Bayer & Janssen v. Apotex: Thromboembolic Patent Suit Dismissed With Prejudice
Bayer AG and Janssen Pharmaceuticals filed suit in Delaware against Canadian generic manufacturer Apotex over US9539218B2, a patent covering prevention and treatment of thromboembolic disorders. The parties jointly stipulated to dismiss all claims and counterclaims with prejudice after 340 days, with each side bearing its own costs.
Pharma patent standoff ends in mutual dismissal in Delaware
Filed on 24 March 2023 in the District of Delaware before Judge Richard G. Andrews, this infringement action saw Bayer AG and Janssen Pharmaceuticals, Inc. assert US9539218B2 — a patent directed to the prevention and treatment of thromboembolic disorders — against Apotex Inc. and Apotex Corp. The case is consistent with standard Hatch-Waxman ANDA litigation, where brand-name manufacturers challenge generic applicants seeking FDA approval to market competing formulations of a protected drug.
The case closed on 27 February 2024 after all parties jointly stipulated to dismiss all claims, defenses, and counterclaims with prejudice under Federal Rules of Civil Procedure 41(a)(1) and 41(c). Notably, Apotex had also asserted its own counterclaims against the plaintiffs, and those too were extinguished by the stipulation. Each party was ordered to bear its own costs, disbursements, and attorneys’ fees — a structure that suggests neither side extracted a clear financial concession from the other.
At 340 days, the resolution is notably swift relative to the multi-year trajectory of most contested ANDA patent trials in Delaware. The with-prejudice dismissal forecloses any re-filing of the same claims, which may signal a negotiated commercial resolution — such as a licensing agreement or authorised-generic arrangement — reached outside the public court record. The specific terms of any settlement remain unknown from the public docket.
Filing to dismissal in 340 days
340 days — resolved well before the typical 2–3 year ANDA patent trial cycle in Delaware
What the with-prejudice stipulated dismissal means for both parties
Stipulated dismissal under FRCP 41(a)(1) and 41(c)
A stipulated dismissal under Rule 41(a)(1) requires both parties’ agreement and takes effect immediately upon filing — no court order is needed. Rule 41(c) extends the same framework to counterclaims. Here, all of Apotex’s counterclaims (likely invalidity and non-infringement) were simultaneously dismissed, making this a full bilateral resolution rather than a one-sided withdrawal.
Bilateral — all claims extinguishedWith prejudice bars refiling — what that means in practice
A with-prejudice dismissal is a final adjudication on the merits for claim-preclusion purposes. Bayer and Janssen cannot refile infringement claims on US9539218B2 against Apotex for the same products. Equally, Apotex cannot revive its invalidity or non-infringement counterclaims. This mutual finality strongly suggests the parties reached a private commercial arrangement — terms of which are not disclosed in the public record.
Claim-preclusive — no refiling permittedEach party bears own costs — no fee-shifting
The stipulation explicitly allocates costs, disbursements, and attorneys’ fees to each party respectively. In patent litigation, a court can award fees in exceptional cases under 35 U.S.C. § 285, but no such award was made here. The symmetric cost allocation is consistent with a negotiated exit rather than a capitulation by either side, and it avoids any admission of weakness.
No fee award — symmetric allocationHatch-Waxman dynamics behind the early resolution
ANDA cases often resolve before trial when commercial realities shift — for example, when a settlement grants the generic an authorised entry date, or when a licensing deal makes continued litigation uneconomical. The 30-month stay triggered by an ANDA filing creates natural settlement pressure. At 340 days, this case resolved before the stay window would typically expire, suggesting both sides calculated that a negotiated outcome served their commercial interests better than a contested validity ruling.
Likely commercial resolutionFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Global pharmaceutical innovator — holder of US9539218B2 covering thromboembolic disorder treatmentSearch in Eureka ↗ |
| Defendant | Apotex, Inc. | Company | Apotex Inc. and Apotex Corp. — Canadian-headquartered generic pharmaceutical manufacturerSearch 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 | Brian Sodikoff | Attorney | Counsel for Apotex, Inc.Search in Eureka ↗ |
| Defendant counsel | Cortlan S. Hitch | Attorney | Counsel for Apotex, Inc.Search in Eureka ↗ |
| Defendant counsel | Kenneth Laurence Dorsney | Attorney | Counsel for Apotex, Inc.Search in Eureka ↗ |
| Defendant counsel | Rachel L. Schweers | Attorney | Counsel for Apotex, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Chief Judge | Delaware District Court — Chief JudgeSearch in Eureka ↗ |
Stipulation of dismissal — official text
The stipulation explicitly names all three plaintiff entities — Bayer Intellectual Property GmbH, Bayer AG, and Janssen Pharmaceuticals, Inc. — and both Apotex entities, ensuring no party can claim they fall outside the preclusive scope. The simultaneous dismissal of Apotex’s counterclaims under Rule 41(c) is significant: invalidity arguments that might otherwise have clouded US9539218B2’s enforceability are now extinguished as between these parties, leaving the patent’s validity formally intact.
US9539218B2 — Prevention and Treatment of Thromboembolic Disorders
US9539218B2 covers methods and formulations directed to the prevention and treatment of thromboembolic disorders — a category encompassing deep vein thrombosis, pulmonary embolism, and stroke prevention in atrial fibrillation patients. The patent, associated with application number US11/883218, sits within the intellectual property estate protecting rivaroxaban (marketed as Xarelto), a direct oral anticoagulant co-developed by Bayer and Janssen. The patent’s issuance as a granted US utility patent with the B2 designation indicates it was granted with amended claims following examination.
Rivaroxaban is among the highest-revenue oral anticoagulants globally, making US9539218B2 a commercially significant asset in Bayer and Janssen’s Xarelto patent thicket. For generic manufacturers, any ANDA targeting a rivaroxaban formulation must navigate this patent alongside multiple other listed patents. The fact that Apotex — one of the world’s largest generic manufacturers — chose to pursue counterclaims rather than concede validity suggests genuine commercial stakes, even if those claims were ultimately resolved privately.
Should your team run an FTO analysis against US9539218B2?
Any pharmaceutical company — generic or specialty — developing an oral anticoagulant or thromboembolic treatment should treat US9539218B2 as a live clearance risk. The patent is not invalidated by this case. Formulation teams working on Factor Xa inhibitors, direct thrombin inhibitors, or any anticoagulant in the thromboembolic indication space should assess whether their compound or dosage form falls within the claim scope before filing an ANDA or NDA.
PatSnap Eureka’s FTO Search Agent enables R&D and IP teams to map claim language from US9539218B2 against your compound’s mechanism, formulation, and indication — flagging overlap risks before they become litigation events. Eureka’s claim monitoring tools can also alert you to continuation or divisional filings from Bayer that may extend protection beyond the current grant, allowing proactive design-around or licensing strategy.
Run a freedom-to-operate analysis on US9539218B2 to assess your product’s exposure
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What this case signals for the thromboembolic drug IP landscape
A swift with-prejudice exit in an ANDA case over a blockbuster-adjacent patent carries specific signals for brand and generic players alike.
With-prejudice dismissals in ANDA suits often conceal licensing terms
When both parties walk away from an ANDA infringement case with prejudice and each bears their own costs, it typically signals a private settlement — potentially an authorised generic agreement or negotiated market entry date. Competitors and market observers should monitor Apotex’s subsequent FDA filing activity and any authorised generic announcements for indirect evidence of settlement terms.
US9539218B2 remains active — non-Apotex generics are still exposed
The dismissal resolves the dispute only between these specific parties. US9539218B2 is not invalidated and remains enforceable. Any other generic manufacturer seeking to market a competing thromboembolic formulation without a licence faces the same litigation risk. Bayer and Janssen retain full rights to assert the patent against subsequent ANDA filers.
Bayer v Apotex — key questions answered
The case was dismissed with prejudice by joint stipulation on 27 February 2024. All claims by Bayer AG and Janssen Pharmaceuticals against Apotex, and all counterclaims by Apotex, were extinguished. Each party bears its own costs, disbursements, and attorneys’ fees.
The plaintiffs asserted US9539218B2, associated with application number US11/883218. The patent covers the prevention and treatment of thromboembolic disorders and forms part of the intellectual property estate protecting rivaroxaban (Xarelto).
A with-prejudice dismissal operates as a final adjudication on the merits for res judicata purposes. Bayer AG and Janssen Pharmaceuticals cannot refile the same patent infringement claims under US9539218B2 against Apotex Inc. and Apotex Corp. for the same accused products.
No. A stipulated dismissal with prejudice does not constitute a ruling on patent validity. US9539218B2 remains an enforceable, granted US patent. Apotex’s invalidity counterclaims were dismissed without any court determination, meaning the patent’s validity is formally intact against all parties other than those bound by the stipulation.
The public record does not disclose the settlement terms. However, with-prejudice dismissals in ANDA litigation after roughly 11 months — before trial — typically suggest a private commercial resolution, such as an authorised generic agreement or a negotiated market entry date. The symmetric cost allocation is consistent with a negotiated outcome rather than a concession by either party.
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