[00:00:00] Speaker 02:
OK, our first case for argument today is 21-1924, UCB versus Ectavis Laboratories.

[00:00:07] Speaker 02:
Mr. Rainey, please proceed.

[00:00:10] Speaker 04:
Good morning, your honors, and may it please the court.

[00:00:12] Speaker 04:
I am Richard Rainey on behalf of UCB.

[00:00:16] Speaker 04:
Our 9 to 2 product failed in 2008 because of crystallization.

[00:00:20] Speaker 04:
It was taken off the market in conjunction with the FDA.

[00:00:24] Speaker 04:
We solved the crystallization problem and patented our solution in December of 2009.

[00:00:29] Speaker 04:
The 589 patent suit is directed to a reticotine to PVP ratio in the range of about 9 to 4 to about 9 to 6.

[00:00:38] Speaker 04:
The reformulated product has gone on to be a tremendous success.

[00:00:41] Speaker 03:
9 to 4 product, that was already covered by the prior patents, right, that are now expired?

[00:00:48] Speaker 03:
The range in the prior patent absolutely covered 9 to 4.

[00:00:53] Speaker 03:
So then you've got a second patent that also claims this very product, that also covers this very product.

[00:01:00] Speaker 04:
We have a patent to a problem that arose after the invention of the original patent that we solved with a narrower range that also is overlapping with the prior art range.

[00:01:12] Speaker 03:
I know we have a rule that says if the prior art discloses a species that falls within a claimed range, that prior art species will anticipate that claimed range.

[00:01:23] Speaker 03:
But then if the prior art discloses an overlapping range that overlaps with your claimed range, then that's not necessarily 102.

[00:01:35] Speaker 03:
That's correct.

[00:01:37] Speaker 03:
Why is the law set up like that?

[00:01:40] Speaker 03:
I mean, if there are these prior art patents that actually claim this very portion of the range you're keying off of for this patent, why isn't that just a 102?

[00:01:51] Speaker 03:
It was already known in the art, this 9 to 4 ratio that you're continuing to market.

[00:01:58] Speaker 04:
I would argue that the range of 9 to 1.5 to 9 to 5 was known.

[00:02:02] Speaker 04:
There's no question about that.

[00:02:04] Speaker 04:
And I think the policy reason behind why you want to permit overlapping ranges and why the court has held that ranges don't disclose either their endpoints or intermediate points as individual embodiments is for good reason.

[00:02:18] Speaker 04:
And actually, this case bears it out.

[00:02:21] Speaker 04:
We saw a problem.

[00:02:22] Speaker 04:
We researched the problem.

[00:02:24] Speaker 04:
We solved the problem.

[00:02:25] Speaker 04:
And we patented.

[00:02:26] Speaker 04:
We described the problem in our patent.

[00:02:28] Speaker 04:
And we claimed the solution, which was unexpected.

[00:02:31] Speaker 04:
to us and to the world, I would submit.

[00:02:35] Speaker 04:
So I think the reason for that is if you have broader ranges in the prior art, for example, you want to encourage people to find further solutions down the road, which might involve narrow ranges, they might involve overlapping ranges.

[00:02:47] Speaker 04:
I don't think it's anything new.

[00:02:49] Speaker 04:
This court has a wealth of precedent dealing with this.

[00:02:52] Speaker 04:
I think there's a very good reason for it, and this case bears it out.

[00:02:55] Speaker 00:
Mr. Rainey, I just wanted to ask you, are you challenging the finding of fact number 129 that PVP was known in the prior as an effective crystallization inhibitor for routine?

[00:03:08] Speaker 00:
Are you suggesting that's clearly erroneous?

[00:03:11] Speaker 04:
I don't think we've challenged specifically that PVP was known as a crystallization inhibitor.

[00:03:17] Speaker 04:
But what would have taught a person of ordinary skill in the art in 2009 to select the ratio of about 9 to 4 to about 9 to 6?

[00:03:24] Speaker 04:
That's really the issue here.

[00:03:26] Speaker 00:
Sure, but there's a good number of findings of fact on obviousness that are contrary to what you're suggesting.

[00:03:33] Speaker 00:
I think you're suggesting that one of ordinary skill in the art would have gone well beyond

[00:03:41] Speaker 00:
based on some of the prior art, would have gone to 1 to 9 with a ratio of 9 to 18, I believe.

[00:03:47] Speaker 00:
Whereas the district court has findings of fact saying that the problem was with the 9 to 2 ratio, and that a person of ordinary skill in the art would have been motivated to try a small increment like 9-4 and 9-5.

[00:04:04] Speaker 04:
Respectfully, the district court also found that a person of ordinary skill in the art, and this is in conclusion of law 46,

[00:04:11] Speaker 04:
A person of ordinary skin and their art would expect similar stability of the claimed range, that's about 9 to 4 to 9 to 6, as compared to the prior art TTS examples, 9 to 2 and 9 to 3.

[00:04:24] Speaker 04:
He also found that the 9 to 4 and 9 to 5 packages did not exist.

[00:04:29] Speaker 00:
That's finding a fact 46.

[00:04:30] Speaker 04:
Conclusion of law, 46.

[00:04:34] Speaker 04:
And there are similar findings in conclusion of law 43 and conclusion of law 44.

[00:04:40] Speaker 04:
where he's very clearly saying to a person who orders to go in the art, they would have seen no difference in stability between 9 to 4 and to 6 and the prior art range of 9, 1.5 to 9, 5.

[00:04:53] Speaker 03:
I guess it looks like these conclusions of Walsh are saying the results would be similar in time.

[00:04:59] Speaker 04:
I mean, to us, at the time of the invention, we believe that's accurate.

[00:05:05] Speaker 04:
People would have looked at these ranges and said they are the same.

[00:05:09] Speaker 04:
They would have resulted in the same.

[00:05:10] Speaker 03:
I guess if the idea is we know that PVP increases stability, why wouldn't it be expected that you would have an upward trend line of stability as you continue to increase PVP?

[00:05:25] Speaker 03:
from 9 to 2 to 9 to 3 to 9 to 4 to 9 to 5 to 9 to 6?

[00:05:28] Speaker 04:
Because he found to the contrary in these findings, and I think correctly so.

[00:05:33] Speaker 04:
While it may have had some impact on stability, let's look at what the art actually did in the Tang reference, which is Mylan's solution to the problem.

[00:05:44] Speaker 04:
They actually, around the same time we did, described in detail how to approach this issue of stability in patches.

[00:05:52] Speaker 04:
And what their solution was,

[00:05:54] Speaker 04:
to Judge Stoll's point, their solution was radically different.

[00:05:59] Speaker 04:
And this played out, frankly, in full during the prosecution of the patent, where it was shown that the Tang Reference teaches going to a much, much higher ratio, 9 to 18 to 9 to 90.

[00:06:16] Speaker 03:
of teaching away, as we understand the term of teaching away in patent law.

[00:06:21] Speaker 03:
I mean, just because you teach a different embodiment that's not part of this claim range, and perhaps arguably is very far from this claim range, why is that necessarily a statement in this reference that tells us that Tang is communicating, please don't do anything less than 9 to 18?

[00:06:42] Speaker 03:
I don't think there was something quite like that statement in Tang.

[00:06:46] Speaker 04:
But it is the only contemporaneous on-point evidence we have of what those of skill in the art would have done.

[00:06:55] Speaker 00:
Why isn't Mueller the closest prior art as the district court found?

[00:07:06] Speaker 04:
Well, because I think the district court's finding about Mueller being the closest prior art was, frankly, tainted by the court's view that the range taught 9 to 4 and 9 to 5, which is, frankly, flatly inconsistent with this court's precedent.

[00:07:19] Speaker 04:
But there's nothing in the Mueller references that even identifies this problem, that identifies using PVP as the solution.

[00:07:27] Speaker 04:
And the reference is 10 years or more prior to the time period in question, whereas Tang

[00:07:34] Speaker 04:
is talking exactly about solving stability problems in patches, preferably including using ritigate.

[00:07:42] Speaker 00:
Do you maintain your interpretation of finding effect 80?

[00:07:46] Speaker 00:
You emphasize it a lot in your briefing.

[00:07:48] Speaker 04:
We do.

[00:07:49] Speaker 04:
And I think if you read it in light of conclusion of law 43, 44, and 46, it's absolutely clear what he's talking about.

[00:07:57] Speaker 00:
He's saying that the assertive claims, the ratios, the range of ratios in the assertive claims in this case, and the like range in Mueller's claims overlap, and there's no meaningful difference in how opposed it would view them.

[00:08:10] Speaker 00:
And I think you're taking that and saying what it means is that there's no difference in how you view the Mueller pattern.

[00:08:18] Speaker 04:
Well, I think that finding is saying that the 9-1 to 5 range and the 9-4 to 9-6 range, a personal ordinance would not see any difference between those ranges across the range.

[00:08:31] Speaker 04:
And that's, I think, exactly what he says in, for example, conclusion of law 46.

[00:08:36] Speaker 04:
So I think that's focusing on- Are you challenging that finding, or are you using that?

[00:08:44] Speaker 04:
We agree with that finding at the time of the invention, that there would have been no, a person who were to spill on the art would have had no reason to think that there would have been enhanced stability at 9-4 to 9-6.

[00:08:56] Speaker 00:
What makes you think that finding number 80 is stated at the time frame of at the time of the invention?

[00:09:03] Speaker 04:
Well, I think in the context, that's what he was talking about of his opinion.

[00:09:09] Speaker 04:
I don't think it can be read any other way, to be fair.

[00:09:16] Speaker 04:
His entire analysis in the obviousness section, as well, makes it very clear that he's talking about the time of the invention.

[00:09:22] Speaker 04:
I would submit.

[00:09:22] Speaker 03:
So is it my understanding or your understanding of fact-finding 80 is that because 92 had this crystallization problem, therefore this finding, the district court concluded that the entire claimed range in the now-expired Mueller patents would also suffer from the same crystallization defect?

[00:09:45] Speaker 03:
That's correct.

[00:09:46] Speaker 03:
OK, what if we disagree with your reading of fact-finding AD?

[00:09:49] Speaker 03:
Where does that leave your case?

[00:09:51] Speaker 04:
Again, I don't think there's any suggestion anywhere in a prior art reference that a person of ordinary school in the art would know to go to 9-4 to 9-6, which is the claimed range.

[00:10:00] Speaker 04:
So what is the motivation?

[00:10:02] Speaker 04:
What is the teaching?

[00:10:03] Speaker 04:
What is the, to borrow KSR's line, what is the rationale for going there?

[00:10:08] Speaker 04:
other than looking at our claims and using them as a roadmap, which we submit happened to.

[00:10:15] Speaker 03:
So I understand you have a Tang narrative.

[00:10:18] Speaker 03:
But what about the counter-narrative, which is just that we know that 9 to 2 has some stabilization problems.

[00:10:26] Speaker 03:
And we know that increasing PVP increases stability.

[00:10:32] Speaker 03:
So if we see that 9 to 2 has a problem, why not go up from 9 to 2

[00:10:37] Speaker 03:
to until we get to a point where we're comfortable with the relative lack of crystallization.

[00:10:42] Speaker 03:
What's wrong with that narrative?

[00:10:44] Speaker 04:
So, several responses to that.

[00:10:46] Speaker 04:
First of all, this is a claimed range of 9-4 to 9-6.

[00:10:48] Speaker 04:
So where's the teaching to go to include 9-6 in that?

[00:10:52] Speaker 03:
Second... This is assumed for the moment that also baked in is the idea that this is a variable that you would just do routine optimization with.

[00:11:00] Speaker 04:
I think this is a classic example of what hindsight is all about.

[00:11:05] Speaker 04:
What is the reason to go to 9-4 to 9-6 when you have a reference that teaches 9-1 to 9-5?

[00:11:10] Speaker 04:
and its embodiment is a failure.

[00:11:15] Speaker 04:
And frankly, I don't know how you ignore what the industry actually did, which is what is represented in Tang.

[00:11:21] Speaker 04:
It's the closest reference for sure and tells you exactly what the industry thought.

[00:11:27] Speaker 04:
Go to a much, much higher ratio to solve this problem.

[00:11:30] Speaker 02:
Would you like to save your time for rebuttal?

[00:11:32] Speaker 04:
Yes, I would.

[00:11:33] Speaker 02:
Thank you.

[00:11:33] Speaker 01:
Thank you very much.

[00:11:36] Speaker 02:
Mr. O'Quinn.

[00:11:38] Speaker 01:
Thank you, Chief Judge Moore.

[00:11:39] Speaker 01:
May it please the court, John O'Quinn, on behalf of activists.

[00:11:42] Speaker 01:
As the district court found, based on an extensive analysis of the facts, the asserted claims are anticipated by each of the Mueller patents and the Braun application are obvious over those references and more.

[00:11:53] Speaker 01:
and are an improper attempt to double patent ratios that UCB had already claimed, but without adding anything else.

[00:12:00] Speaker 02:
Do you need to prevail on anticipation, or can you prevail on obviousness alone?

[00:12:05] Speaker 01:
I can prevail on obviousness alone.

[00:12:07] Speaker 02:
Because I'm really struggling with the district court's articulation of Kenemental and the immediately envisaged language.

[00:12:14] Speaker 02:
It seems like perhaps he didn't read my night deck opinion, which really made it clear that Kenemental does not allow somebody to go in and fill in.

[00:12:23] Speaker 02:
something that wasn't present in the reference, what do you have to say about that issue?

[00:12:30] Speaker 02:
Because I really read that opinion as problematic in terms of expanding obviousness into the domain of, expanding anticipation into the domain of obviousness, which it can't be.

[00:12:43] Speaker 01:
No, I appreciate the question, Chief Judge Moore.

[00:12:45] Speaker 01:
And I think, respectfully, I think he's actually doing the opposite.

[00:12:48] Speaker 01:
I think what he's doing is what this court recognized in Atafina that you can do when you have overlapping ranges, is that you can look at the first range and see whether or not that range, it doesn't matter whether you denominated a range, a set, or a genus, that you can look at that first range

[00:13:07] Speaker 01:
And you can assess.

[00:13:08] Speaker 01:
And it is a question of fact, as this court held both in Osram and in Ineos, as to what that first range would disclose to a person of ordinary skin.

[00:13:18] Speaker 00:
Are you talking about obviousness or anticipation?

[00:13:20] Speaker 01:
I'm talking about anticipation.

[00:13:22] Speaker 03:
But in Atafina, didn't they also look at the criticality of the claim branch?

[00:13:26] Speaker 01:
So Judge Chen, what the court did in Atafina was it first found that the range was too broad to disclose the species within.

[00:13:34] Speaker 01:
and then said there wasn't evidence to show that the differences in the ranges were not critical.

[00:13:42] Speaker 00:
But that's not what the court did here.

[00:13:44] Speaker 00:
What the court did here, following your expert's lead, was to say that this is not a range, but instead disclosing discrete points of whole integers and half integers

[00:13:58] Speaker 00:
And then say, and that was based on her precedent.

[00:14:04] Speaker 00:
And then somehow not, I guess, I think wrongly used precedent.

[00:14:09] Speaker 00:
And then after that said, because there was a discrete point, there was anticipation based on a discrete point.

[00:14:14] Speaker 00:
But I don't understand.

[00:14:16] Speaker 00:
I want to ask you about how it is that somebody could interpret a range as, in this case, as integers and half integers when table 3 specifically has example 2 that says that it's 9 to 1.6.

[00:14:32] Speaker 00:
which is not an integer or a half integer.

[00:14:35] Speaker 01:
Sure.

[00:14:36] Speaker 01:
So Judge Stoll, I think first of all, I mean, you're right.

[00:14:38] Speaker 01:
You have a factual finding.

[00:14:39] Speaker 01:
It's factual finding 81 at appendix 27 that a skilled artisan would see a finite set of

[00:14:47] Speaker 01:
of ratios, I think that is consistent with what this court held in Valiant, for example.

[00:14:54] Speaker 01:
Now, that was an obviousness case.

[00:14:56] Speaker 01:
But just that you can look at the practical realities, including the limitations of measurements.

[00:15:01] Speaker 00:
But what is a new practical reality when the example has 1.6?

[00:15:05] Speaker 01:
So I think that what he is ultimately determining here is that when you look at the balance of the prior art,

[00:15:13] Speaker 01:
And you look at all of all of the prior art and how a skilled artisan would look at this particular range He's coming to the conclusion that it would be clearly erroneous in light of the disclosure of 1.6 in table 3 Well, I don't first of all judge so I don't think that's an argument that's been advanced on on appeal but your argument and

[00:15:37] Speaker 03:
court's fact-finding below, which is that when we look at the claimed range of 9 to 1.5 to 9 to 5, we're only going to look at, we're only going to see half integers and whole integers.

[00:15:52] Speaker 03:
So 1.5, 2.0, 2.5, etc.

[00:15:54] Speaker 03:
In other words, if this patent owner had filed a dependent claim where it said the ratio is 9 to 1.6,

[00:16:04] Speaker 03:
The district court's finding, as I understand it, necessarily is saying, no, you can't get a claim on 9 to 1.6.

[00:16:10] Speaker 03:
Your disclosure lacks written description support for 9 to 1.6, because when I see your claimed range, all I see and all you communicated and possessed are whole integers and half integers.

[00:16:24] Speaker 03:
So Judge Stoll's follow-up question to you, I think, is very relevant to trying to understand what it was that the judge did here to this claimed range.

[00:16:33] Speaker 01:
Well, Judge Senn, coming back to your question, Judge Soule, I mean, I think fundamentally what Judge Jordan was doing was looking at the range and concluding that this is not an infinite range.

[00:16:44] Speaker 01:
This is not a range that discloses an unlimited number of species, an unlimited number of points.

[00:16:54] Speaker 00:
Why isn't it an end run around our range case law?

[00:16:58] Speaker 00:
It kind of seems to me to be so, because the

[00:17:00] Speaker 00:
We have cases that say, if you have overlapping ranges, then you have to show criticality, right?

[00:17:07] Speaker 00:
So I don't think it's that hard to show criticality.

[00:17:11] Speaker 00:
But I think it has to be done.

[00:17:13] Speaker 00:
I don't know that you can take a range, and especially in this case, where you've got 1.6 clearly in the specification, and say that it should be whole and half integers, and therefore I don't have to follow the typical case law for range cases.

[00:17:27] Speaker 01:
Well, Judge Soule, I don't think that the court has laid down a categorical rule that just because something, I mean, you can imagine, for example, that you would have a range that by definition is integers.

[00:17:39] Speaker 01:
I mean, for example, claim three in the Ineos case was like counting carbon atoms.

[00:17:44] Speaker 01:
And that was found to disclose and anticipate the benamide, which had 22 atoms that fell within.

[00:17:52] Speaker 00:
I'm not saying it might not ever apply, but I don't think it applies in your case.

[00:17:57] Speaker 00:
And so that's why I'm asking you about this 1.6.

[00:17:59] Speaker 00:
I'm trying to tell you why I'm troubled so you can tell me how you respond to that.

[00:18:04] Speaker 01:
Right.

[00:18:05] Speaker 01:
I mean, I think in some sense, this is ultimately really not any different than the reasoning in this court's decision in Valiant, where it said, look, even if you want to look at it as having two significant figures, if you want to look at it as having three significant figures, all that would mean is that you would have 100 species that had been disclosed.

[00:18:28] Speaker 01:
And I think in this case, if instead of looking at whole integers or half integers,

[00:18:33] Speaker 01:
You're looking in, you know, one-tenth increments.

[00:18:35] Speaker 01:
That's what you're talking about.

[00:18:36] Speaker 01:
I think the fundamental point that he was making, whether you want to express it in integers or half integers, is that what you have in a range of ratios of 9 to 1.5 to 9 to 5 is a limited universe.

[00:18:53] Speaker 01:
And that the points within that limited universe, any one of those,

[00:18:58] Speaker 01:
that falls within the claimed range would anticipate.

[00:19:02] Speaker 01:
And I think that's certainly clear.

[00:19:04] Speaker 02:
That's your characterization of what you think is the fundamental takeaway from his opinion.

[00:19:10] Speaker 02:
It's not the way the opinion reads.

[00:19:12] Speaker 02:
And we review opinions, and we review fact findings, and we review conclusions of law.

[00:19:19] Speaker 02:
And that argument you made is not what he found.

[00:19:23] Speaker 01:
So Chief Judge Moore, again, I think that what he found, for example, finding a fact 79, is that you have a small and finite number of examples.

[00:19:33] Speaker 01:
And he specifically finds what's relevant here is that a person of ordinary skill in the art would recognize 9 to 4 and 9 to 5 ratios.

[00:19:43] Speaker 01:
And if they would recognize a 9 to 4 ratio,

[00:19:45] Speaker 01:
that anticipates.

[00:19:46] Speaker 01:
But to your original question, Chief Judge Moore, the court doesn't have to address the anticipation issue.

[00:19:52] Speaker 01:
Obviously, the court can address it to give guidance to the bench and the bar on this question of how the intersection between the genus species line of cases and the intersection of the ratio, the overlapping ranges set of cases.

[00:20:08] Speaker 01:
But this court can affirm on the basis of obviousness

[00:20:11] Speaker 01:
alone or obviousness type double patenting.

[00:20:14] Speaker 01:
And it's a very straightforward case for affirmance.

[00:20:17] Speaker 01:
The district court found on the facts that the skilled artisan would be motivated to start with what was known to be therapeutically effective and to make minor upward adjustments.

[00:20:29] Speaker 01:
And he found that

[00:20:30] Speaker 01:
that increasing PVP, it behaved exactly how a person of ordinary skill in New York would have expected.

[00:20:37] Speaker 01:
Because as you increase the PVP, it was known, among other places, in Finding a Fact 129, that this would increase stability.

[00:20:50] Speaker 01:
And so I think he lays out why you would start with what was known to be effective, why the increase in PVP had a known and predictable effect, and that you also knew that adding too much PVP could potentially interfere with drug delivery.

[00:21:09] Speaker 01:
And he makes factual findings about that as well, relying on testimony from their expert, Dr. Guy,

[00:21:17] Speaker 01:
about concerns over negative flux effect.

[00:21:20] Speaker 02:
Can I ask you to turn to fact finding AD because it seems like there is a significant dispute between the parties about how we should understand

[00:21:30] Speaker 02:
what he specifically found in this fact-finding 80.

[00:21:33] Speaker 02:
And I want to know from you, is it critical to your case that we interpret this fact-finding the way you argue as opposed to the way the opponent argues?

[00:21:42] Speaker 01:
I don't think that it is, but I also don't think that their interpretation of fact-finding 80 is a fair interpretation.

[00:21:50] Speaker 01:
I think what the court is doing, and I think this is clear, for example, if you look further in his opinion at page 56,

[00:21:56] Speaker 01:
Appendix 56, is addressing statements in the case law, like, quote, where the claimed range and prior art value are insubstantially different, prima facie obviousness rejection is proper, end quote.

[00:22:10] Speaker 01:
That's his opinion on 56, quoting this court's decision in Henry Cowell, 639, F3 at 1067.

[00:22:18] Speaker 01:
And I think he's also addressing statements in cases like Ineos at page 869, where the court explained in Atafina that, quote,

[00:22:25] Speaker 01:
found that the range disclosed in the prior art was substantially different.

[00:22:31] Speaker 01:
And so I think when he's referring to whether or not there is a meaningful difference in how a skilled artisan would view these ranges, I think he's referring to the raw numbers on the page.

[00:22:44] Speaker 01:
and addressing statements in this court's cases like Cal and Ineos that say, in assessing whether or not there is a presumption of obviousness, are the claimed values, do they substantially overlap

[00:22:59] Speaker 01:
Are they substantially different?

[00:23:01] Speaker 01:
And he was finding that they do meaningfully overlap and that they are not substantially different.

[00:23:07] Speaker 01:
I think on the facts, he then ultimately concludes that the way that increasing PVP behaves or the behavior that you get by increasing PVP

[00:23:18] Speaker 01:
is entirely predictable.

[00:23:20] Speaker 00:
Should we also look at Woody's sites for finding a fat daddy?

[00:23:25] Speaker 00:
The Prowznitz expert testimony?

[00:23:28] Speaker 00:
Yes.

[00:23:29] Speaker 00:
There, Dr. Prowznitz says

[00:23:34] Speaker 00:
There's clearly a substantial overlap in the range of 9-4 and 9-5 between the two claim sets.

[00:23:40] Speaker 01:
Yes, that's Appendix 1455.

[00:23:42] Speaker 01:
That is exactly what he is citing.

[00:23:45] Speaker 01:
So I think that gives context to what the court is saying in finding 80.

[00:23:50] Speaker 01:
And tellingly, when he comes back to this in his conclusions of law at Appendix 56, he cites the same trial testimony.

[00:23:59] Speaker 01:
for the proposition that the claim, quote, significantly overlaps with the 9 to 1.5 to 9 to 5 range taught by the Mueller patents.

[00:24:09] Speaker 01:
And so I think that that belies the idea that this is some sweeping finding by him that a person of ordinary skill in the art would think

[00:24:17] Speaker 01:
that you would expect the exact same crystallization at a 9 to 4 ratio or a 9 to 5 ratio as you would at a 9 to 2 ratio.

[00:24:26] Speaker 01:
What you would expect is that it would behave on a continuum.

[00:24:30] Speaker 01:
And what you found, the district court found, this is an appendix 60, that the alleged unexpected results reported in the 589 patent were actually inconsistent with UCB's internal reports.

[00:24:43] Speaker 01:
which confirmed that sample number five, which had a 9 to 4 ratio, which is actually referred to in the patent, showed that there was crystallization that occurred.

[00:24:54] Speaker 01:
The difference was just how much and how fast the crystallization occurred, which is, again, what you would have predictably expected.

[00:25:02] Speaker 00:
And UCB argues that the district court here relied too much on UCB's own

[00:25:08] Speaker 00:
evidence and experience in creating the invention.

[00:25:11] Speaker 00:
What's your response to that?

[00:25:12] Speaker 00:
Because I think you might have just talked about some of it yourself.

[00:25:15] Speaker 01:
Right.

[00:25:15] Speaker 01:
So Judge Stoll, I think that UCB put its own experience at issue.

[00:25:21] Speaker 01:
And the district court was just simply responding to what UCB had said that it'd done.

[00:25:26] Speaker 01:
Because what UCB did was they said, well,

[00:25:29] Speaker 01:
We initially would have did this, and we figured out what the glass transition temperature would look like.

[00:25:43] Speaker 01:
But if you look at what you actually did, that's not what you did.

[00:25:45] Speaker 01:
What you did was that you immediately began increasing in small amounts.

[00:25:51] Speaker 01:
PVP and starting stability tests based on that.

[00:25:54] Speaker 01:
So I think he was simply, in referencing their own experience, was responding to their own arguments about their own experience.

[00:26:04] Speaker 01:
So ultimately, I think that the obviousness case here turns entirely on the factual findings.

[00:26:12] Speaker 01:
And they have not shown clear error.

[00:26:13] Speaker 03:
Just following up on those internal reports, I think the other side makes criticisms of those internal reports as being reliable evidence to understand what's the likelihood of success here.

[00:26:25] Speaker 03:
And with 9 to 4 saying that, well,

[00:26:32] Speaker 03:
What they're looking for, what we should think about is long-term stability or something like that.

[00:26:37] Speaker 03:
And then also that those reports were kind of quick and dirty tests that used with more crude tools than what you would normally use.

[00:26:50] Speaker 03:
I mean, do you have a response to those?

[00:26:51] Speaker 01:
Well, I do, Judge Chan.

[00:26:54] Speaker 01:
I mean, first of all, I think that's them ultimately quibbling with how a fact finder would perceive the facts.

[00:27:00] Speaker 01:
as they were presented to them.

[00:27:02] Speaker 01:
And I'd point you to appendix 2006 to 2007, as well as appendix 2026, where you can see the results of some of these tests and others that shows that crystallization could be seen on patches with higher PVB content.

[00:27:18] Speaker 01:
At the end of the day, the question for purposes of whether or not there were unexpected results, and that's really the main point that this goes to, is a question of whether it's a difference

[00:27:29] Speaker 01:
whether it behaved in a difference in degree or a difference in kind.

[00:27:34] Speaker 01:
And their case turns on the idea that this was a difference in kind.

[00:27:38] Speaker 01:
And the district court found on the facts that what you had is a difference in degree.

[00:27:41] Speaker 01:
I'm happy to answer any other questions the court might have, whether it's about Tang or teaching away.

[00:27:46] Speaker 01:
But I also see that my time has expired.

[00:27:48] Speaker 01:
So I thank the court for its time.

[00:27:50] Speaker 02:
Thank you.

[00:27:53] Speaker 02:
Mr. Ruffin, Mr. Raney, you have some bottle time.

[00:27:54] Speaker 04:
Thank you very much.

[00:27:55] Speaker 04:
On the last point about difference in kind, I'm not sure you could have a more dramatic example here where our prior product at 9.2 failed and the product at 9.4 was a wild success.

[00:28:07] Speaker 04:
51.5 million patches sold and no evidence, their expert admitted this, no evidence of any contamination by crystallization in those samples.

[00:28:15] Speaker 04:
That's a dramatic difference, frankly.

[00:28:17] Speaker 00:
But didn't the molar patents claim the 9-4 in its range?

[00:28:21] Speaker 04:
Absolutely.

[00:28:22] Speaker 04:
But that's true in overlapping range cases all the time.

[00:28:27] Speaker 04:
Otherwise, we wouldn't be talking about overlapping ranges.

[00:28:30] Speaker 04:
So yes, there is a claim in the prior patent that does cover 9-4.

[00:28:34] Speaker 03:
Just so I understand, are you telling us here today that with 9-4, you never get crystallization?

[00:28:43] Speaker 04:
What I'm saying is that the evidence of record is the 51 million patches that were sold.

[00:28:49] Speaker 04:
Their expert admitted there's no evidence of any crystallization effect.

[00:28:54] Speaker 03:
They couldn't find evidence of any examples of those sold patches having crystallization.

[00:29:01] Speaker 03:
Fine.

[00:29:01] Speaker 03:
But what I'm trying to figure out is are you saying that as a scientific matter, when you're at a 9 to 4 ratio, you have zero crystallization.

[00:29:10] Speaker 03:
You have perfect stability.

[00:29:12] Speaker 04:
I could not answer that question without reference to what's in the record.

[00:29:17] Speaker 04:
And there's evidence the FDA has approved the product.

[00:29:22] Speaker 04:
So they're satisfied with the stability of it.

[00:29:24] Speaker 03:
Sure.

[00:29:24] Speaker 03:
They think it's safe, safe enough.

[00:29:25] Speaker 03:
But then what about the internal reports?

[00:29:29] Speaker 03:
At least there is some evidence that when we go to 9 to 4, they're going to see some crystals.

[00:29:35] Speaker 04:
As we have pointed out in our brief, if you look at those internal reports, there are a number of problems with them, not the least of which is the main report they rely on points out that after the study was done, the researcher realized they may have mishandled the samples, which doesn't leave one with the impression that the results are reliable for any long-term purpose.

[00:29:59] Speaker 04:
And there's no suggestion that the patent here is not enabled.

[00:30:02] Speaker 04:
And this patent is about long-term storage and stability.

[00:30:06] Speaker 03:
There is no attack that there was a non-enablement problem with the Mueller patent.

[00:30:10] Speaker 04:
Was not raised, correct.

[00:30:11] Speaker 04:
And it hasn't been raised here because they're relying on Mueller's anticipatory.

[00:30:20] Speaker 04:
And to the question about the findings, to Chief Judge Moore's question about the findings of anticipation infecting obviousness, finding 120, I think, demonstrates this quite clearly, where he finds Tang is not the closest prior art.

[00:30:35] Speaker 04:
Rather, the Mueller patents are because they disclose and claim TTSs with RPVP ratios of 9 to 4 and 9 to 5.

[00:30:44] Speaker 04:
They don't disclose.

[00:30:46] Speaker 04:
Under this court's case law, Adelphina could not be clearer.

[00:30:49] Speaker 04:
Ranges don't disclose endpoints, and they don't disclose midpoints.

[00:30:54] Speaker 04:
So it may claim it, but it doesn't disclose it.

[00:30:56] Speaker 04:
And that's important for purposes of what a prior art reference teaches.

[00:31:00] Speaker 03:
Just getting back to unexpected results, typically when I see unexpected results in something like a claim range case compared to the prior art,

[00:31:10] Speaker 03:
The prior art range might have you might look at a graph and see the performance level is like this and maybe it's trending up like this But then the claimed range is showing something up here.

[00:31:22] Speaker 03:
And so when you look at the two you think I could none of us could have anticipated that the performance level for the claimed range is just in kind different from the prior art claimed range and I

[00:31:37] Speaker 03:
I don't think I saw anything in the record that tells me a story like that with respect to 9-4 to 9-6 compared to, well, I don't know what to compare it to.

[00:31:49] Speaker 03:
You could compare it to 9-2, 9-3, or you can compare it to 1.5 to 9-5, but that gets us into an overlapping fan range.

[00:31:57] Speaker 03:
Get to my question about what I'm conditioned to normally see in an unexpected results case and why I'm looking for it here and I don't see it.

[00:32:07] Speaker 04:
Actually, the Patent and Suit tells this story quite compellingly.

[00:32:10] Speaker 04:
And if you look at Table 3 in the Patent and Suit, you will see a dramatic difference.

[00:32:15] Speaker 04:
In fact, they relied on that table in a prior litigation, drew a red line.

[00:32:19] Speaker 04:
between 93 and 94.

[00:32:21] Speaker 04:
And the patent then goes on to point out that above 9.6, the flux becomes a problem.

[00:32:27] Speaker 04:
That is, you're not getting enough drug to the person.

[00:32:31] Speaker 04:
So that tells you exactly, and the world exactly.

[00:32:34] Speaker 03:
Which, again, is the reason why you'd want to just do a minimum increase of the PVP.

[00:32:39] Speaker 04:
But you can't use our own discovery against us.

[00:32:42] Speaker 03:
I mean, that's true.

[00:32:43] Speaker 04:
But I think the flux was a known issue.

[00:32:47] Speaker 04:
But interestingly, Tang, again, and I think when you fix the anticipation problem here, Tang comes right back to the fore.

[00:32:55] Speaker 04:
And you see what Mylan thought the solution to that problem was, 9 to 18.

[00:33:01] Speaker 04:
In a long-term stability patch,

[00:33:06] Speaker 04:
I see that I am out of time.

[00:33:09] Speaker 02:
That's OK.

[00:33:10] Speaker 02:
Judge Ten was running over, not you.

[00:33:12] Speaker 02:
Thank you, Mr. Rainey and Mr. Quinn.

[00:33:14] Speaker 02:
This case is taken under submission.

[00:33:16] Speaker 04:
Thank you very much.