BMS & Pfizer v. ScieGen: Apixaban Patent Consent Judgment (21 Days)
Bristol-Myers Squibb and Pfizer jointly sued ScieGen Pharmaceuticals in Delaware over US9326945B2, a patent covering apixaban formulations. The case resolved via consent judgment just 21 days after filing — one of the shortest resolution timelines in Hatch-Waxman patent litigation.
Apixaban formulation patent resolved in 21-day consent judgment
On April 6, 2023, Bristol-Myers Squibb Company and Pfizer Inc. filed a joint patent infringement action against ScieGen Pharmaceuticals Inc. in the U.S. District Court for the District of Delaware before Judge Gregory B. Williams. The suit asserted US9326945B2 — a patent covering apixaban formulations — against ScieGen's pharmaceutical product. Apixaban is the active ingredient in Eliquis, one of the world's best-selling oral anticoagulants, making patent protection over its formulations commercially significant.
The recorded basis of termination is Consent Judgment. The docket order is a stipulation signed by counsel for all parties providing that: all claims, counterclaims, defenses, motions, and petitions are dismissed without prejudice; each party bears its own costs and attorneys' fees; the parties waive any right to appeal; and the court retains jurisdiction to enforce the stipulation and order. The specific substantive terms agreed between the parties are not disclosed in the available record.
Resolution in 21 days is notably rapid for pharmaceutical patent litigation, particularly in Hatch-Waxman ANDA proceedings, which typically span multiple years through claim construction and trial. The swift conclusion suggests the parties reached agreement almost immediately after the action was initiated, though what drove that agreement — whether licensing terms, market access conditions, or other commercial arrangements — is not reflected in the public record.
See Complete Case & Patent Analysis →Filing to Consent Judgment in 21 days
Case resolved in 21 days — an exceptionally short ANDA litigation timeline
US9326945B2 — apixaban pharmaceutical formulations
Any pharmaceutical company, CDMO, or generic drug developer working on apixaban formulations — whether for ANDA filing, 505(b)(2), or international market entry — should treat US9326945B2 as a priority FTO target. Given BMS and Pfizer's demonstrated willingness to file jointly and resolve disputes rapidly under court-entered judgments, there is limited tolerance for unvetted generic entry in this formulation space. The patent's formulation scope means the FTO must extend beyond active ingredient freedom to assess excipient combinations, dosage forms, and manufacturing processes.
Official order — verbatim text
The stipulation and order records that all claims, counterclaims, defenses, motions, and petitions are dismissed without prejudice, with each party bearing its own costs and the parties waiving appeal rights. The recorded basis of termination is Consent Judgment — meaning the court entered the resolution as a binding judgment on agreed terms, with retained jurisdiction to enforce compliance. The specific substantive terms underlying the parties' agreement are not disclosed in the available record.
Consent judgment: what the agreed resolution means for both parties
What a consent judgment means in this context
A consent judgment is a binding, court-entered judgment reflecting terms agreed by the parties themselves. Unlike a unilateral court ruling, it is a negotiated resolution that carries the full force of a court order. Here, the court expressly retains jurisdiction to enforce the stipulation and order, meaning either party may return to court if the other does not comply with agreed terms. The parties also waived any right to appeal.
Court-entered, binding and finalBMS and Pfizer secure a court-entered resolution
As joint plaintiffs and co-holders of US9326945B2, Bristol-Myers Squibb and Pfizer obtained a court-entered consent judgment within 21 days of filing. The case being dismissed without prejudice — as stated in the stipulation — preserves certain optionality under the public record, though the parties also waived appeal rights. The specific terms governing any ongoing commercial or licensing arrangement between the parties are not disclosed in the available record.
Resolved within 21 days of filingScieGen exits the action under agreed terms
ScieGen Pharmaceuticals stipulated to the consent judgment alongside the plaintiffs, agreeing to bear its own costs and attorneys' fees and waiving appeal rights. The underlying terms of any arrangement between ScieGen and the patent holders — including any market entry conditions or licensing provisions — are not disclosed in the available public record. The swift resolution, 21 days from filing, suggests early alignment rather than contested proceedings.
Own costs, appeal rights waivedRapid resolution signals in the apixaban IP landscape
Consent judgments in Hatch-Waxman ANDA cases within three weeks of filing are uncommon and typically suggest that parties had substantive discussions prior to or immediately upon filing. For the apixaban market — anchored by Eliquis — generic entry timing is commercially critical. The consent judgment, with the court retaining enforcement jurisdiction, confirms a durable resolution, though market-access terms remain undisclosed. Competitors and generic filers in this space should monitor the broader ANDA litigation posture around US9326945B2.
Apixaban generic market implicationsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bristol-Myers Squibb Company | Company | /Search in Eureka ↗ |
| Co-Plaintiff | Pfizer, Inc. | Company | Search in Eureka ↗ |
| Defendant | ScieGen Pharmaceuticals, Inc. | Company | /Search in Eureka ↗ |
| Plaintiff counsel | Brian E. Farnan | Attorney | Counsel for Bristol-Myers Squibb CompanySearch in Eureka ↗ |
| Plaintiff counsel | Joseph J. Farnan , Jr. | Attorney | Counsel for Bristol-Myers Squibb CompanySearch in Eureka ↗ |
| Plaintiff counsel | Michael J. Farnan | Attorney | Counsel for Bristol-Myers Squibb CompanySearch in Eureka ↗ |
| Plaintiff law firm | Farnan LLP | Law Firm | Representing Bristol-Myers Squibb CompanySearch in Eureka ↗ |
| Defendant counsel | Patricia Smink Rogowski | Attorney | Counsel for ScieGen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Robert S. Silver | Attorney | Counsel for ScieGen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant law firm | Rogowski Law LLC | Law Firm | Representing ScieGen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Gregory B. Williams | Judge | Delaware District CourtSearch in Eureka ↗ |
R&D signals in the apixaban formulation patent space
Forward-looking patent intelligence on the apixaban formulation landscape — covering BMS and Pfizer portfolio activity, generic challenger positioning, and adjacent innovation opportunities.
BMS and Pfizer's apixaban formulation patent activity
US9326945B2 is one asset within a broader Eliquis formulation and method-of-use patent family co-owned by BMS and Pfizer. Tracking continuation filings, divisional applications, and related composition-of-matter patents in this family reveals the full enforcement perimeter that generic challengers must clear. Monitoring new prosecution activity signals where the co-owners are extending protection.
Eliquis patent family depthFiling trends in oral Factor Xa inhibitor formulations
The oral anticoagulant formulation space — encompassing apixaban, rivaroxaban, and edoxaban — has seen sustained patent filing activity as originators and generics compete on formulation design, bioavailability, and patient compliance claims. Mapping recent filings in this space identifies which generic manufacturers are actively pursuing design-around strategies and which formulation innovations may represent white space.
Factor Xa inhibitor IP trendsScieGen's patent and ANDA filing position in small-molecule generics
ScieGen Pharmaceuticals operates as a generic drug developer with ANDA filings across multiple small-molecule therapeutic areas. Analysing ScieGen's active ANDA pipeline and any associated patent certifications reveals which other branded formulation patents may be in its sights — and which originator companies may face similar consent judgment dynamics in the near term.
ScieGen ANDA pipelineAdjacent apixaban formulation innovations beyond US9326945B2
Outside the core Eliquis formulation claims covered by US9326945B2, adjacent opportunities exist in modified-release apixaban, paediatric dosage forms, combination therapies, and novel excipient systems. These areas may represent patentable white space where generic and specialty pharma companies can build proprietary positions without directly conflicting with the BMS-Pfizer enforcement perimeter.
Apixaban formulation white spaceSimilar apixaban and ANDA formulation patent cases in Delaware
Explore related Hatch-Waxman infringement actions involving apixaban and oral anticoagulant formulation patents litigated in the District of Delaware.
What this case signals for the apixaban and oral anticoagulant IP landscape
A 21-day consent judgment in a pharma patent suit rarely happens by accident — here is what practitioners should take away.
Pre-litigation alignment is reshaping ANDA dispute timelines
A consent judgment reached 21 days after filing strongly suggests substantive negotiations preceded the action itself. Patent holders and generic filers should treat the complaint filing as a signal — not the opening of contested litigation — and have settlement frameworks ready from day one of any ANDA challenge.
US9326945B2 remains an active enforcement asset for BMS and Pfizer
The consent judgment resolves this specific action without prejudice, and the court retains jurisdiction to enforce the order. Any generic manufacturer approaching the apixaban formulation space should conduct a thorough FTO analysis against US9326945B2 and the broader Eliquis patent family before filing an ANDA.
Bristol-Myers v ScieGen — key questions answered
The case resolved via consent judgment — the recorded basis of termination — entered by the Delaware District Court on April 27, 2023, just 21 days after filing. All claims and counterclaims were dismissed without prejudice under the parties' stipulation, with each party bearing its own costs, appeal rights waived, and the court retaining jurisdiction to enforce the order. The specific substantive terms are not disclosed in the available record.
The asserted patent is US9326945B2 (application number US13/579796), covering apixaban formulations. Apixaban is the active ingredient in Eliquis, a leading oral anticoagulant co-developed by BMS and Pfizer. The suit was an infringement action, consistent with Hatch-Waxman ANDA litigation practice.
The available record does not disclose the specific basis for the joint filing structure. BMS and Pfizer are co-developers of Eliquis and appear as co-plaintiffs and joint holders of US9326945B2. Joint plaintiff structures in Hatch-Waxman litigation are consistent with co-ownership arrangements, though the specific contractual basis is not reflected in the public record.
The stipulation provides that all claims, counterclaims, defenses, motions, and petitions are dismissed without prejudice. The recorded basis of termination, however, is Consent Judgment. As stated, the parties have waived any right to appeal or seek relief from the stipulation and order, and the court retains jurisdiction to enforce it. The interplay between the dismissal without prejudice language and the consent judgment characterisation is as recorded — the specific terms are not further disclosed in the available record.
US9326945B2 covers apixaban formulations and has been actively enforced by BMS and Pfizer acting jointly. The swift consent judgment in this case — 21 days from filing — suggests a well-resourced enforcement posture. Generic developers should conduct a thorough FTO analysis against this patent and the broader Eliquis formulation family, including continuation and divisional patents, before committing to an ANDA Paragraph IV certification strategy.
This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.
Nothing on this page constitutes legal advice or a legal opinion on the validity, infringement, enforceability, or scope of any patent or case, and no attorney‑client relationship is created by its use. Any description of an outcome (such as a dismissal, settlement, or consent judgment) is a general summary, not a legal determination. All patents, trademarks, and company or law‑firm names are the property of their respective owners. PatSnap makes no warranty as to the accuracy or completeness of this content and disclaims, to the fullest extent permitted by law, all liability for reliance on it. For advice on a specific matter, consult qualified legal counsel.
PatSnap Eureka searches patents and litigation data to answer instantly.