[00:00:02] Speaker 03:
Okay.

[00:00:03] Speaker 03:
The first argued case this morning is number 17, 1451, par-pharmaceutical incorporated against horizon therapeutics.

[00:00:12] Speaker 03:
Mr. Berge.

[00:00:26] Speaker 02:
Good morning.

[00:00:27] Speaker 02:
May it please the court, Aziz Berge on behalf of par-pharmaceutical.

[00:00:30] Speaker 02:
Your honor, the central dispute in this case is whether the prior art taught the limitation mean conversion of about 60%.

[00:00:38] Speaker 02:
In evaluating whether that limitation is found in the prior art, the board committed multiple legal errors.

[00:00:47] Speaker 02:
First, the board failed to consider the prior art as a whole.

[00:00:51] Speaker 02:
Instead, it used an unprecedented balanced picture test.

[00:00:58] Speaker 02:
Under that newfound test, the board ignored

[00:01:01] Speaker 02:
rates, conversion rates at or below 60%, thereby creating a false dichotomy of right and wrong.

[00:01:10] Speaker 04:
Isn't another way of looking at it is that the board precisely did consider the art as a whole so that when you pointed to the 1919 article by Sherwin, it said, well, we really need to know what 60 years later, 70 years later or something,

[00:01:28] Speaker 04:
a skilled artisan would have thought about that in context of the overall, overall prior art.

[00:01:35] Speaker 04:
And by then, indeed 14 years later, there was pretty good reason to discount that 1919 piece.

[00:01:44] Speaker 02:
Uh, no, your honor.

[00:01:46] Speaker 02:
Uh, what they did was they did a balancing, uh, and under this court's precedent, that's not the appropriate test.

[00:01:52] Speaker 02:
It's not a balancing.

[00:01:54] Speaker 02:
It's on a weighing of the evidence.

[00:01:56] Speaker 03:
Well, you're not saying never.

[00:01:58] Speaker 03:
Doesn't it really depend on the issues as they arise in the case?

[00:02:03] Speaker 02:
They do, Your Honor, but that's not what happened in this case.

[00:02:07] Speaker 02:
In this case, they didn't look at the prior art as a whole.

[00:02:10] Speaker 02:
The requirement is to look at all art, irrespective of when it's published.

[00:02:16] Speaker 02:
You're supposed to look at the prior art as a whole, from earlier to up until the time of the priority date.

[00:02:23] Speaker 01:
What do we have that supports you in that prior art other than, what is it, Sherwin 19?

[00:02:32] Speaker 01:
Sherwin 19.

[00:02:33] Speaker 01:
Sherwin 19, yes.

[00:02:34] Speaker 01:
What do we have other than Sherwin 19 that supports a conversion rate of about 60%?

[00:02:39] Speaker 01:
Sure.

[00:02:40] Speaker 02:
So as your honor alluded to, Sherwin 19 itself discloses conversion rates of 50 to 60%, which overlap 67%.

[00:02:48] Speaker 01:
For one individual.

[00:02:50] Speaker 02:
I'm sorry?

[00:02:50] Speaker 02:
For one individual.

[00:02:52] Speaker 02:
That is correct.

[00:02:53] Speaker 02:
With respect to other art, there was also the Comte reference, which discloses PA conversion of 54%.

[00:03:02] Speaker 02:
And notably, the Comte reference was published in 2002.

[00:03:07] Speaker 02:
That's for another compound, right?

[00:03:13] Speaker 02:
It's not the same compound.

[00:03:15] Speaker 02:
It's part of the claimed compounds in this case, Your Honor.

[00:03:20] Speaker 04:
Can I ask a different question about Comte?

[00:03:22] Speaker 04:
Sure.

[00:03:23] Speaker 04:
Where precisely before the board did you rely on Compt for this proposition?

[00:03:34] Speaker 02:
For purposes of the grounds that we advance?

[00:03:37] Speaker 04:
For purposes of showing a conversion rate more like the one that is claimed here.

[00:03:45] Speaker 04:
I was struck, I guess, by the, I'll call it a fact, but you can tell me if I'm wrong about that.

[00:03:52] Speaker 04:
In your 17 or 18 page recitation in the blue brief about your affirmative case of obviousness, you, I think, very carefully referred to Compt once only in a footnote.

[00:04:03] Speaker 04:
And I don't think the board really talked about Compt on the conversion rate principle.

[00:04:09] Speaker 04:
So I guess my question is, did you, and if so, show me where in your petition say, look at the conversion rate in Compt.

[00:04:19] Speaker 04:
We rely on that.

[00:04:21] Speaker 02:
We do disclose and rely upon the comp reference.

[00:04:25] Speaker 02:
That's part of the institute and grounds.

[00:04:28] Speaker 02:
And specifically with respect to the board relying on it, they did make a factual finding that the comp reference does disclose a conversion rate of about 53%, 54%.

[00:04:40] Speaker 02:
But the error that the board made is they did not apply the teaching in comp with respect to its obviousness analysis.

[00:04:48] Speaker 04:
Where in the board opinion does it discuss comp?

[00:04:51] Speaker 02:
That is found in Appendix 17 spanning Appendix 18, Your Honor.

[00:05:14] Speaker 02:
So the issue here is that the board failed to

[00:05:18] Speaker 02:
address the prior art as a whole.

[00:05:20] Speaker 02:
That was the first error.

[00:05:23] Speaker 02:
Under this court's precedent in Iangrip and Tyco, if there is prior art that discloses the claim range, then the board is obligated to apply the presumption of obviousness.

[00:05:37] Speaker 02:
And that's what they failed to do in this case, thus leading to the second error.

[00:05:42] Speaker 01:
Come back to the question of what you had in the record here that supported you.

[00:05:49] Speaker 01:
Sherwin 19 and Compt.

[00:05:51] Speaker 01:
Is there anything beside those two?

[00:05:55] Speaker 02:
So there's Kazimov as well, Your Honor.

[00:05:57] Speaker 02:
Kazimov uses the data that was in Compt, but it was published in a separate journal.

[00:06:04] Speaker 02:
It was published in 2004, which actually post-dates all of the prior art references that Pat Nohner relies on in this case.

[00:06:12] Speaker 02:
So with respect to the board's findings about Sherwin or their lack of

[00:06:18] Speaker 02:
use of Sherwin being earlier in time, that's, you know, that's not appropriate because later references do disclose incomplete conversion and specifically the 53 and 54 percent.

[00:06:30] Speaker 01:
But what the board is saying is that the overwhelming view was that there was 100 percent or near 100 percent conversion rate, right?

[00:06:44] Speaker 01:
That was what they concluded.

[00:06:46] Speaker 02:
That's what they mentioned, but again, that error stems from the fact that they didn't consider the prior art as a whole.

[00:06:56] Speaker 02:
Had they looked at other art, they would have seen lower conversion rates.

[00:07:01] Speaker 02:
And specifically... Other art, you mean Sherwood 19 and Compt, right?

[00:07:09] Speaker 02:
Sherwood 19, Compt, and Kazimov definitely disclosed incomplete conversion rates.

[00:07:14] Speaker 01:
The other issue to compare... Aren't they... Suppose they look at the entirety, which they seem to have done, and say the overwhelming view was 100% and under these circumstances these two references don't render it obvious.

[00:07:32] Speaker 01:
Are they not entitled to do that?

[00:07:35] Speaker 01:
I'm sorry, can you repeat your question?

[00:07:38] Speaker 01:
They found isolated references, one of which was very old.

[00:07:42] Speaker 01:
suggesting a lower conversion rate, one perhaps in the area of 60%.

[00:07:48] Speaker 01:
But they said that the overwhelming view in the art was 100%.

[00:07:54] Speaker 01:
Are they not entitled to conclude from that that the art would not have suggested using a 60% rate?

[00:08:04] Speaker 02:
I would disagree with that, Your Honor, just because we do have other references that disclose lower conversion rates.

[00:08:10] Speaker 02:
And more importantly,

[00:08:11] Speaker 02:
There are legal safeguards that this court has put in place with respect to looking at the prior art as a whole when the obviousness analysis is conducted.

[00:08:22] Speaker 02:
And specifically, as Your Honors well know, in the Iron Grip case, once there is a claim range that is found in the prior art, then the burden of production shifts over to patentee to provide evidence with respect to teaching away or criticality of that range.

[00:08:41] Speaker 02:
And with respect to teaching away, the board found that there was no teaching away.

[00:08:47] Speaker 02:
They rejected patent owners' teaching away arguments.

[00:08:51] Speaker 03:
You've been making much out of this presumption.

[00:08:53] Speaker 03:
I gather you're telling us that we presume it obvious, even though there's no evidence of obviousness.

[00:09:01] Speaker 03:
I don't see you drawing any distinction between the shifting of the burdens of production and a presumption

[00:09:09] Speaker 03:
And again, your brief is very heavily loaded with saying you have to presume it obvious, even though we have no evidence, or the evidence is only of a range.

[00:09:21] Speaker 02:
I would disagree with that, Your Honor.

[00:09:22] Speaker 02:
And specifically in our briefing from pages 32 through 50, we do recite our prima facie obviousness analysis specifically with respect to all of them.

[00:09:31] Speaker 03:
That's not a presumption.

[00:09:32] Speaker 03:
That's a shifting of the burdens of coming forward.

[00:09:35] Speaker 02:
Understood, Your Honor, but we do, to your question regarding other evidence, we do have other evidence with respect to the obvious in this case.

[00:09:43] Speaker 02:
The issue becomes the board was obligated to apply that presumption because there were lower conversion rates that were taught.

[00:09:51] Speaker 02:
And again, as I alluded to earlier, with respect to teaching away, the board rejected all the teachings away and there was no evidence with respect to criticality that the patent owner submitted whatsoever in this case.

[00:10:04] Speaker 03:
And so- Because you ask us to assume that the burden is on them.

[00:10:11] Speaker 03:
And I've been looking for the prima facie case to start with.

[00:10:16] Speaker 03:
And all I keep coming upon is saying you're telling us there's a presumption.

[00:10:21] Speaker 02:
We do also have the prima facie case.

[00:10:23] Speaker 02:
Like I said, Your Honor, we've made multiple arguments in our brief.

[00:10:28] Speaker 02:
One is the presumption, but we've also put forward our prima facie

[00:10:33] Speaker 02:
case, obviousness case in our briefing.

[00:10:37] Speaker 02:
So we have that presented on pages 32 through 50 of our brief, as I mentioned.

[00:10:44] Speaker 02:
But really, the issue becomes that had the board not disregarded the prior art with lower conversion rates.

[00:10:53] Speaker 03:
They didn't disregard it.

[00:10:54] Speaker 03:
They discussed it.

[00:10:55] Speaker 02:
They didn't apply it to their obviousness analysis, Your Honor.

[00:10:59] Speaker 02:
That's the error.

[00:11:01] Speaker 02:
We're saying that

[00:11:02] Speaker 02:
Because there was prior art with lower conversion rates, they were obligated to apply the test that's presented.

[00:11:11] Speaker 02:
And that's the presumption of obviousness in this case.

[00:11:17] Speaker 02:
So with respect to the analysis here, as I alluded to, that's what led to the second legal error that the court committed.

[00:11:29] Speaker 02:
They exclusively relied on prior art

[00:11:32] Speaker 02:
with higher conversion rates without properly regarding and giving credit to conversion rates with lower conversion rates.

[00:11:43] Speaker 02:
I'd like to shift real quickly and address one other issue that Patent Owner has raised in their red brief, and that is with respect to their argument that the Bruce Loan 91 does not teach any of the limitations in the independent claims with respect to calculating

[00:12:01] Speaker 02:
an effective dose.

[00:12:03] Speaker 02:
And contrary to the patent owner's argument, Bruce Lo 91 does teach calculating an effective dose based on conversion of the drugs to P-A-G-N.

[00:12:14] Speaker 02:
Dr. Sondheimer, who's the only expert of record in this case, provided expert testimony that the dose in each period in Bruce Lo 91 was calculated based on such conversion.

[00:12:28] Speaker 02:
And the board made those

[00:12:30] Speaker 02:
findings with respect to the calculations at appendix 15 and 16 in this case.

[00:12:39] Speaker 02:
And specifically with respect to the board's finding, the board at appendix 15 goes through its analysis to show that the patient's protein intake was used to calculate the required waste nitrogen.

[00:12:53] Speaker 02:
And then that waste nitrogen was used to calculate the target urinary PGM,

[00:12:59] Speaker 02:
one of the elements in claims one and eight.

[00:13:03] Speaker 02:
And then that target urinary PHN was used in turn, in other words, performing a series of calculations to calculate the doses of PAA project to be administered.

[00:13:17] Speaker 04:
Can I just ask you, maybe when you get up on rebuttal, you can point me to the pages in your petition where you make a specific argument based on comp.

[00:13:29] Speaker 02:
I can provide that on rebuttal, I guess, Your Honor.

[00:13:31] Speaker 02:
I just don't have that handy.

[00:13:34] Speaker 02:
And so for those reasons, Your Honor, we respectfully ask that this court reverse the board's finding with respect to obviousness.

[00:13:42] Speaker 03:
Thank you.

[00:13:43] Speaker 03:
We'll save you rebuttal time.

[00:13:54] Speaker 03:
Mr. Green.

[00:13:56] Speaker 00:
Good morning, Your Honor.

[00:13:58] Speaker 00:
Robert Green on behalf of Horizon.

[00:14:02] Speaker 01:
Let me start by a... So you've got a 101 problem here, right?

[00:14:06] Speaker 01:
It's not exactly involved because it's a board proceeding and an IPR, but you've got a 101 problem.

[00:14:12] Speaker 01:
This looks an awful lot like a Mayo patent, right?

[00:14:16] Speaker 00:
I would say it's distinguishable.

[00:14:18] Speaker 00:
In fact, it requires not only a determination of a dose, but a treatment that's then made to the UCD patient based upon that dose.

[00:14:29] Speaker 00:
There's an active step that's required in this.

[00:14:31] Speaker 00:
It's more than just a calculation.

[00:14:33] Speaker 00:
It's actually a requirement for the treatment.

[00:14:36] Speaker 01:
Is there pending litigation in district court about 101?

[00:14:42] Speaker 00:
The litigation related to this actually was filed in the Eastman District of Texas.

[00:14:47] Speaker 00:
That has been stayed pending the outcome of this proceeding.

[00:14:50] Speaker 00:
There was an allegation made of a 101 issue by part.

[00:14:55] Speaker 00:
In that case, it's not going to trial, and it's been stayed.

[00:14:59] Speaker 01:
There's a potentially interesting issue here under the decision in Praxair about the relationship between 101 and 103.

[00:15:08] Speaker 01:
It's not been raised here.

[00:15:11] Speaker 01:
You're familiar with Praxair?

[00:15:12] Speaker 01:
In general, yes, Judge.

[00:15:15] Speaker 00:
We do not believe that there's a 101 issue here in view of the fact that there's more than just a thought process that's involved.

[00:15:24] Speaker 00:
This is no different than any other

[00:15:26] Speaker 00:
treatment claim in the pharmaceutical industry, where there is a determination made as to the dose, and the dose is then applied.

[00:15:35] Speaker 00:
And that's exactly what's happening.

[00:15:37] Speaker 01:
I don't mean to take up your time with that, but one-on-one is not involved.

[00:15:42] Speaker 00:
It is not in this case at this time.

[00:15:43] Speaker 00:
That's right.

[00:15:45] Speaker 00:
At the district board, that's a different issue to be dealt with by the judge at a future time.

[00:15:50] Speaker 00:
So let me address a few things here.

[00:15:52] Speaker 00:
First, clearly, the board spent a lot of time

[00:15:57] Speaker 00:
looking at the underlying references, and they came to a conclusion.

[00:16:00] Speaker 00:
And that conclusion was that the state of the art that was used in the petition by Parr was not representative of the art at the time, the pertinent time.

[00:16:09] Speaker 00:
That was a fact finding by the district court.

[00:16:12] Speaker 00:
And I'd say that alone was the basis then for moving forward with a decision that was made by the board.

[00:16:21] Speaker 00:
They looked at the references, and if you go

[00:16:26] Speaker 00:
If you go, for example, to one of the references.

[00:16:29] Speaker 04:
I understand very clearly what the board said at your urging about Sherwin 1919.

[00:16:36] Speaker 04:
What did the board say about Compt?

[00:16:41] Speaker 00:
They said very little, other than the fact they acknowledged that it existed.

[00:16:46] Speaker 00:
There was no real effort made by PAR to

[00:16:53] Speaker 00:
emphasize the teaching of comp.

[00:16:56] Speaker 00:
There's a reason for that.

[00:16:56] Speaker 04:
And I just saw in the petition, there's a single sentence footnote, I think, on page 111.

[00:17:01] Speaker 00:
Yes.

[00:17:01] Speaker 04:
Of the appendix.

[00:17:02] Speaker 04:
And that's all.

[00:17:03] Speaker 04:
Nevertheless, comp has this percentage in it that's lower than 60.

[00:17:10] Speaker 00:
Well, it's a lot lower than 60.

[00:17:12] Speaker 00:
I think the reason why.

[00:17:13] Speaker 04:
And it involves several different kinds of compounds.

[00:17:15] Speaker 04:
But there's no board analysis to say, there's board analysis saying, if you look at, sure,

[00:17:23] Speaker 04:
Sherwin 33, I can discount Sherwin 1919.

[00:17:27] Speaker 04:
I don't see a counterpart to that in the board's discussion of comp, which, aside from everything else, is much more recent.

[00:17:34] Speaker 00:
I would agree there is no specific discussion.

[00:17:36] Speaker 00:
But the board did point out when it first addressed comp that there was more to comp than simply testing that they needed to look at.

[00:17:45] Speaker 00:
Sure, there was an eight-hour time frame during which they collected the sample.

[00:17:51] Speaker 00:
Not 24.

[00:17:51] Speaker 00:
24 is a standard in the art.

[00:17:54] Speaker 00:
And in fact, the testimony from the expert, Dr. Sondheimer, in this matter, was that the values that were set forth in COMPT did not relate to a 24-hour process, and that there was continued flow, if you will, of the glyceral phenylbutyrate

[00:18:22] Speaker 00:
that was still coming out at the eight-hour time frame.

[00:18:25] Speaker 00:
And inherently, I think all that happened here is the board looked at this and said, well, what good is this data point?

[00:18:32] Speaker 00:
It was admitted that the testing actually had not been done over what was then accepted to be a 24-hour period.

[00:18:38] Speaker 00:
The existence of the conjugate that occurs after the administration of a PAA prodrug takes some time.

[00:18:45] Speaker 00:
And there's a reason why you see in the references the vast majority, if not all,

[00:18:50] Speaker 00:
Other than this, go to a 24-hour time frame.

[00:18:53] Speaker 04:
And the expert declaration that you were just talking about is your expert declaration?

[00:18:58] Speaker 04:
No.

[00:18:58] Speaker 04:
With the patent owners?

[00:18:59] Speaker 04:
No.

[00:19:00] Speaker 00:
It was the patent owners, right.

[00:19:02] Speaker 00:
And he even says.

[00:19:03] Speaker 04:
I'm sorry, I'm confused.

[00:19:05] Speaker 04:
Whose expert was this?

[00:19:06] Speaker 00:
It was Pahr's.

[00:19:07] Speaker 00:
Pahr's?

[00:19:07] Speaker 00:
Pahr's expert, yes.

[00:19:09] Speaker 04:
At a reply stage?

[00:19:10] Speaker 04:
No, it didn't submit any expert testimony at the reply stage.

[00:19:15] Speaker 04:
With its petition, or what?

[00:19:16] Speaker 00:
Yeah, with the petition to judge.

[00:19:18] Speaker 00:
It did.

[00:19:19] Speaker 04:
So in your patent owner response, did you have anything either in your lawyer's document or your expert document addressing comp?

[00:19:28] Speaker 00:
We did not have an expert to address it, but we did address, for example, Dr. Sondheimer's declaration at appendix 175, where he specifically said the summed value of what was determined to have been

[00:19:44] Speaker 00:
the result of the administration of the drug, understates excretion.

[00:19:51] Speaker 00:
This is their expert that says it understates excretion.

[00:19:54] Speaker 04:
So you just relied on their expert.

[00:19:55] Speaker 04:
And then did they come back in their reply, again, their lawyer's document and their reply, and address that outcome?

[00:20:05] Speaker 00:
The only issue that they addressed was there was testimony during a deposition by Dr. Sondheimer that he thought

[00:20:14] Speaker 00:
His view, unsupported totally, was that, well, it really had tapered off.

[00:20:20] Speaker 00:
Well, indeed, it did taper off.

[00:20:22] Speaker 00:
It was still being reviewed on an ongoing basis until they stopped at eight hours.

[00:20:29] Speaker 00:
And at that point in time, there still was PHA or P-A-G-N that was being determined at that point to exist.

[00:20:36] Speaker 00:
The other problem, though, with CompTI is the value here, the value is

[00:20:42] Speaker 00:
not 54.

[00:20:45] Speaker 00:
The value is actually 32.6.

[00:20:46] Speaker 00:
That's a conversion to P-A-G-N.

[00:20:50] Speaker 00:
That's what we're talking about here, Judge.

[00:20:52] Speaker 00:
They found, for whatever reason in the testing that they did, they found another agent, PBGN, which was also determined to exist at that time.

[00:21:03] Speaker 00:
The data points in here, as I said, they're not substantive.

[00:21:08] Speaker 00:
They don't have support based upon

[00:21:11] Speaker 00:
normal approach to doing a study like this.

[00:21:14] Speaker 00:
The dosing of this was five grams.

[00:21:16] Speaker 00:
If you look at the art that's in the record, again, Dr. Sondheimer, when he was addressing the data points, going back actually to SIMO, sorry, going back to the 2019 version, showed that there was

[00:21:39] Speaker 00:
There were four data points, and what Dr. Sondheimer said was the only ones that I considered to be useful, in essence, were those that were based on 10 and above, the two data points at 10 and 15.

[00:21:53] Speaker 00:
So when they were back and looking at the underlying prior art from Sherwin 19, their own experts said, I need to look not at the five

[00:22:06] Speaker 00:
gram dose, I need to look at the 10 and above.

[00:22:08] Speaker 00:
And that's what they looked at.

[00:22:10] Speaker 00:
So the other problem here, and I assume the board is made up of underlying experts in this field as well, the board looks at this and says, well, what are we supposed to do?

[00:22:21] Speaker 00:
The 24-hour time frame wasn't used.

[00:22:25] Speaker 00:
It was cut off before we could determine how much was determined to exist.

[00:22:31] Speaker 00:
We look at the data here, and it's not the 50

[00:22:34] Speaker 00:
that they're asserting it to be.

[00:22:35] Speaker 00:
It's in the 36 range.

[00:22:38] Speaker 00:
And inherently, if you're, of course, an ordinary skill in the art, you see that teaching account to you, I think you simply set it aside.

[00:22:47] Speaker 01:
What did the board say about COMPT in the initiation decision?

[00:22:55] Speaker 00:
My recollection is they did not rely.

[00:22:58] Speaker 00:
COMPT was part of the

[00:23:02] Speaker 00:
decision to move forward, but there was real no discussion with respect to they had in the decision to institute a statement about what comp was but that was it there was no discussion about why they were in my comp was actually included and that other than the fact that was requested by PAR at the time so they did consider it was part of the institution decision And in requesting institution, what did PAR say about comp?

[00:23:32] Speaker 00:
To my recollection, Your Honor, they said essentially nothing other than the footnote, which appears in their response.

[00:23:48] Speaker 00:
Again, I think comp is a red herring.

[00:23:50] Speaker 00:
And Kozomoff, his data comes from comp.

[00:23:54] Speaker 01:
Yes?

[00:23:55] Speaker 01:
Maybe comp could be dismissed.

[00:23:58] Speaker 01:
The problem is that it wasn't really addressed by the board.

[00:24:02] Speaker 00:
It was considered though, Your Honor.

[00:24:04] Speaker 00:
And clearly, if you look at their final written decision, they referred to it as part of the institution decision on ground one.

[00:24:12] Speaker 00:
They captioned their determination on that decision by saying that comp is part of it.

[00:24:18] Speaker 00:
And what they said was basically what Horizon set forth was evidence

[00:24:26] Speaker 00:
that the values that were being used at the critical time were those that were in the 90 to 100 range.

[00:24:33] Speaker 00:
And what they also relied on was when you look at the references that were involved that they relied on, such as Sherwin 33, the Bufinal label.

[00:24:47] Speaker 00:
And our position on Schiphol 22, which was a reference that they brought to the table,

[00:24:54] Speaker 00:
We argued in each of those cases.

[00:24:57] Speaker 00:
Sure went 33.

[00:24:58] Speaker 00:
There was a 24-hour time frame, 95% conversion.

[00:25:03] Speaker 00:
Chippell, their reference, 95% conversion.

[00:25:07] Speaker 00:
And Bufinal, which Par indicates shouldn't be given any consideration whatsoever, of course, is a label that was set forth based on standards from the FDA.

[00:25:19] Speaker 00:
So to say that there should be no

[00:25:23] Speaker 00:
credit given for what's on the Bufinal label, I think is ignoring the fact that it actually was endorsed by the FDA.

[00:25:32] Speaker 00:
So PAR addressed none of that.

[00:25:37] Speaker 00:
None.

[00:25:38] Speaker 00:
We put those issues on the table and what did they say to PTAP?

[00:25:42] Speaker 00:
Nothing on those points during the proceeding.

[00:25:46] Speaker 00:
And what was the board supposed to do at that point?

[00:25:49] Speaker 00:
They took a look then at the prior art

[00:25:51] Speaker 00:
They saw the prior art that was relied upon by Horizon, saw that this was timely, decided to decide the case on that basis, and in fact said, very specifically, Parr took no position on these.

[00:26:07] Speaker 00:
Another point, which I think is quite important in this case, if you look at the prior art as a whole, and the question really is, what was a post-it going to look at?

[00:26:19] Speaker 00:
Well, go back and take a look at

[00:26:21] Speaker 00:
Bruce Lowe, 647 Patton, 1980.

[00:26:27] Speaker 00:
What's he cite to?

[00:26:29] Speaker 00:
Does he cite to Schiphol?

[00:26:32] Speaker 00:
I'm sorry, to Sherman, 19?

[00:26:36] Speaker 00:
He does, but only for a totally different proposition than the conversion rate of PAA to PHEN.

[00:26:43] Speaker 00:
Instead, what's he cite to for that purpose?

[00:26:46] Speaker 00:
Sherman, 33.

[00:26:49] Speaker 00:
And what's he say?

[00:26:50] Speaker 00:
There was a conversion rate of 95% shown in Sherwin 33.

[00:26:55] Speaker 00:
He also points to that purpose clearly to establish the database that he was in using in the testing at that point.

[00:27:08] Speaker 00:
And you can't ignore the fact that he was an expert.

[00:27:12] Speaker 00:
He is the one that actually came to the forefront and established the use of PAA progrugs or PAA itself

[00:27:20] Speaker 00:
to treat UCD.

[00:27:23] Speaker 00:
He is the icon in that.

[00:27:25] Speaker 00:
And for him to ignore specifically Sherwin 19's teaching and instead to point to Sherwin 33, I think tells anyone a skill in the art that Sherwin 19, as we have argued but was not adopted by the board, in fact is a reference which would not have been considered at the time of the invention to be telling with respect to exactly what the

[00:27:51] Speaker 00:
at the time, the PAA to PHA conversion rate would have been.

[00:28:00] Speaker 00:
I can't imagine anyone that would have a better set of background credentials than Saul Brusalo can solve.

[00:28:09] Speaker 00:
There are many other issues, Your Honors.

[00:28:11] Speaker 00:
I see I'm down to 46 seconds or so that I would like to address, but if you have any specific questions of my short time left, I would be pleased to address those.

[00:28:22] Speaker 03:
Any more questions?

[00:28:24] Speaker 03:
Any more questions?

[00:28:25] Speaker 03:
Well, thank you, Mr. Green.

[00:28:27] Speaker 00:
Thank you, Judge.

[00:28:40] Speaker 03:
Mr. Berger.

[00:28:41] Speaker 02:
Thank you, Your Honor.

[00:28:42] Speaker 02:
Judge Toronto, with respect to your question about citations to Compt, we did cite Compt, as you mentioned,

[00:28:50] Speaker 02:
on Appendix 111, in addition to, in our petitioner's reply, Appendix Pages 2298, also Appendix Pages 2306 through 2308.

[00:29:07] Speaker 02:
Judge Dyke, with respect to Your Honor, about a different drug.

[00:29:11] Speaker 02:
The drug in comp is sodium phenylbutyrate.

[00:29:15] Speaker 02:
It is a prodrug.

[00:29:17] Speaker 02:
a PAA, and that's what's claimed in the 012 patent.

[00:29:22] Speaker 02:
And specifically, there's an explanation regarding that at Appendix 165.

[00:29:32] Speaker 02:
Judge Newman, with respect to your question about Sherwin and the fact that it was earlier in time and what the board said about Sherwin 19, that doesn't take away from the fact that

[00:29:46] Speaker 02:
There was no discrediting of Sherwin 19.

[00:29:50] Speaker 02:
Specifically, the board made a specific finding that Sherwin 33, that Patent Owner relies upon, did not discredit Sherwin 19.

[00:30:00] Speaker 02:
So from that perspective, Sherwin 19 is still good prior art.

[00:30:05] Speaker 02:
As I mentioned earlier, it's consistent.

[00:30:08] Speaker 02:
The later prior art has disclosures of PAA conversions that are consistent.

[00:30:14] Speaker 02:
with the Sherwin 19 reference.

[00:30:16] Speaker 02:
And absent any teaching away, any discrediting, or any other unexpected results with respect to the claim range, it's error for the board to discount and disregard the Sherwin 19 reference.

[00:30:37] Speaker 02:
The other thing I'd like to mention regarding Sherwin 33, which is what the patent owner relies upon

[00:30:43] Speaker 02:
That reference does not measure PAGN conversion, which is the claim limitation in this case.

[00:30:51] Speaker 02:
What it measures is PAA.

[00:30:54] Speaker 02:
And that's different than what's recited in the patent claim.

[00:30:58] Speaker 02:
So from that perspective alone, that's not even art that should be considered.

[00:31:03] Speaker 02:
And we have made that argument all along.

[00:31:06] Speaker 02:
And we did make that argument down below.

[00:31:10] Speaker 02:
And specifically, those are at appendix pages 2303 through 2306.

[00:31:15] Speaker 02:
I think that's all I have, unless your honors have any further questions.

[00:31:32] Speaker 03:
Any more questions?

[00:31:33] Speaker 03:
Well, thank you.

[00:31:36] Speaker 03:
Thank you.

[00:31:37] Speaker 03:
Thank you both.

[00:31:38] Speaker 03:
The case is taken under submission.