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.
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.
Filing to Consent Judgment in 160 days
Resolved in 160 days — well below the typical Hatch-Waxman 30-month stay window.
Consent judgment entered: what the injunction means for both parties
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 prejudiceCelgene 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 securedUSV 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 deferredPomalidomide 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 maintainedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Celgene, Corp. | Company | Pharmaceutical innovator (Bristol Myers Squibb subsidiary) — holder of NDA 204026 for Pomalyst® (pomalidomide)Search in Eureka ↗ |
| Defendant | USV Pvt., Ltd. | Company | USV Pvt. Ltd. — Indian generic pharmaceutical manufacturer, ANDA 220322 filer for pomalidomide.Search in Eureka ↗ |
| Plaintiff counsel | Alexander Lee Callo | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Charles Michael Lizza | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Sarah Ann Sullvian | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff counsel | William C. Baton | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff law firm | Saul Ewing LLP | Law Firm | Representing Celgene, Corp.Search in Eureka ↗ |
| Defendant counsel | Eric I. Abraham | Attorney | Counsel for USV Pvt., Ltd.Search in Eureka ↗ |
| Defendant counsel | Kristine L. Butler | Attorney | Counsel for USV Pvt., Ltd.Search in Eureka ↗ |
| Defendant law firm | Hill Wallack LLP | Law Firm | Representing USV Pvt., Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
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.
US8,828,427; US9,993,467; US10,555,939 — Pomalidomide (Pomalyst®) patents
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.
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.
Run a freedom-to-operate analysis on US10555939B2 to assess your product’s exposure
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Portfolio viewWhat 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.
Successor-in-interest clause extends Celgene’s enforcement posture post-BMS integration
The consent judgment explicitly binds USV’s successors and assigns while also reserving enforcement rights for Celgene’s successors. Given Bristol Myers Squibb’s ownership of Celgene, this clause ensures the injunction survives any portfolio restructuring and can be enforced by BMS directly — a structurally important provision for multi-drug acquirers managing inherited ANDA litigation.
Early consent judgments can reset the competitive landscape for parallel ANDA filers
When a first-filer ANDA challenger consents to judgment early, it may affect 180-day exclusivity forfeiture triggers for other generic filers under Hatch-Waxman. Competitors with pending pomalidomide ANDAs referencing NDA 204026 should assess whether USV’s consent judgment affects their own exclusivity positioning and entry timing strategy.
Celgene v USV — key questions answered
The consent judgment permanently enjoins USV Private Limited from making, selling, offering to sell, importing, or distributing its ANDA 220322 pomalidomide product in the United States until expiration of US Patents 8,828,427; 9,993,467; and 10,555,939, including all extensions and pediatric exclusivities. All claims were dismissed with prejudice and no costs were awarded to either party.
Celgene asserted three patents: US8,828,427, US9,993,467, and US10,555,939 — all listed in connection with NDA 204026 for Pomalyst® (pomalidomide). The patents cover composition, formulation, and method-of-use aspects of pomalidomide and collectively form the ‘Patents-in-Suit’ referenced in the consent judgment.
Yes. The consent judgment explicitly states that nothing in the order restricts the FDA from approving ANDA No. 220322. USV may also maintain its Paragraph IV certification and engage in research activities permitted under 35 U.S.C. § 271(e)(1). However, USV cannot commercialise the approved product in the US until the Patents-in-Suit expire.
The consent judgment binds only USV and its successors in the context of ANDA 220322. Other ANDA filers referencing NDA 204026 are not directly bound. However, the judgment may affect 180-day generic exclusivity forfeiture triggers under Hatch-Waxman depending on USV’s first-filer status, and it signals Celgene’s willingness to enforce the three patents-in-suit aggressively against any challenger.
The case resolved in 160 days — well within the 30-month Hatch-Waxman stay period. This suggests USV assessed the strength of Celgene’s three-patent portfolio and determined that contesting validity or non-infringement posed greater commercial risk than accepting the injunction. Consent judgments of this type typically reflect a negotiated outcome, potentially including an agreed future market entry date, though no such terms are disclosed in the public record.
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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