Litigation

Untitled case

Litigation

1:25-cv-00667

Patents at issue (1)

Summary

A district court case concerning US patent 11850424 filed in the Delaware District Court.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

This patent infringement litigation, Case No. 1:25-cv-00667, is unfolding in the District of Delaware and involves two medical device operating companies focused on treatments for sleep-disordered breathing. The plaintiff is Inspire Medical Systems, Inc., a company based in Minneapolis, Minnesota, known for pioneering minimally invasive solutions for Obstructive Sleep Apnea (OSA) through electrical stimulation of upper airway nerves. The defendants are Nyxoah SA and its wholly-owned subsidiary Nyxoah, Inc. (collectively, "Nyxoah"), which also develop devices for treating OSA. Inspire alleges that Nyxoah's "Genio" product infringes its patents. The Genio system consists of an implantable stimulator and an activation chip worn on the chin via an adhesive patch, designed to deliver power and control signals to the implantable device, which electrically stimulates the hypoglossal nerve.

The asserted patents are U.S. Patent Nos. 10,898,709, 11,806,526, and 11,850,424, all titled "Stimulation for treating sleep disordered breathing." These patents generally describe devices and methods for treating sleep disordered breathing, such as obstructive sleep apnea, by stimulating an airway patency related nerve. Specifically, they cover nerve stimulation techniques, some of which may be performed asynchronously (without synchronization to sensed respiratory information), aiming to maintain or increase upper airway patency and minimize collapse. The case is currently presided over by Judge John Campbell Barker in the District of Delaware. The District of Delaware is a particularly significant venue for patent litigation due to its highly experienced patent bench and its status as the state of incorporation for a majority of major U.S. technology and pharmaceutical companies.

This litigation is notable for several reasons. It represents a direct competition between two operating companies in the rapidly developing market for implantable solutions for obstructive sleep apnea. Furthermore, the case has been consolidated with a related action, 1:25-cv-01147, where Nyxoah SA and Nyxoah, Inc. are plaintiffs against Inspire Medical Systems, Inc., indicating a broader intellectual property dispute between the parties. In parallel to the district court proceedings, Nyxoah has also challenged the validity of U.S. Patent No. 11,850,424 via an inter partes review (IPR2026-00090) filed with the Patent Trial and Appeal Board (PTAB) on December 17, 2025. The parties are actively engaged in scheduling, with a jury trial anticipated in late 2027.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

The patent infringement litigation, Case No. 1:25-cv-00667, involves Inspire Medical Systems, Inc. (Plaintiff) and Nyxoah, Inc. et al. (Defendants) in the District of Delaware, concerning U.S. Patent No. 11,850,424, among others. The case is currently active with a trial scheduled for late 2027.

Here's a chronological overview of the key legal developments and outcomes:

Filing & Initial Pleadings:

  • May 30, 2025: Inspire Medical Systems, Inc. filed a complaint against Nyxoah, Inc. et al. in the District of Delaware, asserting infringement of U.S. Patent Nos. 10,898,709, 11,806,526, and 11,850,424.
  • August 25, 2025: Nyxoah, Inc. answered the complaint and asserted counterclaims seeking declaratory judgments of invalidity for all three patents.

Pre-trial Motions of Substance:

  • November 18, 2025: A Magistrate Judge issued a Memorandum Order (D.I. 50) disqualifying Inspire's counsel. Inspire filed objections to this order (D.I. 55), and Nyxoah filed a response (D.I. 57).
  • November 21, 2025 - January 20, 2026: All deadlines in the Scheduling Order (D.I. 30) were stayed.
  • January 1, 2026: A Joint Stipulation and Order to Extend Stay (D.I. 61) was entered, extending the stay until twenty-one days after the Court issued a ruling on Inspire's objections to the disqualification order.
  • March 2, 2026: An Order Lifting Stay (D.I. 71) was entered, formally ending the stay. While the specific ruling on D.I. 55 that resolved the disqualification issue and led to the lifting of the stay is not explicitly detailed in the provided snippets, the lifting of the stay indicates a resolution was reached.
  • March 2, 2026: The parties submitted competing proposals for a revised scheduling order, primarily disputing the trial date. Inspire proposed maintaining the December 13-17, 2027 trial date, while Nyxoah proposed a schedule with trial around February 22, 2028.
  • March 6, 2026: An Amended Scheduling Order (D.I. 73) was entered, setting trial for December 13, 2027.

Claim Construction (Markman) Outcomes:

  • A Claim Construction Hearing (Markman hearing) is scheduled for October 29, 2026. [cite: 3 (from previous search output)] No Markman outcome has been reached yet.

Discovery Milestones with Strategic Significance:

  • The discussions surrounding the revised scheduling order indicate that sufficient time was to be allowed for fact discovery, including the possibility of discovery in both the United States and Europe. [cite: 5 (from previous search output)] Specific significant milestones in discovery were not detailed in the provided information.

Trial Events, Verdict, and Post-Trial Motions:

  • A jury trial is currently scheduled for December 13, 2027. [cite: 3 (from previous search output)] No trial events or verdicts have occurred.

Settlement, Dismissal, Judgment, or Appeal:

  • The case is active and ongoing in the District of Delaware, with future dates set for claim construction and trial. There has been no final disposition, such as settlement, dismissal, or judgment.

Parallel PTAB IPR/PGR Proceedings:

  • December 18, 2025: Nyxoah, Inc. and Nyxoah SA concurrently filed three Inter Partes Review (IPR) petitions challenging the three patents asserted by Inspire in the district court litigation. These included IPR2026-00090 (for U.S. Patent No. 10,898,709), IPR2026-00091 (for U.S. Patent No. 11,806,526), and IPR2026-00092 (for U.S. Patent No. 11,850,424).
  • Relation to Litigation: The IPR petitions were filed while the district court litigation was stayed. Inspire argued against institution, noting that the district court had indicated it would consider a stay if the IPRs were instituted. Inspire also raised arguments concerning 37 C.F.R. § 42.104(b)(3) regarding "means for" elements and the Fintiv factors for discretionary denial.
  • April 13, 2026: The Director of the USPTO issued a Discretionary Decision to Deny institution for IPR2026-00090, which targeted U.S. Patent No. 10,898,709. [cite: 7 (from previous search output)]
  • Status of IPR2026-00092: As of the latest available information, a specific institution decision for IPR2026-00092 (for U.S. Patent No. 11,850,424) has not been explicitly detailed in the provided search results. Given that it was filed concurrently with IPR2026-00090 and involved similar arguments and patents, it is highly likely to have been subject to a similar decision, potentially a discretionary denial, especially in light of the USPTO Director's recent policies on discretionary denials, including factors like "second bite at the apple" scenarios and domestic manufacturing presence. However, without a direct citation for IPR2026-00092, its definitive outcome remains unconfirmed.

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

In case 1:25-cv-00667, Inspire Medical Systems, Inc. v. Nyxoah, Inc. et al., filed in the District of Delaware, Inspire Medical Systems, Inc. is the plaintiff. While the case status was marked as "Closed" in some listings as of May 30, 2025, later docket entries from March 2026 indicate ongoing litigation activity, including discussions about scheduling and a stay of the action.

Counsel of record for Inspire Medical Systems, Inc. are:

Local Counsel:

  • Anthony D. Raucci
    • Role: Local Counsel
    • Firm: Morris Nichols Arsht & Tunnell LLP, Wilmington, Delaware
    • Experience: Morris Nichols Arsht & Tunnell LLP has a strong intellectual property practice with a focus on patent infringement litigation, frequently appearing in the U.S. District Court for the District of Delaware for clients in technology, food, and life sciences. The firm often serves as local counsel in complex patent disputes. Anthony D. Raucci is noted as actively involved in communications with the court regarding scheduling in this case.
  • Rodger D. Smith, II
    • Role: Local Counsel
    • Firm: Morris Nichols Arsht & Tunnell LLP, Wilmington, Delaware
    • Experience: As part of Morris Nichols, Smith would be involved in the firm's robust patent litigation practice in Delaware, representing clients in various intellectual property disputes.

Former Lead Counsel (Disqualified):

  • Latham & Watkins LLP was initially identified as lead counsel for Inspire Medical Systems, Inc.. However, the defendants' motion to disqualify plaintiff's counsel was granted by a Memorandum Order on November 18, 2025. Subsequent filings explicitly mention "Inspire's goals in substituting counsel," confirming a change in lead representation. The disqualified attorneys included:
    • Michael A. Morin
    • Rachel R. Blitzer
    • Rachel L. Weiner Cohen
    • Tiffany Weston
    • Richard Lowry
    • Joseph Previti

Current Lead Counsel:

The specific firm and attorneys who have substituted as lead counsel for Inspire Medical Systems, Inc. following the disqualification of Latham & Watkins LLP are not explicitly identified in the provided search results. While recent docket entries indicate the ongoing involvement of Morris Nichols Arsht & Tunnell LLP as local counsel, details on the new lead counsel team were not found.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

In the patent infringement case Inspire Medical Systems, Inc. v. Nyxoah, Inc. et al. (1:25-cv-00667) in the District of Delaware, the defendants, Nyxoah SA and Nyxoah, Inc., are represented by the following counsel:

Duane Morris LLP

  • Jarrad M. Gunther - Attorney for Petitioners (in IPR proceedings, suggesting a lead role in the overall patent defense strategy).
    • Office Location: Philadelphia, PA.
    • Relevant Experience: Mr. Gunther is a registered patent attorney.

Morris, Nichols, Arsht & Tunnell LLP

  • Rodger D. Smith II - Local Counsel.
    • Office Location: Wilmington, DE.
    • Relevant Experience: Mr. Smith appears to be actively involved in communication with the court regarding scheduling matters.

It is important to note that a motion to disqualify the plaintiff's original counsel, Latham & Watkins LLP, was granted in November 2025, due to a conflict of interest stemming from prior work for Nyxoah. The current counsel for Nyxoah was instrumental in this disqualification.

The available information largely focuses on the IPR proceedings and communications with the court, so specific roles like "lead counsel" for all aspects of the district court case are inferred from the context of their appearances and filings.