A Blog About Intellectual Property Litigation and the District of Delaware

The Honorable Sherry R. Fallon

As defenses go, there's few better than "I don't infringe." Unfortunately, it's quite difficult to prove at the motion to dismiss stage. It is, after all, the rare complaint that contains the dark seed of its own demise on this front.

mmm . . . dark seeds
mmm . . . dark seeds AI-Generated, displayed with permission

You might think that a motion to dismiss based on non-infringement would be a little bit easier in the ANDA context. After all, you have this giant document listing everything in your product and what it does. You would be wrong.

Such was the lesson of Judge Fallon's opinion in Allergan, Inc. v. Mankind Pharma Ltd., C.A. No. 23-272 (D. Del. Dec. 21, 2023), unsealed last week. The patent there required (amongst dozens of assorted buffers, reagents, uppers, downers, and excipients) a phosphate buffer. The defendant responded by pointing out that none of the 3.2 trillion ingredients listed in their ANDA contained any phosphorus.

(Eds. Note—for the liberal arts majors amongst you, phosphorous is a pretty big part of anything "phosphate")

They thus moved for judgment on the pleadings of no literal infringement, reasoning that the ANDA controlled the infringement inquiry. Judge Fallon denied the motion however, holding that it was possible future evidence might contradict the ANDA:

Mankind Pharma insists that the ANDA specification controls the infringement inquiry. However, the case law cited by Mankind Pharma in support of this proposition explains that the infringement inquiry is based not only on the ANDA filing, but also on "other materials submitted by the accused infringer to the FDA, and other evidence provided by the parties." The Federal Circuit explained "[i]t is ... possible, at least in theory, that other evidence may directly contradict the clear representations of the ANDA and create a dispute of material fact[,]" even if "[s]uch circumstances [are] unlikely to arise in practice[.]" Consistent with this recitation of the applicable standard, each case cited by Mankind Pharma was decided on a fully developed record, either on summary judgment or following a bench trial.

Allergan, Inc. v. Mankind Pharma Ltd., C.A. No. 23-272, at 5-6 (D. Del. Dec. 21, 2023) (internal citations omitted).

This case follows several similar decisions in the district, Novartis Pharmaceuticals Corp. v. Alembic Pharms. Ltd, C.A. No. 22-1395-RGA, 2023 WL 6387975, at *5 (D. Del. Sept. 29, 2023) and InfoRLife SA v. Sun Pharm. Ind. Ltd, C.A. No. 21-1740-WCB, D.I. 153 at 4-5 (D. Del. Nov. 21, 2022), which the opinion discusses at some length. Neither of those cases however were quite as factually stark as the one presented here, where the claims clearly require phosphorus, and the ANDA includes . . . no phosphorus.

We've talked a lot about "plain meaning" constructions, and how our judges have sometimes pushed back against parties who offer plain meaning constructions without any indication of what the actual meaning of the term is.

Magistrate Judge Fallon issued an R&R today on an offshoot of this issue. In PPC Broadband, Inc. v. Charles Industries, LLC, C.A. No. 22-1517-GBW-SRF (D. Del. Jan. 8, 2024), the parties disputed the construction of only a single term, "drop cable." Plaintiff proposed not construing the term at all, and offered a generic definition as an alternative. The defendant proposed a specific construction that added limitations to the claim.

The patent at issue is directed towards a wall-mounted box that …

Any time someone moves to withdraw, the question is: Will the client be able to convince the next set of lawyers that the client will pay?
Any time someone moves to withdraw, the question is: Will the client be able to convince the next set of lawyers that the client will pay? Micaela Parente, Unsplash

Having to move to withdraw because a client won't pay is the absolute worst. You have ethical duties to your client, but you can't work for free. You are stuck in a position where you need to tell the Court enough that it will let you out—but you can't tell it everything without violating the ethics rules. The local rules also place some procedural hoops in the way of a motion to withdraw. It's tricky!

Even worse is when the other side opposes your withdrawal, because then you are potentially …

The Delaware bar lately, arguing over redactions to discovery dispute letters
The Delaware bar lately, arguing over redactions to discovery dispute letters Hasan Almasi, Unsplash

Based on the redaction disputes I've seen in couple of cases lately, some of us here in Delaware have forgotten that the high Avandia standards for access to public materials do not apply to discovery dispute letters and their attachments, as Judge Fallon confirmed last month:

[T]he common law right of access does not extend to discovery motions and supporting materials because the "underlying discovery material itself is not a judicial record." Genentech, Inc. v. Amgen, Inc., C.A. No. 17-1407-CFC et al., 2020 WL 9432700, at *3 (D. Del. Sept. 2, 2020) (citing Leucadia, Inc. v. Applied Extrusion Techs., Inc., …

Drug patents are legion, and they are prone to flock together. In ancient times, a patent would describe A molecule that cured . . . the dancing plague (?) and that would be the end of that. But one bright fellow after another came up with new ways to extend the life of a drag patent, from formulation, to method of treatment, to the new hip thing -- interaction patents.

The gist of these patent claims is pretty basic

  • You've got a drug that you normally give in amount A.
  • You've got atypical patient with whose taking drug B, or has condition C (these pretty much always have something to do with the liver, don't ask me why, I was …

Andrew Russell

When a party asks to do something outside of the time limits set by the scheduling order, the Court looks to whether there is "good cause" under FRCP 16(b)(4) to modify the scheduling order. Good cause requires diligence, generally meaning that the movant could not have reasonably met the deadline it's trying to move.

Last week we got two examples of diligence analyses from the Court, one that found that a party was diligent, and one that didn't. I thought it would be interesting to line them up and compare them.

"Immediately" = Good Cause

First, Judge Fallon found good cause where a plaintiff sought to depose a third-party witness after the close of fact discovery, after the …

It begins with a series of interminably long emails. I say that you really should be producing these documents—I cite cases, exhaustively describe the items sought, and cite check the whole thing like it's headed to the Supreme Court. You respond by pointing out that I am just hopelessly misguided, and have perhaps been drinking. You also cite cases.

Eventually everyone gets on the phone to hash things out. Two hours later you agree to take my positions "under advisement" and call it a day.

Meet and confer accomplished.

Why is this one so creepy?  It's just supposed to be werewolves shaking hands
Why is this one so creepy? It's just supposed to be werewolves shaking hands AI-Generated, displayed with permission

It's not always that bad, but there is definite potential for one or both parties to drag the process out. It's rare to see any consequences to this sort of slow-rolling, as it's usually invisible to the Court.

Every now and then, though, someone gets called out for it, and yesterday was one of those days. The dispute in TwinStrand Biosciences, Inc. v. Guardant Health, Inc., C.A. No. 21-1126-GBW-SRF (D. Del. Apr. 24, 2023) (Oral Order) was your usual request that a party supplement an interrogatory. Judge Fallon granted the motion, but took the unusual step of noting the somewhat tortured history of the parties' correspondence

Guardant's second supplemental response to Interrogatory No. 6 provides some of this information for only one of the Asserted Patents. Guardant represented that it would produce and identify documents responsive to the Interrogatory under Fed. R. Civ. P. 33(d) as discovery continued. Guardant's responses to Plaintiffs' requests for supplementation of Interrogatory No. 6 during the meet and confer process suggest that Guardant may have additional responsive information that has not yet been disclosed. (As of March 17, 2023, Guardant represented it "will provide our position or a supplementation in due course"); (As of April 4, 2023, Guardant was "considering [Plaintiffs'] proposal and hope[s] to have a response soon."). Otherwise, Guardant could have put the matter to rest and avoided burdening the Court by simply confirming that it had no additional information responsive to Interrogatory No. 6.

The phrasing here is not quite a rebuke, but parties generally like to keep their name as far removed from ...

Cédric Dhaenens, Unsplash

Judge Fallon made an opinion public today that deals with whether a plaintiff can get discovery on unlaunched, abandoned, and future products in the lead up to a preliminary injunction hearing. The Court held that discovery on those products was not proportional to the needs of the case:

Zwift has shown that the document discovery requested by Wahoo is not proportional to the needs of the case at this stage of the proceedings. (D.I. 72) The complaint establishes that Wahoo was aware of Zwift’s unlaunched and abandoned hardware products, yet it did not raise these products in its motion for a preliminary injunction, indicating that the relevance of the requested discovery to the preliminary injunction inquiry …

A lot of things can go wrong in law. Keeping track of the labyrinthine tangle of laws, local rules, standing orders, and judicial preferences, is a daunting task. Checking and re-checking documents to make sure they comply with all of these rules is enough to make a person a bit neurotic. But, with the aid of experience and some hard lessons, you eventually come to grips with things and develop a certain comfort with the systems hard edges.

Until of course you stumble upon something new to worry about, and then you get the shakes all over again.

This cartoon is much darker than I intended, but I'm out of credits for the month
AI-Generated, displayed with permission

To that end, I submit to you this footnote in Cipla USA, Inc. v. Ipsen Biopharms., Inc., C.A. No. 22-552-GBW-SRF (D. Del. Mar. 1, 2023) (R&R), on the dangers of not checking your links:

In support of this assertion, Ipsen cites an "Update to Information Regarding Medicare Payment and Coding for Drugs and Biologics," dated May 18,2007. (D.I. 23 at 4 n.4) A document by the same name and having the same date is referenced in Cipla's complaint. (D.I. 1 at [Paragraph] 5c) To the extent that these documents are, in fact, the same, the court may consider them as "matters incorporated by reference" into the complaint without converting the motion to dismiss to one for summary judgment. See Kickjlip, Inc. v. Facebook, Inc., 999 F. Supp. 2d 677, 682 (D. Del. 2013). In this case, however, there are different hyperlinks associated with the document in the complaint and in Ipsen's reply brief. (Compare D.I. 1 at, 5c with D.I. 23 at 4 n.4) The hyperlink in the complaint functions, whereas the hyperlink in the reply brief does not. Ipsen does not set forth any basis for the court's consideration of the material, and the court cannot independently verify whether this material is the same as the document referenced in the complaint due to the defective hyperlink.

Id. at 7 n.4.

Oof. To Summarize here -- the defendant moved to dismiss and cited a document that was linked in, but not attached to, the complaint. The Court declined to consider it, because the link in the brief was ...

Split Cup
Tania Melnyczuk, Unsplash

Judge Fallon issued an order yesterday recognizing the split in the district court on how the judges handle IPR estoppel—specifically the question of whether IPR estoppel may apply to prior art products that are cumulative of patents or publications that could have been raised in the IPR:

ORAL ORDER . . . IT IS ORDERED that Plaintiff's motion to strike Defendant's amended invalidity contentions based on IPR estoppel is DENIED without prejudice. The parties dispute whether IPR estoppel should apply to Defendant's invalidity theories based on prior art systems, products, and/or knowledge. Under 35 U.S.C. § 315(e)(2), Defendant is barred from asserting an invalidity defense based on "any ground that [Defendant] raised or reasonably could …