[00:00:00] Speaker 01:
099, Prusinius versus Carer Pharmaceuticals.

[00:00:46] Speaker 03:
Good morning, your honors.

[00:00:57] Speaker 03:
Joe Swick on behalf of the appellants.

[00:00:59] Speaker 03:
May it please the court.

[00:01:01] Speaker 03:
This court has characterized a preliminary injunction as a drastic and extraordinary remedy.

[00:01:08] Speaker 03:
My argument today is going to focus on three key errors made by the district court in granting this drastic and extraordinary remedy.

[00:01:16] Speaker 03:
we stand on our briefs with respect to the remaining heirs.

[00:01:19] Speaker 03:
First, regarding Farah's inequitable conduct claim, the district court made both a legal error and a clearly erroneous factual error in determining that Farah had not raised a substantial question on its inequitable conduct claim.

[00:01:34] Speaker 01:
I'm just interested.

[00:01:34] Speaker 01:
Have you found any other cases of ours where inequitable conduct was the validity basis upon which a preliminary injunction was being opposed?

[00:01:44] Speaker 01:
Because it seems like

[00:01:46] Speaker 01:
Inequitable conduct is in its separate box from obviousness and anticipation, and it seems like certainly after Therosense, there are very high burdens that go along with establishing inequitable conduct.

[00:01:57] Speaker 01:
I personally don't recall seeing a preliminary injunction case where inequitable conduct was the validity contention.

[00:02:03] Speaker 03:
Your Honor, my memories, same as yours, I don't recall any specifically on that issue.

[00:02:09] Speaker 01:
And your view on the law is that the district court should have and would have concluded that there was a substantial question of validity or unenforceability, technically, I guess, raised by what you put forward on inequitable conduct.

[00:02:24] Speaker 03:
That's correct, Your Honor, especially if they had applied the correct standard.

[00:02:30] Speaker 01:
What's the correct standard, substantial question of validity?

[00:02:33] Speaker 03:
Well, Your Honor, that's the second point I want to make, is regarding the preliminary injunction standard, the court made a legal error in applying the Titan Tire test for preliminary injunction versus the Amazon.com test for preliminary injunction.

[00:02:48] Speaker 00:
Well, isn't this just a question of different linguistics?

[00:02:53] Speaker 00:
You have to show the likelihood of success.

[00:02:56] Speaker 00:
And that means validity and infringement.

[00:02:59] Speaker 00:
And if there's a showing that there's a real problem, then you haven't satisfied that problem.

[00:03:13] Speaker 03:
Yes, Your Honor.

[00:03:15] Speaker 03:
OK.

[00:03:15] Speaker 03:
I understand.

[00:03:16] Speaker 03:
I think there is a very big difference between a substantial question as it's been laid out by the Amazon.com case and the Titan Tire standard, which has been laid out

[00:03:27] Speaker 03:
In the Amazon.com case, the way multiple panels in this court has interpreted it is that the challenger in this case, our client, needs to raise only a substantial question as to invalidity or unenforceability in this case.

[00:03:44] Speaker 03:
And the other side does have the chance to present their own evidence on the other side.

[00:03:48] Speaker 01:
The only thing I would differ with you is the word you used, only.

[00:03:53] Speaker 01:
as if your cabiding substantial question is to not being a big deal.

[00:03:57] Speaker 01:
That word only is, I don't think, appears in Amazon or any of our cases.

[00:04:02] Speaker 01:
The cases apply substantial question of invalidity, which is a pretty stringent standard, is it not?

[00:04:09] Speaker 01:
I mean, I have no basis to believe it isn't, right?

[00:04:12] Speaker 03:
Well, Your Honor, I think we've got to remember the context.

[00:04:14] Speaker 03:
This is a preliminary injunction stage where

[00:04:16] Speaker 03:
There has not been full discovery.

[00:04:18] Speaker 03:
There has not been expert depositions.

[00:04:19] Speaker 03:
There hasn't been getting ready for trial.

[00:04:21] Speaker 01:
We're at a very preliminary... So where do you think the difference is?

[00:04:23] Speaker 01:
What you say, the district court erred by applying Titan Tire.

[00:04:26] Speaker 01:
Right.

[00:04:26] Speaker 01:
What is the difference between the standard he employed from Titan Tire and the standard you derive from Amazon?

[00:04:32] Speaker 03:
Right.

[00:04:33] Speaker 03:
So amazon.com has the substantial question where essentially a substantial question

[00:04:39] Speaker 03:
in my mind, is less than 51%.

[00:04:41] Speaker 03:
It's almost similar to a substantial evidence when you're reviewing a factual.

[00:04:46] Speaker 01:
How do we know that?

[00:04:48] Speaker 01:
I mean, you're interpreting.

[00:04:49] Speaker 01:
You're not using the words of Amazon.com.

[00:04:52] Speaker 01:
You're coming up with your own conclusion.

[00:04:55] Speaker 01:
Has our court ever applied Amazon and said substantial question means less than 51%, less than 50%?

[00:05:02] Speaker 03:
No, I'm just trying to explain theoretically what it means in my mind.

[00:05:05] Speaker 04:
Why can't we just use the language of the actual factor itself?

[00:05:10] Speaker 04:
What's the likelihood of success that the patent owner is going to be able to withstand your unenforceability challenge?

[00:05:19] Speaker 03:
Your Honor, the problem with using the standard of just likelihood of success is that we have this precedent.

[00:05:25] Speaker 03:
We have this case law from Amazon.com, which was the binding presidential opinion.

[00:05:30] Speaker 04:
But obviously it has to equate with the actual time-tested standard of likelihood of success on the merits, likelihood of success that

[00:05:41] Speaker 04:
they will be able to prove at trial that your products are infringing their patent.

[00:05:46] Speaker 04:
Likelihood of success on the merits of the validity question that they will be able to withstand your unenforceability challenge.

[00:05:56] Speaker 04:
Right?

[00:05:57] Speaker 04:
Now, whatever we've said has to comport with that.

[00:06:02] Speaker 04:
Right.

[00:06:03] Speaker 04:
Has to bend towards that.

[00:06:05] Speaker 04:
And so now we have this language, substantial question of validity.

[00:06:08] Speaker 04:
substantial question of unenforceability for your purposes.

[00:06:14] Speaker 04:
Substantial question itself could be a little indeterminate, what that means.

[00:06:20] Speaker 04:
It sounds like your preferred conception is something that's rather minor.

[00:06:28] Speaker 04:
But I'm not so sure that that would be consistent with the origins of the inquiry, which is likelihood of success on the merits.

[00:06:38] Speaker 03:
I understand your point, Your Honor, and certainly other circuits have talked about likelihood of success as just being likelihood of success.

[00:06:45] Speaker 03:
But we've seen that there is multiple panel decisions from this court

[00:06:50] Speaker 03:
where they have applied the Amazon.com.

[00:06:52] Speaker 00:
We have just blessed by the Supreme Court likelihood of success.

[00:06:57] Speaker 00:
And you're saying two of our panels have used different language.

[00:07:01] Speaker 00:
Isn't it the job of this court, this panel, to determine whether the language really means anything different?

[00:07:10] Speaker 03:
Yeah, I would certainly welcome that opportunity for the court.

[00:07:16] Speaker 01:
Tell me if I'm wrong, but I don't see anything in the cases which we've applied the substantial question standard to diverge at all from what we would use for likelihood of success.

[00:07:26] Speaker 01:
I don't think we've ever said it's under 50%.

[00:07:29] Speaker 01:
I don't think the narrative in the cases and how we analyze this substantial question points us to something like under 50%.

[00:07:37] Speaker 03:
OK, Your Honor.

[00:07:38] Speaker 01:
Am I wrong about that?

[00:07:39] Speaker 03:
I'm not aware of any cases, but I will say that the district court itself talked about the different standards from Amazon.com and Titan Tire.

[00:07:48] Speaker 03:
And he said, in this case, it may make a difference.

[00:07:51] Speaker 03:
So even in the district court's mind, he's seeing a difference in the standards.

[00:07:55] Speaker 04:
And am I wrong that the district court's long discourse on the formulations in Amazon and Titan Tire, he was really

[00:08:07] Speaker 04:
focused on the question of should he just look at one party's evidence or should he be looking at both parties' evidence in terms of assessing the likelihood of success on validity or on enforceability?

[00:08:20] Speaker 03:
That's not my reading, Your Honor.

[00:08:22] Speaker 03:
My reading is he has seen different standards, different burdens of proof, and he's trying to reconcile which is really the correct burden of proof in this case.

[00:08:31] Speaker 03:
And the end

[00:08:32] Speaker 03:
He says, quote, I will therefore attempt to remain faithful to the Federal Circuit case law and apply the Titan synthesis.

[00:08:39] Speaker 03:
And he makes that conclusion, even though earlier in his opinion, he says when there's conflicting panel-type decisions, the older precedent applies.

[00:08:47] Speaker 03:
It hasn't been reversed en banc.

[00:08:49] Speaker 03:
And in this case, this is Amazon.com.

[00:08:51] Speaker 03:
So in one case, he's saying Amazon.com is the test that should be applied.

[00:08:56] Speaker 03:
But for some reason, at the end, he gets and says, well, I'm going to apply it.

[00:08:59] Speaker 04:
He says the test, my understanding of his

[00:09:02] Speaker 04:
discourse was he was talking about how the amazon.com could be read to be limited to just looking at the challengers evidence and argument only and whether that evidence and argument itself raises a substantial question of validity without considering the patent owners rebuttal evidence and then he ultimately concluded after reading everything including type entire that no the better reading of amazon.com to the extent that there's a conflict which

[00:09:32] Speaker 04:
he concluded there wasn't, is that you consider everybody's evidence, everybody's argument, in trying to figure out ultimately whether a substantial question of validity has been raised.

[00:09:42] Speaker 04:
That's my understanding of the reading.

[00:09:44] Speaker 04:
Is there something else in particular?

[00:09:45] Speaker 03:
No, he certainly did.

[00:09:46] Speaker 03:
Yes, Your Honor, you're absolutely correct that he did go through that type of analysis.

[00:09:50] Speaker 03:
We, as the appellants, have never made the argument that you can only consider our evidence.

[00:09:55] Speaker 03:
We've always agreed that it is a weight of evidence on both sides.

[00:09:58] Speaker 01:
OK, so you take that off the table.

[00:09:59] Speaker 01:
Where was the court wrong in terms of the standard he applied?

[00:10:02] Speaker 03:
Right, right.

[00:10:02] Speaker 03:
We've never argued that he can't consider both sides of the evidence.

[00:10:06] Speaker 03:
The question is, once you do look at both sides' evidence, what is the standard to apply?

[00:10:12] Speaker 03:
And is it that they need to show a likelihood of success on the merits, or that

[00:10:17] Speaker 03:
We are, they have the burden to show that we're unlikely to prevail on our defenses.

[00:10:22] Speaker 03:
Or is it just we raise a substantial question to see if they can counter it.

[00:10:25] Speaker 03:
But there absolutely is a difference.

[00:10:28] Speaker 03:
And the judge has said so.

[00:10:29] Speaker 00:
The likelihood of success is the test, right?

[00:10:33] Speaker 00:
Substantial question on the merits is the reverse of that.

[00:10:38] Speaker 00:
It's the negative of the test.

[00:10:41] Speaker 03:
Your Honor, the way I see it is there is the likelihood of success

[00:10:44] Speaker 03:
standard, but the way this court has interpreted what does that mean in various situations is, has the defendant raised a substantial question?

[00:10:52] Speaker 03:
This is a preliminary injunction.

[00:10:54] Speaker 03:
It's very early stage of the case.

[00:10:55] Speaker 01:
Can you look at page A11?

[00:10:57] Speaker 01:
Because maybe I'm misreading what he's trying to say there.

[00:11:02] Speaker 01:
But the first full paragraph says, Titan Tiger doesn't merely overturn it.

[00:11:08] Speaker 01:
It's not in power to do, though.

[00:11:10] Speaker 01:
It rather reconciles it.

[00:11:12] Speaker 01:
I believe it succeeds in doing that.

[00:11:14] Speaker 01:
And then it seems to me the district court is setting out the standard, which is about to apply, placing the burden on the defendant to raise a substantial issue, in which case the patentee must demonstrate the likelihood it will exceed in meeting its ultimate burden of persuasion by clearing convincing evidence.

[00:11:33] Speaker 01:
Isn't that exactly?

[00:11:34] Speaker 01:
I mean, they use substantial issue rather than substantial question.

[00:11:38] Speaker 01:
Where's the discrepancy here between

[00:11:42] Speaker 01:
What's wrong with this?

[00:11:45] Speaker 03:
Well, what's wrong with that, Your Honor, is he's mixing and matching and seeing, trying to, I think he's just confused of really what the standards are in the two cases, because that's not what Titan Tire said.

[00:11:57] Speaker 03:
Titan Tire did not say, well, as long as we raise a substantial issue, then they have to go next.

[00:12:02] Speaker 03:
What Titan Tire said to test is, basically,

[00:12:05] Speaker 03:
on page 1378 of Tight and Tire, an injunction shall issue unless the patentee is unlikely to succeed on the merits of the validity issue, because the patentee is unable to establish that the alleged infringers in validity defense lack substantial merit.

[00:12:20] Speaker 03:
So that's the language of Tight and Tire.

[00:12:22] Speaker 01:
I don't know.

[00:12:23] Speaker 01:
I'm confused now.

[00:12:24] Speaker 01:
I'm sorry.

[00:12:24] Speaker 01:
Maybe I'm confused.

[00:12:25] Speaker 01:
You were maybe myself.

[00:12:26] Speaker 01:
But are you advocating a tight one?

[00:12:29] Speaker 01:
You're presumably saying the two are different.

[00:12:32] Speaker 01:
Correct.

[00:12:32] Speaker 01:
And which one are you advocating?

[00:12:34] Speaker 03:
Amazon.com is the standard that should have applied.

[00:12:36] Speaker 01:
Yeah, and that's a substantial question.

[00:12:38] Speaker 01:
But in the sentence I just read you, he says, we're placing the burden on the defendant to raise a substantial issue, in which case the patentee, you've agreed the patentee gets to speak out then and try to rebut the substantial issue matter.

[00:12:56] Speaker 01:
Why is that not?

[00:12:58] Speaker 01:
Just like what we said in Amazon.com?

[00:13:00] Speaker 03:
Because, again, he's meandering through the different case law.

[00:13:03] Speaker 03:
He's trying to pick up little pieces of Amazon.com by saying that.

[00:13:06] Speaker 03:
But at the end, he says, I'm going to apply Titan Tire.

[00:13:09] Speaker 03:
And that's the test I'm applying.

[00:13:11] Speaker 03:
Why is he trying to pick up Amazon.com and almost essentially create a new test where I'm going to take little bits and pieces from Titan Tire and Amazon.com and essentially come up with my own test?

[00:13:22] Speaker 03:
Substantial issue, he uses that language.

[00:13:24] Speaker 03:
That language is not an intent.

[00:13:26] Speaker 04:
read our own case law, and we'll figure it out.

[00:13:30] Speaker 04:
What other arguments do you have?

[00:13:31] Speaker 04:
You're quickly running out of time.

[00:13:32] Speaker 03:
Yeah, and I see I'm in my rebuttal time, so I'd like to reserve that if I could, please.

[00:13:35] Speaker 01:
Well, why don't you?

[00:13:36] Speaker 01:
Is there any other compelling point you want to make with us so we can extend the time of that?

[00:13:40] Speaker 01:
We took a lot of your time discussing this.

[00:13:44] Speaker 03:
That's all I want to say on that standard right there.

[00:13:46] Speaker 04:
OK, but you said you had three points, and you only got to point one.

[00:13:50] Speaker 03:
Oh, OK.

[00:13:50] Speaker 03:
If you want to talk about my other points, OK, sure.

[00:13:52] Speaker 04:
Just identify them.

[00:13:53] Speaker 03:
So that you don't waive them.

[00:13:55] Speaker 03:
The second issue I want to talk about is the preliminary injunction standard, which you talked about.

[00:14:01] Speaker 03:
The third issue I want to talk about is regarding the fairest non-infringement and unclean hands defense.

[00:14:08] Speaker 03:
And the problem with those offenses is the court ruled against on this, but the court did not make Rule 52A findings a fact.

[00:14:17] Speaker 03:
And specifically regarding the non-infringement arguments that we raised,

[00:14:22] Speaker 03:
The court said, quote, that it has interpreted the term buffer in such a way that it's fatal to our non-infringement argument.

[00:14:36] Speaker 03:
But the question there and the problem there is he never took our argument.

[00:14:40] Speaker 00:
Your argument is that a buffer cannot be a buffer in a solid state.

[00:14:46] Speaker 03:
That is one argument, yes.

[00:14:47] Speaker 00:
Because that's like saying a hammer cannot be a hammer when it isn't banging a nail.

[00:14:52] Speaker 00:
It is still a buffer, even when it isn't operating as a buffer and solution.

[00:14:57] Speaker 03:
Correct.

[00:14:58] Speaker 03:
Correct.

[00:14:58] Speaker 00:
So there's... Correct, but that's not the... That's contrary to the argument you made.

[00:15:04] Speaker 03:
Well, the problem is, Your Honor, that there is expert evidence on both parties' constructions that were offered, and then there's expert testimony on both theories.

[00:15:15] Speaker 03:
Our experts said that a buffer cannot act as a buffering agent in a biophilized solid state.

[00:15:23] Speaker 03:
Their experts said, well, it actually can, because there's residual moisture that might be there.

[00:15:27] Speaker 03:
So what did the district court conclude?

[00:15:29] Speaker 03:
Did the district court take their evidence, or did it take our evidence?

[00:15:32] Speaker 00:
The point is, it's a buffer if it's capable of buffering in an appropriate situation.

[00:15:38] Speaker 03:
Right.

[00:15:39] Speaker 03:
And the appropriate situation in that case would have to be in a liquid state.

[00:15:42] Speaker 03:
But the claim is limited to a solid lyophilized composition.

[00:15:47] Speaker 03:
And that's the problem.

[00:15:48] Speaker 03:
So either the sodium phosphate is acting as a buffer in a dry state.

[00:15:54] Speaker 03:
We don't think that can happen.

[00:15:56] Speaker 03:
Or the sodium phosphate is acting as a buffer in the liquid state, in which case the lyophilized composition, which is a required claim, exists in the solid state, no longer exists.

[00:16:07] Speaker 03:
So for that reason, we just want to know what the district court concluded on this.

[00:16:11] Speaker 03:
There's evidence on both sides.

[00:16:13] Speaker 03:
This is an unreviewable issue because the district court made no findings.

[00:16:16] Speaker 03:
He took a Markman decision, gave us a Markman construction, and we expected, OK, fine.

[00:16:22] Speaker 03:
We understand you made your construction.

[00:16:23] Speaker 03:
How does that apply to our specific dibasic sodium phosphate heptahydrate?

[00:16:29] Speaker 03:
Well, how does ours act in a way that actually would meet the claim?

[00:16:32] Speaker 03:
And that finding is never there.

[00:16:34] Speaker 03:
So we can't review that.

[00:16:36] Speaker 03:
I can't make arguments to you.

[00:16:37] Speaker 03:
And he's really hand tied to everybody in this courtroom because he hasn't made those factual findings.

[00:16:40] Speaker 00:
If I have a composition.

[00:16:42] Speaker 00:
reading the toxin, the poison, and it has arsenic in it.

[00:16:49] Speaker 00:
You're essentially saying that if it's not administered to a person where it acts as a person, as a poison, it's not a poison.

[00:16:59] Speaker 00:
That's essentially your argument with respect to a buffer in a solid state where it's not yet acting as a buffer.

[00:17:07] Speaker 00:
It still is a buffer.

[00:17:10] Speaker 03:
It's a buffer in some states, but it's not a buffer in other states.

[00:17:14] Speaker 03:
And the claims are directly limited to a certain point in time.

[00:17:17] Speaker 00:
When you say states, you're not referring to Maryland or Virginia.

[00:17:21] Speaker 03:
No, I'm sorry.

[00:17:21] Speaker 03:
It's really certain points in time.

[00:17:24] Speaker 03:
A sodium phosphate can act as a buffer and have buffering action when it is in a liquid state.

[00:17:29] Speaker 03:
But in a solid state, our contention it is not.

[00:17:33] Speaker 03:
Their contention it is in certain circumstances.

[00:17:35] Speaker 03:
How does that apply to our sodium phosphate, and specifically

[00:17:38] Speaker 03:
Which situation is that?

[00:17:40] Speaker 03:
We don't know.

[00:17:41] Speaker 01:
OK.

[00:17:42] Speaker 01:
We've exceeded your time.

[00:17:43] Speaker 01:
We'll restore a couple minutes for rebuttal.

[00:17:45] Speaker 03:
Thank you, Your Honor.

[00:17:51] Speaker 02:
May it please the court.

[00:17:52] Speaker 02:
The district court did not abuse its discretion, and Farah has not shown any abuse of discretion.

[00:17:57] Speaker 01:
What do you make of this debate you've been having about what standard the district court applied and whether that was correct or not?

[00:18:04] Speaker 02:
Your Honor, as we have summarized in the brief, we agree with the way Judge Chen described it.

[00:18:09] Speaker 02:
The district judge here was reviewing was, can he look at the patent owner's evidence to determine whether there was a likelihood of success or not?

[00:18:18] Speaker 02:
And that's how the district judge read the case law.

[00:18:21] Speaker 02:
As it turns out, and as the district court noted, as applied, those cases that he was referring to also look at both sides' evidence, including the Amazon case itself.

[00:18:32] Speaker 02:
And here, as applied,

[00:18:34] Speaker 02:
We don't believe that that debate has to be resolved in this particular case, although if it were, we've favored the Titan Tire because it's a clearer recitation and because it takes eBay into account.

[00:18:45] Speaker 02:
But the reason it doesn't need to be resolved or the resolution of it does not affect the outcome is because the district court said on page 23, under either analysis,

[00:18:54] Speaker 02:
Fresenius' copy had shown a likelihood of success on the merits as to this inequitable conduct claim that's not being raised.

[00:19:01] Speaker 04:
You did say that on one particular point, it would be a closer question, right?

[00:19:05] Speaker 02:
Yes.

[00:19:06] Speaker 02:
And in the beginning of the opinion, he notes that where there is a close question, that's where he's going to address it.

[00:19:10] Speaker 02:
And on page 23, he says it would be a closer question under the way he applied or understood the Amazon test.

[00:19:17] Speaker 02:
But even as to that, which was literally, did they raise a substantial question or not, the district court said no.

[00:19:24] Speaker 02:
And on the same page, it's because likelihood of success, particularly on intent, there was no evidence, no showing of any kind, as to evidence of intent to have the inequitable conduct called into question.

[00:19:35] Speaker 04:
Before I forget, how come there isn't a 30-month stay in this case?

[00:19:38] Speaker 02:
There isn't a 30-month stay in this case because of the timing of interest and a footnote in the district court's opinion.

[00:19:43] Speaker 02:
But essentially, the patent here was listed after the ANDA was submitted, so that the timing was that the patent

[00:19:52] Speaker 02:
The whole timeline of events was Fresenius Copy developed its product, applied for a patent, launched its product.

[00:19:58] Speaker 02:
Then there is an ANDA that was submitted.

[00:20:01] Speaker 02:
Then the patent gets issued.

[00:20:03] Speaker 02:
So under that timeline of events, there isn't an automatic 30-month stay.

[00:20:06] Speaker 02:
But FARA still has the obligation to say, here's a notice letter with your patent enlisted, and then we go forward in the litigation.

[00:20:14] Speaker 02:
But there's no 30-month stay where the patent is listed after the ANDA is filed.

[00:20:23] Speaker 02:
Referring then to the standard review, I think we've addressed that particular question.

[00:20:30] Speaker 02:
Council then also spent and addressed the inequitable conduct issue.

[00:20:34] Speaker 02:
But again, that really relates to the same point that the district court made, that under either analysis, Fresenius-Kabi was likely to succeed.

[00:20:42] Speaker 02:
And particularly the intent prong, which we don't even read as being appealed in the opening brief, that was enough to show that Fresenius-Kabi had a likelihood of success on the merits.

[00:20:51] Speaker 01:
What about your friend's final point, which was the absence of factual findings with respect to the infringement and its relationship to the claim construction argument?

[00:21:00] Speaker 02:
Your Honor, we do believe there were sufficient findings here because there was only one issue that FERA itself had even presented.

[00:21:07] Speaker 02:
And as the district court notes on page 11 of the opinion, FERA's only objection was a claim construction issue.

[00:21:14] Speaker 02:
Can it be that you call something a buffer in a solid before it's put into the liquid?

[00:21:19] Speaker 02:
And the district court resolved that issue, which was a claim construction issue, as a matter of law with the claim construction order issued the same day.

[00:21:27] Speaker 02:
And important to note, the claim construction opinion was incorporated by reference in the preliminary injunction decision.

[00:21:33] Speaker 02:
This is another fact that the reply brief didn't address, saying that there were

[00:21:37] Speaker 02:
two different things.

[00:21:37] Speaker 01:
I don't understand.

[00:21:38] Speaker 01:
So you're saying that the other side kind of waived, that they conceded at some point that under the claim construction that the district court reached, they would lose on infringement?

[00:21:51] Speaker 02:
Your Honor, they didn't expressly waive it.

[00:21:53] Speaker 02:
But here's what happened.

[00:21:54] Speaker 02:
And the district court addresses this on the bottom of page 10 going into 11, that Fresenius Cabe submitted an expert report by Dr. Klybanov addressing all of the elements.

[00:22:03] Speaker 02:
And the district court says on the top of page 11,

[00:22:06] Speaker 02:
The only item that Farah challenges from that, and we agree that was the correct factual finding.

[00:22:11] Speaker 01:
Are you sure we're looking at the same thing?

[00:22:13] Speaker 01:
Because I'm not seeing.

[00:22:14] Speaker 02:
The bottom of 11 going to 12.

[00:22:17] Speaker 02:
I apologize.

[00:22:17] Speaker 01:
OK.

[00:22:18] Speaker 01:
All right.

[00:22:19] Speaker 02:
Bottom of page 11, Fresenius's expert submits that Farah's proposed generic formulations fall within the limitations of each of those claims.

[00:22:26] Speaker 02:
So there is a finding that the judge has made that, as to the elements, an expert has submitted an analysis

[00:22:32] Speaker 02:
And the next sentence says, Farah's only challenge to those infringement allegations per se is that the patent requires a buffer, and goes on from there to this liquid versus solid analysis, which the district court says his claim construction opinion renders that argument and distinction fatal.

[00:22:48] Speaker 02:
And therefore, there is a likelihood of success for Farzani's caveat trial.

[00:22:56] Speaker 04:
At this point, when the preliminary injunction motion was granted, did the other side have

[00:23:03] Speaker 04:
Opportunity yet to depose your expert who filed the declaration from the prosecution?

[00:23:12] Speaker 02:
Opportunity, yes.

[00:23:13] Speaker 02:
But they didn't take it.

[00:23:15] Speaker 02:
And what I mean by that is, Your Honor, the parties discussed how should discovery proceed.

[00:23:19] Speaker 02:
And Fresenius Cabe issued deposition notices.

[00:23:23] Speaker 02:
And Ferris Council called and said, maybe we don't need discovery.

[00:23:26] Speaker 02:
Let's work it out.

[00:23:27] Speaker 02:
And then they submitted a letter to the court saying, we don't believe discovery is required.

[00:23:32] Speaker 02:
And that is what happened.

[00:23:34] Speaker 01:
So what's going on now?

[00:23:35] Speaker 01:
This preliminary injunction issued like a year ago, right?

[00:23:38] Speaker 01:
It wasn't a year ago.

[00:23:39] Speaker 02:
The litigation is still ongoing, Your Honor.

[00:23:41] Speaker 02:
There is no trial date that's been set.

[00:23:43] Speaker 02:
There are some discovery items that remain open.

[00:23:46] Speaker 02:
And we expect discovery would close by the end of the year and trial sometime next year.

[00:23:52] Speaker 04:
In the 084 provisional?

[00:23:56] Speaker 04:
which is incorporated by reference into the patent.

[00:23:58] Speaker 04:
I understand that.

[00:24:00] Speaker 04:
It talks about, there's formulations A and B, and there's a parentheses range for A 0.16 to 0.34, and for B 0.22 to 0.27.

[00:24:13] Speaker 04:
Just curious, are those ranges the same kinds of ranges that you see in table two for a formulation CDE where they represent ranges over time?

[00:24:27] Speaker 04:
Or are they individually tested versions of A where they were just all over the map and they just tested it at these particular levels?

[00:24:40] Speaker 02:
The data for A and B was not in the provisional, and I think that's why you're asking what does the actual data show.

[00:24:46] Speaker 04:
The spec, the provisional spec says the T3 did not increase over time.

[00:24:54] Speaker 04:
But then in these parenthetical ranges, the suggestion is, you know, if you go from 0.16 to 0.34, if you're using the same kind of analysis that you're using in Table 2, well, that is a change and an increase over time.

[00:25:11] Speaker 04:
So that's why I'm just trying to understand what do these ranges actually represent?

[00:25:16] Speaker 02:
Unfortunately, the record doesn't have the data side by side in that provisional for that point.

[00:25:21] Speaker 02:
So I don't have the answer to that from this.

[00:25:23] Speaker 02:
We do know from the other data, though, that your honor is correct, there is a difference in the way the slopes are over time, but it just depends on what the comparison is.

[00:25:32] Speaker 02:
So if the comparison is A, B, to C, D, and E, you would see a difference over time.

[00:25:38] Speaker 02:
But to make sure that we're getting in the context of the issue presented, what the

[00:25:43] Speaker 02:
appellant is saying is that this data should have been included in the utility.

[00:25:47] Speaker 02:
No, I understand.

[00:25:48] Speaker 04:
I'm trying to figure out if you can explain to me what did this non, what did this provisional application mean when it said formulations A and B for T3 did not increase over time, and yet we have parentheticals that the most reasonable reading would suggest that they do increase over time, unless there's some other understanding of what those ranges represent.

[00:26:12] Speaker 02:
There is no other understanding that could be interpreted both ways.

[00:26:16] Speaker 02:
Importantly... When you say both ways, what are the two ways?

[00:26:19] Speaker 02:
That there was no increase over time or that the... How would that be no increase over time, 0.16 to 0.34?

[00:26:25] Speaker 02:
I'm sorry, that the data was interpreted as no increase over time depending on where those data points were.

[00:26:31] Speaker 02:
One way to read it is 0.16 was at the beginning and 0.34 is at the end.

[00:26:36] Speaker 02:
Another is it could be

[00:26:38] Speaker 02:
It says varied from 0.16 to 0.34.

[00:26:40] Speaker 02:
So it can go up and down, as has happened in other of the sets of reported data.

[00:26:46] Speaker 02:
So unfortunately, it's just not clear whether the person reviewing that underlying data was looking at it and saying, here's a trend that I do or don't see, or if there was an up and down of the same numbers.

[00:26:58] Speaker 02:
But to make sure that we're talking about the same thing here, as far as it affects the appeal, though, Your Honor, all of those A through E were about 10 milligram of mannitol

[00:27:06] Speaker 02:
batches.

[00:27:07] Speaker 02:
So the point here is that they were not the claimed invention.

[00:27:10] Speaker 02:
All of those used the higher prior levels of Manitol, and that's what is different than what was discussed in the full utility application and the later declaration, all of which focus on what happens if we go from 10 milligrams to 3 milligrams of Manitol.

[00:27:25] Speaker 02:
And that did show, in all of those cases, a trend of increased resistance to the stability issues that had been... Right.

[00:27:32] Speaker 04:
Using a die-basic buffer, right?

[00:27:36] Speaker 04:
Correct.

[00:27:37] Speaker 04:
What about for a tri-basic buffer?

[00:27:39] Speaker 04:
Also, there's... Going from 10 milligrams mannitol to 3 milligrams mannitol.

[00:27:43] Speaker 04:
Is there anything in the record that says, yes, ooh, this is unexpected.

[00:27:48] Speaker 04:
We also get increased stability when we go down from 10 to 3 milligrams mannitol for a tri-basic.

[00:27:55] Speaker 04:
For one tri-basic to one dibasic, that's... No, from tri-basic, you stay with tri-basic with 10 milligrams mannitol.

[00:28:03] Speaker 04:
and then you stick with tri-basic with three milligrams of mannitol, do you get the unexpected results, the allegedly unexpected results?

[00:28:10] Speaker 02:
Yeah, I'm not aware of data on that particular point, because by the time of the declaration, the comparisons had been made of two kinds, dibasic versus dibasic in figure one of the declaration that the inventor had submitted, and then the dibasic of the invention versus the tri-basic of the prior art in figure two.

[00:28:26] Speaker 04:
And that's where the declarant said they compared T4 with

[00:28:33] Speaker 04:
with the claimed invention using dibasic against a grandfather product?

[00:28:40] Speaker 04:
Is the grandfather product the 10 milligram mannitol with tribasic?

[00:28:44] Speaker 04:
Yes, correct.

[00:28:45] Speaker 02:
So figure two was making the comparison of what happens when you compare the invention to the prior art literally head-to-head, which is what the examiner is asking.

[00:28:53] Speaker 02:
And figure one was saying, if we stay within dibasic but only change the mannitol, what happens?

[00:28:58] Speaker 02:
In both cases, there was improvement of the stability of results.

[00:29:03] Speaker 02:
earlier in the provisional had noted, if the dibasic is what they believed to have been better.

[00:29:08] Speaker 02:
So then when they were working within the dibasic to dibasic in figure one, that's what they were able to show was the effect of increased stability resistance was really due to the 3 milligrams of mannitol and not to any of the other variables.

[00:29:20] Speaker 02:
That's the conclusion they were able to reach.

[00:29:22] Speaker 02:
And the examiner in the notice of allowance said, yes, I see that that shows the difference between 10 and 3 milligrams of mannitol does have an unexpected benefit to stability.

[00:29:32] Speaker 02:
And here, the district court looked at that analysis and concluded that there, as a matter of fact, that was no substantial question had been raised, and then said that under the traditional Rule 65 analysis, that there would be no likelihood of success for Farah and a likelihood of success for Fresenius Coppi on the merits at trial.

[00:29:53] Speaker 02:
Your Honor, unless there are other questions, I'm happy to cede the time on other issues.

[00:30:00] Speaker ?:
Thank you.

[00:30:10] Speaker 03:
And there's just a few more points in rebuttal.

[00:30:14] Speaker 03:
Regarding the evidence that Farah presented on the non-infringement defenses, there absolutely was non-infringement evidence submitted by the declaration of Dr. Palmeri.

[00:30:26] Speaker 03:
And the joint appendix citations for that are APX 1909, 1914 through 1915.

[00:30:33] Speaker 03:
And then the counter evidence by Dr. Klippanoff was on pages 2214 through 15, 22, 27,

[00:30:40] Speaker 03:
through 29.

[00:30:41] Speaker 03:
Your Honors, counsel raised the merits of the inequitable conduct claim and the fact that the tri-basic sodium phosphate data was omitted from the non-provisional.

[00:30:57] Speaker 03:
It was in the provisional, and then for some mysterious reason, and we still have not gotten a reasonable explanation why, when it came time to file the non-provisional, that data disappears.

[00:31:10] Speaker 03:
After the non-provisional application is filed, the examiner looks at it and says, that's interesting.

[00:31:15] Speaker 03:
What I'd really like to see is a comparison between the tri-basic sodium phosphate compositions and this di-basic sodium phosphate compositions that you have.

[00:31:25] Speaker 03:
And it's ignored.

[00:31:27] Speaker 03:
They don't raise their hand and say, examiner, guess what?

[00:31:30] Speaker 03:
We actually did present that data a long time ago.

[00:31:32] Speaker 03:
And that data actually showed the tri-basic sodium phosphate was stable over time.

[00:31:37] Speaker 03:
They never raised their hand.

[00:31:38] Speaker 03:
In fact, they next do a declaration where they again go to this dibasic versus dibasic comparisons.

[00:31:45] Speaker 03:
The examiner has told them, I want to see the closest prior art comparison.

[00:31:48] Speaker 03:
That's never done by them.

[00:31:50] Speaker 03:
We know the evidence existed.

[00:31:51] Speaker 03:
It was in the provisional.

[00:31:52] Speaker 03:
It's never mentioned.

[00:31:54] Speaker 03:
And it's ultimately tremendously unfair that the examiner never had the opportunity to look at that data.

[00:32:00] Speaker 03:
The data is what matters to the examiner.

[00:32:03] Speaker 04:
examiner doesn't have the ability to go out and if it's incorporated by reference though and there's no dispute that the provisional was incorporated by reference then we have case law where we have said as a matter of law that's treated as if those contents are actually in the application itself and so they so I mean we can't know whether the examiner actually read the contents of the provisional

[00:32:33] Speaker 04:
It's hard to say that there has been some specific intent to deceive the examiner when the examiner is charged with reviewing and reading the actual specification, which these contents have been incorporated into.

[00:32:49] Speaker 03:
And Your Honor, regarding the case law and specific intent, I think the MPHJ versus Rico case that we just cited is really very instructive as to the intent.

[00:32:59] Speaker 03:
And again, that was an incorporation by reference type situation where

[00:33:02] Speaker 03:
The non-provisional was trying to incorporate the provisional.

[00:33:05] Speaker 03:
It was looked at in terms of claim construction.

[00:33:08] Speaker 03:
And did the applicants really have an intent to limit the construction in a certain way?

[00:33:15] Speaker 03:
And because information that was limiting in the provisional was pulled out by the time it went to the non-provisional, this court found that, wow, that really shows a lot of intent.

[00:33:27] Speaker 03:
They had it in the provisional, got yanked out when it came time to the non-provisional.

[00:33:32] Speaker 03:
That showed an intent.

[00:33:33] Speaker 03:
They really wanted to give up the limiting information.

[00:33:35] Speaker 03:
So incorporation by reference, as this court said, is a question of law.

[00:33:40] Speaker 03:
It's reviewed de novo.

[00:33:42] Speaker 03:
And in this case, we think the MPHG versus RICO case is quite instructive to show how when you look at the broad circumstances and all the circumstances in here, you'll see an intent to omit the information.

[00:33:58] Speaker 01:
One final point.

[00:33:59] Speaker 01:
All right, Your Honor.

[00:34:03] Speaker 03:
Your Honor, I just want to say another error that we think the district court made was in ignoring the examiner's reason for allowance when she said that she was allowing claims in this case, quote, since applicants have discovered that the previous formulations are unstable.

[00:34:21] Speaker 03:
The problem with that is we know the previous formulations were not unstable.

[00:34:24] Speaker 03:
The previous formulations with a tribase containing

[00:34:27] Speaker 03:
formulations that were in the provisional, but then were never highlighted in the non-provisional.

[00:34:31] Speaker 03:
So the premise for the examiner's allowances, well, they've shown that the prior art grandfather products are unstable, so now they have a new stable version.

[00:34:42] Speaker 03:
Well, the problem is that premise is wrong.

[00:34:44] Speaker 03:
It's dead wrong.

[00:34:45] Speaker 03:
We know from the information that was yanked out of the provisional application that there was data showing that the grandfathered prior art compositions containing tri-basic sodium phosphate was stable over time.

[00:34:57] Speaker 03:
So that's the last point I want to make on that.

[00:34:59] Speaker 03:
Unless Your Honors has further questions, I'll conclude.

[00:35:02] Speaker 03:
Thank you.

[00:35:04] Speaker 01:
Thank you.