Analyzing Inari Medical: In At Least One Judge’s Court, There’s Enough Bad News for Everyone

In October 2025, a federal district judge with an active docket of patent suits addressed the question of whether the filing (and, presumably, the service) of a complaint for patent infringement in and of itself precludes the defendant from asserting that it was unaware of the patent (and, thus, could not be a willful infringer). The bad news for plaintiffs: the answer was no. The court also addressed the question of whether a defendant could utilize a Rule 12(b) (6) motion to dismiss a plaintiff’s assertion of entitlement to enhanced damages under 35 U.S.C. §284 for willful infringement. The bad news for defendants: the answer was no again.

While these rulings by a single district judge are not binding authority on any other judge, they may signal the beginning of small but potentially significant changes in patent litigation practice. Lawyers who represent patent owners and accused infringers alike would be wise to take notice.

Pleading Willful Infringement

I may be wrong, but it sure seems like nearly every complaint for patent infringement I read these days includes an allegation that the infringement has been and is willful. This is not exactly surprising. A finding of willful patent infringement can lead to enhanced (possibly treble) damages and an award of attorney fees. If a plaintiff is looking to scare a defendant into folding its tent, accusing the defendant of willful infringement seems like an inexpensive way to do so.

To be sure, there are always some cases where there has been back and forth between the parties before suit is filed, and the plaintiff has a clear picture that the defendant has no meaningful defense. In such cases, alleging willful infringement seems justified.

But there are also cases in which the plaintiff has no idea about the defendant’s state of mind, in part because the defendant may be totally unaware of the existence of plaintiff’s patent. To be sure, such lack of awareness can be rectified with a cease-and-desist letter before filing suit. But many patent owners are reluctant to send such a letter, as it can provide the basis for a declaratory judgment action filed by the accused infringer in a less than convenient forum.

Accordingly, in some cases, the plaintiff will just assert willful infringement in its complaint and take the position that the complaint itself made the defendant aware of the patent. In some situations, the patentee may recognize that the infringement that preceded the complaint may not have been willful. But the patentee may believe that continuing the infringement after receiving the complaint made the infringement willful going forward. In such situations, the plaintiff might file an amended complaint after some sort of decent interval, or even a separate new complaint relying on the filing of the first complaint as proof of willful conduct.

The Inari Medical Case

Enter Chief Judge Colm Connolly of the United States District Court for the District of Delaware. He seems to have struggled with these issues since at least 2021, when he expressed his views in one case, but acknowledged that he was “not without doubts.” However, in Inari Medical, Inc. v. Inquis Medical, Inc., No. 24-2023, 2025 U.S. Dist. LEXIS 202313 (D. Del., Oct. 25, 2025), Judge Connolly has now made clear that his doubts have been resolved.

This new opinion addressed a Rule 12(b) (6) motion by the defendant Inquis to dismiss assertions in Inari’s complaint that Inari was entitled to enhanced damages for willful infringement. (The opinion also addresses the knowledge aspect of indirect infringement, i.e. inducement and contributory infringement, but this article is limited to the Court’s treatment of willful infringement).

Judge Connolly denied the motion as it related to willful infringement. He first addressed the question of whether a filed complaint provides the requisite pre-suit knowledge needed for willfulness-based enhanced damages. He concluded that it does not. He quoted his own prior opinion where he had said, “It seems to me neither wise nor consistent with principles of judicial economy to allow court dockets to serve as notice boards for future legal claims for…enhanced damages.” He then held that one or more versions of the complaint filed in one lawsuit cannot provide the required knowledge for a willful infringement claim in that lawsuit. But, with seeming reluctance, he allowed that a first complaint could suffice as proof of knowledge in a second lawsuit asserting the same claim.

Judge Connolly then turned to the motion at hand. Given his apparent disdain for seemingly unsupported assertions of willfulness in complaints, one might expect him to be sympathetic to efforts to remove such assertions. However, he concluded that a demand for enhanced damages is a request for relief and is not a “claim” that is subject to possible dismissal under Rule 12(b) (6), which allows dismissal for failure to state a “claim” upon which relief may be granted. Judge Connolly gave notice that, going forward, he would no longer even entertain Rule 12(b) (6) motions to dismiss demands for enhanced damages. But he confirmed that a plaintiff can preserve its right to seek enhanced damages by simply asking for them in its prayer for relief.

Where Do We Go From Here?

As noted above, the Inari decision represents the views of one trial judge. But his reasoning seems sufficiently compelling that those views may spread to other judges in the District of Delaware and perhaps beyond. So, ignoring them may be a bad idea.

That said, how should litigators play out these scenarios in courts where Inari represents the current state of play? Let’s begin with defendants. Suppose a defendant was totally unaware of the patent before the suit, but the plaintiff expressly alleged in its complaint that the infringement was willful. One option is to simply do nothing, as the allegation of willfulness in the pleading would seem to have no legal effect, and it can simply be denied in an answer.

As we have seen, in Judge Connolly’s courtroom, a Rule 12(b) (6) motion would not even be entertained. But perhaps a Rule 11 motion may be called for. Rule 11(b) (3) requires that an attorney filing a pleading certifies that the factual contentions have evidentiary support; and since the pleading itself is not cognizable evidence to support knowledge, the plaintiff may have no other evidence to justify the allegation.

However, Rule 11(b) (3) also allows for “factual contentions [which]…, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery….” Where a plaintiff has no basis whatsoever to believe that the defendant was aware of the patent before the suit, nor any real basis for asserting that pre-suit knowledge was likely, attempting to rely on this provision could not only get the defendant’s motion granted, but it may cost counsel valuable credibility going forward.

Another possibility is Rule 12(f), which allows a court to strike from a pleading “scandalous matter,” which is an assertion that improperly casts a derogatory light on a party. But motions to strike are often said to be disfavored drastic remedies which judges have considerable discretion to deny if the allegation has some possible relation to the controversy.

Could a defendant move for summary judgment? Rule 56(a) does allow a party to seek summary judgment on a “part” of a claim. But is a willful infringement as a basis for enhanced damages a “part” of a claim like ownership and infringement or—again—only a remedy? Moreover, any such motion for summary judgment at the outset of a case would likely be met with an affidavit under Rule 56(d) asserting the need for discovery.

In short, a defendant which had no knowledge of the patent before it was sued and which receives an allegation of willful infringement is not altogether without options. But the best option may well be to do nothing.

What about plaintiffs who have no proof that the defendant knew about the patent? For starters, they can and should make sure that the prayer for relief at the end of their complaint requests enhanced damages under Section 284. But what about alleging willful infringement in the body of the complaint? If the case is assigned to Judge Connolly, just don’t do it. If they are filing suit in the District of Delaware, and the case may or may not be assigned to Judge Connolly, unless they wish to roll the dice, same advice.

But what if you are filing in another court where the judges haven’t addressed these issues? Not all judges agree with Judge Connolly as to whether an allegation in a complaint can supply the knowledge needed for willfulness. As the Inari opinion notes, Judge William Bryson of the U.S. Court of Appeals for the Federal Circuit reached a different conclusion while sitting by designation in—you guessed it—the District of Delaware.

On the other hand, while Judge Connolly will not entertain Rule 12(b) (6) motions in such circumstances, other judges may be happy to entertain such motions, and then grant them, especially where there are no other plausible facts alleged in support of the willfulness claim. And as we have seen, there may be other viable options for recourse available to defendants.

Plaintiffs and their counsel who suspect that infringement might be willful may want to just proceed the old-fashioned way. Serve discovery requests on the defendant asking for documents mentioning the patent, communications about the patent, and legal advice about the patent. If the defendant waives privilege and produces an opinion, you will have proof positive that the defendant knew of the patent. And if the opinion looks and smells sound (albeit, in your view, incorrect), you may not want to waste resources on trying to prove willfulness. On the other hand, if the defendant maintains privilege and offers no opinion at trial, its privilege log will at least give you proof of when the defendant was aware of the patent, even though 35 U. S. C. §298 prevents you from using the lack of legal advice to prove willfulness.

It is a good bet that Inari will get cited to and considered by other judges in due course.  Time will tell whether Inari started a trend, or is just an outlier.