[00:00:00] Speaker 04:
Our final case this morning is number 22-1878, Estella's US LLC versus Aspera.

[00:00:08] Speaker 04:
Second, Mr. Hughes.

[00:00:11] Speaker 05:
Thank you, Your Honor, and may it please the court, Paul Hughes, for appellants.

[00:00:16] Speaker 05:
Four principal factors taken together established that the district court abuses discretion in striking appellants infringement evidence.

[00:00:25] Speaker 05:
First, there was a boldly asymmetrical process

[00:00:28] Speaker 05:
Haspera was allowed to amend its ANDA at the 11th hour for the stated purpose of defeating appellants' infringement claim contentions, but appellants were not able to meaningfully respond.

[00:00:40] Speaker 05:
Second, the court reopened discovery to allow for supplemental infringement contentions, and appellants fully complied with the schedule.

[00:00:49] Speaker 04:
I'm trying to understand the scope of that order.

[00:00:53] Speaker 04:
So help me with the chronology here.

[00:00:56] Speaker 04:
If I understand it, Apotex was the first generic to suggest that it was going to amend its and, is that correct?

[00:01:07] Speaker 04:
Yes, your honor.

[00:01:08] Speaker 04:
And when that happened, there was a hearing before the district court in April of 2021, correct?

[00:01:19] Speaker 04:
Yes, your honor.

[00:01:20] Speaker 04:
And at that hearing, your client objected to the amendment.

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And it was disclosed that other generics, including Haaspera, intended to amend their andes.

[00:01:40] Speaker 04:
And as I understand it, your client suggested that there be a stipulation among the parties as to the scope of supplemental discovery.

[00:01:53] Speaker 04:
Is that fair?

[00:01:54] Speaker 05:
Well, Your Honor, I think talking about that April 7th, 2021 hearing is important because my friends... No, no, you're not answering my question.

[00:02:01] Speaker 04:
Just answer my question.

[00:02:03] Speaker 05:
Your Honor, I think what the parties said at that hearing repeatedly was they needed discovery because they didn't want to be blindsided about what was going to be in the end of it.

[00:02:11] Speaker 04:
And there was a suggestion that there would be a stipulation for supplemental discovery, right?

[00:02:18] Speaker 04:
Yes, Your Honor.

[00:02:19] Speaker 04:
Okay.

[00:02:20] Speaker 04:
And your client and Apotex entered into such a stipulation, correct?

[00:02:26] Speaker 05:
Well, Your Honor, the ultimate order that was entered at Appendix Page 20... No, please answer my question.

[00:02:32] Speaker 04:
Your client and Apotex entered into a stipulation, right?

[00:02:36] Speaker 05:
Your Honor, I don't think that's quite correct.

[00:02:38] Speaker 05:
It's not correct?

[00:02:39] Speaker 05:
What ultimately occurred was the order that was issued at 2020 to 2021 that was the result of the parties working together.

[00:02:47] Speaker 04:
But first, I'm not asking you what happened later.

[00:02:51] Speaker 04:
My first thing is that there was a stipulation between your client and Apotex, right?

[00:02:59] Speaker 05:
I believe that's correct, Your Honor, but that ultimately resulted in the key order reopening discovery at 2020 and 2021.

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And I think we're the court.

[00:03:08] Speaker 04:
My problem with your argument that the order here goes beyond the end amendment

[00:03:15] Speaker 04:
is that in that very stipulation, and this is dated April 28, 2021.

[00:03:22] Speaker 04:
It's not in the joint appendix.

[00:03:26] Speaker 04:
It's under the heading of sculptural discovery.

[00:03:29] Speaker 04:
It says, on April 14, 2021, plaintiffs

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That's your client, to oppose that the, quote, scope of the Supplemental Discovery Clause, quote, would be the, quote, DMF and amendments, close quote.

[00:03:43] Speaker 04:
A week later, Apotex agreed.

[00:03:46] Speaker 04:
Are you suggesting that somehow the later stipulations with respect to the other generics had a broader purpose than the Apotex stipulation?

[00:03:56] Speaker 05:
Well, a few things about that, Your Honor.

[00:03:58] Speaker 05:
First, I think about the Apotex stipulation.

[00:04:00] Speaker 05:
That's at docket 715.

[00:04:03] Speaker 05:
The parties made clear that to the extent they're talking about a limited scope of discovery, it is about evidentiary discovery that they're addressing.

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There is never an agreement with HOSPERA that there is going to be a limitation on.

[00:04:16] Speaker 04:
I'm trying to understand.

[00:04:27] Speaker 04:
that there's a limited scope of discovery, and it's going to be limited to the end amendments and the DMF amendment.

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And I'm asking you a simple question.

[00:04:38] Speaker 04:
Given that the scope of discovery by specific agreement of the parties was limited to those purposes for purposes of evidence, what is there to suggest that the stipulation for discovery as to the other defendants would be different?

[00:04:54] Speaker 05:
Well, Your Honor, a few things.

[00:04:56] Speaker 05:
First, I don't agree that that is limited on the stipulation of the discovery.

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But second, even if we assume that, I don't think that changes my argument in any material way.

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Because this was a supplemental infringement contention that was necessitated by the ANDA and the DMF.

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What is the ultimate nature of the case here was they amended the ANDA for the express stated purpose of gutting the underlying infringement claims.

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This was a direct response

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limited to that, I'm saying, what is there about the later stipulation that suggests that it had a broader purpose?

[00:05:43] Speaker 05:
So if you look at the text of this, and that's Appendix page 2020 to 2021, it says there's nothing about limiting the scope of it.

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It says, in fact, that there's the allowance for supplemental infringement contentions.

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And we think that allowance for supplemental infringement contentions, again, that's entered by Judge Connolly, not by Judge Burke, is clear on its face that it allows the parties to change their infringement contentions in view of the fact that the ANDA was forthcoming.

[00:06:07] Speaker 01:
And again, when that stipulation was reached, the price of- Let me just follow up on Judge Dyke's line of questioning.

[00:06:11] Speaker 01:
Can we turn to appendix 712 to 713?

[00:06:15] Speaker 01:
And this appears to be plaintiff's letter to the Honorable Christopher Burke in opposition

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and Haspera's motion to strike.

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So if I'm not mistaken, this would have been on behalf of your client.

[00:06:32] Speaker 00:
Is this accurate?

[00:06:33] Speaker 00:
Yes, Your Honor.

[00:06:34] Speaker 00:
OK.

[00:06:34] Speaker 01:
So now if we look at top of 712, it talks about the court agreed and entered a supplemental discovery schedule concerning the plan DMF and ANDA amendments.

[00:06:45] Speaker 01:
Do you see that at the top of 712?

[00:06:47] Speaker 01:
Yes, Your Honor.

[00:06:48] Speaker 01:
And then let's go to Appendix Page 713.

[00:06:51] Speaker 01:
So in that first full paragraph at the end of that, it talks about plaintiff's contentions and expert opinion related to defendants and amendments, the focus of the supplemental discovery agreed to by the parties and ordered by the court.

[00:07:07] Speaker 01:
So my reading, at least, of this part of Appendix Page 713 seems to

[00:07:15] Speaker 01:
honestly align with Judge Dyke's points that he was making with respect to Apotex.

[00:07:20] Speaker 01:
But this seems very specific also to Aspera and limits the scope of supplemental discovery.

[00:07:25] Speaker 05:
Your Honor, I think, again, this goes to our central point.

[00:07:28] Speaker 05:
In saying that it's limited to the ANDA amendments, it's true that the ANDA amendments had the effect of taking water out of one part of the process.

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But our whole point was, in order to respond to that, we found a different part of the process that had water.

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So I don't think there's anything that suggests that this is a facial limitation saying that the scope of the discovery period was any more limited than what the court said at the top of 2020.

[00:07:52] Speaker 05:
And what the same letter says at appendix 710 is that this is all necessitated.

[00:07:57] Speaker 05:
This is in that first full paragraph.

[00:07:59] Speaker 05:
Quote, after the original close of fact discovery, expert discovery, and shortly before trial, defendants announced plans to amend key product release specifications, the DMF and their ANTA specification,

[00:08:09] Speaker 05:
that are central to the infringement issues in this case, and ask the court to move the trial date to allow them to do so.

[00:08:13] Speaker 05:
In response to the request, the court delayed trial, reopened discovery, and defendant produced those amendments in a new sample for testing.

[00:08:19] Speaker 05:
This is showing that that was completely consistent with what my clients understood the court to have done, which was to say, we're going to move trial, and we're going to reopen in light of these amendments.

[00:08:31] Speaker 04:
OK, let's assume, unless Judge Cunningham.

[00:08:40] Speaker 04:
scope of discovery was limited to the end amendments.

[00:08:44] Speaker 04:
And so under the penny pack factors, how do you suggest that there was error in the district court's decision to bar the discoveries untimely?

[00:09:02] Speaker 05:
Of course, recognizing we disagree on the timeliness issue, but assuming as the district court suggests that we're wrong about that, what ZF Meritor suggests is that

[00:09:10] Speaker 05:
The criticality of the evidence is quite essential.

[00:09:13] Speaker 05:
And one looks to the broader weighing of the importance of that evidence in the broader facts.

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And I think there are a few things that are critical here.

[00:09:22] Speaker 05:
It is defendants who said that these were very significant amendments that were done for the purpose of gutting the existing infringement contentions.

[00:09:32] Speaker 05:
And here's what Hospira said at the closing of the trial.

[00:09:35] Speaker 05:
This is a trial transcript, 787 to 788, docket 978.

[00:09:39] Speaker 05:
They said, quote,

[00:09:40] Speaker 05:
These aren't tiny changes.

[00:09:42] Speaker 05:
These are big changes for the precise purpose of addressing the issue that we've been talking about in this case.

[00:09:47] Speaker 05:
You're saying these are big, significant changes.

[00:09:49] Speaker 04:
But they didn't affect the other theory that you're now presenting.

[00:09:52] Speaker 04:
If they didn't, the amendments, the end amendments, did not impact the theory that you are now arguing about.

[00:10:01] Speaker 05:
But that takes us, again, to our central contention in this case, Your Honor.

[00:10:05] Speaker 05:
Is that correct?

[00:10:06] Speaker 05:
Right.

[00:10:07] Speaker 05:
If what occurred here, which is after plaintiffs were locked in with their theory that occurred in November, it took Haas-Spira nine months until August 24, 2021, to propose their amendments.

[00:10:20] Speaker 05:
So they waited to the 11th hour to put those amendments in.

[00:10:23] Speaker 05:
They did so, as I just quoted, for the precise purpose of gutting the existing infringement contention.

[00:10:29] Speaker 05:
If that is permissible without a plaintiff being able to amend his theory in response, no one can ever limit

[00:10:35] Speaker 05:
or narrow their infringement contentions, again, for fear of the same sort of trap being sprung.

[00:10:41] Speaker 01:
And I don't think- Why didn't you include this new theory in your original infringement contentions at the earlier part of the litigation?

[00:10:48] Speaker 05:
Why didn't you?

[00:10:49] Speaker 05:
We chose a theory, Your Honor, that Judge Connolly himself recognized.

[00:10:52] Speaker 05:
Haspira had substantial reason to be concerned about.

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That's his decision appendix 188 to 189, based on their documents.

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And it also was applicable to multiple defendants, because it was at the API supplier.

[00:11:04] Speaker 05:
rather than downstream.

[00:11:06] Speaker 05:
And we knew that we were going to have a limited time to put on our case.

[00:11:09] Speaker 05:
Judge Connolly gave us 11 hours inclusive

[00:11:12] Speaker 05:
of opening and closing.

[00:11:13] Speaker 05:
That was 10 hours, not just to prove infringement, but also address invalidity, obviousness, anticipation.

[00:11:19] Speaker 05:
We knew we were short.

[00:11:19] Speaker 01:
But why wouldn't, like typically in litigation, you're going to preserve all the theories and then you narrow your case as you get closer to trial.

[00:11:26] Speaker 01:
Can you just give me a sense of why that wasn't the approach that was utilized?

[00:11:29] Speaker 05:
We knew that based on what was going to occur with Judge Connolly, we were going to have to limit.

[00:11:33] Speaker 05:
We were doing the responsible thing at the outset of limiting the case.

[00:11:37] Speaker 05:
And again, Your Honor, I think courts, appropriately in complex Andy cases, encourage, if not require, parties to limit.

[00:11:45] Speaker 05:
If the result is that what Haas-Spera did is appropriate, no one can limit again.

[00:11:49] Speaker 04:
You weren't required to limit your infringement contentions to the theory that you did present.

[00:11:55] Speaker 04:
You could have included in the infringement contentions the broader theories.

[00:12:00] Speaker 05:
Well, Your Honor, that's the rule that we don't think this court should endorse, is to tell parties that they've got to belt and suspenders everything up in the event that an ANDA defendant late in the case makes an amendment to gut the infringement contention that's been presented.

[00:12:14] Speaker 05:
Because if that's the rule,

[00:12:15] Speaker 05:
There's no end to that, which means not just additional contentions, but additional claims are going to have to be brought with all of the resulting invalidity contentions and work for the parties and the courts.

[00:12:26] Speaker 05:
It's going to lead to a rule that massively, exponentially increases the amount of work that goes into these cases if a late ANDA amendment is allowed.

[00:12:35] Speaker 05:
As the court said in fairing, these ANDA amendments are quite important because they restrict what it is that the party is allowed to sell by the FDA.

[00:12:43] Speaker 05:
And because they restrict what is the party's allowed to say, it gives the defendant quite a bit of power to be able to push through a latent litigation and amendment to gut the existing infringement contentions.

[00:12:53] Speaker 01:
That's why- You were permitted to update your infringement case to account for that amendment by updating your old theory with new testing, correct?

[00:13:01] Speaker 05:
But, Your Honor, what they- Is that right?

[00:13:03] Speaker 05:
But Your Honor, I think that's correct.

[00:13:05] Speaker 05:
But I don't think relevant.

[00:13:06] Speaker 05:
And it's not relevant for the reason that the whole purpose of what they amended as they admitted, as I read earlier and they said in their briefs, was to gut our existing theory.

[00:13:15] Speaker 05:
And so they were successful at doing that.

[00:13:17] Speaker 05:
And so I don't think it's right to say, well, you could have amended in that theory that was gutted by the fact of the amendment when we had another very valid theory that was present.

[00:13:27] Speaker 05:
And they had more than sufficient time to be able to address this.

[00:13:29] Speaker 05:
Dr. Seed's testimony.

[00:13:31] Speaker 05:
said that it would take weeks, not months, to run that new testing.

[00:13:35] Speaker 05:
And again, this is critical because we only had five weeks and three days from when they amended their AMDA to when our contentions were due.

[00:13:41] Speaker 05:
They then had six weeks in order to turn around their expert report.

[00:13:44] Speaker 05:
And I appreciate those are tight timelines, but those tight timelines existed because of the fact that Hospira chose to amend its product and not just chose to amend, but very late.

[00:13:54] Speaker 05:
Again, our original infringement contentions were filed in November 2020.

[00:13:59] Speaker 05:
It took them nine months to make this amendment and four and a half months to even tell the court that they were intending to do so.

[00:14:05] Speaker 05:
So these changes were occasioned by their very late in the day changes.

[00:14:09] Speaker 01:
If we conclude there's no abuse of discretion, do you agree that we do not need to reach the harmless error analysis?

[00:14:16] Speaker 05:
That would come if the court agrees that there is abuse of discretion, Your Honor.

[00:14:19] Speaker 05:
So I agree, but we think this is a prototypical case for abuse of discretion.

[00:14:25] Speaker 03:
Preserve my time.

[00:14:26] Speaker 03:
OK, we'll give you two minutes.

[00:14:29] Speaker 03:
Thank you.

[00:14:29] Speaker 03:
Mr. Klein.

[00:14:33] Speaker 06:
Thank you, and may it please the court, Charles Klein for Hotspira.

[00:14:37] Speaker 06:
Council made a critical concession.

[00:14:39] Speaker 06:
He said, we chose a theory.

[00:14:42] Speaker 06:
In fact, there were four choices that plaintiffs made in this case that led directly to Judge Burke's exercise of his wide discretion to strike the theory.

[00:14:54] Speaker 06:
The first choice they made, as Judge Cunningham mentioned, was at the outset.

[00:15:00] Speaker 06:
They knew, throughout this case, they've known that Aspera takes Form G and dissolves it in a water-based solution.

[00:15:06] Speaker 06:
They had every incentive to preserve a theory of infringement if they thought that was even a viable theory.

[00:15:14] Speaker 06:
Plaintiffs have been represented by four large law firms.

[00:15:17] Speaker 06:
These are two very sophisticated pharmaceutical companies.

[00:15:21] Speaker 06:
There was no limitation on their infringement contentions.

[00:15:25] Speaker 06:
In fact, their infringement contentions were quite lengthy, yet they never once said, Hesperus compounding process infringed.

[00:15:33] Speaker 06:
That was a choice they made.

[00:15:36] Speaker 06:
In fact, their expert initially conceded when we asked him, are you offering this theory?

[00:15:41] Speaker 06:
He said, no.

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This was not some kind of simple infringement theory.

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Their own expert said this was complex based on esoteric science.

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They made a choice.

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They didn't assert it.

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They have to live with that choice.

[00:15:54] Speaker 06:
Then they made three other choices.

[00:15:57] Speaker 06:
First one is in April 2021, when Judge Connolly decided to consider the amended ANDA, at that point in time, they could have said, well, Your Honor, if you consider this amended ANDA, we should have the right to completely revisit our contentions, and we do want the right

[00:16:14] Speaker 06:
to argue that Hasmir's compounding process infringed.

[00:16:18] Speaker 06:
They could have done that in April 2021.

[00:16:21] Speaker 06:
It would have given us months to consider appropriate testing, consider the appropriate fact witnesses.

[00:16:27] Speaker 06:
We would need to bring the trial discovery.

[00:16:29] Speaker 06:
But no, they didn't say that.

[00:16:31] Speaker 06:
What they said instead was, we don't think that the amendment should change our evidence or our position, appendix 1065 to 1066.

[00:16:41] Speaker 06:
That was a decision they made.

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And they didn't preserve any type of fairing argument.

[00:16:48] Speaker 06:
Then they made another decision.

[00:16:51] Speaker 06:
At some point in time, and we don't know when, they decided that they were going to, as their expert said, go from no opinion to an opinion.

[00:17:00] Speaker 06:
We don't know when that happened, but it happened long before they disclosed to us for the first time.

[00:17:06] Speaker 06:
They waited as long as possible to tell Hospira

[00:17:09] Speaker 06:
that now its own compounding process could be at issue in the case.

[00:17:14] Speaker 06:
They waited until the deadline for supplemental contentions to change their contentions.

[00:17:20] Speaker 06:
What they should have done, and the choice they made, is as soon as they thought they would

[00:17:25] Speaker 06:
even start considering a theory that hosperous process infringes, they should have gone to the court and sought leave to amend their contentions.

[00:17:34] Speaker 01:
What's your best citation regarding the scope of supplemental discovery?

[00:17:37] Speaker 01:
Do you have something you can point out to you, or maybe it's the best source?

[00:17:41] Speaker 06:
Yeah, so there are a number of things we can point to.

[00:17:45] Speaker 06:
Number one, the discussion of the Apotex case is correct.

[00:17:51] Speaker 06:
And supplemental discovery was discussed in connection with the Apotex case and our case at the same time at the April conference.

[00:17:59] Speaker 06:
And in DI-709, I don't believe it's in the appendix, the parties agreed.

[00:18:09] Speaker 06:
They agree, quote, supplemental discovery will be limited.

[00:18:13] Speaker 06:
And Judge Burke relied on that when he said supplemental discovery should be limited not only for apothec, but for hospir.

[00:18:20] Speaker 06:
It's the same type of issue.

[00:18:22] Speaker 06:
And ANDA was amended.

[00:18:25] Speaker 06:
The schedule itself.

[00:18:29] Speaker 06:
I mean, just reading the schedule, it implies that it's limited because it starts off with the requirement that the amended ANDA be produced.

[00:18:39] Speaker 06:
And then everything after that proceeds.

[00:18:42] Speaker 06:
And it's one-sided discovery.

[00:18:46] Speaker 06:
open-ended discovery, its plaintiffs got to take discovery from the defendants, including Hasfear.

[00:18:51] Speaker 06:
And that was done on purpose.

[00:18:53] Speaker 06:
Judge Connolly talked about that.

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Had discovery been reopened and any contention be amended, we would have had the right to take discovery related to a brand new theory.

[00:19:04] Speaker 06:
But the discovery was one way.

[00:19:06] Speaker 06:
And then, of course, it talks about supplemental contentions and supplemental expert opinions, implying it's supplementing something that was preserved, not a change, a brand new contention or opinion.

[00:19:18] Speaker 01:
What's your best response to opposing counsel's argument that somehow this is asymmetrical in terms of what was allowed to be done here?

[00:19:26] Speaker 06:
Yeah, in fact, I want to talk about that.

[00:19:29] Speaker 06:
Because number one, they got all the discovery they requested.

[00:19:33] Speaker 06:
At the hearing, they said, this is Appendix 1062, this is in April 2021 with Judge Connolly, if the court is willing to entertain testimony and evidence from the defendants about these amendments,

[00:19:46] Speaker 06:
then we do feel we would need discovery about them because we would be in an unfair position.

[00:19:52] Speaker 06:
They got what they asked for.

[00:19:54] Speaker 06:
They asked for discovery about the amendments.

[00:19:56] Speaker 06:
Judge Connolly agreed.

[00:19:57] Speaker 06:
They got the discovery.

[00:19:58] Speaker 06:
They had a new expert opinion related to the amendments that was presented at trial.

[00:20:03] Speaker 06:
And so they got what they asked for.

[00:20:05] Speaker 06:
And I do also want to point out, because there was an implication that Haspera made this change.

[00:20:14] Speaker 06:
The only reason Haspera amended its ANDA was because it had to, because its independent supplier changed the DMF.

[00:20:21] Speaker 06:
Once that happened, we had to amend the ANDA.

[00:20:24] Speaker 06:
And all that amended ANDA says, as plaintiffs themselves characterize it, it changes a release specification.

[00:20:31] Speaker 06:
It doesn't change the product.

[00:20:33] Speaker 06:
It says, after Curia finishes making its product, it has to test it to ensure that plaintiff's patents are being respected.

[00:20:41] Speaker 06:
That's all the ANDA amendment does.

[00:20:44] Speaker 06:
And so in addition, the Farrin case contemplates.

[00:20:49] Speaker 06:
It says that the statute, the Hatch-Raxson statute, actually contemplates ANDA amendments during litigation.

[00:20:55] Speaker 06:
It says, the quote is, the statute contemplates that the ANDA will be amended as a matter of course.

[00:21:03] Speaker 06:
And in addition,

[00:21:07] Speaker 06:
As counsel conceded, they made their own choices.

[00:21:12] Speaker 06:
They made their own choice as to what to ask for when Judge Connolly allowed us to amend the ANDA.

[00:21:21] Speaker 06:
They made their choice as to when to disclose their new theory, and they waited to the last possible moment instead of giving us fair notice.

[00:21:29] Speaker 06:
And also, when arguing criticality, they made the choice in front of Judge Burke to say they want to proceed with all their original theories and the new theory.

[00:21:42] Speaker 06:
They could have said to Judge Burke, this new theory is our real theory.

[00:21:47] Speaker 06:
We're going to abandon all the old theories.

[00:21:49] Speaker 06:
This theory really is critical.

[00:21:51] Speaker 06:
to our case, but they decided not to do that.

[00:21:54] Speaker 06:
They wanted to have their cake and eat it too.

[00:21:56] Speaker 06:
And they held on to their original theories.

[00:21:59] Speaker 06:
And there were many theories, by the way.

[00:22:01] Speaker 06:
There was an independent theory that the crude intermediate infringe, the

[00:22:05] Speaker 06:
Form F, intermediate infringed, the API infringed.

[00:22:08] Speaker 06:
They had theories of direct infringement, induced infringement, infringement before the Ando Amendment, infringement after the Ando Amendment.

[00:22:15] Speaker 06:
They had all these theories that were presented at trial, and they lost them all.

[00:22:19] Speaker 06:
This was not some critical theory.

[00:22:20] Speaker 06:
It was a backup Hail Mary theory.

[00:22:23] Speaker 06:
And Judge Burke called them out on that and said, this is not really a critical theory.

[00:22:29] Speaker 06:
If it were, you would have preserved it, and you would have emphasized, you would have gone forward on just this theory if it really weren't critical.

[00:22:39] Speaker 06:
The case they rely on is the ZF Meritor case, which actually says,

[00:22:46] Speaker 06:
quote, plaintiff's conscious choice to rely so heavily on data that was ultimately found to be unreliable weighs against a finding of abuse of discretion.

[00:22:57] Speaker 06:
And that's the point.

[00:22:58] Speaker 06:
That's my theme of the argument, which is they made their choices.

[00:23:02] Speaker 06:
They made their choices.

[00:23:03] Speaker 06:
They have to live with it.

[00:23:04] Speaker 06:
They can't argue for an abuse of discretion based on the choices that they made.

[00:23:16] Speaker 06:
I do want to make two more points in my limited time, really based on arguments they made in their brief.

[00:23:25] Speaker 06:
Their theme, especially in their reply brief, was that Hasfear changed its product, and therefore they have the right to completely change the case.

[00:23:33] Speaker 06:
And first of all, there were two products.

[00:23:35] Speaker 06:
There's the API product, and then there's Hasfear's finished product.

[00:23:40] Speaker 06:
Neither product changed.

[00:23:42] Speaker 06:
As I discussed a moment ago, there was just a release specification change.

[00:23:46] Speaker 06:
The product itself didn't change.

[00:23:48] Speaker 06:
But even more importantly, plaintiffs are precluded.

[00:23:51] Speaker 06:
from arguing that the product changed, because we tried to judge Connolly the question of whether the API infringed before the end amendment.

[00:24:00] Speaker 06:
Judge Connolly found no infringement, and they haven't appealed it.

[00:24:04] Speaker 06:
That issue is now set.

[00:24:06] Speaker 02:
At the end of the day, what was the legal effect of the amendment on both parties' positions in the litigation?

[00:24:14] Speaker 06:
Well, Judge Connolly considered whether there was infringement before or after and found no infringement during either time period.

[00:24:23] Speaker 06:
They haven't even appealed any of the trial rulings.

[00:24:26] Speaker 06:
They haven't appealed any.

[00:24:27] Speaker 04:
I don't understand what you're saying.

[00:24:29] Speaker 04:
There was no decision about their new theory.

[00:24:35] Speaker 06:
Judge Connolly found that their original theory before the Ande Amendment

[00:24:42] Speaker 06:
was insufficient to show infringement.

[00:24:44] Speaker 04:
Right.

[00:24:44] Speaker 04:
Yeah.

[00:24:45] Speaker 04:
And that theory became more difficult as a result of the Anne Amendment, right?

[00:24:50] Speaker 04:
No.

[00:24:51] Speaker 04:
He considered it separately.

[00:24:52] Speaker 06:
He considered the evidence before the Anne Amendment.

[00:24:55] Speaker 04:
I understand.

[00:24:55] Speaker 04:
But in fact, it became more difficult as a result of the Anne Amendment, right?

[00:25:00] Speaker 06:
Well, the ultimate infringement question did become more difficult for them.

[00:25:04] Speaker 06:
I agree with that.

[00:25:05] Speaker 06:
But Judge Connolly looked at all of the theories that they were asserting.

[00:25:10] Speaker 06:
They were relying on testing to show that there was infringement.

[00:25:13] Speaker 06:
And Judge Connolly said none of that testing showed infringement.

[00:25:17] Speaker 06:
And so did it affect the outcome?

[00:25:19] Speaker 06:
At the end of the day, it didn't affect the outcome, because they would have lost had we not amended the ANDA.

[00:25:25] Speaker 06:
And that's not speculation.

[00:25:26] Speaker 06:
They're not appealing.

[00:25:27] Speaker 06:
They're not appealing any of Judge Connolly's findings.

[00:25:30] Speaker 02:
I wasn't asking about affecting the outcome.

[00:25:33] Speaker 02:
I was asking about affecting the positions that the parties were taking during this whole process.

[00:25:42] Speaker 06:
It bolstered our position, if that's what you're asking.

[00:25:47] Speaker 06:
I mean, absolutely.

[00:25:50] Speaker 06:
Because now we had a release specification that was specifically designed to provide a check after the API product was made.

[00:26:00] Speaker 02:
Why wouldn't Estella then have the opportunity to address this point that made your position more advantageous as a result of the amendment?

[00:26:09] Speaker 06:
They did.

[00:26:10] Speaker 06:
They did have the opportunity.

[00:26:11] Speaker 06:
That was my point.

[00:26:12] Speaker 06:
They had the opportunity to take any discovery they wanted into the end amendment.

[00:26:17] Speaker 06:
They got samples.

[00:26:18] Speaker 06:
And the end amendment does not specifically speak to the intermediates used by Curia to make the API.

[00:26:27] Speaker 06:
And so what they did is they tested the form F intermediate.

[00:26:31] Speaker 06:
They came up with a new opinion that there is infringement in the form F intermediate, even

[00:26:36] Speaker 06:
after the ANDA and DMF amendments, and they presented that at trial.

[00:26:40] Speaker 06:
They had the right to present that evidence at trial.

[00:26:43] Speaker 06:
And so in a sense, they also got additional evidence to present at trial that they would not have had but for the ANDA amendment.

[00:26:51] Speaker 04:
I think the point is that the ANDA amendments didn't affect their new theory one way or the other, right?

[00:27:02] Speaker 06:
Oh, yeah.

[00:27:03] Speaker 06:
Oh, I'm sorry.

[00:27:04] Speaker 06:
Correct.

[00:27:04] Speaker 06:
Their new theory had nothing to do with the Ande Amendment for the simple reason the Ande Amendment has nothing to do with a spurious compounding process, nothing whatsoever to do with it.

[00:27:15] Speaker 06:
So it was a brand new theory.

[00:27:16] Speaker 06:
And as Judge Burke held, it wasn't based on any new evidence.

[00:27:20] Speaker 06:
It wasn't based on anything in the DMF.

[00:27:22] Speaker 06:
It wasn't based on anything

[00:27:24] Speaker 06:
in the amended ANDA.

[00:27:25] Speaker 06:
It was based on knowledge that they had at the beginning of the case that Haspera dissolves form G in a water-based solution plus a document, a dissolution document that Haspera produced during discovery.

[00:27:37] Speaker 06:
That's what they based their new theory.

[00:27:39] Speaker 06:
And their entire argument is that because Haspera amended the ANDA, they get a do-over.

[00:27:43] Speaker 06:
They get to come up with a brand new contention that they could have made earlier, didn't, decided not to make, and can radically change the case in terms of new witnesses, new evidence, different types of testing shortly before trial.

[00:28:00] Speaker 06:
And that's why Judge Burke, in his wide discretion, said, we can't do this.

[00:28:05] Speaker 06:
Hasbir, you'd be too prejudiced.

[00:28:17] Speaker 06:
The other point I just want to make briefly based on arguments in the brief is they made it sound like this is

[00:28:25] Speaker 06:
facially a clean infringement theory, the notion that, of course, if you take 4G, dissolve it in a water-based solution, you're going to get infringement.

[00:28:34] Speaker 06:
That is a vast oversimplification and oversimplification.

[00:28:39] Speaker 04:
The issue's not before us.

[00:28:40] Speaker 04:
How can we address that?

[00:28:41] Speaker 06:
OK.

[00:28:43] Speaker 06:
I wanted to clarify that.

[00:28:45] Speaker 06:
And counsel also did make a reference to the fact that our expert said he could conduct testing in a matter of weeks.

[00:28:54] Speaker 06:
But the testing at issue that he was asked about was, can you come up with testing as to the effect of Form G in the presence of water?

[00:29:05] Speaker 06:
He said, yeah, you could do something like that in a matter of weeks.

[00:29:07] Speaker 06:
That's not the question.

[00:29:08] Speaker 06:
The question here is much more complicated.

[00:29:11] Speaker 06:
Can you test what happens when you dissolve form G?

[00:29:14] Speaker 06:
For the purpose of completely dissolving it as soon as possible, does it just dissolve?

[00:29:20] Speaker 06:
Or does it go through what their expert described as a complex conversion process based on esoteric science?

[00:29:27] Speaker 06:
And their own expert said the testing to do that

[00:29:30] Speaker 06:
It's something that takes a long time.

[00:29:33] Speaker 06:
It's highly specialized.

[00:29:36] Speaker 06:
And it's something called in situ ramen testing.

[00:29:39] Speaker 04:
OK.

[00:29:39] Speaker 04:
I think we're out of time.

[00:29:40] Speaker 04:
Thank you.

[00:29:45] Speaker 05:
Thank you, Your Honor.

[00:29:46] Speaker 05:
Just a few brief points.

[00:29:48] Speaker 05:
First, my friend began with the April 7, 2021 hearing, but he repeated what was a clip quote in his brief.

[00:29:54] Speaker 05:
He quotes that Appendix 1066, where counsel for appellants said, quote, we don't think these amendments should change our evidence or our position.

[00:30:02] Speaker 05:
He leaves out the rest of that sentence, which says, but we don't want to be blindsided if we don't know the details.

[00:30:08] Speaker 05:
And this was all before the amendment went in.

[00:30:10] Speaker 05:
And again, at 1064, we complained of unfair moving target and explained that we needed discovery precisely for these purposes.

[00:30:17] Speaker 05:
Second, about the relatedness here, our theory has always been that it converts in the presence of water.

[00:30:22] Speaker 05:
There's no denying that the ANDA Amendment removed water from the place that we are previously focused on.

[00:30:28] Speaker 05:
It is not a significant change, and we think well within reason, to show that there is conversion to water in other parts of the process.

[00:30:37] Speaker 05:
Third, my friend focused at length on his view that this was not a change to the product or a small change, but is completely inconsistent with what he told Judge Connolly

[00:30:46] Speaker 05:
at trial, which again, quote, these aren't tiny changes.

[00:30:49] Speaker 05:
These are big changes for the precise purpose of addressing the issue that we're talking about in this case, trial transcript 787 to 788.

[00:30:56] Speaker 05:
To win before Judge Connolly, they made the representation that this completely changed the product.

[00:31:01] Speaker 05:
They're now telling this court the exact opposite.

[00:31:03] Speaker 05:
That's not credible.

[00:31:05] Speaker 05:
Fourth, that

[00:31:06] Speaker 05:
We haven't appealed the outcome as to the pre-amendment simply because that's not the product they're going to sell and is not relevant for this court's consideration.

[00:31:14] Speaker 02:
What about the arguments that your friend is making that you had choices and you didn't take or make certain choices that you're now regretting?

[00:31:27] Speaker 05:
Well, Your Honor, that's because they changed the product after the close of discovery.

[00:31:30] Speaker 05:
The way this works is

[00:31:32] Speaker 05:
They choose the product.

[00:31:33] Speaker 05:
We make choices about infringement.

[00:31:34] Speaker 05:
That goes to the court.

[00:31:36] Speaker 05:
The change-up that happened here was they chose the product.

[00:31:39] Speaker 05:
We made our choices about the infringement contentions.

[00:31:42] Speaker 05:
Then they changed the product.

[00:31:43] Speaker 04:
So that's the critical issue.

[00:31:45] Speaker 04:
If they changed the product, according to you, in the end amendments, you could have come in and said, OK, this now affects our whole theory.

[00:31:56] Speaker 04:
And we think we need a new theory here.

[00:31:58] Speaker 04:
And we'd like to present this.

[00:32:00] Speaker 04:
But you didn't do that.

[00:32:00] Speaker 05:
I don't think that's right, because what we got at 1220 was a clear order saying we can give supplemental infringement contentions.

[00:32:07] Speaker 05:
That was clear as day that we were under the impression we could do exactly what we did.

[00:32:11] Speaker 04:
You didn't raise the new theory, right?

[00:32:15] Speaker 04:
Until much later.

[00:32:17] Speaker 05:
Your Honor, we raised it in compliance with the schedule.

[00:32:20] Speaker 05:
And again, this was in response to their nine-month delay from when we gave our infringement contentions to when they changed the Andan Amendment, which they admit was for the purpose of undoing this.

[00:32:31] Speaker 05:
And again, the whole reason why there was a change to theory is because there was a change to the product that they said was a significant, substantial change

[00:32:39] Speaker 05:
undercut infringement.

[00:32:40] Speaker 05:
There has to be some measure of balance between the two.

[00:32:43] Speaker 04:
OK, all right.

[00:32:43] Speaker 04:
I think we're out of time.

[00:32:44] Speaker 04:
Thank you.

[00:32:45] Speaker 04:
Just both counsel, these confidentiality markings in the brief are really not responsive to this court's requirements.

[00:32:56] Speaker 04:
You marked water as confidential.

[00:32:58] Speaker 04:
You didn't mark it as confidential.

[00:33:00] Speaker 04:
I appreciate that you clarified that for the court before the hearing, but you should not have had the inconsistent markings in the first place.

[00:33:09] Speaker 05:
Thank you, Your Honor.

[00:33:10] Speaker 05:
We were trying to preserve Husbeer's information.

[00:33:12] Speaker 05:
We went to the effort to try to clarify that before.

[00:33:15] Speaker 04:
He just wasn't thinking about the markings to see if they're consistent.

[00:33:19] Speaker 04:
There's no way they're consistent in any event.

[00:33:22] Speaker 04:
All right.

[00:33:22] Speaker 04:
I thank both counsels.

[00:33:23] Speaker 04:
The case is submitted.

[00:33:24] Speaker 04:
That concludes our reception for this meeting.