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Celgene v. USV: Pomalyst® Patent Consent Judgment | PatSnap
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Case ID2:25-cv-06320
FiledMay 2025
ClosedNov 2025
Patent Litigation

Celgene v. USV: Consent Judgment Locks In Pomalyst® Patent Protection

Celgene Corp. sued Indian generic manufacturer USV Pvt. Ltd. in the District of New Jersey over three patents protecting its pomalidomide drug Pomalyst®. The case resolved in 160 days with a consent judgment and permanent injunction barring USV from commercialising ANDA No. 220322 until all three patents — including extensions and pediatric exclusivities — expire.

Resolution time
160days
Resolved in 160 days — well below the typical Hatch-Waxman 30-month stay window.
Patents asserted
3
US8,828,427; US9,993,467; and US10,555,939 — three Pomalyst® pomalidomide composition and method patents asserted
Outcome
Consent Judgment
Stipulated injunction entered; all claims dismissed with prejudice, no costs awarded to either party.
Cost ruling
No Cost Award
Parties agreed to bear their own costs, disbursements, and attorneys’ fees under the consent judgment.
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Celgene Secures Injunction Against Pomalidomide Generic Entry via ANDA 220322

Filed on 30 May 2025 in the District of New Jersey, this Hatch-Waxman infringement action pitted Celgene Corporation — holder of NDA 204026 for Pomalyst® (pomalidomide) — against USV Private Limited, an Indian generic pharmaceutical company that had filed ANDA No. 220322 seeking US approval of a pomalidomide drug product. Celgene asserted three patents: US8,828,427, US9,993,467, and US10,555,939, each covering aspects of pomalidomide composition and use in the treatment of multiple myeloma.

The case closed on 6 November 2025 via a stipulated consent judgment signed by both parties and entered by the court. The judgment permanently enjoins USV and its successors from making, selling, offering to sell, importing, or distributing the USV ANDA Product in the United States until expiration of all three patents-in-suit, including any extensions and pediatric exclusivities. All claims, counterclaims, and affirmative defenses were dismissed with prejudice, and no costs or attorneys’ fees were awarded to either party.

The 160-day resolution is notably swift, suggesting USV opted not to contest validity or non-infringement, likely calculating that the strength of Celgene’s patent portfolio and the risk of a contested 30-month stay made early settlement commercially rational. The public record does not disclose whether any side-payment or licensing arrangement accompanied the consent judgment, which is common in Hatch-Waxman settlements but not reflected in the publicly filed order.

Case at a glance
Case no.2:25-cv-06320
CourtNew Jersey
JudgeN/A
FiledMay 30, 2025
ClosedNovember 6, 2025
Duration160 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 160 days

Resolved in 160 days — well below the typical Hatch-Waxman 30-month stay window.

Case timeline: Complaint filed MAY 30 2025, AUG–SEP — 160 days total Horizontal timeline showing the three key events in Celgene, Corp. v USV Pvt., Ltd. from filing to resolution. Source: PACER, New Jersey District Court. MAY 30 2025 Complaint filed Pre-trial proceedings NOV 6 2025 Consent Judgment 160 DAYS TOTAL
Dismissal terms

Consent judgment entered: what the injunction means for both parties

Legal mechanism

Consent judgment blocks generic launch until patent expiry

A consent judgment in a Hatch-Waxman case operates as a court-entered stipulation: both parties agree to its terms without a full trial on the merits. Here, USV effectively conceded the injunctive relief Celgene sought, accepting a bar on commercialising ANDA 220322 for the full remaining life of all three patents-in-suit, including extensions and pediatric exclusivities. Dismissal with prejudice closes off any re-litigation of these specific claims between these parties.

Dismissed with prejudice
Patent holder outcome

Celgene preserves Pomalyst® exclusivity without trial risk

Celgene achieved the practical equivalent of a trial win — a permanent injunction against USV’s ANDA product — without exposing its patents to a validity challenge on the merits. The consent judgment explicitly preserves enforcement rights for Celgene’s successors and assigns, reinforcing the commercial value of the Pomalyst® IP estate. No costs were awarded, consistent with a negotiated resolution rather than a contested judgment.

Injunction secured
Generic challenger outcome

USV deferred from US market pending patent expiry

USV cannot commercialise its pomalidomide ANDA product in the US until all three patents expire, including any extensions or pediatric exclusivities. Notably, the consent judgment preserves USV’s right to maintain its Paragraph IV certification and to engage in research activities under 35 U.S.C. § 271(e)(1), leaving a pathway for future market entry once the patent estate clears. The FDA is also not restricted from approving ANDA 220322 in the interim.

Market entry deferred
Commercial implications

Pomalidomide generic competition remains constrained

With USV enjoined through patent expiry, Celgene’s Pomalyst® franchise retains a key line of defence against this ANDA challenger. Other generic filers referencing NDA 204026 remain subject to separate litigation. The consent judgment’s express prohibition on USV assisting third-party infringers signals Celgene’s intent to prevent indirect routes around the injunction. Stakeholders tracking pomalidomide generic entry timelines should monitor expiry dates for all three patents-in-suit, including pediatric exclusivity periods.

Exclusivity maintained
Legal analysis based on PACER docket records for case 2:25-cv-06320 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffCelgene, Corp.CompanyPharmaceutical innovator (Bristol Myers Squibb subsidiary) — holder of NDA 204026 for Pomalyst® (pomalidomide)Search in Eureka ↗
DefendantUSV Pvt., Ltd.CompanyUSV Pvt. Ltd. — Indian generic pharmaceutical manufacturer, ANDA 220322 filer for pomalidomide.Search in Eureka ↗
Plaintiff counselAlexander Lee CalloAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselCharles Michael LizzaAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselSarah Ann SullvianAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselWilliam C. BatonAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff law firmSaul Ewing LLPLaw FirmRepresenting Celgene, Corp.Search in Eureka ↗
Defendant counselEric I. AbrahamAttorneyCounsel for USV Pvt., Ltd.Search in Eureka ↗
Defendant counselKristine L. ButlerAttorneyCounsel for USV Pvt., Ltd.Search in Eureka ↗
Defendant law firmHill Wallack LLPLaw FirmRepresenting USV Pvt., Ltd.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiff Celgene Corporation (“Celgene”) and Defendant USV Private Limited (“USV”), the parties in the above-captioned action, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this 6th day of November, 2025: ORDERED, ADJUDGED, AND DECREED as follows: 1. 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. As used in this Consent Judgment, the term “USV ANDA Product” shall mean a drug product manufactured, imported, used, sold, offered for sale, marketed, or distributed pursuant to Abbreviated New Drug Application No. 220322 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. 8,828,427; 9,993,467; and 10,555,939. 4. Until expiration of the Patents-in-Suit, including all extensions and pediatric exclusivities, USV, 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 USV 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 Celgene, 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 pomalidomide-containing drug product that references NDA 204026 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 Celgene. 5. Compliance with this Consent Judgment may be enforced by Celgene 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. All claims, counterclaims, affirmative defenses and demands pertaining to the Patents-in-Suit are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. 8. Nothing herein prohibits or is intended to prohibit USV 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. 9. Nothing herein prohibits or is intended to prohibit USV from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). 10. Nothing herein restricts or is intended to restrict the U.S. Food and Drug Administration from approving Abbreviated New Drug Application No. 220322 or the USV ANDA Product.”
Source: PACER Docket, Case 2:25-cv-06320, New Jersey District Court

The consent judgment is notable for what it preserves as much as what it prohibits. By expressly retaining USV’s Paragraph IV certification rights and § 271(e)(1) research exemption, and by declining to restrict FDA approval of ANDA 220322, the order reflects a negotiated balance: Celgene secures market exclusivity for the patent term while USV retains a commercially viable position for post-expiry entry. The dismissal with prejudice forecloses any later challenge to these patents by USV in the context of ANDA 220322, but the absence of a merits ruling means the patents’ validity was never tested.

PACER case 2:25-cv-06320 · Public docket record Explore in Eureka ↗
Patent at issue

US8,828,427; US9,993,467; US10,555,939 — Pomalidomide (Pomalyst®) patents

Publication No.US10555939B2
Application No.US15/976808
Patent details
ProductPomalidomide pharmaceutical compositions and methods of use (Pomalyst®)
Cited in actionMay 30, 2025

Publication No.US8828427B2
Application No.US12/783390
Patent details
ProductPomalidomide compositions and formulations covering Pomalyst® drug product
Cited in actionMay 30, 2025

Publication No.US9993467B2
Application No.US14/998262
Patent details
ProductPomalidomide treatment methods and dosing regimens for multiple myeloma
Cited in actionMay 30, 2025

The three patents-in-suit — US8,828,427 (application US12/783390), US9,993,467 (application US14/998262), and US10,555,939 (application US15/976808) — collectively form part of the patent estate protecting Celgene’s Pomalyst® (pomalidomide), an immunomodulatory agent approved for relapsed/refractory multiple myeloma and Kaposi sarcoma. The patents cover composition, formulation, and method-of-use aspects of pomalidomide, providing overlapping claim layers that extend commercial protection across different patent expiry windows.

For the generic pharmaceutical sector, this three-patent stack illustrates a common innovator strategy: listing multiple patents in the FDA’s Orange Book against a single NDA to force ANDA filers into multi-front Paragraph IV litigation. Each patent carries its own expiry date and potential for extension via patent term adjustment or pediatric exclusivity, compounding the entry barrier. Competitors considering pomalidomide ANDAs should map each patent’s independent expiry date and assess whether any are vulnerable to IPR or post-grant challenge before committing to Paragraph IV certifications.

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Freedom to operate

Should you run an FTO against US8,828,427, US9,993,467 & US10,555,939?

Any pharmaceutical company developing a pomalidomide-containing drug product referencing NDA 204026 — whether as an ANDA filer, a contract manufacturer, or a formulation partner — should conduct a freedom-to-operate analysis against all three Pomalyst® patents before advancing clinical or regulatory work. The consent judgment’s broad injunction language, covering making, importing, selling, and distributing, signals Celgene’s intent to enforce aggressively against any party in the supply chain.

PatSnap Eureka’s FTO Search Agent can rapidly map the claim scope of each patent, identify potentially blocking claims for a proposed pomalidomide formulation, and surface prior art relevant to validity challenges. With three overlapping patents and multiple expiry windows to navigate, automated claim-by-claim analysis saves significant time and reduces the risk of missing a blocking claim before an ANDA filing strategy is finalised.

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Related litigation

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Strategic implications

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

Celgene’s rapid resolution via consent judgment reinforces how innovators use layered patent portfolios to deter generic entry without trial risk.

Three-patent stacking strengthens Hatch-Waxman negotiating leverage

Asserting multiple patents covering a single drug product — here composition and method claims across three patents — raises the cost and risk calculus for ANDA filers significantly. USV’s decision to consent to judgment rather than challenge validity suggests the portfolio depth made litigation commercially unattractive. Innovators should audit whether their NDA-listed patents present similarly layered claim coverage.

Preserved Paragraph IV rights may signal a future entry date deal

The consent judgment explicitly preserves USV’s Paragraph IV certification rights and its FDA approval pathway for ANDA 220322. This is a hallmark of Hatch-Waxman settlements that include an agreed future entry date — typically tied to patent expiry. The public record does not disclose any such date, but the preservation language is consistent with that structure and warrants monitoring.

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Full strategic analysis in PatSnap Eureka
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Frequently asked questions

Celgene v USV — key questions answered

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Monitor pomalidomide ANDA litigation and Pomalyst® patent expiry

Use PatSnap Eureka to track new ANDA filings referencing NDA 204026, monitor expiry timelines for all three Pomalyst® patents, and run FTO analysis before advancing any pomalidomide generic programme.

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