Oral Argument Before the CAFC
Elysium got its day in Court before the US Court of Appeals for the Federal Circuit this morning, and you get to hear the 30-minute recording:
This is a soon-to-be-failed bullshit appeal of Elysium's already-failed bullshit challenge to ChromaDex's pharmaceutical patent, the '086 Patent.
The '807 Patent, which covers health supplements like Niagen and Basis, is not being challenged.
We already covered the points being considered on appeal when we reviewed Elysium's Opening Brief, ChromaDex's Opposition Brief, and Elysium's Reply Brief. In short, the question is what does the word "isolated" mean in a patent of "isolated nicotinamide riboside."
The court below (Patent Trial and Appeal Board, or "PTAB") said that it didn't know exactly what "isolated" meant, but it had to at least mean the composition of the patented formula must contain more than an insignificant amount of NR, and anything less than, say, 25% would not be isolated.
The problem Elysium is facing on appeal is that they need to show that NR is isolated when it appears in its natural form as skim milk or buttermilk. But it isn't isolated from the milk, so what is it isolated from -- the cow?
The problem ChromaDex is facing on the appeal is that the "25%" is drawn from a slightly different part of the specification -- it wasn't exactly there for that purpose, and it seems kind of arbitrary -- so even if ChromaDex should win on some definition of "isolated," why shouldn't the CAFC remand to the PTAB to try again to find a better reason for why Chromadex wins? Essentially, the CAFC would be saying, "We agree that you win, but we're not sure what is the best reason, so why don't we all spend another remand-and-appeal cycle figuring that out."
That would be a problem for ChromaDex because ChromaDex has already spent 2.5 years in this particular branch of the litigation -- the original challenge before the PTAB was filed in 2017. ChromaDex doesn't much care what the most perfect definition of "isolated" is -- any reasonable definition defeats Elysium's challenge based on milk -- because the source from which something is isolated can never already be isolated -- and ChromaDex just wants to be done.
The judicial voices you hear on the recording are the Appellate Judges randomly assigned to the case: Evan Wallach, Sheldon Jay Plager, and Kara Stoll. Elysium's case was argued by Jeremy Younkin of Foley Hoag. ChromaDex's case was argued by John Abramic, who was just named managing partner of Steptoe's Chicago office.
Elysium was basically dead in the first minute as a result of this exchange:
COURT: Dartmouth says that under your preferred construction of isolated if one milks a cow or if one skims fat off whole milk that one has isolated NR. Is that a fair characterization of your proposed construction?
ELYSIUM: Yes, Your Honor. We do believe that skim milk falls within the scope of Claim 2, that it's covered by it.
COURT: And milk coming out of a cow has been isolated?
ELYSIUM: It certainly could be, Your Honor. We are not pressing that argument on appeal, and I don't think the Court needs to get there in order to resolve this issue.
COURT: It's not a question of needing to get there. If we're there, I think that's problematic.
[Elysium next makes a bullshit argument that because ChromaDex didn't challenge the PTAB's adverse ruling on Claims 1 and 3-5, then the Court must assume that milk can be prior art sufficient to invalidate the patent. I won't go into the legalese around why this is a bullshit attempt at judicial estoppel, but the Court was having none of it.]
COURT: It all comes down to the meaning of "isolated." As I understand it, you're relying on the breadth of a broad definition that says something to the effect of , "As used herein in this specification, the word "isolated" means _____, and it's broad.
ELYSIUM: Yes, Your Honor.
COURT: And that's what you're relying on. And you think we should NOT consider anything else in this specification then, including the repeated examples which say that the NR can be isolated from milk.
That's a tough start for Elysium.
Ten minutes later, they got this:
CHROMADEX: It is impossible to read a claim that calls for NR that's isolated from a natural source [milk] on the source itself from which you isolate the NR... COURT: They want you to read it onto the cow.
CHROMADEX: If you look at their reply brief, we argued that there's no way that you can read this on milk that comes from a cow. And if you look at their response in their reply brief, they say, "No, no, no, we're not talking about whole cow's milk. We're talking about processed milk here." They're trying to draw a line between cow's milk and processed milk. Why? Because the prior art is skim milk and buttermilk. That's processed milk. But today you heard a response where they were waffling a little bit about whether "Isolated NR" would cover whole milk coming from a cow --
COURT: I don't think it was a waffle. It was conceded.
CHROMADEX: ...This line that they are trying to draw between processed and unprocessed is just silly.
COURT: I think he might have even admitted today that in his view unprocessed milk would satisfy this claim. I believe that he admitted that.
CHROMADEX: I think he did say that today.
COURT: ...No matter what the claim construction is, it can't include milk.
CHROMADEX: ...Under their construction, you pick a banana off a tree and you've got yourself a natural source of NR. But if you peel that banana, it's no longer a natural source. One of the examples is eggs. Whole eggs from a chicken. You crack those eggs and remove the shell, and all of a sudden that's processed, and it's not a source. Meats is another one. Presumably under their construction any sort of butchering of the meat --
COURT: You're beating this horse to death. Whether it's skinned, or not.
CHROMADEX: But the reason I'm beating this horse to death is that -- and this goes to the point that Your Honors made about what the appellants have called the alternate construction. And I think appellants have kind of mischaracterized this alternate construction. Because what the Board said was, 'Okay, if you don't like the 25% limitation we still have no anticipation.' Why is that? Well you heard the appellants say that there's a portion of the specification that says when you isolate NR from milk you have to get rid of all these other components, so that means it has to have a high purity level. But that's not what the Board said in its alternate interpretation. What the Board said is..."The NR present in skim milk is not isolated because significant components remain after the fat is removed." So what the Board is saying is that if you don't like the 25%, we know that there has to be something more than an insignificant amount. And there is no evidence that the prior art has anything more than an insignificant amount. And how do we know that? Dartmouth submitted evidence in its brief...that whole milk has .0001097% NR..."
So you can see that the Court has no affection for Elysium's argument for overturning the PTAB, nor should they.
Still, the Court has to figure out what to do. Should they uphold the 25% construction, or the alternate construction, or what?
COURT: "...If we conclude the PTAB's claim construction is not supportable because they incorporated the 25% from an inappropriate part of the written description, can we still find that they were correct on their anticipation ruling, and if so, how?"
CHROMADEX: "Absolutely. Two different ways..."
The first way is that to rule that no matter what "isolated" means, as a matter of law you can't read anything as being "isolated" from itself. So if the patent says that NR has to be isolated from milk, then milk cannot also BE isolated NR.
The second way is through the alternate construction -- there has to be some level of isolation, and it has to be more than insignificant, and there is no evidence that there is significant NR in milk.
COURT: If we don't like the claim construction, don't we have to send it back to the PTAB and say, 'Your claim construction doesn't work; re-think it"? Or can we just go ahead and adopt their anticipation ruling?
CHROMADEX: You can adopt their anticipation ruling for those two reasons that I just said...
Elysium returns in rebuttal to try to rescue its position, but with no apparent success. At one point, the Court makes a joke -- "Your view is that they've milked that for all its worth?" -- which apparently went right over Elysium's head. "That's better than udderly," the Court added.
But time was up. And then in a twist ending that illustrated the value of having judges who are smart, wise, and learned enough to effectively preside over the matters before them -- rather than cronies and political hacks -- the Court said:
COURT: Time's up. I would commend counsel -- I don't know if you're familiar with it, but I would commend you both to the actual history of Dr. Goldberger. He is a fascinating character.