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Actelion v. Bristol-Myers Squibb & Celgene | Ponesimod vs Ozanimod Patent | PatSnap
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Case ID2:21-cv-18695
FiledOct 2021
ClosedOct 2024
Patent Litigation

Actelion v. BMS & Celgene: S1P Receptor Modulator Patent Dispute Over PONVORY and ZEPOSIA

Actelion Pharmaceuticals sued Bristol-Myers Squibb and Celgene over US10251867B2, a patent tied to ponesimod (PONVORY), alleging BMS’s ozanimod product ZEPOSIA and its starter packs infringed that patent. The case ran 1,111 days before being administratively terminated following a court-ordered referral to mediation, suggesting the parties were guided toward a negotiated resolution.

Resolution time
1111days
1,111 days — nearly 3 years from filing to administrative termination via mediation referral
Patents asserted
1
US10251867B2 — ponesimod S1P receptor modulator therapy for relapsing multiple sclerosis
Outcome
Case Terminated
Administratively terminated pending mediation completion; no merits judgment on record
Cost ruling
Not recorded
No cost or fee award indicated in the public termination record
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

S1P modulator rivals head to mediation in NJ District Court patent clash

Actelion Pharmaceuticals Ltd. and its US affiliate filed suit on 15 October 2021 in the District of New Jersey against Bristol-Myers Squibb, Celgene Corp., and Celgene International II, SARL. The complaint asserted infringement of US10251867B2, a patent covering ponesimod — the active ingredient in Actelion’s PONVORY — against BMS’s competing ozanimod product marketed as ZEPOSIA, including a 7-Day Starter Pack and a Starter Kit combining the starter pack with a 30-count 0.92 mg bottle. Both molecules are sphingosine-1-phosphate (S1P) receptor modulators approved for relapsing forms of multiple sclerosis, placing them in direct commercial competition.

The case was administratively terminated on 30 October 2024 after the court referred the matter to mediation, ordering the parties to coordinate on mediator selection. Administrative termination in this context is a procedural step — not a final judgment — that keeps the case off the active docket while mediation proceeds. The basis of termination is recorded simply as ‘Case Terminated,’ without specifying settlement, dismissal with prejudice, or any other merits disposition, leaving the ultimate resolution of the infringement claims unresolved on the public record.

A duration of 1,111 days before mediation referral is consistent with complex pharmaceutical patent litigation, where claim construction, expert discovery, and potential invalidity counterclaims typically extend timelines. The court’s decision to refer the parties to mediation rather than proceed to trial suggests either a scheduling or judicial efficiency consideration, or that the parties signaled willingness to negotiate. What drove the final outcome — whether a confidential settlement was reached or the case was later reinstated — is not determinable from the publicly available docket record.

Case at a glance
Case no.2:21-cv-18695
CourtNew Jersey
JudgeN/A
FiledOctober 15, 2021
ClosedOctober 30, 2024
Duration1111 days
OutcomeCase Terminated
Verdict causeInfringement Action
BasisCase Terminated
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 Case Terminated in 1111 days

1,111 days — nearly 3 years from filing to administrative termination via mediation referral

Case timeline: Complaint filed OCT 15 2021, APR–MAY — 1111 days total Horizontal timeline showing the three key events in Actelion Pharmaceuticals, Ltd. v Bristol-Myers Squibb from filing to resolution. Source: PACER, New Jersey District Court. OCT 15 2021 Complaint filed Pre-trial proceedings OCT 30 2024 Case Terminated 1111 DAYS TOTAL
Dismissal terms

Mediation referral and administrative termination: what the record shows

Legal mechanism

Administrative termination pending mediation is not a final judgment

When a federal district court refers a case to mediation and administratively terminates it, the case is removed from the active docket but is not dismissed. No ruling on the merits is made. If mediation fails, either party may typically move to reopen. The public record here records only ‘Case Terminated’ — it does not confirm settlement, dismissal with or without prejudice, or any agreed resolution of the underlying infringement claims.

Procedural termination
Resolution ambiguity

Public record is silent on whether a settlement was reached

The termination basis does not specify whether mediation produced a confidential settlement, a licence, or a walkaway. In pharmaceutical patent disputes of this scale — two competing MS therapies, multiple Celgene entities, and three defence firms — confidential licensing terms are common. However, asserting any specific resolution would go beyond what the docket supports. The practical effect on ZEPOSIA’s commercial freedom-to-operate against this patent remains publicly unknown.

Settlement status: unconfirmed
Plaintiff position

Actelion’s PONVORY patent claim remains unresolved on the merits

Actelion secured no public judgment of infringement or damages. Without a merits ruling, US10251867B2 has not been judicially validated against ZEPOSIA. However, the patent remains granted and enforceable. If the case was closed without a settlement that included a licence or covenant not to sue, Actelion may retain the ability to re-assert the patent in future proceedings, subject to any agreement reached in mediation.

No merits ruling obtained
Defendant position

BMS and Celgene avoided a public infringement finding

BMS and Celgene entities faced no adverse judgment on infringement or validity, which is commercially significant for ZEPOSIA’s continued market position. The S1P receptor modulator space is competitive, and a public infringement ruling could have had label or formulary implications. Mediation referral allowed both sides to explore terms privately. Without confirmation of a licence, however, the patent cloud over ZEPOSIA products from this case has not been formally lifted on the public record.

No adverse ruling recorded
Legal analysis based on PACER docket records for case 2:21-cv-18695 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffActelion Pharmaceuticals, Ltd.CompanyPharmaceutical innovator (Janssen/J&J group) — holder of US10251867B2 covering ponesimodSearch in Eureka ↗
Co-PlaintiffActelion Pharmaceuticals US, Inc.CompanySearch in Eureka ↗
DefendantBristol-Myers SquibbIndividualBMS and Celgene entities — developers and marketers of ozanimod (ZEPOSIA) for relapsing MSSearch in Eureka ↗
Co-DefendantCelgene, Corp.CompanySearch in Eureka ↗
Co-DefendantCelgene International II, SARLIndividualSearch in Eureka ↗
Plaintiff counselJustin Taylor QuinnAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselKeith J. MillerAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff law firmRobinson Miller LLCLaw FirmRepresenting Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Defendant counselCharles H. ChevalierAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselChristine A. GaddisAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselJason Robert HalpinAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselJOSHUA L. STERNAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselMichael Scott MillerAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselMichael V. CaracappaAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselRachel Spears JohnstonAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselStephen R. DonatAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant counselWilliam H. TrousdaleAttorneyCounsel for Bristol-Myers SquibbSearch in Eureka ↗
Defendant law firmGibbons PCLaw FirmRepresenting Bristol-Myers SquibbSearch in Eureka ↗
Defendant law firmTompkins, Mcguire, Wachenfeld & Barry, LLPLaw FirmRepresenting Bristol-Myers SquibbSearch in Eureka ↗
Defendant law firmWilmer Cutler Pickering Hale And Dorr, LLPLaw FirmRepresenting Bristol-Myers SquibbSearch in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“This matter is hereby referred to mediation and is administratively terminated pending completion of mediation. The Court shall communicate with the parties as to the selection of the mediator.”
Source: PACER Docket, Case 2:21-cv-18695, New Jersey District Court

The court’s recorded verdict — referring the matter to mediation and administratively terminating the case — is procedural rather than substantive. It reflects a judicial preference to facilitate private resolution of this pharmaceutical patent dispute rather than proceed through trial. No findings on infringement, validity, or damages were made. The administrative termination means the docket is formally closed but does not bar reinstatement if mediation does not produce a binding resolution. This type of outcome is common in the District of New Jersey for multi-party pharmaceutical patent cases involving commercially marketed products.

PACER case 2:21-cv-18695 · Public docket record Explore in Eureka ↗
Patent at issue

US10251867B2 — Ponesimod S1P receptor modulator for relapsing multiple sclerosis

Publication No.US10251867B2
Application No.US14/732013
Patent details
ProductPonesimod (PONVORY) — oral S1P receptor modulator therapy for relapsing multiple sclerosis
Cited in actionOctober 15, 2021

US10251867B2, filed under application number US14/732013, covers ponesimod — an oral sphingosine-1-phosphate (S1P) receptor modulator developed by Actelion and approved by the FDA as PONVORY for relapsing forms of multiple sclerosis. S1P receptor modulators work by sequestering lymphocytes in lymph nodes, reducing the autoimmune attack on myelin. The patent was asserted against BMS’s ozanimod (ZEPOSIA), a competing S1P modulator, suggesting Actelion believes at least some claims of this patent extend to structurally or mechanistically related compounds beyond ponesimod itself.

The S1P receptor modulator class has become a major commercial battleground in MS therapeutics, with Novartis’s fingolimod (Gilenya), Actelion/Janssen’s ponesimod (PONVORY), and BMS’s ozanimod (ZEPOSIA) all competing for the same relapsing MS patient population. A granted patent asserted across competitor products in this space carries significant strategic weight — both for blocking market access and for generating licensing leverage. For any company with a pipeline S1P modulator or a follow-on MS therapy, US10251867B2 and its related family should be treated as a high-priority FTO target.

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

Should you run an FTO against US10251867B2 before advancing your S1P modulator?

Any R&D team developing an S1P receptor modulator for autoimmune or neurological indications — particularly relapsing MS, inflammatory bowel disease, or related conditions — should treat US10251867B2 as a mandatory FTO checkpoint. Actelion’s decision to assert this patent against ozanimod, a chemically distinct S1P modulator from a different structural class, signals that the patent’s claims may be drafted broadly enough to capture competing mechanisms of S1P receptor engagement, not just ponesimod’s precise structure.

PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map independent and dependent claims of US10251867B2 against the specific structural and functional features of a candidate compound. Eureka can identify related Actelion/Janssen family members, flag pending continuations that could extend coverage, and surface prior art that may bear on validity. For BD teams assessing an S1P modulator asset acquisition, Eureka can generate a rapid landscaping report to inform due diligence before term sheet stage.

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Related litigation

Similar S1P modulator and MS therapy patent cases in U.S. district courts

Explore comparable pharmaceutical patent infringement actions involving S1P receptor modulators and relapsing MS therapies litigated in U.S. district courts, including the District of New Jersey.

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Actelion Pharmaceuticals, Ltd. patent enforcement history, New Jersey case history, Actelion Pharmaceuticals, Ltd.’s full IP portfolio, and comparable case analysis
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Strategic implications

What this case signals for the S1P modulator and MS therapy IP landscape

Two leading MS therapies, one contested patent, and a mediation exit: the case highlights how pharmaceutical rivals manage IP risk without public adjudication.

S1P modulator patents are active enforcement territory in MS therapeutics

Actelion’s willingness to assert US10251867B2 against a direct commercial rival signals that S1P receptor modulator IP is being actively policed. Companies developing or marketing competing MS therapies — including next-generation S1P modulators — should treat this patent family as a live enforcement risk, not a dormant filing.

Mediation referral in NJ District Court is a common off-ramp in pharma IP disputes

The District of New Jersey — a dense hub for pharmaceutical patent litigation — regularly refers complex drug patent cases to mediation before trial. Practitioners should anticipate mediation as a likely inflection point in NJ pharma cases and build confidential settlement optionality into litigation strategy from the outset, particularly where both parties hold commercial products.

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Frequently asked questions

Actelion v Bristol-Myers — key questions answered

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Map the S1P modulator patent landscape before your next development milestone

Actelion’s assertion of US10251867B2 against a structurally distinct competitor product signals broad claim risk in the S1P space. Use PatSnap Eureka to run FTO analysis and monitor Actelion, BMS, and Janssen filings in real time.

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