Bayer & Janssen v. Macleods: Cardiovascular Patent Dismissed With Prejudice in 223 Days
Bayer AG and Janssen Pharmaceuticals filed a patent infringement action against generic manufacturer Macleods Pharmaceuticals in Delaware over US10828310B2, a patent covering methods of reducing cardiovascular event risk. The parties reached a stipulated dismissal with prejudice in just 223 days, with each side bearing its own costs — suggesting a negotiated resolution before trial.
Stipulated exit in rivaroxaban cardiovascular patent row
On 16 June 2023, Bayer AG and Janssen Pharmaceuticals, Inc. — co-owners of the Xarelto (rivaroxaban) franchise — filed suit against Macleods Pharmaceuticals Ltd. and its US subsidiary in the District of Delaware. The action centred on US10828310B2, a method-of-use patent directed at reducing the risk of cardiovascular events, asserted under the Hatch-Waxman framework. Chief Judge Richard G. Andrews presided. Plaintiffs were represented by Morris, Nichols, Arsht & Tunnell LLP; Macleods by Abrams & Bayliss, LLP.
The case closed on 25 January 2024 — just 223 days after filing — via a joint stipulation invoking Federal Rules of Civil Procedure 41(a)(1) and 41(c). Under the stipulation, all claims and defences asserted by both sides were dismissed with prejudice. Crucially, each party agreed to bear its own litigation costs, disbursements, and attorneys’ fees, which is a hallmark of a negotiated commercial resolution rather than a court-imposed outcome.
The speed of resolution — under eight months — and the symmetrical cost-bearing arrangement strongly suggest the parties reached a confidential settlement, likely involving a licence or agreed entry date for Macleods’s generic product. The public record does not disclose any licence terms or market access conditions. What remains unknown is whether Macleods received a consent judgement of non-infringement or simply agreed to delay its generic launch, a distinction with significant commercial consequences for both parties.
Filing to dismissal in 223 days
Case resolved in 223 days — well under the median ANDA patent trial timeline in Delaware
Stipulated dismissal with prejudice — what the joint filing means
Rules 41(a)(1) and 41(c): voluntary exit, full finality
A Rule 41(a)(1) dismissal is filed by the parties jointly without requiring court approval. Rule 41(c) extends this mechanism to counterclaims, cross-claims, and third-party claims — meaning Macleods’s own defences and any invalidity counterclaims are also extinguished. The court is not required to make any merits finding. This mechanism is the standard vehicle for Hatch-Waxman settlements once commercial terms are agreed.
No merits ruling requiredWith prejudice bars Bayer and Janssen from re-suing Macleods on these claims
A dismissal with prejudice operates as an adjudication on the merits under res judicata principles. Bayer and Janssen cannot refile the same infringement claims against Macleods under US10828310B2. Symmetrically, Macleods’s invalidity and non-infringement counterclaims — if any were formally asserted — are also resolved with prejudice. This gives both parties clean legal certainty, consistent with a structured commercial settlement.
Permanent bar on re-litigationEach party bears own costs — a signal of balanced negotiation
In contested patent litigation, cost awards typically follow the outcome or reflect relative litigation conduct. Here, both sides agreed to absorb their own fees. This arrangement is common when neither party prevailed on the merits and the case resolved through a licence or entry-date agreement. It also avoids any ‘exceptional case’ fee-shifting analysis under 35 U.S.C. § 285, which would require a court finding of subjective bad faith or exceptionally weak claims.
No § 285 fee exposureHatch-Waxman timing makes settlement terms highly consequential
Under Hatch-Waxman, an ANDA filer’s agreed entry date can determine when a generic reaches market — potentially worth hundreds of millions in the rivaroxaban space. A 30-month stay would have expired around late 2025 absent settlement. The confidential terms governing when (or whether) Macleods may launch its generic product are the commercially critical outcome here, not the court filing itself. Absent disclosure, the market impact remains opaque.
Entry date terms undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Pharma IP co-owners — holders of US10828310B2 (rivaroxaban cardiovascular risk method)Search in Eureka ↗ |
| Defendant | Macleods Pharmaceuticals | Company | Indian generic pharmaceutical manufacturer and its US commercial subsidiarySearch 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 | A. Neal Seth | Attorney | Counsel for Macleods PharmaceuticalsSearch in Eureka ↗ |
| Defendant counsel | April M. Ferraro | Attorney | Counsel for Macleods PharmaceuticalsSearch in Eureka ↗ |
| Defendant counsel | G. Mason Thomson | Attorney | Counsel for Macleods PharmaceuticalsSearch in Eureka ↗ |
| Defendant counsel | John M. Seaman | Attorney | Counsel for Macleods PharmaceuticalsSearch in Eureka ↗ |
| Defendant counsel | Teresa M. Summers | Attorney | Counsel for Macleods PharmaceuticalsSearch 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 language — ‘all claims and defenses asserted by Plaintiffs against Macleods and all claims and defenses asserted by Macleods against Plaintiffs’ — is deliberately comprehensive, extinguishing the full bilateral litigation including any invalidity counterclaims Macleods may have filed. The with-prejudice designation and mutual cost-bearing clause are consistent with a negotiated commercial resolution. The court made no finding on infringement, validity, or enforceability of US10828310B2.
US10828310B2 — Rivaroxaban method of reducing cardiovascular event risk
US10828310B2 (application number US16/264032) is a method-of-use patent protecting the administration of rivaroxaban — marketed as Xarelto — for reducing the risk of cardiovascular events such as myocardial infarction and stroke. Method-of-use patents of this type are granted on specific therapeutic indications rather than the compound itself, allowing brand holders to extend exclusivity beyond the base compound patent. The application was filed with the USPTO and ultimately issued to Bayer Pharma AG and Janssen Pharmaceuticals as co-assignees.
In the pharmaceutical sector, method-of-use patents are a primary line of defence against generic erosion once base compound patents expire. Xarelto is one of the world’s highest-revenue anticoagulants, and any cardiovascular-indication patent in this family carries substantial commercial weight. Enforcement against ANDA filers is standard practice and is expected to continue against other generic applicants. The patent’s survival through litigation — without any invalidity ruling — maintains its full deterrent value for the remaining patent term.
Should your ANDA or generic product be cleared against US10828310B2?
Any pharmaceutical company developing or commercialising a generic rivaroxaban product that references the cardiovascular risk-reduction indication must assess exposure under US10828310B2. The patent survived this litigation without a validity challenge reaching the merits. R&D and regulatory teams preparing ANDA submissions for the rivaroxaban cardiovascular indication should treat this patent as a live enforcement risk and obtain claim-by-claim FTO analysis before filing a paragraph IV certification.
PatSnap Eureka’s FTO Search Agent enables claim-level mapping of US10828310B2 against your formulation and proposed label language, flagging potential infringement exposure before you commit to an ANDA filing strategy. Eureka’s claim monitoring also tracks continuation applications and any newly issued patents in the Bayer–Janssen rivaroxaban family, so your IP team receives early warning if the enforcement perimeter expands.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman patent cases in the anticoagulant and cardiovascular drug space
PatSnap Eureka tracks related litigation across truck body equipment, vehicle accessories, and comparable infringement actions in the Georgia district system.
What this case signals for the Xarelto IP enforcement landscape
A fast, bilateral dismissal in a Hatch-Waxman case typically marks the endpoint of a licence negotiation — not a litigation defeat.
Rapid resolution in Delaware ANDA cases often reflects a licence, not weakness
Sub-eight-month dismissals with prejudice in Hatch-Waxman litigation are consistent with authorised generic agreements or negotiated entry dates. Brand holders like Bayer and Janssen routinely resolve ANDA disputes before trial to control launch timing and protect exclusivity windows. The absence of any court ruling on validity or infringement should not be read as a concession by either party.
US10828310B2 remains in force — other generic filers face the same enforcement risk
The dismissal with prejudice binds only Macleods. Any other ANDA applicant referencing Xarelto’s cardiovascular-risk indication remains exposed to enforcement under US10828310B2. Companies with pending or contemplated ANDA filings in the rivaroxaban space should treat this patent as an active enforcement asset and conduct thorough FTO analysis before proceeding.
Bayer v Macleods — key questions answered
The case was dismissed with prejudice on 25 January 2024 by joint stipulation under Federal Rules of Civil Procedure 41(a)(1) and 41(c). All claims and defences by both sides were extinguished. Each party bears its own costs. No court ruling on infringement or patent validity was issued.
The patent asserted is US10828310B2 (application US16/264032), a method-of-use patent protecting rivaroxaban (Xarelto) for reducing the risk of cardiovascular events. It is co-owned by Bayer Pharma AG and Janssen Pharmaceuticals, Inc. The patent remains in force following the dismissal.
Dismissal with prejudice operates as a final adjudication on the merits under res judicata. The plaintiff cannot refile the same claims against the same defendant. In an ANDA context, it typically accompanies a confidential settlement involving a licence or agreed generic entry date. The patent’s validity is not decided by the court.
No. The dismissal with prejudice binds only the named parties — Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. US10828310B2 remains fully enforceable against any other ANDA applicant referencing the cardiovascular risk-reduction indication. Other generic filers should conduct independent FTO analysis.
Mutual cost-bearing is standard in negotiated Hatch-Waxman dismissals where no party prevailed on the merits. It avoids a fee-shifting analysis under 35 U.S.C. § 285, which requires a court finding of an ‘exceptional case’. The arrangement is consistent with a commercial settlement where both sides accepted compromise terms, though no settlement terms are publicly disclosed.
PatSnap Eureka searches patents and litigation data to answer instantly.