[00:00:00] Speaker 04:
Next case is Galderma Laboratories et al.

[00:00:03] Speaker 04:
versus M. Neal Pharmaceuticals et al.

[00:00:07] Speaker 04:
2019, 1021, and 1093.

[00:00:11] Speaker 04:
Mr. Lombardi.

[00:00:21] Speaker 01:
Good morning, Your Honors, and may it please the Court.

[00:00:23] Speaker 01:
I intend to address two issues.

[00:00:26] Speaker 01:
Of course, if your honors have questions on others, I'm happy to address them too.

[00:00:29] Speaker 01:
But two main issues as part of this appeal.

[00:00:31] Speaker 01:
The district court made error with respect to its ruling on the Chang patents by not properly applying the doctrine of prosecution history estoppel and not giving effect to clear and unmistakable statements concerning the scope of the invention.

[00:00:47] Speaker 01:
And with respect to Ashley too, the district court erroneously

[00:00:52] Speaker 01:
applied doctrine of equivalence and found infringement on doctrine of equivalence when that issue was not tried.

[00:01:00] Speaker 01:
I will start with the Chang patents.

[00:01:02] Speaker 01:
And with respect to the Chang patents, I don't think that there's much of a dispute that Chang, the patentee, the applicant, gave up a delayed release portion

[00:01:15] Speaker 01:
that releases in the stomach.

[00:01:17] Speaker 01:
They made that statement.

[00:01:19] Speaker 03:
So I agree.

[00:01:20] Speaker 03:
They made the statement clear as day.

[00:01:23] Speaker 03:
And if those statements were all this record contained, I would be with you 100%.

[00:01:29] Speaker 03:
You don't have to regurgitate the statements.

[00:01:31] Speaker 03:
There are many of them, and they're clear.

[00:01:34] Speaker 03:
They were trying to get, in order to overcome Seth, which

[00:01:39] Speaker 03:
Leaks if I by the way if I start to approach you have a lot of things mark confidential if at any point you think I approach on anything that's confidential wave your hands jump up and down do something I'll try to stop I think I know where those lines are but I'm not positive I present you so raising your hand is better than jumping up

[00:01:57] Speaker 03:
I'm not sure I could jump up and Well in any event so chef leaked some of its extended release in the stomach So they wanted to get over chef So one of the ways they attempted to do so was by saying oh, no when we used the word delayed release It means nothing in the stomach nothing until you get to the intestines outside the pH of the stomach nothing

[00:02:19] Speaker 03:
And I understand that this product kind of arguably works like chef.

[00:02:24] Speaker 03:
So there's no doubt in my mind that all of those statements amount to disclaimer if in isolation, but we're supposed to read the prosecution history as a whole to figure it out.

[00:02:34] Speaker 03:
And in the end, on pages 17.023 and 17.024,

[00:02:39] Speaker 03:
The board rightly, by the way, I think, rejected that construction argument and said, no, delayed release, there is no plain meaning of delayed release that we can find that requires it to not release until after it leaves the stomach.

[00:02:56] Speaker 03:
Delayed release, and they cited a number of exhibits, always means release any time after prompt administer, promptly.

[00:03:08] Speaker 03:
has some releasing the stomach now the board went on to find they overcame chef for other reasons but the board the patentee made statements attempting to define a term differently than the normal mean and the board rejected those attempts clearly and unequivocally so my problem for you is I walked away from this prosecution understanding that they were not allowed by the PTO

[00:03:31] Speaker 03:
to give that term the construction they wanted to give it, and it would be given a broader term.

[00:03:37] Speaker 03:
So my problem is, prosecutor history is stopple.

[00:03:39] Speaker 03:
Part of the purpose of that is notice to the world.

[00:03:42] Speaker 03:
Want to put the world on notice as to what the scope of this claim will and will not cover.

[00:03:46] Speaker 03:
So when the board has clearly and unmistakably said no, that is not the construction,

[00:03:52] Speaker 03:
How is the world on notice that no, we're going to bind the patentee to its earlier assertions, even though the board expressly rejected them?

[00:04:02] Speaker 01:
I'm sorry that took a long time.

[00:04:03] Speaker 01:
That's OK.

[00:04:05] Speaker 01:
And I don't dispute any of the facts that you talked about.

[00:04:07] Speaker 01:
I do dispute the conclusion, and that's because

[00:04:10] Speaker 01:
Prosecution history of Staple is oriented towards what the patentee, what the applicant said.

[00:04:16] Speaker 01:
It's not oriented to what others said.

[00:04:18] Speaker 01:
And that's shown up in the case law, the Pods case, the South Walk case.

[00:04:23] Speaker 03:
The problem is all of those cases you point to, and I read every single one of them, what they have to do with is not allowing the patentee to be bound

[00:04:30] Speaker 03:
by something the PTO says that the patentee didn't embrace or accept.

[00:04:36] Speaker 03:
You know, it's, it's where those cases are says, oh no, prosecution's re-stopple can only occur based on something an applicant says.

[00:04:41] Speaker 03:
It can't affect the applicant.

[00:04:44] Speaker 03:
It can't hurt the applicant when an examiner states something about it that the applicant doesn't accept or endorse.

[00:04:49] Speaker 03:
Do you agree with that characterization of the case law?

[00:04:52] Speaker 01:
I don't, Your Honor, and I think what the case law shows is... Which case?

[00:04:57] Speaker 01:
Well, I think I should talk broadly, but I think if we talk about Pods and Southwall, in those cases, the patent owner made distinctions of the prior art.

[00:05:08] Speaker 01:
The Patent Office didn't even rely on those statements.

[00:05:13] Speaker 05:
Yeah, but what about a case...American Piledriver, to me, seems to be the closest case.

[00:05:18] Speaker 05:
That's a case where

[00:05:20] Speaker 05:
an argument was made that integral should have a single piece construction.

[00:05:24] Speaker 05:
And the patent office said, no, we're not going to give integral a single piece construction.

[00:05:30] Speaker 05:
And yet, nonetheless, this court, among with other evidence, relied on that statement by the patent owner in interpreting the meaning of the word integral.

[00:05:41] Speaker 03:
exactly and I think that is that is I think our strongest case on the point that it is not what the patent office a really big difference between that case in your case is the court in that case said all of the intrinsic evidence all of it the claims claim differentiation in the spec

[00:05:58] Speaker 03:
pointed to the construction the same construction the patentee was arguing and the court was de novo deciding what the construction should be and then the court said moreover the prosecution history takes away any doubt clearly they didn't have any doubt because they went through all the evidence that it all pointed in one direction because they said because in the during prosecution even the applicant said this is the plain meaning to be given so i mean that doesn't that seem quite a bit different because in that case

[00:06:24] Speaker 03:
Every piece of evidence pointed to that definition.

[00:06:26] Speaker 03:
And here, no piece of evidence points to the definition that the patentee wants to give it.

[00:06:31] Speaker 01:
But Your Honor, I think the point here, the question here, is what the patentee said, not what the Patent Office... Because I think it should be what a skilled artisan takes away from the prosecution.

[00:06:44] Speaker 01:
Well, I think that the cases indicate that it is what the patentee said that we look to.

[00:06:50] Speaker 01:
We do look at what a reasonable competitor would conclude based on the prosecution history and what the patentee said.

[00:06:57] Speaker 01:
But that's why American Piledriver is a case strongly in our favor, because in that case, the patent office actually went against, denied what the patentee said.

[00:07:07] Speaker 01:
But the patentee was still held to what they said.

[00:07:09] Speaker 03:
No, you weren't held to it.

[00:07:11] Speaker 03:
The court said every piece of evidence in the case pointed to that being the correct construction.

[00:07:16] Speaker 03:
They weren't held to it.

[00:07:17] Speaker 03:
There's nothing in that case that says we hold them to it.

[00:07:19] Speaker 03:
It's not the plain and ordinary meaning, but we're nonetheless going to hold them to it.

[00:07:23] Speaker 05:
What is the claim construction in this case, by the way?

[00:07:25] Speaker 05:
I don't think that the claim construction is limited to the position that the patent owner took in the prosecution history.

[00:07:32] Speaker 05:
Am I right about that?

[00:07:34] Speaker 01:
The claim construction on delayed release is that essentially anything that does not immediately release

[00:07:40] Speaker 04:
In other words, your view is that 8 milligrams of sustained release is not delayed release.

[00:07:46] Speaker 01:
That's true, Your Honor, but claim construction is not the issue here.

[00:07:50] Speaker 01:
We're on Pop Artistician History of Staple, which isn't the claim construction point.

[00:07:54] Speaker 01:
They didn't have a literal infringement case to bring on Chang.

[00:07:58] Speaker 05:
We're talking about- I think they brought one, they tried to bring one, but it was late, right?

[00:08:02] Speaker 01:
Yes, that's right.

[00:08:03] Speaker 01:
They tried to bring one and I think it's fair to characterize it as the district court found it to be waived and wouldn't let them go forward and struck their contention.

[00:08:11] Speaker 01:
So we don't have a literal infringement case here.

[00:08:13] Speaker 01:
All we have is a doctrine of equivalence case.

[00:08:16] Speaker 01:
So all the talk about claim construction in this case, I don't believe is relevant to the issues, Your Honor.

[00:08:21] Speaker 01:
What's relevant to the issues is whether prosecution history estoppel establishes a bar to the doctrine of equivalence infringement case that they're making.

[00:08:31] Speaker 03:
So you think none of the claims construction is relevant to this and prosecution history estoppel should be treated differently, yet you're telling me I should follow Piledriver, which was a claim construction case?

[00:08:39] Speaker 03:
Well, Your Honor, and I think- So do you not see just a tiny bit of hypocrisy in that?

[00:08:43] Speaker 03:
And hypocrisy is too harsh a word.

[00:08:45] Speaker 01:
I'll take it back.

[00:08:46] Speaker 01:
I agree.

[00:08:46] Speaker 01:
It's too harsh a word, Your Honor.

[00:08:47] Speaker 01:
But I do think that prosecution history is stoppable and prosecution disclaimer.

[00:08:52] Speaker 01:
And I concede that American Piledriver was a prosecution disclaimer case.

[00:08:56] Speaker 01:
That is correct.

[00:08:57] Speaker 03:
No, it was a claim construction case.

[00:08:58] Speaker 03:
It wasn't a prosecution disclaimer case.

[00:09:00] Speaker 01:
Well, correct, Your Honor.

[00:09:01] Speaker 01:
Correct.

[00:09:03] Speaker 01:
But my point is that prosecution disclaimer arises in the context of claim construction.

[00:09:08] Speaker 01:
But I think that the important points here are similar between prosecution history is stoppable

[00:09:13] Speaker 01:
and what goes on in the claim construction context.

[00:09:15] Speaker 01:
You look to see what the patentee said about its invention, about the scope of its invention.

[00:09:20] Speaker 03:
But even when the examiner, and see, I agree with you.

[00:09:23] Speaker 03:
In any case where it's at all ambiguous, I would 100% be in your favor.

[00:09:27] Speaker 03:
Like if the examiner said, well, I don't know about that.

[00:09:29] Speaker 03:
Or if the examiner said, well, even if true, it doesn't overcome your reference.

[00:09:32] Speaker 03:
Or if the examiner left any ambiguity, but here we're on pages 17, 023, and 024, they say, we understand your argument.

[00:09:39] Speaker 03:
They articulate the argument for what

[00:09:40] Speaker 03:
the claim should be construed and they say we unquivocally reject it.

[00:09:44] Speaker 03:
That is not a correct construction.

[00:09:46] Speaker 03:
We will not construe the claim that way.

[00:09:49] Speaker 03:
You still think that somehow a skilled artisan, because what I'm worried about is confusion for skilled artisans down the road.

[00:09:57] Speaker 03:
You still think a skilled artisan who read that would understand that nonetheless these claims are in fact limited

[00:10:04] Speaker 03:
to delayed release only occurring in the intestine, even though the examiner came along and said, that is absolutely wrong.

[00:10:14] Speaker 03:
And that's what I worry about.

[00:10:15] Speaker 03:
What I worry about is that the rule of law that you're asking us to adopt in this case is going to create a lot of confusion down the road for ordinary skilled artisans who are going to walk away from the prosecution with a clear idea that Pandy did not get what they wanted on this term.

[00:10:28] Speaker 03:
Not didn't overcome the rejection, but the board said no.

[00:10:31] Speaker 01:
And Your Honor, respectfully, I think that the rule that you seem to be advocating would create more confusion.

[00:10:37] Speaker 01:
Because then, rather than it being based solely on the statements of the patentee, which I submit is what the law is now, we're now into the case of, what did the PTAB say?

[00:10:47] Speaker 01:
Well, is that good enough, or do we have to wait until the Federal Circuit reviews what the PTAB said?

[00:10:52] Speaker 01:
Is that good enough, or do we have to wait until there's a motion unbound?

[00:10:54] Speaker 01:
Is that good enough, or do we wait for the Supreme Court to determine?

[00:10:57] Speaker 03:
Just to be clear, most of our cases, most of the fact patterns we get are nowhere near as clear as this one.

[00:11:01] Speaker 03:
This one is a beautiful fact pattern because you have really clear statements by the patentee, which if they were all in the record, I'd say hands down disclaimer.

[00:11:09] Speaker 03:
And then the clearest rejection I could imagine by the PTO.

[00:11:13] Speaker 03:
So maybe this is not a great case to make important law in because most cases are going to be fuzzy.

[00:11:20] Speaker 03:
So maybe this is the kind of case where we just say, in this case, giving these facts

[00:11:25] Speaker 03:
Here's what should happen.

[00:11:27] Speaker 04:
I assume you're not arguing the distinction between comprising and insisting on.

[00:11:34] Speaker 01:
We are arguing.

[00:11:35] Speaker 01:
That's the estoppel-by-amendment argument, Your Honor.

[00:11:39] Speaker 01:
And what happened there was that the claims very clearly were amended from comprising, and I'm paraphrasing, but comprising a DR and an IR portion to consisting of a DR and an IR portion.

[00:11:51] Speaker 01:
There's no dispute that our product goes beyond a DR and an IR portion.

[00:11:56] Speaker 01:
And they've made those.

[00:11:57] Speaker 04:
Which would have been encompassed by consisting of.

[00:12:01] Speaker 01:
consisting of does not encompass our invention.

[00:12:05] Speaker 01:
Comprising would have.

[00:12:07] Speaker 01:
Yes, yes, yes.

[00:12:08] Speaker 01:
Comprising was broader.

[00:12:10] Speaker 01:
It got narrower.

[00:12:10] Speaker 04:
You have something more than the 10 and the 30.

[00:12:14] Speaker 01:
That's right.

[00:12:15] Speaker 01:
It would permit something more than that.

[00:12:17] Speaker 01:
In this case, we don't have just the 10 and the 30, just the IR and the DR. And so that is another basis for estoppel in this case.

[00:12:26] Speaker 01:
And that is the prosecution issued by amendment argument.

[00:12:30] Speaker 01:
The district court got that wrong because the district court got the presumptions wrong.

[00:12:34] Speaker 04:
I want to spend a minute or two.

[00:12:36] Speaker 04:
even though you're a battle time on Ashley?

[00:12:39] Speaker 01:
I will, Your Honor.

[00:12:40] Speaker 01:
The basic point on Ashley was that, and I will say that this was without doubt a confusing case because of the number of patents.

[00:12:49] Speaker 01:
But the district court, unfortunately, ruled on the theory that was not tried.

[00:12:55] Speaker 01:
And we had this doctrine of equivalence theory on Ashley II that the district court decided on.

[00:13:02] Speaker 01:
Galderma did not open with that theory.

[00:13:05] Speaker 01:
Galderma did not present evidence on that theory.

[00:13:07] Speaker 01:
Galderma did not present experts on that theory.

[00:13:10] Speaker 01:
They did not present a closing on that theory.

[00:13:12] Speaker 01:
And when we said to confirm that this had not been tried,

[00:13:16] Speaker 01:
They did not rebut what we said.

[00:13:19] Speaker 01:
So it was simply not tried.

[00:13:22] Speaker 01:
The district court, we believe, based on the way the briefing was done, relied on something from factual presentation from the Ashley 1 patents and so the Ashley 2 patents.

[00:13:33] Speaker 01:
and came to a conclusion that there's doctrine of equivalence.

[00:13:36] Speaker 01:
But the problem is that the record has to have particularized testimony and linking argument as to the insubstantiality of the differences.

[00:13:44] Speaker 01:
That is completely lacking here.

[00:13:47] Speaker 01:
And so the actually two findings should be reversed.

[00:13:51] Speaker 05:
I have another question going back to the argument based estoppel.

[00:13:56] Speaker 05:
One of the concerns I have is, I'm sure you'll agree with me, that when a patent owner takes a particular position in claim construction and it's a clear and unmistakable surrender, they can later retract from that.

[00:14:09] Speaker 05:
They can say something affirmatively and say,

[00:14:12] Speaker 05:
Hey, the patent office didn't agree with my claim construction, so I am now taking the position that that is no longer my position of how the claim should be interpreted.

[00:14:23] Speaker 05:
My concern is this.

[00:14:25] Speaker 05:
What mechanism is there for a patent owner to submit such a paper in a circumstance like this where you have an IPR proceeding

[00:14:34] Speaker 05:
with the final decision by the board, what kind of mechanism is there, if any, for the patent owner to say, hey, I retract, I no longer think that that's the right position?

[00:14:44] Speaker 05:
Because come on, let's face it, everybody's going to want to do that.

[00:14:47] Speaker 01:
Yeah.

[00:14:48] Speaker 01:
And I think that when you need a mechanism, you make one.

[00:14:54] Speaker 01:
You submit something.

[00:14:55] Speaker 01:
You attempt to do it, at least.

[00:14:58] Speaker 05:
Do you know of a particular mechanism with the PTO?

[00:15:00] Speaker 05:
Because I know the PTO could say, hey, we have the right to not accept that paper.

[00:15:06] Speaker 05:
I realize no paper was filed here.

[00:15:07] Speaker 05:
There was no attempt.

[00:15:09] Speaker 05:
But I really am just even thinking about cases going forward.

[00:15:12] Speaker 05:
Do you know of any mechanism?

[00:15:14] Speaker 05:
I mean, this is not district court.

[00:15:15] Speaker 05:
I mean, District Court, you do have a lot more opportunities to file papers.

[00:15:20] Speaker 05:
The PTO proceedings, as I understand it from their trial guide, could be more limited in terms of what papers are allowed to be provided.

[00:15:29] Speaker 01:
And I agree that there's a limitation.

[00:15:30] Speaker 01:
What I would say, Your Honor, is

[00:15:32] Speaker 01:
I can't answer that there is a specific mechanism as I stand here right now.

[00:15:38] Speaker 01:
I cannot.

[00:15:39] Speaker 01:
However, the fact that it wasn't even attempted here, it wasn't even tried, shouldn't detract, that shouldn't get them off the hook for the statements they made.

[00:15:49] Speaker 01:
They're responsible for the statements they made.

[00:15:52] Speaker 01:
They know what they say in the file history is important and is going to be relied on by others.

[00:15:58] Speaker 01:
And they took those positions.

[00:15:59] Speaker 01:
And it shouldn't be the problem of the patent challenger to overcome their failure or their regret at positions that they took before.

[00:16:12] Speaker 04:
You have used all your time, Mr. Lombardi, but we will give you two minutes of rebuttal.

[00:16:16] Speaker 00:
Thank you, Your Honor.

[00:16:18] Speaker 04:
Mr. Flatman.

[00:16:20] Speaker 00:
Your Honors, may it please the Court?

[00:16:22] Speaker 00:
There's no firm conviction of a mistake by the district court here and there's no allegation of clear error in the factual findings.

[00:16:37] Speaker 00:
Well, Your Honor, we did and we also presented particularized evidence to the district court.

[00:16:44] Speaker 00:
Where did you make that argument?

[00:16:46] Speaker 00:
We first of all raised it in our pretrial briefing and then we

[00:16:52] Speaker 00:
Presented the evidence and testimony of our experts.

[00:16:56] Speaker 05:
Can you identify the particular record sites for that?

[00:16:59] Speaker 00:
Absolutely, Your Honor.

[00:17:00] Speaker 03:
Because if you're talking about the evidence with regard to sub antibacterial amount limitation, that's a separate limitation and a separate claim.

[00:17:08] Speaker 03:
And I saw that you raised DOE with regard to that and introduced evidence on it, but I saw no argument or evidence on the microflora.

[00:17:15] Speaker ?:
Okay.

[00:17:16] Speaker 00:
Your Honor, just to give you the sites first for the pre-trial order, that's A4540, 47, and 54, where we raised that we were going to attempt to prove Dr. McFadden's infringement of the actual two patents.

[00:17:31] Speaker 05:
I also raised... Do you want to show us?

[00:17:34] Speaker 05:
I mean, that could be very helpful for you here to actually go to A4540 and show us where it is.

[00:17:40] Speaker 00:
Oh, certainly, Your Honor.

[00:17:52] Speaker 00:
So at 4540, paragraph 41, we raised as an issue to be tried whether Amnil infringes any of the asserted claims of the Ashley 572 patent under the doctor of equivalence.

[00:18:05] Speaker 00:
That is the Ashley 2 patent, which contains the microflora, no reduction in microflora term, but not the subantivacterial.

[00:18:14] Speaker 03:
So just out of curiosity, if you have a patent claim with five elements, and you argue particularized testimony to a jury or a judge,

[00:18:22] Speaker 03:
that claim one is in for element one is infringed on to the doctor's equivalence and your expert says the function, way and result of how element one is equivalent to what the accused device does.

[00:18:31] Speaker 03:
But you never say anything at all about element four.

[00:18:33] Speaker 03:
You never offer particularized testimony from any expert about function, way and result with regard to element four.

[00:18:39] Speaker 03:
Do you think you have now have a right

[00:18:42] Speaker 03:
to have the jury find that the doctrine of equivalence has been satisfied with regard to element four?

[00:18:49] Speaker 00:
In this particular instance, yes, Your Honor.

[00:18:52] Speaker 03:
Without any particularized testimony whatsoever, not even a conclusory statement by an expert that these two things are equivalent.

[00:19:00] Speaker 00:
Your Honor, respectfully, there was particularized evidence on this point, and I can explain.

[00:19:05] Speaker 00:
The no reduction in skin microflora term was similar and consistent with

[00:19:10] Speaker 00:
the parallel term, no subantibiotic amount, which was the scaffold on which the experts put in their testimony.

[00:19:19] Speaker 00:
And that's because the non-antibiotic amount terminology required no, or substantially no, antibiotic activity in four areas of the body.

[00:19:30] Speaker 00:
One of those areas was the skin.

[00:19:32] Speaker 00:
And the evidence was presented at that point that there was no reduction in microflora of the skin based on the Skidmore study.

[00:19:39] Speaker 00:
which the judge relied on in his opinion, at A49-50, and example 38 of the patent, which the judge found to be the strongest intrinsic evidence

[00:19:52] Speaker 00:
of no reduction in microflora.

[00:19:53] Speaker 00:
So it was all presented chapter and verse.

[00:19:56] Speaker 03:
What evidence is it?

[00:19:58] Speaker 03:
Your expert testified as to sub antibacterial amount.

[00:20:02] Speaker 03:
He said, yes, it does.

[00:20:03] Speaker 03:
It functions the same way.

[00:20:04] Speaker 03:
And this is an 88 of the appendix.

[00:20:08] Speaker 03:
But I just don't see anything on microflora.

[00:20:12] Speaker 00:
I'm happy to point the court to the relevant sections.

[00:20:15] Speaker 00:
And a couple of them are

[00:20:17] Speaker 00:
A5462-77, which is the Janell direct testimony of our expert Dr. Janell, at A5465, page 171.

[00:20:27] Speaker 00:
A5462.

[00:20:30] Speaker 03:
Would it help if you just slow down for me?

[00:20:32] Speaker 03:
Certainly, Your Honor.

[00:20:36] Speaker 03:
A5462.

[00:20:37] Speaker 03:
Okay, so where is he testifying?

[00:20:40] Speaker 03:
Well, I gave you the range there, Your Honor, and... 5462 is four microfiche tiny pages, so... I know.

[00:20:47] Speaker 03:
Maybe you could tell me what page and line them are.

[00:20:49] Speaker 00:
I will point you to some pin sites instead, Your Honor, which I think will be more helpful and more illustrative.

[00:20:54] Speaker 00:
At A5465, page 171.

[00:21:00] Speaker 00:
Okay.

[00:21:01] Speaker 00:
Let me just get that as well, Your Honor.

[00:21:08] Speaker 03:
This is the Skidmore stuff.

[00:21:09] Speaker 00:
Yes, so he's discussing Skidmore, in particular, and comes to the conclusion at lines 15 to 17, based on Skidmore, that the results were essentially that there was no difference between the doxycycline and placebo for any organism at either time.

[00:21:26] Speaker 00:
This is skin microflora, Your Honor, and he's presenting that because that is part of the first element.

[00:21:33] Speaker 00:
No reduction in skin microflora.

[00:21:35] Speaker 00:
If you go to A5467, just a little down the road at page 178, he concludes, based on Skidmore and the label, at line 22 to 23, the FDA concluded the same thing.

[00:21:52] Speaker 00:
It, that is a 40-milligram doxycycline, functions as a subantibacterial amount.

[00:21:59] Speaker 00:
And he goes on to talk about no detect on page 179, same appendix site, no detectable long-term effects on bacterial flora of four representative areas, one of which is the skin.

[00:22:11] Speaker 00:
Again, no reduction in skin microflora.

[00:22:15] Speaker 04:
Council, let's go to Trane.

[00:22:18] Speaker 00:
Certainly, Your Honor.

[00:22:20] Speaker 04:
How can 30 and 2?

[00:22:23] Speaker 00:
I didn't hear you, Your Honor.

[00:22:24] Speaker 04:
How can 30 and 2?

[00:22:27] Speaker 04:
plus 8, which is not DR, the equivalent to 30 and 10 DR. I'm being cautious here because it's not my confidential information, your honor.

[00:22:42] Speaker 00:
The council will let me proceed.

[00:22:44] Speaker 00:
Yes.

[00:22:45] Speaker 00:
So what the district court concluded was that the DR component consisted of, was built of two parts.

[00:22:51] Speaker 00:
There was a two milligram component that was enterically coded outside.

[00:22:56] Speaker 00:
Which was DR. Which was indisputably a DR portion.

[00:23:01] Speaker 00:
Right.

[00:23:02] Speaker 00:
And then buried within the 30 milligrams of immediate release in the sphere, there was a barrier and then eight more milligrams of material.

[00:23:17] Speaker 04:
which is sustained release.

[00:23:19] Speaker 00:
Right.

[00:23:20] Speaker 04:
And the courts... And I didn't mean to trample on confidential information, but usually what's submitted to the FDA is not confidential, is it?

[00:23:28] Speaker 00:
I'm not sure what the status of their formulation is right now in terms of confidentiality at the FDA.

[00:23:35] Speaker 00:
Okay.

[00:23:36] Speaker 00:
But what the district court concluded, and there's been no allegation of clear error in this finding, is that the 2 plus 8 equals 10, and that the outer

[00:23:47] Speaker 00:
immediate release layer of 30 milligrams on the sphere, plus the barrier that went around the 8 milligrams constituted a mechanism of delayed release, such that it met the claim construction of not releasing immediately or promptly after oral administration.

[00:24:03] Speaker 04:
So this isn't accepted as a fact that this sustained release emptied into the stomach, which means not delayed release?

[00:24:13] Speaker 00:
No, I don't believe so, Your Honor.

[00:24:17] Speaker 00:
What was found by the district court, and it's not challenged, as I understand it, as a factual finding, is that the eight milligrams, indisputably, did not release promptly following oral administration because of the inner position of the outer layer and that other barrier.

[00:24:38] Speaker 00:
District Court relied on the evidence presented by the experts, weighed the testimony of the experts, weighed all of the internal documentation that was presented as evidence during the trial, and came to that conclusion.

[00:24:49] Speaker 00:
And there's no clear error in that finding.

[00:24:52] Speaker 00:
Your Honor, sticking with Chang, what Palant is asking for would be extraordinary.

[00:25:01] Speaker 00:
it's clear that the claim construction arguments and prior distinctions that were made by the applicant during the IPR were rejected on their face thoroughly.

[00:25:10] Speaker 05:
How do you distinguish American Piledrave?

[00:25:14] Speaker 00:
Well, I distinguish it, I think, on that basis.

[00:25:18] Speaker 00:
It wasn't a case where a claim construction that was erroneously urged and then rejected by the Patent Office was then

[00:25:30] Speaker 00:
forced upon the applicant.

[00:25:34] Speaker 05:
Actually, it was.

[00:25:34] Speaker 05:
I mean, it's a claim construction case, and the term was integral.

[00:25:38] Speaker 05:
So American Pile Driving unambiguously argued, I'm actually quoting from the case, argued that integral meant one piece during the examination.

[00:25:47] Speaker 05:
cannot attempt to distance itself from the disavowal of broader scope, is what they said.

[00:25:52] Speaker 05:
And they said that the patent office had said that they weren't going to give integral the one piece definition.

[00:26:04] Speaker 05:
So how do I distinguish that?

[00:26:06] Speaker 00:
I think on the basis that the intrinsic evidence in that case supported the claim construction in the position that was being urged by the applicant as well.

[00:26:16] Speaker 05:
Here though, you know, it's kind of weird to take that as your distinction when what we're talking about isn't claim construction.

[00:26:23] Speaker 05:
We're talking about DOE and whether statements that a patent order makes during prosecution, and we've said that IPRs or statements made during IPRs are

[00:26:34] Speaker 05:
statements that are akin to statements made during other types of prosecution, and that the patent owner is bound by those.

[00:26:42] Speaker 00:
But here, I think that the primary distinction is that no reasonable competitor could rely on those statements made by the applicant when they were clearly and soundly rejected by the board.

[00:26:51] Speaker 05:
Well, in this case, in American Pile Driving, the patent office rejected the claim construction property by the patent owner as well.

[00:26:59] Speaker 00:
And in that sense, though, but in this particular case, if we reach the other conclusion, we would have this anomalous situation where the patent applicant was held both to a rejected claim construction on one hand,

[00:27:13] Speaker 00:
and to the correct claim construction on the other.

[00:27:17] Speaker 05:
You're emphasizing that the district court here adopted the corrected construction and nobody has challenged that on appeal?

[00:27:23] Speaker 00:
It is unchallenged on appeal and it's the construction therefore that this court would apply.

[00:27:28] Speaker 00:
It's the lens through which this court would look when determining whether the district court committed any clear error in applying the facts.

[00:27:36] Speaker 05:
I have one more question for you, which is the same question that I had asked opposing counsel, which is what options, if any, are there for somebody in a position like your client for correcting a claim construction position after the PTO or the board reject it during an IPR?

[00:27:52] Speaker 00:
I'm not aware of any, Your Honor, and in this particular instance, there would have been no need to do so in terms of public notice function because anyone reading the board's final written decision would see that that position was that the applicant's statements were rejected and that the claims were distinguished from the art only on the same basis that they're rejected on and that they were rejected by in the district court, namely the actual correct claim construction.

[00:28:19] Speaker 05:
You could do a petition for rehearing, right?

[00:28:22] Speaker 05:
Is that only allowed by somebody who disagrees with the decision of the board?

[00:28:27] Speaker 05:
You're kind of in a weird situation.

[00:28:29] Speaker 05:
They didn't adopt or claim construction, but you still won.

[00:28:32] Speaker 00:
Right.

[00:28:32] Speaker 00:
And I don't think we had a right to petition for rehearing in that instance.

[00:28:37] Speaker 00:
It could be wrong, but I don't believe we did.

[00:28:39] Speaker 00:
And we did win, ultimately, on the merits, so we never would have taken that route.

[00:28:44] Speaker 00:
And I think the important point is that we actually did win and did distinguish the art ultimately in front of the board based on the claim construction that was adopted here that was applied correctly by the district court.

[00:28:58] Speaker 00:
And that's unchallenged here on appeal.

[00:29:02] Speaker 00:
Their position would also create an anomalous situation where the scope of equivalence would be narrower than literal infringement in this case, as opposed to an equitable.

[00:29:11] Speaker 05:
Why didn't you assert a literal infringement case here?

[00:29:14] Speaker 00:
Why didn't we?

[00:29:18] Speaker 00:
We were procedurally barred.

[00:29:19] Speaker 00:
We thought that we received evidence that showed that they literally infringed.

[00:29:26] Speaker 00:
And let's be honest here, the proofs, I think, at least the findings that the district court made, would suffice for literal infringement.

[00:29:32] Speaker 00:
He found that they had a delayed release 10-milligram component.

[00:29:35] Speaker 05:
Did you not, is it just a question of timing and when you made your literal infringement case?

[00:29:41] Speaker 00:
Yes.

[00:29:41] Speaker 00:
We thought we got the evidence later in the game.

[00:29:44] Speaker 00:
We tried to amend our contentions.

[00:29:45] Speaker 00:
The judge disagreed and said, no, you're stuck with equivalence.

[00:29:50] Speaker 00:
Now, the proofs were sufficient to prove literal infringement.

[00:29:54] Speaker 00:
And you see that in the judge's findings, where he finds at A-76 and A-77 to 78.

[00:30:02] Speaker 03:
So your argument, basically, that which literal infringes has to infringe other DOE, kind of like that which is anticipated has to be obvious.

[00:30:12] Speaker 00:
It's certainly at least the limit.

[00:30:15] Speaker 00:
It can't be narrower.

[00:30:16] Speaker 00:
They've sort of put the cart before the horse.

[00:30:18] Speaker 00:
They haven't urged a reversal in the claim construction.

[00:30:21] Speaker 00:
But they urge estoppels that would result in the anomalous position of equivalence being narrower.

[00:30:27] Speaker 00:
And that's not been the opinion of this Court and any of the presidents that I've reviewed.

[00:30:34] Speaker 00:
Just briefly again on Ashley, well actually on the amendment based estoppel, I think it's important just to address that briefly.

[00:30:42] Speaker 00:
It doesn't apply here because they fall literally within the territory consisting of

[00:30:49] Speaker 00:
a 10-milligram DR and a 30-milligram IR.

[00:30:54] Speaker 00:
The court's so found under its unchallenged clank construction that they had those components.

[00:30:59] Speaker 00:
So even if

[00:31:01] Speaker 00:
we were limited to the territory that was not surrendered.

[00:31:06] Speaker 00:
They would fall within.

[00:31:07] Speaker 00:
But the amendment was also tangential, as this court recently found in its Eli Lilly case.

[00:31:15] Speaker 00:
It was tangential to anything having to do with the distinction that was being made in the prosecution record.

[00:31:21] Speaker 00:
It was made to distinguish high dose prior art, which showed 100 to 200 milligrams of doxycycline being used.

[00:31:29] Speaker 00:
And that was clear in the record

[00:31:31] Speaker 00:
in both the responses of the applicant at A7763 and A7806-7 and in the reasons for allowance where the examiner made this very point at A7865 that the distinction was over high dose doxycycline.

[00:31:49] Speaker 00:
Nothing to do with the accused product here or any distinctions there.

[00:31:54] Speaker 04:
Council, as you can see, your red light is on.

[00:31:57] Speaker 04:
Do you have a final thought?

[00:31:59] Speaker 00:
Just a final thought on Ashley.

[00:32:01] Speaker 00:
And Your Honors, there is particularized evidence, as I pointed out, some of it throughout the record.

[00:32:06] Speaker 03:
The evidence you were pointing to went to a different claim and a different element in that claim.

[00:32:10] Speaker 03:
It wasn't even the same claim language.

[00:32:12] Speaker 00:
It was presented in the context of a different element, which encompassed the no reduction of skin microflora point, because it involved four areas, including the skin.

[00:32:21] Speaker 00:
And the primary evidence that was presented throughout the record.

[00:32:24] Speaker 03:
It was evidence presented by your expert when speaking about a different claim

[00:32:30] Speaker 03:
possibly in a whole different patent, or was it the same exact patent?

[00:32:32] Speaker 03:
I don't even remember, but totally different claim.

[00:32:35] Speaker 03:
It wasn't presented with relevance to this claim or this element.

[00:32:38] Speaker 00:
The element was in both sets of patents, no reduction in skin microflora.

[00:32:42] Speaker 03:
No, they weren't, he was not testifying as to the reduction in skin flora, was he, in that particular place?

[00:32:48] Speaker 00:
Respectfully, yes.

[00:32:49] Speaker 00:
Yes, Your Honor, that's exactly what he was testifying about.

[00:32:52] Speaker 00:
He said, with regard to Skidmore, which is a skin microflora study, that there was essentially no difference

[00:32:57] Speaker 00:
that it showed that it had no significant difference between placebo with regard to placebo.

[00:33:04] Speaker 00:
That is exactly the no reduction in skin microflora term as it was construed by the district court.

[00:33:10] Speaker 00:
And that is, the record is replete with that.

[00:33:12] Speaker 00:
At A5465, page 171, A5477, page 221.

[00:33:18] Speaker 04:
Thank you, counsel.

[00:33:20] Speaker 04:
I think we have your answer.

[00:33:21] Speaker 00:
Yes, your honor.

[00:33:24] Speaker 04:
Mr. Lombardi has some rebuttal time.

[00:33:29] Speaker 01:
Thank you, Your Honor.

[00:33:30] Speaker 01:
With respect to Ashley 2, Your Honor has it right, there is no particularized finding.

[00:33:37] Speaker 01:
There is nothing there that indicates that any of the quotations that he read from relates to Ashley 2 or a doctrine of equivalence finding.

[00:33:46] Speaker 01:
So we're in a situation where the burden apparently, according to my colleague on the other side, is on us to have gleaned from this record that we should have responded to a theory that they did not raise.

[00:33:59] Speaker 01:
I did want to address the point about the pretrial order.

[00:34:02] Speaker 01:
That was the A4540 reference.

[00:34:05] Speaker 01:
What also happened in the trial court was that my colleague argued in another context that a pretrial order does not constitute trying the case.

[00:34:14] Speaker 01:
And that's at A568.

[00:34:16] Speaker 03:
So he said that merely saying that you're going to address this in the pre-trial order... To be honest, he said, how saying I'm going to argue DOE with regard to claims in a particular patent is particularized evidence and testimony with regard to precise elements in a precise claim.

[00:34:31] Speaker 01:
Correct.

[00:34:32] Speaker 01:
Correct.

[00:34:33] Speaker 01:
And A568 confirms, I believe, that they've admitted that.

[00:34:36] Speaker 01:
With respect to Chang, Your Honor, I understood counsel to concede that there is an IR, a DR, and a SR, sustained release portion of the amniote product.

[00:34:49] Speaker 01:
That takes it beyond the scope of the consisting of language of the claims, which was just DR and IR.

[00:34:56] Speaker 01:
And Your Honors, with respect generally to prosecution history, Estoppel,

[00:35:00] Speaker 01:
Your Honor, I do believe that this is a classic case of where prosecution history estoppel should operate.

[00:35:08] Speaker 01:
I understand that the PTAB ruled against them.

[00:35:12] Speaker 01:
However, they're responsible for the statements that they make.

[00:35:15] Speaker 01:
They're on notice that statements they make in the public record are used by competitors to determine what their product can be.

[00:35:22] Speaker 01:
That's exactly what happened with Amnil, which redesigned its product after the PTAB.

[00:35:27] Speaker 04:
What did the PTAB say, in effect, concerning the distinction between sustained and delayed release?

[00:35:36] Speaker 01:
With respect to sustained and delayed release, they said that anything that did not, that released immediately, a sustained release started to release immediately, and so therefore wasn't delayed release.

[00:35:48] Speaker 01:
That's what the PTAB said.

[00:35:49] Speaker 01:
Thank you, Your Honor.

[00:35:51] Speaker 04:
Thank you, Counsel.

[00:35:52] Speaker 04:
The case is submitted.