[00:00:00] Speaker 06:
OK, our second and last appeal we're hearing today is Appeal Number 22-1394, Areas 2 Incorporated versus Alphagen PB Research and Development, LLC.

[00:00:17] Speaker 06:
Mr. Lowe, whenever you're ready.

[00:00:18] Speaker 01:
Thank you, Judge Chen.

[00:00:27] Speaker 01:
Good morning.

[00:00:28] Speaker 01:
May it please the court.

[00:00:32] Speaker 01:
My name is Jeremy Lowe here on behalf of Albigen.

[00:00:35] Speaker 01:
We think the district court mostly got this right.

[00:00:39] Speaker 01:
Buprenorphine, Bima Films would have been obvious to Opposa.

[00:00:43] Speaker 01:
But there are a few places we think the district court erred, starting with the backing layer limitation of the 539 patent.

[00:00:51] Speaker 01:
The only record evidence is that the Pryorak-Bashisht reference discloses the claim backing layers.

[00:00:59] Speaker 01:
There's no dispute that it's acidic.

[00:01:01] Speaker 01:
Mishniat Cohn, on behalf of Albigen, presented unrebutted testimony that the backing layers are the same and have the same pH.

[00:01:11] Speaker 01:
None of their experts attempted to even rebut her testimony.

[00:01:15] Speaker 06:
Your expert didn't actually try to create an example and test an example, right?

[00:01:22] Speaker 01:
That's true.

[00:01:23] Speaker 01:
That would require some clinical trials to test the pharmacokinetics in a human being.

[00:01:28] Speaker 01:
I'm not sure that this court has ever made that requirement.

[00:01:31] Speaker 01:
In fact, I think it would be quite dangerous to do that.

[00:01:33] Speaker 01:
So no, we did not.

[00:01:34] Speaker 01:
We depended on prior art disclosures.

[00:01:38] Speaker 06:
OK.

[00:01:40] Speaker 06:
Why would it require human testing?

[00:01:43] Speaker 01:
the pharmacokinetic studies.

[00:01:45] Speaker 06:
I mean, I suppose... We're talking about the backing layer of the pH.

[00:01:48] Speaker 01:
I'm sorry.

[00:01:49] Speaker 01:
There was the Cmax.

[00:01:50] Speaker 01:
The unexpected results was increased in bioavailability.

[00:01:53] Speaker 01:
Okay.

[00:01:54] Speaker 06:
Okay.

[00:01:54] Speaker 06:
I'm a little lost now.

[00:01:55] Speaker 01:
Okay.

[00:01:55] Speaker 06:
I thought you led with the backing layer claims.

[00:01:58] Speaker 01:
I did.

[00:01:58] Speaker 01:
I led with the... Am I wrong?

[00:01:59] Speaker 01:
Correct.

[00:02:00] Speaker 01:
Led with the backing... Okay.

[00:02:00] Speaker 06:
We're talking about...

[00:02:02] Speaker 06:
whether that Vashis-1 reference necessarily teaches this range of pH.

[00:02:12] Speaker 01:
You're right.

[00:02:13] Speaker 01:
We could have reformulated it.

[00:02:15] Speaker 06:
So this is the part I'm trying to understand.

[00:02:16] Speaker 06:
Why didn't you guys come up with, develop a backing layer per the instructions disclosed in Vashis-1, and then test what the pH is of that backing layer?

[00:02:28] Speaker 01:
Yes, that's an incredibly complex, expensive endeavor that we did not do only because we felt so strongly that the Vishish backing layer was identically disclosed in the 539 pad.

[00:02:39] Speaker 01:
You might recall the Vishish specification is identical to the 866 pad.

[00:02:43] Speaker 06:
Is it identified?

[00:02:45] Speaker 01:
Yes.

[00:02:45] Speaker 06:
I mean, as I understand it, there were at least, you know, one could argue that there are very minor differences, but there are at least some differences in the listed formulation ingredients.

[00:02:56] Speaker 01:
The only difference that we can tell, Your Honor, is that in the example one of the 539 patent, it is listed as a driveway, whereas in the

[00:03:06] Speaker 01:
Vashishth reference, it's a wet weight.

[00:03:08] Speaker 01:
But as the examiner would even recognize, I mean, these are identical components.

[00:03:13] Speaker 01:
Maybe she could not tell whether they were identical amounts.

[00:03:16] Speaker 01:
That's what our expert came in.

[00:03:17] Speaker 01:
Mishneak-Cone says, look, subtract water, compare atoms to atoms.

[00:03:23] Speaker 02:
The numbers are slightly different on two of the components.

[00:03:25] Speaker 01:
They are slightly different.

[00:03:28] Speaker 06:
So that's my concern.

[00:03:31] Speaker 06:
So maybe not identical.

[00:03:34] Speaker 06:
Identical would be going too far.

[00:03:36] Speaker 01:
I overstated.

[00:03:38] Speaker 02:
Be helpful to us if you don't overstate.

[00:03:41] Speaker 02:
Yes.

[00:03:41] Speaker 02:
There's a lot of over and understating in the briefs on both sides.

[00:03:45] Speaker 02:
I don't have time to go through with you here, but you know what I'm talking about.

[00:03:48] Speaker 01:
Yes, that's regrettable.

[00:03:50] Speaker 02:
Makes our job a little harder.

[00:03:52] Speaker 01:
Yes.

[00:03:53] Speaker 02:
Let's focus.

[00:03:54] Speaker 01:
And our view is that, based on the record, Dr. Mishnyakone was only asked about the difference with one component, polyparaben, I believe.

[00:04:04] Speaker 01:
She said that rounding made no difference.

[00:04:06] Speaker 01:
There was no other testimony about rounding in the entire case.

[00:04:10] Speaker 02:
What about the elephant in the room?

[00:04:12] Speaker 01:
What's that?

[00:04:12] Speaker 02:
What about the elephant in the room?

[00:04:15] Speaker 02:
You know what I'm talking about?

[00:04:16] Speaker 01:
No.

[00:04:17] Speaker 01:
I'm sorry, Your Honor.

[00:04:18] Speaker 02:
The declaration.

[00:04:19] Speaker 01:
Yes.

[00:04:20] Speaker 02:
You don't see that as an elephant in the room?

[00:04:22] Speaker 06:
That was clearly the elephant in the room to me.

[00:04:25] Speaker 06:
OK.

[00:04:27] Speaker 01:
Sure.

[00:04:27] Speaker 02:
In fact, it squashed everything.

[00:04:30] Speaker 01:
And I think that's why it's so prejudicial in this case to allow that hearsay.

[00:04:35] Speaker 02:
In your testimony, the best you could do at the trial was to say, oh, that doesn't make sense.

[00:04:42] Speaker 01:
And we believe it doesn't make sense.

[00:04:44] Speaker 02:
No, I don't really care what the lawyer would believe.

[00:04:47] Speaker 02:
I really care about what the record shows.

[00:04:50] Speaker 01:
The only testimony about that declaration is that it doesn't make sense.

[00:04:52] Speaker 01:
That's correct.

[00:04:54] Speaker 02:
And that's essentially irrelevant.

[00:04:57] Speaker 01:
It's irrelevant.

[00:04:59] Speaker 02:
It doesn't say why it doesn't make sense.

[00:05:03] Speaker 02:
It doesn't say we've tested it a million times, and it always comes out the same.

[00:05:07] Speaker 02:
And therefore, of necessity, this has to be an outlier.

[00:05:11] Speaker 02:
It doesn't say that.

[00:05:13] Speaker 02:
It disproves the notion that there's inherently.

[00:05:17] Speaker 01:
Well, we think that even if this just declaration is considered, none of their experts testified about it.

[00:05:24] Speaker 01:
None of their experts relied about it.

[00:05:26] Speaker 01:
None of their experts supported the declaration to say, yeah, that number actually does make sense to me.

[00:05:32] Speaker 02:
Do they need to?

[00:05:34] Speaker 01:
We think that the only evidence on the record is Missionant Cohn's testimony saying that the backing layers are the same, the backing layers are identical.

[00:05:43] Speaker 01:
And furthermore, based on the comparison, she believed that the pH was within the range of Bell Buca because the components were also identical to Bell Buca.

[00:05:54] Speaker 01:
Did we have to prove that?

[00:05:56] Speaker 02:
I'm not sure.

[00:05:57] Speaker 02:
Nobody asked Mr. Vashiste how he possibly came up with that number?

[00:06:01] Speaker 01:
He did not appear at trial.

[00:06:02] Speaker 01:
Correct.

[00:06:04] Speaker 05:
As I recall, during the... Was there a deposition?

[00:06:08] Speaker 01:
During deposition, he did appear.

[00:06:10] Speaker 02:
Was his deposition read into testimony?

[00:06:14] Speaker 01:
There were portions of his deposition read into his testimony.

[00:06:17] Speaker 02:
When you say he wasn't here, what did you mean by that?

[00:06:19] Speaker 01:
He did not appear alive physically at trial.

[00:06:22] Speaker 02:
But the testimony was a record, and you didn't object to the testimony.

[00:06:25] Speaker 02:
So you wanted me to think he wasn't there.

[00:06:28] Speaker 02:
It's another example of over-perduing, isn't it?

[00:06:30] Speaker 01:
No, I certainly don't want you to think that he wasn't there.

[00:06:34] Speaker 01:
My only point was, if this declaration was in,

[00:06:38] Speaker 01:
And the Schist or any of their experts had attempted to rely upon it.

[00:06:43] Speaker 01:
I think we could have had a hearsay objection.

[00:06:45] Speaker 01:
I think we could have tested the probative value of that.

[00:06:48] Speaker 01:
I mean, that was not our declaration.

[00:06:49] Speaker 01:
That was something that they factually said to the Patent Office.

[00:06:53] Speaker 01:
And she opined that it did not make any sense.

[00:06:56] Speaker 01:
That was some total of the testimony about the Schist declaration.

[00:07:01] Speaker 06:
In the post-trial briefing, I believe your opening post-trial brief brought up the Schist declaration.

[00:07:09] Speaker 06:
Maybe not for this particular point, but your post-trial brief brought it up.

[00:07:13] Speaker 06:
And then BDSI's post-trial brief brought up the Vichy's declaration and pointed out

[00:07:20] Speaker 06:
Um, no, uh, but she's one couldn't possibly inherently teach this claims backing layers, uh, pH range, because as you can see from this declaration, uh, he actually formulated one of these backing layers.

[00:07:34] Speaker 06:
I know you say it's really expensive to do that, but he went ahead and did that.

[00:07:37] Speaker 06:
Yeah, he did say he did.

[00:07:40] Speaker 06:
And he said it came out to 5.61.

[00:07:43] Speaker 06:
And then I looked at your reply post-trial brief, and I don't see a response to that at all.

[00:07:50] Speaker 06:
Am I missing something?

[00:07:51] Speaker 01:
No, you're not.

[00:07:53] Speaker 01:
And frankly, maybe we missed something.

[00:07:55] Speaker 01:
We did not think that declaration was in for the truth of the matter assert.

[00:07:59] Speaker 01:
Of course, we introduced the JPM.

[00:08:01] Speaker 06:
OK, but you were thinking that silently to yourself.

[00:08:03] Speaker 01:
I must have been, yes.

[00:08:04] Speaker 06:
You didn't say that in the post-trial reply brief when you had the opportunity to object to their reliance on the Vashis' declaration.

[00:08:12] Speaker 06:
which stated under a declaration that the pH was 5.61.

[00:08:20] Speaker 06:
So I guess what I'm trying to figure out now is, do you really have the right to object now when you did have the right to object below and you sat on your hands and didn't say anything?

[00:08:36] Speaker 01:
Maybe we should have, Your Honor, had we anticipated it.

[00:08:39] Speaker 01:
This hearsay objection was never made.

[00:08:42] Speaker 01:
It's as if the district court sort of anticipated it.

[00:08:47] Speaker 01:
But yes, you're right.

[00:08:48] Speaker 01:
Maybe we could have made a bigger deal out of it in our post trial brief.

[00:08:51] Speaker 01:
But at the end of the day, I think even consideration of the vicious declaration, even assuming that you don't have to assume that the pH measurements were made according to the agreements of the party years later, assuming that the remake was faithful, assuming that the pH readings were of the liquid and not the surface measurement, even if you assume all of those things that are not in the record and we have no basis to make that assumption, even still, the only testimony

[00:09:19] Speaker 01:
Of record, at trial, is Michigan at cones, saying that there is no difference between the backing layers.

[00:09:26] Speaker 03:
You mentioned there were depth destinations that went in with respect to this particular, I want to say it correctly, issue.

[00:09:33] Speaker 03:
Did any of those speak to the declaration?

[00:09:35] Speaker 03:
Give me just a little bit of snapshot on those depth destinations that were read in.

[00:09:41] Speaker 01:
Sitting here today, I don't recall all of the details, but I also do not believe that there was any testimony submitted to the record about how the pH measurements were made.

[00:09:52] Speaker 01:
I'm just looking at my council to see if that is the case.

[00:09:56] Speaker 01:
But I believe that's the case, Your Honor.

[00:09:59] Speaker 01:
I don't think the parties reached an agreement at that time as to whether it was a liquid blend that was to be measured or the dry surface of the film that was to be measured.

[00:10:08] Speaker 01:
Actually, that was sort of an infringement contention.

[00:10:11] Speaker 01:
The parties ultimately decided it was a liquid blend.

[00:10:14] Speaker 01:
But we don't know if in the past, Dr. Vachish would have been privy to that decision.

[00:10:22] Speaker 01:
So we just don't know what he did.

[00:10:30] Speaker 06:
Was that wasn't raised below in your post-trial briefing?

[00:10:35] Speaker 01:
It was not raised below in the post-trial briefing.

[00:10:38] Speaker 06:
I don't think it was raised in your blue brief either.

[00:10:42] Speaker 06:
Am I right?

[00:10:43] Speaker 01:
That's right.

[00:10:44] Speaker 01:
It was in response.

[00:10:45] Speaker 01:
You can treat that, I think, with all of these things as attorney argument if they're not in the record.

[00:10:50] Speaker 01:
Some of these things, like I think the hearsay issue, maybe the rounding issue, are things that both parties sort of had to adjust based on the district court's decision.

[00:11:01] Speaker 01:
But I think for us anyway, we very much tried to stick to the record.

[00:11:07] Speaker 01:
I think hopefully you can appreciate that in our citations to the transcript.

[00:11:16] Speaker 01:
Moving over to the pharmacokinetic limitations of the 866 pattern.

[00:11:23] Speaker 01:
We believe that a POSA would have known that buprenorphine-bima films with an effective amount would naturally result in the claimed properties.

[00:11:32] Speaker 06:
All of the evidence, we think... Is this the inherency argument?

[00:11:35] Speaker 01:
This is the pharmacokinetic limitation, the inherency argument, the natural result.

[00:11:40] Speaker 06:
This is the theory that Judge Connolly found was waived and wasn't raised.

[00:11:48] Speaker 01:
He is, our understanding, I think he's very clear in his opinion about what he viewed as stricken, which is, inherency based on Tupolsky alone.

[00:11:59] Speaker 02:
Now, our combination is to point out for what we should be looking at.

[00:12:03] Speaker 02:
He actually entered an order striking, right?

[00:12:07] Speaker 01:
Correct.

[00:12:08] Speaker 01:
He struck several legal offenses.

[00:12:10] Speaker 02:
And isn't his order striking pretty clear what he's striking?

[00:12:14] Speaker 02:
He said in that footnote, or two footnotes later, that with respect to the... Isn't the question of the waiver of the inherency issue, turns on whether his order was correct?

[00:12:32] Speaker 01:
I don't believe so.

[00:12:33] Speaker 02:
His order was the document that excluded it, not his opinion.

[00:12:39] Speaker 01:
Well, I think his opinion is... Let me ask you this.

[00:12:42] Speaker 02:
I know you're not in agreement with anything.

[00:12:45] Speaker 01:
No, no, that's not true.

[00:12:46] Speaker 02:
The point is, if it's the order, what's the standard of review?

[00:12:52] Speaker 01:
Well, I think it's abuse of discretion for the trial court's procedures.

[00:12:58] Speaker 01:
Well, a couple of things.

[00:12:59] Speaker 01:
One, he struck general legal offenses, Judge Connolly.

[00:13:02] Speaker 02:
So if it's abuse of discretion, where is his discretion abused?

[00:13:07] Speaker 01:
We are not suggesting that he abused his discretion in any way regarding what he struck.

[00:13:14] Speaker 01:
We are not presenting that issue to the court.

[00:13:17] Speaker 02:
My point is that no one framed the issue.

[00:13:21] Speaker 02:
We need to frame the exact issues that we have to decide.

[00:13:24] Speaker 00:
Yes.

[00:13:25] Speaker 02:
And by the time he gets to his opinion, he's explaining his answers.

[00:13:28] Speaker 02:
But his footnote forward doesn't make any sense.

[00:13:33] Speaker 02:
The first sentence doesn't make any sense.

[00:13:35] Speaker 02:
There isn't an adherency argument based on Topovsky alone.

[00:13:38] Speaker 01:
Agree.

[00:13:39] Speaker 02:
No one ever made it.

[00:13:40] Speaker 02:
Correct.

[00:13:40] Speaker 02:
So when he has a sentence in the opinion that doesn't make any sense, you say, well, why?

[00:13:44] Speaker 02:
We don't need to pay attention to that.

[00:13:46] Speaker 02:
It's the same argument you make with regard to his opinion on the secondary consideration standard, right?

[00:13:53] Speaker 01:
Correct.

[00:13:53] Speaker 02:
To ignore it.

[00:13:54] Speaker 02:
So you can't have it both ways.

[00:13:56] Speaker 01:
We're not asking.

[00:13:58] Speaker 02:
What I'm saying is that if the focus of attention is on the order instead of footnote four, you have just conceded there's no abuse of discretion in his order.

[00:14:07] Speaker 01:
We concede there's no abuse of discretion with respect to waiver.

[00:14:11] Speaker 01:
As to Topolski alone, you're correct.

[00:14:13] Speaker 01:
We do not believe we've ever argued Topolski alone.

[00:14:16] Speaker 02:
Then you don't have a case.

[00:14:17] Speaker 01:
No, our combination for both inherency.

[00:14:20] Speaker 02:
But my point is, the inherency argument is gone.

[00:14:24] Speaker 02:
You just gave it away.

[00:14:26] Speaker 01:
Inherency based on Topolski alone is gone.

[00:14:28] Speaker 01:
Our inherency argument is based on Topolski, Todd, and Bullock.

[00:14:31] Speaker 02:
When you read his order, he's not barring inherency on Topolski alone.

[00:14:38] Speaker 02:
He's barring your exact theory that you want to have here.

[00:14:41] Speaker 02:
That would be surprising.

[00:14:43] Speaker 02:
He needed to read to you from the motion to strike.

[00:14:47] Speaker 02:
And you know exactly what it said in its paragraphs, right?

[00:14:50] Speaker 01:
The motion where they drew red boxes.

[00:14:52] Speaker 02:
And he exactly adopted the motion to strike on this point.

[00:14:55] Speaker 02:
And the motion to strike was to strike the very argument that you're making in your post-argument reply in brief.

[00:15:03] Speaker 01:
Our understanding of that, Your Honor, is that he observed the red boxes, but he did not say in his order, those red boxes are what I'm striking, is inequitable conduct, anticipation.

[00:15:14] Speaker 02:
He voted the paragraphs, didn't he, in his order?

[00:15:16] Speaker 02:
You have his order ready?

[00:15:25] Speaker 02:
You want to read paragraphs 38 to 39?

[00:15:29] Speaker 02:
What page is on your legal defense sheet?

[00:15:32] Speaker 02:
8050.

[00:15:33] Speaker 02:
8050, correct.

[00:15:35] Speaker 02:
8050.

[00:15:36] Speaker 01:
Defendant's legal defenses of inherent anticipation and inequitable conduct.

[00:15:42] Speaker 02:
And appear at page 38, 39.

[00:15:45] Speaker 01:
Right.

[00:15:45] Speaker 01:
And so.

[00:15:46] Speaker 02:
And you have 38 to 39.

[00:15:48] Speaker 02:
Did you bring that?

[00:15:53] Speaker 01:
Sorry, Your Honor.

[00:15:54] Speaker 01:
Let's drop the pages.

[00:16:00] Speaker 01:
And you're on the blue brief?

[00:16:05] Speaker 03:
I'm sorry.

[00:16:16] Speaker 03:
Appendix page you're on right now.

[00:16:20] Speaker 01:
I am in 8050 of the appendix, I believe.

[00:16:26] Speaker 01:
Sorry, I just lost my spot.

[00:16:27] Speaker 01:
That is the order.

[00:16:30] Speaker 01:
And then I'm also at appendix.

[00:16:33] Speaker 02:
What I want to read are the legal defenses that were stated in paragraphs, pages 4, pages 38, 39.

[00:16:42] Speaker 02:
Right.

[00:16:43] Speaker 01:
And I think that's where this Tepulski alone comes from.

[00:16:46] Speaker 01:
That was certainly in our drafting, I believe, on our part, saying that Tepulski's rendered it obvious itself.

[00:16:56] Speaker 01:
position all along since the contentions has been.

[00:16:59] Speaker 01:
It's a combination of Tepolsky's buprenorphine-pimethyl with buprenorphine.

[00:17:05] Speaker 01:
acidified to a pH according to Todd and, frankly, all of the other prior art.

[00:17:10] Speaker 01:
And there's a reasonable expectation that one would achieve pharmacokinetics.

[00:17:14] Speaker 01:
Bollingham, in fact, shows that with respect to buprenorphine, there's not much improvement to be had with T first and C max.

[00:17:22] Speaker 01:
But we think the evidence shows, and this is consistent, we also believe that the district court's finding on obviousness,

[00:17:29] Speaker 01:
which is a post that would expect to at least improve upon those properties using Topolsky's far superior beam of device that prevents swallowing and has all of the other advantages over Bullingham's tablets.

[00:17:43] Speaker 01:
Your Honor, I see I have 45 seconds left remaining.

[00:17:47] Speaker 01:
Do you have 45 seconds left?

[00:17:48] Speaker 01:
I thought I was on the other side of 12.

[00:17:50] Speaker 01:
I'm not.

[00:17:50] Speaker 01:
Thank you.

[00:17:51] Speaker 01:
Sorry about that.

[00:17:52] Speaker 06:
Yeah, we'll restore your rebuttal time, okay?

[00:17:57] Speaker 01:
Thanks very much.

[00:17:58] Speaker 06:
Appreciate that.

[00:18:00] Speaker 06:
It's time to hear from the others.

[00:18:01] Speaker 01:
Thank you.

[00:18:24] Speaker 04:
May it please the court and good morning.

[00:18:26] Speaker 04:
Howard Levine for Appellees, Cross Appellants, Bio Delivery Sciences.

[00:18:32] Speaker 04:
And I'd like to start with the 866 patent, but I'm happy to start with whatever the honors want.

[00:18:37] Speaker 04:
On the 866 patent.

[00:18:40] Speaker 04:
I'm sorry, are you starting with your cross appeal?

[00:18:41] Speaker 04:
No, no, no.

[00:18:43] Speaker 04:
There are attack on claims four and five of the 866 patent.

[00:18:45] Speaker 04:
The PK.

[00:18:46] Speaker 04:
PK limitations.

[00:18:48] Speaker 04:
All right, go ahead.

[00:18:48] Speaker 04:
So Your Honor, we believe this court can affirm the opinion of the district court that those two claims are not obvious for three reasons.

[00:18:56] Speaker 04:
One, as we've said, they've only relied on a combination of three.

[00:19:01] Speaker 04:
It's a hard, obvious combination.

[00:19:03] Speaker 04:
Three references to Polsky, Bullingham, and Todd.

[00:19:07] Speaker 04:
And there has to be motivation to make the combination of those three references.

[00:19:12] Speaker 04:
Two, the question of whether there's motivation is a pure question of fact.

[00:19:17] Speaker 04:
Three, the district court found, based on an extensive record, there was no motivation, saying there was also no motivation to combine Bullingham with other references to obtain the claimed form of kinetic properties.

[00:19:29] Speaker 04:
And that factual finding was well supported by the record.

[00:19:32] Speaker 04:
And Alvegen, we respectfully submit, have not come close to meet its burden, showing that was clearly erroneous, which is their burden on appeal.

[00:19:39] Speaker 04:
And in fact, during the trial,

[00:19:42] Speaker 04:
Their expert basically said that those parameters weren't important, that they weren't meaningful, that outside of this case, persons of ordinary skill wouldn't care about them.

[00:19:51] Speaker 04:
The FDA wouldn't care about them.

[00:19:53] Speaker 04:
Avigin, in their brief, wrote that they weren't meaningful.

[00:19:56] Speaker 04:
So based on that, the district court correctly said.

[00:20:01] Speaker 02:
Did the expert say that both of the limitations were meaningless?

[00:20:05] Speaker 02:
I'm sorry.

[00:20:06] Speaker 02:
Or was it just claim four?

[00:20:08] Speaker 04:
Their expert said that claim four was meaningless.

[00:20:11] Speaker 04:
That's correct.

[00:20:12] Speaker 02:
And then in their brief.

[00:20:13] Speaker 02:
I'm just correcting what you just said a moment ago.

[00:20:16] Speaker 04:
Well, in their brief, they said both.

[00:20:18] Speaker 04:
In fact, they characterized their own expert as saying both are not.

[00:20:21] Speaker 02:
I think they were talking about the testimony.

[00:20:24] Speaker 04:
You're absolutely right, Your Honor.

[00:20:25] Speaker 02:
For the testimony, there are- Could you please try to be a little more careful, both of you?

[00:20:30] Speaker 02:
Absolutely.

[00:20:31] Speaker 04:
Absolutely.

[00:20:32] Speaker 02:
The clear is that the testimony went to claim four.

[00:20:34] Speaker 02:
Correct.

[00:20:35] Speaker 02:
And said, as to the picking the particular moment in time when you first notice whether or not there's been any effect is meaningless.

[00:20:43] Speaker 04:
Correct.

[00:20:44] Speaker 04:
And in their post trial brief, they said, not us, this is at appendix page 7913, as Dr. Schaefer testified,

[00:20:53] Speaker 04:
The parameters of claim four and five are not meaningful.

[00:20:57] Speaker 02:
Well, that was a little mistake.

[00:20:58] Speaker 02:
That's another one.

[00:21:00] Speaker 02:
Your adversary has already said they made a few mistakes.

[00:21:02] Speaker 02:
That's a little mistake they made.

[00:21:04] Speaker 02:
That's certain.

[00:21:04] Speaker 02:
Did we necessarily tax them with that mistake?

[00:21:07] Speaker 04:
I think that was the, they were, I don't think it was.

[00:21:10] Speaker 02:
Can an attorney give up a point?

[00:21:12] Speaker 04:
Absolutely.

[00:21:13] Speaker 04:
Absolutely.

[00:21:13] Speaker 04:
I think they could concede it.

[00:21:14] Speaker 04:
And I think they were trying to make that point to show that those claim limitations weren't meaningful because they.

[00:21:20] Speaker 02:
Right.

[00:21:20] Speaker 02:
I mean, it just shocked me because it's so patently clear that claim five is meaningful.

[00:21:26] Speaker 04:
I agree with you, Your Honor.

[00:21:28] Speaker 04:
And that was the point is that.

[00:21:30] Speaker 04:
For obviousness in particular, and particularly in obviousness, the burden is on them.

[00:21:36] Speaker 04:
So by convincing evidence, they need expert testimony.

[00:21:40] Speaker 04:
Our expert basically was saying at least a claim for that it wasn't meaningful.

[00:21:44] Speaker 04:
And in their brief, they characterized as saying both of them.

[00:21:48] Speaker 04:
So we think that's powerful evidence.

[00:21:49] Speaker 04:
And more recently, in the Trisfi-Actavis case,

[00:21:54] Speaker 04:
It was the same judge, it was Judge Connolly.

[00:21:56] Speaker 06:
Non-precedential opinion, right?

[00:21:58] Speaker 04:
What?

[00:21:59] Speaker 06:
Non-precedential opinion.

[00:22:00] Speaker 04:
Non-precedential opinion, but Kennedy sided, and it's not precedential because it applied well-established principles of law.

[00:22:06] Speaker 04:
That that case came out after our red reef, but was cited by them in their reply.

[00:22:10] Speaker 02:
We still don't need to rub it in I mean Come on It's perfectly obvious that in front of this judge whether or not a firm or go kinetic property is of no interest To oppose it is like hello the most important issue that you're going to deal with right if you're talking about combining references, right?

[00:22:28] Speaker 04:
Right, correct

[00:22:29] Speaker 04:
And that was one of the holdings in that case.

[00:22:34] Speaker 02:
So we think that- I mean, the record favors you on this point, because the other side coupled claims four and five into the mouth of their own expert, which the expert didn't say.

[00:22:45] Speaker 04:
Right.

[00:22:46] Speaker 02:
And so they're stuck with that.

[00:22:48] Speaker 04:
Stuck with that.

[00:22:49] Speaker 04:
And we think there's really no record evidence anyway that there was motivation to combine Bullingham, since Bullingham doesn't really show at least a four-hour effect.

[00:22:59] Speaker 04:
You don't even need to get there.

[00:23:00] Speaker 04:
Right.

[00:23:00] Speaker 02:
You don't even need to get there.

[00:23:02] Speaker 02:
So let's move to the- And the whole theory, the reason that you would not combine, because the pose is indifferent, the other side doesn't challenge that rationale.

[00:23:10] Speaker 02:
Correct.

[00:23:11] Speaker 02:
So move on.

[00:23:12] Speaker 02:
What about the waiver issue?

[00:23:13] Speaker 05:
You have the inherency issue.

[00:23:16] Speaker 02:
So inherency.

[00:23:18] Speaker 02:
Is that governed by footnote four, or is it governed by the district court's order?

[00:23:23] Speaker 04:
We think it's governed by, well, we think we have to read them all together.

[00:23:27] Speaker 04:
And that he wrote footnote four in light of his order.

[00:23:30] Speaker 04:
And his order is, like we said, on appendix page 8050.

[00:23:36] Speaker 04:
And I think in their reply brief, Alvagen said that the district court just struck general defenses of anticipation and equitable conduct.

[00:23:43] Speaker 04:
That's, if you could see, that's not what he struck.

[00:23:46] Speaker 04:
He struck defense, legal defense, of inherency.

[00:23:50] Speaker 02:
And that's- Can we look at the reply brief and see exactly what- I think it's pages 38 to 39.

[00:23:59] Speaker 02:
Correct.

[00:23:59] Speaker 04:
And that's on pages appendix 7911 and appendix 7912.

[00:24:03] Speaker 04:
And I- Is that in 911?

[00:24:09] Speaker 04:
Yes.

[00:24:09] Speaker 04:
It's in volume two of the appendix.

[00:24:12] Speaker 04:
Appendix 7911 and Appendix 7912 is where we put the red boxes.

[00:24:21] Speaker 04:
Which, by the way, we were ordered to.

[00:24:23] Speaker 04:
The judge ordered us to box the testimony so there was no question about what was struck.

[00:24:30] Speaker 04:
The argument that was struck is, as evidence to trial, the use of Topolski's Bima device to administer buprenorphine, according to claim one, was obvious.

[00:24:39] Speaker 04:
It is axiomatic that the inherent properties from the administration of an obvious drug delivery devices are equally obvious, C. santoris.

[00:24:47] Speaker 04:
That was struck.

[00:24:48] Speaker 04:
No question.

[00:24:51] Speaker 04:
The other thing that was struck is the text at pages 13

[00:24:57] Speaker 04:
on their reply brief, which is at appendix page 7955.

[00:25:00] Speaker 04:
And that was also in the red box.

[00:25:17] Speaker 04:
And if I can skip down a little bit, it says, consequently, the obvious combinations of Polsky's Bima device with known therapeutic doses of buprenorphine inherently results in the pharmacokinetic properties of claims in four, claims four and five, citing precision.

[00:25:31] Speaker 04:
And that was struck.

[00:25:32] Speaker 04:
So we think at least those inherency arguments were clearly struck.

[00:25:36] Speaker 04:
And the only thing that was preserved was a combination of the three references.

[00:25:40] Speaker 04:
And the judge found there were, and you needed Bullingham to get those pharmacognetic properties.

[00:25:45] Speaker 04:
We don't, we contend they're not even in Bullingham, not even close.

[00:25:48] Speaker 02:
Interestingly enough, when it comes to the motions that strike facts, we didn't move to strike the facts concerning the inherency theory, right?

[00:26:02] Speaker 04:
Correct.

[00:26:03] Speaker 04:
We moved to strike those legal arguments in the brief.

[00:26:07] Speaker 02:
In terms of the motion to strike the facts, the facts that had been asserted under that theory, you did not move to strike those and you didn't strike them.

[00:26:18] Speaker 02:
If you look at your defendant's proposed findings of fact 1994 and note 3141 and whatever, exclude the facts that were with regard to the theory that was struck.

[00:26:31] Speaker 02:
Right.

[00:26:32] Speaker 02:
In terms of sort of a messiness of what the record shows us.

[00:26:37] Speaker 02:
Right.

[00:26:39] Speaker 04:
So we believe for those reasons.

[00:26:43] Speaker 02:
Well, so where do we come out on?

[00:26:45] Speaker 02:
I read the briefs and lawyers' arguments going around.

[00:26:50] Speaker 02:
And I read here that Mr. Lowe says that the judge was wrong to say that they waved the inherency argument.

[00:26:59] Speaker 02:
And so I'm trying to find the thing I'm reviewing, and it looks to me like I'm reviewing the order, because the order is the way he struck it out.

[00:27:09] Speaker 04:
Judge Clevenger, I don't think they challenged in their blue brief that the judge was wrong in what he struck.

[00:27:15] Speaker 02:
There's been a concession, as I understood it, from Mr. Lowe that he doesn't complain about the order.

[00:27:23] Speaker 02:
He said there's no abuse of discretion.

[00:27:25] Speaker 04:
All right, so I think it's struck.

[00:27:28] Speaker 04:
That inherency argument of use of buprenorphine in a Tepulski device would inherently give you those parameters as struck.

[00:27:34] Speaker 02:
Opinion four is a description of what he understood his order to mean.

[00:27:42] Speaker 02:
Right.

[00:27:43] Speaker 02:
And it's incorrect, the first sentence.

[00:27:47] Speaker 02:
There is no inherency arguments based on Tepulski alone.

[00:27:50] Speaker 06:
So as I understand Mr. Lowe's argument, his argument is forget about the order, because

[00:27:57] Speaker 06:
Footnote 4 is the final culminating statement of what was struck.

[00:28:03] Speaker 06:
And what was struck was a theory of inherency based on DePolsky alone.

[00:28:08] Speaker 06:
And so to that extent, he doesn't feel the need to have to challenge whatever happened in the order, because Footnote 4 rolls it all up and tells us what's in and what's out.

[00:28:22] Speaker 04:
We disagree with that.

[00:28:23] Speaker 04:
And in fact, footnote four cites the motion to strike.

[00:28:26] Speaker 04:
It does.

[00:28:28] Speaker 02:
It cites the hearing.

[00:28:29] Speaker 04:
The hearing transcript.

[00:28:31] Speaker 04:
Right, where he read four times.

[00:28:33] Speaker 04:
And then the hearing transcript gets pretty clear.

[00:28:35] Speaker 04:
Yeah.

[00:28:36] Speaker 04:
Yes.

[00:28:37] Speaker 04:
Tonally.

[00:28:38] Speaker 04:
Yes.

[00:28:39] Speaker 04:
So I mean, I think, Judge Cleminger, when I read that, I had a similar reaction to you.

[00:28:45] Speaker 04:
And then I went back and read the hearing transcript.

[00:28:47] Speaker 04:
Because he has it right after.

[00:28:49] Speaker 04:
He has, I'm sorry, it's appendix page 42, footnote 4.

[00:28:54] Speaker 04:
Albigen waved the argument that the pharmacokinetic properties are inherent in Topolski alone by not raising that contention before trial.

[00:29:00] Speaker 04:
And then he directly cites the transcript, which specifically shows what was struck.

[00:29:05] Speaker 04:
So I think Topolski alone is a euphemism for not including Bullingham.

[00:29:11] Speaker 04:
And that was what was discussed at the hearing.

[00:29:13] Speaker 04:
The only combination they made

[00:29:15] Speaker 04:
was how to have bullying him.

[00:29:17] Speaker 04:
So when he says to Pulsky alone, he means not bullying him.

[00:29:20] Speaker 04:
And that's why he says two sentences later,

[00:29:23] Speaker 04:
Only consider the the inherency argument with respect to the obviousness combination of Dapolsky, Morrow or Morrow, Todd and Bullingham.

[00:29:30] Speaker 04:
But as explained below, there was no motivation to combine Bullingham with the other references to obtain the claimed form of kinetic properties.

[00:29:37] Speaker 04:
So we think it's pretty clear that it's got to be that three combination.

[00:29:41] Speaker 04:
There was no motivation to get to Bullingham, so the judgment should be affirmed on that basis.

[00:29:48] Speaker 04:
Regarding the 539 patent,

[00:29:52] Speaker 04:
I mean, he relied on the declaration that they themselves put into evidence.

[00:29:58] Speaker 04:
I mean, and the cases are legion.

[00:30:01] Speaker 04:
The United States Supreme Court, a party introducing evidence cannot complain on appeal that the evidence was erroneously omitted.

[00:30:08] Speaker 04:
Same thing in the Third Circuit, which is bindings.

[00:30:10] Speaker 04:
It's a non-patent issue.

[00:30:12] Speaker 04:
A party introducing evidence cannot complain on appeal that the evidence was erroneously omitted.

[00:30:17] Speaker 04:
This is from the First Circuit.

[00:30:18] Speaker 04:
It will be no surprise that we reject Washington's appellate claim of error based on the emission of the audio tapes, which they had admitted for its own tactical reasons.

[00:30:26] Speaker 04:
That is classic waiver.

[00:30:28] Speaker 04:
So our position is, not only was it a joint exhibit where they waived all exhibits, and we could have put it in, and it would have gone into evidence and not been hearsay, but they affirmatively put it in, asked questions about it to try to make us look bad, which is why they did it, and the evidence the judge heard

[00:30:46] Speaker 04:
looked at the declaration.

[00:30:47] Speaker 04:
He had seen Dr. Rasheed testified by everyone testified by video in this case.

[00:30:52] Speaker 04:
It was a virtual trial.

[00:30:53] Speaker 04:
And Dr. Rasheed testified by video, just like everybody else, and thought that he was credible and accepted the declaration.

[00:31:00] Speaker 04:
It's in evidence.

[00:31:01] Speaker 04:
So we think that's dispositive of the 539 issue.

[00:31:04] Speaker 04:
The backing layer is not described in the prior art.

[00:31:07] Speaker 04:
Claim 9 cannot be obvious on that basis.

[00:31:10] Speaker 03:
So was the deposition testimony on the declaration itself?

[00:31:14] Speaker 04:
So, no.

[00:31:15] Speaker 04:
There was testimony on how you measure pH in the mucoadhesive layer, not the backing layer, because they didn't think, they didn't, no one knew that that was important at that time.

[00:31:26] Speaker 04:
But he went through in detail and explained

[00:31:28] Speaker 04:
Following the showing example the patent how it was always at least the Mico adhesive layer was always measuring the liquid phase and in fact every document in the case from BDSI when they're measuring layers It's always in a liquid phase.

[00:31:41] Speaker 04:
So that testimony was in the record.

[00:31:44] Speaker 04:
There was deposition testimony that

[00:31:46] Speaker 04:
You know, he had this thing made.

[00:31:48] Speaker 04:
They did it according to example.

[00:31:50] Speaker 04:
Alva didn't put that testimony on the record.

[00:31:52] Speaker 04:
We didn't think we needed it because we had the declaration in.

[00:31:55] Speaker 04:
And it was admissible.

[00:31:57] Speaker 04:
They put it into evidence.

[00:31:58] Speaker 04:
And we thought that was enough.

[00:32:00] Speaker 04:
Is that helpful?

[00:32:01] Speaker 03:
Yes.

[00:32:01] Speaker 03:
Can you address your cross appeal and also specifically any arguments on burden of proof before you wrap?

[00:32:08] Speaker 03:
The long felt need question.

[00:32:09] Speaker 03:
Long felt need.

[00:32:10] Speaker 04:
Yeah.

[00:32:11] Speaker 04:
So we thought, and we presented evidence at trial, that there was a long felt need for Belva Yuga.

[00:32:18] Speaker 06:
No, we understand that.

[00:32:19] Speaker 06:
Your objection is that the judge said something that sounds like he was using a clear and convincing evidence burden proof when it was really just a preponderance standard.

[00:32:29] Speaker 04:
We understand that.

[00:32:30] Speaker 04:
Right.

[00:32:31] Speaker 06:
He said at the end of his analysis, this does- The question is, if we see that that's the only error in his analysis for these claims on your cross appeal,

[00:32:44] Speaker 06:
Is it possible that that's just harmless error, given that the evidence of long felt need

[00:32:52] Speaker 06:
to the extent that there was a need identified by the time of the priority date of 2006, it's very, very hard to say it was long felt.

[00:32:59] Speaker 06:
And our own expert was quite equivocal about how long felt of a need it was recognized.

[00:33:07] Speaker 06:
And he said, maybe the early 2000s.

[00:33:11] Speaker 06:
And so then we're left with, at best, just a few years.

[00:33:16] Speaker 06:
And so what I'm telling you right now is,

[00:33:19] Speaker 06:
If the judge had not said it clearly and convincingly, if those words had not been in there, then it's an easy affirm.

[00:33:28] Speaker 06:
It's an easy affirm based on this record.

[00:33:31] Speaker 04:
So I would disagree respectfully, Your Honor, for one reason, and one reason only, is that in that part of the opinion, he said the only evidence that BDSI puts forward to show there was a long felt need is the testimony of their expert.

[00:33:45] Speaker 04:
It's not true.

[00:33:46] Speaker 04:
Their expert agreed.

[00:33:47] Speaker 04:
So he had two clinicians.

[00:33:49] Speaker 04:
practicing in the art, at the same time saying there was a recognized need in 2000 for opioids that were safer and better and wouldn't kill patients.

[00:33:59] Speaker 04:
Both of them.

[00:33:59] Speaker 06:
And he said, wait a second, where is that?

[00:34:04] Speaker 04:
That is at page 7163, 7164, page 549, 1 to 7.

[00:34:11] Speaker 04:
Hold on, hold on.

[00:34:14] Speaker 06:
7163?

[00:34:17] Speaker 04:
Yes.

[00:34:25] Speaker 06:
A lot of words on this page.

[00:34:32] Speaker 04:
Yes, so if you look at the cross, the little sites, page 548.

[00:34:38] Speaker 06:
OK, that's 7164.

[00:34:41] Speaker 04:
7164 at the bottom, line 22.

[00:34:44] Speaker 06:
Line, I'm sorry, 22?

[00:34:50] Speaker 04:
Yes.

[00:34:52] Speaker 04:
And this is me asking questions.

[00:34:53] Speaker 04:
I said, in fact, you are aware of this data

[00:34:56] Speaker 04:
in the turn of the century, in the mid-2000s, in the early 2000s, is that right?"

[00:35:01] Speaker 04:
He answered, yes.

[00:35:02] Speaker 04:
Now, the data was the deaths due to opioids.

[00:35:05] Speaker 04:
Now, I messed up in that question because I asked two different dates.

[00:35:08] Speaker 04:
So then I repeated it.

[00:35:09] Speaker 04:
Just so my question is clear, I said two different things.

[00:35:13] Speaker 04:
In fact, were you aware of this data in the early 2000s?

[00:35:16] Speaker 04:
Is that correct?

[00:35:17] Speaker 04:
Yes.

[00:35:18] Speaker 04:
And then he gave a whole long answer about how he was aware.

[00:35:20] Speaker 04:
He was seeing the signal.

[00:35:22] Speaker 04:
It was definitely there.

[00:35:24] Speaker 04:
So he was aware of data in the early 2000s?

[00:35:27] Speaker 04:
Correct.

[00:35:28] Speaker 04:
That showed that the deaths were increasing, that there were poisonings, and that they needed something.

[00:35:34] Speaker 06:
OK, but how can it be, even if his recognition that something was happening that was not good by the early 2000s, how can three, four years be enough of a long felt need?

[00:35:52] Speaker 04:
Well, the filing of the patent was 2006.

[00:35:56] Speaker 06:
Long felt, but unmet need.

[00:36:01] Speaker 04:
Usually that's judged as the filing date, and that's four or five years of increased deaths, people dying from opioids.

[00:36:07] Speaker 04:
And that's a lot.

[00:36:09] Speaker 04:
And if it was just our clinician, but the fact that the two clinicians agreed that, look, there was a problem there.

[00:36:15] Speaker 04:
And in fact, that's why the inventor started the invention, to find a drug that was able to use a low dose of buprenorphine

[00:36:22] Speaker 04:
have high bailability to have less abuse, less trust.

[00:36:26] Speaker 06:
If hypothetically we were to affirm on the PK claims and the backing layer claims, would you still want a remand on long felt need for Chief Judge Connolly to re-look at the long felt need question under a preponderance of evidence standard?

[00:36:42] Speaker 04:
Well, we also have unexpected results.

[00:36:45] Speaker 04:
Put that to the side.

[00:36:46] Speaker 04:
OK.

[00:36:47] Speaker 04:
I mean.

[00:36:48] Speaker 04:
Some appeals are conditional.

[00:36:51] Speaker 04:
Let me put it this way.

[00:36:52] Speaker 04:
Our overwhelming hope is to have an affirmance on the two areas that you held.

[00:36:58] Speaker 04:
We think his decision was wrong, particularly on unexpected results.

[00:37:02] Speaker 06:
Well, that depends on the arguments that you made.

[00:37:06] Speaker 06:
And then, obviously, there's other arguments you did not make that now I'm looking at for the first time.

[00:37:11] Speaker 06:
We don't have to debate that right now.

[00:37:12] Speaker 06:
You're out of time.

[00:37:14] Speaker 06:
So anyway, we'll give you, I don't know, 90 seconds on your part.

[00:37:18] Speaker 04:
Thank you.

[00:37:19] Speaker 04:
Thank you, Your Honor.

[00:37:20] Speaker 04:
Thank you.

[00:37:20] Speaker 04:
Thank you very much.

[00:37:27] Speaker 06:
Mr. Lowe, you have three minutes.

[00:37:36] Speaker 01:
Thank you, Judge Chen.

[00:37:38] Speaker 01:
With respect to Dr. Schaeffer's statement, first of all, Bollingham shows that a post-it would measure a T first, shows that a post-it would measure a duration of action.

[00:37:48] Speaker 01:
That is within the reference itself.

[00:37:50] Speaker 01:
Dr. Schaeffer, I believe, was explaining that these numbers are meaningful if you know the assay used to measure them, because then you can compare them to other numbers if you know their assay.

[00:38:01] Speaker 01:
because each assay has a limit of detection.

[00:38:04] Speaker 01:
T first is the first signal that that assay would see.

[00:38:07] Speaker 01:
So it's not surprising that a more sensitive assay will see T first sooner.

[00:38:12] Speaker 01:
So I think in Schaeffer's view, to be fair to his testimony, he qualified that by saying it's not meaningless if you don't know the assay.

[00:38:21] Speaker 01:
But of course, he went on to say, Bollingham measured it, measured both in fact.

[00:38:27] Speaker 01:
And with respect to Bollingham,

[00:38:30] Speaker 01:
In the strike that with respect to the meaningless limitations, Mr. Levine is right.

[00:38:36] Speaker 01:
We did sort of argue both sides of that.

[00:38:39] Speaker 01:
They are patently meaningless under this court's decision in Santeros and also what the district court cited personally if it's inherent.

[00:38:48] Speaker 01:
if it's inherent, right?

[00:38:49] Speaker 01:
So meaningless if inherent in that context.

[00:38:52] Speaker 01:
And also, to the extent that they have any meaning, right?

[00:38:57] Speaker 01:
Bollingham says they have meaning.

[00:38:59] Speaker 01:
A post would clearly measure them.

[00:39:00] Speaker 06:
It shows that about the best you can get with short of a BEMA device is- Because your post trial briefing, where's your best argument for motivation to combine Bollingham with Topolski and Todd?

[00:39:14] Speaker 06:
I saw a reasonable expectation of success argument.

[00:39:17] Speaker 06:
I saw an argument that Boeingham discloses these PK values.

[00:39:22] Speaker 06:
But I never really saw it ever get put together on motivation to combine why a skilled artisan would be motivated to go for, shoot for these particular PK values.

[00:39:35] Speaker 01:
OK.

[00:39:36] Speaker 01:
I believe we addressed that in the blue brief on 37 through 42.

[00:39:41] Speaker 01:
Yellow brief 38 through 43.

[00:39:43] Speaker 01:
I'm sorry.

[00:39:44] Speaker 01:
The post-trial brief below.

[00:39:45] Speaker 01:
Oh, I'm sorry.

[00:39:45] Speaker 01:
I misunderstood your question.

[00:39:48] Speaker 01:
Can I ask you to repeat that, please?

[00:39:49] Speaker 06:
The post-trial briefing that you presented to Chief Judge Connolly on motivation to combine Bullingham with Topolski and Todd to get these particular PK values.

[00:40:01] Speaker 06:
I was looking through your post-trial briefing, both your opening brief and your reply brief, and I didn't really see your side put together the case for why a skilled artisan in this art would shoot for these particular PK values and therefore would be motivated, based on Bullingham's disclosure, to get those numbers and make sure that the Topolski-Todd combination would yield those numbers.

[00:40:25] Speaker 01:
I believe we attempted that on page 39 of 10X7912.

[00:40:30] Speaker 01:
This will be the first full paragraph where we describe how Bollingham measures the tee first.

[00:40:35] Speaker 01:
Bollingham measures the duration of action.

[00:40:42] Speaker 01:
And then we say, in view of Bullingham, Posto would have had a reasonable expectation of success.

[00:40:46] Speaker 01:
I suppose that assumes motivation, given that Bullingham is directed to buprenorphine, pharmacokinetics, and tablets.

[00:40:54] Speaker 01:
Topolski's directed to improvements on tablets.

[00:40:57] Speaker 01:
Todd's directed to buprenorphine, an acidic pH.

[00:41:02] Speaker 03:
So you don't have anywhere you specifically say motivation to combine, right?

[00:41:06] Speaker 01:
I can't see it on this page where we use the word motivation to combine.

[00:41:11] Speaker 01:
We conclude with there's an expectation of success.

[00:41:15] Speaker 01:
Looking at this paragraph, I don't see it, Your Honor.

[00:41:16] Speaker 01:
I'm sorry.

[00:41:19] Speaker 06:
Do you have a final thought?

[00:41:22] Speaker 01:
Only like Mr. Levine, Your Honor, we are sincerely hoping for an affirmance in our favor.

[00:41:29] Speaker 01:
And we thank you very much for your time.

[00:41:32] Speaker 01:
I appreciate that.

[00:41:35] Speaker 06:
All right.

[00:41:35] Speaker 06:
And across the field, you have a little bit of time.

[00:41:38] Speaker 06:
Let's say, I said 90 seconds.

[00:41:41] Speaker 06:
So you get 90 seconds.

[00:41:45] Speaker 04:
200% bioavailability.

[00:41:48] Speaker 04:
None of the prior art came close to that.

[00:41:49] Speaker 04:
None of it.

[00:41:50] Speaker 04:
Johnson showed that ethanol solutions like Tauber using had 30%.

[00:41:55] Speaker 06:
As I understand your briefing below and your post-trial brief, your theory of unexpected results was this is unexpected because what one skill in the art would expect is as pH level goes down, bioavailability would also go down, not up.

[00:42:20] Speaker 04:
Correct.

[00:42:20] Speaker 04:
Well, that was for motivation and reasonable expectation of success.

[00:42:24] Speaker 06:
And also in the unexpected results section of your post-trial brief, I didn't see an argument that said, OK, OK, OK.

[00:42:33] Speaker 06:
One would expect bioavailability to go up to some degree when you have the pH for this drug go down, when you use this drug at this particular pH level.

[00:42:47] Speaker 06:
But you wouldn't get this kind of super increased level.

[00:42:52] Speaker 06:
And that's where the unexpected result is.

[00:42:55] Speaker 04:
Well, in terms of suboxone, for example, which has a super low pH of 3.5, which is what they've argued, the bioavailability is 25%.

[00:43:07] Speaker 04:
So no, we never agreed that having a low pH would give you increased bioavailability.

[00:43:13] Speaker 04:
because all the references in the prior art that had low pH, such as Suboxone and Todd, had 25% or 30%.

[00:43:21] Speaker 04:
So we said there would be no motivation and no reasonable expectation of success of getting a high bioavailability.

[00:43:28] Speaker 04:
But then we said, we have tremendous results.

[00:43:31] Speaker 04:
And that was the whole point.

[00:43:32] Speaker 04:
Fin directly, we have a chart in our brief, in our blue brief, on page.

[00:43:37] Speaker 04:
I'm talking about your first trial.

[00:43:39] Speaker 04:
page 18 of our appellate brief.

[00:43:42] Speaker 04:
The same chart was in our post-trial brief.

[00:43:45] Speaker 04:
I'm not sure of the page, but it's the chart that's on page 18 of our blue brief to show that the results are tremendous.

[00:43:52] Speaker 04:
So we definitely

[00:43:55] Speaker 04:
With respect, we believe we preserved the argument that we had extraordinary results, 228% over suboxone.

[00:44:02] Speaker 04:
Our expert at trial said 80%, which is three times greater than suboxone, is about the level you would get by injecting buprenorphine into the muscle.

[00:44:11] Speaker 04:
That's extraordinary.

[00:44:12] Speaker 04:
That's what our expert said.

[00:44:13] Speaker 06:
Is it possible to conclude that there was just harmless error on lung felt need if we conclude that just

[00:44:20] Speaker 06:
There's no reasonable person to conclude that this is long felt need, even under a preponderance of the evidence standard.

[00:44:29] Speaker 04:
Your Honor, you can conclude that.

[00:44:32] Speaker 04:
We do not agree as the appellee.

[00:44:35] Speaker 04:
But you certainly can reach that decision.

[00:44:37] Speaker 02:
When you make an argument in your brief that this harmless error issue isn't being raised by the other side.

[00:44:43] Speaker 04:
Correct.

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

[00:44:44] Speaker 04:
We don't believe they could have said it's harmless error.

[00:44:49] Speaker 04:
We think he used the wrong standard.

[00:44:51] Speaker 04:
And given the claims that you've lost on, 3 in 10 inspire earlier than the backing of the last time.

[00:44:57] Speaker 04:
That's correct.

[00:44:58] Speaker 04:
That's correct.

[00:44:58] Speaker 04:
So that's why it's much more, and we agree, Your Honor, it's much more important to win on their appeal than to win on our cross-appeal.

[00:45:06] Speaker 02:
But you're not prepared to yield the cross-appeal.

[00:45:10] Speaker 04:
I'm not prepared to.

[00:45:11] Speaker 02:
On the condition that you prevail on the others.

[00:45:14] Speaker 02:
I'm not prepared to do it.

[00:45:16] Speaker 06:
And then hypothetically, you get to look at Chief Judge Connolly again.

[00:45:20] Speaker 04:
We have another trial before him eventually, anyway, for another defendant.

[00:45:25] Speaker 04:
But at this point, we're not prepared to do it.

[00:45:27] Speaker 04:
It's a use-wise.

[00:45:28] Speaker 04:
Yeah.