This week, Judge Bryson issued his findings of fact and conclusions of law following trial in Janssen Pharmaceuticals, Inc., v. Tolmar, Inc., C.A. No. 21-1784-WCB (D. Del. Feb. 26, 2024), and ANDA action. The opinion is long and thorough, and I thought the section on enablement was worth noting.
The patent at issue covers a "dosing regimen" for giving an anti-psychotic drug "to a psychiatric patient in need of treatment for psychotic disorder." According to the method, two loading doses of the drug are given, and then a maintenance dose is given between 21 and 38 days later (a "17-day window").
Defendant argued that the patent was not enabled, first because a person of …
Shh. They're not "invalid," they're "canceled" and "in the public domain"Kristina Flour, Unsplash
Yesterday Nate wrote about Judge Bryson's opinion that a plaintiff was not bound by its prior allegation that a product infringed two claims, because plaintiff's statement deals with an issue of law, not fact.
Today, I think it's worth discussing another aspect of the same decision, where Judge Bryson addressed a motion by plaintiff to preclude the defendant from discussing the same two invalid claims, claims 9 & 9 of the two asserted patents.
The the PTAB canceled claims 9 and 9 in an IPR, and plaintiff now asserts only claims that depend on those two canceled claims. It moved to prevent defendant from …
Lawyers are famously careful. We double-knot our shoes. We check the expiration date on milk, cheese, and even BACOS-brand non-bacon chunks. More than anything, we are famous for hemming and hawing and avoiding a direct response to seemingly simple questions in a transparent attempt to avoid saying something that might later be used against us.
This is a tale of one such admission that turned out alright.
So maybe don't worry so much.
DOOOOO - DO -DO -DO -DO - DA -DO -DO -DO -DO DOODLE-OOODLE DOOOOAI-Generated, displayed with permission
The initial complaint in Prolitec Inc. v. ScentAir Technologies, LLC, C.A. No. 20-984-WCB (D. Del. Jan. 12, 2024) (Mem. Op.) stated pretty baldly that the defendant infringed claim 9 of the patents-in-suit.
(Eds. note, for no sensible reason it was claim 9 of both patents. I spent about 15 minutes trying to figure out how best to parse that grammatically, briefly toying with "claims 9," like "attorneys general" before realizing I don't get paid for this and giving up).
There were claim charts and everything.
This is normally what you want in a complaint, really. You kind of have to accuse them of infringement after all. The difficulty is that claims the ninth (?) were both invalidated at IPR and so the plaintiff was left to assert various dependent claims. They amended the complaint accordingly, removing any reference to the now-cancelled niners (?).
When it came to trial, defendant wanted to use the earlier complaint as evidence that their own products practiced all but the few extra limitations of the dependent claims, thus bolstering their invalidity and damages cases.
Plaintiff argued that the original complaint could not be used against it because it had been superseded (I sometimes see this called "rendered a nullity" which I quite like) by the amended complaint. Accordingly, they moved in limine to prevent those statements from being used against them at trial.
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.
Dauberts, especially of technical experts, are notoriously difficult. An error needs to be pretty blatant for the Court to find that it's not mere grounds for cross-examination. Moreover, it tends to be hard to find something useful to cite in a Daubert brief because the inquiry is often very fact-specific.
Thankfully we have Judge Bryson's opinion in Prolitec Inc. v. ScentAir Technologies, LLC, C.A. No. 20-984-WCB (D. Del. Dec. 13, 2023) (Mem. Op.), which sets forth a pretty bright line rule on a technical failure that warrants exclusion—failure to use a control in an experiment.
AI-Generated, displayed with permission
The specific experiment at issue was elegant in its awfulness. The claims required that the lid to a device have a "tortuous passage" that assisted in preventing leakage. To test if the accused product's tortuous passage prevented leakage, the plaintiffs' expert filled up the device, turned it on its side and checked for leaks. Finding none, he opined that the passage prevented leakage.
Judge Bryson noted the obvious flaw in this test and excluded the experts opinion:
ScentAir’s third and most telling objection is that Dr. Hultmark did not also test a device similar to the Breeze cartridge but lacking a tortuous passage, in order to determine whether that device would leak when filled 45 percent full of fragrance oil and placed on its side . . . .Given that there was no control for Dr. Hultmark’s test, the fact that the Breeze product did not leak under those conditions does not show that it was the tortuous passage in the Breeze cartridge that was responsible for the absence of leakage. Because Prolitec has failed to provide a satisfactory answer to this flaw in Testing Configuration 1, I find that the evidence regarding that test would not be helpful to the jury, and the evidence will therefore be excluded.
Id. at 28-29.
That's about as straightforward a Daubert ruling as I've ever seen. I'll hope to cite it myself soon (enemies beware!)
Speaking of clever procedural manuevers, here's the "fish tank" my loving wife got me when I asked for oneAndrew E. Russell, displayed with permission
Judge Bryson issued an opinion today in Michael R. Cahill, Trustee of the Hunt Irrevocable Trust v. Air Medical Group Holdings, Inc., C.A. No. 21-679-WCB (D. Del. Oct. 16, 2023). In it, he describes a clever procedural maneuver that failed, but resulted in a positive outcome anyway.
The case involves an breach of contract claim affirmative claim and counter-claim. The Court granted summary judgment for the plaintiff on their affirmative claim, holding that it was time-barred under a provision of the contract that set out a time for bringing claims.
Judge Bryson recently unsealed his opinion in Janssen Pharmaceuticals Inc. v. Tolmar, Inc., C.A. No. 21-1784-WCB (D. Del. Sept. 8, 2023), in which he grants summary judgment of no anticipation by a reference under (Pre-AIA) § 102(a).
As a reminder, pre-AIA § 102(a) covers prior art that was available "before the invention" of the patent.
Here, the plaintiff argued that it had reduced the invention to practice before the date of the prior art. The defendant responded that, sure, they reduced an embodiment to practice before the prior art, but they didn't conceive of the invention's full scope:
Tolmar does not appear to dispute that the June 2007 clinical trials practiced …
Lawyers, especially patent lawyers, are artists in the medium of obfuscation. Much of the job is finding the fuzzy areas at the edges of seemingly straightforward language and tugging at them to suit your needs. At best, it leads to moments of mad brilliance that Van Gogh might envy.
So it was in the case (fast becoming one of my favorites in the district) of a Markman dispute in Impossible Foods Inc. v. Motif Foodworks, Inc., C.A. No. 22-311-WCB (D. Del. Aug. 15, 2023).
Person, cow, not cow, camera, tvAI-Generated, displayed with permission
The term in question was "non-animal."
As you probably gathered from the caption, the patent covered various fake meats (Facon, Soysauge, Ham-pty promises) with "non-animal" ingredients.
Being naturally averse to spoilers, I read the opinion until I got to the disputed term, and then stopped to ask myself "what could the dispute possibly be?" before peaking into the parties' arguments. I sat there a full 10 minutes before shaking my head and giving up.
As it happens, it was more reasonable than it looks at first blush. Impossible argued for the definition I'd immediately jumped to—not from an animal (or in the parlance of lawyers "derived from a non-animal source"). Motif's position, however was that the particular ingredients had to be chemicals (here, proteins) that were "not naturally present in animals" as opposed to merely not harvested from animals in this instance.
Judge Bryson ultimately sided with Impossible for boring science and law reasons. But game recognizes game, so I felt obliged to call out this impressive little dispute. I hope you readers are as inspired as I was.
You don't get to pick your jobs in the P.I. biz. A good gumshoe takes what walks in the door, and the only questions he asks are "how much?" and "permanently?" The only answer he'll take is a raised eyebrow and and that money gesture when you rub your thumb against two fingers.
Hamburglar was of the old school. 40 years ago he had a reputation that could make a clown go back into his little car with all his friends and drive off without so much as a honk. When the doc said his arteries were starting to look looked like string cheese, he put that all behind him - hung up his shingle and started trying to solve …
We try to keep it light here at IP/DE, but sometimes I actually learn something and I feel sort of obliged to pass it on. You know, some real dark arts stuff that I wouldn't have known if I didn't have to read absolutely everything written in the district for this blog.
AI-Generated, displayed with permission
Today's bit of lore today is about damages, and a split amongst district courts that visiting Judge Bryson has taken a stand on. Can a corporate parent can claim lost profits that would have initially accrued to its subsidiary?
The trite answer to this is "no." The Federal Circuit has squarely held that "a patentee may not claim, as its own damages, the lost profits of a related company." Warsaw Orthopedic, Inc. v. NuVasive, Inc., 778 F.3d 1365, 1375 (Fed. Cir. 2015). However, as Judge Bryson pointed out in his opinion in Kaneka Corp v. Designs For Health, Inc., C.A. No. 21-209 (D. Del. Mar. 3, 2023) (Mem. Op. & Order), several courts have held that lost profits of a subsidiary can still be claimed if they flow "inexorably" from the subsidiary to the parent.
Judge Bryson agreed, stating
To be sure, the Federal Circuit has not expressly recognized that lost profits can be awarded when those profits flow inexorably from a subsidiary to the patentee . . . I find the weight of district court authority on that point to be ...
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