[00:00:00] Speaker 03:
Last on the case for the day is United Therapeutics Corporation versus Liquidia Technologies Inc.

[00:00:10] Speaker 03:
Number 22-2133.

[00:00:11] Speaker 03:
Mr. Jay, when you're ready.

[00:00:16] Speaker 04:
Thank you, Your Honor.

[00:00:16] Speaker 04:
I may please record William Jay for United Therapeutics.

[00:00:20] Speaker 04:
The board rested on evidence that was neither sworn nor substantial.

[00:00:25] Speaker 04:
Those are the two problems I'd like to address today.

[00:00:27] Speaker 04:
So starting with the problem of the unsworn Winkler Declaration.

[00:00:32] Speaker 04:
The parties defending the board's decision are attempting to defend it on a ground that the board itself never gave.

[00:00:39] Speaker 04:
That's waiver.

[00:00:41] Speaker 04:
Board does not grant a waiver.

[00:00:43] Speaker 04:
The board was not asked to grant a waiver.

[00:00:45] Speaker 04:
And if you look at the sole reference to waiver in the re-hearing decision, footnote one of the re-hearing decision, it doesn't actually say the board is granted such a waiver.

[00:00:54] Speaker 06:
Now here you thoroughly deposed Winkler, right, and obtained sworn testimony as part of that deposition, right?

[00:01:01] Speaker 04:
He was deposed, that's right, a week before our patent owner response was due.

[00:01:05] Speaker 06:
Did that essentially cure some of your concerns about the lack of penalty of perjury statement?

[00:01:13] Speaker 04:
It did not, Your Honor, and I'd like to explain why I am

[00:01:17] Speaker 04:
The board rested on the idea that United Therapeutics Council had admitted that there was no prejudice and I'd like to I'd like to address that too.

[00:01:26] Speaker 04:
But you've asked specifically about the deposition and the board's procedures are set up so that objections are raised and if necessary supplemental evidence is served.

[00:01:35] Speaker 04:
right after the trial is instituted.

[00:01:38] Speaker 04:
Deposition, on the other hand, comes, in this case, right before the substantive patent order responses do.

[00:01:45] Speaker 04:
So even if you thought that a proper way to handle an objection like this was to deal with it at deposition, that wouldn't fit with the way the board schedules its proceedings.

[00:01:56] Speaker 04:
These are expedited proceedings.

[00:01:57] Speaker 04:
There's limited discovery.

[00:01:59] Speaker 04:
And to require parties to use the deposition

[00:02:03] Speaker 04:
to essentially clean up an attestation that the other side did not make would impinge on the party's ability to use the deposition to actually explore the facts.

[00:02:15] Speaker 04:
In other words, if the other side's position is that we should have, at the deposition, gone through each of the factual environments and say, do you swear that this is true under penalty of perjury, that would take up the entire deposition.

[00:02:29] Speaker 04:
and prevent us from exploring the things that actually require exploration of deposition.

[00:02:35] Speaker 04:
But what the board has done in cases like this is said that what parties are supposed to do when a problem like this arises, they're supposed to come to the board.

[00:02:45] Speaker 04:
They're supposed to say, I would like to submit supplemental evidence.

[00:02:49] Speaker 04:
May I please have a waiver of the applicable requirements?

[00:02:55] Speaker 04:
as the board said, quite pointedly, at I think page 57 of its decision, the other side did not do that here.

[00:03:02] Speaker 04:
And what the board then rested on on the next page is the supposed lack of prejudice.

[00:03:09] Speaker 04:
But I think what my co-counsel had said to the board in the oral hearing was two things.

[00:03:15] Speaker 04:
So the board only quotes half a sentence.

[00:03:17] Speaker 04:
the sentence before that and the half a sentence after that or what what I would like the court to look at if you're if you're looking at page 759 of the appendix because the Council for United Therapeutics identified two sources of prejudice.

[00:03:30] Speaker 04:
One is that we didn't have the opportunity to object to the request to submit this as supplemental evidence.

[00:03:37] Speaker 04:
In other words, if the other side had come forward and said we have a good cause, we would like

[00:03:42] Speaker 04:
a waiver, we would have been able to oppose that.

[00:03:44] Speaker 04:
Instead, they engaged in self-help and submitted a supplemental declaration at the reply stage.

[00:03:50] Speaker 06:
Let me just interrupt for one second.

[00:03:51] Speaker 06:
I thought you originally were on appendix page 57.

[00:03:53] Speaker 06:
You say you want to go to appendix page 759?

[00:03:55] Speaker 04:
I apologize, Your Honor.

[00:03:56] Speaker 04:
Let me clarify.

[00:03:57] Speaker 04:
So at page 58, the board relies on a colloquy from the oral hearing.

[00:04:02] Speaker 04:
The transcripts of the oral hearing is at page 759, like the relevant colloquy.

[00:04:07] Speaker 04:
The point I'm making is that the board quotes half a sentence out of context, and what I urge the court to look at is the sentence before and the entirety of the sentence.

[00:04:23] Speaker 04:
So before the quoted sentence, what United Therapeutics Council has said is that, in that sense, there is some prejudice, meaning we weren't given an opportunity to oppose a request to supplement.

[00:04:34] Speaker 04:
And then the second, then there's the quoted portion.

[00:04:36] Speaker 04:
And then Council goes on to say, except for the fact that Your Honor relied upon the petition and the expert declaration.

[00:04:43] Speaker 04:
In other words, the fact that the board is relying on the unsworn testimony is itself a source of prejudice.

[00:04:49] Speaker 04:
The party is not following the rules of evidence, has not properly secured an exception from them, and has nonetheless been able to persuade the board to rely on that.

[00:05:00] Speaker 05:
What I want to ask you about is I heard you in presenting this argument say that the board referred to one way to correct this problem is to seek a waiver.

[00:05:13] Speaker 05:
But I don't see

[00:05:15] Speaker 05:
That's what exactly the board said.

[00:05:17] Speaker 05:
The board said one way to correct this problem is to give authorization to, I thought, correct the unsporn declaration, not authorization for us to waive.

[00:05:31] Speaker 05:
I don't see that.

[00:05:32] Speaker 05:
So I don't know if that matters, but it might matter.

[00:05:36] Speaker 05:
Does the board really have to wait for a party to ask for it to waive a rule, or can it just apply its rule that says the board may waive its rules?

[00:05:47] Speaker 04:
OK, I see what you're asking.

[00:05:49] Speaker 04:
So I think that if the question is, can the board do this suespante without being asked?

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

[00:05:56] Speaker 04:
So let me bracket for a moment whether it can waive the penalties of perjury requirement, because we say those come from the statute and not from the board's rules.

[00:06:06] Speaker 04:
We think that, at a minimum, if the board were doing that, it would do so explicitly and say that it's granting a waiver.

[00:06:12] Speaker 04:
This is similar to what this court confronted in the Align versus ITC case, in which the agency and the party defending its decision came to this court and said, we read this as having granted a waiver.

[00:06:25] Speaker 04:
And the court said, when agencies waive the application of their rules, they say so explicitly.

[00:06:31] Speaker 04:
That's because agencies have to follow their own rules, or they will be reversed for being arbitrary and capricious.

[00:06:35] Speaker 04:
If they're not going to follow their own rules because they're granting a waiver, they say so explicitly.

[00:06:40] Speaker 04:
Now, we, of course, think that you could not waive the requirement of sworn testimony.

[00:06:45] Speaker 04:
Sorry, that the board could not waive the requirement of sworn testimony at all.

[00:06:48] Speaker 04:
If I may, I'd like to pick up on that point.

[00:06:51] Speaker 04:
There are a couple reasons for that.

[00:06:52] Speaker 04:
One has to do with the IPR statute in particular.

[00:06:55] Speaker 04:
The petition, when relying on expert testimony, is required to use affidavits or declarations.

[00:07:02] Speaker 04:
The government suggests that there could be some third category of evidence that is neither an affidavit nor a declaration that's permissible.

[00:07:10] Speaker 04:
We think that's not right, and I think that could be seen in two parts of Section 316, which is the

[00:07:17] Speaker 04:
provision that governs actual trial proceedings before the board, which says, number one, the only people that you can depose are people who have testified by affidavit or declaration.

[00:07:26] Speaker 04:
Number two, it says that the patent owner in presenting expert testimony in its patent owner response must proceed by affidavit or declaration.

[00:07:35] Speaker 04:
So we think that it makes sense structurally to read the corresponding provision in 312A3 that you must proceed by affidavit or declaration as mandatory.

[00:07:45] Speaker 04:
Now, liquidity suggests that a declaration doesn't have to be a sworn declaration.

[00:07:50] Speaker 04:
We think that just can't be squared with section 25.

[00:07:52] Speaker 04:
And I would analogize to the way that the Supreme Court has amended the rules of civil procedure.

[00:07:58] Speaker 04:
Rule 56 used to say affidavit.

[00:08:00] Speaker 04:
It now says affidavit or declaration.

[00:08:02] Speaker 04:
It doesn't have to say sworn declaration because, as the 2010 advisory committee notes say, everybody knows that you look at section 1746, that's how you do a declaration that is a substitute for sworn testimony.

[00:08:13] Speaker 03:
If we agree with you that this is statutory and the board has no authorization to waive these requirements, does that

[00:08:24] Speaker 03:
Nonetheless, is it still subject to a harmless error analysis?

[00:08:28] Speaker 04:
So any APA case is subject to the rule of prejudicial error, and we're not disputing that.

[00:08:34] Speaker 04:
But we think that in an ordinary evidentiary case, harmless error looks like this.

[00:08:39] Speaker 04:
The fact finder didn't rely on the exhibit in question.

[00:08:42] Speaker 04:
Therefore, it was harmless error.

[00:08:44] Speaker 04:
So whether it was hearsay or unauthenticated or something like that.

[00:08:46] Speaker 04:
So here, it's unquestioned that the board predicated its decision on the unsworn Winkler declaration.

[00:08:53] Speaker 04:
It just said,

[00:08:54] Speaker 03:
I get that.

[00:08:56] Speaker 03:
But the board did explain why it thought it was not prejudicial here.

[00:09:01] Speaker 03:
And can you just, I know you attempted to say, do you think it's just per se prejudicial or that there was something more that you would have done if you knew the board was going to rely on it?

[00:09:11] Speaker 04:
Well, so three things.

[00:09:13] Speaker 04:
I mean, one, it's per se prejudicial once the board relies on it in the final written decision.

[00:09:17] Speaker 03:
Two, I think the board can, I just want to parse these.

[00:09:21] Speaker 03:
Why is that true?

[00:09:22] Speaker 03:
Like, if you submit an improper affidavit, and the board says, nevertheless, we find this person is credible, his testimony is supported, he has the right credentials, and you all got a chance to cross-examine him on all the merits of his testimony, and therefore, no credentials.

[00:09:46] Speaker 03:
You don't think they can make that kind of analysis.

[00:09:49] Speaker 03:
Now, whether they did or not, I assume you're going to get to.

[00:09:52] Speaker 03:
But suppose they did that very thorough, no prejudice analysis that I just suggested.

[00:09:58] Speaker 03:
Would that not be within the board's authority?

[00:10:00] Speaker 04:
So respectfully, Your Honor, that sounds more like a waiver analysis rather than

[00:10:05] Speaker 04:
Although this is improper evidence, you are not harmed by our relying on it because the board has to follow its own regulations.

[00:10:12] Speaker 04:
One of those regulations, even setting aside the statutes, is only admissible evidence.

[00:10:17] Speaker 04:
It's not admissible evidence if it's not sworn.

[00:10:19] Speaker 04:
So I think that's sort of the

[00:10:20] Speaker 04:
the sequence that we would follow there.

[00:10:23] Speaker 04:
The considerations that you laid out sound more like considerations for granting a waiver.

[00:10:28] Speaker 04:
It would have to lay out its reasoning and it could not be arbitrary and capricious.

[00:10:32] Speaker 04:
I think that the inconsistency with its own prior decisions, the two decisions that it itself cites at page 57 of the appendix in which Hardy didn't come forward and give a timely opportunity to cure the error, that's really where the prejudice comes from.

[00:10:46] Speaker 04:
In the sequence of an IPR,

[00:10:48] Speaker 04:
There's not a lot of time between when trial is instituted and when the patent owner response is due.

[00:10:53] Speaker 04:
And so we had only a week between when the deposition occurred and we actually had to file the patent owner response.

[00:11:00] Speaker 04:
At that time, when we virtually walked into the deposition, we did not know to what extent the expert was going to stand by his declaration or not.

[00:11:10] Speaker 04:
We had raised this objection, got nothing served in response.

[00:11:14] Speaker 04:
And so, I mean, to my colleague with Judge Gunningham, the question is, were we going to devote the entire deposition to asking whether he stands by his declaration or not?

[00:11:22] Speaker 03:
So can I just, I understand a bit what you're saying, but can I just follow up?

[00:11:28] Speaker 03:
Is there something differently you would have done as to the contents

[00:11:33] Speaker 03:
his declaration and what the board relied on in its merits ruling if it had been sworn or not sworn.

[00:11:42] Speaker 04:
Well, let me approach that this way.

[00:11:44] Speaker 04:
So I think that his not having signed the attestation would have allowed him to walk away from pretty much anything that he needed to and our not knowing whether he was going to stand by it.

[00:11:57] Speaker 04:
I think that that's the prejudice because it affects how we prepare for and take the deposition.

[00:12:03] Speaker 05:
I understand the question and I suppose if our focus was on curing the other side's problem for it then I suppose we could do that not not knowing what answer we would get of course and I suppose

[00:12:30] Speaker 05:
Because you didn't know what he was going to withdraw and take back.

[00:12:34] Speaker 05:
You could ask that question.

[00:12:37] Speaker 04:
I guess I would just submit that it's not our burden to try and cure the error.

[00:12:42] Speaker 04:
Sorry, cure the failing.

[00:12:45] Speaker 04:
What we tried to do was to explore at that position the topics that we would explore at that position.

[00:12:50] Speaker 04:
And it's certainly correct that we've responded.

[00:12:52] Speaker 03:
But that's what I guess I was trying to ask about.

[00:12:54] Speaker 03:
Would you have explored them in any different way

[00:12:57] Speaker 03:
if it had been a sworn declaration versus the declaration that you had.

[00:13:03] Speaker 03:
And can you provide any explanation about whether you told the Lord that or not?

[00:13:10] Speaker 04:
So I can't point to either an exchange that would have been different or other than the exchange about whether the headers indicated that or some evidence that this has been written by counsel because of the close similarity between the petition and the declaration.

[00:13:35] Speaker 05:
And that's something you wouldn't have asked because it was not sworn?

[00:13:39] Speaker 04:
So I think that if he had sworn that these were his beliefs at the end of the declaration, I guess it wouldn't have been necessary to ask the first of the two questions.

[00:13:52] Speaker 04:
I guess, yes, I think we still would have inquired into why they hadn't.

[00:13:55] Speaker 06:
He did ask him, did he write it?

[00:13:56] Speaker 06:
And he said, yes.

[00:13:58] Speaker 04:
That's correct That's what which I submit is somewhat different than asking whether he stands by everything in it or whether in other words He wrote it, but he never gave the attestation that it was true and correct under penalty of perjury But I mean like we've many of us all been at these depositions like part of the whole reason you're doing the deposition is to find out does he stand by the things said in there and It's just helping your case.

[00:14:24] Speaker 06:
I'm kind of

[00:14:25] Speaker 06:
having difficulty understanding how your actions would have been different if there had been that statement of perjury.

[00:14:30] Speaker 04:
So I definitely take the point, Judge Cunningham, about the ordinary purpose of a deposition.

[00:14:34] Speaker 04:
But I would just submit that it's a little bit different in an IPR, because all the direct evidence comes in in declaration form.

[00:14:40] Speaker 04:
Depositions are limited to those who have provided declarations.

[00:14:43] Speaker 04:
Discovery is very limited.

[00:14:45] Speaker 04:
And this sort of gets back to the question Judge Hughes had asked about the waiver point.

[00:14:49] Speaker 04:
But the board never sees live testimony.

[00:14:52] Speaker 04:
All of this it sees in written form.

[00:14:55] Speaker 04:
And that's why it's particularly important that the written evidence that it relies upon, which is separate from the depositions that the other side then uses to impeach that declaration, that the written declaration has to be impressed with the guarantees of trustworthiness that go with the sworn attestation.

[00:15:11] Speaker 04:
That's why this is not consistent with the rules of evidence.

[00:15:15] Speaker 06:
Is there anything else you want to talk about?

[00:15:17] Speaker 06:
I think you have two points.

[00:15:17] Speaker 06:
I feel bad that we've taken up all the time.

[00:15:21] Speaker 03:
Quickly, because you made completely exhausted your rebuttal time, too, which we'll restore.

[00:15:25] Speaker 04:
I appreciate the indulgence.

[00:15:29] Speaker 04:
I won't test the court's patience.

[00:15:32] Speaker 04:
Really, all that I wanted to point out was just if you look at paragraph 151 of the Winkler Declaration, which is really the only thing that the board relies on,

[00:15:41] Speaker 04:
for the limitation about contacting the solution with the base.

[00:15:47] Speaker 04:
You'll see that it is quite conclusory.

[00:15:49] Speaker 04:
It does not recite anything in the prior art.

[00:15:52] Speaker 04:
And most importantly, it does not deal with the process-based objections about pot reactions, about potassium hydroxide, that our expert gave at pages 11, 988 and 11, 934 to 35 of the appendix.

[00:16:08] Speaker 04:
Thank you.

[00:16:08] Speaker 04:
Thank you very much.

[00:16:16] Speaker 01:
with your name?

[00:16:17] Speaker 01:
Absolutely.

[00:16:19] Speaker 01:
It is Sanya Sukh Duang.

[00:16:23] Speaker 01:
Sukh Duang?

[00:16:24] Speaker 01:
Yes.

[00:16:24] Speaker 01:
Thank you.

[00:16:27] Speaker 01:
I think you've taken 12 minutes.

[00:16:30] Speaker 02:
Good morning.

[00:16:30] Speaker 02:
May it please the court.

[00:16:31] Speaker 02:
Sonia Sukdu on behalf of Liquidia.

[00:16:35] Speaker 02:
The issue here is really the veracity of Dr. Winkler's declaration.

[00:16:40] Speaker 02:
That's really the heart of the matter.

[00:16:42] Speaker 02:
Dr. Winkler testified, and he was asked specifically, and this is at appendix page 12-004,

[00:16:50] Speaker 02:
during the deposition associated with his first declaration.

[00:16:54] Speaker 02:
Can you provide truthful and accurate testimony here today?

[00:16:57] Speaker 02:
And the answer was unequivocally yes.

[00:16:59] Speaker 02:
When you look at the rest of the appendix in the deposition, it's appendix page 12014, counsel spent a number of questions asking about who wrote the declaration,

[00:17:13] Speaker 02:
what specific portions of the declaration, like the header of the declaration, and then turned Dr. Winkler specifically to his signature page.

[00:17:21] Speaker 02:
And this is that appendix page 12014.

[00:17:23] Speaker 02:
And said, is that your signature?

[00:17:26] Speaker 02:
Yes.

[00:17:28] Speaker 02:
They could have explored quite easily if they thought, do you stand?

[00:17:32] Speaker 02:
It's a single question.

[00:17:33] Speaker 02:
Do you believe everything you put in your declaration is true and accurate?

[00:17:37] Speaker 02:
That would have taken 10 seconds of the deposition.

[00:17:41] Speaker 02:
They didn't ask that question.

[00:17:42] Speaker 02:
And the reason why they didn't ask that question goes to your point, Judge Cunningham, is that the point of a deposition is to ask, do you stand by the points in your declaration?

[00:17:53] Speaker 02:
looking at countervailing evidence that they decide to put in front of the declarant, do you still believe your statement is correct?

[00:17:59] Speaker 02:
Looking at the statements itself, in light of the prior art Dr. Winkler cited, do you believe that these statements are correct?

[00:18:07] Speaker 02:
And importantly here,

[00:18:09] Speaker 02:
Dr. Winkler's declaration is not in isolation.

[00:18:12] Speaker 02:
If you look at the board's final written decision, and I believe it's in pages eight, appendix pages eight through 10, and specifically appendix page nine, the board in its final written decision discusses the SteadyMed IPR involved the 393 patent that belonged to UTC.

[00:18:36] Speaker 02:
And they specifically say that Dr. Winkler was the declarant in that case as well, and provided substantially similar testimony.

[00:18:46] Speaker 05:
So the question as to whether Dr. Are you suggesting that one is under oath?

[00:18:53] Speaker 02:
I'm not raising it to the point as being under oath.

[00:18:56] Speaker 02:
And yes, it was.

[00:18:59] Speaker 02:
If the question is, did UTC question the veracity of Dr. Winkler, could he have stepped back and walked away from everything that he said in his declaration and said, oh, if you had told me I had to swear this under penalty of perjury, you're right.

[00:19:15] Speaker 02:
I'm unwilling to stand by my declaration.

[00:19:18] Speaker 02:
The point of pointing out this portion of the final written decision is that if the question is the veracity of his testimony,

[00:19:27] Speaker 02:
the veracity of his declaration and what he said.

[00:19:30] Speaker 02:
He said similar things in a prior IPR.

[00:19:34] Speaker 02:
The question of veracity itself, which is really what the oath is supposed to be about, the question of veracity.

[00:19:39] Speaker 05:
This all goes to harmless error, right?

[00:19:40] Speaker 05:
I mean, just to be sure.

[00:19:41] Speaker 02:
It's all harmless error.

[00:19:42] Speaker 02:
And going to Judge Hughes' question.

[00:19:44] Speaker 02:
Just a minute.

[00:19:44] Speaker 05:
I just want to make sure I understand.

[00:19:47] Speaker 05:
So the argument on the other side is that the statute says that there has to be certain kind of evidence.

[00:19:52] Speaker 05:
That certain kind of evidence has to be including oath.

[00:19:55] Speaker 05:
that wasn't done.

[00:19:56] Speaker 05:
Right.

[00:19:58] Speaker 05:
And you're saying well review under the APA you know if it's harmless error even if there was an error then you know that that's we can affirm in this case.

[00:20:09] Speaker 05:
I think that's what you mean.

[00:20:11] Speaker 05:
Yes.

[00:20:12] Speaker 05:
So all of this is going to show look it's right.

[00:20:14] Speaker 05:
There should have been an oath but

[00:20:16] Speaker 05:
Any error was harmless because of the deposition and there's nothing that they can show they would have done differently and You know, mr. Dr. Winkler's porosity was truly tested.

[00:20:27] Speaker 02:
Yes, and I just wanted to make sure and I I know you assume this in your question the whether it's a statutory requirement is a separate issue we don't believe it is and

[00:20:37] Speaker 02:
But I'm assuming for your question, even if it is a statutory requirement, we believe this is harmless error.

[00:20:43] Speaker 02:
The reason for that is if you look at the American Farm Lines case, if you look at the board's decision, even if you look at counsel's statements in the oral hearing during the IPR, the question is whether it's substantial prejudice or not.

[00:21:04] Speaker 02:
And with respect to the points that counsel pointed to, I believe it's appendix page 750-90 pointed to you, counsel for UTC said, well, if liquidity had asked for permission to submit a replacement declaration, we may have opposed that if we wanted to.

[00:21:24] Speaker 02:
There is, quote, some prejudice there.

[00:21:27] Speaker 02:
Some prejudice is not the standard and not high enough to meet the burden that they have to establish with respect to substantial evidence.

[00:21:34] Speaker 05:
What do you think he's referring to when you say some prejudice?

[00:21:38] Speaker 02:
But honestly, Your Honor, I'm not quite sure.

[00:21:40] Speaker 02:
I think it's the fact that they just were not given the right to oppose such a motion.

[00:21:47] Speaker 02:
And that itself is the prejudice.

[00:21:49] Speaker 02:
And not a more substantive, we would have argued something differently.

[00:21:56] Speaker 05:
We would have chosen- But you said they would have argued something to oppose the motion.

[00:22:01] Speaker 02:
Yes.

[00:22:01] Speaker 02:
And that's it.

[00:22:03] Speaker 02:
The prejudice, the some prejudices, we were not given an opportunity to oppose a motion.

[00:22:08] Speaker 03:
What is that prejudice?

[00:22:09] Speaker 03:
I mean, if you submitted an inadequate declaration, and again, let's assume the statute of requirements.

[00:22:17] Speaker 03:
We don't get into the waiver issue.

[00:22:18] Speaker 03:
And they don't know whether the board's going to rely on it or not.

[00:22:23] Speaker 03:
Shouldn't they be given a chance to respond to your request to say, you should accept this even though it's inadequate for these reasons?

[00:22:32] Speaker 03:
And they get to say, no, you shouldn't.

[00:22:34] Speaker 03:
And maybe they could have convinced the board not to rely on it.

[00:22:38] Speaker 03:
they weren't given that chance.

[00:22:39] Speaker 03:
Why isn't that prejudice that is harmful?

[00:22:45] Speaker 02:
I think they were given that opportunity in their motion to exclude, which was denied and was briefed.

[00:22:53] Speaker 02:
So the motion to exclude is substantially the same argument presented here.

[00:22:59] Speaker 02:
If there was a different argument to be had,

[00:23:03] Speaker 02:
We would have seen it in the motion to exclude, in addition to the arguments they presented, if there was a different position to be had.

[00:23:11] Speaker 02:
We would have seen it here on appeal as well.

[00:23:15] Speaker 03:
So I take it, and this is probably an unfair summary, but let me give it to you.

[00:23:22] Speaker 03:
Basically, all these violations that we're talking about are procedural, and there's no real challenge to the veracity and the merits of what he said.

[00:23:32] Speaker 03:
They have arguments about why it's wrong, and it shouldn't be relied on.

[00:23:36] Speaker 03:
But that the board, whether or not it was sworn,

[00:23:41] Speaker 03:
relied on what he said, and there was no reason to not allow the board to do that.

[00:23:48] Speaker 02:
Correct.

[00:23:49] Speaker 02:
Under the procedural rules of the board, and the board did actually a very thorough job, and I was the counsel that argued before the board at the IPR hearing.

[00:23:57] Speaker 03:
Shouldn't the board be, I think Mr. Jay referenced cases

[00:24:05] Speaker 03:
this is for the PTO counsel.

[00:24:07] Speaker 03:
But shouldn't the board be consistent in applying these rules and not let's suck in when they want to rely on it and keep it out if they don't want to rely on it?

[00:24:15] Speaker 03:
Isn't that the definition of arbitrariness?

[00:24:17] Speaker 02:
I believe the board has been consistent in this in the cases that Mr. J cited.

[00:24:23] Speaker 02:
Those are situations where the party raising the issue that the declaration was not sworn

[00:24:31] Speaker 02:
chose to not depose that individual and did not be, chose to not establish the veracity of the testimony, which then allowed them to say to the board, your honors, there is no sign that this declaration and this declarant is actually being truthful.

[00:24:55] Speaker 02:
And so by taking the opportunity

[00:24:57] Speaker 02:
to depose, and in other words, depose them rigorously.

[00:25:01] Speaker 03:
You're saying because they did a good job in discovery and talking to your witnesses that they should therefore forfeit their argument about following the rules.

[00:25:15] Speaker 02:
Well, they haven't forfeited the argument.

[00:25:18] Speaker 02:
But the argument that they need to raise is that because the oath was not there, there is substantial prejudice.

[00:25:26] Speaker 02:
because of the oath, not because of something else said in the declaration.

[00:25:31] Speaker 02:
Now, if Dr. Winkler testified, yes, I stand behind my declaration during his deposition, and then all of a sudden retracted everything, then the question becomes, well, one, the oath isn't there, and two, this witness lacks credibility.

[00:25:45] Speaker 02:
Here,

[00:25:49] Speaker 02:
If they could establish that there was substantial prejudice because the oath was missing itself, that something about that oath deprived them an opportunity to do something other than just make a procedural objection, then there might be some merit to the argument here.

[00:26:08] Speaker 02:
But in this situation, because they took that opportunity

[00:26:13] Speaker 02:
because they deposed Dr. Winkler twice, and again, in their own terms rigorously, and that the board, in rendering its final written decision, went through all those factors and waived.

[00:26:26] Speaker 02:
And going to your question, Judge Stoll, to Mr. Jay, you don't need to, the board doesn't need to wait for permission to deal with its own rules.

[00:26:37] Speaker 02:
And that's what it did here.

[00:26:38] Speaker 02:
It can do it, for lack of a better term, to respond to.

[00:26:40] Speaker 05:
What is your support for that?

[00:26:42] Speaker 02:
Because its own section 42, 37 CFR section 42, the board has the right to waive its rules.

[00:26:49] Speaker 02:
It doesn't say the board has a right to waive its rules only upon request.

[00:26:54] Speaker 02:
It has the right and it gave itself the right.

[00:26:57] Speaker 06:
Approximately how many hours of deposition were taken?

[00:27:01] Speaker 02:
So there were two declarations, an original declaration with the petition and then a reply declaration.

[00:27:08] Speaker 02:
Going to just the original declaration on this issue, I would have to say it was just short of the full seven hours.

[00:27:15] Speaker 02:
They're entitled to seven hours.

[00:27:17] Speaker 02:
It was just short of the full seven hours.

[00:27:19] Speaker 02:
When you look at the reply, again, it was probably just shy of seven hours.

[00:27:23] Speaker 05:
Was the reply under oath?

[00:27:25] Speaker 02:
The reply was under oath, yes.

[00:27:27] Speaker 02:
And so combined,

[00:27:29] Speaker 02:
And in the reply declaration, Dr. Winkler reiterated some points in his opening declaration because they dealt with the issue of whether you remove the intermediate isolation step.

[00:27:43] Speaker 02:
You'd have close to, I'd say, 12 to 13 hours of deposition.

[00:27:47] Speaker 06:
Did they make any arguments they had an inadequate amount of time because of the lack of the perjury statement?

[00:27:53] Speaker 06:
Like, they basically needed more time to really test this declaration?

[00:27:57] Speaker 02:
No, they did not.

[00:27:58] Speaker 02:
And they did not use the full time.

[00:27:59] Speaker 02:
So to the extent they argued they didn't have enough time, well, you still had probably an hour and a half of time available.

[00:28:08] Speaker 02:
There was one point made about the substance.

[00:28:11] Speaker 02:
I can certainly address that if you'd like.

[00:28:12] Speaker 02:
Otherwise, I yield my 18 seconds.

[00:28:17] Speaker 02:
Thank you.

[00:28:34] Speaker 03:
Sorry, Ms.

[00:28:37] Speaker 03:
Quiller?

[00:28:37] Speaker 00:
Yes, that's correct.

[00:28:38] Speaker 00:
Your Honors, and may it please the court, the board did not abuse its discretion in deciding to waive its rule requiring direct testimony in the form.

[00:28:47] Speaker 03:
Can I ask you about that?

[00:28:48] Speaker 03:
Because I'm not sure that it matters so much about how it plays out, but it might.

[00:28:53] Speaker 03:
Did the board, the department looked at it, didn't suggest that it was a waiver, it suggested a judicial

[00:29:00] Speaker 03:
Are those the same thing in your view?

[00:29:05] Speaker 00:
Well, I think if you look at whether when it was using its discretion to waive

[00:29:11] Speaker 00:
it looked at whether or not it was prejudice.

[00:29:13] Speaker 03:
Where are you saying it used this discretion to make the decision?

[00:29:18] Speaker 00:
Yes, so if you look first at Appendix 58, and that's where it decided that there was no undue prejudice.

[00:29:25] Speaker 00:
Leading up to this, and there's- Can you just let us- Certainly.

[00:29:29] Speaker 05:
Okay.

[00:29:30] Speaker 05:
Because I have the same question.

[00:29:32] Speaker 00:
So I think backing up, in totality,

[00:29:35] Speaker 00:
And this is in alignment with the aligned BITC case that UTC's counsel discussed.

[00:29:42] Speaker 00:
In totality, the evidence shows that the board did waive its rules.

[00:29:45] Speaker 00:
So it started by discussing the rules, and that's a couple of pages back.

[00:29:50] Speaker 00:
It just cites the rules, and it says it has to be in the form of an affidavit.

[00:29:53] Speaker 00:
But then looking at the top of Appendix 58, it says, it acknowledges that the

[00:29:58] Speaker 00:
the declaration was defective, but then it looks at whether or not there was undue prejudice.

[00:30:04] Speaker 00:
That's showing that it sees the rules, it says it's defective, but it's looking at whether or not to use its discretion to waive its rules.

[00:30:11] Speaker 00:
And if there is any question about that... But it doesn't cite the rule.

[00:30:15] Speaker 05:
Correct.

[00:30:15] Speaker 05:
It says it can waive its rule, and it doesn't say we are using our discretion to waive.

[00:30:20] Speaker 00:
So if there was any question about that, it's resolved by Appendix 67, Note 1, which is the rehearing decision

[00:30:26] Speaker 00:
which is where it cites the fact that the board, our regulations allow us to waive or suspend a requirement of part 42 of our rules.

[00:30:35] Speaker 00:
And that's directly following its citation of 4250-3.

[00:30:38] Speaker 00:
So in the aligned BITC case, there it found there was no waiver, because there was no evidence that the commission in that case acknowledged that they had a rule to follow.

[00:30:49] Speaker 00:
There was no discussion of the reasons why it may want to waive its rules.

[00:30:54] Speaker 00:
And then the ITC commission in that case did not take the chance to waive its rules when there was an opposition.

[00:31:02] Speaker 03:
So does this argument, is there a difference in this argument if we find that the statute required this more declaration?

[00:31:11] Speaker 00:
Yes, of course.

[00:31:11] Speaker 00:
Now, while I disagree and our brief lays that out, the board cannot waive a statutory requirement.

[00:31:16] Speaker 00:
So in that case, we'd look to, I would say, two answers.

[00:31:20] Speaker 00:
And again, I won't go through why we do not believe the statute requires.

[00:31:24] Speaker 00:
That's in our briefs.

[00:31:25] Speaker 00:
But first, the statute doesn't require exclusion, even if an oath is required.

[00:31:30] Speaker 00:
So the Diaz v. Air Force case says, an agency's violation of its statutory procedural requirements does not invalidate the agency's action

[00:31:39] Speaker 00:
when Congress has not expressed any consequences.

[00:31:42] Speaker 00:
So because the statute does not say a consequence for not having it in the form of an affidavit, it does not require a reversal.

[00:31:49] Speaker 00:
But going further than that, as your honors have recognized, there is a rule of prejudicial error.

[00:31:54] Speaker 00:
And here.

[00:31:55] Speaker 03:
So I guess that's my question is, why are we going to get into this mess of what the statute requires, whether the board actually weighs its rules or all that kind of stuff, when we could just say,

[00:32:07] Speaker 03:
we could look at this and say, whatever the argument, the board found a lack of prejudice.

[00:32:13] Speaker 03:
We find that argument supported.

[00:32:15] Speaker 03:
And therefore, we don't need to reach those other issues.

[00:32:18] Speaker 00:
That certainly cuts to the case.

[00:32:20] Speaker 00:
Well, it is important to the agency to establish the fact that it has the ability to waive its own rules.

[00:32:25] Speaker 03:
And for future cases, I mean, if it's only the agency's own rules, I don't think there's any question that the agency can waive its own rules.

[00:32:35] Speaker 03:
But if there is a statutory command, the agency can't ignore statutes if, as you say, it may not have consequences.

[00:32:45] Speaker 03:
We've held that in other cases.

[00:32:48] Speaker 03:
Or it's still subject to prejudicial error.

[00:32:51] Speaker 03:
But that's a different question than saying the agency can waive it.

[00:32:55] Speaker 00:
It would just leave the question open for another day of whether or not this is a requirement that the agency could waive.

[00:33:02] Speaker 00:
So in a future case,

[00:33:04] Speaker 00:
it will inform the board's actions of whether or not it is a simple waiver or whether or not we're now facing a case which is going to come before this court, which is looking at whether or not the admission of an unscored declaration, which does not happen routinely, but whether that is prejudicial error.

[00:33:24] Speaker 00:
So I think answering the question about whether or not the statute does require it will certainly cut through.

[00:33:31] Speaker 00:
and provide guidance to parties in the future.

[00:33:34] Speaker 00:
But as Your Honor recognizes, this case on the merits of itself can be decided because there was no prejudice tied to the goal that the rule was designed to protect, which is the guarantee of truthfulness.

[00:33:46] Speaker 00:
That's to protect the board and the person that's filing the declaration.

[00:33:50] Speaker 00:
This having an attestation of truthfulness requires that the board know that they have a guarantee of truthfulness.

[00:33:57] Speaker 06:
Did there be no deposition taken?

[00:34:00] Speaker 06:
of the expert, do you believe that there would have been a better argument on prejudice or potentially a different outcome that would be applied by that?

[00:34:09] Speaker 00:
I think the board's decisions certainly weigh out that there could have been a different outcome.

[00:34:15] Speaker 00:
Every case, of course, is decided on the facts of its own merits.

[00:34:18] Speaker 00:
But in the other cases where there were not a deposition or the argument was raised at institution phase, where there is no

[00:34:25] Speaker 00:
deposition process.

[00:34:27] Speaker 00:
In those cases the board had excluded the deposition, but here it felt it had the guarantee of truthfulness that it needed to be able to rely on it.

[00:34:36] Speaker 00:
And there's no prejudice tied to that guarantee.

[00:34:39] Speaker 00:
All the prejudice that has been discussed is either about a completely different document, the opposition to the replacement declaration, or about the merits of the case.

[00:34:49] Speaker 06:
What about

[00:34:51] Speaker 06:
opposing counsel's concern on timing.

[00:34:53] Speaker 06:
They seem to be concerned about the timing of when it was known.

[00:34:57] Speaker 06:
I don't know if they would agree it was known, but take it for purposes of answering this question that it was known that you could, the expert was basically standing by its statements in the declaration.

[00:35:10] Speaker 06:
What about the timing of that since it wouldn't have been known perceivably until the deposition in light of the way things played out in this particular case?

[00:35:18] Speaker 00:
So with respect to their saying that they didn't know whether or not, I've yet to see how that has changed their tactics with respect to what they would have done.

[00:35:29] Speaker 00:
You all go into a deposition, and experts in my experience can change their mind frequently with or without an oath.

[00:35:38] Speaker 00:
So I don't see how the presence of an oath or the lack of an oath prior to a deposition changed the tactics during the deposition itself.

[00:35:48] Speaker 00:
Thank you.

[00:35:53] Speaker 03:
I'll restore your control for a minute.

[00:35:56] Speaker 04:
Thank you, your honor, and I'm just going to focus on the authentication and attestation requirements.

[00:36:05] Speaker 04:
Actually, I'm going to interrupt you right away.

[00:36:09] Speaker 03:
Can I just ask you this, and it's related to what I asked the townhouse council.

[00:36:16] Speaker 03:
And I know you don't agree with it, but if we see that there's, if we find no prejudice here, is there any reason that we would address whether this is a statutory or a regulatory requirement, whether it was waiver or not?

[00:36:28] Speaker 03:
If we find no prejudice, then that resolves the case.

[00:36:32] Speaker 04:
So I think I'm going to disagree with the concept of prejudice that you're making into your question.

[00:36:38] Speaker 04:
But I think that the reason to address it is because the board and the PTO, more generally, and parties in IPRs need to understand what happened here and what the law is.

[00:36:52] Speaker 04:
Because the board resists the idea that there is a statutory obligation to provide sworn testimony and not unsworn testimony.

[00:37:02] Speaker 03:
and the upshot of the... So you're asking us to decide an issue that perhaps we don't need to reach to give guidance?

[00:37:13] Speaker 04:
Well, here's why I think in order to reject... You understand my reluctance, right?

[00:37:18] Speaker 03:
I do.

[00:37:18] Speaker 03:
I would like to, I'm not speaking for my colleagues in this, but decide the case on the most narrow of ground possible and if we found no prejudice that would certainly be more narrow than

[00:37:29] Speaker 03:
whether this is a statutory or regulatory command.

[00:37:32] Speaker 04:
But I think that the reason that some of the questioning has spun out and that the other side has advocated for why there would be no prejudice is you took a deposition and

[00:37:45] Speaker 04:
as the colloquy with Miss Queller brought out, puts parties to the really awful choice.

[00:37:52] Speaker 04:
If you take the deposition, you are waiving your evidentiary objection.

[00:37:57] Speaker 04:
And if the court's going to hold that and is going to hold that that is the concept of prejudice that is going to allow something that is not evidence and does not comport with the rules and did not receive a waiver from the board, nonetheless comes into evidence and nothing can be done about it.

[00:38:12] Speaker 04:
in an evidentiary sense.

[00:38:14] Speaker 04:
I think the court ought to tell the agency and the bar that.

[00:38:19] Speaker 04:
We don't think that would be a correct holding, precisely because these are statutory guarantees, precisely because this is an expedited proceeding that relies on these guarantees of trustworthiness before a fact-finder that never gets to lay eyes on any of these witnesses.

[00:38:34] Speaker 04:
That's why having the expert sign an attestation right when the opinion is given

[00:38:41] Speaker 04:
is essential, especially because, as we pointed out in our brief, if the expert puts in the thing, even if it's been written by counsel, even if other things that we're not arguing happened here were to happen, the expert's then going to be somewhat reluctant to back away from it later on in the proceeding.

[00:39:01] Speaker 04:
That's another way in which you'll never really know what the prejudice looked like if the argument is, by taking a deposition, you're going to cure any of the prejudice that you might have argued.

[00:39:11] Speaker 04:
This is a statutory violation to be treated as such.

[00:39:14] Speaker 03:
Thank you.