waxman § 271(e)(2)(A)
Patent holder outcome

Permanent injunction secures SAVELLA® market exclusivity for patent life

Allergan and AbbVie secured a court-ordered permanent injunction blocking Macleods from commercialising its generic milnacipran HCl tablets for the entire remaining life of the ‘220 patent, including any PTE or paediatric exclusivity extensions. The admission of validity strengthens the patent’s public record and raises the bar for any future ANDA challenger seeking to distinguish this concession. Plaintiffs also preserved the right to pursue future actions involving the ‘220 patent and other products.

Injunction granted — full patent term
Challenger outcome

Macleods blocked from generic launch; appeal rights expressly waived

Macleods is permanently enjoined and has waived all appeal rights under the terms of the consent order. This forecloses any future challenge to the order itself. However, the stipulation is expressly limited to ANDA No. 210944 and milnacipran HCl tablets in those specific strengths — meaning Macleods retains standing to challenge the ‘220 patent in a future action involving a different product or formulation. All other claims, counterclaims, and defences were dismissed without prejudice.

No appeal rights — product-specific bar
Commercial implications

Validated ‘220 patent raises entry costs for all future SAVELLA® ANDA filers

A publicly recorded admission of validity by a generic challenger is a meaningful signal to subsequent ANDA filers. Any competitor considering a Paragraph IV certification against the ‘220 patent must now contend with this stipulated concession in the litigation record. Patent term extensions and paediatric exclusivities could further extend the exclusivity window. Companies with pipeline generic fibromyalgia products should conduct fresh FTO analysis and assess whether design-around or IPR strategies remain viable against the ‘220 patent.

Heightened bar for future generic challengers
Legal analysis based on PACER docket records for case 1:24-cv-00847 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.CompanyPharmaceutical IP holding and commercialisation entity — holder of US7994220 (SAVELLA®)Search in Eureka ↗
Co-PlaintiffAbbVie, Inc.CompanySearch in Eureka ↗
DefendantMacleods PharmaceuticalsIndividualIndian generic pharmaceutical manufacturer and its US affiliate seeking FDA approval via ANDA No. 210944Search in Eureka ↗
Co-DefendantMacleods Pharma USA, Inc.CompanySearch in Eureka ↗
Plaintiff counselJeremy A. TiganAttorneyCounsel for ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.Search in Eureka ↗
Plaintiff counselMegan Elizabeth DellingerAttorneyCounsel for ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.Search in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.Search in Eureka ↗
Defendant counselR. Touhey Myer.AttorneyCounsel for Macleods PharmaceuticalsSearch in Eureka ↗
Defendant law firmKratz & Barry LLPLaw FirmRepresenting Macleods PharmaceuticalsSearch in Eureka ↗
Presiding judgeJudge Maryellen NoreikaJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“The Court, upon the consent and request of Plaintiffs Allergan Pharmaceuticals International Limited and AbbVie Inc. (collectively, “Plaintiffs”) and Defendants Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc., (collectively, “Macleods”), hereby acknowledges the following Stipulation and issues the following Order in the above-captioned action. STIPULATION 1. This Court has subject matter jurisdiction over this patent infringement action (the “Action”) and personal jurisdiction over Plaintiffs and Macleods for purposes of the Action. 2. Venue is proper in this Court as to Plaintiffs and Macleods for the Action. 3. Plaintiffs have asserted claims against Macleods for infringement of U.S. Patent No. 7,994,220 (“the ’220 patent) in connection with Macleods’ submission of Abbreviated New Drug Application (“ANDA”) No. 210944 directed to generic milnacipran hydrochloride tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg strengths, to the U.S. Food and Drug Administration (“FDA”). Case 1:24-cv-00847-MN Document 16 Filed 01/10/25 Page 1 of 3 PageID #: 60 2 4. Macleods admits that the ’220 patent is enforceable, valid, and would be infringed by the commercial manufacture, use, and/or sale within the United States of the generic milnacipran hydrochloride tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg strengths, that are the subject of Macleods’ ANDA No. 210944. 5. Macleods admits that the submission of ANDA No. 210944 to the FDA for purposes of obtaining regulatory approval to engage in the commercial manufacture, use, and/or sale within the United States of the generic milnacipran hydrochloride tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg strengths, was an act of infringement of the ’220 patent under 35 U.S.C. § 271(e)(2)(A). 6. The parties agree that all other claims, counterclaims, and defenses asserted against each other in Plaintiffs’ and Macleods’ pleadings in the Action, including the allegations and averments contained therein, should be dismissed, without prejudice. ORDER Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Macleods, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT: 1. The filing of ANDA No. 210944 was an act of infringement of the ’220 patent under 35 U.S.C. § 271(e)(2)(A). 2. All other claims, counterclaims, and defenses asserted by the parties against each other in Plaintiffs’ and Macleods’ pleadings in the Action, including the allegations and averments contained therein are hereby dismissed, without prejudice. 3. Macleods, its officers, agents, servants, employees, and attorneys, and all other persons in active concert or participation with any of them who receive actual notice of this Order by personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the generic Case 1:24-cv-00847-MN Document 16 Filed 01/10/25 Page 2 of 3 PageID #: 61 3 milnacipran hydrochloride tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg strengths, described by ANDA No. 210944 during the life of the ’220 patent, including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs. 4. Plaintiffs and Macleods each expressly waive any right to appeal or otherwise move for relief from this Stipulation And Order. 5. This Court retains jurisdiction over Plaintiffs and Macleods for purposes of enforcing this Stipulation And Order. 6. This Stipulation And Order shall finally resolve the Action between the Parties. 7. This Stipulation And Order is without prejudice to any claim, defense, or counterclaim in any possible future action between Macleods and any of the Plaintiffs regarding the ’220 patent, and a product other than the generic milnacipran hydrochloride tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg strengths, described by ANDA No. 210944. 8. The Clerk of the Court is directed to enter this Stipulation And Order forthwith in the Action”
Source: PACER Docket, Case 1:24-cv-00847, Delaware District Court

The consent order is unusually strong for a defendant: Macleods not only conceded the statutory act of infringement under § 271(e)(2)(A) but explicitly admitted the ‘220 patent’s validity and enforceability — concessions that go beyond the minimum required to resolve an ANDA case. The permanent injunction tracks the full statutory patent life including extensions, and the express waiver of appeal rights by both parties eliminates any post-order challenge pathway. The without-prejudice carve-out for future disputes involving different products suggests the parties negotiated a narrowly scoped resolution, likely to avoid creating broader precedential exposure.

PACER case 1:24-cv-00847 · Public docket record Explore in Eureka ↗
Patent at issue

US7994220B2 — Milnacipran hydrochloride tablet formulations (SAVELLA®)

Publication No.US7994220B2
Application No.US11/535237
Patent details
ProductMilnacipran hydrochloride tablet formulations for fibromyalgia (SAVELLA®), 12.5–100 mg
Cited in actionJuly 19, 2024

US Patent No. 7,994,220 (application number 11/535,237) covers milnacipran hydrochloride tablet formulations commercialised as SAVELLA®, an SNRI (serotonin-norepinephrine reuptake inhibitor) approved by the FDA for the management of fibromyalgia. The patent’s claims, as implicitly validated by Macleods’ admission, are sufficiently robust to cover the full range of tablet strengths (12.5 mg, 25 mg, 50 mg, and 100 mg) that constitute a commercially complete ANDA product line.

The ‘220 patent sits in a competitive intersection of formulation chemistry and CNS therapeutics — a space where ANDA challengers routinely attempt Paragraph IV certification on grounds of obviousness or prior art. Macleods’ decision to admit validity rather than challenge suggests the patent’s claims are well-differentiated from the prior art. For competitors in the fibromyalgia and SNRI space, the ‘220 patent — now buttressed by a court-recorded validity admission — represents a meaningful exclusivity barrier that requires careful design-around analysis before any generic development programme is initiated.

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

Should you run an FTO against US7994220 before filing a milnacipran ANDA?

Any pharmaceutical company or contract manufacturer considering generic milnacipran hydrochloride tablets in the US market must treat the ‘220 patent as a primary clearance risk. The publicly recorded admission of validity by Macleods raises the evidentiary bar for any future invalidity argument. R&D teams developing alternative salt forms, dosage strengths, or modified-release formulations should commission claim-scope analysis before committing to an ANDA filing strategy.

PatSnap Eureka’s FTO Search Agent can map the full claim scope of US7994220 against your candidate formulation, identify relevant prior art that pre-dates the application, and surface any pending continuations or related patents in the AbbVie/Allergan milnacipran portfolio that could extend risk beyond the ‘220 patent. Automated patent family monitoring ensures your team is alerted to any new filings or PTE applications before they affect your development timeline.

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Related litigation

Similar Hatch-Waxman ANDA infringement cases in Delaware District Court

Explore related Paragraph IV ANDA patent infringement actions litigated in the District of Delaware involving brand pharmaceutical formulation patents and generic challengers.

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Strategic implications

What this case signals for the Hatch-Waxman pharmaceutical IP landscape

A swift admission of infringement in ANDA litigation often signals stronger-than-average patent positions and has downstream consequences for all prospective generic competitors.

Admissions of validity in ANDA cases create compounding effects for brand holders

When a generic defendant formally admits a patent is valid and enforceable — rather than simply withdrawing its Paragraph IV certification — that admission enters the public litigation record. Subsequent challengers must address or distinguish it, effectively raising the cost and risk of any future invalidity campaign against the same patent.

175-day resolution signals a patent that could not be challenged on the merits

Macleods resolved the case before any substantive briefing on invalidity or claim construction. This timeline, combined with the explicit validity admission, is consistent with a patent that offers limited grounds for attack via IPR, inter partes review, or district court invalidity arguments — a material concern for any company monitoring the SAVELLA® competitive landscape.

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Frequently asked questions

ALLERGAN v Macleods — key questions answered

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