[00:00:00] Speaker 02:
The next case for argument is 21-2342, Par Pharma versus Eagle Pharmaceuticals.

[00:00:06] Speaker 02:
Mr. Black, please proceed.

[00:00:09] Speaker 00:
Please, the court.

[00:00:10] Speaker 00:
This appeal presents an important doctrinal question that goes to the heart of the nature of proof and handle litigation.

[00:00:18] Speaker 00:
The district court in footnote two of its opinion stated that it, quote, struggled mightily, unquote, with reconciling this court's decisions on the use of the end of specifications in real world evidence.

[00:00:30] Speaker 00:
We agree that the law requires clarification, but disagree with the district court's approach.

[00:00:37] Speaker 03:
Where is the ambiguity here?

[00:00:41] Speaker 03:
Do you dispute that the range in the ANDA that they filed is outside of the range in your claims?

[00:00:51] Speaker 00:
No.

[00:00:51] Speaker 00:
The paper ANDA that they filed said 3.6 was the top end of their

[00:00:57] Speaker 00:
release specification, which is interpreted to mean 3.64.

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

[00:01:00] Speaker 03:
So we all agree with that.

[00:01:03] Speaker 03:
What's in the paper is correct.

[00:01:04] Speaker 03:
OK.

[00:01:05] Speaker 03:
And isn't there case law that says that the framework for ANDA litigation, you presume for purposes of infringement analysis that ANDA filers are bound by the representations in the ANDA?

[00:01:18] Speaker 00:
There is.

[00:01:18] Speaker 00:
And there is also a case law that says that if there is evidence that despite the representations, the product will infringe,

[00:01:25] Speaker 00:
that evidence must be accepted and considered by the district court.

[00:01:28] Speaker 00:
That's in Tyco and Abbott.

[00:01:31] Speaker 00:
And therein lies the conflict.

[00:01:33] Speaker 00:
Because in this case.

[00:01:34] Speaker 02:
Is this all with regard to your 271E2 argument?

[00:01:38] Speaker 00:
It's regard to both, Your Honor.

[00:01:39] Speaker 00:
We put the 271A argument first, because it's quite clear under the evidence, we believe, that we're entitled to a judgment declaration that if they sell a product, release the product, at above 3.6, they will infringe.

[00:01:54] Speaker 00:
And we put that to make the point that we're entitled to that declaration to avoid the conflict between the ANDA as approved by the FDA now, it's been approved, and the patent rights.

[00:02:04] Speaker 00:
We also believe that it follows from that finding, which we believe must be made under the evidence, that we're entitled to.

[00:02:10] Speaker 02:
So do you get a declaration that if someone infringes your patent, they will infringe your patent unless you can prove that you're entitled

[00:02:18] Speaker 02:
to the DJ by evidence that would suggest that there is a real and imminent threat that they're going to infringe your patent.

[00:02:25] Speaker 02:
And in this case, the district court found that you failed to meet that burden of proof because you couldn't establish any substantial or even insubstantial batches that clearly resulted in the up-drift that would cause infringement.

[00:02:43] Speaker 02:
I don't see what the conflict is that you're looking for.

[00:02:46] Speaker 00:
What we proved, Your Honor, is that if they sell a product at above 3.6, these products will turn into infringing products when they go into the market.

[00:02:55] Speaker 02:
No, you didn't.

[00:02:56] Speaker 02:
Where did you prove this?

[00:02:59] Speaker 00:
The district court himself said that the range of variation among the products is 0.05 after release and during the shelf life.

[00:03:10] Speaker 02:
Except that the evidence of record was that they weren't manufacturing batches at 3.6.

[00:03:16] Speaker 02:
So the evidence in the record in this case showed that the batches they were manufacturing was typically at the lower end of their range.

[00:03:24] Speaker 02:
So even if there is a slight upward drift, they still weren't exceeding the range and falling into your infringing pattern.

[00:03:31] Speaker 02:
So it doesn't seem to me you've met your burden of proof.

[00:03:35] Speaker 00:
It depends what the burden of proof is and the case is.

[00:03:38] Speaker 00:
Congress, we believe, set up a century.

[00:03:40] Speaker 02:
Well, wait.

[00:03:40] Speaker 02:
There's two different provisions, right?

[00:03:42] Speaker 02:
When you say what the burden of proof is, there's what should be your burden of proof to establish a 271E victory versus what should be an A victory.

[00:03:49] Speaker 02:
So tell me which of those sections your current argument you're about to make is correct.

[00:03:54] Speaker 00:
I think it applies to both, Your Honor.

[00:03:55] Speaker 00:
Congress set up the Hatch-Waxman Act to make sure that there would not be conflicts between authorizations issued by the FDA and authorizations, right to exclude, issued by the patent office.

[00:04:06] Speaker 00:
Those two are concentric circles.

[00:04:07] Speaker 00:
They should not meet.

[00:04:08] Speaker 00:
Congress said we're going to create an artificial act of infringement at the time of the filing of the ANDA because there was substantial doubt and case law saying that that was too early to create declaratory judgment jurisdiction.

[00:04:20] Speaker 00:
They said district court should decide these issues.

[00:04:22] Speaker 00:
Will there be a conflict between the ANDA product, between the ANDA's file, and the issue path?

[00:04:28] Speaker 00:
Here, the antifiling, despite the litigation, despite all the focus we've put on the pH above 3.6, EGLE has maintained, requested, and now obtained approval from the FDA to release a product at 3.64.

[00:04:43] Speaker 00:
Whether they do so in manufacturing, whether they choose to do so or not, we know not at this point, because there's no more discovery in the case, and the product is on the market.

[00:04:51] Speaker 00:
But the fact of the matter is, the FDA approved the release of this product at pH 3.64.

[00:04:58] Speaker 00:
And under Sinovian, whether or not they decide to exercise that, whether or not they swear to the court that they won't do it, whether they point to other things in their ANDA that they say suggest that that won't happen, is insufficient to prevent the conflict.

[00:05:13] Speaker 02:
And you think that applies to 271A.

[00:05:14] Speaker 02:
I tried to get you distinguished.

[00:05:15] Speaker 02:
You may have an argument with this argument you just made that would fall under 271E.

[00:05:19] Speaker 02:
I don't see how that falls under 271A.

[00:05:21] Speaker 00:
Well, I'll stick with 271E then.

[00:05:23] Speaker 02:
No, but do you see my point?

[00:05:24] Speaker 02:
Under 271A, the question is, what could they make?

[00:05:27] Speaker 02:
The question is, what products?

[00:05:29] Speaker 00:
They can make a product.

[00:05:30] Speaker 00:
So I now see your question.

[00:05:33] Speaker 00:
Let me try a different way.

[00:05:37] Speaker 00:
We established that their in-process release specification takes you up to 3.54.

[00:05:44] Speaker 00:
And their witness, their expert, admitted that the variation in between in-process testing and very short period of later release testing can be as high as 0.07, which would take you to 3.61.

[00:05:58] Speaker 00:
So it's not completely theoretical to assume that they are going to have a product at that level.

[00:06:04] Speaker 02:
3.61 doesn't emerge.

[00:06:06] Speaker 00:
3.61 is a release number would infringe because of the upward drift after that.

[00:06:12] Speaker 03:
No.

[00:06:12] Speaker 03:
Well, you didn't prove the upward drift.

[00:06:14] Speaker 03:
They had this whole dispute over optimization.

[00:06:17] Speaker 03:
We had this whole dispute about optimization.

[00:06:20] Speaker 03:
And the district court made findings which are

[00:06:24] Speaker 03:
susceptible to death rental treatment.

[00:06:27] Speaker 03:
And no, I mean, you're saying stuff here as if it's true and proven and established.

[00:06:33] Speaker 03:
And it's not quite the opposite.

[00:06:35] Speaker 00:
What we proved was limited.

[00:06:37] Speaker 00:
I agree.

[00:06:38] Speaker 00:
We proved that.

[00:06:40] Speaker 00:
if they use their internal process specification at 3.54, that there were examples in a limited number of samples that we had that went up 0.7 to 361.

[00:06:51] Speaker 03:
And they came back and they said, look, we've got this optimization process that procures

[00:06:55] Speaker 03:
And the district court looked at the evidence they presented, looked at the evidence you presented, and concluded no, you had not established that there was necessarily or that there was likelihood of this upward drift.

[00:07:13] Speaker 03:
Am I misstating what went down here?

[00:07:15] Speaker 00:
No, Your Honor.

[00:07:17] Speaker 03:
Well, don't you get to re-litigate that?

[00:07:18] Speaker 00:
No, we don't.

[00:07:19] Speaker 00:
We do not get to re-litigate it.

[00:07:20] Speaker 00:
He made a finding that there's 0.05 on either side, and that's not enough to establish.

[00:07:26] Speaker 03:
And that's true, right?

[00:07:28] Speaker 03:
I mean, if they don't come within the range, if it's 3.64, that's still not within the patent claim.

[00:07:35] Speaker 00:
Right.

[00:07:35] Speaker 00:
But if they release it 3.64, which they're allowed to do under their ANDA, and this is the 271E argument now.

[00:07:41] Speaker 00:
Their ANDA permits them to release a 3.64.

[00:07:45] Speaker 00:
Their argument that they won't do it is insufficient under Sinovian.

[00:07:49] Speaker 00:
And the evidence that the district court found that there is variation of 0.05 on either side, that would result in infringement of products in the real world.

[00:07:59] Speaker 00:
And on that basis, the product should have been precluded, at least until they amend their ANDA in some fashion, to give up the scope that they asked for.

[00:08:07] Speaker 03:
I thought the 3.64 included that 0.05 thing, not that it's 3.64 and they get additional, right?

[00:08:20] Speaker 00:
Well, their release specification is 3.6, which includes 3.64 because of that.

[00:08:28] Speaker 03:
OK, but you don't then get an extra add-on for that.

[00:08:30] Speaker 00:
It's 3.64.

[00:08:31] Speaker 00:
They can release a 3.64.

[00:08:33] Speaker 00:
They would be within FIANDA, and that would not infringe.

[00:08:37] Speaker 00:
Agreed.

[00:08:38] Speaker 00:
The record evidence, including the district court's finding, is that this product can float up 0.05, sometimes down, sometimes up.

[00:08:46] Speaker 00:
We showed 32 out of 45 times it goes up.

[00:08:49] Speaker 00:
And the point is, if they release it 364, they're strictly complying with the release specification.

[00:08:54] Speaker 00:
But that product will turn into an infringing product in the marketplace.

[00:08:58] Speaker 00:
And because they've asked for the authorization.

[00:09:00] Speaker 03:
When you just said that product will turn into infringing.

[00:09:04] Speaker 03:
It will.

[00:09:05] Speaker 03:
And I don't see the findings.

[00:09:06] Speaker 03:
I mean, they talked about what's in the specification and the optimization.

[00:09:10] Speaker 03:
Didn't the district court conclude that that's not correct, that there's not evidence?

[00:09:15] Speaker 00:
No.

[00:09:16] Speaker 00:
My statement is a conditional one.

[00:09:18] Speaker 00:
I want to be clear.

[00:09:20] Speaker 00:
It's for purposes of the hypothetical and.

[00:09:23] Speaker 00:
They asked for the right to release at 3.64.

[00:09:26] Speaker 00:
Our position is this.

[00:09:28] Speaker 00:
If they do release at 3.64, there was evidence, and the district court even found, that after release, the product will drift.

[00:09:39] Speaker 00:
It's unbuffered.

[00:09:39] Speaker 00:
That's why.

[00:09:41] Speaker 00:
If this product drifts even 0.01 pH units up,

[00:09:45] Speaker 00:
it will reach the infringing range.

[00:09:48] Speaker 00:
Therefore, the FDA should not have been permitted to approve this product, because under the real world fact of instability of the pH of this product, it will drift into the infringing range.

[00:10:00] Speaker 00:
The district court made no finding on that point, but he did make a finding specifically that there is a 0.05 variation in the product up and down.

[00:10:10] Speaker 03:
You just said that it's curious, because you just said the FDA should not have been allowed to do this.

[00:10:15] Speaker 03:
And there was a citizen petition filed with the FDA that was resoundingly rejected, correct?

[00:10:21] Speaker 03:
That's correct.

[00:10:23] Speaker 03:
All right.

[00:10:24] Speaker 03:
to the extent you're making allegations that you concede are what the FDA should have done in the first instance.

[00:10:33] Speaker 03:
And you used whatever process you have there, and you lost.

[00:10:38] Speaker 00:
I meant it in this sense.

[00:10:41] Speaker 00:
We're not here challenging the FDA's findings or jurisdiction.

[00:10:45] Speaker 00:
Citizens Petition wasn't before the district court.

[00:10:47] Speaker 00:
My point is that under the Hatch-Waxman Act, the FDA should have been precluded from approving the ANDA in this format, because that's the purpose of the Hatch-Waxman Act.

[00:10:56] Speaker 00:
In 271E says that the time for approval should have been reset until patent expiration.

[00:11:04] Speaker 00:
It's a matter of law.

[00:11:06] Speaker 00:
That's our main point.

[00:11:07] Speaker 02:
What is the optimization process

[00:11:09] Speaker 02:
What's the impact of the optimization process that they represent that they're going to use have on the drift?

[00:11:17] Speaker 00:
It has no impact at all, because any promises, anything that they say they're going to do is irrelevant if they maintain the right to release a product.

[00:11:24] Speaker 02:
I didn't ask you what was the evidence that was introduced about how the optimization process would limit drift.

[00:11:37] Speaker 00:
OK, so their expert admitted that even with the optimization batches, and we had a limited number of them, that we saw upward drift of up to 0.07.

[00:11:47] Speaker 00:
Is this Dr. Park?

[00:11:49] Speaker 00:
Yes, that's correct.

[00:11:50] Speaker 00:
OK.

[00:11:50] Speaker 00:
And he conceded that was true.

[00:11:54] Speaker 02:
And the district court did not even with the optimization process, you are saying the evidence of record is

[00:12:02] Speaker 02:
that there might be direct respect to 0.7, but I believe they said it would center around 0.05, right?

[00:12:08] Speaker 00:
The district court made a finding, which I do think was clearly erroneous, that it would be 0.05 one way or the other, because we had talked about it.

[00:12:14] Speaker 03:
Well, I also thought the district court made a finding that they wouldn't release a product at 3.64, because then they would be in danger of violating the stability specification.

[00:12:26] Speaker 03:
So what you've been representing here today, all about they're going to release it at 3.64 and the problems with doing that, I thought that was off the table.

[00:12:37] Speaker 00:
What I'm saying is they can't release it above 3.64.

[00:12:41] Speaker 00:
And we're not saying they will, because that would result in potential criminal penalty.

[00:12:46] Speaker 03:
Well, no, no, no, no.

[00:12:47] Speaker 03:
Maybe I'm wrong.

[00:12:48] Speaker 03:
But I have in my notes that the district court found they wouldn't release a product

[00:12:53] Speaker 03:
at 3.64 because then they would be in danger of violating the stability.

[00:13:01] Speaker 00:
I see your question, Your Honor.

[00:13:02] Speaker 00:
And the trouble with that finding is it's legally irrelevant what their intent is.

[00:13:06] Speaker 00:
If they've asked the FDA to approve at 3.64, that's synovian.

[00:13:10] Speaker 00:
You can't get around what you've asked for in the end.

[00:13:15] Speaker 00:
by swearing that you won't do it or pointing to other things.

[00:13:19] Speaker 03:
The district court looked at the stability specification, which is part of all of this, and relied on them complying with that.

[00:13:30] Speaker 00:
The stability specification, all it says is that they made a promise that they would test a batch once a year, and if they found a problem, they would

[00:13:38] Speaker 00:
go back to the FDA.

[00:13:39] Speaker 00:
And the FDA would then address it if they felt there was a safety or efficacy issue.

[00:13:43] Speaker 03:
So you're saying, bottom line is, there's no guarantee of any of this, that they're going to do what they sworn they're going to do, and what the district court concluded was sufficient to ensure that they were going to do it.

[00:13:55] Speaker 03:
And that is not enough.

[00:13:57] Speaker 00:
I will say that it's not on their intent.

[00:14:00] Speaker 00:
I take your point.

[00:14:01] Speaker 00:
They have maintained and obtained an FDA approval to release a 3.64.

[00:14:06] Speaker 00:
If they don't want to use that authority that they have obtained from the FDA, they need to disclaim it.

[00:14:13] Speaker 00:
And they refuse to do that in the district court.

[00:14:15] Speaker 00:
Perhaps there's an inference there.

[00:14:16] Speaker 00:
But we're not pursuing the case on intent.

[00:14:19] Speaker 00:
There's a conflict between the application as approved, because that 3.64 number will result in a 3.65 or above product.

[00:14:28] Speaker 00:
And therefore, the FDA spec.

[00:14:30] Speaker 00:
that they've asked for approval for.

[00:14:31] Speaker 00:
They have the power to amend that.

[00:14:33] Speaker 00:
They've asked for it because it's in conflict with our patent.

[00:14:35] Speaker 00:
And Congress set up the Hatch-Waxman Act to resolve conflicts early between the exclusivity granted by the Patent Office and the right to sell a product granted by the FDA.

[00:14:46] Speaker 00:
If there are no further questions, I reserve my remaining time.

[00:14:51] Speaker 02:
Mr. Quinn.

[00:14:54] Speaker 04:
Thank you, Chief Judge Moore.

[00:14:55] Speaker 04:
May it please the court, John O'Quinn on behalf of Eagle Pharmaceuticals.

[00:14:58] Speaker 04:
Hahrer tries to make a simple case complicated because it cannot show infringement based on how the express specification of the ANDA defines the relevant aspects of the product, the district court's factual findings, and this court's precedents.

[00:15:13] Speaker 04:
The ANDA here facially defines a non-infringing product.

[00:15:17] Speaker 04:
And the district court also found on the facts that Eagle's product would, in fact, not infringe.

[00:15:23] Speaker 04:
That should be the end of the matter, and the district court's judgment should be affirmed.

[00:15:27] Speaker 04:
Now, to be clear, PAR has never argued that EGLE's product will infringe if it complies with all of the ANDA's specifications.

[00:15:37] Speaker 04:
All of them.

[00:15:38] Speaker 04:
That's the release specification.

[00:15:40] Speaker 04:
That's the stability specification, which is a representation as to what the pH for the entire shelf life of the product should be.

[00:15:47] Speaker 04:
And the in-process specifications, which have the effect, as the district court found, of limiting what the product is that can actually be

[00:15:57] Speaker 02:
produced and so there could be an upward drift of up to point oh seven.

[00:16:05] Speaker 04:
Chief Judge Moore, Dr. Parr did not agree that there could be an upward drift.

[00:16:09] Speaker 04:
He agreed that there was some amount of variation even in the post-optimization data that showed that sometimes it could be a little bit higher than where it was at release, and sometimes it could be a little bit lower than where it was at release.

[00:16:26] Speaker 04:
And the district court relied on that

[00:16:32] Speaker 04:
at Appendix 21 in finding that, as a factual matter, that as Pahr's expert admitted, fluctuations were in the neighborhood of 0.05 pH units and generally around 3.5 to 3.52, and found factually that it follows that the pH measurements for eagles and a product would be between 3.45

[00:16:55] Speaker 04:
in 3.57, not only at the time of their release, but over their shelf lives.

[00:17:00] Speaker 04:
He also found as a factual matter.

[00:17:02] Speaker 04:
This is at appendix 23.

[00:17:04] Speaker 02:
I'm looking at paragraph 29.

[00:17:06] Speaker 02:
And am I wrong in seeing that the district court has made findings that there's a plus or minus 0.05 shift?

[00:17:15] Speaker 04:
Well, I think with the district court, I'm sorry, you were looking at which paragraph, Your Honor?

[00:17:19] Speaker 02:
29 on page 21.

[00:17:27] Speaker 02:
Par is correct that pH measurements for the tested batches varied over the course of the batch's life.

[00:17:32] Speaker 02:
Correct.

[00:17:33] Speaker 02:
And then he goes through and analyzes them, and he shows that, I think, I could be wrong, but I read this paragraph as the district core, including that there can be up to, basically, there can be a 0.05 shift one way or the other, plus or minus.

[00:17:47] Speaker 04:
Yeah, I think what the...

[00:17:49] Speaker 04:
What the district court was doing, Chief Judge Moore, was finding that the PARS expert admitted that these fluctuations compared to the fluctuations that existed in the pre-optimized process were only in the neighborhood of as much as 0.05 and what they were generally located around.

[00:18:06] Speaker 04:
And he just simply said that if you assume

[00:18:08] Speaker 04:
the PARS expert is right about that and treated it essentially as a concession, then that would mean that the actual product... Wait a minute.

[00:18:14] Speaker 02:
You said these are pre-optimization.

[00:18:16] Speaker 02:
The paragraph said the pH fluctuations observed over the shelf life of the post-optimization batches.

[00:18:22] Speaker 04:
No, that's what I'm saying.

[00:18:22] Speaker 04:
That these were post-optimization and that they were only 0.05, which was less than the fluctuation that was observed with the pre-optimization batches.

[00:18:32] Speaker 02:
That was the... Yes, but if you do sell a product at 3.64, which

[00:18:38] Speaker 02:
Have you sought FDA approval to be able to sell a product at 3.64?

[00:18:41] Speaker 04:
I think when you look at all of the specifications together, Chief Judge Moore, that the answer to that question is ultimately no.

[00:18:48] Speaker 04:
And the reasons for that is because all of the specifications work together to limit what the product is that can actually be produced.

[00:18:57] Speaker 02:
So you have not sought FDA approval

[00:19:01] Speaker 02:
to sell a product out of the gate at 3.64.

[00:19:03] Speaker 02:
Your client has not sought that approval.

[00:19:06] Speaker 04:
So Chief Judge Moore, I don't dispute that the release specification is up to 3.6 and that that rounding would be 3.64.

[00:19:16] Speaker 04:
What I am saying is that we also have sought approval for a product that will maintain a non-infringing pH for the entire life of the product.

[00:19:29] Speaker 02:
So your client recognizes that it can't sell a product at 3.64.

[00:19:36] Speaker 02:
because there is some potential drift.

[00:19:40] Speaker 02:
And so you're saying we have sought FDA approval to sell a product where only if we can control the drift so that it doesn't go above 364.

[00:19:49] Speaker 02:
And so if that means we can't sell above 359, we're not selling above 359 because if there's a 0.05 potential drift.

[00:19:57] Speaker 02:
That's what you're saying?

[00:19:58] Speaker 04:
Well, I'm not saying that the client concedes that there is a drift, and again, particularly an upward drift.

[00:20:04] Speaker 04:
But I am saying that the client recognizes.

[00:20:06] Speaker 02:
The district court seems to have found that there's a drift in your batches.

[00:20:09] Speaker 04:
Well, the district court found that there could be variation.

[00:20:12] Speaker 04:
He specifically rejected that it was necessarily an upward drift.

[00:20:16] Speaker 03:
Can we look at page 20, appendix 29?

[00:20:20] Speaker 03:
Because I don't know, maybe I'm reading stuff out of context.

[00:20:24] Speaker 03:
Are these findings of the district court?

[00:20:26] Speaker 03:
Because he says, it is true that the product blah, blah, blah, and it is true a pH of 3.64 would meet that specification.

[00:20:34] Speaker 03:
But the release specification is not the only specification in Eagles and up.

[00:20:38] Speaker 03:
And it is not accurate to say that EGLE seeks authority to release products into the marketplace with pH values up to 3.64.

[00:20:47] Speaker 03:
Rather, are you looking at that comparison?

[00:20:49] Speaker 04:
I am, and that is precisely my point, Judge Prost.

[00:20:52] Speaker 04:
That's precisely my point, is that all of the specifications, the release specification, the stability specification,

[00:20:57] Speaker 04:
And the in-process specification, which actually limit what the pH can be just before release, all operate to limit, as not only a functional matter, but a legal matter, what the product is that actually can be produced and released.

[00:21:14] Speaker 04:
And these in-process specifications.

[00:21:16] Speaker 02:
So what is it that you're seeking, that your client is seeking permission to actually release?

[00:21:22] Speaker 02:
Because according to the very sentence Judge Pros just read,

[00:21:26] Speaker 02:
It says it's not accurate to say that EGLE seeks authority to release products into the market with pH values up to 3.64.

[00:21:33] Speaker 02:
So theoretically, your ANDA asks for 3.64.

[00:21:39] Speaker 02:
The district court has made a finding

[00:21:41] Speaker 02:
that that's not accurate, that you are not seeking permission to release a 364.

[00:21:45] Speaker 02:
Is that correct?

[00:21:47] Speaker 04:
Well, I think, Chief Judge Moore, that it really distills to this.

[00:21:51] Speaker 04:
We are seeking authority to release a product that complies with all of the specifications.

[00:21:57] Speaker 04:
In fact, and the FDA in rejecting poor citizen petition.

[00:21:59] Speaker 02:
The district court made a fact finding.

[00:22:02] Speaker 02:
Feeble seeks authority.

[00:22:05] Speaker 02:
It's not accurate to say.

[00:22:08] Speaker 02:
that EGLE seeks authority to release products into the market with a pH value up to 3.64.

[00:22:13] Speaker 02:
Is that correct or not?

[00:22:15] Speaker 02:
That's a finding of the district.

[00:22:16] Speaker 04:
I think it is correct, Chief Judge Moore, because number one, with the in-process specifications that limit what the pH of the product can be just before release, we would not be able to release a product.

[00:22:30] Speaker 04:
We would not have authority to then

[00:22:31] Speaker 03:
turn around and release a product at 3.64, it would be impossible in addition to these... Well, if the district court went on to find you are seeking a limit, you are seeking authority to distribute products that have a pH of between 3.4 and 3.6 from the time of their release for distribution through the entirety of the product's shelf lives.

[00:22:50] Speaker 03:
That's...

[00:22:54] Speaker 03:
pH specification and the stability pH specification.

[00:22:58] Speaker 04:
That's exactly right, Judge Prost.

[00:22:59] Speaker 04:
And so it has to comply with all of them through their shelf life.

[00:23:02] Speaker 04:
And if that means that as a factual matter or as a practical matter that we cannot release at 3.64 because there is a risk that it might not satisfy the stability specification, then we have not sought authorization to do that.

[00:23:18] Speaker 03:
When you say if, it's not enough.

[00:23:20] Speaker 03:
It's right here in black and white.

[00:23:22] Speaker 03:
If that's what he said, if that's not what you're allowed, the district court made these findings about what you were allowed to do and what you weren't allowed to do.

[00:23:31] Speaker 03:
And it seemed like that was your position.

[00:23:32] Speaker 03:
You agreed with it.

[00:23:34] Speaker 04:
I think we're in vigorous agreement here.

[00:23:36] Speaker 04:
I mean, at the end of the day, you have on its face

[00:23:39] Speaker 04:
an ANDA that defines a non-infringing product.

[00:23:42] Speaker 04:
And in Bayer versus Elan, this court was clear that even if there are factual issues as to whether the defendant can comply with the specification, they are not material factual issues because 331D prohibits the defendant from selling any product that doesn't meet the ANDA specification.

[00:23:58] Speaker 03:
Along those lines, your friend cites two cases, the Abbott and the Tyco case.

[00:24:03] Speaker 03:
And I'm assuming you think that those are distinguishable from the facts here.

[00:24:08] Speaker 04:
Yeah, I don't think that those cases are pertinent here.

[00:24:13] Speaker 04:
And I don't think that they change the analysis from the analysis that this court discussed in both fairing one and fairing two.

[00:24:21] Speaker 04:
You just look at the ANDA and how it's defined.

[00:24:23] Speaker 04:
And if the ANDA doesn't answer the question, then you look at the facts.

[00:24:26] Speaker 04:
Here, I think the district court did both.

[00:24:28] Speaker 04:
Either way, we're not infringing.

[00:24:30] Speaker 04:
And the way, in terms of

[00:24:33] Speaker 04:
of Abbott, the Brahmanideen court at page 13.

[00:24:39] Speaker 04:
78 specifically addressed the Abbott case, and specifically said, look, that addresses a different issue.

[00:24:45] Speaker 04:
And it treated that language in Abbott as dicta.

[00:24:47] Speaker 04:
But then the court, and it was the same authoring judge in Tyco, addressed that issue again and identified that it was not unreasonable if you had an example for somebody to assert infringement, even though the ANDA on its face defined a non-infringing product, if

[00:25:06] Speaker 04:
the ANDA, if there were errors in the ANDA itself.

[00:25:10] Speaker 04:
In other words, if there were errors in the calculations of the ANDA itself.

[00:25:14] Speaker 04:
Now, there are no allegations here that there are errors in the ANDA.

[00:25:18] Speaker 04:
Their argument is not that if we comply with it.

[00:25:25] Speaker 02:
What was the evidence you introduced in response to Mr. Parr's drift evidence?

[00:25:31] Speaker 02:
For example, does your client have any evidence that's in this record?

[00:25:36] Speaker 02:
that, yes, there is drift, but it's only at the point 02.

[00:25:41] Speaker 02:
What was your evidence regarding drift?

[00:25:44] Speaker 04:
Chief Judge Moore, I think the data is all our data.

[00:25:48] Speaker 04:
And if you look at page 30 of the red brief, we've identified the difference in the variation that was seen in the post-optimization

[00:25:58] Speaker 04:
batches versus the pre-optimization batches.

[00:26:02] Speaker 04:
The top line that you see shows that there was significant variation in pre-optimization.

[00:26:07] Speaker 04:
And the reason for that is because it didn't require thorough mixing.

[00:26:11] Speaker 04:
And the process was changed.

[00:26:13] Speaker 04:
And this isn't just a statement to the court.

[00:26:17] Speaker 04:
This isn't just like a passing reference to the FDA.

[00:26:22] Speaker 02:
These don't help me that much.

[00:26:24] Speaker 02:
What if any

[00:26:26] Speaker 02:
Drift, does your client agree exists post optimization?

[00:26:33] Speaker 04:
Chief Judge Moore, I don't think that the evidence shows that there is drift in any particular direction.

[00:26:38] Speaker 02:
There is no trend of- I didn't ask you if there was drift in a particular direction.

[00:26:43] Speaker 02:
I asked if there was drift.

[00:26:44] Speaker 02:
Well, I think the drifts are- Does the evidence show there's any drift?

[00:26:48] Speaker 04:
I think at most, the evidence shows that there could be variation of 0.05 after release.

[00:26:55] Speaker 02:
What they're doing is they're just simply taking... And that could go either way.

[00:26:58] Speaker 04:
It could go up or down.

[00:26:59] Speaker 04:
It could.

[00:27:00] Speaker 04:
Their infringement theory is based on a lot of ifs.

[00:27:02] Speaker 02:
But if the evidence shows there can be up to 0.05 drift, and if you have represented that you will sell a product that will maintain an under 3.64 status for its entire shelf life,

[00:27:18] Speaker 02:
Doesn't that mean you can't release a product that's at 3.59, unless you come up with a new and better optimization process that helps you further contain the drift?

[00:27:30] Speaker 04:
Well, the optimization process that is part of the ANDA and the pH that it requires, which they admit at page 21 of their reply brief is binding, so it's not optional, requires that immediately before release,

[00:27:46] Speaker 04:
that the pH be no more than 3.54.

[00:27:49] Speaker 04:
So you have an in-process specification.

[00:27:53] Speaker 02:
So you're saying that the specification that you all have filed automatically limits your client to not releasing a product higher than a pH of 3.54.

[00:28:04] Speaker 04:
Well, with some potential for variation from the post-filtration to the release step, but yes is the short answer, is that the final step before release is a stabilization step that was added based on what was found pre-optimization.

[00:28:26] Speaker 02:
And so you're saying the ANDA that's being approved by the FDA limits your clients based on all of the different specifications to not releasing a product above 3.54?

[00:28:38] Speaker 04:
I'm not sure that it's that particular number.

[00:28:43] Speaker 04:
I'd point you to the district court's factual finding, or at least I think it's a factual finding, a page

[00:28:48] Speaker 04:
23 well, he says it is he says quote I find as a matter of fact that even if Eagles This is appendix 23 even if Eagles and a product were not required as a matter of law to maintain the stability specification He has found that we are whatever that means It's appendix 23

[00:29:12] Speaker 02:
I don't see your evenness statement, but I might be missing it.

[00:29:16] Speaker 04:
Maybe I have the wrong page.

[00:29:19] Speaker 04:
I apologize.

[00:29:21] Speaker 02:
Because these are numbered paragraphs.

[00:29:23] Speaker 02:
It would help if you help me hone in.

[00:29:27] Speaker 04:
I'm sorry.

[00:29:28] Speaker 04:
It begins on the previous page, paragraph 31 at the bottom.

[00:29:37] Speaker 04:
And he says, I find, therefore, as a matter of fact that even if Eagle's ANDA product were not required as a matter of law to maintain the stability pH specifications set forth in Eagle's ANDA, because Eagle will have to use the optimized manufacturing process it committed to the FDA, the product Eagle will manufacture and sell will not have a pH that would drift into the range of pH limitation claimed in the asserted patents.

[00:30:03] Speaker 04:
And they've conceded at page 21 of their reply brief

[00:30:06] Speaker 04:
that these in-process specifications, they danced about this below and suggested, well, maybe this didn't really count.

[00:30:13] Speaker 04:
But it's actually in the ANDA itself.

[00:30:16] Speaker 04:
We represented to the FDA at appendix 2931.

[00:30:20] Speaker 04:
and 2955, that these steps were implemented to provide greater assurance that we would.

[00:30:27] Speaker 01:
So are you basically saying you've committed to a process that even though the upper end of your range is the 364, it's that you're going to release a product that at most will drift to 364, but not released at 364 and go above that?

[00:30:43] Speaker 04:
Absolutely, Judge Hughes.

[00:30:44] Speaker 04:
That's exactly right.

[00:30:45] Speaker 04:
And so I think there's no infringement under 271E, because on its face,

[00:30:49] Speaker 04:
The ANDA defines a non-infringing product, and whether you can make it, whether you can comply with the ANDA is a different question, as Bayer versus Elon makes clear.

[00:30:58] Speaker 04:
This is not synopia.

[00:30:59] Speaker 02:
OK, Mr. McQuain, your time's up.

[00:31:00] Speaker 02:
Thank you very much.

[00:31:01] Speaker 04:
Thank you, Chief Judge Moran.

[00:31:03] Speaker 02:
Mr. Black, Mr. Poon went over by about a minute and a half, so we'll give you two minutes of the level time.

[00:31:07] Speaker 02:
That should even out the time.

[00:31:11] Speaker 00:
Thank you, Your Honor.

[00:31:12] Speaker 00:
A couple of clarifying points.

[00:31:14] Speaker 00:
The in-process specification is a test that they do while the product is being manufactured.

[00:31:20] Speaker 00:
The top end of that is 3.54.

[00:31:23] Speaker 00:
They ask for a release.

[00:31:24] Speaker 00:
They later, not much later, but they later do testing.

[00:31:27] Speaker 00:
And they have to meet the release spec, which is 3.6, which means 3.64.

[00:31:33] Speaker 00:
There was proof from Dr. Park, who was actually their expert, that there is evidence of drift of up to 0.07 between in-process and actual release.

[00:31:42] Speaker 03:
But don't we think the judge may do it?

[00:31:43] Speaker 03:
I haven't skimmed the whole record.

[00:31:45] Speaker 03:
I mean, I don't know.

[00:31:46] Speaker 03:
Maybe some of your witnesses said something.

[00:31:48] Speaker 03:
But the district court was free to balance the testimony of the various sides to look at the data and to reach other conclusions.

[00:31:55] Speaker 03:
So I'm not sure if pointing to something one of your witnesses said is dispositive

[00:32:00] Speaker 00:
I'm only pointing to that one because it was in response to a comment he made about what the in-process spec means, and to Chief Judge Moore's question about what their witnesses said.

[00:32:12] Speaker 00:
These comments came from their witnesses.

[00:32:14] Speaker 00:
The key factual point we don't dispute is the one the district court made, which is that this product can go up or down 0.05 after release.

[00:32:23] Speaker 00:
So you ask a series of questions, Chief Judge Moore and Judge Hughes, about whether or not they intended to release at

[00:32:30] Speaker 00:
3.59, which would preclude, under the factual findings of the district court, drift up into the infringing range.

[00:32:36] Speaker 00:
And we really didn't get an answer.

[00:32:39] Speaker 00:
And most importantly, we didn't get an answer in the district court.

[00:32:42] Speaker 00:
We did have an answer from Doc.

[00:32:43] Speaker 02:
You did get an answer in the district court.

[00:32:45] Speaker 02:
You got an answer.

[00:32:45] Speaker 02:
They will not release a product that, even after the drift, takes it above 364.

[00:32:51] Speaker 02:
So you got your answer.

[00:32:53] Speaker 02:
And if they violate that, this is a DJ you're asking for.

[00:32:57] Speaker 02:
They're not actually doing anything wrong yet.

[00:33:00] Speaker 02:
So if they violate that, you can always run right back to court.

[00:33:03] Speaker 02:
And then on top of the fact that you'd have an infringement case, you'd also have a case against them for basically making misrepresentations to the court.

[00:33:12] Speaker 00:
Well, Your Honor, the problem is, Sinovian said that's not how we do ANDA cases.

[00:33:16] Speaker 00:
That a promise by them not to do something that's permissible under their ANDA is not sufficient.

[00:33:21] Speaker 02:
It's not a promise by them to do something.

[00:33:22] Speaker 02:
Their ANDA does not permit it.

[00:33:24] Speaker 02:
Their ANDA requires both the release and the stability specifications be complied with.

[00:33:29] Speaker 02:
They understand that.

[00:33:31] Speaker 02:
So they can't release a product.

[00:33:33] Speaker 02:
It might be right now, you've established or they've established there's an up to 0.05 drift.

[00:33:39] Speaker 02:
Perhaps they'll come up with a better optimization product that further reduces drift.

[00:33:43] Speaker 02:
So it's not the case that they're for all times limited to 359.

[00:33:46] Speaker 02:
They might be able to better stabilize that drug over time.

[00:33:51] Speaker 02:
They know it can't, during any point in its shelf life, go above 364.

[00:33:56] Speaker 02:
They've made representations to us and to the FDA to that extent.

[00:34:00] Speaker 02:
If they do it, boy, don't you have a great record to go back to the district court with?

[00:34:04] Speaker 00:
We won't know until long after all the damage has been done.

[00:34:08] Speaker 00:
We have no access to their release specifications.

[00:34:11] Speaker 00:
We don't know what they're doing.

[00:34:13] Speaker 02:
Can't you just test the products?

[00:34:15] Speaker 00:
We can play whack-a-ball with them in the marketplace.

[00:34:18] Speaker 00:
We can try to find them.

[00:34:19] Speaker 00:
We can test them.

[00:34:19] Speaker 00:
The drift takes place over a long period of time.

[00:34:22] Speaker 00:
That's not the way Hatch-Waxman is supposed to work.

[00:34:24] Speaker 00:
Congress said issues like this should be resolved.

[00:34:26] Speaker 00:
We should have had a judgment in the district court for finding... And it got resolved.

[00:34:30] Speaker 02:
They have a release specification and a stability specification.

[00:34:34] Speaker 02:
They have guaranteed the FDA for the entire shelf life.

[00:34:37] Speaker 02:
This product won't exceed 364.

[00:34:39] Speaker 02:
I don't see how you can say that violates 271A.

[00:34:43] Speaker 02:
That's what they were granted permission for, a product that throughout its shelf life will not violate 364.

[00:34:48] Speaker 02:
Seems pretty straightforward.

[00:34:51] Speaker 00:
Your Honor, we submit that we were entitled to below a finding of some sort under 271A or 271A to put into writing and make it as a final judgment that they cannot release it above 359.

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

[00:35:06] Speaker 02:
Okay, I thank both counsel.

[00:35:07] Speaker 02:
This case is taken under submission.