Inspire: Company Files Patent Lawsuit Seemingly to Delay Competition; A Closer Look at the Patents at Issue and Potential Paths Forward

Sterne Kessler’s Richard Crudo, director in the Electronics and Trial & Appellate Practice Groups, spoke to The Capitol Forum to discuss the merits of a recent patent lawsuit within the healthcare industry.

An implantable sleep apnea device from the company Nyxoah has been on the market in Europe since 2020 with plans to launch in the U.S. upon earning final approval from the Food and Drug Administration. The company however, is now facing patent infringement claims in a case filed by Inspire Medical Systems, which also markets and sells a sleep apnea implant.

On the possible outcomes for patent litigation, Crudo comments, “It seems that at least the claims called out in the complaint don’t precisely say where the device is implanted, only that there is a non-cardiac means or element for stimulating an upper airway patency-related nerve or a hypoglossal nerve. So, the claims do seem to be broad enough to cover a device that is implanted in various locations and on either side of the tongue, as long as the device stimulates the right nerves. And that issue may come down to what ‘upper airway patency-related nerve’ means in the claims.”

He continues, “To determine whether there’s infringement, the court won’t compare Inspire’s product to Nyxoah’s product—it will compare Inspire’s patent claims to Nyxoah’s product. [But] if Nyxoah argues, for example, that the patents are obvious, it would really help Inspire if they could show that the Inspire product is co-extensive with the patent claims and that the product is commercially successful. So, it could become relevant, but it might not be dispositive as to any issue, and certainly not infringement.”

On the topic of a preliminary injunction in this case, Crudo says it “isn’t trivial by any means.” “What [Inspire] would have to show in order to prevail on a preliminary junction is, among other things, a likelihood of success on the merits both as to infringement and invalidity, as well as irreparable harm, which could include, for example, loss of business opportunities, price erosion in cases where it’s a tight market, loss of goodwill, and other forms of injury that cannot be redressed by monetary damages.”

If Nyxoah decides to proceed with its U.S. launch, Crudo states “Any sales made now could be acts of infringement if the court finds that their product reads on Inspire’s patent claims. Any time a company launches during litigation, as opposed to after final resolution, it’s at their own peril, especially if the plaintiff moves for a preliminary injunction. If Nyxoah were to launch now, and Inspire were to move for a preliminary injunction and prevail, Nyxoah would have to immediately take their product off the market.”