[00:01:00] Speaker 03:
Okay, the next argued case is number 181522, Aspera Incorporated Against Arm Nail Pharmaceuticals.

[00:01:08] Speaker 03:
Mr. Maddox, when you're ready.

[00:01:28] Speaker 00:
May it please the court.

[00:01:30] Speaker 00:
of the three grounds for reversal raised here, the one with the most far-reaching implications for anti-litigation going forward.

[00:01:37] Speaker 03:
Can you pick up a little, please?

[00:01:39] Speaker 00:
I beg your pardon.

[00:01:40] Speaker 00:
Of the three grounds presented here, the one with the most far-reaching implications beyond this case is the infringement as a matter of law, the Synovian ruling that the district court made.

[00:01:51] Speaker 00:
And we submit that it was erroneous in two ways.

[00:01:56] Speaker 00:
But the bottom line is the district court took Synovian

[00:02:00] Speaker 00:
where it's never been before, and where this court in Farring declined to take it.

[00:02:06] Speaker 00:
And that is when the end is silent about the claim and there's not a match, you go on and you treat an end of patentee as you would any other patentee, prove infringement.

[00:02:19] Speaker 02:
Well, it seems that this case doesn't squarely fit with Farring, even if you say it doesn't squarely fit with Synovian.

[00:02:30] Speaker 00:
OK.

[00:02:31] Speaker 00:
Well, I'm sorry, would you like me to?

[00:02:37] Speaker 02:
Yeah, go ahead.

[00:02:38] Speaker 00:
Sure.

[00:02:39] Speaker 00:
It doesn't squarely fit in Zinovian.

[00:02:43] Speaker 00:
And I think the judge, as you know, took two steps to get where he ended up.

[00:02:49] Speaker 00:
First, he said, I'm going to take this spec that says 90 to 110 percent of label strength, and I'm going to interpret that to mean

[00:03:00] Speaker 00:
no more than 90%, I'm sorry, no more than 10% decrease in potency at two years as measured by long-term stability testing conditions.

[00:03:13] Speaker 00:
And then having done that transformation, which we say was clear error, you look at the text, 90 to 110 is not 90 to 100.

[00:03:22] Speaker 00:
If the spec had been 90 to 100, maybe it made sense.

[00:03:26] Speaker 00:
But the spec was going for something very different, and when you look at

[00:03:29] Speaker 00:
the facts he cited on 30, excuse me.

[00:03:35] Speaker 00:
None of them actually say that.

[00:03:38] Speaker 00:
They have their expert reciting 90 to 110.

[00:03:40] Speaker 00:
They have their inventor saying when they were trying to come up with their product, they were shooting for no more than 10%.

[00:03:48] Speaker 00:
But no one actually connects how you get from a 90 to 110 of labeled strength, even over shelf life, from that to no more than 10%

[00:03:59] Speaker 00:
decrease as measured by one of two industry standard tests.

[00:04:06] Speaker 02:
But once... But the judge... I mean, this is my point about I asked if this wasn't distinguishable from fairing.

[00:04:13] Speaker 02:
I mean, yes, there were some inferences that the court drew from the ANDA itself, but they weren't attenuated.

[00:04:21] Speaker 02:
They weren't so far removed as the inferences in fairing.

[00:04:26] Speaker 02:
the court said, and the court did a careful analysis of what the ANDA was pointing to.

[00:04:33] Speaker 02:
So I guess I'm trying to understand how you think this is so squarely within Synovian, or I'm sorry, so squarely within fairing when I just don't see the comparison between the two.

[00:04:45] Speaker 00:
Okay, let me ask just this.

[00:04:48] Speaker 00:
Once the court interpreted 90 to 110 to mean no more than 10%,

[00:04:54] Speaker 00:
after two years, which we do think is a clear error, but I understand you say no.

[00:05:00] Speaker 00:
Then you were sort of squarely inferring land in that you then had the same parameter, decrease, but you had different time points.

[00:05:11] Speaker 00:
And the heart of the district court's analysis, once he did that, and this is a quote from A-52,

[00:05:23] Speaker 00:
He says, look, it becomes clear that a decrease of not more than 10% over 24 months imposes a limitation, not just for 24 months, but for all time points, less than 24 months as well.

[00:05:34] Speaker 00:
And that's how he reasoned.

[00:05:36] Speaker 00:
And then he said, well, since you've got that, this means you would include 2% at five months.

[00:05:44] Speaker 00:
If you're 10% at 24 months, this obviously includes 2% at five months.

[00:05:49] Speaker 00:
Now, if you recall from fairing,

[00:05:52] Speaker 00:
the limitation and the spec they were dealing with there.

[00:05:55] Speaker 00:
The limitation was 100% dissolution at 120 minutes.

[00:06:00] Speaker 00:
That was the claim.

[00:06:02] Speaker 00:
And the spec in fairing was at least 80% dissolution at 60 minutes.

[00:06:09] Speaker 00:
And so you could apply the exact same reasoning of the district court to fairing and get the different result.

[00:06:16] Speaker 02:
But the difference here is that given the

[00:06:23] Speaker 02:
the measurements that you used with respect to the stability of the formulations, why wasn't it fair for the court to say, assuming we're using the same measurements that were used in connection with the ANDA?

[00:06:42] Speaker 00:
I beg your pardon.

[00:06:43] Speaker 02:
I mean, what the court said is, I'm only doing exactly what the

[00:06:50] Speaker 02:
the ANDA did in terms of figuring out how to measure stability.

[00:06:56] Speaker 02:
And if I'm using the same measurements that they're using and this is where I come out, why isn't that inference a fair one?

[00:07:03] Speaker 00:
Well, two things.

[00:07:04] Speaker 00:
One, it's not the same as used in the ANDA.

[00:07:07] Speaker 00:
The ANDA used both in their stability sections.

[00:07:10] Speaker 00:
And throughout the case, it's been undisputed.

[00:07:13] Speaker 00:
You need to use both.

[00:07:14] Speaker 00:
The FDA requires you to use both.

[00:07:17] Speaker 00:
And everyone uses both.

[00:07:19] Speaker 00:
But moving on to

[00:07:21] Speaker 00:
Where's the fairing problem once he's done that?

[00:07:24] Speaker 00:
It's here, because in fairing, he could have written the sentence in fairing.

[00:07:29] Speaker 00:
It becomes clear that a specification of at least 80% dissolution at 60 minutes imposes a limitation not just for 60 minutes, but for all the time points greater than 60 minutes as well.

[00:07:43] Speaker 00:
If you have a spec that says you gotta have at least 80% dissolution at 60, you're gonna overlap

[00:07:51] Speaker 00:
100% dissolution, not 120, because dissolution doesn't go down.

[00:07:55] Speaker 00:
He did an inference that this court, with respect to time point, that this court didn't do, and said, look, time points are silent.

[00:08:03] Speaker 00:
You've got to be treated like any other patentee.

[00:08:06] Speaker 00:
That's where we see the deviation from fairing.

[00:08:10] Speaker 01:
My understanding of fairing was there was a question mark in that product as to what the dissolution rate actually would be over 60 minutes.

[00:08:20] Speaker 01:
Even if the ANDA product would meet the third recited dissolution rate for 60 minutes, it was unclear whether the ANDA product was going to have the same dissolution at the other marker points.

[00:08:37] Speaker 01:
Here, this ANDA product certainly encompasses a product in which there's no more than 2% concentration loss

[00:08:51] Speaker 01:
at 24 months.

[00:08:53] Speaker 01:
And so that would necessarily mean it also would be no more than a 2% concentration loss at five months.

[00:09:03] Speaker 01:
And if that's true, then this and a description encompasses the claimed invention.

[00:09:13] Speaker 01:
How does it not encompass the claimed invention?

[00:09:16] Speaker 00:
If you accept the transformation, and by the way... You're 90% to 110% requirement, right?

[00:09:25] Speaker 01:
If you convert that to... Doesn't that encompass losing no more than 2% of the concentration at 24 months?

[00:09:35] Speaker 00:
It's a different measure.

[00:09:36] Speaker 00:
It's what do you have at the end of 24 months of shelf life?

[00:09:40] Speaker 00:
Not of testing, not of stability testing.

[00:09:43] Speaker 00:
That measure is going to

[00:09:45] Speaker 00:
shelf life, which is a different thing.

[00:09:47] Speaker 01:
Wouldn't it not encompass products that after 24 months loses something less than 2% concentration?

[00:09:58] Speaker 00:
Is it possible that there is a product that could meet that spec, stay within 90 to 110 over a shelf life, and not lose more than 2% under long-term testing conditions?

[00:10:12] Speaker 00:
I don't know, I'd want to see the long-term testing condition results that's different than where we are at two years.

[00:10:18] Speaker 00:
And especially, we'd like to see long-term testing results at five months.

[00:10:23] Speaker 01:
I guess I'm trying to understand why is it unreasonable to read your description of 90 to 110 at 24 months as encompassing a product that doesn't lose more than 2% concentration after 24 months.

[00:10:38] Speaker 00:
And I'm suggesting it's the same

[00:10:42] Speaker 00:
whether it's reasonable or not, I suppose, it's the same time point inference that this court declined to make.

[00:10:50] Speaker 02:
But the district court said that the inference flowed naturally from the ANDA.

[00:10:57] Speaker 02:
If you put the ANDA together with the contemplation of the two-year shelf life and the proposed labeling, if you put those three together, the inference flowed naturally from that.

[00:11:07] Speaker 02:
Are you saying that that's in Synovian

[00:11:10] Speaker 02:
there can be zero inference, even if it's completely a logical one?

[00:11:17] Speaker 00:
I'm saying, first of all, I don't see how 110 to 90, or 90 to 110, becomes 90 to 110, because that's really what they're saying.

[00:11:27] Speaker 00:
They're saying you take 90 to 110, and you say you can't lose more than 10.

[00:11:31] Speaker 00:
Well, if you're going to just ignore the 110 part and just assume you started at 100, and you came below 90, I guess that makes sense.

[00:11:39] Speaker 00:
But this was not

[00:11:40] Speaker 00:
that spec.

[00:11:41] Speaker 00:
It wasn't the stability specs are in the stability testing and the stability data, which they couldn't prove infringement on in the end.

[00:11:49] Speaker 00:
This is a different animal.

[00:11:51] Speaker 01:
But even if you say... I'm still lost because even under your position, your position is, well, you can't lose more than 20 after two years.

[00:12:00] Speaker 01:
But to me, that covers you can't lose more than two after two years.

[00:12:04] Speaker 00:
You can't lose more than

[00:12:06] Speaker 01:
20%.

[00:12:06] Speaker 01:
And then the claim says you can't lose more than 2%.

[00:12:10] Speaker 01:
At five months tested in one particular test.

[00:12:13] Speaker 01:
But just for purposes of this fact pattern, you can't lose more than 20% after 24 months.

[00:12:22] Speaker 01:
It encompasses you can't lose more than 20% after 24 months.

[00:12:28] Speaker 00:
It encompasses a great deal.

[00:12:30] Speaker 01:
If it encompasses that, and then why wouldn't that

[00:12:34] Speaker 01:
result, you can't lose more than 2% after 24 months, necessarily also encompass, you can't lose more than 2% at month five.

[00:12:43] Speaker 00:
If we were talking about the same testing, it would encompass that.

[00:12:48] Speaker 00:
But the claim is talking about a particular test regime that's used not at two years, it's used at five months.

[00:12:55] Speaker 02:
OK, can we go back to my question?

[00:12:57] Speaker 02:
Yes.

[00:12:57] Speaker 02:
And assume for purposes of this question that the inference is a reasonable one.

[00:13:02] Speaker 00:
OK.

[00:13:03] Speaker 02:
All right?

[00:13:03] Speaker 02:
Because when I said even if the inference is a reasonable one, would you say you can't have any inference under Sinovian and all you did was say, but it's not a reasonable inference?

[00:13:12] Speaker 02:
I'm sorry.

[00:13:13] Speaker 02:
So assume it's a reasonable inference.

[00:13:15] Speaker 02:
Are you saying that under Sinovian there can be zero opportunity for inferences even if it's a completely reasonable one?

[00:13:21] Speaker 00:
There are two inferences going.

[00:13:23] Speaker 00:
And the inference from 90 to 110 to 90, sorry, to no more than 10.

[00:13:31] Speaker 00:
if that's the inference, that's the inference.

[00:13:33] Speaker 00:
I would say it's a question of fact, but there it is.

[00:13:38] Speaker 00:
What I'm suggesting is that in fairing, the same reasonable inference was there, and this court didn't take it, because this court wanted to stay on silence, or you need an actual direct hookup, otherwise it can be a slippery slope, and a whole third route to Pat, and the plaintiffs.

[00:13:58] Speaker 02:
The inference.

[00:14:01] Speaker 02:
on my question, that you can have zero inferences no matter how logical.

[00:14:06] Speaker 00:
No, you can have some inferences, I'm sure.

[00:14:10] Speaker 00:
But this court already looked at one particular inference in Ferris and didn't take it and said, no, you go back to traditional plan.

[00:14:18] Speaker 00:
And that inference was on time point.

[00:14:21] Speaker 00:
Because in faring, just as greater than 80% dissolution at 60 minutes, you could infer that that overlaps with

[00:14:30] Speaker 00:
whatever's going to give you the claim of 100% dissolution at 120 minutes, because dissolution doesn't reverse, just as the district court said here.

[00:14:40] Speaker 00:
This court said, no, it's silent as to 120 minutes.

[00:14:45] Speaker 00:
Go prove your case.

[00:14:48] Speaker 00:
I may turn to a definite.

[00:14:51] Speaker 03:
OK, to move on?

[00:14:53] Speaker 03:
Yes.

[00:14:53] Speaker 03:
All right, let's hear from the other side.

[00:14:55] Speaker 03:
OK.

[00:15:04] Speaker 04:
Thank you your honor and may it please the court.

[00:15:08] Speaker 04:
I will try to speak up, but I have a very bad head cold and I hope I don't infect anyone.

[00:15:15] Speaker 04:
The Senovian fits our case to a tee we believe.

[00:15:18] Speaker 04:
We believe that the district court's application was straightforward and non-controversial and let me tell you why and I want to sort of change the jargon that we've been using but I think it's helpful to think of the claim limitation in Senovian as a ceiling

[00:15:35] Speaker 04:
The claim specified that an impurity should not exceed the concentration of more than about 2% at five months.

[00:15:43] Speaker 04:
The ANDA here, I'm sorry, the ANDA in Sanovian sought, I have to start over here, I apologize very much.

[00:15:54] Speaker 04:
The claim in Sanovian specified that a contaminant should not exceed, the concentration of a contaminant should not exceed 0.25%.

[00:16:04] Speaker 04:
The Ando there sought approval to manufacture a generic version of the drug, but the concentration of the impurity in the Ando was to be 0.6%.

[00:16:14] Speaker 04:
So it was a ceiling.

[00:16:18] Speaker 04:
You could not exceed 2% in the case of the claim, 6% in the case of the higher ceiling.

[00:16:27] Speaker 04:
The Sinovian court found that the Ando sought approval both for a drug that would infringe under 2.5% and a drug that would

[00:16:34] Speaker 04:
not infringe above 2.5 percent.

[00:16:38] Speaker 04:
But that was enough to entitle the patentee to a judgment of infringement as a matter of law.

[00:16:44] Speaker 04:
In our case it's the same.

[00:16:46] Speaker 04:
Excuse me.

[00:16:47] Speaker 04:
Claim 6 of the 106 patent is about stability.

[00:16:50] Speaker 04:
It sets a ceiling for the loss of the active pharmaceutical ingredient at no more than about 2 percent at five months.

[00:16:57] Speaker 04:
The ANDA seeks approval of a ceiling

[00:17:00] Speaker 04:
for a loss of no more than about 10% with a shelf life of 24 months.

[00:17:06] Speaker 04:
And when Judge Andrews rationalized the baseline, and Judge Shenu were asking about this rationalized the baseline to fix it so that he could talk about 100% as opposed to 90 to 110%, it doesn't make any difference because if he hadn't done that, the ask in the end, if you will, the ask for approval would have made

[00:17:28] Speaker 04:
the concentration was even higher so it would always it would always have encompassed the not more than two percent but he he did rationalize the baseline makes it easier to talk about but it doesn't change the result plus this argument about rationalizing the baseline being here I don't think that argument was ever made I think it was waived but it as I say it doesn't matter if it was waived or not the outcome is the same can you talk about fairing because that's what their opposing council focused on and pointed out that those were

[00:17:58] Speaker 01:
different time points, and that our court was unwilling to make certain inferences about other non-disclosed time points in the ANDA, having only been offered one time point in the ANDA.

[00:18:14] Speaker 01:
And isn't that kind of what we've got going on here?

[00:18:18] Speaker 01:
Two different time points.

[00:18:19] Speaker 04:
I think it's different.

[00:18:23] Speaker 04:
synovian is a narrow enough case um... that it it can be distinguished from faring uh... synovian uh... i don't know i'm not here to debate how narrow it is it's it it clearly encompasses the facts in our case but i think it's narrow enough that it avoids the problem in faring or faring at least it is distinguishable as is uh... presenting a different problem the case there involved a modified release of lyseteta i think that's how it's pronounced uh... there were three patents

[00:18:52] Speaker 04:
They claim both ceilings and floors.

[00:18:55] Speaker 04:
I talked about ceilings in Sunovion.

[00:18:57] Speaker 04:
In fairing, there were ceilings and floors.

[00:19:01] Speaker 04:
As you pointed out, the dissolution rate was unclear, so that was a challenge when it came to trying to figure out whether it would meet a ceiling and a floor at the same time in the same pattern.

[00:19:13] Speaker 04:
And it turned out that the combination of floors and ceilings

[00:19:17] Speaker 04:
in the claims were compared to the single floor that was requested in the end all the end of requested was i think floor eighty percent dissolution uh... in a point in time uh... it turns out that given the combination of ceiling and floors and the uncertainty about the dissolution rate that just wasn't possible in any one of the three patents to determine whether the approval was being sought would result in a

[00:19:45] Speaker 04:
a drug being manufactured that would infringe any of those pats required more information information was available on the on the face of the patent and so the court there correctly declined to to uh... uh... make a finding uh... under under the rationals of synovian uh... to me what what did synovian mean though when it's said and asked to resolve the question of infringement in the first instance

[00:20:12] Speaker 04:
So I think it means... Pretty strong statement.

[00:20:15] Speaker 04:
It's a strong statement, but I think that that's what Judge Andrews did.

[00:20:19] Speaker 04:
I think what he did as an example of in the first instance, he specifically found, and this is in the joint appendix as part of his opinion, that at five months, the Andes sought approval of up to a 10% ceiling of loss.

[00:20:35] Speaker 04:
And that is approval for a ceiling of loss of up to 2%, which would include

[00:20:41] Speaker 04:
infringement and it also would include up to between two percent and ten percent loss which would not be infringing but that's enough to find infringement under the rationale of synovium.

[00:20:57] Speaker 04:
He was able to make that finding very straightforwardly because he knows what shelf life means and he knows that when you promise a shelf life or you're seeking

[00:21:11] Speaker 04:
approval for a shelf life of 24 months that never exceeds a 10% loss.

[00:21:18] Speaker 04:
What that means is that at one month it will be not more than a 10% loss, at two months it's not more than a 10% loss, at three months it's not more than a 10% loss, and so on.

[00:21:27] Speaker 04:
So when he looks at the five month time point, he easily sees that what's being sought is approval to manufacture a generic version that will not exceed 10%

[00:21:39] Speaker 04:
five months, and that falls right in the Synovian rule.

[00:21:42] Speaker 04:
That's exactly what the case was in Synovian.

[00:21:46] Speaker 02:
But the district court acknowledged that at first glance, the measurement of time points specified in the defendants ANA and the 106 may appear not to read on one another, right?

[00:21:57] Speaker 04:
I agree he says that.

[00:21:58] Speaker 02:
Started with that.

[00:21:59] Speaker 04:
I agree with that.

[00:22:00] Speaker 02:
And then he applied a number of inferences to fight infringement, even if they're logical inferences.

[00:22:09] Speaker 02:
Isn't that more like what we said you can't do in fairing than what we said you could do in snow?

[00:22:16] Speaker 04:
Well, in fairing you can study, I think, I didn't do it, but I believe from the opinion that's clear that you can study the anda, you know, until the cows come home, proverbially, and you'll never be able to figure it out.

[00:22:29] Speaker 04:
I don't think Judge Andrews had to do a very searching review of the anda here.

[00:22:33] Speaker 04:
It's very straightforward.

[00:22:36] Speaker 04:
If you're

[00:22:36] Speaker 04:
If you're asking for approval to manufacture a drug that will not, where the concentration will not exceed 10% over the shelf life of the drug, you're asking for 10% for every time point along that 24-month period, and that would include at the five-month period.

[00:22:56] Speaker 04:
And that's not a difficult thing to figure out.

[00:22:58] Speaker 04:
Plus, there's no dispute

[00:23:00] Speaker 04:
that shelf life means testing under long-term conditions.

[00:23:03] Speaker 04:
I know something was said about the testing conditions, so it's no dispute about that.

[00:23:07] Speaker 04:
Dr. Yaman, their expert, conceded that everyone in the industry would understand that when you're talking about shelf life of a drug that will be administered to a patient, you're talking about testing under long-term conditions, because that's how it's done.

[00:23:21] Speaker 04:
That's what it means in this field of art.

[00:23:25] Speaker 04:
So the fact that

[00:23:27] Speaker 04:
Judge Andrews had to read and think a little, should not take this ruling out of the principle of synovian.

[00:23:36] Speaker 04:
He didn't have to do anything that was difficult.

[00:23:38] Speaker 04:
He didn't have to do anything that required looking at anything other than the ANDA and the patent.

[00:23:44] Speaker 02:
How much more work would it have been to prove infringement as a matter of fact?

[00:23:48] Speaker 02:
You just would have had to have a lot more samples, right?

[00:23:50] Speaker 04:
Well, the problem was we would have had to have a lot more samples of the allegedly infringing drug.

[00:23:55] Speaker 04:
We only had a very small sample set because the FDA requires only a very small sample set.

[00:24:01] Speaker 04:
And because the FDA requires only a very small sample set, we said that should be enough because the FDA, after all, is an expert.

[00:24:08] Speaker 04:
And if it's enough, if a small sample set... This is a Hatch-Waxman case.

[00:24:13] Speaker 03:
Wasn't that the background for how infringement was presented?

[00:24:19] Speaker 04:
Well, that's right, Your Honor.

[00:24:20] Speaker 04:
I think that Sinovian makes particularly good sense in the background of a Hatch-Waxman case, because it's not necessarily expected.

[00:24:28] Speaker 04:
In fact, it might be considered a routine for infringement not to be challenged, because you're copying a drug, and you're copying the label of the drug.

[00:24:38] Speaker 04:
And it would make sense that it ought to be possible to determine if there's infringement on the face of the and in comparison to the patent claim.

[00:24:49] Speaker 04:
To me, Sinovian makes tremendous sense.

[00:24:51] Speaker 04:
I don't think we'll have, by affirming Judge Andrews here, I don't think it'll have any far-reaching consequences.

[00:24:57] Speaker 04:
In fact, I think most people will just look at that and say, oh, that was an easy call, because I don't think this is a difficult case.

[00:25:02] Speaker 04:
I think it falls squarely within Sinovian, and we'd ask the court to affirm.

[00:25:10] Speaker 04:
I do have a little bit of time left.

[00:25:11] Speaker 04:
I'm happy to talk about inherency, but I don't feel the need to talk.

[00:25:14] Speaker 01:
But what did the inventors actually invent here?

[00:25:17] Speaker 01:
What's their inventive contribution?

[00:25:19] Speaker 04:
well so what did they give to the world here so they figured out a way to uh... to make it uh... stable the the the problem and i didn't invent the pharmaceutical composition that's not been personal that that that was incorrect and that's that's a good event glass containers that was in the that's correct okay well where is it well so the two percent limitation and not more than two percent limitation was not prior that was conceded that's why

[00:25:50] Speaker 04:
Neil had to try to prove it.

[00:25:53] Speaker 01:
Was the invention finding those special subclass of glass containers that can prevent more than 2% loss of concentration after five months?

[00:26:05] Speaker 04:
So I don't think that's right.

[00:26:06] Speaker 04:
I think the combination, it wasn't any particular element.

[00:26:12] Speaker 04:
Because as you pointed out, the glass in the stopper

[00:26:16] Speaker 04:
were in the prior art.

[00:26:17] Speaker 04:
What wasn't in the prior art, and this goes to the inherency question really, what wasn't in the prior art, wasn't shown to be in the prior art, wasn't argued to be in the prior art, are all of the things that were controlled for in example five of the patent.

[00:26:30] Speaker 04:
And what I'm talking about is the samples that were presented to the court, to the district court, as evidence of inherency were samples that were made in a particular way.

[00:26:41] Speaker 04:
And the way in which they were made included

[00:26:44] Speaker 04:
the type one glass and the teflon coated stopper but also included controlling for the method of fill including a nitrogen blanket occupying the headspace inside the sealed container and also filtering for pardon me filtering for contaminants and

[00:27:13] Speaker 04:
in controlling the pH.

[00:27:14] Speaker 02:
So all of those things.

[00:27:15] Speaker 02:
So are you saying that they figured out a way to make it stable, or did you just figure out that it could be stable, if properly stored?

[00:27:27] Speaker 04:
I guess it would be the latter.

[00:27:28] Speaker 04:
They found a way to, and they showed in the patent, and the tests that were used by Amniel and offered to the court to try to prove inherency, they were tests that Hotspirit itself prepared to demonstrate

[00:27:42] Speaker 04:
that hospira could manufacture a stable 4 micrograms per milliliter concentration of dexmitetomidine and achieve a 24-month shelf life.

[00:27:56] Speaker 04:
That's the invention, I think.

[00:27:58] Speaker 04:
And what the inventors accomplished was they found a way where they could reliably do that.

[00:28:04] Speaker 04:
And they taught other people how to do it in their patents.

[00:28:09] Speaker 04:
That's an invention under our law, and particularly where there was not even a dispute about this question of the 2% limitation being somewhere in the prior.

[00:28:20] Speaker 04:
It's not there.

[00:28:21] Speaker 04:
It's not in the prior.

[00:28:22] Speaker 04:
There was only one route to go, and the route was inherency.

[00:28:25] Speaker 04:
And the evidence that they put in to support their argument of inherency fell woefully short.

[00:28:31] Speaker 01:
There's another district court opinion that recently invalidated these claims under Section 103.

[00:28:37] Speaker 04:
Yes.

[00:28:38] Speaker 01:
And have you filed your notice of appeal yet?

[00:28:42] Speaker 04:
We have filed it.

[00:28:42] Speaker 01:
OK.

[00:28:44] Speaker 01:
Just hypothetically speaking, an affirmance here wouldn't impact in any way this court's review of that appeal.

[00:28:54] Speaker 04:
An affirmance here would not impact the review of that other case.

[00:28:57] Speaker 04:
That's correct.

[00:28:58] Speaker 01:
Because it's a different record.

[00:29:00] Speaker 04:
It's a different record, but it's a different party.

[00:29:04] Speaker 03:
I don't think we need to resolve that point.

[00:29:07] Speaker 03:
It's not a simple one.

[00:29:10] Speaker 04:
Yeah, I agree with that.

[00:29:10] Speaker 04:
It's not a simple one.

[00:29:11] Speaker 04:
I think, and I'll leave it at that, your honor.

[00:29:15] Speaker 04:
I do have some thoughts about it, but I'll leave it at that.

[00:29:17] Speaker 04:
And I have a few seconds left.

[00:29:19] Speaker 04:
I feel like I'm done unless you have more questions for me.

[00:29:23] Speaker 03:
The inherency is really the problem.

[00:29:26] Speaker 03:
And your position is that it was not obvious to go to 2%.

[00:29:33] Speaker 03:
Turns out the beneficial property

[00:29:37] Speaker 03:
is present.

[00:29:38] Speaker 03:
Is that right?

[00:29:39] Speaker 04:
I think it's a fair statement, Your Honor.

[00:29:41] Speaker 04:
I don't mean to be conceding anything, but I'm comfortable saying that.

[00:29:45] Speaker 04:
That is our position.

[00:29:47] Speaker 04:
They were able to do something that was unexpected.

[00:29:49] Speaker 04:
They thought it would be a tremendous challenge going from a high concentration down to this four microgram concentration, which in this area of pharmaceuticals is a very, very, very low concentration.

[00:30:03] Speaker 04:
And I think everyone expected that it would not be stable.

[00:30:06] Speaker 04:
at that concentration.

[00:30:07] Speaker 04:
And they were able to solve the problem and come up with a drug that could be solved as a premixed drug with a 24-month shelf life, which was an accomplishment that deserved a patent, in our view.

[00:30:21] Speaker 04:
And we would ask the court to affirm Judge Andrews.

[00:30:25] Speaker 03:
Anything else?

[00:30:28] Speaker 03:
OK.

[00:30:28] Speaker 03:
Thank you.

[00:30:31] Speaker 00:
Brief rebuttal.

[00:30:33] Speaker 00:
Yes, Judge O'Malley.

[00:30:34] Speaker 00:
With respect to inferences,

[00:30:36] Speaker 00:
It's going to have to be some.

[00:30:38] Speaker 00:
I understand.

[00:30:40] Speaker 00:
We suggest that if you're going to start inferring about science and what this technical thing means and how that converts to what test protocol and so forth, those inferences should be based on actual expert evidence or data, not attorney arguments.

[00:30:52] Speaker 00:
Second.

[00:30:53] Speaker 02:
So what you're saying is they should have just gotten a lot more samples?

[00:30:59] Speaker 00:
No, they could have had their expert witness say, Judge, this

[00:31:03] Speaker 00:
Here's how 90 to 110 means less than 110.

[00:31:06] Speaker 00:
And here's how this argument was all attorney argument.

[00:31:11] Speaker 00:
There was no expert evidence submitted.

[00:31:13] Speaker 00:
There was no scientific evidence.

[00:31:14] Speaker 00:
There was nothing.

[00:31:16] Speaker 00:
So if there's going to be inferences from Tanovi, then maybe there should be.

[00:31:21] Speaker 00:
They should require actual scientific evidence to support.

[00:31:25] Speaker 00:
Second, it's going to be something you're wrestling with.

[00:31:28] Speaker 00:
Because in medicines, of course, the court wrote,

[00:31:31] Speaker 00:
We don't apply Sinovian with and a quote does not on its face establish infringement.

[00:31:36] Speaker 00:
It is a slippery slope once you start opening this up.

[00:31:39] Speaker 00:
Where you stop it obviously is up to you, but the court has been holding back Sinovian and I would suggest for good reason.

[00:31:48] Speaker 00:
Lastly, and inferring, you're holding there or at least what you wrote.

[00:31:54] Speaker 00:
You said here, however,

[00:31:56] Speaker 00:
The ANDA does not clearly describe a product that meets the limitations of the asserted claims."

[00:32:01] Speaker 00:
That was quoting Snovian, Farron quoting Snovian.

[00:32:04] Speaker 00:
And you wrote, rather, the 2010 ANDA is silent with respect to the claim limitations of the patent and suit, which do not specifically, I'm sorry, which do not specify dissolved dissolution rate at 60 minutes.

[00:32:18] Speaker 00:
You were calling out the absence of the time point.

[00:32:22] Speaker 00:
And then you went on your way.

[00:32:24] Speaker 02:
What would you want us to do if we were to say, OK, this isn't Synovian, even if it's not fairing, but we think there needed to be a more developed showing of infringement?

[00:32:36] Speaker 02:
Do we remand for a new trial on infringement?

[00:32:40] Speaker 00:
Well, obviously, I would like you to reverse.

[00:32:42] Speaker 00:
But if that is where you come out as you grapple with how Synovian is going to spread,

[00:32:46] Speaker 00:
then I would suggest we would have to go back to the court for actual expert evidence, which they should have put in.

[00:32:54] Speaker 02:
But how complicated would that expert evidence be?

[00:32:57] Speaker 02:
That's my problem.

[00:32:58] Speaker 02:
If these are just logical inferences, so you just want them to put an expert on to say this is a logical inference?

[00:33:05] Speaker 00:
Well, I'd like to be able to have an expert to explain why it's not.

[00:33:09] Speaker 00:
There are many logical inferences all of us can make about science and be wrong.

[00:33:16] Speaker 00:
And so if there's going to be inferences, and if it's not going to be a question of honest face, and if it's not going to be a bright line rule for Sanove, which has its own benefits.

[00:33:28] Speaker 00:
And remember here, we're not talking about the difference between winning and losing a case.

[00:33:33] Speaker 00:
We're talking about whether the end of patentee gets treated like all other patentees and has to focus on the product that will or likely will be introduced.

[00:33:43] Speaker 00:
And that's

[00:33:44] Speaker 00:
something the court has been mindful of since the Glaxo case.

[00:33:48] Speaker 00:
And that's why Ferring said, when you don't have the match, you go to the Glaxo case, which says, come prove your case like anyone else.

[00:33:59] Speaker 00:
Now, there are some representations made about their proof at trial.

[00:34:02] Speaker 00:
It's in the record, but the judge simply did not credit their expert.

[00:34:09] Speaker 00:
And they don't challenge that.

[00:34:11] Speaker 00:
it was for them to come up with an expert that they would credit.

[00:34:14] Speaker 00:
And if they wanted to, they could have had that expert address the specification, give his opinion as to how it would relate to testing under a specific protocol at five months and so forth and so on.

[00:34:27] Speaker 00:
And those would have been an expert report, and I could have had my experts talk about this and show you, frankly, why it's not true.

[00:34:33] Speaker 00:
But to leave it to whatever seems like a logical inference to a non-expert,

[00:34:40] Speaker 00:
Seems to us to be a mistake.

[00:34:41] Speaker 03:
I see I'm out of time.

[00:34:46] Speaker 03:
Thank you.

[00:34:46] Speaker 03:
Thank you both.

[00:34:47] Speaker 03:
The case is taken under submission.