Unified Patents v. Inspire Medical Systems Inc

Unified Patents is a member-based organization dedicated to improving patent quality and deterring unsubstantiated or invalid patent assertions, particularly from non-practicing entities (NPEs). Inspire Medical Systems Inc. is an operating medical technology company based in Minneapolis, Minnesota, specializing in innovative and minimally invasive solutions for obstructive sleep apnea (OSA). Their flagship product is the Inspire therapy, an implantable neurostimulation system.

The patent at issue in this proceeding is U.S. Patent 11806526, titled "Stimulation for Treating Sleep Disordered Breathing." This patent broadly describes a device for treating sleep disordered breathing that includes a stimulation element designed to stimulate an airway-patency-related nerve. This patent is one of three related patents (along with 10898709 and 11850424) that Inspire Medical Systems Inc. has asserted in parallel district court litigation. The accused product is Nyxoah's "Genio" device, an implantable neurostimulation system for OSA treatment, which Inspire Medical Systems Inc. alleges infringes its patents in a separate district court case.

The current proceeding, IPR2026-00091, was filed by Nyxoah, Inc. et al. against Inspire Medical Systems Inc. before the Patent Trial and Appeal Board (PTAB). The PTAB is an administrative body within the U.S. Patent and Trademark Office (USPTO) that offers an alternative to district court litigation for challenging patent validity, often being a faster and more cost-effective venue. This IPR, however, is no longer pending; it was terminated on April 13, 2026, when the Board issued a "Director Discretionary Decision: Deny," meaning institution of the IPR was not granted on procedural grounds. While the initial prompt identified Unified Patents as the plaintiff, the official petitioner in IPR2026-00091 is Nyxoah, Inc. et al. Unified Patents tracks this IPR, listing Nyxoah as the petitioner, suggesting they may be monitoring the case, consistent with their mission to improve patent quality.

This case is notable due to the direct competition between two operating companies, Inspire Medical Systems and Nyxoah, in the growing market for obstructive sleep apnea treatments, particularly regarding implantable neurostimulation devices. The IPR, though ultimately denied institution, was part of a broader patent dispute where Inspire initially sued Nyxoah for infringement in district court, leading Nyxoah to challenge Inspire's patents at the PTAB. The discretionary denial by the PTAB is a significant procedural outcome, as such denials can impact litigation strategies and the overall landscape of patent challenges, particularly when parallel district court proceedings are ongoing.

This analysis details the legal developments concerning US Patent No. 11,806,526, focusing on the Inter Partes Review (IPR) proceeding IPR2026-00091 and related district court litigation.

Key Legal Developments and Outcome

1. District Court Litigation – Inspire Medical Systems, Inc. v. Nyxoah, Inc. et al. (D. Del.)

• Complaint for Patent Infringement (May 2025): Inspire Medical Systems, Inc. initiated a patent infringement lawsuit against Nyxoah, Inc. in the U.S. District Court for the District of Delaware. Inspire accused Nyxoah's "Genio" sleep apnea treatment system of infringing three of its patents, including US Patent No. 11,806,526. The lawsuit sought an injunction to prevent Nyxoah from entering the U.S. market and to recover damages. The case number for this litigation is 1:25-cv-00667-RGA.
• Answer, Affirmative Defenses, and Counterclaims (August 25, 2025): Nyxoah, Inc. and Nyxoah, SA (collectively "Nyxoah") responded to Inspire's complaint by filing an answer, affirmative defenses, and counterclaims. In their response, Nyxoah denied infringing Inspire's patents.

2. District Court Litigation – Nyxoah, Inc. et al. v. Inspire Medical Systems, Inc. (D. Del.)

• Counterclaim Lawsuit (September 2025): In response to Inspire's initial lawsuit, Nyxoah, Inc. filed its own patent infringement lawsuit against Inspire Medical Systems, Inc. in the U.S. District Court for the District of Delaware (Case No. 1:25-cv-01147). Nyxoah's suit alleged that Inspire's Inspire IV and Inspire V devices infringe on three of Nyxoah's patents (US Patent Nos. 8,700,183, 9,415,215, and 9,415,216) and sought injunctive relief and damages.

3. Parallel PTAB IPR Proceeding – IPR2026-00091

• Filing of Inter Partes Review Petition (December 17, 2025): Nyxoah, Inc. et al. filed an Inter Partes Review (IPR) petition, IPR2026-00091, against Inspire Medical Systems, Inc. concerning US Patent No. 11,806,526 before the Patent Trial and Appeal Board (PTAB).
• Institution Decision - Discretionary Denial (April 13, 2026): The PTAB issued a decision on April 13, 2026, to discretionarily deny the institution of IPR2026-00091. This means the PTAB decided not to proceed with a review of the patentability of the claims of US Patent No. 11,806,526.
• Termination (April 13, 2026): Concurrently with the discretionary denial, the IPR proceeding was terminated on April 13, 2026.
• Refund Request (May 7, 2026): Following the denial of institution, the Petitioners requested a refund of the post-institution fee on May 7, 2026. A notice of refund was issued by the Board on May 18, 2026.

Current Posture:

The IPR proceeding, IPR2026-00091, has concluded with a discretionary denial of institution, meaning the challenged claims of US Patent No. 11,806,526 were not reviewed by the PTAB. This allows the validity of US Patent No. 11,806,526 to be litigated in the ongoing district court case, Inspire Medical Systems, Inc. v. Nyxoah, Inc. et al. (1:25-cv-00667-RGA), without a parallel PTAB validity challenge. Both the initial infringement suit by Inspire and Nyxoah's countersuit remain active in the District of Delaware.

In the Inter Partes Review (IPR) case IPR2026-00091, the provided case metadata identifies Unified Patents as the plaintiff. However, public records for IPR2026-00091 consistently list Nyxoah, Inc. et al. as the Petitioner and Inspire Medical Systems, Inc. as the Patent Owner (Defendant) concerning US patent 11806526.

Adhering to the instruction to treat the provided case metadata as authoritative for party names, Unified Patents is considered the plaintiff in this analysis. Nevertheless, based on publicly available docket information for IPR2026-00091, Unified Patents is not listed as the petitioner, and therefore, specific counsel of record for Unified Patents in this particular IPR cannot be identified.

Unified Patents, as an organization dedicated to deterring abusive patent assertions and improving patent quality through mechanisms like IPRs, employs in-house legal counsel for managing patent office proceedings and often works with various law firms for PTAB litigation.

While not identified as counsel of record for IPR2026-00091, Unified Patents has several Senior Patent Counsel on staff who are involved in their IPR activities:

• Jordan Rossen - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents (in-house).
  • Note: Participates in webinars discussing PTAB interactions and other patent law topics.
• Jessica Marks - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents (in-house).
  • Note: Speaker on topics related to amplifying underrepresented voices at the PTAB.
• Michelle Aspen - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents (in-house).
  • Note: Has spoken on topics such as Fintiv denials in light of ITC cases.
• Ellyar Barazesh - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents (in-house).
  • Note: Has discussed strategies for filing ex parte reexaminations.
• Jonathan Stroud - Chief IP Counsel, Unified Patents.
  • Firm: Unified Patents (in-house).
  • Note: Has participated in discussions on improving the quality of issued U.S. patents.
• Ashraf Fawzy - Legal Head - SEP, Unified Patents.
  • Firm: Unified Patents (in-house).
  • Note: Speaker on the USPTO's request for comments on discretionary denials.

These individuals hold significant roles within Unified Patents' legal department and are actively involved in the organization's mission, including managing and litigating post-grant petitions like IPRs. However, without Unified Patents being listed as a petitioner in the official docket for IPR2026-00091, no specific counsel of record can be attributed to them for this exact case.

In IPR2026-00091, where Inspire Medical Systems Inc. is the Respondent (Patent Owner), the following counsel represents the defendant(s):

• Name: Timothy E. Bianchi

  • Role: Lead Counsel
  • Firm: Schwegman Lundberg & Woessner, P.A.
  • Office Location: Minneapolis, MN
  • Note: Timothy Bianchi is a principal at his firm and is active in patent challenges, opinions, and patent litigation strategy, specifically representing patent owners in inter partes reviews (IPRs) and reexaminations. His background includes medical devices. He has been recognized as "PTAB Litigator of the Year" by Managing Intellectual Property.

• Name: Bryan Phillips

  • Role: In-house Counsel (SVP, General Counsel, Chief Compliance Officer, and Corporate Secretary)
  • Firm: Inspire Medical Systems, Inc.
  • Office Location: Minneapolis, MN (Inspire Medical Systems is headquartered in Minneapolis)
  • Note: Mr. Phillips joined Inspire in January 2021 and previously served as patent counsel at Guidant Corporation's Cardiac Rhythm Management Group.