Bayer AG v. Alembic: Cardiovascular Patent Suit Dismissed Without Prejudice
Bayer AG and Janssen Pharmaceuticals filed suit against generic pharmaceutical maker Alembic in the Delaware District Court, asserting US10828310B2 covering cardiovascular event risk reduction. After 174 days, plaintiffs voluntarily dismissed all claims without prejudice under Rule 41(a)(1)(A)(i), preserving the right to refile.
Bayer and Janssen exit Delaware suit against Alembic — door stays open
On June 18, 2025, Bayer AG and Janssen Pharmaceuticals, Inc. filed patent infringement claims against Alembic in the U.S. District Court for the District of Delaware before Judge Richard G. Andrews. The suit centred on US10828310B2, a patent covering methods of reducing the risk of cardiovascular events, consistent with the type of protection typically sought over branded pharmaceutical compounds in ANDA-related proceedings.
On December 9, 2025 — 174 days after filing — plaintiffs invoked Federal Rule of Civil Procedure 41(a)(1)(A)(i) to voluntarily dismiss all claims without prejudice. A without-prejudice dismissal leaves the underlying infringement claims legally unresolved: Bayer and Janssen are not precluded from reasserting the same patent against Alembic in a future action, and no judgment on the merits was entered against either party.
The 174-day timeline suggests the dismissal occurred before substantive motion practice or trial, which is consistent with settlement negotiations, licence discussions, or a strategic recalibration of enforcement posture. The public record does not disclose whether any commercial agreement accompanied the dismissal, meaning the full strategic context remains unknown. Parties in this position frequently revisit enforcement once ANDA review milestones or product launch timelines shift.
Filing to Voluntary dismissal in 174 days
174-day case duration — typical for early ANDA dismissals before substantive motion practice
Voluntarily dismissed without prejudice: what the ruling means for both parties
Rule 41(a)(1)(A)(i) dismissal: no merits adjudication
Under Fed. R. Civ. P. 41(a)(1)(A)(i), a plaintiff may dismiss an action without a court order before the opposing party serves an answer or motion for summary judgment. This produces no judgment on the merits — the patent’s validity and infringement are entirely unresolved. The court record is formally closed, but the legal dispute is not settled by adjudication.
Procedural exit — no merits rulingWithout prejudice: refiling remains available to Bayer and Janssen
A voluntary dismissal ‘without prejudice’ explicitly preserves the plaintiff’s right to refile the same claims. This contrasts with a ‘with prejudice’ dismissal, which would bar future suits on the same cause of action. The public record states the dismissal is without prejudice, meaning Bayer and Janssen retain full enforcement optionality against Alembic under US10828310B2 if commercial or regulatory circumstances change.
Refiling right preservedAlembic avoids adverse judgment — but patent risk persists
Alembic obtains an immediate reprieve: no injunction, no damages award, and no finding of infringement. However, because the dismissal is without prejudice, Alembic cannot treat this outcome as clearance. The patent US10828310B2 remains in force, and any commercial step toward launching a generic cardiovascular product covered by its claims could trigger refiling. Alembic would be prudent to maintain FTO analysis.
No clearance — patent still activeUnresolved patent creates ongoing uncertainty for generic entry
For the broader generic pharmaceutical sector, a without-prejudice dismissal in a cardiovascular ANDA case signals that the patent holder retains strategic flexibility. Competitors monitoring this space should not interpret the dismissal as market clearance. The absence of a disclosed settlement or licence agreement means the patent’s enforceability against Alembic’s specific product formulation remains untested — a condition that typically sustains commercial risk for generic launch planning.
Ongoing IP risk for generic entrantsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Global pharmaceutical company — holder of US10828310B2 (cardiovascular risk reduction)Search in Eureka ↗ |
| Defendant | Alembic | Individual | Generic pharmaceutical manufacturer Alembic, likely pursuing ANDA approvalSearch in Eureka ↗ |
| Plaintiff counsel | Derek James Fahnestock | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Rodger Dallery Smith , II | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Bayer AGSearch in Eureka ↗ |
| Defendant counsel | Anne Shea Gaza | Attorney | Counsel for AlembicSearch in Eureka ↗ |
| Defendant counsel | Samantha G. Wilson | Attorney | Counsel for AlembicSearch in Eureka ↗ |
| Defendant law firm | Young Conaway Stargatt & Taylor, LLP | Law Firm | Representing AlembicSearch in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice invokes Rule 41(a)(1)(A)(i), the self-executing voluntary dismissal mechanism available before an answer or summary judgment motion is served. The explicit ‘without prejudice’ designation is legally significant: it confirms no res judicata bar attaches and the plaintiffs retain full standing to reassert infringement claims under US10828310B2 against Alembic in a future action. No merits findings — on validity, claim construction, or infringement — were made, leaving the patent’s enforceability entirely open.
US10828310B2 — Cardiovascular event risk reduction therapy
US10828310B2, filed as application US16/264032, protects methods directed at reducing the risk of cardiovascular events. In the pharmaceutical context, such claims typically cover specific dosing regimens, patient population criteria, or therapeutic administration methods associated with a branded cardiovascular compound. The patent’s grant underpins the originator’s ability to delay generic market entry by asserting infringement against ANDA filers who challenge or design around the protected method.
For the cardiovascular therapeutics sector, this patent represents a commercially significant enforcement asset. Branded cardiovascular drugs targeting event risk reduction — such as those managing atrial fibrillation, thrombosis, or acute coronary syndrome — typically carry substantial revenue profiles, making patent term extension and lifecycle management through method-of-use patents a standard strategic tool. Any generic manufacturer seeking FDA approval for a competing product must assess whether its labelling or indicated use could trigger infringement exposure under this patent’s claims.
Should you run an FTO against US10828310B2?
Any pharmaceutical manufacturer, formulator, or ANDA filer developing a generic cardiovascular therapy in the risk-reduction space should treat US10828310B2 as an active clearance concern. The patent was asserted in active litigation as recently as mid-2025, and the without-prejudice dismissal confirms it has not been invalidated, disclaimed, or licensed publicly. Product and regulatory teams planning cardiovascular generic launches in the US market should commission FTO analysis before ANDA submission and again before commercial launch.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US10828310B2 against your product’s method of use and proposed labelling, surface continuation and divisional applications in the same patent family, and identify prior art that may support an invalidity argument or design-around strategy. For in-house IP teams managing pipeline risk across cardiovascular portfolios, Eureka’s monitoring tools can alert you to new Bayer or Janssen enforcement actions the moment they are filed.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar cardiovascular pharmaceutical patent suits in Delaware District Court
Cases involving cardiovascular method-of-use patents litigated in the Delaware District Court, including ANDA-linked infringement actions against generic entrants.
What this case signals for the cardiovascular pharmaceutical IP landscape
A without-prejudice exit from a Delaware pharma patent suit rarely marks the end of a dispute — it often marks a pause.
Without-prejudice dismissals preserve enforcement pressure on generic filers
Bayer and Janssen’s exit under Rule 41(a)(1)(A)(i) without prejudice means no legal bar exists to refiling against Alembic. Generic manufacturers in cardiovascular therapy should treat this outcome as a temporary status, not market clearance. Patent holders routinely use this mechanism to reset strategy while maintaining enforcement optionality.
US10828310B2 remains unlitigated — validity and scope are untested
Because no substantive ruling was issued, US10828310B2’s claim scope and validity have not been tested in court. This leaves uncertainty for any party — not just Alembic — seeking to commercialise cardiovascular therapies that may read on the patent’s claims. A thorough FTO analysis against this patent remains commercially essential.
Bayer v Alembic — key questions answered
The voluntary dismissal without prejudice means Bayer AG and Janssen Pharmaceuticals dropped all infringement claims against Alembic without any court ruling on the merits. Under Rule 41(a)(1)(A)(i), this exit leaves no res judicata bar — the plaintiffs can refile the same claims under US10828310B2 against Alembic in the future. No finding of infringement or invalidity was made.
Yes. The without-prejudice dismissal in case 1:25-cv-00753 does not affect the validity or enforceability of US10828310B2. The patent was never adjudicated on the merits. It remains an active patent asset that Bayer AG and Janssen Pharmaceuticals can assert against Alembic or other parties in future infringement actions.
The public record does not disclose the reason. Common drivers of early voluntary dismissals in pharmaceutical ANDA cases include confidential settlement agreements, authorised generic licence negotiations, strategic recalibration pending ANDA review outcomes, or a decision to refile on amended grounds. The 174-day duration suggests the case ended before substantive motion practice, which is consistent with pre-trial commercial resolution.
US10828310B2 is a US patent filed under application number US16/264032, asserted by Bayer AG and Janssen Pharmaceuticals. It covers methods of reducing the risk of cardiovascular events. In pharmaceutical litigation, such method-of-use patents typically protect specific therapeutic regimens, patient selection criteria, or dosing methods associated with a branded cardiovascular drug, and are commonly asserted in ANDA-related proceedings to delay generic entry.
The dismissal provides no legal clearance for Alembic to launch. Because the case was dismissed without prejudice, Bayer and Janssen retain the right to refile infringement claims under US10828310B2 at any time. Alembic would need to assess FDA ANDA approval status, any outstanding 30-month stay periods, and conduct a thorough FTO analysis against the patent before any commercial launch decision.
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