New Amsterdam LLC v. Medtronic: SINUVA Sinus Implant Case Dismissed With Prejudice
New Amsterdam, LLC filed a patent infringement action against Medtronic, Inc. and affiliated entities in the Eastern District of Texas, asserting US6916483B2 against the SINUVA Sinus Implant. The plaintiff voluntarily dismissed the case with prejudice under Rule 41(a)(1)(A)(i) after 265 days, permanently closing its infringement claims.
A high-stakes sinus implant infringement action that ended before trial
On September 15, 2023, New Amsterdam, LLC filed a patent infringement action in the Eastern District of Texas (Case No. 2:23-cv-00421) against Medtronic, Inc., Medtronic USA, Inc., Medtronic Xomed, Inc., and Intersect ENT, Inc. The suit asserted US6916483B2, targeting Medtronic’s SINUVA Sinus Implant — a corticosteroid-eluting device indicated for recurrent nasal polyposis. The defendant group represents Medtronic’s full ENT and sinus-care commercial infrastructure, suggesting the plaintiff sought broad coverage of the product’s manufacture, distribution, and sale.
The case closed on June 6, 2024, when New Amsterdam filed a Notice of Voluntary Dismissal With Prejudice pursuant to Rule 41(a)(1)(A)(i). The court accepted and acknowledged the notice, dismissing all pending claims and causes of action with prejudice and denying all remaining relief requests as moot. A dismissal with prejudice is a final adjudication on the merits as a matter of law — New Amsterdam is permanently barred from re-asserting the same claims against the same defendants on the same patent.
The 265-day timeline from filing to dismissal is consistent with early resolution before significant claim construction or merits briefing, though the public record does not disclose whether a settlement was reached, a licensing agreement executed, or the plaintiff elected to withdraw for strategic or evidentiary reasons. The use of Rule 41(a)(1)(A)(i) — a unilateral plaintiff dismissal without requiring court or defendant consent — typically signals resolution occurred before the defendant filed an answer or motion for summary judgment, or that the parties reached a private agreement whose terms remain confidential.
Filing to Case Terminated in 265 days
265 days from filing to dismissal — below the median for contested E.D. Texas patent cases
Voluntary dismissal with prejudice: what the closure means for both parties
Rule 41(a)(1)(A)(i): plaintiff’s unilateral exit — but permanent
Rule 41(a)(1)(A)(i) permits a plaintiff to dismiss an action without a court order by filing a notice, but only before the opposing party has served an answer or a motion for summary judgment. Here, New Amsterdam elected dismissal WITH prejudice — a higher standard than the rule’s default. Once accepted by the court, this operates as a final judgment on the merits, permanently extinguishing the asserted claims against these defendants.
Voluntary — prejudice specifiedWith prejudice means no second bite at the apple
A dismissal with prejudice is the most terminal outcome short of an adverse trial verdict. New Amsterdam cannot refile this infringement action against Medtronic or its named affiliates on US6916483B2 for the same accused product. This forecloses future opportunistic re-assertion and materially reduces the patent’s enforcement leverage against this defendant group. Importantly, the public record does not confirm whether a financial settlement accompanied the dismissal.
Re-assertion barredMedtronic and affiliates achieve finality without a merits ruling
For Medtronic, Inc., Medtronic USA, Medtronic Xomed, and Intersect ENT, the with-prejudice dismissal provides litigation closure without the cost or risk of a full trial. However, because no court invalidated US6916483B2 or ruled on non-infringement, the patent’s legal validity remains intact. Other potential defendants in the sinus implant space cannot rely on this outcome as precedent for their own exposure to the same patent.
Closure without invalidity rulingSINUVA cleared — but US6916483B2 remains enforceable against others
Because the case resolved without a validity or infringement determination, US6916483B2 retains its full presumption of validity under 35 U.S.C. § 282. Competitors in the drug-eluting sinus implant space — and any new entrants — cannot draw comfort from this dismissal. The patent may still be asserted against other SINUVA-adjacent or competing sinus implant technologies. Freedom-to-operate analysis against US6916483B2 remains essential for any participant in this space.
Patent validity intactFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | New Amsterdam, LLC | Company | Patent assertion entity — holder of US6916483B2 targeting sinus implant technologySearch in Eureka ↗ |
| Defendant | Medtronic, Inc. | Company | Medtronic, Inc. and affiliates — global medical device manufacturer, maker of SINUVA Sinus ImplantSearch in Eureka ↗ |
| Co-Defendant | Intersect Ent, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Medtronic USA, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Medtronic Xomed, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Medtronic, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Christopher A. Honea | Attorney | Counsel for New Amsterdam, LLCSearch in Eureka ↗ |
| Plaintiff law firm | Garteiser Honea PLLC | Law Firm | Representing New Amsterdam, LLCSearch in Eureka ↗ |
| Defendant counsel | Fred Irvin Williams | Attorney | Counsel for Medtronic, Inc.Search in Eureka ↗ |
| Defendant counsel | John Wittenzellner | Attorney | Counsel for Medtronic, Inc.Search in Eureka ↗ |
| Defendant counsel | Lea Norkus Brigtsen | Attorney | Counsel for Medtronic, Inc.Search in Eureka ↗ |
| Defendant counsel | Michael James Fagan , Jr. | Attorney | Counsel for Medtronic, Inc.Search in Eureka ↗ |
| Defendant law firm | Michael Fagan | Law Firm | Representing Medtronic, Inc.Search in Eureka ↗ |
| Defendant law firm | Williams, Simons & Landis PLLC | Law Firm | Representing Medtronic, Inc.Search in Eureka ↗ |
| Defendant law firm | Williams, Simons & Landis PLLC (Austin) | Law Firm | Representing Medtronic, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Texas Eastern District CourtSearch in Eureka ↗ |
Official order — verbatim text
The court’s acceptance of the voluntary dismissal with prejudice under Rule 41(a)(1)(A)(i) is a procedural endpoint, not a substantive merits ruling. The language ‘ACCEPTS AND ACKNOWLEDGES’ reflects the court’s ministerial role — once a qualifying notice is filed, dismissal is self-executing. Critically, the with-prejudice designation was chosen by the plaintiff, not imposed by the court, which typically suggests the plaintiff received something of value in exchange for permanently surrendering its claims against this defendant group.
US6916483B2 — drug-eluting sinus implant technology
US6916483B2 (application number US10/200355) covers technology in the field of implantable drug-delivery devices for sinus cavities — a domain directly implicated by Medtronic’s SINUVA Sinus Implant, which delivers mometasone furoate to the ethmoid sinuses following endoscopic sinus surgery. The patent’s prosecution history and application date suggest coverage of core structural and delivery-mechanism features that may read on bioabsorbable or sustained-release ENT implant architectures. The B2 designation confirms this is a granted utility patent that survived examination.
Within the ENT device sector, drug-eluting sinus implants represent a high-value commercial niche — SINUVA carries a significant per-procedure cost and is deployed in a large annual surgical population. A patent reading on this product’s core mechanism poses material revenue risk for Medtronic and creates a competitive moat for the patent holder. For rival ENT device developers, particularly those working on next-generation bioabsorbable sinus stents or steroid-eluting platforms, US6916483B2 warrants independent FTO evaluation regardless of this case’s outcome.
Should your ENT device team run an FTO against US6916483B2?
Any company developing, manufacturing, or commercialising drug-eluting nasal or sinus implants — including bioabsorbable stents, steroid-releasing spacers, or post-surgical ENT delivery devices — should treat US6916483B2 as an active FTO consideration. The with-prejudice dismissal in this case provides no invalidity shield: the patent’s claims remain presumptively valid and fully enforceable against parties not named in this action. The SINUVA product category is a commercially significant target, and the assertion strategy here suggests an active enforcement posture by the patent holder.
PatSnap Eureka’s FTO Search Agent enables R&D and IP teams to map US6916483B2’s independent claims against your device’s structural features, delivery mechanism, and active agent — identifying overlap risk before product launch. Eureka can also surface related continuation applications, design-arounds adopted by other ENT device manufacturers, and the full prosecution history to assess claim breadth. For in-house counsel managing a sinus or ENT device portfolio, a proactive clearance search is materially lower cost than reactive litigation defence in E.D. Texas.
Run a freedom-to-operate analysis on US6916483B2 to assess your product’s exposure
Run FTO in Eureka →Similar drug-eluting sinus implant patent cases in E.D. Texas and federal courts
Cases involving drug-eluting ENT implants and sinus delivery device patents asserted in E.D. Texas and comparable federal patent venues.
What this case signals for the medical device sinus implant IP landscape
A with-prejudice dismissal in a single-patent ENT device suit carries distinct implications for enforcement strategy and competitive FTO planning.
With-prejudice dismissals often signal confidential resolution, not patent weakness
When a plaintiff dismisses with prejudice before a merits ruling, the most commercially plausible explanation is a private resolution — potentially including a licensing agreement or one-time payment. The absence of a public settlement record is typical in medical device disputes involving specialty implant technology. IP teams at competing ENT device firms should treat the underlying patent as still commercially live.
E.D. Texas remains a plaintiff-favoured venue for medical device patent assertions
The Eastern District of Texas continues to attract single-patent infringement actions targeting large device manufacturers. The 265-day lifecycle of this case — shorter than average for a contested E.D. Texas docket — suggests early resolution dynamics that may reflect defendant incentive to avoid prolonged discovery in a plaintiff-friendly forum. Defendants in this jurisdiction should assess early-exit strategies carefully.
New v Medtronic — key questions answered
The with-prejudice dismissal means New Amsterdam, LLC is permanently barred from re-asserting the same claims under US6916483B2 against Medtronic and its co-defendants for the SINUVA Sinus Implant. However, the patent itself was not invalidated — it retains full presumptive validity and can still be enforced against other parties.
The public record does not confirm a settlement. The case was closed by voluntary dismissal with prejudice under Rule 41(a)(1)(A)(i). This mechanism is consistent with a confidential resolution — potentially including licensing — but no settlement terms have been filed on the public docket.
Intersect ENT, Inc. was a key Medtronic acquisition in the ENT drug-eluting implant space and is the commercial entity most directly associated with SINUVA. Naming Intersect ENT alongside Medtronic, Inc., Medtronic USA, and Medtronic Xomed suggests the plaintiff sought to cover the full commercialisation chain — manufacture, distribution, and sale — of the accused product.
Yes. Because no court issued a ruling on invalidity, non-infringement, or claim construction, US6916483B2 remains fully enforceable under 35 U.S.C. § 282. Companies in the sinus implant or ENT drug-delivery device sector cannot treat this dismissal as clearing their FTO path against this patent.
Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure permits a plaintiff to voluntarily dismiss an action without a court order by filing a notice before the opposing party serves an answer or a motion for summary judgment. In this case, New Amsterdam filed such a notice and elected dismissal with prejudice — a more permanent outcome than the rule’s default — which the court accepted as self-executing.
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