[00:00:04] Speaker 00:
We have five cases on our calendar this morning.

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Three will be argued, all patent cases, two from the PTO, one from a district court.

[00:00:15] Speaker 00:
We have two submitted cases, an employee case and a veteran's case, and they will not be argued.

[00:00:23] Speaker 00:
First case, first argued case is Byer Farmer AG at Al versus Watson,

[00:00:33] Speaker 00:
2016-21-69, Mr. Jay.

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

[00:00:44] Speaker 04:
May it please the court to have a slightly scratchy voice this morning.

[00:00:46] Speaker 04:
And I hope the court will let me know if I'm not able to be heard.

[00:00:51] Speaker 04:
William Jay from Goodwin Proctor for the Appellants.

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This case involves a patent claiming an established drug combined with an off-the-shelf excipient package.

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And the case really didn't boil down to a

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dispute between testifying experts.

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But this is a case, rather, in which the art itself establishes not only the elements that are combined here, but also the motivation to combine them.

[00:01:14] Speaker 04:
In this case, the motivation to make an orally disintegrating tablet.

[00:01:19] Speaker 01:
Part of the difficulty with your case is that you had so many references that you threw out there.

[00:01:23] Speaker 01:
I got the feeling you were hoping something would stick to the wall.

[00:01:27] Speaker 01:
And you go through the transcripts, and there's two sentences on this references.

[00:01:32] Speaker 01:
And two sentences on that reference.

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What are the key references that you want to rely on?

[00:01:37] Speaker 04:
I'd be happy to go through that, Your Honor.

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So I think there are three really key issues.

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One is motivation to make an ODT.

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One is whether the particular mannitol sorbitol combination would be used.

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And then one is the teaching away argument that Bayer used.

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on the first part, on whether there is a motivation to make an ODT.

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The two that I'd like to point you to right off the bat are Chang, which says explicitly that erectile dysfunction drugs can be considered candidates for this dosage form.

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And then also the Furitsu patent application from the Eastside Pharmaceutical Company, which said that there was brisk demand for ODT formulations in the erectile dysfunction area.

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And those were relied on not just in briefing, but at trial.

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And you're right, Judge O'Malley, that the discussion of Chang didn't consume a lot of transcript pages.

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But that's because it's a short reference, and it says what it says.

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The other side didn't testify about it.

[00:02:45] Speaker 01:
Well, tell me what transcript phrases really speak to Chang, because there was so little on it that I was having a hard time trying to understand.

[00:02:54] Speaker 01:
You can understand a trial.

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judge's frustration when all they've got is a bunch of stuff with very little discussion of them.

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

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And there were other issues being tried in the case, which are not before Your Honors, that were all crammed into the available time.

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So what I point Your Honor to is appendix page 448, which is where Dr. Jacobs, the defense expert, was asked about Chang.

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And that's transcript page 311.

[00:03:25] Speaker 01:
Right.

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And that's it.

[00:03:26] Speaker 01:
It's like two sentences, right?

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That's right.

[00:03:28] Speaker 04:
And then Chang itself, which of course is in the record at 19024, which I think says, as I've just described it, that these are considered candidates for this dosage form for ODT.

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There certainly are other references like that.

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And I think the point is not necessarily that the judge didn't deal with one individual reference among many.

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We're not insisting that every single reference cited anywhere needs its own discussion and opinion.

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But in this case, the district court did not deal with our affirmative submission, with our affirmative references, establishing this motivation in the art at all.

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The court instead dealt with what I might call the negative motivation, or the sounds of silence argument made by the other side.

[00:04:14] Speaker 01:
So what you're saying basically is you could just have a witness and you could say,

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What's the name of this reference?

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What's the name of that reference?

[00:04:24] Speaker 01:
What's the name of that reference?

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And that's all you have to do for the purposes of proving your case by clear and convincing evidence?

[00:04:32] Speaker 04:
Well, I think that the point we were trying to prove is that there was an established motivation, not just based on subjective testimony by an expert, but set out in the art.

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And there were a series of references that we relied on.

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None of these references is especially

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long or complex, the point that we're relying on is stated explicitly in them.

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And I think if the other side wanted to disagree with the point that we made in any of them, I think it could have brought that out.

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What it brought out instead was the idea that in two references in particular, Habib and Fu, there are these tables.

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And the absence of erectile dysfunction from table two in Fu, which is expressly described as examples,

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that the district court found was an indication that these were not a candidate for formulation of an ODT.

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We think that if we had made no affirmative submission of reference after reference saying that there was such a motivation, maybe that would be an OK thing for the district court to do.

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But there's no testimony that says that that shows a motivation.

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That's what my problem is.

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It says, yes, this is Chang.

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Boom.

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You move on to the next reference.

[00:05:49] Speaker 04:
Right.

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But Dr. Jacobs certainly did testify that there was a motivation.

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He walked through the reasons why this motivation would exist.

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He explained why that makes sense in the context of an erectile dysfunction drug.

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So for example, erectile dysfunction drugs.

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I point to me to the best testimony from Jacobs.

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I know that we've got the issue with it where the trial court found that Jacobs was not credible.

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Yes.

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And I wouldn't let this pass until it

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I think that the... Did he find Jacobs not credible at all, or did he find Jacobs not credible on particular things, like the type of packaging that would be necessary for drugs and things like that?

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I think that his complaint with Dr. Jacobs were really two things.

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One had to do with what he deemed to be deviations from the expert report, and the other had to do with his purported use of hindsight.

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Now, I don't think that that can impeach the references that Dr. Jacobs kind of explained without... And him contradicting himself.

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There are three things.

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Well, that's the expert report that I'm alluding to, my first answer to Judge Moore.

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And on that, I take the point that you can't go beyond your expert report.

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But I think the point is that in his expert report, he said that there is a convenience benefit to having this ODT formulation.

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And that's fine if he's not able to go beyond that.

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But the point is that

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there is this convenience benefit.

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And that's supported by all of this literature, you know, Foo, for example.

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But then on cross-examination, he conceded that that convenience benefit really isn't there in a lot of circumstances.

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Respectfully noted.

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What he said was that the benefit was marginal compared to the, and he was being asked about a specific tablet form.

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But he said the benefit was marginal.

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I think that even if that's right,

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that that's enough, that a marginal benefit, this is a blockbuster area, perhaps this wouldn't be as big as the original tablet.

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But there certainly is a motivation in a drug that is targeted to geriatric population.

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The district court found that expressly in page 11.

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And when the art clearly teaches that that's one of the two target populations for orally disintegrating tablets,

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It's not a stretch to say that that convenience factor is a reason to make this formulation.

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And I think it's instructive to look at what the other side put in the other.

[00:08:24] Speaker 01:
I understand your point about saying it might not be a stretch.

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But I guess what I'm trying to put myself into the perspective of what it is we're supposed to do here.

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We're reviewing a trial court judgment.

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And the trial court made credibility determinations, findings of fact.

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I mean, teaching away is a finding of fact.

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So we'd have to find that to be clearly erroneous.

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Not just that if we were looking at it first, we might agree with you.

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So far, you've pointed me to very little in the transcript that is, as you call it, your affirmative case.

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So what else?

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You say that those two references are key references.

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What are your other key references?

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Or is that it?

[00:09:11] Speaker 04:
I think that there are, in addition to those two, I mean, there are a series of other patents and patent applications that we've cited, each of which stands for the basic proposition that other pharmaceutical companies saw erectile dysfunction drugs generally as a candidate for exploration in this area.

[00:09:33] Speaker 01:
And then... Okay, and which references are the key ones for that proposition?

[00:09:39] Speaker 04:
Bell-Huff, I think.

[00:09:41] Speaker 01:
But you, I mean, this is one of the problems you had in your brief to us, is you tell us Bellhuff is a 2002 reference, but it's not.

[00:09:49] Speaker 01:
It's a 1998 reference.

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And the trial judge dealt with that question.

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I mean, you conceded in your gray brief that, yes, you were wrong on that.

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That's right.

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It was published in 2002.

[00:10:01] Speaker 04:
But of course, a patent application isn't published if it's been abandoned.

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And so Dr. Wicks conceded that there's absolutely nothing in the prior

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nothing, suggesting that anyone would have thought that Pfizer had abandoned the application, other than Dr. Wicks' own opinion that the number of years since the... Well, it's not just his own opinion.

[00:10:22] Speaker 01:
It's our law that talks about the fact that if something sits out there for years and years and years and no one does anything with it, then it at least is indicative that it wasn't so obvious that people would be jumping on the train.

[00:10:35] Speaker 04:
I take that point, Your Honor.

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And if what we were talking about was just an old reference, that would be one thing.

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But when you have Pfizer's competitors at the same time saying that there's robust demand for this type of product, and in addition, the mere age of reference is not enough.

[00:10:57] Speaker 01:
It's a factor.

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I get you that.

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It's not enough.

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But that's a factor that the trial court relied upon.

[00:11:04] Speaker 01:
I mean, you just keep saying there's a bunch of references that you threw out there.

[00:11:07] Speaker 01:
This is my very problem with this record.

[00:11:09] Speaker 01:
So what other references?

[00:11:11] Speaker 01:
What are your key references?

[00:11:12] Speaker 01:
You've given me Chang, and you've given me Forretzu.

[00:11:16] Speaker 01:
Right.

[00:11:17] Speaker 01:
And you say Belhoff, but the trial court dealt with that one.

[00:11:23] Speaker 01:
What else?

[00:11:24] Speaker 04:
Well, again, the trial court dealt with that only by saying that the absence of a commercial product from Pfizer

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the sort of silence from Pfizer after it said it was developing the product, which also dealt with how we use the reference.

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The trial judge said that that's an indication that there's no motivation.

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But ultimately, the teaching of the patent application is still true.

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It's still a published piece of art, whether or not it ultimately is commercialized.

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And I think it's important to look at the context of this

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of this product, and I see that I'm into my rebuttal time, but I want to make sure to give this answer.

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This is a product where there really is only one big drug on the market, it's Viagra.

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And the other two drugs didn't come along until 2003.

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So Pfizer may well have had reasons of its own, the lack of competition being the number one reason, not to come out with this own product that doesn't indicate that it wasn't a desirable product or that it couldn't be done, certainly though that there's no motivation.

[00:12:29] Speaker 04:
If there are no further questions at this time, I'd like to reserve my ring.

[00:12:32] Speaker 00:
We will save you rebuttal time, Mr. Jay and Mr. Burrell.

[00:12:44] Speaker 03:
Good morning, Your Honors.

[00:12:45] Speaker 03:
David Burrell for Bayer.

[00:12:47] Speaker 03:
May it please the Court.

[00:12:49] Speaker 03:
Before addressing the particular arguments that Watson made, I think it's worthwhile to take a step back and observe that, as Judge O'Malley observed, this is not a typical obviousness case where a challenge- Why don't you focus instead on motivation to combine?

[00:13:02] Speaker 02:
Because it seems like there are a lot of references that are cited and a lot of references that the expert talked about on motivation to combine and how these references expressly

[00:13:18] Speaker 02:
suggest you should take ED drugs and put them in ODT formulations, or alternatively say people are working on developing exactly that.

[00:13:28] Speaker 02:
And the district court seemed to kind of fly by and not really discuss them.

[00:13:33] Speaker 02:
So why don't you start with that and tell me why that's not a problem?

[00:13:36] Speaker 03:
Yes, I'm happy to, Judge Moore.

[00:13:39] Speaker 03:
The district court did, in fact, consider the testimony of all of the references advanced by Watson at trial in support of that proposition.

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There is no dispute.

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that it was known that erectile dysfunction drugs were candidates for orally disintegrating tablets.

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But I would submit, and your case law holds, that that's not enough.

[00:13:58] Speaker 03:
The question is not what is possible, but what is desirable.

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And Dr. Witts, Bayer's expert, testified that Vardenafil would not have been considered a good candidate for an ODT.

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That's at page A675 and 676 of the appendix.

[00:14:15] Speaker 03:
The district court agreed with Dr. Wicks after reviewing all of the testimony and all of the arguments advanced by Watson.

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And the fact that it was out there doesn't mean that it was desirable.

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There were many reasons that Watson put forth a trial about why it would be desirable, including what Watson just mentioned, the ease of swallowing.

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But that point was dealt with at trial.

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Dr. Wicks testified clearly that that's not a major benefit with respect to erectile dysfunction drugs.

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And contrary to his expert report, or contrary to his direct testimony, Dr. Jacobs, Watson's sole prima facie obviousness expert, admitted that on cross-examination.

[00:14:54] Speaker 02:
And Dr. Wicks further testified that if one were concerned... You're saying a lot of this, but as I read the district court's opinion, this doesn't feel to me to be the basis of his fact findings.

[00:15:06] Speaker 02:
If you look at his opinions on page eight and nine, he talks about

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Moreover, the post-op would not have considered Vardenafil to be a good candidate for formulation as an ODT because Vardenafil was known as an erectile dysfunction medication and ODTs were not considered particularly applicable in this area.

[00:15:34] Speaker 02:
Yet all of this prior art, so much of it says ED drugs are good candidates for

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ODT and Vardenafil in particular, some of them say.

[00:15:45] Speaker 02:
So I don't understand how that fact finding isn't clearly erroneous, because that fact finding doesn't seem to be what you suggested, which is there isn't a good reason to make the combination, so much as him suggesting that it isn't known that ED drugs could be

[00:16:06] Speaker 02:
reformulated in ODT formats.

[00:16:09] Speaker 03:
If I could have two responses, Your Honor.

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The first is that the prior art does not say that Bardenafil or ED drugs are good candidates for ODTs.

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Rather, it just reflects that they're candidates.

[00:16:21] Speaker 03:
Watson uses the term good candidates in their reply brief, citing the Chang.

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One will read Chang in vain.

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for the quote, good candidate.

[00:16:29] Speaker 03:
It simply is not there.

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The prior simply reflects that it was a candidate for an EV drug, and the district court agreed with that.

[00:16:36] Speaker 02:
I don't understand.

[00:16:37] Speaker 02:
For Ritsu, which can be found at the appendix at 19077, is a European patent application directed to exactly this.

[00:16:51] Speaker 02:
The title is Tablets Immediately Disintegrating in the Oral Cavity, and it's all about

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the ED drugs.

[00:16:59] Speaker 02:
I mean, that's what I understand.

[00:17:00] Speaker 02:
I'm going to probably say it wrong, but phosphodiesterase?

[00:17:05] Speaker 03:
Phosphodiesterase.

[00:17:06] Speaker 03:
That's close.

[00:17:07] Speaker 03:
That's close.

[00:17:08] Speaker 03:
The principle here, Your Honor, is that Bayer did not dispute a trial and the district court does not dispute in its opinion that it was known that ED drugs could be used

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as ODTs, but this court's case law is consistent.

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That simply is not enough.

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The question, as this court put it in Winter versus Wang, is not what is feasible, but what is desirable.

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It was known in that case that a single prior art reference, the Warrock reference, disclosed a chisel block option and a deadbolt option.

[00:17:39] Speaker 03:
It was known, just as it's known here, that ED drugs can be used as ODTs.

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And the court said, there's nothing that teaches you to do it as a deadbolt rather than a chisel block.

[00:17:48] Speaker 03:
Same result in Rolls-Royce.

[00:17:49] Speaker 02:
It was known that... I don't understand.

[00:17:52] Speaker 02:
If everybody knew how to make

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ED drugs is an ODT, how is that claimed composition not then obvious?

[00:18:02] Speaker 02:
It's almost like you want to prove that it would be a commercially good idea to go that way.

[00:18:08] Speaker 02:
And I feel that the district court's opinion had many of those, unfortunately,

[00:18:13] Speaker 02:
same trappings, where he kept making the comparison to Levitra.

[00:18:17] Speaker 02:
Why would anybody change Levitra?

[00:18:20] Speaker 02:
Well, that's the commercial embodiment, and that's not the right focus.

[00:18:24] Speaker 02:
And you pretty much acknowledge in your brief that that wasn't the right focus, because it's not.

[00:18:28] Speaker 02:
The focus isn't

[00:18:29] Speaker 02:
on the commercial product.

[00:18:31] Speaker 03:
Except respectfully, that wasn't the sole focus of the district court.

[00:18:34] Speaker 03:
And to the extent the district court focused on it, it was because Watson put forth that evidence at trial.

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And the district court was dealing with the alleged commercial motivation that Watson advanced.

[00:18:45] Speaker 03:
The district court was simply responding to Watson's arguments.

[00:18:48] Speaker 03:
But I think more fundamentally, the question of whether

[00:18:52] Speaker 03:
the ODT would have been used for Vardentifil is just one of three propositions that Watson acknowledges it must prove by clear convincing evidence and that it must show clear error in the district court's opinion.

[00:19:04] Speaker 03:
Even if for one were to somehow conclude that the district court erred in finding as to question one that Vardentifil may have been obvious as an ODT and the persuasive expert testimony

[00:19:16] Speaker 03:
I think shows otherwise.

[00:19:18] Speaker 02:
There's still no error in the proposition that one would not have used mannitol and sorbitol together in such an ODP, let alone- The district court, it seems, failed to acknowledge Joshi, and I don't know if I'm saying that right, J-O-S-H-I at all.

[00:19:34] Speaker 02:
In fact, when he says at page 12 of his opinion, additionally, there was nothing in the prior art that would have given the posa

[00:19:44] Speaker 02:
a reason to use sorbitol in addition to mannitol in N-O-D-T.

[00:19:51] Speaker 02:
That statement is absolutely false in light of Joshi, which is the use of mannitol and sorbitol.

[00:19:59] Speaker 02:
And it was clearly presented.

[00:20:00] Speaker 02:
So how do you defend that?

[00:20:03] Speaker 03:
Because, again, the question, Your Honor, is not what he's disclosed, but what would have been desirable.

[00:20:08] Speaker 02:
No, that's not what he's... No, that's his finding of fact.

[00:20:11] Speaker 02:
His finding of fact is not what is desirable.

[00:20:14] Speaker 02:
His finding of fact is there was nothing in the prior art that would have given Apposa a reason to use sorbitol and mannitol in an ODT and yet Joshi is exactly on that point.

[00:20:26] Speaker 02:
The use of sorbitol and mannitol

[00:20:27] Speaker 02:
and says it overcomes fracking, fricking, I don't know, something.

[00:20:31] Speaker 02:
It overcomes something.

[00:20:32] Speaker 02:
The thing where the pill crushes up and falls apart.

[00:20:35] Speaker 03:
The reason, when he talks about there is no reason in the prior art, that's what I'm using as a proxy for desirability.

[00:20:41] Speaker 03:
There has to be a reason to do something.

[00:20:43] Speaker 02:
And Yoshi says it overcomes, what was it?

[00:20:46] Speaker 03:
Fridability.

[00:20:47] Speaker 03:
Dr. Wicks explains, first of all, at page A685 through 686,

[00:20:54] Speaker 03:
Manital and Sorbitol would not have been expected to overcome the friability problem, first of all.

[00:20:59] Speaker 03:
And second of all, he explains that 685, 686, and 701, that the newer Durasolve and WoWTAB formulations that have Manital only overcome any friability problems and do not require specialized packaging.

[00:21:12] Speaker 03:
And that is what a person of ordinary skill would have wanted to use.

[00:21:15] Speaker 03:
He says at 676 and 683 that a person of ordinary skill would have wanted to use established technology.

[00:21:21] Speaker 03:
And he gives reasons for that.

[00:21:23] Speaker 03:
It would have been cheaper.

[00:21:24] Speaker 03:
There were regulatory advantages for doing that and the district court on this point found Dr. Wicks persuasive and found Dr. Jacobs unpersuasive.

[00:21:34] Speaker 03:
The question is not what the prior arc means to you or me or to a lawyer

[00:21:39] Speaker 03:
The question simply is what the prior art means to a person of skill, and on that point, Dr. Witts testified clearly that there was no reason in the prior art to use mannitol and sorbitol rather than mannitol alone.

[00:21:51] Speaker 03:
That is what every single commercial embodiment used, and that's what everyone would have used at the priority date in 2005.

[00:21:58] Speaker 03:
The question is not what was available, the question is what would have been desirable.

[00:22:03] Speaker 03:
Watson's own cases reflect that proposition, the Henry Fulton case it cites provides an actual reason that was persuasive to the court in order to find something was obvious.

[00:22:13] Speaker 02:
Maybe the reason is because PharmaBurst was an off-the-shelf product that was commercially available and in fact used in this case and that PharmaBurst was well known in the art at the time.

[00:22:23] Speaker 03:
Well, the fact that it was used in this case can't be used

[00:22:26] Speaker 03:
in evaluating the obviousness of the invention.

[00:22:28] Speaker 03:
That's what the inventors did.

[00:22:29] Speaker 03:
But the fact that it was available, again, doesn't make it desirable.

[00:22:33] Speaker 03:
It means that someone could have used PharmaBurst, but no one would have used PharmaBurst.

[00:22:37] Speaker 03:
A person of ordinary skill would have opted for Manital only for all of the reasons described by Dr. Witts in his testimony at 676 and 685.

[00:22:47] Speaker 03:
The third issue here, though, even if one were to get past using a Bardenfil ODT and using Manitol and Sorbitol, both of which the district court addressed and rejected, is the third issue, whether one would have used an immediate release formulation.

[00:23:02] Speaker 03:
And here, Watson asserts no legal error whatsoever and not a single piece of prior art.

[00:23:09] Speaker 03:
There is no contemporaneous evidence suggesting that someone would use an immediate release formulation.

[00:23:15] Speaker 03:
Their argument rests entirely on the testimony of their expert, Dr. Jacobs, who, again, the district court found not credible and not persuasive.

[00:23:24] Speaker 03:
It cannot be clear air for the district court to have concluded that the discredited testimony of Watson's expert was insufficient to carry a clear and convincing burden.

[00:23:37] Speaker 03:
There were two reasons that Dr. Witz explained a person of ordinary skill would not have used an immediate release formulation.

[00:23:44] Speaker 03:
The first was bioavailability, which the district court adopted in A11.

[00:23:49] Speaker 03:
Dr. Wicks explained on the basis of the Levitra label, that's at 19-4-13, that a person of ordinary skill would have considered increased bioavailability dangerous.

[00:24:00] Speaker 03:
And the way to get around that problem, the solution to that problem, he explains, at 6-79 through 6-81, is to make a delayed release ODT.

[00:24:09] Speaker 03:
Dr. Jacobs never testified in response.

[00:24:13] Speaker 03:
Watson had no response whatsoever for that testimony.

[00:24:16] Speaker 03:
It went in unrebutted.

[00:24:18] Speaker 03:
And on appeal, Watson somehow suggests that Dr. Jacobs did testify about it.

[00:24:23] Speaker 03:
Even were that so, Dr. Jacobs was found to be not credible.

[00:24:26] Speaker 03:
But it's not so.

[00:24:27] Speaker 03:
Check the citation, A457 and 458.

[00:24:31] Speaker 03:
He's not testifying about the label at all.

[00:24:33] Speaker 03:
He's simply saying low bioavailability of Libetra would not be a problem.

[00:24:38] Speaker 03:
That's a separate issue from the one that Dr. Witts addressed and the District Court adopted.

[00:24:42] Speaker 03:
A person of ordinary skill would have wanted the same bioavailability of Levitra and would have considered increased bioavailability dangerous and problematic.

[00:24:52] Speaker 03:
That is a factual finding of the District Court and, respectfully, there is no basis whatsoever to reverse that finding.

[00:24:58] Speaker 03:
Dr. Witts' testimony was based on contemporaneous prior art, the Brown Reference at A-16088.

[00:25:06] Speaker 03:
which says that in these circumstances where one has an existing product on the market, when one's making an ODT, the ODT must be bioequivalent.

[00:25:15] Speaker 02:
I'm having a little bit of trouble following your argument right now.

[00:25:18] Speaker 02:
Are you directing your argument at his teaching away finding based on bioavailability and taste?

[00:25:24] Speaker 02:
Is that what you're talking about?

[00:25:26] Speaker 03:
I frankly don't see it as just a teach away argument.

[00:25:28] Speaker 03:
I think that Watson bears the burden to show a motivation, a reason to use immediate release, and the prior product may ferment.

[00:25:35] Speaker 02:
Yes, but the teaching away based on bitterness of the taste and the bioavailability, even if that was a fact finding that wasn't clearly erroneous, you still have to put that on the scale.

[00:25:47] Speaker 02:
Obviousness is a question of law, and we balance all of it.

[00:25:51] Speaker 02:
Is there a motivation combined?

[00:25:53] Speaker 02:
Well, there are certainly some, at a minimum, obstacles or setbacks if we accept the teaching away arguments.

[00:25:59] Speaker 02:
However, if seven or so references actually expressly indicate

[00:26:04] Speaker 02:
that ODTs are good candidates.

[00:26:06] Speaker 02:
I understand you don't think they say that, but suppose that I did.

[00:26:09] Speaker 02:
ED drugs are good candidates for making it an ODT formulation.

[00:26:15] Speaker 02:
You would weigh all of that together, wouldn't you?

[00:26:17] Speaker 02:
These aren't separate arguments.

[00:26:19] Speaker 02:
This all goes to whether there's a motivation.

[00:26:22] Speaker 02:
You know, basically, it seems to me these all go to the ultimate question of obviousness where we have to weigh everything to know them.

[00:26:29] Speaker 03:
Respectfully, I think they are separate questions, Your Honor.

[00:26:32] Speaker 03:
This claim is not directed to a Vardentafil ODT.

[00:26:36] Speaker 03:
It's directed to an immediate release Vardentafil ODT.

[00:26:39] Speaker 03:
So that the question of all these references that Your Honor referred to that say it's a good idea to have a Vardentafil release ODT

[00:26:46] Speaker 03:
None of them say immediate release.

[00:26:48] Speaker 03:
None of them get you to the claim.

[00:26:49] Speaker 03:
There is a separate burden that Watson must carry.

[00:26:52] Speaker 03:
And Watson embraced that at trial and agrees on appeal that it must carry a clear and convincing burden that a person of ordinary skill would have used an immediate release ODD.

[00:27:02] Speaker 03:
That's a separate question that the district court addressed and that this court would then have to address.

[00:27:07] Speaker 03:
And on that question, there is no prior suggesting it.

[00:27:11] Speaker 03:
Watson asserts nothing.

[00:27:13] Speaker 03:
All it had was the testimony of its expert, who again was found to be non-credible.

[00:27:18] Speaker 03:
and non-persuasive.

[00:27:20] Speaker 03:
And even he didn't testify as to the crucial piece of evidence as to bioavailability, which was the Levitra label at A19413.

[00:27:29] Speaker 03:
So even setting aside any possible dispute about whether it would have been obvious to make a Bardenophil ODT or whether it would have been obvious to use sorbitol and mannitol together, this third point stands alone as a basis for affirmance.

[00:27:42] Speaker 03:
And respectfully, Watson has no evidence to sustain its burden and cannot show clear air on appeal.

[00:27:50] Speaker 00:
Thank you, Mr. Burrill.

[00:27:51] Speaker 00:
Thank you.

[00:27:52] Speaker 00:
Mr. Jay has some rebuttal time, three minutes plus.

[00:27:59] Speaker 04:
Thank you, Your Honors.

[00:28:00] Speaker 04:
In my rebuttal, I'd like to touch briefly on Manitol Sorbitol and on the teachaway point.

[00:28:06] Speaker 04:
And the colloquy with Judge Moore about Joshi, I think, has brought out the really key point about Manitol and Sorbitol.

[00:28:13] Speaker 04:
The other side's case does not deal with the key point from Joshi, which is low compression forces.

[00:28:19] Speaker 04:
Adding sorbitol allows you to do the same thing to the friability benefit at lower compression forces, which doesn't sacrifice dissolution speed.

[00:28:28] Speaker 04:
This is testified to at 453, but it's all set out right there in Joshi.

[00:28:32] Speaker 04:
On the immediate release formulation, Dr. Jacobs testified at 455 to 56, 455 and 56, that you would make an immediate release formulation if you could, unless there was a reason not to, because it is much, much simpler.

[00:28:49] Speaker 04:
than the delayed release formulation.

[00:28:51] Speaker 04:
And on that... Where is that testimony?

[00:28:54] Speaker 04:
455 to 56.

[00:28:56] Speaker 04:
Now, my friend is trying to say that Dr. Jacobs was found not credible, but certainly the credibility finding has nothing to do with anything in that testimony.

[00:29:07] Speaker 04:
There's no deviation from the expert report.

[00:29:09] Speaker 04:
There's no allegation that he came up with that through hindsight.

[00:29:14] Speaker 04:
On the Levitra label, as we pointed out, from the Levitra label itself, and this is pointed out in our post-trial briefing as well, at page A19314, which I think is the right page site, the label itself says that Levitra is safe and effective, including for geriatric patients, at 5 milligrams, 10 milligrams, and 20 milligrams.

[00:29:37] Speaker 04:
The only basis for this teachaway argument is that

[00:29:41] Speaker 04:
They recommend starting geriatric patients at a lower dosage, at five milligrams.

[00:29:45] Speaker 04:
But they say it is safe for all patients at all of these dosage strengths.

[00:29:49] Speaker 04:
The district court simply did not deal with that.

[00:29:53] Speaker 04:
Back, if I may, to the documentary evidence in the prior arc.

[00:29:57] Speaker 04:
So ultimately, what the district court chose to rely on was what I referred to as the sounds of silence argument.

[00:30:04] Speaker 04:
The absence of erectile dysfunction drugs from these two tables in Habib

[00:30:09] Speaker 04:
and in food.

[00:30:10] Speaker 04:
And that cannot contradict the affirmative statements in the art that a person of skill in the art would have a motivation to make this.

[00:30:19] Speaker 04:
As my friend said, at page 690, Dr. Wicks conceded that they were at least candidates.

[00:30:26] Speaker 04:
And the reason that they are good candidates is set out in our affirmative case.

[00:30:30] Speaker 04:
Now, the district court did not, as my friend would have it,

[00:30:35] Speaker 04:
credit the idea that swallowing is not a benefit.

[00:30:38] Speaker 04:
If you look at page 676, what their expert testified to, what Dr. Bix testified to was that for Vargenafel in particular, he's relying on the Freiburg patent, swallowing is not a benefit because in, sorry, a patient with a swallowing disorder would not use an ODT because they would instead use a parenteral or a buccal or a sublingual formulation.

[00:31:01] Speaker 04:
The district court did not credit that testimony, and it's frankly not credible, because that patent doesn't even deal with erectile dysfunction use.

[00:31:11] Speaker 04:
It deals with the use of Vardentafil for another use, treating diabetes mellitus.

[00:31:15] Speaker 04:
And the idea that perennial use, like injections, would be an alternative for someone who has a distaste for swallowing a larger pill.

[00:31:24] Speaker 04:
is just not credible.

[00:31:25] Speaker 04:
The art teaches that ODTs are desirable to patients who don't like swallowing tablets.

[00:31:31] Speaker 04:
And the patient population and the uses of this drug are right in the heartland of what ODTs are intended for.

[00:31:41] Speaker 00:
Thank you, Mr. J. I have your argument.

[00:31:43] Speaker 00:
We'll take the case under revised