A Blog About Intellectual Property Litigation and the District of Delaware


Entries for date: 2025

Some Quick Data Points on Sufficient Facts to Allege Willfulness in a Complaint

Andrew E. Russell, Oct. 3, 2025
Willfulness MTD

I have no idea what image would go with this, so here is a mildly interested chipmunk.
I have no idea what image would go with this, so here is a mildly interested chipmunk. Andrew E. Russell, displayed with permission

Yesterday, Judge Andrews granted two motions to dismiss willfulness allegations for a failure to allege knowledge. The orders are short and sweet, and provide some examples of the kinds of allegations that are not sufficient to allege knowledge of the asserted patent in support of a willfulness claim.

First, in New Directions Technology Consulting, LLC v. Abbott Laboratories Inc., C.A. No. 25-506-RGA (D. Del.), the Court granted the willfulness portion of a motion to dismiss in just three sentences:

The motion to dismiss the willfulness allegations is GRANTED. Alleging that employees of Defendants attended a 2016 presentation on the topic of "Benefits of IP Partnering for Drug Delivery Telemanagement" provides no factual basis for an allegation of willfulness. Nor does the allegation that in 2021 an online article "Patents are Important for Smart Healthcare Products"-- described the patents and that Defendants subscribe to the online publication.

New Directions Technology Consulting, LLC v. Abbott Laboratories Inc., C.A. No. 25-506-RGA, D.I. 18 (D. Del. Oct. 2, 2025).

This decision was quick, issuing less than two motions after the motion to dismiss, although it only addressed the motion in part. The Court referred the motion's remaining allegation re: § 101 to Magistrate Judge Tennyson.

The Court also issued an uncommonly ...

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Biologic, My Shipmate

Nathan R. Hoeschen, Oct. 2, 2025
Biologics Safe Harbor

Sailing is one of those endeavors that really make you respect the ancestors. As a kid (and indeed, a thirty-something) it seemed like a simple matter or pointing a sheet in the wind to go forward. Then you actually go on one of these crazy things and—even setting aside the knots—there's this mad calculus that goes into what turns where when that somehow makes you best off when you're perpendicular to the actual wind. Real witchcraft.

Ludomil Sawicki, Unsplash

This, of course, brings us to one of my favorite areas of patent law, the safe harbor provision. For those, less familiar, Judge Barker's opinion this week in Merus N.V. v. Xencor, Inc., C.A. No. 24-913-JCB, D.I. 35 (D. Del. Sep. 30, 2025), gives a good overview.

Briefly, 35 U.S.C. § 271(e)(1) allows one to make/use/etc, a patented invention "solely for uses reasonably related to the development and submission of information under" a qualifying regulatory regime. This most often comes into play in the ANDA context where the generic manufacturer can use the otherwise patented drug to perform the necessary studies to submit their ANDA to the FDA.

The situation is somewhat more complicated in Merus. The patents there

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“Whoops, we forgot to put the basis for the motion in the brief.”

Andrew E. Russell, Oct. 1, 2025
Letter Briefs Legal Writing

"Did I forget to say why we should win the motion?" AI-Generated, displayed with permission

When you're drafting a brief, it can easy to get bogged down in all of the in-the-weeds counter-arguments and surrounding issues, and to kind of forget about the main point you need to make.

Years ago, in a patent case, I wound up needing to write three initial drafts of three summary judgment briefs in a week. Fun, right? The first two came together OK. The third one, not so much. It was a complicated motion involving many potential counter-arguments.

I remember thinking the initial draft was pretty good when I clicked send on the e-mail attaching it. How could it not be? In just …

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Made Special, Just For You

Nathan R. Hoeschen, Sept. 30, 2025
Contributory Infringement

Anyone who's been a lawyer long enough to read blogs about will have purchased some custom-made legal accessories. A monogrammed briefcase is a classic, as are cuff links and (for the daring) a bolo tie. The especially theatrical amongst you might get a cape, walking stick or dark altar. The important thing is that it fits, and is monogrammed.

I wasn't sold on the dark altar, but it actually came with a monogrammed cape, so...
I wasn't sold on the dark altar, but it actually came with a monogrammed cape, so... AI-Generated, displayed with permission

This of course, naturally leads me to contributory infringement and especially whether a product is "especially made or adapted for use" in an infringing process and not "suitable for substantial non-infringing use."

This analysis is often factually intense, but it doesn't …

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Opinion: Why You Usually Shouldn't Accuse Opposing Counsel of Dishonesty or Bad Faith

Andrew E. Russell, Sept. 29, 2025
Letter Briefs KB

Lying
Joshua Hoehne, Unsplash

As we mentioned recently, there was some discussion at the 2025 D. Del. Bench and Bar about the role of Delaware counsel. We may have a more detailed post about that at some point in the future. But today I wanted to offer some thoughts on one specific thing that good Delaware counsel does: avoiding allegations of dishonesty or bad faith.

Most Delaware counsel tend to be involved with filings of one type or another. Under the Local Rules, association with Delaware counsel is required, and Delaware counsel must be the registered users of CM/ECF.

In practice, that means we handle a ton of filings, typically drafted by out-of-state co-counsel. Delaware counsel's level of involvement …

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Notes from the 2025 D. Del. Bench & Bar

Andrew E. Russell, Sept. 28, 2025
DED

District Court Seal

Whew! The 2025 District of Delaware Bench and Bar conference wrapped up on Friday (has it really been two years!?). It was a wonderful event, as always, and the organizers did an amazing job. All of the panels were great, but I particularly enjoyed Judge Andrews' incredible interview of Judge Bryson (and I heard the same from others).

The conference was especially fun for me this year, because I received a lot of in-person feedback about this blog. Thank you all!! One request was to keep our posts short, and I'll try to do that today.

For anyone who missed it, here are some notes from the conference, organized loosely by topic:

Judges, Visiting Judges, & the Court …

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Use This One Simple Trick to Not Get Your Summary Judgment Motion Instantly Denied, Pt. 2

Andrew E. Russell, Sept. 24, 2025
Concise Statement of Facts Summary Judgment

I will, in fact, die on this hill—at least until something from the Court shows I'm wrong.
I will, in fact, die on this hill—at least until something from the Court shows I'm wrong. AI-Generated, displayed with permission

Last year we had a post entitled "Use This One Simple Trick to Not Get Your Summary Judgment Motion Instantly Denied." That post related to motions before judges who require a concise statement of facts with summary judgment motions. The "one simple trick" was that, rather than including a long list of atomic facts like "x said this at deposition" and "lines x:xx - y:yy of the patent specification say z," you state the actual material fact that you are relying on and cite those atomic facts as support for the broader fact.

Beyond that, your concise …

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Throwback . . . Thuesday . . .

Nathan R. Hoeschen, Sept. 23, 2025
Interference

As a man of letters, I am often astounded by the power of certain small and simple expressions to remain in the general consciousness for decades.

Why does taco Tuesday still ring so true? Any number of callow admen must have attempted to start Fish Friday (a natural choice for many reasons), macaroni Monday, or Waldorf Salad Wednesday, yet all of these efforts are long forgotten.

Will any of us recognize the next great cultural alliteration when it arrives, or will it be known only in history's telling?

saracohenn, Unsplash

All of this is only in reference to the title, so if you've read it so far please see me for a coupon redeemable for a discount at any …

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Don't Fall Into the Late-Daubert Trap

Andrew E. Russell, Sept. 22, 2025
FRE 702 Daubert

Don't be late...
Don't be late... Man Holding Handbag, Andy Beales, Unsplash

In the District of Delaware, Daubert motions (i.e., motions to exclude expert testimony under FRE 702) are normally due at the same time as case dispositive motions, and often share a page limit.

This makes a lot of sense, since Daubert motions are often more or less dispositive of central substantive issues in the case. Sometimes, if the party cannot present expert testimony on a particular substantive issue, they essentially just lose (although for other things, not so much).

Often, parties will present their primary Daubert issues at the deadline, only to realize later on that there are other lingering issues that fit the Rule 702 case law. …

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Court Permits Accused Infringer to Re-Raise Failed § 101 Argument at Trial

Andrew E. Russell, Sept. 19, 2025
Trial Motion to Dismiss

How many attorneys would have made the choice to re-assert <a href='#' class='abbreviation' data-bs-toggle='tooltip' data-placement='top' title='35 U.S.C. § 101: Inventions patentable'>§ 101</a> at trial after conclusively losing on that issue at the <a href='#' class='abbreviation' data-bs-toggle='tooltip' data-placement='top' title='Motion to Dismiss'>MTD</a> stage? Not many, I'm guessing.
How many attorneys would have made the choice to re-assert § 101 at trial after conclusively losing on that issue at the MTD stage? Not many, I'm guessing. Oliver Roos, Unsplash

I still remember when, as a first-year associate (circa 2009), a senior attorney explained to me that courts will not hold a patent "valid," and instead will normally only say that it is "not invalid." It seemed like a bit of a silly distinction at the time, but it actually makes perfect sense, and it has come up again and again in my practice since then.

Courts do not typically hold that a patent is "valid" because that would suggest it is impervious to future challenges. Instead, courts often hold that a patent is "not invalid," i.e., that the moving party in a case before the Court failed to show that the patent was invalid due to some circumstance. That language recognizes that another party on another day might yet prove the opposite: that the patent is invalid.

This came up recently in Laboratory Corporation of America Holdings v. Natera, Inc., C.A. No. 21-669-GBW (D. Del.). In that case, the defendant had originally brought a motion to dismiss on § 101 grounds, and Judge Stark denied it. Id., D.I. 28 at 7.

Now, almost four years later and in the lead-up to trial, the plaintiff moved in limine to preclude the defendant from re-raising its failed § 101 argument:

Plaintiff "seeks to preclude Natera from presenting argument or evidence regarding patent eligibility of the Asserted Patents under § 101." . . . Plaintiff contends that such preclusion is warranted because (purportedly) "[t]he Court has already spoken on patent eligibility and has ruled that the Asserted Patents are directed to eligible subject matter."

Id., D.I. 325 at 4.

The Court denied the motion, and will permit the defendant to re-raise its § 101 argument at trial. The Court offered ...

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