[00:01:05] Speaker 00:
Next case was Allergan versus Sandoz, Lupin, Hitech, et al.

[00:01:11] Speaker 00:
2014-12-75.

[00:01:15] Speaker 00:
Ms.

[00:01:18] Speaker 00:
Maynard, when you're ready.

[00:01:34] Speaker 05:
Dan Maynard for Appellant Sandoz.

[00:01:37] Speaker 05:
I'm going to be presenting arguments for all of the defendants on the arguments in our brief, and then Mr. Roth is going to address the arguments in his separate brief for three minutes, and then I would like to reserve three minutes for rebuttal.

[00:01:47] Speaker 05:
Mr. Riposi is also here if you have questions about Lupin's other arguments.

[00:01:54] Speaker 05:
The patents here claim nothing new.

[00:01:57] Speaker 05:
They simply recite a narrower range of the same combination

[00:02:03] Speaker 05:
for the same use, as in Allergan's own now expired prior art patents.

[00:02:09] Speaker 00:
But isn't it new to have the lower dose of the Mataprost and the higher doses of GAK?

[00:02:18] Speaker 05:
No, Your Honor.

[00:02:19] Speaker 05:
Both of those ranges were already disclosed in their three prior art patents, which they indeed asserted against this new product in the Orange Book.

[00:02:28] Speaker 05:
So they claim at the same time that their prior art patents covered this very product.

[00:02:33] Speaker 05:
Yet, somehow, they're entitled to new patent coverage, having already enjoyed their entire patent coverage for this very product.

[00:02:41] Speaker 00:
But weren't they disclosed only as part of a genus and not specifically in combination?

[00:02:48] Speaker 05:
No, Your Honor.

[00:02:48] Speaker 05:
They were disclosed, the range, the prior patents disclosed both a range of the mataprost and covered gramatoprost in the precise concentrations covered here, which is preferably about 0.01

[00:03:03] Speaker 05:
to about 1%.

[00:03:04] Speaker 05:
In other words, a less than 1% range.

[00:03:06] Speaker 05:
And then also, the preservative back was one of five preferred preservatives listed in their prior art patents in a range from 0 to 1,000 parts per million.

[00:03:20] Speaker 05:
So in fact, it's the same chemical composition here, judges' glory,

[00:03:24] Speaker 05:
It's just a different range.

[00:03:26] Speaker 05:
It's not a genus species in that sense.

[00:03:28] Speaker 05:
It's exactly the same species.

[00:03:29] Speaker 05:
It's just a different range.

[00:03:31] Speaker 05:
They've already claimed and obtained patent coverage for this very product.

[00:03:35] Speaker 00:
Well, the species is a particular combination, a particular concentration, a combination of the particular concentrations.

[00:03:44] Speaker 05:
And that particular combination was disclosed in the prior art patent.

[00:03:49] Speaker 05:
And that creates a potent case of obviousness.

[00:03:52] Speaker 00:
Can you point out exactly where in the prior op that is?

[00:04:02] Speaker 05:
Yes.

[00:04:02] Speaker 05:
In the 819 patent, I am in volume three of the... Of the 819 patent.

[00:04:09] Speaker 05:
I'm in column eight, and it says I'm in around line four.

[00:04:15] Speaker 05:
The therapeutically efficient amount typically is between about

[00:04:20] Speaker 00:
But that's the genus, right?

[00:04:23] Speaker 00:
That doesn't say .01 specifically, right?

[00:04:28] Speaker 05:
It does not disclose .01 by name, but it does by range, Judge Laurie.

[00:04:35] Speaker 00:
In other words, that's the genus.

[00:04:37] Speaker 05:
I think that even if one looks at it and calls it a genus and a species, the species is within this genus.

[00:04:46] Speaker 05:
It is disclosed.

[00:04:48] Speaker 05:
But I don't think the sort of genus species analogy, like in a lead compound case, is the right way to look at this.

[00:04:53] Speaker 05:
Because this is the same chemical structure that they're claiming now.

[00:04:57] Speaker 05:
In fact, they claim that these patents cover the product that we're trying to market now.

[00:05:03] Speaker 00:
And how about the BAK at the 200 PPM level?

[00:05:09] Speaker 05:
Yes, your honor.

[00:05:10] Speaker 05:
So slightly further down that page, column 8 still, line 15.

[00:05:15] Speaker 05:
Sorry, it's a tongue twister.

[00:05:17] Speaker 05:
preferred preservatives that may be used in the pharmaceutical compositions of the present invention include but are not limited to benzalkonium chloride.

[00:05:28] Speaker 05:
That's back.

[00:05:29] Speaker 05:
That's the first one listed.

[00:05:30] Speaker 05:
It's the most commonly used preservative and eye drop product.

[00:05:33] Speaker 00:
Once again, that's a broad range.

[00:05:36] Speaker 05:
The range, Your Honor, is from zero to a thousand parts per million.

[00:05:43] Speaker 05:
But that's the same range that was present in this court's decision in Allergan v. Sando, the same exact range of the same exact preservative back.

[00:05:51] Speaker 05:
And this court found the composition patent there obvious over that prior disclosure.

[00:05:57] Speaker 01:
And it's not- But doesn't this specific combination that we're talking about here, this so-called species, have unexpected results?

[00:06:06] Speaker 01:
No, you're- The efficacy is

[00:06:11] Speaker 01:
pretty close to the 0.03% beta-prose, at the same time with less hyperemia and the BAK functions to improve corneal penetration.

[00:06:31] Speaker 01:
All of that alleged to be a surprise, an unexpected result.

[00:06:37] Speaker 05:
It's not an unexpected result that's probative of non-obviousness for this reason.

[00:06:42] Speaker 05:
The fact that it's almost as effective as .03% is just simply a difference in degree.

[00:06:53] Speaker 05:
It would have been expected to be less effective, and it's simply not quite as effective.

[00:06:58] Speaker 05:
And all the district court found was that it was just not quite as effective.

[00:07:05] Speaker 05:
And it was more not quite as effective as one would have thought.

[00:07:08] Speaker 05:
And that's a classic difference in degree, which this court has said, and indeed the Supreme Court.

[00:07:13] Speaker 02:
And is the district court also based that finding on the fact that the 200 level of the back had greater penetrability and that that was unexpected because that wasn't shown in the prior art?

[00:07:28] Speaker 05:
Well, two points about that, Judge Sheese.

[00:07:30] Speaker 05:
One, that property.

[00:07:32] Speaker 05:
is not claimed in these claims, that the penetration would be enhanced.

[00:07:36] Speaker 05:
And therefore, we don't have to show that that wasn't unexpected, nor should it be probative of non-obviousness for these claims that don't claim that.

[00:07:48] Speaker 00:
The relevant property doesn't have to be claimed to be relevant to unexpectedness.

[00:07:54] Speaker 05:
Well, Your Honor.

[00:07:56] Speaker 00:
And in fact, hiados back was

[00:08:01] Speaker 00:
thought to be a disadvantageous compound was looked at as almost being toxic.

[00:08:07] Speaker 05:
Well, in fact, may quarrel with your premise to start with.

[00:08:12] Speaker 05:
I mean, I think that in the Allergan v. Sandoz case, where the court struck the combination claim but upheld the clinical result claim, if it were true that an unclaimed, unexpected result

[00:08:29] Speaker 05:
could save a claim, then one would have thought the two would have come out the same there, but they did not.

[00:08:35] Speaker 05:
But even accepting your honor's premise.

[00:08:37] Speaker 00:
And it's always been true for decades, an unclaimed, unexpected result is relevant to obviousness.

[00:08:44] Speaker 05:
Even if it's unexpected, in fact, it's not relevant to obviousness unless it's probative of non-obviousness.

[00:08:52] Speaker 05:
And a difference in degree is not probative of non-obviousness,

[00:08:56] Speaker 05:
And that's been true since the Supreme Court decision in Smith in 1837.

[00:08:59] Speaker 05:
So it has to be a difference in kind.

[00:09:04] Speaker 05:
All they've shown here is that this combination is not quite as ineffective as one would have thought it would be.

[00:09:12] Speaker 05:
And that is just a classic difference in degree.

[00:09:14] Speaker 05:
The fact that the back might be the cause of that

[00:09:20] Speaker 05:
is nothing but stating the result of an obvious combination, and that's not enough to get you patentability.

[00:09:27] Speaker 05:
In fact, when one looks at the figures in these patents, figures one and two show that the back enhanced the penetration in their 50 parts per million product as well.

[00:09:37] Speaker 05:
That was disclosed in the prior art.

[00:09:40] Speaker 05:
So the closest prior art, again, is their prior art patent that they claim covered this very product, and it had back in it as well

[00:09:50] Speaker 05:
And the figures in these patents show that it increased the penetration.

[00:09:56] Speaker 05:
So there's nothing here but a classic change in degree.

[00:09:59] Speaker 05:
It's not enough to get the new patent coverage on essentially the exact same content.

[00:10:03] Speaker 02:
On these points about the teaching away and the unexpected results that the district court found against you for, I mean, it seems like those are factual findings.

[00:10:11] Speaker 02:
Are you saying that those are clear error?

[00:10:14] Speaker 02:
I know you're trying to frame it as a legal issue,

[00:10:18] Speaker 02:
But it seems to me that they really are, the notion of whether something taught away, or at least the more troubling one to me is the unexpected results, that that's a really very specific factual finding.

[00:10:31] Speaker 02:
And it seems like there's testimony from an expert on the other side to support that.

[00:10:38] Speaker 02:
Your argument sounds perfectly reasonable to me that the 50 percent showed greater penetrability.

[00:10:45] Speaker 02:
I'm not here to reweigh the facts.

[00:10:48] Speaker 02:
Those are clear error standards, and it seems hard that you have a hard battle to overcome.

[00:10:55] Speaker 05:
In Galderma, this court recognized that the result was unexpected in the sense of unexpected as a fact, but not legally probative of non-obviousness.

[00:11:05] Speaker 05:
And so it is a legal question.

[00:11:07] Speaker 02:
Although Galderma also found several factual findings

[00:11:11] Speaker 02:
clearly erroneous too to get to its results.

[00:11:13] Speaker 02:
So are you asking us to do that, find these factual findings clearly erroneous like we did in Galdemar?

[00:11:21] Speaker 02:
Or is there some way that we can just say those factual findings are not as, you seem to be saying that they're not probative of non-obviousness, but I don't really quite understand that.

[00:11:31] Speaker 05:
They're not probative of non-obviousness, Judge Hughes, because a difference in degree is not probative of non-obviousness.

[00:11:37] Speaker 05:
That's a question of law.

[00:11:38] Speaker 05:
This Court has held that.

[00:11:41] Speaker 05:
for decades, that it has to be something more than a simple small improvement within a choice and a range.

[00:11:49] Speaker 05:
And you're essentially almost talking about optimizing the prior art range and getting something slightly better.

[00:11:53] Speaker 05:
And in fact, it's not better.

[00:11:54] Speaker 05:
It's just not as bad as they thought it would be.

[00:11:57] Speaker 05:
And that is just a classic difference in degree that shouldn't entitle them to a new invention.

[00:12:02] Speaker 01:
But it's better in the sense that it produces less hypoemia.

[00:12:08] Speaker 05:
But that's totally unexpected.

[00:12:10] Speaker 05:
The district court found that at AA80, that reducing the... Oh, I may have given the wrong page number.

[00:12:16] Speaker 05:
But the district court specifically found, and Allergan conceded, that there was a motivation to reduce the amount of bimodipros, and the district court expressly found that bimodipros increases hyperemia, and so there would be an incentive to reduce that.

[00:12:28] Speaker 05:
So that's a completely unexpected, totally expected, and they don't challenge that.

[00:12:33] Speaker 05:
If I could, I don't want to run out of my rebuttal time, but if the court had questions on written description about the, because I think there's not adequate written description on the clinical results claims, the... You've got 50 seconds to talk about example five.

[00:12:50] Speaker 05:
Example five, thank you Judge Lurie.

[00:12:52] Speaker 05:
Example five doesn't report anything about the formulation that they're claiming here.

[00:12:57] Speaker 05:
It has a different...

[00:12:59] Speaker 00:
It certainly has come down from .03, close to .01, and the BAK has gone up from 50 to not quite 200, but it's certainly gone up in that direction.

[00:13:12] Speaker 05:
That's true, Your Honor, but those combinations were in the prior art.

[00:13:18] Speaker 05:
That's nothing but repeating prior art patents.

[00:13:21] Speaker 05:
It doesn't tell you anything about the precise formulation here.

[00:13:25] Speaker 05:
If I may save my 10 seconds for everybody, I'd appreciate it.

[00:13:29] Speaker 00:
We will do that.

[00:13:31] Speaker 00:
Ms.

[00:13:31] Speaker 05:
Brooks.

[00:13:33] Speaker 00:
Oh, Mr. Roth is going to speak for three minutes.

[00:13:43] Speaker 00:
Didn't mean to slide you, Mr. Roth.

[00:13:45] Speaker 00:
It's okay.

[00:13:46] Speaker 03:
No offence.

[00:13:48] Speaker 03:
May I please record?

[00:13:51] Speaker 03:
I'm here for Appellant High Tech.

[00:13:54] Speaker 00:
You're going to talk about pH.

[00:13:56] Speaker 03:
pH and written description.

[00:13:58] Speaker 03:
quickly I'll try to get both quickly in my three minutes.

[00:14:01] Speaker 03:
I just want to address one thing.

[00:14:04] Speaker 03:
Dan was correct, it was page 880 in paragraph 70 and if you look at the sentence there and by Allergan's own admission there was a motivation to select a lower concentration of the mataprost because it was known in the prior art that the mataprost causes hyperemia.

[00:14:20] Speaker 03:
So they admitted it's not, they know that.

[00:14:22] Speaker 03:
Lowering the mataprost to reduce hyperemia was not what was expected.

[00:14:26] Speaker 01:
On to

[00:14:27] Speaker 01:
But it wasn't expected that if you lower the dose, you could get something that's still as effective or almost as effective.

[00:14:34] Speaker 03:
Right, and that's where the percentage increase comes in.

[00:14:42] Speaker 03:
That merely showing a bigger percentage of the benefit is not an unexpected result.

[00:14:52] Speaker 03:
Also, the point was made about 200 VAK

[00:14:57] Speaker 03:
being toxic, if you know that.

[00:14:59] Speaker 03:
Latanoprost, which is in the same class of compounds as Banatoprost, both prostaglandins, uses 200 BAK.

[00:15:08] Speaker 03:
Now, Allergan has made this argument about, about, Latanoprost being different because somehow it complexes.

[00:15:16] Speaker 03:
But I think they're being, that's not quite, quite correct.

[00:15:21] Speaker 03:
I mean, if you look at what they argued to FDA to get approval of Lumigan 0.01,

[00:15:27] Speaker 03:
They argued that 200 back was safe.

[00:15:30] Speaker 03:
And what did they cite in support of that?

[00:15:32] Speaker 03:
Latanaprost.

[00:15:34] Speaker 03:
But now, when it comes to keeping generics off the market, no, no, you can't rely on latanaprost.

[00:15:39] Speaker 03:
It's a different product.

[00:15:41] Speaker 03:
And there are other products that are, five other products that use 200BAK.

[00:15:46] Speaker 03:
And yes, all products have toxicity.

[00:15:48] Speaker 03:
Botox, Allergen's best-selling product, is one of the, it's made from botulinum.

[00:15:54] Speaker 03:
one of the most toxic substances on earth known to man.

[00:15:59] Speaker 03:
So yes, all drugs have toxicities and they have benefits and they have to be weighed against each other.

[00:16:08] Speaker 03:
And that's why BAC is prevalent.

[00:16:10] Speaker 03:
I really wanted to talk about 112 and pH, but I'm running out of time.

[00:16:15] Speaker 03:
On 112, we have an argument based on

[00:16:22] Speaker 03:
on written description on the 118 and 353 patents, and those patents claim a clinical benefit, that the .01% matapros 200 PPM back formulation has lower hyperemia, and at least as much IOP lowering as the .03% formulation of the prior art.

[00:16:38] Speaker 03:
The patent specs says nothing about that.

[00:16:40] Speaker 03:
That clinical comparison does not show up at all in the patent specification.

[00:16:45] Speaker 03:
Allegan argues that the .01% formulation is a best-mode formulation, but there are

[00:16:51] Speaker 03:
many best-mode formulations, dozens in the spec.

[00:16:54] Speaker 03:
And there's no statement in the spec that the best-mode formulations satisfy this claim clinical comparison.

[00:17:01] Speaker 00:
What about example five?

[00:17:03] Speaker 03:
Example five relates to a formulation J. Formulation J has 0.015% bimodiprost and 125% perparspermia and BAC.

[00:17:12] Speaker 03:
50% more bimodiprost, 60% less BAC.

[00:17:15] Speaker 03:
Now that's a very different formulation.

[00:17:18] Speaker 03:
I mean Allergan argues that

[00:17:19] Speaker 03:
citing to some deposition testimony that may or may not be in evidence properly, that the clinical feature is obvious from the spec, or predictable from the spec.

[00:17:31] Speaker 03:
But this court has held, in an opinion you authored, Ariadne versus Eli Lilly, that a patent spec that merely renders a claim obvious does not satisfy the written description of the claim.

[00:17:42] Speaker 03:
I'm out of time.

[00:17:42] Speaker 03:
Thank you very much.

[00:17:43] Speaker 00:
All right.

[00:17:44] Speaker 00:
Thank you, Mr. Roth.

[00:17:46] Speaker 00:
Ms.

[00:17:46] Speaker 04:
Brooks.

[00:17:47] Speaker 04:
Thank you, Your Honor.

[00:17:51] Speaker 04:
May I please the court?

[00:17:54] Speaker 04:
What has been studiously ignored and failed to be addressed by appellants is this.

[00:18:01] Speaker 04:
What Gallderm has simply said is if there's a range that's been disclosed in the prior art, then one must look to see is there a motivation to pick a particular number within that range.

[00:18:14] Speaker 04:
Or if one looks at the prior art, does it teach away from the claimed invention?

[00:18:19] Speaker 04:
Or are there new and unexpected results?

[00:18:22] Speaker 04:
Or are there other pertinent secondary considerations?

[00:18:25] Speaker 04:
This is right from Galderma, so let's answer that question.

[00:18:28] Speaker 04:
What was the motivation to pick from the range a 200 part per million BAK when the prior ART was at 50 parts per million?

[00:18:39] Speaker 04:
We would submit there was no such motivation, and in fact it was the Pellanthone expert, Dr. Samples, who testified as follows about BAK.

[00:18:48] Speaker 04:
This is the teachings in the prior art about VAK.

[00:18:51] Speaker 04:
It is a natural born killer.

[00:18:53] Speaker 04:
It is from Satan.

[00:18:55] Speaker 04:
It will increase your interocular pressure, the very thing you're trying to decrease with this medication.

[00:19:01] Speaker 04:
It will increase hyperemia, the very problem that the inventors were trying to solve with this reformulation.

[00:19:08] Speaker 04:
It will peel the corners of your corneal cells.

[00:19:12] Speaker 04:
So this isn't a side effect we're talking about here.

[00:19:14] Speaker 04:
We're talking about true toxicity.

[00:19:16] Speaker 04:
So if we take that and we put it into Galderma, if in that case the adapalene, by increasing it, wasn't simply gonna make a little more irritation, it was gonna make your acne worse and it was gonna give you eczema, then would that invention have been obvious in Galderma?

[00:19:34] Speaker 04:
I would submit no, it wouldn't have.

[00:19:35] Speaker 04:
And that's what we have here.

[00:19:37] Speaker 04:
An exceedingly toxic drug that all the prior artists teaching get away from use as little as possible.

[00:19:44] Speaker 04:
Now, appellant, the last counsel that was here, said to the court, well, but there were two, Zalitan and Trabatan, they were on the market at higher BAKs.

[00:19:54] Speaker 04:
As he conceded, in the record, the evidence was that they had to use that much BAK because the BAK was complexing with the Latanoprost in the case of Zalitan and with the Traboprost in the case of Trabatan.

[00:20:08] Speaker 04:
And therefore, the preservative part of the BAK

[00:20:12] Speaker 04:
was a very small amount, so they had to put that much in.

[00:20:15] Speaker 04:
But even having done that, they then immediately began efforts to try to get rid of it.

[00:20:21] Speaker 04:
In travitans, the evidence is that they got rid of it all together with travitan C. They got eliminated the BAK.

[00:20:30] Speaker 04:
In zalotans, the ASADA patent that was discussed at trial and is at A8178, details the efforts of the zalotan inventors to reduce the BAK.

[00:20:41] Speaker 04:
So everything points in the direction of do not pick a higher amount of BAK.

[00:20:47] Speaker 04:
Pick a significantly lower amount.

[00:20:49] Speaker 04:
And this appellants studiously avoid because they have no choice.

[00:20:53] Speaker 02:
I mean, those factual findings are certainly in your favor.

[00:20:56] Speaker 02:
But what really troubles me about this is that it seems like if the district court had made factual finding on the other side, there's probably evidence to support them.

[00:21:05] Speaker 02:
and that we would then be identical to Galderma.

[00:21:08] Speaker 02:
And it seems very troubling to me that we have a case that seems on all fours with this one, and it's coming out a different way because of different factual findings that really don't seem all that different.

[00:21:23] Speaker 04:
Well, I would respectfully disagree, Your Honor, in that the difference is this.

[00:21:27] Speaker 04:
In Galderma, we were talking about one point.

[00:21:29] Speaker 04:
We have to look at the invention as a whole here.

[00:21:31] Speaker 04:
We're not just talking about lowering the active from 0.03 to 0.01.

[00:21:36] Speaker 04:
We're talking about raising the preservatives from 50 parts per million to 200 parts per million.

[00:21:42] Speaker 04:
Galderma was simply talking about changing the amount of the active ingredient and actually raising it so that it would be more effective.

[00:21:51] Speaker 02:
And what Galderma was saying- I don't read Galderma as confining itself to just obviousness within one range though.

[00:21:58] Speaker 02:
I mean, you have two ranges here, but they're both disclosed in your prior art patent, and they both use the same kind of ingredients, and they're just now different in degree and different in effect, which seems to me precisely what Galderma said is obvious.

[00:22:16] Speaker 04:
I would assume they're not a difference in degree.

[00:22:17] Speaker 04:
They are a significant difference in kind, and that's the difference with Galderma.

[00:22:21] Speaker 04:
Yes, it could apply to multiple ranges,

[00:22:24] Speaker 04:
but then you have to do the Galderma analysis for each of those ranges.

[00:22:29] Speaker 04:
So the question is, as far as picking 200 PPM BAK, what does the prior art tell us?

[00:22:35] Speaker 04:
Now, that range was disclosed in the Woodward patent in 1997, but the inquiries in 2005, what would they have known in 2005?

[00:22:46] Speaker 02:
Let me ask you this, you want to dispute the prior art that discloses the 200 back because it has this

[00:22:52] Speaker 02:
they combined or something, I don't know the chemical words for it.

[00:22:55] Speaker 02:
But if the district court had made an opposite factual finding that those did actually disclose the 200 back, would you think that's clearly erroneous?

[00:23:03] Speaker 04:
Yes, it would have been, but he didn't.

[00:23:05] Speaker 04:
What he found was that the 200 parts per million wasn't disclosed as a free BAK of 200 parts per million.

[00:23:16] Speaker 04:
There was only a small amount of free BAK.

[00:23:18] Speaker 04:
And everybody knows that BAK

[00:23:21] Speaker 04:
increases hyperemia.

[00:23:22] Speaker 04:
So what we really have here, Your Honor, is the district court found our way.

[00:23:26] Speaker 04:
We are the appellees.

[00:23:29] Speaker 04:
The court would have to find that every single one of those factual issues was clearly erroneous.

[00:23:35] Speaker 04:
And we have multiple ones.

[00:23:37] Speaker 04:
And so that is just the situation.

[00:23:39] Speaker 04:
Had it come out different, had we been the blue brief, I would be arguing before Your Honor that the court was clearly erroneous.

[00:23:45] Speaker 04:
But in this case, the district court

[00:23:48] Speaker 04:
found every single factual issue in favor of the appellees.

[00:23:54] Speaker 04:
I don't know if your honors have any other specific questions of what was addressed.

[00:23:57] Speaker 04:
I would just very quickly like to point out that your honors did ask about the unexpected results of .01 versus .03 being as effective.

[00:24:09] Speaker 04:
And those were indeed unexpected results because the label width

[00:24:14] Speaker 04:
reference, the prior art, where they compared 0.03, 0.01, and timolol.

[00:24:19] Speaker 04:
The testimony is that 0.01 wasn't just inferior.

[00:24:23] Speaker 04:
It was inferior to the tune of two millimeters of mercury difference in IOP.

[00:24:28] Speaker 04:
And Dr. Noecker, which the court found credible and accepted his testimony, said that every millimeter of mercury counts and that it could make the difference between having to have surgery and not having to have surgery.

[00:24:41] Speaker 04:
Having permanent damage to the optic nerve

[00:24:43] Speaker 04:
or not having permanent damage to the optic nerve.

[00:24:46] Speaker 04:
That, again, is a difference in kind, not a difference in degree.

[00:24:50] Speaker 00:
Tell us why there's adequate written description of the superior results with the .01 200.

[00:25:01] Speaker 00:
We talked about example five.

[00:25:03] Speaker 00:
Example five is not precisely on point.

[00:25:05] Speaker 04:
It is not precisely on point, but it is very close.

[00:25:08] Speaker 04:
It is a prophetic example that says one would expect by reducing the bimatopros

[00:25:13] Speaker 04:
from .03 to I believe in that one it was .15 that you would expect a reduction in hyperemia.

[00:25:23] Speaker 04:
So that's exactly what we were looking for here.

[00:25:26] Speaker 04:
It also teaches about raising the BAK from 50 to 125.

[00:25:31] Speaker 04:
The key that's in the patent that is not in the prior art are figures one and two.

[00:25:37] Speaker 04:
They show that BAK surprisingly acted as a penetration enhancer

[00:25:43] Speaker 04:
for the mammatoprost.

[00:25:45] Speaker 04:
And so while appellants are saying, well, that's not the claim, it is the claim.

[00:25:50] Speaker 00:
The only way... Are these claims that recite results original claims?

[00:25:56] Speaker 04:
Yes, Your Honor.

[00:25:56] Speaker 04:
We have two sets of claims.

[00:25:58] Speaker 04:
We have the formulation claims, and then we have the claims that say it has to be that the .01 has to have the same or similar efficacy to the .03, and that is also... And a claim is part of the specification?

[00:26:12] Speaker 04:
Correct, Your Honor.

[00:26:13] Speaker 04:
We also have that.

[00:26:13] Speaker 04:
The claim is part of the specification.

[00:26:15] Speaker 04:
And we have something else here.

[00:26:16] Speaker 04:
One more thing.

[00:26:17] Speaker 04:
We have the actual formulation for Lumigan.01.

[00:26:22] Speaker 04:
So if I am one of skill in the art, on the written description, the question is, one of skill in the art, looking at the patent, could they see whether or not the inventors were truly in possession of the claimed invention?

[00:26:34] Speaker 04:
We look, we see the actual formulation of Lumigan 0.01, we see the prosthetic example, and we see figures one and two, which taught for the first time, opposite of the prior art.

[00:26:45] Speaker 04:
The prior art showed that an uncharged molecule like Benadipros would not have its penetration enhanced by BAK, just the opposite.

[00:26:55] Speaker 04:
In fact, it would have it inhibited.

[00:26:57] Speaker 04:
our inventors stumbled upon the surprising result that in fact it increased penetration.

[00:27:03] Speaker 04:
So what does that mean?

[00:27:04] Speaker 04:
That means that when a skill in the art would know that we could lower it from .03 to .01 while maintaining efficacy.

[00:27:11] Speaker 04:
Why?

[00:27:12] Speaker 04:
Because we got the increased penetration.

[00:27:14] Speaker 04:
And we only knew that because our inventors stumbled upon it and that's what's shown in figures one and two.

[00:27:20] Speaker 04:
You have to look at all the specifications.

[00:27:22] Speaker 02:
Can I ask you this?

[00:27:23] Speaker 02:
During the lifetime of your prior art patent that claimed these very broad ranges, if a competitor had come on the market with this new formulation and gotten sued by you presumably because it was within the range of your prior art patent, could they have argued to get out of the patent coverage that it actually wasn't covered by your prior art patent because the prior art taught away and this was unexpected results?

[00:27:48] Speaker 02:
Or would they have infringed your prior art patent with this new formulation?

[00:27:54] Speaker 04:
You know, that's an interesting question, Your Honor.

[00:27:56] Speaker 04:
I guess the answer is they would have infringed it.

[00:27:59] Speaker 00:
All questions from the bench are presumed to be answered.

[00:28:04] Speaker 04:
That's what we call a say something to give oneself a moment to think statement.

[00:28:10] Speaker 04:
Your Honor is what they could have argued, I assume.

[00:28:14] Speaker 04:
is that the claims were, in the Woodward patent, that the claims would be invalid then because they weren't supported by written descriptions showing that that particular formulation would in fact have been supported by the specifications.

[00:28:30] Speaker 04:
So I think they could have, now luckily I can say that because it's expired, but I think they might have had an argument that that was not supported, but ours is supported because we have

[00:28:41] Speaker 04:
details in our specification that were not in the original 1996 Woodward patent.

[00:28:48] Speaker 04:
If your honors have any other questions, I will cede four minutes of my time.

[00:28:55] Speaker 04:
Thank you.

[00:28:56] Speaker 00:
Why don't you just address PH, which was addressed before, but you can give them a chance to respond if Ms.

[00:29:05] Speaker 00:
Maynard wishes to.

[00:29:06] Speaker 04:
Yes, Your Honor.

[00:29:07] Speaker 04:
So it's a very simple issue.

[00:29:09] Speaker 04:
And again, it was a factual finding.

[00:29:11] Speaker 04:
The question is this.

[00:29:11] Speaker 04:
The claim reads about 7.3.

[00:29:15] Speaker 04:
High-tech formulation is 7.2.

[00:29:17] Speaker 04:
Dr. Noah testified that in his expert opinion is one of skill in the art, 7.2 is about 7.3.

[00:29:28] Speaker 04:
The court accepted that as a factual finding that the court made.

[00:29:33] Speaker 00:
And the patent that discloses and claims about 7.3 also has 7.4 in it?

[00:29:41] Speaker 04:
That is what our expert testified.

[00:29:43] Speaker 00:
Well, I mean, you read it.

[00:29:46] Speaker 00:
I think it includes 7.

[00:29:48] Speaker 00:
It states 7.4, doesn't it, as well as 7.3.

[00:29:53] Speaker 04:
I believe so, Your Honor.

[00:29:54] Speaker 04:
But the claim itself that we're talking about

[00:29:57] Speaker 04:
to get the exact wording, I will look at the 504, is a composition having a pH of about 7.3, which consists essentially of, and then it gives the .01% of the matapross, 200 parts per million BAK, and the rest, the phosphate buffer, the water, et cetera.

[00:30:17] Speaker 04:
And so the claim says about 7.3.

[00:30:19] Speaker 04:
The factual inquiry is, is 7.2 about 7.3?

[00:30:24] Speaker 04:
The judge found that it was.

[00:30:26] Speaker 04:
was not clearly erroneous.

[00:30:28] Speaker 04:
It's a rather straightforward infringement argument.

[00:30:32] Speaker 00:
Thank you, Ms.

[00:30:33] Speaker 00:
Brooks.

[00:30:33] Speaker 04:
Thank you very much.

[00:30:34] Speaker 00:
Ms.

[00:30:34] Speaker 00:
Maynard has three minutes to rebut.

[00:30:41] Speaker 05:
I appreciate your exploring my time, Dr. Laurie.

[00:30:43] Speaker 05:
If I could make quick points on the Galderma.

[00:30:48] Speaker 05:
Galderma builds on precedent from this cohort dating back to 1930s.

[00:30:52] Speaker 05:
It doesn't mention genus and species.

[00:30:55] Speaker 05:
It says that when something is within a prior art range and you attempt to claim it again, there must be something beyond just that.

[00:31:05] Speaker 05:
Come over, come in.

[00:31:06] Speaker 02:
I see where you're going with Galdurman, and it seems to me that if the district court had made different factual findings, then it would be on all forms.

[00:31:17] Speaker 02:
But it does say that when you're within ranges,

[00:31:21] Speaker 02:
you know, then it falls to the patentee to show unexpected results and teaching away or things like that.

[00:31:28] Speaker 02:
And that's precisely what the district court found here.

[00:31:31] Speaker 02:
And I have a hard time seeing how those findings, even if I might disagree with them, are clear error.

[00:31:37] Speaker 05:
The district court found almost exactly the same kinds of things in Galderma, Judge Hughes.

[00:31:42] Speaker 05:
And the court held the patents obvious because it is not a teaching away

[00:31:49] Speaker 05:
just because a known composition is slightly inferior to another known composition for the same use.

[00:31:55] Speaker 05:
And so the Galderma held the teaching away, said to the extent we have to hold it clearly erroneous, we hold those finds clearly erroneous.

[00:32:01] Speaker 05:
To the extent you think you need to do that, I think the same is true here.

[00:32:04] Speaker 05:
There's nothing but that here.

[00:32:07] Speaker 02:
The back 200 parts- So the teaching away, I think you're close on, but the unexpected result, it seems to me that that finding

[00:32:16] Speaker 02:
is supported by pretty strong expert testimony that is hard to get around.

[00:32:22] Speaker 05:
Well, in Galderma, there is a finding that there is an unexpected outcome.

[00:32:28] Speaker 05:
There was also that finding in Galderma that the Galderma Court of Appeals let stand but said a difference in degree is not, as a legal matter, does not amount to

[00:32:41] Speaker 05:
evidence of non-obviousness.

[00:32:42] Speaker 05:
And that is exactly the same thing that we have here.

[00:32:45] Speaker 05:
And in response to your question, to opposing counsel, they asserted the 891 patent in this case.

[00:32:52] Speaker 05:
I can't find all the complaints because they're not in the JA, but at A344 is the cover page to the original complaint against Watson.

[00:33:00] Speaker 05:
And in the first paragraph it says, this is an action for infringement of the United States Patent 504 and the 819 patent.

[00:33:08] Speaker 05:
They've been blocking people from using this current product during the whole life of their previous patent, and the patent laws don't allow that.

[00:33:18] Speaker 05:
That is the basis of the Galderma line of cases.

[00:33:21] Speaker 05:
If I could make one more point about the written description.

[00:33:30] Speaker 05:
Example five is not close enough, as my colleague pointed out.

[00:33:33] Speaker 05:
It's significantly different, 50% different than the amount of the amount approached, 60% different in the amount of fact.

[00:33:40] Speaker 05:
And Judge Lurie, the results claim, it's my understanding that they aren't original claims, that they first appeared in 2012.

[00:33:48] Speaker 05:
This product, the Lumigan .01 product, was introduced to the market in 2010.

[00:33:54] Speaker 00:
So these plans that recite results were added during prosecution of those patents?

[00:34:04] Speaker 05:
I am reporting information that's been told to me.

[00:34:06] Speaker 05:
I understand that they were added in 2012.

[00:34:08] Speaker 00:
While the applications in which they issued were pending?

[00:34:16] Speaker 05:
May Mr. Roth address it because I think he knows better than I. Briefly.

[00:34:22] Speaker 03:
Yes, they were first introduced in February 2012 in the application leading to the 118 and 353 patents.

[00:34:33] Speaker 03:
As a third continuation from 2005 was the original application.

[00:34:38] Speaker 03:
The original application in 2005 didn't have any clinical elements.

[00:34:41] Speaker 03:
Only had them in 2005.

[00:34:43] Speaker 03:
But the clinical elements as claimed were first introduced to the spec or the claim in February 2012.

[00:34:50] Speaker 05:
And I have sites, I think, for that, Your Honor.

[00:34:52] Speaker 05:
A26801, A26829-32, A29641, A29663666.

[00:35:02] Speaker 05:
We would request that you reverse.

[00:35:06] Speaker 00:
Thank you.

[00:35:06] Speaker 05:
Thank you, Your Honor.

[00:35:08] Speaker 00:
Ms.

[00:35:08] Speaker 00:
Mayne, we'll take this case under review.

[00:35:13] Speaker 03:
Can I address the CAH?

[00:35:14] Speaker 00:
No, I think the argument is over.