Sequential Innovation
and the Modern Patent Moat

October 23, 2025

In May 2025, Inspire Medical Systems sued Belgian competitor Nyxoah in the U.S. District Court for the District of Delaware, alleging infringement of several patents related to hypoglossal nerve stimulation (HNS) for treating obstructive sleep apnea (OSA). Nyxoah counterclaimed, asserting its own patents against Inspire.

The case involves competing technologies for treating a chronic and widespread condition affecting millions of patients. It also raises foundational legal and policy questions about the role of patents in shaping access to second-generation medical technologies. While the dispute is often described as a classic “incumbent vs. disruptor” conflict, the legal issues are more complex—and the outcome may turn less on who was “first” or “better,” and more on how courts interpret obviousness, blocking patents, and injunctive relief in a rapidly evolving device market.

Competing Technologies, Parallel Claims

Hypoglossal nerve stimulation was first commercialized in the U.S. by Inspire in 2014. Its system, which relies on unilateral stimulation of the hypoglossal nerve, has dominated the market for more than a decade.

Nyxoah’s Genio device, approved by the FDA in 2024, represents a different engineering approach: bilateral stimulation, a leadless design, full-body MRI compatibility, and wireless charging. Nyxoah claims its approach improves efficacy and reduces patient burden. Inspire, however, alleges that Genio relies on methods and system architectures already covered by its patents.

Nyxoah has countered by asserting its own patents on bilateral stimulation and electrode placement against Inspire’s newer generation devices. In other words, both parties claim ownership of critical pieces of the technology stack—a common occurrence in mature medical device markets where foundational patents overlap with incremental or complementary improvements.

Obviousness and the Scope of Patent Protection

A central doctrinal fault line in this litigation is 35 U.S.C. § 103, which bars patent protection for inventions that would have been obvious to a person of ordinary skill in the art.

Inspire is likely to argue that bilateral stimulation is an obvious extension of its unilateral method. Under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), combining known elements in a way that yields predictable results may be deemed obvious. From this perspective, bilateral stimulation could be framed as simply applying an established principle to both sides of the airway rather than one—a classic “obvious to try” scenario.

Nyxoah will likely counter with a nonobviousness argument, emphasizing technical and clinical distinctions: bilateral stimulation purportedly provides unique functional advantages, solves limitations Inspire’s system left unresolved, and required distinct engineering solutions. Under Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013), such factors can weigh heavily against an obviousness finding, especially when secondary considerations like commercial success or long-felt need support the claim of inventive step. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034 (Fed. Cir. 2016) (en banc), similarly underscored the probative value of such evidence.

The outcome of this doctrinal question will shape not only patent validity, but the scope of market exclusivityavailable to either party.

Blocking Patents and Strategic Leverage

The fact that both parties hold patents over different aspects of the technology introduces the familiar problem of blocking patents — a situation in which multiple patent owners control complementary pieces of an innovation. Federal Circuit decisions such as Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310 (Fed. Cir. 2018), and Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731 (Fed. Cir. 2013), have addressed such dynamics, emphasizing how overlapping rights can influence both competitive behavior and the evidentiary weight of secondary considerations.

Here, Inspire’s patents may be foundational, covering core HNS functionality. Nyxoah’s patents may relate to subsequent technical advances. That relationship could produce several outcomes: it could give Inspire a dominant market position if its patents are interpreted broadly; it could allow Nyxoah to claim an independent market position if its patents survive obviousness challenges; or it could lead to a cross-licensing equilibrium in which neither party can exclude the other entirely.

Procedural Posture and Market Effects

The choice of Delaware as venue is not incidental. The district has a deep bench of patent expertise and a predictable litigation schedule, but its very litigation timeline has market effects. Patent litigation in Delaware typically spans several years, often with parallel Federal Circuit review. During that period, uncertainty itself functions as an economic tool: incumbents may maintain market share, challengers face barriers to scaling, and investors and payers often adopt a wait-and-see posture.

This strategic use of litigation delay is not unique to Inspire or Nyxoah; it is a well-documented feature of med-tech markets, where regulatory and IP hurdles often intersect.

Injunction Standards and Public Interest

A further inflection point may arise from the availability of injunctive relief. Inspire may seek to prevent Nyxoah from commercializing its device during the pendency of the litigation. Since eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), courts apply a four-factor equitable test, requiring proof of irreparable harm and considering the public interest.

In the medical device context, the public interest factor often carries unusual weight. In Cordis Corp. v. Boston Scientific Corp., 99 F. App’x 928 (Fed. Cir. 2004), injunctions issued where multiple alternatives were available. However, when injunctions would limit patient access to clinically meaningful treatments, courts have shown restraint. Whether Nyxoah’s technology offers substantial patient benefits relative to Inspire’s could materially affect the injunction calculus.

An injunction would have immediate commercial implications, effectively deciding market structure before validity and infringement are fully adjudicated.

Policy Tension: Innovation Incentives vs. Market Access

This litigation highlights a broader policy tension embedded in the patent system. Patents are designed to incentivize innovation by granting exclusivity, but they can also delay the dissemination of subsequent improvements. From one perspective, Inspire’s patents represent a justified reward for pioneering HNS technology. From another, if Nyxoah’s improvements are meaningful, exclusive enforcement could limit patient access to potentially better treatments.

Patent law has tools to navigate this tension: robust application of KSR to prevent overreach, reliance on secondary considerations to protect true advancements, and careful use of equitable injunction standards under eBay. How the court balances those tools here will reverberate beyond this particular market.

Potential Endgames

Three broad outcomes are plausible.

First, Inspire could prevail on infringement and validity, effectively preserving its control over the U.S. market.
Second, Nyxoah could prevail, either invalidating Inspire’s asserted claims or proving noninfringement, allowing it to compete independently.
Third, and perhaps most likely in a blocking patent scenario, the parties could reach a cross-licensing agreement that allows parallel competition under negotiated economic terms.

Each outcome has distinct consequences for pricing, innovation cycles, and patient access — and all are legally plausible depending on how the obviousness and injunction questions are resolved.

A Broader Structural Question

This case is not just about who wins a patent dispute in Delaware. It sits at the intersection of innovation policy, patent doctrine, and health economics. The outcome will influence how first movers and fast followers position themselves in future med-tech markets, and how courts assess the boundaries between protecting early innovation and enabling technological progress.

In short: this is not only a litigation story; it is a test of how the U.S. patent system governs sequential innovation.And unlike market narratives that cast one party as the hero and the other as the villain, the legal reality is more nuanced. Both Inspire and Nyxoah have colorable claims — and both are navigating a system that gives incumbents strong defensive tools while still leaving room, in theory, for challengers.