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1130 Allergan versus Tempo Pharmaceuticals.

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Ready?

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I think so.

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Why don't you proceed.

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Good morning, your honors.

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May it please the court, Jonathan Singer, for appellants.

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In assessing unexpected results in this case, the district court made two errors that dramatically affected the outcome.

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First, the district court elevated a statistical analysis of phase two data, much of which was confidential, in place of what the prior art reference actually said.

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about the Phase II and, perhaps more importantly, what skilled artisans require of Phase IIs.

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There's so much going on in this case.

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I don't want to say anything that's confidential.

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Is this the Schirmer tier test?

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Is that what we're talking about, or is it something else?

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What we're talking about is an analysis of, if you will, Your Honor, an analysis of confidential Phase II data that has now been made public, so it's not

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that confidential in that sense, versus people can know, versus looking at what the prior art said in setting the expectation for what would be an unexpected result.

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I think that the court's authorities... And that's, in your view, a legal error?

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That's a legal error in requiring a statistical analysis of that data versus looking at what the prior art actually says.

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The overall effect of that was to essentially take statements that were made in the prior reference, and they were rendered, if you will, annulled.

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And in fact, the district court's opinion did not mention perhaps the most significant statement in the Stevenson reference, which stated that the most consistent results in the sister Shermer testing, your honor,

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were achieved by the point one formulation.

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And that was not addressed by the district court in its decision.

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And that's because the district court rejected that claim, that statement, in the prior art based on the analysis of the confidential phase two data.

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And I think it's important because the prior art uses this language of comparison.

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The prior art here is comparing one formulation to another to treat that prior art for what it says.

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In using comparisons, it proves the point, if you will, your honor, that using a statistical analysis to assess it is inappropriate.

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And the district court erred in doing that.

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What about using a statistical analysis not to replace it, but to compare?

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I think the statistical analysis was used to compare in respect to the phase three, your honor.

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And I think there's nothing wrong with considering it there.

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Because I think as our colleagues on the other side said, you're allowed to judge whether or not the unexpected result actually occurred.

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But in setting that baseline of what persons of skill in the art would expect, because that's what we're trying to address, you have to look at what the prior art actually said.

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And I think it's important, particularly with the phase two.

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In the phase two, the district court's opinion is at cross odds with itself.

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It says that the phase two was not designed to yield statistically significant differences between the various formulations.

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And then found, not surprisingly, that there weren't any.

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And that therefore, persons of skill would treat all these things the same, because they

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weren't statistically significant differences.

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But that's not what people of skill were doing.

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They knew that this study wouldn't yield statistically significant differences.

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But nonetheless, we're using it for the very purpose that the district court said that they would not, which is to make comparisons between the various formulations to figure out which ones to move forward with.

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So I believe that's a legal error, certainly the overall result of what the overall assessment of unexpected results of the court's authorities are clear.

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That's an issue of fact.

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But this point of looking to confidential information, going behind the prior art, if you will, to use an assessment of statistics in contradiction to what the prior art says is error.

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I think the second point that I would say dramatically affected the outcome of the case was in assessing both the phase two and phase three again in the unexpected results inquiry the district court weighed each measure identically both giving weight to really counting noses if you will and I think the court's opinion is very clear on that point in terms of counting which ones were statistically significant and which ones

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were not and the claims of course require increased enhanced tear production an actual therapeutic treatment of the disease and the case was replete with evidence I don't think either side really argued this point that the art was searching for something that would in fact treat the disease i.e.

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would in fact enhance tear production and by treating each thing the same

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the district court elevated those things that didn't indicate whether or not there was a therapeutic success over those things that did indicate there was a therapeutic success.

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Counselor, in your view, did the Dean I reference disclose the formulations of the claimed amounts?

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I'm sorry.

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Did the Ding 1 reference disclose the formulations of the claimed amounts?

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It disclosed a range that encompassed the claimed amounts, Your Honor.

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Within that range, it disclosed the formulation.

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Right.

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In the range, no dispute here, that in the ranges in Ding, the formulation of the patents ensued fell within those ranges.

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And so this court's range case law, I think both sides have argued different aspects of that case law.

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this court's range case law is applicable.

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And interestingly, the ding one.

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It's applicable in that there's a prima facie case of obviousness.

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That's what this court's authorities say, whether it's a presumption or prima facie or there's a burden.

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That's just, I mean, it's a semantics we've been arguing about, important ones nonetheless.

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But yes, we acknowledge that that is what this court's authorities say.

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And then the question becomes, in terms of the burden shifting

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approach or burden, shifting isn't the right word, the burden of production that this court places on parties like Allergan is to come forward with evidence of unexpected results, teaching away a result-oriented... And to be sure, it's not the burden of persuasion that shifts, it's the burden of production.

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Absolutely, and that's critical here in the sense that Allergan came forward, that's what the trial was about.

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was whether Allergan had satisfied that burden in showing unexpected results.

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And therefore, in making errors and assessing what measures were relevant, what the prior art said, and setting the expectation, Allergan didn't have a chance, if you will.

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If statistics are going to be required, if statistically significant differences are going to be required in phase two, then no one's going to be able to meet

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that standard in setting the expectation.

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Because frankly, the studies are too small.

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And if you have a prior reference, Judge Raina, that says flat out that one formulation is the most consistent in the measure that is most significant, the actual objective measure, the court ought to rely on that and not go behind it to make a determination at page A51 of the district court's opinion

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that the p-values for that difference weren't significant enough.

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The prior art said what it said.

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With respect to the second error, if you will, the weighing of each measure the same, that is where the FDA's ultimate, if you will, judgment on the ultimate efficacy of this product comes in.

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There's a lot of dispute between the parties as to what the measures are appropriate and what are not.

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And the FDA is the one, the agency charged by all of us to assess whether products are safe and efficacious, such that they can be marketed.

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And the FDA determined, again, looking at statistics and using those statistics in the way that persons of skill use them.

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that the .05 formulation was, quote, favored over the .1 formulation.

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And the district court rejected that finding, again, because the district court went behind that analysis to say, well, that's not a difference between two formulations, statistically.

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Something being favored, that's not enough.

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It has to be statistically significantly different

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than each other.

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Again, when the studies aren't designed to show that.

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What we're trying to show when we're getting drugs approved at the FDA is whether things are different than placebo or vehicle.

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And I submit to you... Isn't there a difference between something being favored and unexpected results?

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I mean, you can have a range of options that work.

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One of them may work better than the other, but that doesn't mean that the slightly less better one or the slightly more better one is unexpected.

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It's just better.

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That's the difference in degree and kind, if you will.

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Right.

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I mean, unexpected results is usually, well, we're plucking this point out of the range and nobody would have predicted that it would have had this effectiveness.

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because everything else points to a completely different part of the range.

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But the differences here seem pretty minor, and isn't that what the district was, what it was focusing on, was that the .1 probably worked okay, but the .5 works a little bit better, or maybe a lot better.

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Well, actually, I think the, you have to take the prior art for what it says, and the .05 was in the prior art.

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The prior art paper, Stevenson paper, was not shown to work at all.

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based on the objective measures of tear protection.

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It wasn't even mentioned in the prior article not working at all.

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And in the corneal staining and other staining measures, it was the worst performing and essentially didn't perform to approve.

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But there's other evidence that points the other way.

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I mean, I know your friends on the other side are going to get up and start pointing us to all that evidence.

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You think we should just disregard it.

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I'm not saying you should disregard

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the other evidence, but that other evidence doesn't point to, if you will, Judge Hughes.

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The surprising result, you have to remember, is the increasing the castor oil component.

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That taking that formulation that's in the prior art reference that's described, .05, looking at the data in there, seeing the lack of performance on the objective measures, some improvement on subjective measures which don't relate to the claims, and then say,

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We're going to double the amount of the vehicle, which all the evidence at trial would suggest would hamper the formulation.

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That's the surprise of the result.

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So you're suggesting, just going back to Judge Raina's question about the legal standard we're applying, and Judge Hughes just referenced it, the test is that it requires a difference in kind, not just a degree.

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That's correct.

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And so Judge Bryson here evaluated

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So the results and concluded they were not unexpected in terms of the difference in kind, not of degree.

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That's the universe we're operating in.

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That is correct.

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That was his ultimate decision.

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But again, it was based on setting the expectation based on that confidential analysis of the statistical data versus what the prior art said.

[00:14:02] Speaker 01:
You're running out of time, but I'd like, before you sit down, if you could address the blocking patterns issue.

[00:14:06] Speaker 01:
Absolutely.

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And the blocking patent issue here is, we'll state our disagreement with the Accorda decision, but we recognize now that that has come out.

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And so what the blocking... Wait, I'm sorry.

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I didn't understand what you just said.

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You're not... We understand the Accorda decision has now come out.

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Okay.

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So the framework that the parties were briefing a little bit different than what they were briefing initially.

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But the issue there on the blocking patent is that there was evidence presented at trial that these patents are the patent.

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the Ding 1 patent was not in fact sufficiently regarded as strong enough if you will to be a blocking patent.

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The whole rationale for a patent being a blocking patent is the assumption that by that patent foreclosing if you will the later formulation.

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Are you saying that the blocking aspect of a blocking patent lies in the strength of the patent versus

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its its activity in the in the in the marketplace it is certainly that has to be relevant your honor if people do not believe that that patent has sufficient strength um... if they believe it to be not blocking other things that they might do because they'll do it still be covered that has to be part of the important isn't that the patent that has the range that covers this specific formulation it it does judge shoes but

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But that patent also would cover other activities with cyclosporine.

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People using 0.1 cyclosporine, 0.2 cyclosporine.

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And the evidence at trial was that people tried and attempted to use 0.1 and 0.2 cyclosporine.

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It has to affect the analysis of a blocking patent.

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And the district court did not assess this.

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that people looking at this patent, which is described as a blocking patent, did not regard it as a blocking patent.

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And that's, I believe, what the Accorda case says, that this is a fact-specific inquiry as to whether things are, in fact, blocking patents or not under the economics.

[00:16:31] Speaker 04:
Good morning.

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May it please the court?

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This is a case about unexpected results, and Allergan lost that case at trial on the facts.

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Allergan tried to tell a story at trial in which the 0.1% formulation of cyclosporine performed better in the phase two trials than the 0.05%, and then the 0.05% supposedly surprisingly performed better than 0.1%

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in the phase three trials, and this is the basis of their unexpected result.

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The problem that Allergan has is that the district court found, in an uncommonly thorough and detailed 135 page long opinion, that as a matter of fact, the two formulations in the phase two trial performed just about the same, and the two formulations in the phase three trial performed just about the same, and to the extent...

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all make sense.

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What I hear your friend arguing is we shouldn't look at any of that stuff because the actual prior art references said something different.

[00:17:39] Speaker 04:
But that's not accurate, Your Honor.

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And again, the district court was very careful to look at the references themselves and the publicly available information in determining what expectations a person of skill in the art would have formed.

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And so for example, the district court looked at the Stevenson reference, which was the publication that described the results of the phase two

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trials, and one can look at the face of Stevenson and see the key results.

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It says, and this can be found at page 1-9-200 of the joint appendix, the results on the face of the reference are there was no clear dose-response relationship between .01 and .05.

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There wasn't a superior performance, in other words, by the higher dosage of the drug.

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And it says that the point, and contrary to

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what Mr. Singer suggested.

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The district court, of course, was very careful to look at exactly what the reference described.

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And you can find at page 42 of the court's opinion the discussion of the fact that on some measures the 0.1 percent performed better and on other measures the 0.05 percent performed better.

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What Stevenson says in black and white is

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Cyclosporine A .01% produced the most consistent improvement in objective and subjective endpoints.

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And .05% gave the most consistent improvement in patient symptoms.

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And the vehicle also performed well, perhaps because of its long residence time on the ocular surface.

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So the vehicle, which is to say the emulsion that has the castor oil in it but no cyclosporine, itself created better results over baseline than the versions that have the cyclosporine in it.

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And so the conclusion of Stevenson is that cyclosporin A 0.05% and 0.1% were deemed the most appropriate formulations for future clinical studies, which is exactly what then happened in phase three.

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Those two formulations were put into the phase three studies.

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So what the district court found, based on Stevenson, was that a person of skill in the art, seeing no dose response, seeing that all of the formulations tested had few to no side effects, had negligible blood concentrations,

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would have thought that there wasn't a better performance by the higher dose.

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How do you respond to your colleague on the other side's argument that the district court erred when they relied on an assessment of statistical analysis to the detriment of the teachings of the prior art?

[00:20:13] Speaker 04:
That's not at all what the district court did, your honor.

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I think first of all, the court was very careful in its analysis to distinguish between what was publicly available and what was

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confidential information with regard to the FDA submissions.

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However, when the unexpected result is supposedly that 0.05 percent performed surprisingly and unexpectedly better in the Phase III trials, it is fair to look at the available data, not to figure out what a person of skill and the art would have expected, but to find out whether there actually is a difference in effect

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at all that would be surprising or would not be surprising.

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And so what the court did was to having evaluated first the publicly available information and concluded that a person would have thought they did the same.

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The .05% and the .1% performed the same in phase two and in phase three.

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The court then looked at the underlying data to see if perhaps there was a difference in effect that was not reflected in the publicly available information.

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and concluded that no, even if one looks at the underlying data, one sees no difference in performance.

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And I think it's not correct to suggest that the district court required statistical significance instead of considering what people of skill and the art would have thought.

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At page 49 of its opinion, the court specifically said it was not requiring statistical significance as the test of unexpected results.

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What the court did, though, was

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to evaluate, and of course there was testimony from art experts.

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The other side's experts were not the only ones to put in evidence.

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Art experts testified that people would read the prior art and expect no difference.

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And even to the extent that people would have been surprised in 1999 when the Phase III trials came out, any surprise that they would have had would have been gone by 2003, which is the relevant time point for people still in the art looking at these facts.

[00:22:15] Speaker 04:
So it's just not

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It's just not true that the court required statistical significance in order to find an unexpected result.

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I would note, in addition, that the argument that Allergan makes at one point in its brief is that people of skill and the art sometimes can reach conclusions or make expectations without having the benefit of statistically robust studies, which is, of course, true.

[00:22:45] Speaker 04:
But it's one thing to say that people of skill and the art can form expectations in the absence of statistical evidence.

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It's another thing to say, which is what they have to say here, that given statistical evidence that there is no difference in performance, a person of skill and the art is nevertheless free to say, well, I don't care about the statistics.

[00:23:05] Speaker 04:
I look at the graphs on my own.

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And without regard to statistics, I make my own conclusions.

[00:23:10] Speaker 04:
That's what the district court rejected.

[00:23:14] Speaker 04:
I think, again, as a matter of fact, it's simply not true that there was an unexpected result.

[00:23:22] Speaker 04:
The evidence on that is really extremely strong.

[00:23:30] Speaker 04:
On the question of the legal standard, it doesn't sound to me like we have a difference in opinion on that.

[00:23:37] Speaker 04:
I think everyone agrees that there is a prima facie case of obviousness because the restasis formulation

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fell within the ranges disclosed in the Ding 1 patent, that it's then up to the other side to come forward with evidence of unexpected results if it wants to overcome that prima facie case.

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And that's what they failed to do here.

[00:24:02] Speaker 04:
And therefore, the prima facie case stands and invalidates the patent.

[00:24:08] Speaker 04:
That's essentially what the district court found.

[00:24:10] Speaker 00:
What about the blocking patent?

[00:24:12] Speaker 04:
So the district court

[00:24:14] Speaker 04:
considered that the product was commercially successful and that there was for at least some people a long felt need, but said correctly under this court's precedence that the effect of those secondary considerations was blunted by the existence of the CAS-1-342 patent and the DING-1 patent, which revealed the solution to the problem

[00:24:42] Speaker 04:
but prevented other people from experimenting with or carrying out that solution.

[00:24:48] Speaker 00:
In your view, did Acorda raise the kind of evidence or the discussion?

[00:24:53] Speaker 00:
I mean, Judge Bryson didn't have the benefit of Acorda when he issued his opinion here.

[00:24:58] Speaker 00:
Did Acorda change the landscape or require anything further from district courts than Judge Bryson did here?

[00:25:05] Speaker 04:
No, Your Honor, I don't believe it did.

[00:25:06] Speaker 04:
I think that we could go all the way back to the Teva versus, Merck versus

[00:25:13] Speaker 04:
Teva case and the Galderma versus Tomar case.

[00:25:17] Speaker 00:
Well, he relied on those cases.

[00:25:18] Speaker 00:
Those were law, and then the court came out and amplified that a little.

[00:25:24] Speaker 04:
Well, I think, pardon me.

[00:25:26] Speaker 01:
In the court, we defined a blocking patent as one where practice of a later invention would infringe the earlier patent.

[00:25:33] Speaker 01:
How do we look at the word practice?

[00:25:36] Speaker 01:
Were the pens in this case, were they being practiced?

[00:25:42] Speaker 01:
Well, I think the point of that passage in Accorda is that even though Ding Won made it obvious... In other words, does there have to be commercialization in order for there to be a practice of a later invention or just simply possessing and owning the patent?

[00:26:03] Speaker 01:
Is that enough?

[00:26:04] Speaker 04:
Yes, I believe that possessing and owning the patent is enough if it's a blocking patent because obviously

[00:26:11] Speaker 01:
The point of the block... Even where there's no commercialization of a pen?

[00:26:15] Speaker 04:
Yes, because the point is that... So the logic of the commercial success as a secondary consideration of non-obviousness is that where there's an economic incentive to solve a problem and where the solution is obvious, people will bring a product to market that solves the problem and then later products to market won't be as successful.

[00:26:38] Speaker 04:
The fact here is that

[00:26:40] Speaker 04:
even though DING-1 told the whole world how to make these kinds of emulsions and the patent, the Restasis formulation is just one sort of example from the set of DING-1 that doesn't perform any better or worse than any of the other examples in the set from DING-1.

[00:26:56] Speaker 04:
People weren't free to use DING-1 as a blueprint to bring their own products to market because they infringed, they would have infringed DING-1 if they tried to do that.

[00:27:05] Speaker 04:
And we know, of course here,

[00:27:07] Speaker 04:
that Auergan intended Dinghuan and Casuan to be blocking patents because they listed them in the Orange Book specifically for the purpose of preventing other people from bringing competing products to market.

[00:27:17] Speaker 04:
So it's a little ironic for them to say that, you know, we don't know if anyone else was blocked.

[00:27:22] Speaker 04:
Well, then why did you list it in the Orange Book?

[00:27:25] Speaker 04:
It was clearly their intent to block other people from doing it.

[00:27:29] Speaker 04:
To go back to your question, Chief Judge Prost, I don't think that Accorda changed that framework.

[00:27:33] Speaker 00:
Well, Accorda seems to call out that it's

[00:27:36] Speaker 00:
factual inquiry.

[00:27:37] Speaker 00:
It's not different from what we've said before, but it kind of talks again about the need for evaluating the facts and circumstances.

[00:27:45] Speaker 00:
So based on what you said, what more of a fact or circumstance would you look to other than the fact that this prevented others from going on the market?

[00:27:57] Speaker 04:
Well, I think that what Accorda was doing when it talked about the facts and circumstances, it was responding to the comments in the

[00:28:05] Speaker 04:
the Merck Sharpenedone against Hospira case, which suggested that a categorical rule that simply saying if there's more than one patent covering the product, therefore we throw out commercial success, we don't look at it.

[00:28:17] Speaker 04:
I think that Accordo was saying that's a sensible rule.

[00:28:20] Speaker 04:
We can't have a categorical approach to this sort of thing.

[00:28:24] Speaker 04:
But one has to be sensitive to the possibility that what at first appears to be a blocking

[00:28:30] Speaker 04:
may not end up blocking it, for example, because people are willing to license it.

[00:28:34] Speaker 04:
And in this very case, the Casuan 342 patent was developed at the University of Georgia and owned by Sandoz.

[00:28:42] Speaker 04:
But Sandoz was willing to license it to Allergan, and that's why Allergan was able to develop its products.

[00:28:50] Speaker 04:
And so although Casuan was a blocking patent after Allergan got the exclusive license,

[00:28:56] Speaker 04:
it wasn't necessarily a blocking patent when it was owned by someone else who was willing to license it.

[00:29:00] Speaker 04:
I think those are the kinds of factual nuances that a CORDA permits people to consider when they are in the record.

[00:29:06] Speaker 04:
But a CORDA doesn't say that there has to be some searching examination of additional facts.

[00:29:13] Speaker 04:
I think what a CORDA says is that based on the limited evidence that's usually available on these sorts of things, the district court has to make a

[00:29:21] Speaker 04:
a judgment, and that's what the district court did here.

[00:29:23] Speaker 04:
I would also point out that there was evidence in the record that these were blocking patents, and that evidence, when uncontested by the other side of the court, can find that at JA 18864-65, which is economist's testimony on the blocking effect of the patent in the market and the fact that by 2014, when DING 1 expired,

[00:29:47] Speaker 04:
Allergan's position with Restasis had become so dominant that it was not an attractive molecule to compete with.

[00:29:59] Speaker 04:
So I would just add one other point going back to the obviousness question.

[00:30:07] Speaker 04:
Mr. Singer ended with the notion that the surprise here was that the 0.05% formulation did as well

[00:30:16] Speaker 04:
in the Phase III trials as .1, even though it had a higher concentration of castor oil.

[00:30:22] Speaker 04:
And of course, there was plenty of evidence at trial that castor oil can be a good thing, that castor oil is good for treating dry eye.

[00:30:29] Speaker 04:
And in fact, the DING2 patent, the 607 patent, specifically says that the installation of the castor oil emulsion without the cyclosporine increases the measured tear volume.

[00:30:42] Speaker 04:
And that can be found at Joint Appendix 19476.

[00:30:45] Speaker 04:
So there was plenty of evidence from which people in the art would have thought that increasing the castor oil was a perfectly sensible thing to do.

[00:30:53] Speaker 04:
And in fact, DING-1 had examples in which the ratio of cyclosporine to castor oil was the same as that used in their stasis product.

[00:31:01] Speaker 04:
And they were found to be perfectly suitable emulsions to use for the treatment of dry eye.

[00:31:07] Speaker 04:
And so this notion that there was some kind of problem with increasing castor oil

[00:31:13] Speaker 04:
is a figment of Allergan's imagination, it was a fear that some people within Allergan had based on secret pharmacokinetic studies that they had conducted that led them to think that it might be a problem.

[00:31:29] Speaker 04:
But when the trials were actually run, it turned out not to be a problem.

[00:31:33] Speaker 04:
And in that regard, I think Inrei Geisler is instructive, which we cite in our briefs, which says that if the inventors have an assumption

[00:31:43] Speaker 04:
about the world that turns out to be wrong later, it doesn't mean that people with skill and the art at the later point in time would necessarily share that assumption and be surprised.

[00:31:52] Speaker 00:
Can I ask you kind of a housekeeping question and your friend can either confirm or reject what you're saying?

[00:31:59] Speaker 00:
There's this other case pending, the IPR case.

[00:32:02] Speaker 04:
Yes, Your Honor.

[00:32:02] Speaker 00:
My understanding is that the patents here

[00:32:10] Speaker 00:
comprise some of what's pending, but that there are additional patents or claims that are at issue in the IPRs that are not covered by this case.

[00:32:18] Speaker 00:
There's an overlap.

[00:32:19] Speaker 00:
In other words, there's an overlap.

[00:32:21] Speaker 00:
All of these are covered in the IPRs, but the IPRs include other claims.

[00:32:25] Speaker 04:
That's correct, Your Honor.

[00:32:27] Speaker 04:
There are six patents at issue in the IPR appeal.

[00:32:30] Speaker 04:
There are only four patents at issue in this appeal.

[00:32:32] Speaker 00:
But the ones that are at issue in this appeal are also in the IPR.

[00:32:35] Speaker 04:
That's correct.

[00:32:38] Speaker 04:
I see that my time is just about up.

[00:32:39] Speaker 04:
I thank the court, if there are no further questions.

[00:32:49] Speaker 03:
Thank you, your honor.

[00:32:52] Speaker 00:
You agree with just the House?

[00:32:53] Speaker 03:
Yeah, that's correct.

[00:32:55] Speaker 03:
Sorry.

[00:32:58] Speaker 03:
On the blocking patent issue, the district court treated that, if you will, as a sort of a per se, that the

[00:33:06] Speaker 03:
patent because it covered rustasis was a blocking patent.

[00:33:09] Speaker 03:
The point I was trying to make in my opening argument was the Accorda case talks about this being a factual-based inquiry.

[00:33:18] Speaker 03:
And as part of that inquiry, it ought to be the law that we can assess whether others' efforts, while they weren't after the same formulation as Allergan, were covered by the so-called blocking patent.

[00:33:36] Speaker 03:
that would inform the analysis of whether or not a patent that's, quote unquote, assumed to be blocking really is regarded in the industry as blocking.

[00:33:46] Speaker 03:
And the important point to remember about this block, this patent, is that it was exceedingly narrow.

[00:33:52] Speaker 03:
It related to requiring two particular recipients at particular levels.

[00:33:57] Speaker 03:
And so people were free to develop other cyclosporin formulations at their will.

[00:34:03] Speaker 03:
And therefore, the patent wasn't really regarded as blocking the ability to use cyclosporine to ultimately fill the need.

[00:34:14] Speaker 03:
And finally, I would just read for the court two things from Stevenson and compare to what the district court said.

[00:34:21] Speaker 03:
Stevenson talks about the Shermer tears test at page A19204 and says the most consistent improvements were in the cyclosporine A 0.1% group, and that at A19203,

[00:34:33] Speaker 03:
says about the corneal staining, cyclosporine A .1% produced the greatest improvement from baseline in corneal staining.

[00:34:42] Speaker 03:
And the district court rejected that finding at page A50 based on the P values from the confidential phase two analysis.

[00:34:50] Speaker 03:
I see that I'm out of time.

[00:34:52] Speaker 03:
Thank you.