[00:01:05] Speaker 04:
We will hear argument next in case number 181657 Thermalife International against GNC Corporation.

[00:01:47] Speaker 02:
Morning.

[00:01:48] Speaker 02:
May it please the court?

[00:01:50] Speaker 02:
My name is Bill Atkins.

[00:01:51] Speaker 02:
I represent Stanford University.

[00:01:55] Speaker 02:
The district court aired below by finding that there was a one gram threshold in the 459 patent.

[00:02:01] Speaker 02:
That claim construction was wrong for a number of different reasons.

[00:02:04] Speaker 04:
Suppose I did not really think that was a claim construction so that the issue isn't whether it found a one gram limitation in the 459, but rather that the 459

[00:02:14] Speaker 04:
claim requiring a certain kind of nitric oxide enhancement reaction, as a matter of fact in the world, required one gram, which I gather your expert testified to based on some public knowledge before the filing of the lawsuit.

[00:02:34] Speaker 02:
So there are three points I'd like to make in response to that.

[00:02:36] Speaker 02:
First of all, the expert was discussing mostly a post-filing.

[00:02:43] Speaker 02:
Filing of what?

[00:02:45] Speaker 04:
Post-filing the patent, but if it's not a claim construction issue, that's really pretty irrelevant What about it certainly wasn't post filing of the lawsuit?

[00:02:54] Speaker 02:
So in a reply brief what we put in was a 750 milligram hypothetical if you put in 750 milligrams Then you could conceivably not infringe claim one, but you could infringe a dependent claim 20

[00:03:08] Speaker 01:
But what if, so I think the point is that, you know, you probably understand this, but in infringement, there's the two parts, first, claim construction, second, comparing the properly construed claim to the accused vice.

[00:03:24] Speaker 01:
And here, how would that dependent claim be infringed if the independent claim is not?

[00:03:30] Speaker 01:
It doesn't make sense to me.

[00:03:32] Speaker 01:
There would be expert testimony saying, you know, the limitations of claim one can't be satisfied.

[00:03:38] Speaker 01:
unless there's one gram of L-arginine available.

[00:03:42] Speaker 01:
And so the limitation of claim one still would not be satisfied, even if the range limitation in the dependent claim was satisfied.

[00:03:49] Speaker 01:
So I don't understand your answer.

[00:03:52] Speaker 02:
So when does claim one actually get infringed, before the study or after the study?

[00:03:57] Speaker 02:
So let's just say for the sake of argument that the study that says one gram happens in 1999.

[00:04:01] Speaker 02:
The patent was filed well before that.

[00:04:05] Speaker 02:
So before that, there is infringement

[00:04:08] Speaker 01:
But afterwards there's no infringement?

[00:04:09] Speaker 01:
When I'm looking at the time of the filing of the patent to determine whether there's infringement, you look at the time of when the suit was filed, right?

[00:04:16] Speaker 01:
I understand your point for claim construction, but if it's a two-part process where the question of the one gram comes in the second step, then how can that, how do we look, why would we look at the filing of the patent to determine the timing of, instead of in claim construction?

[00:04:38] Speaker 02:
Yes, because you heard from the appellant just before us, if you change the claim terms over time, that's not fair.

[00:04:46] Speaker 02:
And what you're doing is applying, I realized you're talking about the second step.

[00:04:50] Speaker 02:
But the truth of the matter is that you can't infringe before and then all of a sudden you do it.

[00:04:56] Speaker 02:
I'm sorry, that's backwards.

[00:04:58] Speaker 02:
You can infringe before.

[00:05:00] Speaker 02:
And then when there's a study that says, oh, Eureka, one gram is not effective, then that becomes non-infringing.

[00:05:08] Speaker 01:
Why not?

[00:05:08] Speaker 01:
Experts make admissions all the time.

[00:05:10] Speaker 01:
Things happen at trial.

[00:05:12] Speaker 01:
Facts come out and they impact that second step of the infringement analysis.

[00:05:16] Speaker 02:
Because, well, for starters, you're talking about the effective amount, the prophylactic dose and effective amount.

[00:05:23] Speaker 02:
If you're talking about that effective amount, what you're saying is that over time that can change, right?

[00:05:30] Speaker 06:
Well, the views of experts as to what the effective amount can certainly change

[00:05:36] Speaker 06:
And as Judge Stoll says, that's a matter for the jury to decide whether they believe expert A or expert B based on the most recent science that they bring into the courtroom.

[00:05:46] Speaker 06:
Why is that?

[00:05:47] Speaker 06:
That isn't a claim construction issue.

[00:05:49] Speaker 06:
That's just a question of whether you've claimed efficacy and if the other side can prove inefficacy, they win.

[00:05:58] Speaker 02:
And if that efficacy is based on a study that comes out well after the patent, that's fine in your view.

[00:06:04] Speaker 02:
Because that's the second step in the infringement in the application of the properly construed claim to the accused products, or in this case, the method.

[00:06:13] Speaker 02:
Why not?

[00:06:15] Speaker 02:
But that effective amount was actually contrary to claim 20.

[00:06:22] Speaker 02:
It's contrary to the specification, the teachings of the patent, and everything from that time frame.

[00:06:29] Speaker 02:
The expert here said in 1993 when this patent was filed,

[00:06:33] Speaker 02:
They didn't know what the effective amount was.

[00:06:35] Speaker 02:
They didn't know precisely what the effective amount was.

[00:06:37] Speaker 01:
At the time of the filing of the lawsuit, they did know, and it was a specified amount, or at least according to that expert.

[00:06:42] Speaker 01:
That expert said it had to be at least one gram, right?

[00:06:47] Speaker 02:
Not at the time of the filing of the lawsuit.

[00:06:49] Speaker 02:
When was it?

[00:06:51] Speaker 02:
That testimony came up in the invalidity trial three years after the patent expired.

[00:06:55] Speaker 04:
Right, but in the fees proceeding, I don't remember.

[00:06:58] Speaker 04:
Tell me if I'm wrong.

[00:06:59] Speaker 04:
I'm sorry?

[00:07:00] Speaker 04:
In the fees proceeding, tell me if I'm wrong about this, I don't remember that there was any argument by your side that the knowledge that the expert attested to in the invalidity trial was not available at the time of the filing of the lawsuit.

[00:07:20] Speaker 02:
Not available at the time of the filing of the lawsuit.

[00:07:21] Speaker 04:
I think he relied on some sort of, was it some publication that

[00:07:27] Speaker 04:
Predates the filing of the lawsuit.

[00:07:29] Speaker 02:
It wasn't some so what the testimony was in a definite the guy's name the gentleman Sorry, the gentleman's name was Boger Bo ger Dr. Boger testified in deposition and at trial he was asked Hey, there's a piece of prior art.

[00:07:43] Speaker 02:
That's point two five two five milligrams Did you did you require more than point would point two five be effective?

[00:07:51] Speaker 02:
And he said no At trial he was pushed and said would point two five be effective

[00:07:57] Speaker 02:
Consistent with his deposition, he said no.

[00:08:00] Speaker 02:
He said no because the normal human body, according to his testimony, is four to six kilograms, not kilograms, of arginine.

[00:08:08] Speaker 02:
And he went up to .5.

[00:08:10] Speaker 02:
He said, what do you base that on?

[00:08:12] Speaker 02:
There are studies back at the time after filing of the patent, filing the patent, that say that that would be ineffective.

[00:08:20] Speaker 02:
He's then pushed for one question and said, well, what about one gram?

[00:08:25] Speaker 02:
And his testimony is fairly obtuse on that, but what he's getting at is he's talking about studies post-filing.

[00:08:32] Speaker 06:
Post-filing the patent.

[00:08:33] Speaker 02:
Post-filing the patent.

[00:08:34] Speaker 06:
But not post-filing the lawsuit.

[00:08:36] Speaker 02:
Correct.

[00:08:38] Speaker 04:
I think we should hear from Mr. Diasis since you used all your time including your rebuttal, but we will restore your rebuttal time.

[00:08:58] Speaker 00:
Thank you, Your Honor.

[00:09:00] Speaker 00:
Good morning, and may it please the court.

[00:09:01] Speaker 00:
Robert Gajosa from Latham and Watkins on behalf of Thermalife International.

[00:09:05] Speaker 00:
I want to go straight to the point that you raised, Judge Bryson, about the question of infringement being for the jury.

[00:09:10] Speaker 00:
And that highlights the error in this case, because the bifurcation that was pressed by the defendants effectively foreclosed any discovery on infringement, fact and expert.

[00:09:20] Speaker 00:
Yet after a five-day bench trial that occurred three and a half years after filing the suit, at that time, the district court found

[00:09:28] Speaker 00:
on dispute of fact that there was invalidity because there was a broad range covered by these claims.

[00:09:35] Speaker 06:
Right.

[00:09:35] Speaker 06:
But the problem here is that there was a lawsuit which was initiated where, at least as found by the district judge, substantial portions of which were inconsistent with known evidence about the amount required for efficacy.

[00:09:56] Speaker 06:
That's the way the district judge viewed it.

[00:09:58] Speaker 06:
So the problem is not that there was no opportunity to have a jury trial on the asserted claims or the level required for efficacy, but rather that it was brought, this lawsuit was brought at a time that was either known or should have been known, that the amounts at issue in many of these products were not sufficient to be effective.

[00:10:22] Speaker 00:
Well, Your Honor, it wasn't known.

[00:10:23] Speaker 00:
And we know that in two ways.

[00:10:25] Speaker 06:
Was it known as of 2013 when the filing of the lawsuit occurred?

[00:10:30] Speaker 00:
Correct.

[00:10:30] Speaker 00:
Because the standard here is whether or not you have a reasonable basis to file a suit.

[00:10:34] Speaker 00:
The artificial omniscience standard that's assigned to a Posita is not assigned to a patentee filing suit.

[00:10:40] Speaker 00:
They do not have to know of every single study.

[00:10:42] Speaker 00:
And what we had here at the outset of the case were three important facts.

[00:10:46] Speaker 00:
One was that the claim itself did not have any limitations.

[00:10:49] Speaker 00:
Two was that the Markman order from the prior case incurring any limitations.

[00:10:53] Speaker 00:
But most importantly, even putting aside the Woods declaration, what we have is Mr. Kramer's testimony, that he looked at the advertising materials, he looked at the ingredients list, and he compared them to the patent itself.

[00:11:05] Speaker 00:
And he said in his testimony that any dose for some of the patents would qualify.

[00:11:10] Speaker 00:
And importantly, because of the bifurcation, that was never tested in terms of infringement, but we do know

[00:11:17] Speaker 00:
that during the case.

[00:11:19] Speaker 04:
Am I right in thinking, this is my recollection, correct me if I'm wrong, that with the exception of claim three of the 006 and its dependent claims, all of the claims at issue required, let's just call it efficacy, the very same efficacy nitric oxide enhancement that was discussed in the 459.

[00:11:39] Speaker 00:
I believe it was just the 916 patent also required the sufficiency of the dose.

[00:11:43] Speaker 00:
The 874 patent had a

[00:11:45] Speaker 00:
a specific dose that had to be given on a per milligram per day basis.

[00:11:50] Speaker 00:
And that type of dose would establish the efficacy.

[00:11:53] Speaker 01:
But what we knew- All of the asserted claims of the 916 had that limitation?

[00:11:57] Speaker 00:
The sufficiency?

[00:11:59] Speaker 00:
Yes.

[00:12:00] Speaker 00:
Yes.

[00:12:01] Speaker 00:
And I think it's important in that context, because what that shows is the imminent reasonableness of Mr. Kramer's belief that any dose for the 459 patent would have that sufficient amount.

[00:12:11] Speaker 00:
Because, and we know that- I'm sorry.

[00:12:13] Speaker 04:
I'm very, very confused.

[00:12:15] Speaker 04:
If almost all of the claims required efficacy, NO enhancement, I'm using that as a shorthand for the terminology in the 459 and I think most of the rest, then a question would arise if you're filing a lawsuit.

[00:12:29] Speaker 04:
Would that enhancement occur with the doses that I'm seeing on these labels?

[00:12:35] Speaker 04:
It's a factual question.

[00:12:36] Speaker 04:
It seems not to have been investigated and I don't understand why it's reasonable to say,

[00:12:44] Speaker 04:
any amount would do without investigating efficacy?

[00:12:48] Speaker 00:
Well, in terms of efficacy, that's the statements on the labels themselves.

[00:12:51] Speaker 00:
But we know from another critical fact that it was reasonable to believe any dose would satisfy that amount sufficient.

[00:12:58] Speaker 00:
In the invalidity contentions that the defendants filed, they said, and I quote, for the sufficient term, any amount of L-arginine inherently enhances nitric oxide production.

[00:13:11] Speaker 00:
Any amount.

[00:13:13] Speaker 00:
So why the bifurcated infringement stayed that?

[00:13:16] Speaker 00:
There's no proceedings.

[00:13:18] Speaker 04:
In their invalidity contention, you can see it's a 10-421.

[00:13:22] Speaker 00:
It's a 10-421, Your Honor.

[00:13:25] Speaker 00:
It also appears on 10... I'm sorry?

[00:13:28] Speaker 01:
1-0-4-2-1.

[00:13:28] Speaker 00:
1-0-4-2-1.

[00:13:31] Speaker 01:
And that was in their validity contentions.

[00:13:35] Speaker 01:
Invalidity contentions.

[00:13:37] Speaker 00:
Yes.

[00:13:37] Speaker 00:
That's what the defendant's position was.

[00:13:38] Speaker 01:
Did you have another site that you were going to give us?

[00:13:41] Speaker 00:
Yes.

[00:13:42] Speaker 00:
Particular phrases repeated several times.

[00:13:46] Speaker 00:
There's also 10424 and 10427.

[00:13:48] Speaker 00:
The same statement appears there, where they say any amount of- I don't recall this argument being made in the briefs.

[00:14:00] Speaker 00:
It wasn't made in the briefs, exactly.

[00:14:02] Speaker 00:
But what the defendant said in their briefing was that they pointed to these invalidity confessions, both below and on briefing.

[00:14:09] Speaker 00:
And you can find that on pages 29 of Vital's brief.

[00:14:12] Speaker 00:
and also pages 48 to 49 of Vital's brief, and page 66 of Hitech's brief.

[00:14:17] Speaker 00:
They pointed to these contentions to show that they did give adequate notice.

[00:14:22] Speaker 00:
But what it shows is that it was reasonable at that time.

[00:14:25] Speaker 00:
Throughout the 3 and 1 half years, the defendants were representing that any amount of arguing would invalidate.

[00:14:32] Speaker 00:
In addition to that, the defendants also, for the 459 patent,

[00:14:41] Speaker 00:
itself said that they asserted products with 105 milligrams.

[00:14:48] Speaker 00:
That's at A10403.

[00:14:49] Speaker 00:
They asserted invalidity based on a product that had 250 milligrams.

[00:14:54] Speaker 00:
That's on A10357.

[00:14:56] Speaker 00:
So throughout this case, the defendant's position was any amount of arginine would suffice.

[00:15:03] Speaker 00:
That was identical to Mr. Kramer's testimony, that any dose in this particular patent would indeed infringe.

[00:15:11] Speaker 00:
The district court decided, in validity in this case, by adopting a broad reading of the prior art, that the sufficient amount was 1 milligram to 1,500 milligrams.

[00:15:21] Speaker 00:
So the defendants prevailed on their theory that any amount, this broad range, invalidated the patent.

[00:15:28] Speaker 01:
I want to back up for a second.

[00:15:29] Speaker 01:
I'm looking at page 10, 421.

[00:15:32] Speaker 01:
And the claim limitation relied on is, it says, having an amount of L-arginine

[00:15:39] Speaker 01:
sufficient to increase the level of nitric oxide production in said human host.

[00:15:44] Speaker 01:
Does that differ at all from the claim limitation at issue that we're looking at, claim one of the 459 patent?

[00:15:51] Speaker 00:
It does not, Your Honor.

[00:15:52] Speaker 01:
I mean, it's got different words.

[00:15:53] Speaker 00:
It does, but they were construed together, and the parties agreed that they should be construed together, and that's at A710 of the appendix.

[00:16:00] Speaker 00:
You can see where the district court construed them together, and the parties were arguing that they mean the same thing across the 916 patent and the 459 patent.

[00:16:08] Speaker 00:
So you have these clear statements.

[00:16:10] Speaker 00:
For the 459 patent, the invalidity contention said products at 105 milligrams, 250 milligrams invalidated.

[00:16:18] Speaker 00:
In the construction of the term for sufficient amount, they said any amount.

[00:16:22] Speaker 00:
That's wholly consistent with what Mr. Kramer was saying at the outset of the case.

[00:16:26] Speaker 00:
And indeed, they were successful in that strategic choice.

[00:16:29] Speaker 00:
They bifurcated, stayed infringement, made these broad claims, took advantage of that to then invalidate the patent, which the district court agreed with.

[00:16:37] Speaker 00:
And then instead of packing up their bags and going home on this theory, they changed the rules of the game at the end.

[00:16:44] Speaker 00:
And they came back and said, all along, you should have known that you had a one gram amount.

[00:16:49] Speaker 00:
And Judge Stoll, you'd mentioned in your previous questions that things do happen at trial.

[00:16:54] Speaker 00:
And the only clear statement we had here from the expert that one gram mattered was at trial.

[00:16:59] Speaker 00:
But at the outset of the case, that expert's statement did not exist.

[00:17:03] Speaker 00:
It was reasonable, shown by the defendants, continued

[00:17:07] Speaker 01:
The district court's opinion suggests that in doing the analysis, that there was no review at all of the labels.

[00:17:17] Speaker 01:
Is that true?

[00:17:18] Speaker 00:
No.

[00:17:18] Speaker 01:
It seems to be contradicted by the testimony.

[00:17:21] Speaker 00:
She actually corrected that on reconsideration.

[00:17:24] Speaker 00:
She said, I recognize that there are review of the labels.

[00:17:27] Speaker 00:
Mr. Kramer's testimony on that fact is very clear.

[00:17:31] Speaker 00:
And indeed, he said specifically, I reviewed the ingredients list, and he compared them.

[00:17:36] Speaker 00:
One of the objective ways that you can tell that there was analysis here is that, unlike prior cases where you had, that this court has seen, where you have a nuisance lit against filing all claims on all patents against all products, here it was carefully parsed.

[00:17:51] Speaker 00:
There's different limitations, as Mr. Kramer described, for each of the patents.

[00:17:55] Speaker 00:
And so they were matched to the products.

[00:17:57] Speaker 00:
And you can see that on page 26 of Stanford's opening brief, where they have a chart.

[00:18:01] Speaker 00:
Not all the patents are asserted against all the products themselves.

[00:18:06] Speaker 00:
So that in and of itself is objective proof that there was consideration of those dosage levels, combined with the fact that you had, throughout it, the consideration of the invalidity contention saying that it's any amount.

[00:18:19] Speaker 00:
The defendants here didn't just hide under a rock that this court said would be a consideration under Stonebasket.

[00:18:24] Speaker 00:
They built the rock, and they dropped it on plaintiffs.

[00:18:28] Speaker 00:
At the end of the trial, they changed their tune.

[00:18:30] Speaker 00:
And indeed, it also shows that the record was incomplete because the district court

[00:18:36] Speaker 00:
effectively granted summary judgment on the disputed question of a complex technical fact without a complete record on it.

[00:18:42] Speaker 00:
And that's shown most clearly in the one example that she gave for determining and saying on page 13 of her opinion that there is a basic fact that the labels would show.

[00:18:54] Speaker 00:
And that's this five milligram amount that she talks about on that page.

[00:18:57] Speaker 00:
That five milligram amount comes from a declaration of vitals attorney on page Apex 11586.

[00:19:03] Speaker 00:
You can see that.

[00:19:04] Speaker 00:
There is no support whatsoever given for the 5-milligram amount.

[00:19:09] Speaker 00:
Yet the district court adopted it as fact.

[00:19:12] Speaker 00:
That proves in this context that the way that the 285 fees were awarded is something that this court has never seen before, and it was improper because it was effectively a grant of summary judgment on a disputed fact question.

[00:19:25] Speaker 06:
But you didn't ask for an evidentiary hearing on the 285 question, as I recall.

[00:19:32] Speaker 06:
Those words, no, Your Honor.

[00:19:33] Speaker 06:
But what we did say- Well, not only not those words, but you even opposed oral argument, if I recall correctly.

[00:19:40] Speaker 00:
We opposed oral argument after the district court canceled oral argument.

[00:19:43] Speaker 00:
So the way that worked, the district court canceled oral argument, and then High Tech moved, and we opposed that motion.

[00:19:49] Speaker 06:
High Tech wanted to have oral argument, and you didn't.

[00:19:52] Speaker 06:
It seems to me you're hard pressed now to say, well, not only should we have had oral argument as we did, but we should also have had an evidentiary hearing

[00:20:04] Speaker 00:
I think in 2020 hindsight, that maybe would have been the proper course, but it was a strategic one to oppose something that if you look at the district court denying oral argument on a motion, that does indicate, reasonably indicate that the motion will not be successful in that respect.

[00:20:18] Speaker 00:
I think that's what they were probably thinking.

[00:20:20] Speaker 04:
Your paper filing in opposition to the fees request argued what exactly?

[00:20:26] Speaker 00:
It argued repeatedly that there was not adequate opportunity for discovery on infringement.

[00:20:31] Speaker 00:
It argued the individual amounts themselves would be reasonable for the 500 amount.

[00:20:36] Speaker 00:
And on page 13 of the district court's opinion, that's where she says there was no argument that you could possibly have infringement.

[00:20:42] Speaker 00:
It was directed to the 500 amount, because the theory was, I believe, that at least the 500 amount that appears in the dependent claim would have to be reasonable.

[00:20:51] Speaker 00:
But they did repeatedly say that they needed the opportunity to complete the record.

[00:20:54] Speaker 00:
And that's at 11.051 of the record.

[00:20:57] Speaker 00:
That's at also 11.053, 11.054.

[00:21:01] Speaker 00:
9 and 11.063.

[00:21:03] Speaker 00:
We call those out in our reply brief at pages 16 to 17 of Thermal Life and go through the litany of S. But what that highlights here is that there was no opportunity for infringement discovery.

[00:21:15] Speaker 06:
Let me ask you a question.

[00:21:17] Speaker 06:
Well, you can finish your point, and then I have a question I'd like to ask.

[00:21:21] Speaker 06:
You were completing a point.

[00:21:22] Speaker 00:
I didn't want to interrupt.

[00:21:23] Speaker 00:
Oh, I was just saying that that shows that there was no opportunity here to have fulsome discussion of what the facts actually were.

[00:21:29] Speaker 00:
And indeed, that's confirmed by what the district court did in simply adopting statements in the declaration by attorneys for VITAL for this 5-milligram amount that came from nowhere.

[00:21:38] Speaker 06:
OK.

[00:21:39] Speaker 06:
Let me ask you.

[00:21:40] Speaker 06:
I found the record to be confusing as to the status of one of VITAL's products, the AEXNO.

[00:21:48] Speaker 06:
That was a product that, according to the record, as I read it, had been discontinued in 2008.

[00:21:58] Speaker 06:
wasn't clear to me.

[00:21:59] Speaker 06:
It wasn't originally in the complaint.

[00:22:02] Speaker 06:
It wasn't clear to me.

[00:22:03] Speaker 06:
It was in the infringement contentions.

[00:22:05] Speaker 06:
Yes, Your Honor.

[00:22:09] Speaker 06:
But what is your argument with respect to that claim against vital?

[00:22:14] Speaker 06:
Because that's the only claim that doesn't rely on the 459 claim one.

[00:22:18] Speaker 00:
So in terms of that, you are correct that it appeared in the infringement contentions.

[00:22:21] Speaker 00:
That product is mentioned in one of the labels for the other vital products.

[00:22:26] Speaker 00:
I believe it's a synthesized product, and you can see that label at 11-470-71 on the record.

[00:22:32] Speaker 00:
And so that's where it came out.

[00:22:34] Speaker 00:
And indeed, it did appear in the contentions themselves.

[00:22:37] Speaker 00:
And the contentions, you can see in the contentions themselves, the A10515 is a label for it.

[00:22:45] Speaker 00:
And the contentions for Vital can be found that were asserted just a few months after filing the case in December of 2013

[00:22:55] Speaker 00:
a 10676 and a 6234259.

[00:23:01] Speaker 00:
Well, I guess my question really goes to this.

[00:23:04] Speaker 06:
If, with respect to vital and not high tech, but with respect to vital alone, if it's true as vital contends that the 459 claim one is invalid or not invalid, but it could not have legitimately been pressed because of the one gram

[00:23:24] Speaker 06:
efficacy limitation, all you would be left with with respect to vital would be the AEXNO and that only as I calculated one year of potential liability because they had stopped selling it in 2008 and the claim was filed in 2013.

[00:23:47] Speaker 06:
Would that have been enough by itself to support an action against vital such that

[00:23:54] Speaker 06:
it would have been fine to proceed against FIDAL without the 459 and the products associated with the 459.

[00:24:02] Speaker 00:
By itself?

[00:24:02] Speaker 00:
Yes, Your Honor.

[00:24:03] Speaker 00:
And the reason for that is in the statute, as this Court has discussed in Checkpoint and SFA v. Newegg, you do have a statutory right to bring a suit, regardless of the amount of damages.

[00:24:12] Speaker 00:
And it simply can't be the case that you could only bring a patent suit if you have above a certain threshold of damages, even if the damages there were small.

[00:24:19] Speaker 00:
But for that product itself,

[00:24:22] Speaker 00:
there's no, it still is contested that it was discontinued.

[00:24:27] Speaker 00:
That website that's in the record showing that it was not discontinued and still on sale as of 2016.

[00:24:34] Speaker 00:
So that is still a disputed fact.

[00:24:36] Speaker 00:
And that goes, again, back to what the district court did here in the fundamental error.

[00:24:40] Speaker 00:
There was disputed facts here without any opportunity for discovery.

[00:24:45] Speaker 00:
And as such, it is a rush to summary judgment without even considering these material disputes of fact.

[00:24:52] Speaker 00:
And at the very least, what the district court had to do, if indeed this court finds that it was unreasonable for some of those products in the 459 patent, where the timing of the expert's admission comes at trial, at the very least, what the district court had to do was trace the fees and match the misconduct that supposedly happened.

[00:25:15] Speaker 00:
Causal connection to the fees that were awarded.

[00:25:19] Speaker 00:
But there was no connection here.

[00:25:21] Speaker 04:
We should hear from Mr. DiGiovanni now.

[00:25:23] Speaker 04:
Thank you.

[00:25:24] Speaker 00:
Thank you.

[00:25:40] Speaker 03:
Good morning and may it please the court.

[00:25:42] Speaker 03:
Frank DiGiovanni on behalf of Vital Pharmaceuticals.

[00:25:45] Speaker 03:
This was an extraordinary case of a plaintiff, two plaintiffs, and their predatory

[00:25:51] Speaker 03:
strategy to sue 81 defendants, indeed virtually the entire supplement industry.

[00:25:57] Speaker 04:
Can you focus just on the argued baselessness of the claim and not on the other suits?

[00:26:03] Speaker 03:
I'm sorry, Your Honor, I didn't hear that.

[00:26:05] Speaker 04:
Please focus on the found baselessness of the individual suit and please ignore for current purposes the rest of the lawsuits brought.

[00:26:16] Speaker 03:
Okay.

[00:26:16] Speaker 03:
Thank you.

[00:26:17] Speaker 03:
So in terms of this case, what

[00:26:19] Speaker 03:
Judge Sammartino found, and she lived with the case for four years, was that there was no reasonable basis to allege infringement against vital or high-tech.

[00:26:27] Speaker 03:
She also found that the defendants, I'm sorry, the plaintiffs failed to undertake a reasonable pre-filing investigation with regard to the products that were accused and the patents.

[00:26:38] Speaker 04:
How does that fit with your invalidity contentions that Mr. Gaiarsa spent some time relying on?

[00:26:44] Speaker 03:
Sure, Your Honor.

[00:26:45] Speaker 03:
The statement that was just referenced at

[00:26:48] Speaker 03:
page 10... 10-4-21.

[00:26:51] Speaker 03:
10-4-21.

[00:26:53] Speaker 03:
That had never been raised before.

[00:26:54] Speaker 03:
This is the first time we're hearing of that.

[00:26:56] Speaker 06:
Well, let's talk about it now, because it's been raised.

[00:26:59] Speaker 03:
Well, first of all, that appears with regard to a reference called the flex reference, which in my recollection was not something that was raised at trial or appears in the judge's opinion, invalidated opinion.

[00:27:12] Speaker 04:
I think his point was you filed a formal document saying that any old amount will do

[00:27:19] Speaker 04:
So how could it be unreasonable for his client to file a lawsuit on the same premise?

[00:27:26] Speaker 03:
Because it was known since 1993 or so that, in fact, one gram or less was insufficient.

[00:27:33] Speaker 06:
Then why did you make this statement?

[00:27:35] Speaker 03:
Well, this is the first time I'm seeing this, Your Honor.

[00:27:38] Speaker 03:
Well, I know, but this patent, first of all, that was not the 459 patent that this is being referenced to.

[00:27:43] Speaker 03:
This is a different patent.

[00:27:43] Speaker 01:
But isn't this what I heard earlier was that this claim term was construed by both parties to have the same meaning.

[00:27:50] Speaker 01:
So that doesn't matter, right?

[00:27:52] Speaker 03:
Actually, no, Your Honor.

[00:27:53] Speaker 03:
There was no construction of the term amount sufficient.

[00:27:57] Speaker 01:
So you're saying this claim limitation has a different, we should give a different interpretation of that?

[00:28:03] Speaker 03:
Well, that limitation is a bit different.

[00:28:06] Speaker 03:
The difference, one of the differences that I just noticed is that in the 459 patent, it's L-arginine and L-arginine hydrochloride.

[00:28:18] Speaker 03:
This limitation here is something different.

[00:28:21] Speaker 01:
It also... It just says L-arginine and it's physiologically acceptable soft.

[00:28:26] Speaker 01:
Sounds to me like you just said the same thing.

[00:28:28] Speaker 03:
Well, it's a little bit different because in the prosecution history for the 459 patent, which is in our brief, they disclaimed any

[00:28:35] Speaker 03:
any other salts other than LRG and hydrochloride.

[00:28:40] Speaker 03:
So there is a difference between that limitation that's being addressed in that claim chart and the limitation in the 459 patent.

[00:28:47] Speaker 04:
But if there are differences in the limitations, doesn't that highlight the potential problem with the district court having focused only on the 459 and not the others?

[00:29:01] Speaker 03:
I would say no, Your Honor, because what's required is an amount sufficient.

[00:29:05] Speaker 03:
So in order for the plaintiffs to file suit, in order for them to do the pre-filing investigation, they needed to conclude that, in fact, the products, the accused products, met the limitation.

[00:29:17] Speaker 03:
And there's nothing in the record.

[00:29:18] Speaker 03:
We challenged them on their exceptional case motion about their pre-filing investigation.

[00:29:23] Speaker 03:
We said they didn't and they couldn't have made a proper analysis of the products and compared them against the patent.

[00:29:30] Speaker 03:
And what did they come back with?

[00:29:31] Speaker 03:
There's nothing in the record.

[00:29:33] Speaker 01:
They had labels, they had advertisements that they looked at that said that it satisfied the claim limitation, right?

[00:29:40] Speaker 01:
And the district court said that the advertisements weren't sufficient.

[00:29:45] Speaker 01:
I guess in juxtaposition with this statement by your client that it doesn't matter how much, so long as some amount is there that it will satisfy the limitation, that's a little disconcerting.

[00:29:59] Speaker 03:
Well, I guess I would say to this, first of all, that's not the 459 patent.

[00:30:03] Speaker 03:
So my client was not interested in that patent, because the 459 is what was accused.

[00:30:09] Speaker 06:
Who drafted this?

[00:30:12] Speaker 06:
On behalf of which of the various parties to the invalidity proceeding was this submitted?

[00:30:18] Speaker 06:
Was this submitted on behalf of all parties?

[00:30:21] Speaker 03:
I don't know, Your Honor.

[00:30:22] Speaker 04:
It's titled Defendants S Apostrophe.

[00:30:25] Speaker 03:
Defendants jointly work together, and that's why the case proceeded as it did.

[00:30:29] Speaker 03:
all the parties and the judge were asked to be efficient and we proceeded on invalidity only, so I believe it was defendants' contentions.

[00:30:37] Speaker 06:
Now if I understand it correctly, the 459 and the 916 have efficacy requirements in them, an amount sufficient to produce endogenous NO.

[00:30:49] Speaker 06:
The 872 and the 006 do not.

[00:30:53] Speaker 06:
Is that fair?

[00:30:55] Speaker 03:
Your Honor,

[00:30:56] Speaker 06:
My client was accused of... Well, before you get into your client, is that a fair characterization of the way the patents break down?

[00:31:04] Speaker 03:
And the answer is, I don't know, because my client was only accused of the 459 patent.

[00:31:08] Speaker 06:
So I was only... Your client being vital?

[00:31:12] Speaker 03:
My client being vital.

[00:31:13] Speaker 06:
But you were accused of the AEXNO, even though all through the record it's unclear whether the AEXNO is part of the case or is not.

[00:31:23] Speaker 06:
But as far as I can see, at least as of the time of the infringement contingents, it was as far as the plaintiffs were concerned.

[00:31:30] Speaker 06:
So there, you were accused under the 872 and the 916, the 872 being a non-efficacy-based claim, right?

[00:31:41] Speaker 03:
Again, Your Honor, the two products that were in the complaint were NO synthesized and NO... But the complaint said these products

[00:31:52] Speaker 06:
but not limited to these products.

[00:31:53] Speaker 06:
And sure enough, when you got to the infringement contentions, in came AEXNO.

[00:31:59] Speaker 06:
And that, even though it was only in for a small period of time, one year roughly, it's still subject to an infringement claim.

[00:32:08] Speaker 06:
So why would your client not have been subject to a lawsuit based on AEXNO?

[00:32:15] Speaker 03:
I would say it hadn't been added to the case.

[00:32:17] Speaker 03:
It wasn't in the

[00:32:18] Speaker 03:
infringement contentions, but it had not been added to the case.

[00:32:21] Speaker 06:
Why had it not been added to the case?

[00:32:23] Speaker 06:
It was in the complaint by implication through the reference to other products, and then when the infringement contentions came in, it was noted to be one of the products on which infringement was predicated.

[00:32:36] Speaker 06:
Why doesn't that constitute enough to add it to the case?

[00:32:40] Speaker 03:
Our position is that that was insufficient.

[00:32:41] Speaker 03:
They needed to amend the complaint.

[00:32:43] Speaker 03:
And in any event, your honor, each of the products, as in the Antonia's case,

[00:32:46] Speaker 03:
each of the products need to be assessed on a product by product basis.

[00:32:51] Speaker 03:
And that was not done here.

[00:32:53] Speaker 03:
So if you look at N.O.

[00:32:54] Speaker 03:
Synthesize, if you look at N.O.

[00:32:56] Speaker 03:
Shotgun, these are the two principal products, these are the two products we would say that were accused, there was no record whatsoever that these could have infringed, or that they did infringe, or that in fact they even had any kind of basis to allege that they infringed.

[00:33:08] Speaker 04:
Can you tell me what does the record say in particular, but not only, the record on the fees request?

[00:33:17] Speaker 04:
about what testing activities the plaintiffs could have undertaken to go beyond the labels on the accused products, beyond the advertising of the accused products, to figure out how much L-Arginine was in a particular recommended serving.

[00:33:37] Speaker 03:
The record does not explain what they could have done, but certainly they could have done testing.

[00:33:42] Speaker 03:
In fact, their own expert...

[00:33:44] Speaker 04:
The record doesn't say, but certainly that there's a problem leaping from one to the other for me.

[00:33:49] Speaker 03:
Your Honor, it was their burden to demonstrate that they could have, that they did assess the infringement.

[00:33:55] Speaker 04:
The district court said there was an inadequate investigation.

[00:33:59] Speaker 04:
Let's assume that there is no scientific possibility of taking the pills or whatever form these things are in and figuring out in a 500 milligram pill with

[00:34:11] Speaker 04:
twelve listed ingredients how much L-Arginine is in there.

[00:34:15] Speaker 04:
So that there is nothing but labels and advertising.

[00:34:19] Speaker 04:
At that point isn't it a little odd to find that there was an inadequate investigation when one hasn't identified what investigation was possible but not done?

[00:34:32] Speaker 03:
There was no investigation even necessary.

[00:34:34] Speaker 03:
Their experts said it was a known fact in science that in fact less than one gram of L-Arginine would not increase

[00:34:40] Speaker 03:
nitric oxide in the bloodstream.

[00:34:43] Speaker 01:
Is it true that that was, that the expert said that three years after, you know, into the filing of the lawsuit?

[00:34:50] Speaker 03:
He testified to it in his deposition that's cited by the district court and in her brief, and then he repeated that at trial.

[00:34:57] Speaker 03:
And that was known prior to the filing of the complaints.

[00:35:00] Speaker 03:
It was known sometime in the mid-90s and any time after that.

[00:35:04] Speaker 01:
And their expert considered it.

[00:35:05] Speaker 01:
When you respond to the argument that

[00:35:07] Speaker 01:
the person doing the investigation didn't have to be one of ordinary scalene art and have knowledge of all the different articles regarding how much was required?

[00:35:17] Speaker 03:
They still had to have some basis under this court's case law to allege infringement of these products.

[00:35:23] Speaker 03:
And when we challenge them on it, they have yet to come forth with anything where they say, here's how we understood that you infringed.

[00:35:30] Speaker 03:
They didn't explain that.

[00:35:31] Speaker 03:
In fact, Judge San Martino says it in her opinion.

[00:35:35] Speaker 03:
that they've never actually challenged the fact that there was any reasonable basis to accuse Vital's products of infringement.

[00:35:42] Speaker 04:
Let me just return to what I was trying to ask.

[00:35:47] Speaker 04:
A number of the accused products have recommended servings well over one gram, some eight grams, measured in milligrams, 8,000 grams, 3,000 grams.

[00:35:56] Speaker 04:
And they say here are a few ingredients.

[00:35:59] Speaker 04:
Do we know anything about whether had they

[00:36:04] Speaker 04:
whether they could have done some tests, get the pills that are in the servings, and figure out how much of the, let's say, eight grams is L-Arginine.

[00:36:13] Speaker 04:
Because if the answer is they couldn't, then I'm not sure what the inadequacy of the investigation was.

[00:36:18] Speaker 03:
Your Honor, I don't believe it's in the record regarding what type of test was done.

[00:36:22] Speaker 04:
And this may be utterly obvious to every scientist in the field, but if it's not in the record, I'm not quite sure what to do about that.

[00:36:29] Speaker 03:
Well, Your Honor, what we do know, though, is as of the date of the filing,

[00:36:33] Speaker 03:
It was known that less than one gram of arginine.

[00:36:36] Speaker 04:
Right.

[00:36:36] Speaker 04:
Let me focus you because I think you're not quite getting what I'm asking.

[00:36:42] Speaker 04:
Let's assume it was known.

[00:36:44] Speaker 04:
You needed a gram.

[00:36:45] Speaker 04:
You now have a bottle that says, here's a pill, one serving, it's eight grams.

[00:36:50] Speaker 04:
How do you know whether there's more than one gram of L arginine in there or not?

[00:36:58] Speaker 04:
If each pill was half a gram,

[00:37:01] Speaker 04:
and it had 20 ingredients, you know there's not one gram.

[00:37:04] Speaker 04:
But a bunch of the pills here, the accused products, have servings of much greater than a gram.

[00:37:12] Speaker 04:
So the question is, how would they know whether there was one gram in the accused products?

[00:37:20] Speaker 03:
I would say this, Your Honor.

[00:37:22] Speaker 03:
The amount of the ingredient could have been learned and then tested itself, by itself, as opposed to testing it with all the other ingredients.

[00:37:30] Speaker 04:
So you just said that.

[00:37:32] Speaker 03:
What in the record supports that?

[00:37:34] Speaker 03:
Well, I would say, Your Honor, the fact that it was known in the art, as Dr. Beauger said, that one gram or less does, it tells you you can take a particular amount and test that amount.

[00:37:45] Speaker 03:
Otherwise, he would not have been able to have the knowledge that less than one gram actually is insufficient.

[00:37:52] Speaker 06:
Well, I'm confused now about when you say the amount.

[00:37:56] Speaker 06:
The amount of what?

[00:37:58] Speaker 06:
If I understand, correct me if I've got the numbers wrong, but if I understand it correctly, again, going back to your products only, let's not talk about high-tech products, but your products, AEX-NO had 3.2 grams of arginine.

[00:38:13] Speaker 06:
Is that correct?

[00:38:14] Speaker 03:
I believe that's correct.

[00:38:15] Speaker 06:
All right.

[00:38:16] Speaker 06:
And the other three products, well, two of the other three products, the shotgun products, had less than 500 milligrams.

[00:38:24] Speaker 06:
of arginine per serving?

[00:38:26] Speaker 03:
Is that right?

[00:38:26] Speaker 03:
Less than five milligrams.

[00:38:28] Speaker 03:
Less than five milligrams is actually a declaration.

[00:38:30] Speaker 06:
Well, there's one place where I see 500 and another place 500.

[00:38:33] Speaker 06:
I don't know if that's a typo, but certainly no more than 500.

[00:38:37] Speaker 06:
Yeah.

[00:38:38] Speaker 03:
It was less than five milligrams.

[00:38:39] Speaker 03:
But yes, you're right, Your Honor.

[00:38:40] Speaker 03:
There is two different declarations, but they're both accurate.

[00:38:43] Speaker 03:
It's less than 500.

[00:38:44] Speaker 03:
Well, what's... Well, it's not worth... Well, perhaps it is.

[00:38:47] Speaker 03:
Sure.

[00:38:48] Speaker 06:
Tell me why they're both accurate.

[00:38:50] Speaker 06:
One saying 500 and the other saying five.

[00:38:52] Speaker 03:
It's saying in the product, there's less than 500 milligrams.

[00:38:56] Speaker 03:
It's true.

[00:38:57] Speaker 03:
I see.

[00:38:57] Speaker 06:
In other words, less than five equals five?

[00:39:00] Speaker 03:
No, not equals five.

[00:39:01] Speaker 03:
It's less than five.

[00:39:02] Speaker 03:
Includes five?

[00:39:02] Speaker 03:
Exactly.

[00:39:03] Speaker 06:
OK.

[00:39:03] Speaker 06:
All right.

[00:39:04] Speaker 06:
But in any event, certainly less than 500 with respect to the two-shock.

[00:39:08] Speaker 06:
And then N-O synthesize no arginine.

[00:39:13] Speaker 03:
That's correct, John.

[00:39:14] Speaker 03:
There's one product that has no L-arginine and no L-arginine hydrochloride.

[00:39:18] Speaker 03:
For plaintiffs to look at that label and accuse it of infringement,

[00:39:23] Speaker 03:
is completely shirking the responsibility of a pre-filing investigation.

[00:39:27] Speaker 03:
There's no way that possibly could have infringed, yet they accused it throughout this entire case.

[00:39:34] Speaker 04:
I think we should hear from your colleague.

[00:39:37] Speaker 03:
Thank you.

[00:39:42] Speaker 05:
Thank you.

[00:39:42] Speaker 05:
May it please the court, Robert Bursley, for high-tech pharmaceuticals.

[00:39:49] Speaker 05:
The district court

[00:39:51] Speaker 05:
did not look only at the pre-filing investigation for the 459 patent year.

[00:39:57] Speaker 05:
It looked at the entire pre-filing investigation.

[00:40:01] Speaker 05:
And the sum total of the record evidence concerning the pre-filing investigation was a handful of sentences from Mr. Kramer's deposition, testimony.

[00:40:14] Speaker 05:
That's it.

[00:40:16] Speaker 05:
He said, and I'm quoting,

[00:40:20] Speaker 05:
Check existing products for their marketing claims and ingredients.

[00:40:25] Speaker 01:
And then... Are you reading from the Kramer deposition testimony?

[00:40:28] Speaker 05:
Yes, Your Honor, and it would be at Appendix 101-87.

[00:40:32] Speaker 05:
Do you have any recollection of how it was determined that somebody was an infringer?

[00:40:46] Speaker 05:
What's your recollection?

[00:40:47] Speaker 05:
This is 101-87.

[00:40:49] Speaker 05:
Check existing products for their marketing claims and ingredients.

[00:40:55] Speaker 05:
Question, what marketing claims would indicate they were an infringer?

[00:40:58] Speaker 05:
Answer, if they said arginine was going to increase nitric oxide, or if the label had a certain dose of arginine in the product.

[00:41:08] Speaker 05:
Then there was some discussion about dosages.

[00:41:10] Speaker 05:
That's it.

[00:41:11] Speaker 05:
That's the entire record evidence on pre-filing investigation.

[00:41:17] Speaker 05:
What was not done?

[00:41:18] Speaker 05:
What is not in this evidence?

[00:41:20] Speaker 05:
There was no analysis of the patents of prosecution history.

[00:41:26] Speaker 05:
There was no careful comparison of the patents to each of the products.

[00:41:31] Speaker 04:
But I'm sorry.

[00:41:34] Speaker 04:
I thought that the sole basis on which the district court found it was unreasonable to proceed was a factual determination that for the claimed effect in many of though not all of the claims at issue, a certain

[00:41:49] Speaker 04:
effect on the body was necessary and that pre-lawsuit science said one gram was necessary.

[00:41:59] Speaker 04:
So that I thought actually you had been contending was actually not a matter of claim construction at all, but the application to the real world of a effectiveness requirement, an efficacy requirement.

[00:42:17] Speaker 05:
But that was not the sole basis for the court's opinion.

[00:42:20] Speaker 04:
And the court... No, but you started talking about claim construction, prosecution history.

[00:42:24] Speaker 04:
What does that have to do with anything?

[00:42:27] Speaker 05:
Well, I was trying to lay out things that Thermalife could have done by way of pre-filing investigation to show that it was exercised.

[00:42:38] Speaker 04:
What could it have done to determine whether each of or all of the accused products

[00:42:46] Speaker 04:
were, um, including one gram or more of LRG?

[00:42:53] Speaker 05:
Well, we could have looked at Zincor Plus's label, which said a serving is one caplet and a caplet contains 325 milligrams total.

[00:43:09] Speaker 04:
Right.

[00:43:10] Speaker 04:
So there are a few of these in which the servings

[00:43:14] Speaker 04:
are well under one gram and it's a little hard to see.

[00:43:17] Speaker 04:
Mesomorph had no LRG.

[00:43:19] Speaker 04:
Right.

[00:43:20] Speaker 04:
I think there are like five or so in which the servings were well over one gram.

[00:43:25] Speaker 05:
That's right.

[00:43:25] Speaker 05:
But for the other patents, the other two of the patents, there were other, you know, antioxidants had to be included.

[00:43:32] Speaker 05:
There was no testimony that, you know, he was determining that other antioxidants were in the products.

[00:43:41] Speaker 01:
Can I direct your attention for a minute to appendix page 10, 357 and 358?

[00:43:46] Speaker 01:
This is another one of those validity charts.

[00:43:51] Speaker 01:
But this one seems to relate specifically to the 459 patent.

[00:43:57] Speaker ?:
OK.

[00:44:01] Speaker 05:
Yes, Your Honor.

[00:44:01] Speaker 01:
I just wanted to ask, I see here, I mean,

[00:44:06] Speaker 01:
It seems to me this is, if you look on page 10, 357, the prior reference is weeder.

[00:44:12] Speaker 01:
And it says that it has 250 milligrams of arginine.

[00:44:16] Speaker 01:
And then you go down to, on page 10, 358, limitation 1.4, which is in an amount sufficient to enhance endogenous endothelial nitric oxide.

[00:44:28] Speaker 01:
And the chart says the formation of nitric oxide was a known and inherent benefit of the administration of L-arginine.

[00:44:36] Speaker 01:
How do you respond to that?

[00:44:38] Speaker 01:
Why doesn't that show that it would have been reasonable at the time of filing the lawsuit to think at least for 250 milligrams of L-Arginine, you would have the claimed benefit?

[00:44:53] Speaker 05:
Well, I think on page 103.58, when it's saying that NO was a known and inherent benefit of the administration of L-Arginine, it's presuming that there's an amount sufficient.

[00:45:04] Speaker 05:
and it doesn't speak there to what an amount sufficient is.

[00:45:09] Speaker 01:
Let me just press just a little bit more.

[00:45:13] Speaker 01:
In the prior page, it says that the capsule contains 250 milligrams of arginine.

[00:45:19] Speaker 01:
So there's at least some minimum provided there on page appendix 10.357.

[00:45:27] Speaker 05:
Right.

[00:45:30] Speaker 05:
I don't think there's, I mean, we don't know how many capitals were taken.

[00:45:33] Speaker 05:
We don't know if it was, you know.

[00:45:36] Speaker 01:
Doesn't that also apply to the infringement analysis?

[00:45:42] Speaker 05:
That the amounts of capitals taken or what the overall dose would be in a day, for example?

[00:45:49] Speaker 01:
Right.

[00:45:49] Speaker 01:
The argument you're making.

[00:45:51] Speaker 01:
Why wouldn't that apply also when you're assessing whether there was infringement at the time of filing?

[00:45:58] Speaker 05:
Well, I think we would have expected to see at a minimum a careful analysis by council going through these patents claim by claim and comparing them to the products, the ingredients in the products, the recommendations for how the products are to be used.

[00:46:23] Speaker 05:
That we would have expected to see that

[00:46:25] Speaker 05:
before these lawsuits were filed and that did not happen.

[00:46:29] Speaker 05:
There is no record evidence that that ever occurred.

[00:46:34] Speaker 04:
If it turned out that a whole lot of these products in fact had more than one gram in a serving of the L-arginine, would it be a basis for exceptionality that there wasn't enough investigation before the suit was brought if it turned out

[00:46:55] Speaker 04:
that investigation would actually have revealed?

[00:46:57] Speaker 05:
Well, that's an interesting question, Your Honor.

[00:46:59] Speaker 04:
I thought it was a premise of the district court that, in fact, there wasn't infringement.

[00:47:06] Speaker 04:
And if only they had done an adequate investigation, they would have figured that out.

[00:47:10] Speaker 05:
As to the 459 patent, which was illustrative, the district court found that the pre-filing investigation as a whole, as to all products, was recklessly inadequate.

[00:47:25] Speaker 05:
And I would also say that under HALO... Reckless drivers don't always have accidents.

[00:47:32] Speaker 06:
So suppose they had been reckless.

[00:47:34] Speaker 06:
I'm asking the same question, but I'm really interested in your answer.

[00:47:38] Speaker 06:
Suppose that they had done this very superficial examination.

[00:47:45] Speaker 06:
And it turns out, as Judge Toronto's question indicates, that there was plenty to have efficacy.

[00:47:53] Speaker 05:
Would that be a basis for fees?

[00:47:56] Speaker 05:
Well, I think that under the circumstances of this case, yes.

[00:48:02] Speaker 05:
If Thermal Life and Stanford got lucky that it just so happened that there might have been a possibility infringement, had the patents been valid, doesn't excuse all of the other conduct that was taken into account.

[00:48:16] Speaker 06:
But the Rembrandt case, for example, and others, stands for the proposition that the misconduct

[00:48:23] Speaker 06:
that has to have some causal relation to the injury suffered.

[00:48:28] Speaker 06:
And here, if in fact there was plenty of the product of the arginine to constitute infringing amounts, then there would have been no injury.

[00:48:42] Speaker 05:
Well, I think another angle here, because we've had some new angles at argument here, is that these patents were

[00:48:53] Speaker 05:
returned back to Stanford from the previous licenser, because in light of the Supreme Court's opinion in KSR, thought these are going to be invalid is obvious.

[00:49:04] Speaker 05:
So shouldn't that have been analyzed?

[00:49:06] Speaker 01:
But that was not part of the district court's analysis here or rationale?

[00:49:11] Speaker 05:
It was not, but the court can obviously affirm for any reason supported by the record.

[00:49:17] Speaker 06:
Speaking of issues that have come up for the first time, do you have any comments on the

[00:49:23] Speaker 06:
invalidity contentions, particularly 10421?

[00:49:27] Speaker 05:
Well, I mean, I would just object because there is plenty of case law that raising a brand new argument or issue for the first time in a little argument by the appellant is improper, just as we had new issues raised in their brief.

[00:49:43] Speaker 05:
And that's not something we've had a chance to analyze or get ready for.

[00:49:48] Speaker 05:
That said, I would substantively respond.

[00:49:52] Speaker 05:
And I would say that the statements in there saying that, you know, that arginine increases in host does not necessarily mean that any amount would be an amount sufficient.

[00:50:09] Speaker 04:
So in opposing your request for fees, did the plaintiffs argue that discovery and factual inquiry into

[00:50:22] Speaker 04:
the whole infringement question or part of it was necessary, I thought.

[00:50:29] Speaker 05:
No, Your Honor.

[00:50:30] Speaker 05:
That was never squarely presented to the district court.

[00:50:36] Speaker 05:
It was after the fact when you're getting to the oral argument or the motion for reconsideration, and they're saying, well, we needed all this more discovery.

[00:50:46] Speaker 05:
We could have put in more evidence about the infringement analysis.

[00:50:51] Speaker 05:
But the fact is,

[00:50:52] Speaker 05:
The plaintiffs had their opportunity to do that, and they didn't take it.

[00:50:56] Speaker 05:
And then they'll wait till the end when things don't turn out their way to start throwing these arguments out.

[00:51:02] Speaker 05:
But there was never really a squarely made request for an evidentiary hearing, for discovery, for anything of that sort.

[00:51:14] Speaker 06:
Now, on that one more point, just to make sure I understand, your argument, and I appreciate

[00:51:22] Speaker 06:
you're hitting this cold.

[00:51:23] Speaker 06:
But your argument with respect to the invalidity contentions was that they're not saying that any amount would work.

[00:51:31] Speaker 05:
My point is it doesn't.

[00:51:33] Speaker 06:
That's exactly what it says.

[00:51:35] Speaker 05:
Well, your honor.

[00:51:36] Speaker 06:
Any amount of L-arginine inherently enhances nitric oxide.

[00:51:40] Speaker 06:
So I don't think that argument gets you anywhere.

[00:51:44] Speaker 05:
Well, your honor, I'm just not prepared to answer that particular question.

[00:51:49] Speaker 05:
Quite honestly.

[00:51:51] Speaker 05:
Thank you.

[00:51:51] Speaker 05:
Thank you.

[00:51:52] Speaker 05:
Baskin Farm.

[00:51:58] Speaker 04:
Restore two minutes for Mr. Atkins.

[00:52:03] Speaker 02:
I have four points.

[00:52:04] Speaker 02:
First of all, why the Stanford patents were returned to Stanford?

[00:52:08] Speaker 02:
They point to an obviousness.

[00:52:11] Speaker 02:
Supreme Court, there's no basis.

[00:52:12] Speaker 02:
That's attorney argument.

[00:52:13] Speaker 02:
Second, White v. Dunbar, the nose of wax.

[00:52:16] Speaker 02:
That's exactly what you're seeing here, more recently in Amazon, which is, let's look at, in validity,

[00:52:22] Speaker 02:
and let's look at infringement in two different ways.

[00:52:25] Speaker 02:
They should be looked at similarly.

[00:52:27] Speaker 02:
In answer to the question that was before, invalidity was brought up certainly in the Stanford reply brief at page 11.

[00:52:34] Speaker 02:
If we go back in time, the Northern District of California construed the claim sufficient amount.

[00:52:40] Speaker 02:
That's at A534.

[00:52:42] Speaker 02:
That's well before these cases were initiated.

[00:52:45] Speaker 02:
The patented issue at

[00:52:49] Speaker 02:
Column 8, line 16 through 21, A425 tells how dosages vary, using people that are young or old, what they've already got in their system, what they're going to add to their system.

[00:53:01] Speaker 02:
All of those were around.

[00:53:04] Speaker 02:
But what I want you to do, if I could, have you open up to one page, A710.

[00:53:22] Speaker 02:
The discussion was that amount was not construed before.

[00:53:28] Speaker 02:
A710, as you turn to it, is defendant's opening claim construction brief.

[00:53:33] Speaker 02:
As you go down to line 19, Johnny and I just, sorry, as you go down to line 19, you'll see there is no support in the intrinsic record for limiting this phrase to a routine or typical dosage.

[00:53:47] Speaker 02:
That's defendants saying there's no limit.

[00:53:51] Speaker 02:
Now, the question for you all is, OK, you say there's no limit here in your claim construction brief, but once invalidity is over, you turn to the one gram and cling to it.

[00:54:04] Speaker 02:
That's not fair, and that's not right.

[00:54:06] Speaker 02:
That goes to the whole claim construction issue.

[00:54:09] Speaker 02:
Your rebuttal time has just ended.

[00:54:11] Speaker 02:
I'm sorry.

[00:54:12] Speaker 02:
Thank you.

[00:54:13] Speaker 04:
I'll hear from Mr. Gayarsa.

[00:54:17] Speaker 04:
Five minutes, please.

[00:54:24] Speaker 04:
Can you point me to the filing you made in the district court in response to their fee request?

[00:54:32] Speaker 00:
I believe it starts at 11051, your honor.

[00:54:35] Speaker 00:
And I did want to read a portion of the response to your question, your honor, that there was no idea.

[00:54:40] Speaker 00:
I believe my friends on the other side said there was no request for more discovery, but it's very clear, and I want to read that to you.

[00:54:47] Speaker 00:
At 11059, we said below,

[00:54:50] Speaker 00:
If the court would now engage in the detailed infringement analysis of products relative to the patent claims it has already invalidated, extensive discovery would need to be taken.

[00:55:01] Speaker 00:
As non-infringement positions, defendants assert, without any expert testimony, are wholly unsupported.

[00:55:07] Speaker 00:
I'm not sure how more clear they could be that they needed more discovery to address it.

[00:55:12] Speaker 00:
I did also want to address a few other points.

[00:55:14] Speaker 00:
There was a question about whether or not those invalidity contentions were by one party or by multiple.

[00:55:20] Speaker 00:
It was actually signed by all the parties.

[00:55:22] Speaker 00:
That was at 10221 to 22.

[00:55:25] Speaker 00:
Also on that point, Judge Stoll, you had pointed to the 250 milligram product.

[00:55:30] Speaker 00:
There's also another product, creatine 5000, asserted specifically against the 459 patent.

[00:55:36] Speaker 00:
And that's at 10403.

[00:55:39] Speaker 00:
And that's 105 milligrams.

[00:55:41] Speaker 00:
Again, that cites 10403.

[00:55:43] Speaker 00:
So it's not just 250.

[00:55:45] Speaker 00:
It's 105.

[00:55:47] Speaker 00:
And in those invalidity contentions, they did say it's an inherent property.

[00:55:53] Speaker 00:
And as I said, in that same claim term that they're reading both ways for both patents, that they read it both ways as saying any amount, which is identical to Mr. Kramer's understanding at the outset.

[00:56:03] Speaker 04:
In addition, if you... So I assume, is this right or not, that your theory of why we might, in fact, be able to

[00:56:14] Speaker 04:
rely in some way on some of these invalidity contentions is that when you did make the argument to the district court that discovery and further record development on infringement was necessary, this is a way of showing why that would not have been a futile exercise.

[00:56:34] Speaker 00:
It's one of two ways, yes, your honor.

[00:56:36] Speaker 00:
But for the invalidity contentions themselves, the only reason they're in the record is because the defendants put them there.

[00:56:43] Speaker 00:
They're in the record for fees because they said, look, it's reasonable to say that this had no basis.

[00:56:50] Speaker 00:
And it's reasonable to say that we didn't give you notice specifically on.

[00:56:55] Speaker 01:
So they argued, as I understand what you're saying, they argued when they were seeking attorney fees.

[00:56:59] Speaker 01:
They didn't just rely on infringement.

[00:57:00] Speaker 01:
They also relied on validity and how clearly invalid the patents were.

[00:57:04] Speaker 00:
The argument wasn't well-developed.

[00:57:06] Speaker 00:
What they were doing is responding to the lack of notice.

[00:57:09] Speaker 00:
And they did the same thing on appeal.

[00:57:10] Speaker 00:
If you look at Vital's brief at pages 29,

[00:57:13] Speaker 00:
48 to 49, and high tax brief at 66.

[00:57:17] Speaker 00:
They also cited the infringement contentions here on appeal.

[00:57:20] Speaker 04:
The invalidity contentions?

[00:57:22] Speaker 00:
Correct, yes.

[00:57:23] Speaker 00:
Invalidity contentions here on appeal.

[00:57:25] Speaker 04:
So, I'm sorry, in the district court, the defendants put in these invalidity contentions in response to your opposition to fees?

[00:57:36] Speaker 00:
I believe they put them in in the opening.

[00:57:38] Speaker 00:
And those citations in here are from the opening.

[00:57:40] Speaker 00:
I'm not sure if it was vital or high-text motion, but it was one of the two parties had it in the opening, I believe.

[00:57:46] Speaker 04:
And just a second to clarify, what was the point that the defendants were making when putting these invalidity contentions into the record?

[00:57:55] Speaker 00:
I believe they responded to two things, as they do on appeal, to show that they didn't have to give notice, but also to show in the totality that potentially it was unreasonable to bring the claims to begin with.

[00:58:06] Speaker 00:
I believe that second one is probably what they're more thinking below.

[00:58:10] Speaker 00:
And on appeal now, what they're relying on is directly to respond to the lack of notice.

[00:58:15] Speaker 00:
But the lack of notice here, I'm sorry, did you?

[00:58:18] Speaker 00:
No, no, go ahead.

[00:58:21] Speaker 00:
In terms of my answer to your question, Judge Serrano, I promised you a second point in terms of the reasonableness.

[00:58:28] Speaker 00:
And that goes back to what my friend was discussing about this five milligram amount that came in the Keston declaration.

[00:58:35] Speaker 00:
which is found at 11,586, that 5-milligram amount doesn't exist.

[00:58:42] Speaker 00:
Indeed, he said it was clear, but if you look at the labels themselves, the label for synthesized says 9,352.

[00:58:49] Speaker 00:
What's the unit on that?

[00:58:54] Speaker 00:
I'm sorry?

[00:58:55] Speaker 01:
You're saying the labels at 9,352?

[00:58:58] Speaker 00:
Yes, the label says 9,352, and that's the first thing, right?

[00:59:05] Speaker 00:
That's preserving, yes.

[00:59:06] Speaker 06:
But that's not of argonine.

[00:59:08] Speaker 00:
That's not of argonine.

[00:59:11] Speaker 06:
If I understood the record correctly, I thought N.O.

[00:59:15] Speaker 06:
Synthesize had no argonine in it.

[00:59:17] Speaker 00:
N.O.

[00:59:17] Speaker 00:
Synthesize does not.

[00:59:19] Speaker 00:
And there's two points.

[00:59:20] Speaker 00:
So what's the point of the 9,000?

[00:59:22] Speaker 00:
It has the salt.

[00:59:23] Speaker 00:
And so what the instructions say is take it with water.

[00:59:25] Speaker 00:
And as any high school chemist knows, if you put a salt in water, it's going to disassociate.

[00:59:28] Speaker 00:
And that point was in the original infringement contentions.

[00:59:32] Speaker 00:
And how much of the salt is in NOSynthesize?

[00:59:37] Speaker 00:
It's not specified, and that's the problem.

[00:59:39] Speaker 00:
It says 9,352, and it lists them in the top 10 ingredients in that.

[00:59:44] Speaker 00:
In addition, the label for NOSynthesize, and this is at 11,470 to 7,1 on the record, it doesn't just say take this once.

[00:59:55] Speaker 00:
It says take it immediately before, during, and after your workout.

[00:59:59] Speaker 00:
So you have three doses.

[01:00:01] Speaker 00:
in close succession.

[01:00:02] Speaker 00:
And it also says, take it with the shotgun product, which does have arginine.

[01:00:08] Speaker 00:
And that shotgun product, on its label, has 4,890 milligrams of a blend, including the salt, and 6,160 milligrams of a blend, including arginine and another salt.

[01:00:22] Speaker 06:
Is there an indication in the record how much arginine is in each of those shotgun and shotgun and MHF?

[01:00:28] Speaker 00:
Not at all.

[01:00:28] Speaker 00:
And that's the problem here.

[01:00:29] Speaker 00:
That goes back to the fundamental issue where we said we needed to test what the declarants were saying.

[01:00:35] Speaker 00:
That declaration for five milligrams had no basis.

[01:00:38] Speaker 00:
It was an attorney for vital who said five milligrams.

[01:00:41] Speaker 00:
There was no explanation.

[01:00:42] Speaker 00:
There's no scientific explanation about where that five milligrams actually came from.

[01:00:47] Speaker 00:
And indeed, that is one of the fundamental problems with this decision here is that it was a rush to summary judgment on a disputed material fact.

[01:00:55] Speaker 01:
I think we have.

[01:00:57] Speaker 01:
Can I ask one last question, which is, just in understanding your point with respect to the validity contentions, is your point also that your client's understanding of what was required for the claims at the time of filing was reasonable, as shown in light of these validity contentions?

[01:01:17] Speaker 01:
I'm just trying to understand.

[01:01:18] Speaker 00:
It confirms it, Your Honor.

[01:01:20] Speaker 00:
It confirms that the defendants also thought it.

[01:01:21] Speaker 00:
And in context, what happened then thereafter was the district court also believed that too.

[01:01:27] Speaker 00:
and found as part of the invalidity decision here that the prior art said one milligram to 1,500 milligrams was a sufficient dose, and credited the defendant's expert for that finding.

[01:01:37] Speaker 04:
And on that basis... Do you agree with the counsel for the other side that nothing in the record identifies what kind of experimental process your people might have gone through with a bottle of the 9,000 milligram to figure out how much L-arginine was in there?

[01:01:56] Speaker 00:
I looked at the record, Your Honor, I did not find anything that would indicate what additional testing could be done.

[01:02:03] Speaker 04:
Thank you.

[01:02:04] Speaker 00:
Thank you.

[01:02:04] Speaker 04:
Case is submitted.