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Celgene & BMS v. Accord Healthcare & MSN — Azacitidine Tablet Patent Injunction | PatSnap
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Case ID1:21-cv-01795
FiledDec 2021
ClosedFeb 2024
Litige en matière de brevets

Celgene & BMS v. Accord & MSN: Azacitidine Patent Consent Judgment with Injunction

Celgene, Bristol-Myers Squibb, and Celgene International successfully secured a consent judgment and permanent injunction against MSN Laboratories and MSN Pharmaceuticals, blocking generic azacitidine tablet entry under ANDA No. 218435. The case, asserting two patents covering oral azacitidine formulations, closed after 799 days with all claims dismissed with prejudice.

Resolution time
799days
799 days — approximately 26 months from filing to consent judgment
Patents asserted
1
US8846628B2 and US11571436 — oral azacitidine tablet formulation patents
Résultat
Injunction Granted
Consent judgment — MSN enjoined from commercialising azacitidine tablets until patent expiry
Cost ruling
No Cost Award
Dismissed with prejudice — no costs, disbursements, or attorneys’ fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Consent injunction blocks generic oral azacitidine entry in ANDA dispute

Filed on 22 December 2021 in the District of Delaware before Judge Jennifer L. Hall, this Hatch-Waxman infringement action was brought by Celgene Corp., Bristol-Myers Squibb Company, and Celgene International SARL against Accord Healthcare Ltd., MSN Laboratories Private Limited, and MSN Pharmaceuticals Inc. The plaintiffs asserted U.S. Patent Nos. 8,846,628 and 11,571,436 against MSN’s ANDA No. 218435, which sought FDA approval for 200 mg and 300 mg azacitidine tablets referencing NDA 214120.

The case closed on 29 February 2024 via a consent judgment that permanently enjoins MSN — including its successors and assigns — from making, importing, selling, or distributing its ANDA product in the United States until expiry of both patents-in-suit. All claims and counterclaims were dismissed with prejudice, with no award of costs or fees to either side. The court explicitly retained jurisdiction to enforce the consent judgment and resolve any future disputes arising from it.

At 799 days, the case ran for roughly 26 months before resolution — consistent with the typical timeline for a negotiated ANDA consent judgment, which often follows completion of claim construction or the exchange of technical expert reports. The consent structure, rather than a contested trial outcome, suggests the parties reached a commercial accommodation, though the specific terms of any licensed entry date or market access arrangement are not disclosed in the public record. MSN retains the right to maintain its Paragraph IV certifications and to conduct activities protected under 35 U.S.C. § 271(e)(1).

Case at a glance
Case no.1:21-cv-01795
CourtDelaware
JudgeJennifer L. Hall
FiledDecember 22, 2021
ClosedFebruary 29, 2024
Duration799 days
OutcomeInjunction Granted
Verdict causeInfringement Action
BasisInjunction Granted
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to settlement in 799 days

799 days — approximately 26 months from filing to consent judgment

Case timeline: Complaint filed May 13 2025, JAN–FEB — 799 days total Horizontal timeline showing the three key events in Celgene, Corp. v Accord Healthcare, Ltd. from filing to voluntary dismissal. Source: PACER, Delaware District Court. DEC 22 2021 Complaint filed JAN–FEB 2021 Pre-trial proceedings FEB 29 2024 Resolved consent judgment 799 DAYS TOTAL
Consent judgment terms

Permanent injunction against MSN until expiry of both azacitidine patents

Legal mechanism

What a consent judgment with injunction means in ANDA litigation

A consent judgment is a court-endorsed agreement between the parties, carrying the same enforceability as a litigated order. Here, MSN agreed to be permanently enjoined from commercialising its ANDA product until both patents expire. This is a common resolution in Hatch-Waxman cases — it gives the patentee certainty of exclusion without the risk of trial, while potentially allowing the generic a negotiated future entry date not visible in the public record.

Injunction by agreement
Dismissal terms

All claims dismissed with prejudice — no costs awarded to either side

The consent judgment dismisses all claims, counterclaims, affirmative defenses, and motions with prejudice, meaning neither party can re-litigate the same issues in a new action. Unusually, no costs or attorneys’ fees were awarded to either side, which is consistent with a mutually negotiated resolution rather than a clear-cut win or loss. The court retains jurisdiction to enforce the judgment, providing plaintiffs a mechanism to act swiftly if MSN breaches the injunction.

With prejudice, no fee award
Scope of injunction

MSN enjoined from all U.S. commercialisation — including third-party assistance

The injunction is notably broad: it covers not only MSN’s direct commercialisation of its ANDA product but also any assistance or cooperation with third parties infringing the patents in connection with azacitidine products referencing NDA 214120. This third-party restriction limits MSN’s ability to partner with or supply a distributor seeking to bring a competing product to market under a related reference drug pathway, reinforcing the plaintiffs’ exclusivity position.

Broad third-party scope
Preserved rights

MSN retains Paragraph IV rights and safe harbour protections

Despite the injunction, the consent judgment preserves MSN’s right to maintain its Paragraph IV certifications against both patents-in-suit and any other patent, and to engage in research or development activities protected under 35 U.S.C. § 271(e)(1). The FDA also remains free to approve ANDA No. 218435. These carve-outs suggest MSN may be positioning for a future entry once the patents expire or if it successfully challenges patent validity through a separate proceeding.

Future entry not foreclosed
Legal analysis based on PACER docket records for case 1:21-cv-01795 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNomTypeDétail
DemandeurCelgene, Corp.EntreprisePharmaceutical IP holding and commercial arm — holder of US8846628 and US11571436 covering oral azacitidineSearch in Eureka ↗
DéfendeurAccord Healthcare, S.A.R.L.EntrepriseGeneric pharmaceutical manufacturer and its U.S. affiliate seeking ANDA approval for azacitidine tabletsSearch in Eureka ↗
Plaintiff counselAmy K. WigmoreAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselAndrew J. DanfordAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselBrian E. FarnanAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselDavid MlaverAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselGerard A. SalvatoreAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselHeather M. PetruzziAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselJoseph J. Farnan , Jr.AttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselLi-tsung A. ChenAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselMichael J. FarnanAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselNora Q.E. PassamaneckAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Defendant counselCorey WeinsteinAttorneyCounsel for Accord Healthcare, Ltd.Search in Eureka ↗
Defendant counselNeal SethAttorneyCounsel for Accord Healthcare, Ltd.Search in Eureka ↗
Defendant counselStamatios StamoulisAttorneyCounsel for Accord Healthcare, Ltd.Search in Eureka ↗
Defendant counselWesley E. WeeksAttorneyCounsel for Accord Healthcare, Ltd.Search in Eureka ↗
Presiding judgeJudge Jennifer L. HallJuge en chefDelaware District Court — Chief JudgeSearch in Eureka ↗
Official verdict

Stipulation of dismissal — official text

“This Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties for purposes of this action only, including as set forth below in Paragraph 6 of this Consent Judgment. 2. As used in this Consent Judgment, the term “MSN ANDA Product” shall mean 200 mg and 300 mg azacitidine tablets manufactured, imported, sold, offered for sale, marketed, or distributed pursuant to Abbreviated New Drug Application No. 218435 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico. 3. As used in this Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 8,846,628 and 11,571,436. 4. Until expiration of the Patents-in-Suit, MSN, including any of its successors and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third party on its behalf, by making, having made, using, selling, offering to sell, importing, or distributing of the MSN ANDA Product in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico, unless and to the extent otherwise specifically authorized by Plaintiffs, and is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the Patents-in-Suit by any such third parties in connection with making, having made, using, selling, offering to sell, importing, or distributing of any azacitidine-containing drug product that references New Drug Application 214120 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico, unless and to the extent otherwise specifically authorized by Plaintiffs. 5. Compliance with this Consent Judgment may be enforced by Plaintiffs and its respective successors in interest or assigns. 6. This Court retains jurisdiction to enforce the terms of this Consent Judgment and to enforce and resolve any disputes related thereto. 7. All claims, counterclaims, affirmative defenses, motions and demands in this action that are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. 8. Nothing herein prohibits or is intended to prohibit MSN from maintaining any “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to the Patents-in-Suit or any other patent. 9. Nothing herein restricts or is intended to restrict the U.S. Food and Drug Administration from approving Abbreviated New Drug Application No. 218435 or the MSN ANDA Product. 10. Nothing herein prohibits or is intended to prohibit MSN from engaging in any activity permitted under 35 U.S.C. § 271(e)(1).”
Source: PACER Docket, Case 1:21-cv-01795, Delaware District Court · Filed February 29, 2024

The consent judgment is structured as a full injunctive resolution: MSN is permanently barred from commercialising its ANDA product in the U.S. until both patents expire. The breadth of the injunction — covering direct acts, third-party assistance, and any azacitidine product referencing NDA 214120 — leaves MSN with no near-term path to market. The no-costs provision and preservation of Paragraph IV rights are consistent with a negotiated resolution, suggesting the parties may have agreed on a confidential future entry date not reflected in the public judgment.

PACER case 1:21-cv-01795 · Public docket record Explore in Eureka ↗
Patent at issue

US8846628 & US11571436 — oral azacitidine tablet formulation patents

Publication No.US8846628B2
Application No.US12/466213
Patent details
AssigneeCelgene, Corp.
ProductUS8846628 — oral azacitidine tablet formulation
Publication typeB2 — grant (with prior publication)
Cited in actionDecember 22, 2021

US8846628 (application number US12/466213) covers formulations and methods relating to oral azacitidine tablets, a DNA methyltransferase inhibitor used in oncology. Azacitidine was historically administered only by injection; the patents protect the formulation innovation enabling oral bioavailability at therapeutic doses. US11571436 appears to be a related continuation asserting overlapping or extended claims. Together, these patents underpin Celgene’s Onureg (azacitidine) tablets, approved for maintenance therapy in acute myeloid leukaemia (AML).

The oral azacitidine patent family represents a high-value exclusivity position in a growing oncology indication. AML maintenance therapy is a commercially significant and expanding market, making these patents prime targets for ANDA challengers seeking generic entry. The combination of a formulation patent and a later-issued continuation creates a layered exclusivity structure that complicates invalidity challenges and extends the effective window of market protection, making this patent family a strategic asset for BMS post-acquisition of Celgene.

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

Should you run an FTO analysis against US8846628 and US11571436?

Any company developing or planning to file an ANDA for an oral azacitidine tablet product referencing NDA 214120 faces direct exposure to US8846628 and US11571436. This case confirms that Celgene and BMS will enforce both patents through to a court-ordered injunction in Delaware. R&D and regulatory teams considering formulation work in the hypomethylating agent space — including 5-azacytidine tablet formulations at any dose — should treat these patents as live blocking assets and commission a full FTO before committing ANDA resources.

PatSnap Eureka’s FTO Search Agent enables rapid claim-by-claim mapping of US8846628 and US11571436 against proposed formulation specifications, and monitors the broader Celgene/BMS azacitidine continuation family for newly granted claims. With the court having retained jurisdiction to enforce the consent judgment, any product that comes within the scope of enjoined activity risks contempt proceedings — making ongoing claim monitoring, not just a one-time FTO, an essential risk management tool for this patent family.

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Related litigation

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Strategic implications

What this case signals for the oral azacitidine and ANDA IP landscape

BMS and Celgene have demonstrated consistent willingness to enforce oral azacitidine patents through to a court-ordered injunction.

Consent injunctions in ANDA cases signal strong patent confidence

When a branded pharmaceutical plaintiff secures a consent judgment with injunction rather than settling on undisclosed commercial terms alone, it typically signals high confidence in the validity and enforceability of the asserted patents. Competitors assessing the oral azacitidine space should treat US8846628 and US11571436 as actively defended assets requiring rigorous FTO analysis before any ANDA filing.

Preserved Paragraph IV rights hint at future generic entry strategy

The explicit preservation of MSN’s right to maintain Paragraph IV certifications is a standard but strategically important carve-out. It suggests MSN has not conceded patent validity — only agreed to market delay. Companies tracking the azacitidine generic pipeline should monitor IPR or post-grant proceedings that MSN or other filers may initiate as the patent expiry horizon approaches.

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Full strategic analysis in PatSnap Eureka
Includes sector IP trends, Judge Treadwell’s case history, and FTO risk assessment for the truck equipment space
BMS/Celgene enforcement patternContinuation patent risk analysisAzacitidine ANDA pipeline map
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Questions fréquentes

Celgene v Accord — key questions answered

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Map your ANDA exposure against the oral azacitidine patent estate

Use PatSnap Eureka to run a full FTO against US8846628 and US11571436, monitor continuation filings, and track enforcement patterns across the BMS/Celgene oncology portfolio before committing ANDA resources.

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