BMS & Pfizer v. Umedica Laboratories: Eliquis Apixaban Patent Dismissed in 15 Days
Bristol-Myers Squibb and Pfizer jointly sued Indian generic manufacturer Umedica Laboratories in Delaware over US9326945B2, the patent covering their blockbuster anticoagulant Eliquis (apixaban). The complaint was voluntarily dismissed without prejudice just 15 days after filing — one of the shortest-lived Hatch-Waxman actions in recent Delaware docket history.
A 15-Day Eliquis ANDA Suit: Rapid Dismissal Raises Strategic Questions
On 30 September 2024, Bristol-Myers Squibb and Pfizer — co-owners of the Eliquis franchise — filed a Hatch-Waxman patent infringement complaint in the District of Delaware against Umedica Laboratories Pvt., Ltd., an Indian generic pharmaceutical manufacturer. The action centred on US9326945B2 and alleged that Umedica’s ANDA seeking approval for 2.5 mg and 5 mg apixaban tablets would infringe the patent covering plaintiffs’ market-leading anticoagulant Eliquis.
The case closed on 15 October 2024 — just 15 days after filing — when BMS and Pfizer filed a voluntary notice of dismissal without prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i). Because no answer or motion for summary judgment had been served by Umedica, the dismissal was effective immediately upon filing and required no court order. No merits rulings, claim constructions, or injunctions were issued, and no costs were assigned to either party.
The speed of dismissal — before defendant counsel even entered an appearance on the docket — strongly suggests the parties reached a pre-litigation resolution, potentially a licensing arrangement or consent judgment agreement negotiated outside court. The public record does not disclose settlement terms. Whether and when BMS and Pfizer may refile against Umedica, or how the dismissal interacts with the 30-month stay mechanism under Hatch-Waxman, remains unknown from the available case data.
Filing to Case Dismissed in 15 days
15 days from filing to dismissal — far below the typical ANDA litigation timeline of 2–3 years
Dismissed without prejudice: what the Rule 41 exit means for both parties
Rule 41(a)(1)(A)(i): unilateral dismissal before any responsive pleading
Under FRCP 41(a)(1)(A)(i), a plaintiff may dismiss a complaint without court approval at any time before the defendant serves an answer or a motion for summary judgment. Because Umedica had not yet responded on the docket, BMS and Pfizer could — and did — exit unilaterally. The dismissal is self-executing: it takes effect on filing, leaving no judgment, no injunction, and no prejudice to either side’s legal position.
No court order requiredWithout prejudice: BMS and Pfizer retain the right to refile
A without-prejudice dismissal extinguishes this case but preserves the plaintiffs’ cause of action. BMS and Pfizer could refile the same infringement claims against Umedica if circumstances change — for example, if a licensing arrangement breaks down or if Umedica’s ANDA moves closer to FDA approval. This is a meaningful strategic reservation, particularly given the ongoing commercial sensitivity of Eliquis and upcoming patent expiry timelines.
Claims preserved for refilingUmedica escapes litigation costs — but faces lingering patent uncertainty
Umedica avoids the cost and delay of contested Hatch-Waxman litigation, which typically spans two to three years in Delaware. However, a without-prejudice dismissal does not clear the patent: US9326945B2 remains valid and enforceable. Umedica’s path to commercial launch of its generic apixaban tablets remains subject to the patent and any licensing terms privately agreed. The absence of a judgment means Umedica cannot claim a court-adjudicated freedom-to-operate.
No FTO established by this rulingRapid resolution suggests a deal — generic entry timeline remains opaque
A 15-day lifecycle — before defendant counsel appeared — is consistent with a pre-negotiated licensing or market-entry agreement executed outside court, a pattern common in late-stage Hatch-Waxman disputes involving major branded drugs. For competing generic manufacturers and market analysts, the resolution provides no public signal on Eliquis patent vulnerability. US9326945B2 remains unchallenged by any judicial ruling in this case, preserving its deterrent value against other ANDA filers.
Likely private resolutionFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bristol-Myers Squibb | Individual | Global biopharmaceutical co-holders of Eliquis franchise — holder of US9326945B2Search in Eureka ↗ |
| Co-Plaintiff | Pfizer, Inc. | Company | Search in Eureka ↗ |
| Defendant | Umedica Laboratories Pvt., Ltd. | Company | Umedica Laboratories Pvt., Ltd. — Indian generic pharmaceutical manufacturer seeking ANDA approval for apixaban tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Brian E. Farnan | Attorney | Counsel for Bristol-Myers SquibbSearch in Eureka ↗ |
| Plaintiff counsel | Joseph J. Farnan , Jr. | Attorney | Counsel for Bristol-Myers SquibbSearch in Eureka ↗ |
| Plaintiff counsel | Michael J. Farnan | Attorney | Counsel for Bristol-Myers SquibbSearch in Eureka ↗ |
| Plaintiff law firm | Farnan LLP | Law Firm | Representing Bristol-Myers SquibbSearch in Eureka ↗ |
| Presiding judge | Judge Gregory B. Williams | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice invokes Rule 41(a)(1)(A)(i) explicitly, confirming this was a unilateral plaintiff exit requiring no judicial action. The phrase ‘without prejudice’ is legally operative: it nullifies any preclusion effect, meaning BMS and Pfizer retain standing to assert US9326945B2 against Umedica in a future action. No claim construction, infringement finding, or validity determination was made. The court issued no order. For Umedica, the absence of a merits ruling means it cannot rely on this case as a defence or estoppel in any subsequent proceeding.
US9326945B2 — Apixaban Oral Tablet Formulation (Eliquis)
US9326945B2 (application number US13/579796) covers formulations of apixaban, a selective factor Xa inhibitor used to reduce the risk of stroke and systemic embolism. The patent protects the specific tablet compositions and formulation characteristics of Eliquis at the 2.5 mg and 5 mg dose strengths that are commercially marketed. Apixaban belongs to a class of direct oral anticoagulants (DOACs) that have largely displaced warfarin in clinical practice, giving the underlying patent estate significant commercial weight.
Eliquis is one of the best-selling pharmaceutical products globally, with annual revenues exceeding $10 billion. US9326945B2 sits within a multi-layered patent estate that BMS and Pfizer have actively enforced through Hatch-Waxman litigation across multiple ANDA filers. For any generic manufacturer seeking to enter the apixaban market, this patent represents a key clearance hurdle. Its continued enforceability following this case means competitors cannot infer any judicial vulnerability and must conduct independent claim-by-claim FTO analysis before launch.
Should you run an FTO analysis against US9326945B2 for apixaban products?
Any pharmaceutical manufacturer or product team developing generic apixaban tablets — including 2.5 mg and 5 mg dose forms — should treat US9326945B2 as an active enforcement risk. This case produced no invalidity or non-infringement ruling. BMS and Pfizer retain full enforcement rights, and the dismissal without prejudice signals ongoing commercial sensitivity around ANDA-based market entry. R&D and regulatory affairs teams should conduct FTO analysis before filing or prosecuting any ANDA referencing Eliquis as the reference listed drug.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map the full Eliquis patent estate, identify claim scope of US9326945B2 relative to proposed generic formulations, and flag related continuation or divisional patents that may present parallel infringement risk. Eureka’s litigation overlay also surfaces the complete Hatch-Waxman enforcement history for apixaban, enabling teams to benchmark settlement and licensing patterns across all known ANDA defendants — critical intelligence for negotiating market-entry timing.
Run a freedom-to-operate analysis on US9326945B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman Apixaban Patent Cases in Delaware Federal Court
Cases involving US9326945B2 and related Eliquis patents asserted by BMS and Pfizer against generic ANDA filers in Delaware District Court.
What this case signals for the generic anticoagulant IP landscape
A 15-day Hatch-Waxman dismissal without prejudice in Delaware is rarely accidental — it typically reflects a deal reached before litigation costs mount.
Speed of dismissal is the signal: watch for consent judgments or licensing filings
When a Hatch-Waxman complaint disappears within 15 days and no defendant counsel appears, the most plausible explanation is a pre-litigation agreement. IP teams monitoring the Eliquis patent estate should watch for any subsequent consent judgment, patent license disclosure, or FDA tentative approval event linked to Umedica’s ANDA, which would confirm the nature of the resolution.
US9326945B2 remains fully enforceableafter this case
No validity or infringement ruling was issued. The patent exits this case entirely intact. Any other generic manufacturer with an ANDA for apixaban tablets faces the same enforcement risk from BMS and Pfizer. Companies contemplating generic entry should treat this dismissal as neutral — not as evidence of patent weakness — and conduct independent FTO analysis against the full Eliquis patent portfolio.
Squibb v Umedica — key questions answered
The case was dismissed without prejudice on 15 October 2024, just 15 days after filing. BMS and Pfizer voluntarily dismissed under FRCP 41(a)(1)(A)(i) before Umedica served any responsive pleading. No merits ruling was issued and the plaintiffs retain the right to refile.
The asserted patent is US9326945B2 (application US13/579796), covering formulations of apixaban — the active ingredient in Eliquis — at 2.5 mg and 5 mg tablet strengths. The action was a Hatch-Waxman infringement claim triggered by Umedica’s ANDA for generic apixaban tablets.
No. The dismissal without prejudice carries no validity or infringement determination. US9326945B2 remains fully valid and enforceable. No court ruling on claim scope, obviousness, or anticipation was made. Other ANDA filers and generic manufacturers cannot rely on this dismissal as evidence of patent weakness.
The public record does not disclose the reason. However, a 15-day dismissal before defendant counsel appeared is consistent with a privately negotiated resolution — potentially a licensing agreement or consent judgment — reached outside court. This pattern is common in late-stage Hatch-Waxman disputes involving high-value branded pharmaceuticals.
The case was filed in the United States District Court for the District of Delaware and assigned to Judge Gregory B. Williams. The plaintiffs were represented by Farnan LLP. No defendant counsel entered an appearance before the voluntary dismissal was filed.
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