Bayer & Janssen v. Indoco Remedies: Rivaroxaban Patents Dismissed With Prejudice
Bayer AG, Bayer Pharma AG, and Janssen Pharmaceuticals brought an ANDA-related infringement action in Delaware against Indoco Remedies over rivaroxaban tablets in 2.5 mg, 10 mg, 15 mg, and 20 mg dosages. The case, covering two formulation patents, closed in 249 days via a bilateral dismissal with prejudice — with each side bearing its own costs.
Bilateral dismissal with prejudice in a Delaware rivaroxaban ANDA dispute
Filed on 23 June 2023 in the District of Delaware before Judge Richard G. Andrews, this action was brought by Bayer AG, Bayer Pharma AG, Bayer Intellectual Property GmbH, and Janssen Pharmaceuticals against Indoco Remedies Limited and its U.S. partner FPP Holding Company LLC. The dispute centred on Indoco’s abbreviated new drug application (ANDA) for rivaroxaban tablets — the active ingredient in Xarelto — at doses of 2.5 mg, 10 mg, 15 mg, and 20 mg. Two patents were asserted: US9539218B2 and US10828310B2, both covering formulation aspects of the drug product.
The case closed on 27 February 2024 via a stipulated dismissal filed under Federal Rules of Civil Procedure 41(a)(1) and 41(c). Critically, the dismissal was entered with prejudice and was mutual — both Plaintiffs’ claims against Indoco and Indoco’s counterclaims against Plaintiffs were extinguished. Each party agreed to absorb its own legal costs. A with-prejudice dismissal extinguishes all dismissed claims permanently; neither side may relitigate the same causes of action arising from these patents and this ANDA.
At 249 days, the resolution is notably swift for a multi-patent ANDA case in Delaware, a jurisdiction known for complex pharmaceutical patent dockets. The speed and mutual nature of the termination — combined with each side bearing its own costs — is consistent with a negotiated resolution, potentially including a confidential settlement or licensing arrangement, though the public record does not confirm this. What drove the early resolution, including any commercial terms between the parties, remains unknown from the public docket.
Filing to dismissal in 249 days
249 days — resolved well under the median ANDA patent case timeline in Delaware
Mutual dismissal with prejudice — all claims and counterclaims extinguished
FRCP 41(a)(1) and 41(c): Stipulated bilateral dismissal
The parties jointly invoked Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, the standard procedural vehicle for a fully negotiated exit from litigation. Rule 41(a)(1) permits voluntary dismissal by stipulation of all parties; Rule 41(c) extends that framework to counterclaims. The court is not required to conduct further proceedings once such a stipulation is filed and signed by all parties.
Stipulated — no judicial ruling on merits‘With prejudice’ bars any refiling on these patents and this ANDA
A dismissal with prejudice operates as a final adjudication on the merits, even though no court found infringement or invalidity. Bayer and Janssen cannot refile claims against Indoco concerning these two patents and this ANDA product. Equally, Indoco’s counterclaims — likely including invalidity and non-infringement defences — are also dismissed with prejudice, preventing Indoco from pursuing a standalone declaratory judgment action on the same grounds.
Final — no reopening permittedEach party bears its own costs — an agreed walk-away
The stipulation explicitly provides that all parties shall bear their own costs, disbursements, and attorneys’ fees. In U.S. patent litigation, fee-shifting under 35 U.S.C. § 285 is reserved for exceptional cases. The absence of any cost award here is typical of negotiated resolutions and suggests neither party sought to characterise the other’s conduct as exceptional. This even-handed allocation is consistent with a commercial compromise rather than a clear win for either side.
No fee-shifting — bilateral walk-awaySettlement or licence likely — but terms are confidential
Mutual with-prejudice dismissal in an ANDA case at this stage — before any substantive Markman ruling or trial — strongly suggests the parties reached a commercial accommodation. In Hatch-Waxman litigation, such outcomes frequently involve a negotiated market entry date or royalty-bearing licence, allowing the generic to launch at a defined future point. However, the public docket contains no licence terms, consent judgment, or settlement agreement, and any such terms would likely remain confidential.
Inferred settlement — unconfirmedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Global pharmaceutical and life sciences group — holder of US9539218B2 and US10828310B2Search in Eureka ↗ |
| Defendant | Indoco Remedies Limited | Company | Indian generic pharmaceutical manufacturer seeking U.S. market entry via ANDA for rivaroxabanSearch in Eureka ↗ |
| Plaintiff counsel | Derek James Fahnestock | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Jack B. Blumenfeld | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Rodger Dallery Smith , II | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Defendant counsel | Kevin M. Capuzzi | Attorney | Counsel for Indoco Remedies LimitedSearch in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Chief Judge | Delaware District Court — Chief JudgeSearch in Eureka ↗ |
Stipulation of dismissal — official text
The stipulation’s bilateral scope is legally significant: it dismisses not only Plaintiffs’ infringement claims but also all of Indoco’s counterclaims and defences with prejudice. This prevents Indoco from later seeking a declaratory judgment of invalidity or non-infringement on US9539218B2 or US10828310B2 in connection with this ANDA. The equal cost allocation and mutual extinguishment of all claims is the textbook signature of a privately negotiated resolution — the parties have drawn a clean line under this dispute without any judicial determination of the patents’ validity or scope.
US9539218B2 & US10828310B2 — Rivaroxaban tablet formulation patents
US9539218B2 (application no. US11/883218) and US10828310B2 (application no. US16/264032) are formulation patents protecting specific aspects of rivaroxaban tablet compositions — the active ingredient in Xarelto, a leading Factor Xa inhibitor used for anticoagulation. The patents cover oral tablet dosage forms at the commercially significant strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. Formulation patents of this type typically claim specific excipient combinations, granulation processes, or dissolution profiles that contribute to bioavailability and stability, rather than the rivaroxaban molecule itself.
Together, these two patents form part of Bayer and Janssen’s lifecycle management strategy for Xarelto, one of the world’s best-selling anticoagulants. Formulation patents in this category are commercially critical because they can extend effective market exclusivity years beyond primary compound patent expiry. Any pharmaceutical company developing generic rivaroxaban tablets for the U.S. market must assess both patents as potential litigation triggers — as Indoco’s experience demonstrates. Co-ownership or co-licensing across Bayer and Janssen entities adds further complexity to clearance analysis.
Should you run an FTO against US9539218B2 and US10828310B2?
Any R&D or regulatory team developing a generic or biosimilar oral anticoagulant tablet — particularly rivaroxaban formulations — should treat these two patents as priority FTO targets. Both were actively enforced in a Delaware ANDA action, confirming that Bayer and Janssen are prepared to litigate formulation claims. The multi-dose scope (2.5 mg through 20 mg) means the risk is not confined to a single product variant. Teams should also assess the broader Bayer and Janssen rivaroxaban patent family for continuation and divisional applications that may carry similar claims.
PatSnap Eureka’s FTO Search Agent allows you to map claim scope across US9539218B2, US10828310B2, and their patent families in a single workflow — surfacing related continuations, divisionals, and equivalent filings in other jurisdictions. Claim monitoring alerts can flag prosecution activity or new assertions tied to these patent families, giving in-house teams and outside counsel early warning before an ANDA filing crystallises into litigation risk.
Run a freedom-to-operate analysis on US9539218B2 to assess your product’s exposure
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What this case signals for the pharmaceutical patent enforcement landscape
A swift bilateral dismissal in a Delaware ANDA case carries specific implications for generic entry strategy and Xarelto patent lifecycle management.
ANDA challengers face formulation patents, not just compound patents
Both asserted patents — US9539218B2 and US10828310B2 — appear to cover formulation aspects of rivaroxaban tablets rather than the compound itself. Generic entrants challenging Xarelto must navigate a layered IP estate. Formulation patents often extend commercial exclusivity well beyond primary compound patent expiry, making FTO analysis across the full patent family essential before ANDA filing.
Delaware remains the dominant venue for Hatch-Waxman ANDA disputes
This case follows a well-established pattern of ANDA plaintiffs filing in Delaware, where pharmaceutical patent litigation infrastructure and predictable scheduling orders are attractive. Companies developing generic pharmaceutical strategies should monitor Delaware dockets for early signals of enforcement posture from originator companies like Bayer and Janssen across their patent portfolios.
Bayer v Indoco — key questions answered
The case was dismissed with prejudice by stipulation of all parties on 27 February 2024, approximately 249 days after filing. All claims by Bayer, Bayer Pharma AG, and Janssen Pharmaceuticals against Indoco, and all counterclaims by Indoco, were extinguished. Each party bore its own costs.
Two patents were asserted: US9539218B2 (application no. US11/883218) and US10828310B2 (application no. US16/264032). Both relate to rivaroxaban tablet formulations covering the 2.5 mg, 10 mg, 15 mg, and 20 mg dosage strengths challenged in Indoco’s ANDA.
A dismissal with prejudice operates as a final adjudication on the merits. Bayer and Janssen cannot refile infringement claims against Indoco on these patents in connection with this ANDA. Indoco’s counterclaims — likely including invalidity and non-infringement assertions — are equally barred. Neither party may relitigate the same dispute.
Rivaroxaban is the active ingredient in Xarelto, a major anticoagulant marketed by Bayer and Janssen. Generic manufacturers like Indoco must file ANDAs to enter the U.S. market and typically certify that listed patents are invalid or not infringed, triggering a 30-month litigation stay. Formulation patents such as those asserted here can extend commercial exclusivity beyond compound patent expiry.
Plaintiffs Bayer and Janssen were represented by Morris, Nichols, Arsht & Tunnell LLP, with attorneys Jack B. Blumenfeld, Derek James Fahnestock, and Rodger Dallery Smith II. Defendant Indoco Remedies and FPP Holding Company LLC were represented by Benesch, Friedlanders, Coplan & Aronoff LLP, with Kevin M. Capuzzi as lead counsel.
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