[00:00:00] Speaker 03:
One from the PTO and one from a district court.

[00:00:05] Speaker 03:
And we've got a case from the claims court that's being submitted in the brief, so we'll not be arguing.

[00:00:13] Speaker 03:
First case is Apotex v. Wyeth, 2015, 1871, Mr. Malenda.

[00:00:19] Speaker 03:
Good morning, Your Honors.

[00:00:27] Speaker 01:
May it please the court?

[00:00:29] Speaker 01:
The claimed three-part composition here is truly the paradigm of obviousness under KSR, a third-generation antibiotic, tycocycline, combined with a well-known sugar and a well-known acid.

[00:00:42] Speaker 01:
And the resolution of this case is as simple as the purported invention here.

[00:00:45] Speaker 01:
That's because a case exactly like this one was already decided by this court after the PTAB's decision, namely the Senju versus Lubin case.

[00:00:53] Speaker 03:
But isn't this a case of combination of references?

[00:00:58] Speaker 03:
And you need motivation to combine, and that's a question of fact, and therefore we defer to the PTO?

[00:01:04] Speaker 01:
I agree, Your Honor.

[00:01:05] Speaker 01:
And motivation to combine is certainly a question of fact.

[00:01:08] Speaker 01:
But the problem here, and this is really one of the main bases for the error that we're asserting, is that the board never addressed to a number of our key motivation arguments below.

[00:01:18] Speaker 01:
because it was focusing on the issue of epimerization and the inventor's problem that it was trying to solve, namely minimizing epimerization.

[00:01:28] Speaker 01:
We have actually two distinct substitution-related arguments.

[00:01:32] Speaker 02:
The red brief says, pages 37 and 38, that in your reply brief, you argued epimeric stability for the first time.

[00:01:47] Speaker 02:
Again, they argue that I'll make a standard waiver argument because of that.

[00:01:55] Speaker 02:
What's your response?

[00:01:56] Speaker 02:
Let me put it this way.

[00:02:00] Speaker 02:
Was this argument raised prior to the reply briefing, and so where is it in the record?

[00:02:05] Speaker 01:
Which arguments specifically aren't?

[00:02:06] Speaker 01:
The motivations to substitute?

[00:02:10] Speaker 02:
In its reply brief, Apotex argued that the board need not limit its analysis to epimeric stability, but instead could find the 828 patent obvious if the person having ordinary skill in the art would have substituted tygocene for mining cyclin in the CN550 compositions for any reason.

[00:02:35] Speaker 02:
Yet Apotex never, in fact, asserted a reason for using lactose with

[00:02:40] Speaker 02:
tied to cyclin other than to reduce epimerization.

[00:02:45] Speaker 01:
Yes, we did in fact raise that argument below, and in fact, if you turn to the... Prior to your reply brief, I'm not asking... One hundred percent, Your Honor.

[00:02:53] Speaker 01:
And in fact, if you turn to page A-160 of the appendix, what you have in paragraph 84 is our argument in the declaration of Dr. Nelson, and if you

[00:03:08] Speaker 01:
Please turn to paragraph 84, where it says, a person of ordinary skill in the art in 2005 would find reason to substitute tigacycline for minocycline in the lyophilized formulation, blah, blah, blah, because the A2 patent states that it was known that tigacycline, quote, has been shown to work where other antibiotics have failed, end quote, and it has been active against methicillin-resistant staphylococcus, et cetera.

[00:03:35] Speaker 01:
And in fact, if you go to heading one there,

[00:03:37] Speaker 01:
It says tiglycycline is an obvious substitution for minocycline.

[00:03:41] Speaker 01:
Thank you.

[00:03:50] Speaker 01:
Yes, your honor.

[00:03:52] Speaker 01:
So in Senju, this court affirmed a finding of obvious involving a simple substitution of an early generation antibiotic with an improved next generation antibiotic in a prior formulation.

[00:04:06] Speaker 01:
And that's exactly what we have in this case.

[00:04:08] Speaker 01:
Here, the Chinese 550 application discloses the second generation antibiotic, minocycline, lactose, and hydrochloric acid.

[00:04:17] Speaker 01:
Wyeth's inventors admit in the background section of the 828 patent that tygocycline is, quote, a chemical analog of minocycline.

[00:04:25] Speaker 01:
So they're very structurally similar.

[00:04:27] Speaker 01:
And an improved antibiotic that, quote, has been shown to work where other antibiotics have failed, end quote, which is the quote we just referred to that Dr. Nelson cited.

[00:04:35] Speaker 01:
Senju dictates that under these facts, a person of ordinary skill and the art would have been motivated to make the simple substitution of generational drugs, thereby rendering the claims invalid as obvious.

[00:04:47] Speaker 01:
While this case can be decided on the facts of Senju alone,

[00:04:50] Speaker 04:
How can this case be decided based on another case's facts?

[00:04:54] Speaker 04:
Look, I get your argument.

[00:04:55] Speaker 04:
It seems to me you had a very strong obviousness case here.

[00:04:59] Speaker 04:
But the board rejected it and found no motivation to combine.

[00:05:03] Speaker 04:
And what do we have to do to find substantial evidence or a lack of substantial evidence?

[00:05:07] Speaker 04:
Because particularly when we're talking about a lack of motivation to combine, that's kind of negative evidence.

[00:05:13] Speaker 04:
I mean, basically, don't we just look to the board's reasoning and say, is there anything

[00:05:18] Speaker 04:
in the record that so substantially contradicts it that we would disagree.

[00:05:24] Speaker 02:
And keeping in mind that they said they didn't believe Dr. Nelson's evidence.

[00:05:33] Speaker 01:
There are two parts to that, Your Honor.

[00:05:35] Speaker 01:
The first of which is that we are very sensitive to the issue of standard review and the issue of substantial evidence.

[00:05:41] Speaker 01:
That's why our brief is limited to only legal errors, and specifically the legal errors that the board committed in not addressing

[00:05:47] Speaker 01:
particular motivation to combine arguments.

[00:05:49] Speaker 01:
So we're not trying to argue.

[00:05:51] Speaker 04:
I get that, but I don't know that that's, even if that's true, and I don't necessarily think it is, that that's still enough to, we're still talking about a factual finding.

[00:06:00] Speaker 04:
They found no motivation to combine.

[00:06:03] Speaker 04:
As long as that's supported by substantial evidence, then we have to affirm, don't we?

[00:06:07] Speaker 01:
I don't believe so, Your Honor, because under, for example, this court's Cutsforth decision,

[00:06:11] Speaker 01:
It's not sufficient for the board to simply lay out the party's arguments and then provide a broad sweeping generalized conclusion, which is exactly what happened here.

[00:06:19] Speaker 01:
There were a number of motivations that we raised.

[00:06:21] Speaker 01:
In some cases, the board recited them but then provided no analysis, which means that that does not enable this court to have anything to actually review.

[00:06:29] Speaker 01:
And so if there's nothing to review, then how can this court do its job?

[00:06:34] Speaker 01:
And that's why cuts forth is so clear about that, which is that the PTAB in this case needs to do its analysis

[00:06:41] Speaker 01:
and show why it's reasoning the way it is.

[00:06:43] Speaker 01:
And it didn't do that in a number of cases due to the legal errors it made, reading limitations into the claims that aren't there, and then focusing only on the problem that the inventors were addressing, namely reducing the pimerization.

[00:06:54] Speaker 03:
Mr. Malenda, one could start with the Chinese reference, which teaches minocycline plus lactose and HCl.

[00:07:03] Speaker 03:
And the question is whether to substitute tigacycline with a minocycline.

[00:07:11] Speaker 03:
The patent we have before us says that pimerization is a more serious problem with tigercycline than with other tetracyclines such as minocycline.

[00:07:22] Speaker 03:
So doesn't that lead away from substituting tigercycline?

[00:07:27] Speaker 01:
I don't believe it does, Your Honor, because we have to keep in mind that KSR has a very broad general test that's flexible with respect to proving obviousness.

[00:07:36] Speaker 01:
And you don't have to just focus on the problem that the inventors were facing.

[00:07:40] Speaker 01:
with respect to epimerization.

[00:07:42] Speaker 01:
There may be other reasons to substitute it.

[00:07:43] Speaker 01:
In fact, Senju gives us a very compelling one, namely the structural similarity of these second generation versus third generation antibiotics.

[00:07:52] Speaker 01:
Also, we have the plain structural similarity of the two molecules side by side.

[00:07:57] Speaker 01:
Your honor will note that there's only a difference in the C9 position.

[00:08:00] Speaker 01:
So that alone would give someone a motivation to simply swap out type of cycling for minocycling in that Chinese reference.

[00:08:13] Speaker 01:
So while we believe that this case can be decided on Senju alone, I'd like to briefly discuss the two legal errors that we've discussed in our briefs.

[00:08:22] Speaker 01:
First, the board erred an important and epimeric stability limitation into the composition claims in violation of longstanding precedent, including Senju.

[00:08:30] Speaker 01:
This caused the board to discredit APOTEX's lead reference, the Chinese 550 application, and one of its secondary references, Palachek, for not teaching a non-existent limitation, which is exactly what happened in Senju.

[00:08:43] Speaker 01:
Second, the board failed to consider motivations to substitute or combine beyond the problem the patentee was trying to solve, that is minimizing epimerization, which it describes in the patent.

[00:08:54] Speaker 01:
This error violates KSR, Senju, and Alcon, among many other cases, which made clear that any reason can serve as a motivation, not just the problem that the patentee was trying to solve.

[00:09:05] Speaker 01:
And with respect to motivation to substitute menocycline for tygocycline, we have two motivations that the board did not analyze.

[00:09:12] Speaker 03:
You mean the reverse.

[00:09:13] Speaker 01:
I apologize.

[00:09:14] Speaker 03:
Tygocycline for menocycline.

[00:09:16] Speaker 01:
Correct.

[00:09:16] Speaker 01:
Exactly.

[00:09:17] Speaker 01:
Substituting tygocycline for menocycline.

[00:09:21] Speaker 01:
So with respect to that substitution of tygocycline for menocycline, the board disregarded two motivations.

[00:09:26] Speaker 01:
The first of which was the Senju improved antibiotic type motivation.

[00:09:31] Speaker 01:
And then the second motivation has to do with

[00:09:33] Speaker 01:
It's just simply that structural similarity and the only difference at the C9 position for tigecycline.

[00:09:38] Speaker 01:
And the board also disregarded two motivations to combine to optimize the pH ranges.

[00:09:44] Speaker 01:
The first of those is the fact that it was the well-known fact that oxidation and epimerization both plague tigecyclines, tetracyclines at different pH levels.

[00:09:53] Speaker 01:
And the inventors admit in the background section of the patent that that was the case.

[00:09:57] Speaker 01:
Secondly, the fact that the recited pH ranges were commonly employed in conventional injection solutions.

[00:10:03] Speaker 01:
And YF doesn't even contest that the board disregarded these motivations, relying on a mere procedural argument as its only defense against those.

[00:10:15] Speaker 01:
So if there are no further questions, I'll reserve the rest of my time for rebuttal.

[00:10:19] Speaker 03:
We will do that.

[00:10:20] Speaker 03:
Thanks, Melinda.

[00:10:22] Speaker 03:
Mr. Burrow.

[00:10:37] Speaker 00:
Good morning, your honor.

[00:10:39] Speaker 00:
May it please the court?

[00:10:40] Speaker 00:
If I may start perhaps with Judge Wallace's question.

[00:10:43] Speaker 02:
Are you satisfied that A160 adequately raises the issue?

[00:10:49] Speaker 00:
No, I'm not.

[00:10:50] Speaker 00:
Respectfully, my opponent read from paragraph 84 of the declaration of Dr. Nelson, its expert, which addresses the issue that tygocycline was known to succeed, where other tetracycline antibiotics had been known to fail.

[00:11:05] Speaker 00:
And he suggests that this is some motivation

[00:11:08] Speaker 00:
separate and apart from epimerization, which was advanced below by Apotex.

[00:11:13] Speaker 00:
He didn't read the next paragraph, paragraph 85 of Dr. Nelson's declaration, which ends, a person of ordinary skill in the art would understand that minocycline and tygocycline undergo C4 epimerization in a solution at a pH of 2 to 3.5 as discussed above.

[00:11:29] Speaker 00:
The following paragraph, paragraph 26, again addresses epimerization.

[00:11:33] Speaker 00:
The idea that there was a motivation separate and apart from any epimerization argument that actually was presented by Apotex as a distinct argument below simply isn't true.

[00:11:44] Speaker 00:
But let's leave that aside for a moment because the argument that we heard today and that we heard in the briefs from Apotex is that the board somehow failed to address this motivation argument.

[00:11:56] Speaker 00:
We heard a few motivation arguments just now.

[00:11:59] Speaker 02:
The board is responding to

[00:12:01] Speaker 02:
It says that it's responding to what was raised.

[00:12:07] Speaker 00:
Absolutely, Your Honor.

[00:12:08] Speaker 00:
And in fact, they went beyond that.

[00:12:11] Speaker 00:
You heard paragraph 84 relied on just now by Apotex from Dr. Nelson's declaration.

[00:12:17] Speaker 00:
If you look on page 12 of the board's opinion, that very paragraph is cited, and it's block quoted.

[00:12:23] Speaker 00:
And the board, after reciting that paragraph,

[00:12:27] Speaker 00:
basically rejects petitioner Apotex and Dr. Nelson's argument, basically saying that neither petitioner nor Dr. Nelson provides information demonstrating that a person of ordinary skill would have relied on this therapeutic effectiveness of tygocycline.

[00:12:42] Speaker 00:
It's not that the board didn't address Apotex's argument.

[00:12:46] Speaker 00:
The board did address Apotex's argument and found it wanting.

[00:12:49] Speaker 00:
They simply were not convinced by the only evidence that Apotex presented below.

[00:12:54] Speaker 00:
The declaration of Dr. Nelson

[00:12:55] Speaker 00:
whom the board found non-credible and guided by hindsight after review of the record.

[00:13:00] Speaker 03:
Mr. Burl, getting down to basics, you've got a composition here, including minocycline and tigacycline is a very similar tetracycline compound.

[00:13:13] Speaker 03:
Why isn't it just plain obvious to substitute one for the other?

[00:13:17] Speaker 00:
Well, in the first instance, there was no finding below, nor is it correct, that tigecycline is very similar structurally to minocycline.

[00:13:25] Speaker 00:
They differ at the 9 position.

[00:13:27] Speaker 03:
Really?

[00:13:27] Speaker 03:
You've got this tetracycline?

[00:13:29] Speaker 00:
They have the same core, and it's an analogue.

[00:13:31] Speaker 00:
That doesn't mean they're structurally similar.

[00:13:33] Speaker 00:
And it doesn't mean that whatever properties are disclosed with respect to minocycline in the prior 550 patent would have been expected to accrue for tigecycline in a different formulation if one made the substitution.

[00:13:46] Speaker 00:
In fact,

[00:13:46] Speaker 00:
The board addressed that very argument at page 14 of its opinion, finding that a person of skill would not have expected all of the benefits of the minus cycling formulation in CN550, stability against light, heat, water, oxygen, to be present in a tigus cycling formulation.

[00:14:04] Speaker 00:
They made that factual finding, which respectfully is not even challenged here on appeal.

[00:14:09] Speaker 00:
The idea that one would just assume that everything that is true of minuscycling in the formulation of CN550 would be true of tygocycling simply is refuted by the record in this case and the board's findings below.

[00:14:23] Speaker 00:
To take just one example, stability against oxygen

[00:14:27] Speaker 00:
Dr. Mitchell, our expert, explained in his declaration at A1728 to A1732 that the way these compounds relate to oxidation, that is breakdown as a result of oxygen, is quite different as a result of that structural difference at the C9 position.

[00:14:46] Speaker 00:
Moreover, there's an entirely different pathway of breakdown that's addressed by Dr. Mitchell at page A1640 of his declaration and further explained at oral argument at A10253 to 254 that says that there is a breakdown by something called the Maillard reaction as a result of the amine, as a result of the substituent at the 9 position of tygocycline that wouldn't be present for minocycline.

[00:15:12] Speaker 00:
So the notion that one could simply substitute back and forth

[00:15:15] Speaker 00:
Tiger cycling for minus cycling because they may look similar to a layman on a piece of paper is simply not reflected in the record.

[00:15:23] Speaker 00:
Dr. Nelson, Apotex's own expert, agreed at A2042

[00:15:30] Speaker 00:
that with respect to breakdown from oxygen, minocycline and tygocycline would be different in terms of the pH at which this breakdown would occur.

[00:15:38] Speaker 00:
Again, that factual record is what the board relied on in reaching the conclusion at A14 that Aputex's argument presented in their petition at page 39, A85, is simply incorrect, that a person of ordinary skill

[00:15:55] Speaker 00:
would not have expected the same advantages from CM550 to accrue to a formulation of tigecycline.

[00:16:02] Speaker 00:
And that's where we get to the primary case on which Apotex relies, Senju, in which it attempts to persuade the court to decide this case in a sort of obviousness by proxy way, that because the claims in Senju on that matter were obvious, the claims here are obvious as well.

[00:16:19] Speaker 00:
That's not how the obvious inquiry works.

[00:16:21] Speaker 00:
And the record in Senju, I submit, is diametrically opposed to the record in factual findings in this case.

[00:16:28] Speaker 00:
To take just one example, the district court in Senju, which by the way found obviousness, and therefore this court's review was a substantial evidence of a finding of motivation of obviousness, the court made extensive factual findings in its initial 2010 opinion, including

[00:16:45] Speaker 00:
that a person of ordinary skill in that art would have expected the new compound called gadifloxacin to be formulated in the same way as the prior art quinolones of the 470 of the 456 patent that had EDTA.

[00:17:00] Speaker 00:
In other words, there was a factual finding by the district court in that case that there would have been an expectation and motivation when moving from lomafloxacin or norfloxacin in the prior art incendio

[00:17:12] Speaker 00:
to Gatti-Floxson in the claims that it would work the same way, that you would have the same advantages.

[00:17:17] Speaker 00:
In fact, there was a clear factual finding by the district court at page 421 of its opinion that said a person of skill would have expected beneficial properties from EDTA to accrue to all of the quinolones, including the new quinolone, Gatti-Floxson, at issue in that case.

[00:17:34] Speaker 00:
In this case, one has precisely the opposite factual finding by the board.

[00:17:38] Speaker 00:
That is, that when one makes the substitution, a person of ordinary skill would not have expected the benefits of the prior art here, CN 550, to accrue.

[00:17:48] Speaker 00:
Moreover, there were a host of other factual findings in Senju, including the fact that the excipient there, EDTA, was a standard excipient in this field.

[00:17:59] Speaker 00:
in the quinolone field that had been used with norefloxacin, pfloxacin, enoxacin, lomofloxacin, ciprofloxacin, and a host of others that I'm likely forgetting.

[00:18:09] Speaker 00:
Here, the record is precisely the opposite.

[00:18:12] Speaker 00:
Lactose was not a standard excipient in the tetracycline field.

[00:18:16] Speaker 00:
And in fact, the evidence in the record, A1673 to 1675 and A1754 to 1758 from Dr. Mitchell,

[00:18:25] Speaker 00:
explains that the actual formulations that a person of ordinary skill would have looked to is not the CN550 formulation with lactose, but rather a host of formulations that a person of ordinary skill would have looked to instead and found better benefits, such as the 060 patent found at A2489, the 528 patent found at A2495,

[00:18:48] Speaker 00:
the 248 patent found at A2662 and the Creel Guard article at A272.

[00:18:55] Speaker 00:
Aputex ignores all of this evidence completely because it does not and cannot fight the proposition that the board's finding that a person of skill wouldn't have been motivated to make this substitution is supported by substantial evidence.

[00:19:10] Speaker 00:
It's not only supported by substantial evidence.

[00:19:12] Speaker 00:
It is the only finding that the board could have made on the record below, and it's not even challenged

[00:19:18] Speaker 00:
by Apotex in this court.

[00:19:21] Speaker 00:
If I could just address briefly the pH motivation argument that counsel referred to as well, I just want to be clear.

[00:19:28] Speaker 00:
We're not only fighting that motivation on the basis of some procedural impropriety.

[00:19:34] Speaker 00:
Rather, the motivation does not work to end up at the claims.

[00:19:39] Speaker 00:
The question in Senju and every other case is whether, if one combined the references and had a motivation to do that, would the claim result?

[00:19:48] Speaker 00:
The pH motivations that are advanced here on appeal by Apotex never lead you to taiga cycling.

[00:19:55] Speaker 00:
The idea that one would have wanted to use a pH of four to five, which by the way was not supported by the record below, which I'll get to in a second, doesn't provide a motivation to use taiga cycling rather than minus cycling.

[00:20:08] Speaker 00:
That is what is missing from Apotex's case.

[00:20:11] Speaker 00:
In all the references they rely on, CM550, Pavelchik, and Nagar, there's no disclosure of Tigus cycling, no teaching of Tigus cycling or its use or its properties.

[00:20:22] Speaker 00:
Council stands up here and says, oh, it's all the same.

[00:20:24] Speaker 00:
We can just substitute Tigus cycling for minus cycling and pretend there's no difference.

[00:20:28] Speaker 00:
But the board found at A10 that the absence of any teaching of Tigus cycling in the record or its properties or use was

[00:20:38] Speaker 00:
devastating for Apotex's case.

[00:20:40] Speaker 00:
And they can't overcome it here.

[00:20:42] Speaker 00:
So they have a series of references, which they attempt to combine, including for pH reasons.

[00:20:48] Speaker 00:
But again, there's no tygocycline.

[00:20:50] Speaker 00:
There's no reason to substitute tygocycline or minocycline.

[00:20:54] Speaker 00:
And the reasons they advanced were addressed by the court, not just to pimerization, but all other reasons were addressed at A10, A12,

[00:21:02] Speaker 00:
A-14, and the board made factual findings that again are not challenged on appeal and in any event are clearly supported by substantial evidence.

[00:21:12] Speaker 00:
If the court has further questions, I'm happy to address them.

[00:21:15] Speaker 03:
Thank you, Mr. Burrell and Mr. Malinda.

[00:21:38] Speaker 01:
Your honors, I'd just like to address a few points that Mr. Burrow raised.

[00:21:41] Speaker 01:
The first which is that he argued that really the Senju argument is linked in some way to the epimerization argument.

[00:21:49] Speaker 01:
And that's simply false.

[00:21:50] Speaker 01:
These are two completely distinct arguments.

[00:21:53] Speaker 01:
They're completely separate.

[00:21:55] Speaker 01:
And basically, he has to argue that Senju and the structural similarity arguments are somehow intertwined with epimerization.

[00:22:01] Speaker 01:
Because if he doesn't make that argument, then this has to go back.

[00:22:04] Speaker 01:
Because it's clear from the board's very conclusory opinion that

[00:22:08] Speaker 01:
The board never addressed issues relating to the send you improvement type argument or structural similarity.

[00:22:15] Speaker 01:
Also, with respect to the P tab reciting certain arguments in a block quote, well, first of all, setting forth an argument in a block quote is not the same thing as analyzing it.

[00:22:25] Speaker 01:
And what's notably absent from the court's opinion is actual analysis with respect to the send you type argument or the substitution argument.

[00:22:36] Speaker 01:
Also, with respect to Judge Wallach's question about raising the issue of substitution, I also just wanted to point, Your Honor, to pages 31 and 32 of the petition, which are cited at A77 through A78 in the appendix.

[00:22:50] Speaker 02:
So how is it not analysis at A12, where following paragraph 84, they begin by saying, Dr. Nelson does not explain, however, why the knowledge that tug-of-the-cycline is effective, quote, where other antibiotics have failed to close, quote,

[00:23:05] Speaker 02:
would lead a person having ordinary skill in the art to substitute, and so on.

[00:23:11] Speaker 01:
That is analysis, is it not?

[00:23:13] Speaker 01:
It's faulty analysis.

[00:23:14] Speaker 01:
And the reason why is because in Senju... You said that there was no analysis.

[00:23:20] Speaker 02:
Now you're saying that nonexistent analysis is faulty.

[00:23:24] Speaker 02:
You see my problem with your art?

[00:23:25] Speaker 01:
OK, there really is an analysis when they say that Dr. Nelson gave any sort of proof as to why that would be true.

[00:23:34] Speaker 01:
Because, understand you, there's nothing more that Dr. Nelson has to do.

[00:23:38] Speaker 01:
Understand you, what you had in that case, was an understanding in the art that there was an improved antibiotic that was replacing a prior generation antibiotic.

[00:23:46] Speaker 01:
And the fact that that was known in the art was enough for that motivation to substitute.

[00:23:51] Speaker 01:
Here we have something even better than that.

[00:23:52] Speaker 01:
What we have is an actual statement within the patent, an admission by the inventors, that tigecycline is an improved antibiotic relative to minocycline.

[00:24:01] Speaker 01:
So we actually have something even better than Senju did.

[00:24:04] Speaker 01:
And the board ignored that.

[00:24:05] Speaker 01:
The board did not address that particular issue.

[00:24:07] Speaker 01:
Dr. Nelson did everything he had to do, which was point to that statement.

[00:24:12] Speaker 01:
And beyond that, that's it.

[00:24:14] Speaker 01:
So under Senju, to the extent the board addressed that with that statement, that's a legal error.

[00:24:19] Speaker 01:
And to the extent it didn't address it as a legal error due to the fact that it was focusing solely on the argument relating to epimerization.

[00:24:28] Speaker 01:
I guess one of the other arguments he says is that the Senju case is diametrically opposed to this one.

[00:24:33] Speaker 01:
I have to be honest with you, Your Honors.

[00:24:35] Speaker 01:
I find that argument breathtaking.

[00:24:37] Speaker 01:
So just to break this down, the primary issue is why one would be motivated to substitute an old antibiotic for a structurally similar one.

[00:24:46] Speaker 01:
And that's exactly what Senju was about.

[00:24:48] Speaker 01:
And in that case, the motivation was known in the art that Gadifloxacin was an improved antibiotic.

[00:24:54] Speaker 01:
Here, the inventors themselves, as I just said,

[00:24:57] Speaker 01:
that tygocycline was an improved antibiotic, so we have something even better.

[00:25:01] Speaker 04:
Then the secondary qu- The problem is you're just arguing all facts though.

[00:25:05] Speaker 04:
I mean just the fact that there's one case dealing with antibiotics, there's another case dealing with antibiotics.

[00:25:10] Speaker 04:
They both involve improved antibiotics.

[00:25:12] Speaker 04:
It doesn't do anything to the fact that the chemical arts can be very unpredictable.

[00:25:16] Speaker 04:
So a third generation antibiotic may react very differently than the second generation.

[00:25:22] Speaker 04:
And it's your burden to show that a person of ordinary skill would have been motivated to combine them.

[00:25:27] Speaker 04:
And if the board disagrees with you,

[00:25:29] Speaker 04:
and rejects your evidence in favor of your friend's evidence, then I don't see how we can, as a matter of law, say that was incorrect.

[00:25:38] Speaker 01:
But Your Honor, the problem is that in a number of the cases that we pointed out in our briefing, they just never did the analysis.

[00:25:43] Speaker 01:
There's really nothing for you to review, because all the board really did was focus on the issue of epimerization.

[00:25:49] Speaker 01:
It discounted our references.

[00:25:50] Speaker 01:
It discounted what Dr. Nelson had to say.

[00:25:52] Speaker 01:
Because if they didn't disclose the criminalization, we'll put them aside.

[00:25:55] Speaker 04:
Let's assume we disagree with you about them disregarding your references.

[00:26:00] Speaker 04:
And we find enough in the opinion to think that they've carefully considered this case.

[00:26:04] Speaker 04:
They've considered all of your arguments.

[00:26:06] Speaker 04:
Even if they didn't write extensively, they rejected them on the facts.

[00:26:10] Speaker 04:
Aren't we in a substantial evidence review land then?

[00:26:12] Speaker 04:
And then don't you have a really difficult problem?

[00:26:15] Speaker 01:
I don't think we can ignore the fact that the board simply gave you nothing to review to assess substantial evidence for.

[00:26:21] Speaker 01:
The board simply didn't do that analysis for you to take the bull by the horns and do the analysis.

[00:26:27] Speaker 01:
Unfortunately, all the board did was provide a sweeping conclusory statement, which is what cuts forth counsels against the board doing.

[00:26:34] Speaker 01:
So I guess just to conclude, what we have here is a send you case.

[00:26:37] Speaker 01:
We have a very simple substitution that provides ample motivation based on an improved antibiotic being substituted for an old one.

[00:26:45] Speaker 01:
And we've also provided the other motivations relating to pH as well as structural similarity in our briefing.

[00:26:50] Speaker 03:
Thank you, Mr. Malenda.

[00:26:52] Speaker 03:
Thank you, counsel.

[00:26:53] Speaker 03:
The case is submitted.