"Counsel, go stand in the corner until you figure out what 'collegiality' means."Mag Pole, Unsplash
Several District of Delaware judges have discovery dispute procedures that require parties to first file a letter stating that the parties have met and conferred but are unable to resolve some disputes, and list the disputes.
This usually works out well, but a few issues can occasionally come up with this procedure. For example:
One party refuses to meet-and-confer, forcing the other side to file solo.
The parties have met and conferred to death, but one party refuses to sign the the joint letter anyway (or just refuses to respond), solely for the purpose of delay.
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 seedsAI-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 mentioned back in October that Judge Hall was confirmed to the District of Delaware. Today, the Court started re-assigning cases from existing judges to Judge Hall. These arrive as a simple one-sentence docket entry:
Case Reassigned to Judge Jennifer L. Hall. Please include the initials of the Judge (JLH) after the case number on all documents filed.
The re-assignments involve cases at multiple stages, including past the close of fact discovery, and cases where Judge Hall was not previously involved as a magistrate judge.
One common question I see is "why did our case get re-assigned"? We can all speculate, but I'm not sure it's safe to read anything into a re-assignment like this beyond "our case was re-assigned …
We've talked a lot about "plain meaning" constructions, and how our judges havesometimespushedback 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 …
I have no idea what picture would go with this post. Enjoy some nice, royalty-free antelope.NEOM, Unsplash
Years ago, Judge Stark added language to his form scheduling order to resolve a common dispute: can an expert submit a declaration in support of summary judgment?
The language requires the parties to agree in advance, at the start of the case, whether they will permit this:
Expert Report Supplementation. The parties agree they [will] [will not] [CHOOSE ONE] permit expert declarations to be filed in connection with motions briefing (including case-dispositive motions).
Judge Stark has since moved up, but several D. Del. judges still use this language in their scheduling orders, including Judges Noreika, Hall, Burke, and …
The ITC is just, constantly issuing opinions. It's always "import this" and "don't export that." Frankly, I don't have the time for it.
That sands through the hourglass, so are the [copyrighted material redacted]Nathan Dumlao, Unsplash
On this historic day, however, Judge Wolson struck back against the relentless tide of ITC opinions. An act for which we at IP/DE will forever be grateful.
The issue came up in the context of a summary judgment opinion in Wirtgen America, Inc. v. Caterpillar, Inc., C.A. No. 17-770-JDW-MPT (D. Del. Jan 4, 2024) (Mem). The plaintiff there had previously prevailed at the ITC on one of the patents, and the ITC had issued (sigh) an exclusion order.
The plaintiff then moved for summary judgment of infringement, citing in support only the ITC's written decision. Judge Wolson, denied the motion:
The ITC’s decision is not factual evidence. It is, instead, a decision that weighs evidence and applies the law. Wirtgen’s reliance on the ITC decision as the sole evidence to support its argument means that I could deny the motion just for a failure of proof. But there are other problems as well.
Even if I treated the ITC’s decision as evidence, it would not suffice to carry Wirtgen’s burden. The decision is not binding on me. And the decision came in a different procedural posture. The ITC weighed the parties’ evidence and reached a conclusion, much like I would do after a bench trial. But, at this stage of the proceedings, I can’t weigh the evidence. Instead, I have to credit any contrary evidence that Caterpillar offers, and it has offered evidence . . .
Wirtgen, C.A. No. 17-770-JDW-MPT, at 10.
Let this serve as a reminder that we all have to keep fighting the good fight.
(Eds. Note - the ITC is actually pretty cool by the standards of IP courts and practitioners)
"Not invalid" may be a double negative, but it's definitely not the same as "valid."Markus Spiske, Unsplash
Chief Judge Connolly issued a short opinion this morning denying a motion for summary judgment that a patent was not patent ineligible, in C.R. Bard, Inc. v. Angiodynamics, Inc., C.A. No. 20-1544-CFC-SRF (D. Del. Jan. 3, 2024).
In short, the patentee had previously succeeded on the issue of § 101 ineligibility at the Federal Circuit, which reversed a lower-court finding of ineligibility and held that:
[T]he asserted claims in Bard’s three patents are directed to eligible subject matter under § 101.
C.R. Bard, Inc. v. Med. Components, Inc., C.A. Nos. 2022-1136, 2022-1186, 2023 U.S. App. LEXIS …
During our long break, when Andrew and I languished upon a beach, trading daiquiri recipes across a bridge table whilst a jazz band played Auld Lang Syne on repeat (they seemed quite uncomfortable in their tuxedos), Judge Bryson brought us an opinion with a new twist on an old PO dispute.
Is this what my life would be like were it not for the blog?AI-Generated, displayed with permission
The Plaintiff in Rheault v. Halma Holdings Inc., C.A. No. 23-700-WCB, was not a corporation. He was just a dude . . . named Rheault. The parties disputed whether Rheault could have access to all of the information produced by the defendants in the action, or if there should be some separate attorney's eyes only tier that he was not privy too.
As Judge Bruson noted, a dispute about whether a particular person should have access to the most confidential documents usually depends upon whether that person is a "competitive decisionmaker."
The question whether a particular individual should be allowed access to highly confidential materials has arisen in a number of cases. Such cases often involve the question whether certain employees of a party, such as in-house counsel, should be permitted access to materials with that designation. The answer to that question typically turns on whether the employees in question are involved in competitive decisionmaking on behalf of the party. If so, those employees are typically barred from having access to materials designated as highly confidential. If not, they are often allowed access to those materials.
Rheault v. Halma Holdings Inc., C.A. No. 23-700-WCB, at 2 (D. Del. Dec. 22, 2023) (Mem. Op.)
Here, however, Rheault was a guy. Presumably he makes his own day to day decisions about whether to go to Arby's or Fudruckers (Arby's), but he wasn't involved in the operation of any particular company (the dispute actually centered upon the contract selling his company to the defendants).
Judge Bryson found this point dispositive, at least in the absence of any evidence that he would rejoin the market imminently and compete with the defendants:
Given that there is no evidence that Mr. Rheault intends to resume activity in his former field of business and that the defendants have not shown any other reason why Mr. Rheault should be denied access to the materials designated as “Highly Confidential—Attorneys’ Eyes Only,” I conclude that the defendants have not satisfied their burden of showing entitlement to the restrictive protective order they have requested.
Merry Christmas and happy holidays to all! We'll be taking a break from posts for a bit as, historically, activity has been slow for the week between Christmas and New Year's. We'll see you in 2024!
The District of Delaware's Default Standard for Discovery requires contentions in patent cases.
One common Delaware counsel question is: what level of detail is required for contentions?
The answer varies on what the concern is. There is a certain level of detail that will probably preclude the Court from ordering you to supplement your contentions—but providing just that bare level of detail may not be enough to preserve all arguments that you later want to make.
On Monday, Judge Burke denied a motion to strike invalidity contentions where a party had disclosed an obviousness theory as to a patent based on modification of a prior art reference, but had not disclosed their intent to cite and rely on their own product as evidence that the modification was obvious.
The plaintiff had moved to strike the discussion of the defendants' own product from their expert reports, on the theory that their contentions failed to to disclose their intent to use that product in their obviousness analysis. Judge Burke denied the motion, and explained that a party need not disclose all evidence in support of its contentions:
Although this is a difficult issue, the Court is not prepared to say that Defendants' actions amounted to an untimely disclosure. This is because Defendants have affirmatively represented that they are not relying on the direct aortic Engager system as prior art itself; instead, they rely on it only as a piece of evidence that will be used to "show that a direct aortic version would have been an obvious modification to Engager 3.0 at the relevant time." (D.I. 361 at 2) In other words, Defendants are relying on the system simply as evidence in support of a theory that was itself timely disclosed. And as Defendants note, courts generally hold that: (a) in validity-related or infringement-related contentions, a party is not required to cite to every piece of evidence that will be used to support a given theory; and (b) it is proper for an expert to expand upon such theories in his expert report. . . . The Court also notes that it is not as if Plaintiff had zero prior knowledge of the existence of the [Defendants'] system. As Defendants point out, they produced documents in discovery regarding this system, and their engineers testified at some length about the device during depositions. . . . (4) In light of the above, the Court cannot say that Defendants' conduct amounts to untimely disclosure that should be stricken.
Speyside Medical, LLC v. Medtronic CoreValve LLC, C.A. No. 20-361, D.I. 447 (D. Del. Dec. 18, 2023).
In my view, the Court is not saying that no evidence at all needs to be disclosed in support of the contentions—just that this particular evidence went beyond what was necessary, under the facts of the case.
This blog is for general informational purposes. It is not an offer to perform legal services, and should not be considered a substitute for legal advice. Nothing in this blog should be construed as forming an attorney-client relationship. If you have legal questions, please consult counsel in your jurisdiction.
![That sands through the hourglass, so are the [copyrighted material redacted]](https://bd6f.s3.amazonaws.com/media/images/nathan-dumlao-5Hl5reICevY-unsplash.max-640x360.webp)
