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.
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.
Filing to Case Dismissed in 175 days
175-day resolution — faster than median Hatch-Waxman district court litigation
Consent order and injunction: what the stipulated resolution means for both parties
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)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 termMacleods 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 barValidated ‘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 challengersFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd. | Company | Pharmaceutical IP holding and commercialisation entity — holder of US7994220 (SAVELLA®)Search in Eureka ↗ |
| Co-Plaintiff | AbbVie, Inc. | Company | Search in Eureka ↗ |
| Defendant | Macleods Pharmaceuticals | Individual | Indian generic pharmaceutical manufacturer and its US affiliate seeking FDA approval via ANDA No. 210944Search in Eureka ↗ |
| Co-Defendant | Macleods Pharma USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Jeremy A. Tigan | Attorney | Counsel for ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Megan Elizabeth Dellinger | Attorney | Counsel for ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing ALLERGAN PHARMACEUTICALS INTERNATIONAL, Ltd.Search in Eureka ↗ |
| Defendant counsel | R. Touhey Myer. | Attorney | Counsel for Macleods PharmaceuticalsSearch in Eureka ↗ |
| Defendant law firm | Kratz & Barry LLP | Law Firm | Representing Macleods PharmaceuticalsSearch in Eureka ↗ |
| Presiding judge | Judge Maryellen Noreika | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
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.
US7994220B2 — Milnacipran hydrochloride tablet formulations (SAVELLA®)
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.
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.
Run a freedom-to-operate analysis on US7994220B2 to assess your product’s exposure
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Portfolio viewWhat 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.
PTE and paediatric exclusivity windows could extend the ‘220 patent injunction further
The consent order explicitly extends the injunction through any patent term extension or paediatric exclusivity granted on the ‘220 patent. Companies modelling generic entry timelines for milnacipran HCl must account for these potential extensions in their commercial planning and FTO assessments.
Without-prejudice dismissal of other claims preserves litigation optionality for both sides
The stipulation dismissed all counterclaims and non-core claims without prejudice, and explicitly carves out the right to future actions involving the ‘220 patent and different products. This preserves AbbVie’s and Allergan’s ability to pursue enforcement against reformulated generics while leaving Macleods a narrow path to challenge the patent in a non-ANDA context.
ALLERGAN v Macleods — key questions answered
Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. admitted that US Patent No. 7,994,220 is valid, enforceable, and would be infringed by commercial manufacture, use, or sale of their generic milnacipran hydrochloride tablets covered by ANDA No. 210944. They also admitted the ANDA filing itself constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
US7994220 covers milnacipran hydrochloride tablet formulations marketed as SAVELLA® by Allergan and AbbVie. SAVELLA® is an SNRI approved by the FDA for the management of fibromyalgia, available in 12.5 mg, 25 mg, 50 mg, and 100 mg tablet strengths. The patent was the sole patent asserted in this ANDA infringement action.
The Delaware District Court entered a permanent consent injunction barring Macleods, its officers, agents, and employees from manufacturing, using, offering to sell, selling within, or importing into the United States the generic milnacipran hydrochloride tablets described by ANDA No. 210944, for the full remaining life of the ‘220 patent including any patent term extensions and paediatric exclusivities, unless Allergan or AbbVie grant a licence.
No. As part of the stipulated consent order entered on 10 January 2025, both Allergan/AbbVie and Macleods expressly waived any right to appeal or otherwise move for relief from the Stipulation and Order. This bilateral waiver effectively makes the order final and unappealable by either party.
Not entirely. The consent order is expressly limited to ANDA No. 210944 and milnacipran hydrochloride tablets in the specified strengths. Paragraph 7 of the order explicitly preserves both parties’ rights in any future action involving the ‘220 patent and a different product. Macleods therefore retains standing to challenge the patent in a future proceeding involving a distinct product formulation, though the validity admission in this case would be a significant factual obstacle in any such proceeding.
Track SAVELLA® patent enforcement and milnacipran generic entry risk
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