[00:00:28] Speaker 01:
Next case is Impacts Laboratories and AstraZeneca versus Lynette Holdings, 2017-2020.

[00:00:36] Speaker 01:
Mr. Basilico.

[00:00:44] Speaker 04:
Thank you, Your Honor, and please the Court.

[00:00:46] Speaker 04:
This is a case in which the district court did conduct an analysis, looked at the prior art, looked at the differences between the prior art and the claimed invention.

[00:00:55] Speaker 04:
and found that every single element of every claim was found in the prior art, that none of those limitations, none of those requirements created an unobvious subject matter except one.

[00:01:09] Speaker 04:
Those findings, with respect to all those other claim elements, are not under consideration.

[00:01:14] Speaker 04:
They have not been challenged by either party in this case.

[00:01:17] Speaker 04:
The one claim element that the district court found to allegedly be missing from the prior art

[00:01:24] Speaker 04:
as characterized by the district court, is a teaching of the combination of a nasal spray with Zoma tryptan.

[00:01:32] Speaker 03:
The claims in the case... Why does there need to be a teaching when the prior art shows the combination?

[00:01:40] Speaker 04:
I agree, Your Honor.

[00:01:41] Speaker 04:
The prior art that we've relied on, the Cheveau reference, expressly and explicitly teaches the combination of a nasal spray with Zoma tryptan.

[00:01:53] Speaker 01:
But Cheveau had more than Zulma tryptans.

[00:01:56] Speaker 01:
It had capryl, caprowel compound associated with it.

[00:02:03] Speaker 01:
And all these references seem to have some, they were diluted.

[00:02:11] Speaker 01:
They recited a lot of compounds.

[00:02:15] Speaker 01:
And there was a lot of evidence here.

[00:02:18] Speaker 01:
The judge heard an expert, Dr. Rappaport, who said,

[00:02:25] Speaker 01:
This finding was surprising, counterintuitive, shocking.

[00:02:31] Speaker 01:
And there was evidence of the license.

[00:02:40] Speaker 01:
Someone paid millions of dollars for this product, lending authenticity to validity.

[00:02:49] Speaker 04:
So let me try to address a couple of those issues.

[00:02:51] Speaker 04:
First of all, Your Honor, with respect to unexpected results, the district court specifically held there were no unexpected results in this case.

[00:02:58] Speaker 04:
That was a ruling.

[00:02:59] Speaker 04:
Again, that's not challenged by the district court.

[00:03:02] Speaker 04:
With respect to your question about Cheveau, Cheveau actually, and I think that's a fog created by the patentees in this case, Your Honor, Cheveau actually only identifies three specific compounds for use in his formulation.

[00:03:20] Speaker 04:
And one of those compounds is described in one sentence.

[00:03:24] Speaker 04:
The other two compounds are, and I can point to the record, are sumatriptan and zolmatriptan.

[00:03:31] Speaker 04:
Those are the, and those are the only two compounds that Cheveau teaches as being active in treating migraine.

[00:03:39] Speaker 01:
But the trial court found, and there are a lot of findings here about what the references disclosed, to which we owe some deference.

[00:03:48] Speaker 01:
And the trial court said that

[00:03:49] Speaker 01:
specifically teachers away from using Zolotriptan, and there was a metabolism issue here.

[00:03:56] Speaker 04:
Yes, that's correct.

[00:03:56] Speaker 01:
I think that's one reason why the expert witness said it was shocking and counterintuitive, because you had to have the metabolism metabolite for the activity, and therefore using Zolotriptan wasn't obvious.

[00:04:13] Speaker 04:
Yeah, so that goes to the teaching away.

[00:04:17] Speaker 04:
The district court

[00:04:18] Speaker 04:
read the Cheveau reference and said the Cheveau reference teaches away from the use of Zolmitryptan in a nasal spray.

[00:04:27] Speaker 04:
That decision is erroneous for a couple of reasons.

[00:04:30] Speaker 04:
Number one, the Cheveau says nothing.

[00:04:34] Speaker 04:
And the basis for that is supposedly this active metabolite.

[00:04:39] Speaker 04:
Active metabolite is not mentioned at all in Cheveau.

[00:04:43] Speaker 04:
It's not mentioned.

[00:04:44] Speaker 04:
And the district court notes that.

[00:04:45] Speaker 04:
But it says it kind of backdork talks about active metabolite, because shev- and this is very important, Your Honor.

[00:04:52] Speaker 04:
One of the main purposes of chevaux is to not use oral dosage forms.

[00:04:59] Speaker 04:
Chevaux says that an oral dosage form has a disadvantage because the active ingredient degrades, i.e.

[00:05:06] Speaker 04:
becomes not useful in the gut.

[00:05:10] Speaker 04:
And therefore, I've made formulations

[00:05:13] Speaker 04:
that are specifically designed to be useful out other than oral, pharyngeal, buccal, and nasal.

[00:05:22] Speaker 04:
And of those three, Chauvet says nasal is preferred.

[00:05:25] Speaker 04:
In fact, nasal is in the title of Chauvet.

[00:05:29] Speaker 04:
So a person skilled in the art, and I would cite the Merck case for this, Your Honor, which says you can't have a teaching away or you can't make a proper argument for teaching away when

[00:05:43] Speaker 04:
The reference that allegedly teaches away plainly and unequivocally teaches toward the invention.

[00:05:50] Speaker 00:
Can I ask this?

[00:05:51] Speaker 00:
Suppose, just for purposes of this question, that the relatively high standard of teaching away isn't met here.

[00:06:01] Speaker 04:
Correct.

[00:06:02] Speaker 00:
The district court formulated its decision in, I think, first, second, third, and at least, I think, the third says,

[00:06:12] Speaker 00:
no motivation and no reasonable expectation of success.

[00:06:17] Speaker 00:
And the underlying core logic was that people understood from the prior art that for Zoma tryptan, it was in fact the metabolite that was doing most of the work.

[00:06:34] Speaker 00:
And therefore, even though it's listed in a quite long list in Cheveau, a much

[00:06:42] Speaker 00:
shorter list in what pellet or whatever.

[00:06:44] Speaker 04:
Well, no, the list in Cheveau is just Sumitriptan and Zolmitriptan.

[00:06:49] Speaker 00:
Well, but that's one little paragraph in a law.

[00:06:51] Speaker 04:
Well, no, that's a paragraph by itself.

[00:06:55] Speaker 00:
We're not disagreeing.

[00:06:56] Speaker 00:
Oh, I'm sorry.

[00:06:56] Speaker 00:
There are many, many, many more paragraphs in Cheveau about what you can put in nasal sprays, right?

[00:07:01] Speaker 04:
There's one more paragraph.

[00:07:02] Speaker 00:
Just one?

[00:07:03] Speaker 00:
Yes.

[00:07:03] Speaker 00:
OK.

[00:07:04] Speaker 00:
All right.

[00:07:06] Speaker 00:
Why isn't the district court's finding of no motivation and no reasonable expectation of success putting aside teaching away enough because doing this with a nasal spray for Zoma tryptan would actually undo what was understood to be at least the main mechanism

[00:07:28] Speaker 00:
forgetting the active ingredients to do its work.

[00:07:35] Speaker 04:
Okay.

[00:07:35] Speaker 04:
A couple of quick points.

[00:07:36] Speaker 04:
Number one, and this is very important, the record is clear and unequivocal that the level of active metabolite appears in the blood using nasal spray at the same level as oral after three hours.

[00:07:54] Speaker 04:
So there's not a question here

[00:07:56] Speaker 04:
that the metabolite would not end up in the user's body.

[00:07:59] Speaker 00:
Right.

[00:07:59] Speaker 00:
The time is important.

[00:08:01] Speaker 04:
Yes.

[00:08:01] Speaker 04:
It would take three hours.

[00:08:02] Speaker 04:
But two things.

[00:08:03] Speaker 04:
Number one, motivation to combine doesn't apply here because we're not combining two references.

[00:08:10] Speaker 04:
Cheveau is one reference.

[00:08:11] Speaker 04:
All of the motivation cases relate to a motivation to take the teaching from one reference and put it with another.

[00:08:18] Speaker 04:
There are some cases where the motivation to combine has to do with

[00:08:24] Speaker 04:
finding something that's not in the reference, and not using another reference, but the level of skill to say it would be motivated to put that missing element in.

[00:08:33] Speaker 04:
We have no missing element here at all.

[00:08:36] Speaker 04:
Both nasal spray and Zolmitryptan are in the case.

[00:08:40] Speaker 03:
OK, but part of the problem here is that neither side has addressed a couple of relevant cases here, which bear on that question, on that argument that you just made.

[00:08:53] Speaker 03:
One of them is Stepan and one is KeneMetal.

[00:08:56] Speaker 03:
Stepan is in the obviousness context and KeneMetal is in the anticipation context, both dealing with this particular issue of when you're going to say that a reference teaches something so that it becomes irrelevant for obviousness purposes as to whether there was a motivation to come on.

[00:09:20] Speaker 03:
And what Stepan says

[00:09:23] Speaker 03:
is if there's a large number of possible combinations in the patent, that won't necessarily result in treating the combinations having been disclosed.

[00:09:37] Speaker 03:
And the chemo metal says something similar in the anticipation context.

[00:09:42] Speaker 03:
And so it seems to me the question is whether

[00:09:46] Speaker 03:
we read this Cheveau patent and also the other patent, Pretzker, whatever it's called, as disclosing the combination because there are too large a number of references in the patent.

[00:10:06] Speaker 04:
Yes.

[00:10:07] Speaker 04:
OK.

[00:10:07] Speaker 04:
So I would say that the Step-On case does not apply here, because there is not a large number of alternatives.

[00:10:13] Speaker 04:
If you look at two, there's two things that are relevant.

[00:10:16] Speaker 01:
But look at Cheveau.

[00:10:18] Speaker 01:
It mentions antibiotics, bacteriostats, antihistamines, and it's a whole long list of things.

[00:10:24] Speaker 01:
So what Judge Deit is saying, if there's a large genus, that doesn't necessarily disclose or render obvious each possible species.

[00:10:34] Speaker 04:
but we're not picking from that list, Your Honor.

[00:10:37] Speaker 04:
That zomatryptan is not in that list.

[00:10:40] Speaker 04:
That long list.

[00:10:42] Speaker 04:
Sotomayor.

[00:10:43] Speaker 00:
It's in two paragraphs below.

[00:10:44] Speaker 00:
Consider Javaux as having a large list of things you can put in a nasal spray.

[00:10:52] Speaker 00:
As it happens, it's in three paragraphs.

[00:10:54] Speaker 00:
So what?

[00:10:54] Speaker 00:
What Judge Lurie was just reading was the first paragraph, which covers a lot.

[00:11:00] Speaker 04:
And even in that case, Your Honor, I would submit there's no

[00:11:03] Speaker 04:
requirement in the law for motivation to combine.

[00:11:07] Speaker 04:
And the reason is this.

[00:11:08] Speaker 04:
It's prima facie obvious for a person skilled in the art to combine an ingredient from one long list or an element, if you want to call it that, an element from one long list with an element from another long list.

[00:11:23] Speaker 04:
Importantly, that does not mean it's per se not obvious, okay?

[00:11:28] Speaker 04:
It's prima facie obvious.

[00:11:31] Speaker 04:
So if I have a long list, it's 100 ingredients.

[00:11:34] Speaker 04:
And let's assume I had a list of 100 applications, which I don't.

[00:11:38] Speaker 04:
There's only three applications, dosage methods in Cheveau.

[00:11:42] Speaker 04:
It's prima facie obvious to pick one from that list of three and one from that list, let's say it's 100.

[00:11:48] Speaker 04:
That's prima facie obvious.

[00:11:50] Speaker 04:
I don't need to show a motivation to combine.

[00:11:53] Speaker 03:
What I do need.

[00:11:54] Speaker 03:
I would have thought you would focus on the paragraph in column three of Shiloh, line 12, which says that active substance can be, in particular, an anti-migraine active substance such as tryptan, such as solitryptan.

[00:12:11] Speaker 03:
In other words, we don't just have a large undifferentiated list here.

[00:12:16] Speaker 03:
We have a paragraph in the prior art which, in particular, focuses on solitryptan.

[00:12:23] Speaker 04:
That's your right, Your Honor.

[00:12:25] Speaker 04:
And that was kind of the point I was trying to make earlier by saying those two things are mentioned in a single paragraph as being the active ingredients for migraine relief.

[00:12:35] Speaker 04:
And there's only those two that are suggested for that.

[00:12:39] Speaker 04:
I think an important point to make here, Your Honor, is that this goes back to the teaching away question.

[00:12:47] Speaker 04:
And that can't apply as well because even if you were to assume all the

[00:12:53] Speaker 04:
the factual determinations that the judge made were correct when, in fact, we think they're clearly erroneous relating to this metabolite issue, you would come to the conclusion that, at most, the use of the nasal spray would be, let's say, expected to have the disadvantage of getting the metabolite into the bloodstream later.

[00:13:15] Speaker 04:
The reason that can't be a teaching away is because the claim allows that.

[00:13:21] Speaker 04:
That is within the scope of the claim.

[00:13:23] Speaker 00:
Why can it not, however, be a sufficient reason for finding insufficient motivation and insufficient expectation of success?

[00:13:35] Speaker 04:
Again, I think if we're not talking about teaching away, we're talking about motivation.

[00:13:43] Speaker 04:
We don't need a motivation here, number one, because there's

[00:13:48] Speaker 04:
a prima facie obviousness.

[00:13:50] Speaker 04:
And number two, as Judge Dyke said, we have the motivation, number one, in Chaveau, where he says, in particular, these are the two drugs for relieving migraine.

[00:14:00] Speaker 04:
And he clearly points to nasal as the preferred way of administering that drug.

[00:14:08] Speaker 04:
The other thing is there's two other references which the district court did not even address, which also specifically teach the use of Zoma tryptan

[00:14:18] Speaker 04:
to by itself, which the judge said is not in the prior art.

[00:14:23] Speaker 04:
And that's Penkler and Robertson.

[00:14:25] Speaker 04:
And those two.

[00:14:26] Speaker 00:
But what was the role of Penkler in your formulation of an obviousness case here?

[00:14:35] Speaker 04:
It was addressing the judge's concern that there was a teaching in the record that.

[00:14:43] Speaker 00:
Did you say or have to say, the way you would in an IPR,

[00:14:48] Speaker 00:
One of our bases for obviousness is obviousness in light of Pankler.

[00:14:55] Speaker 04:
No, I don't think we did, because that was addressing an error in the, our citation of those references explained to the judge that there was motivation in the prior art to combine nasal spray with Zoma tryptan.

[00:15:11] Speaker 04:
The judge concluded that motive.

[00:15:14] Speaker 03:
You were using Pankler not as

[00:15:17] Speaker 03:
that itself rendered this obvious but as evidence that there would be a motivation to combine?

[00:15:22] Speaker 04:
There would be a motivation, and that the judge's reason for not finding a motivation was factually wrong.

[00:15:28] Speaker 04:
The judge said there would be no motivation because there's nothing in the prior art that shows Zoma tryptan works.

[00:15:35] Speaker 04:
Okay?

[00:15:36] Speaker 04:
That was the basis for the judge's conclusion.

[00:15:39] Speaker 04:
And the only thing the judge cited for that was two experts who said they couldn't recall on the stand which items of prior art

[00:15:47] Speaker 04:
disclosed the working of Zolmitryptan as a migraine relief agent.

[00:15:54] Speaker 04:
And Pinkler and Robinson both specifically say Zolmitryptan is a tryptan which was specifically formulated to relieve migraine.

[00:16:03] Speaker 01:
So the.

[00:16:04] Speaker 01:
Robertson You've consumed your time, including your rebuttal time, but we'll give you three minutes back for rebuttal.

[00:16:16] Speaker 02:
May it please the Court, Jim Hurst.

[00:16:19] Speaker 02:
Good morning, Your Honors.

[00:16:20] Speaker 03:
So you would agree, I assume, that if a prior art reference disclosed Zolotriptan and nasal spray, even though it didn't disclose the PHS that we're dealing with here, that we wouldn't be talking about motivation to combine because the prior art would have already told you to make the combination, right?

[00:16:46] Speaker 02:
I disagree, Your Honor.

[00:16:47] Speaker 02:
Let me tell you why.

[00:16:48] Speaker 02:
Because in the obviousness context, I think you look at the prior art as a whole.

[00:16:53] Speaker 02:
That's what the case law teaches.

[00:16:54] Speaker 02:
You look at the prior art as a whole.

[00:16:56] Speaker 02:
And here, the only real meaningful motivation to make a nasal spray for migraine treatment, because it's generally disfavored, especially for systemic treatment, is to get faster relief.

[00:17:07] Speaker 02:
So the prior art as a whole... I'm not understanding.

[00:17:09] Speaker 03:
Why, if the prior art specifically disclosed a combination of Zolotriptan

[00:17:15] Speaker 03:
and a nasal spray, why can't that be part of the starting point for an obviousness analysis without worrying about motivation to combine those things when the combination's already disclosed?

[00:17:27] Speaker 02:
Because I think that one ordinary skill in the art would look at the prior art as a whole and know that the metabolite is two to eight times more potent than zomatryptin itself.

[00:17:40] Speaker 02:
So that POSA would say to themselves,

[00:17:42] Speaker 02:
Is this a good idea?

[00:17:44] Speaker 02:
It's not a good idea.

[00:17:45] Speaker 02:
I do not have a motivation to pursue.

[00:17:47] Speaker 03:
I don't understand how that argument can be consistent with Stepan and with Kenamettle, both of which suggest that if something is disclosed in the prior art that that's, at least Stepan says, that's what you use for the obviousness now.

[00:18:10] Speaker 02:
because, let me make two points, because for preemphasia, obviously, you have to look at all of the art, which would include the teaching about the more potent metabolite, so that would discourage you from moving forward.

[00:18:19] Speaker 03:
Number one, number two, you also... If it's combined already, why do you need a motivation to combine?

[00:18:23] Speaker 02:
Because one of ordinary skill actually considers the art as a whole and evaluates that statement about whether or not it makes sense to actually pursue it, a motivation to pursue it.

[00:18:33] Speaker 02:
And also, Your Honor, we need a reasonable explanation.

[00:18:35] Speaker 01:
But looking back to the low column three that has already been referred to,

[00:18:38] Speaker 01:
In particular, the patent refers to somatriptan and somatriptan for intranasal use.

[00:18:48] Speaker 01:
Isn't that what's claimed?

[00:18:51] Speaker 02:
It is claimed, but look at the rest of the disclosure in Chabot.

[00:18:55] Speaker 02:
There isn't a massively long list here, 25 categories of drugs, 25 categories of drugs, thousands of them.

[00:19:02] Speaker 01:
None of them say in particular.

[00:19:03] Speaker 02:
Take a look at column two.

[00:19:08] Speaker 02:
50, the active substance can be, in particular, and then they describe a class of compounds which would include thousands of compounds.

[00:19:18] Speaker 02:
Thousands of compounds.

[00:19:19] Speaker 02:
And then if you take a look at the very next sentence, the one that you focused on, Judge Lurie, it says, the active substance can also be, in particular, an anti-migraine active substance.

[00:19:30] Speaker 02:
There's hundreds of anti-migraine active substances.

[00:19:33] Speaker 02:
Such as?

[00:19:34] Speaker 02:
Such as atriptin.

[00:19:36] Speaker 02:
There was, in the record, an enormous number of tryptans disclosed in the prior art.

[00:19:41] Speaker 02:
And they say such as.

[00:19:42] Speaker 02:
This is tough prior art.

[00:19:44] Speaker 02:
It's, it's, it's, look, there's no question about the word sumatriptan.

[00:19:48] Speaker 02:
I mean, I'm sorry.

[00:19:49] Speaker 02:
The word zumatriptan is in a patent that has three different routes of administration.

[00:19:54] Speaker 02:
No question about that.

[00:19:55] Speaker 02:
I get that.

[00:19:56] Speaker 02:
But here the judge looked at this specifically and said to, and, and came to the conclusion based on experts that he, our experts, that he found to be

[00:20:06] Speaker 02:
They articulated their opinions convincingly and with reasoned support, and he made a factual finding.

[00:20:13] Speaker 02:
For the other side to prevail in this appeal... Which factual finding do you have in mind?

[00:20:17] Speaker 02:
The key factual finding, I think, is that he's... This district court found that it would be absolutely counterintuitive to make a nasal spray when you have an active metabolite which is more potent than the drug itself.

[00:20:29] Speaker 03:
But he didn't make a finding on the issue we've been talking about just now as to

[00:20:34] Speaker 03:
as to whether the prior art disclosed the combination.

[00:20:39] Speaker 02:
He did, because what he said is, even though it's on this long list of drugs, he talked about Chaveau, even though it's on this long list of drugs, and there's an enormous number of choices, what the district court found was a skilled artisan would look to any other tryptan.

[00:20:53] Speaker 02:
This is a finding at page 58 of the Court's opinion.

[00:20:57] Speaker 02:
A skilled artisan would look to any other tryptans before looking to

[00:21:00] Speaker 02:
to develop a pharmaceutical product that would not take advantage of first-pass metabolism, i.e.

[00:21:06] Speaker 02:
the nasal spray.

[00:21:07] Speaker 03:
That's the question of motivation to combine.

[00:21:10] Speaker 03:
Let me ask a question about motivation to combine.

[00:21:12] Speaker 03:
Let's assume for the moment that there does need to be a motivation to combine.

[00:21:17] Speaker 03:
This record is replete with evidence that there are advantages to a nasal formulation over an oral formulation.

[00:21:29] Speaker 03:
And based on the fact that in the migraine context, the vomiting is a serious problem, and that obviously if you take a pill and throw it up, it's not going to do you any good.

[00:21:43] Speaker 03:
The district court did not pay any attention to that very significant evidence that that would provide a motivation to combine zolotriptan with a nasal spray.

[00:21:56] Speaker 03:
What's your response to that?

[00:21:58] Speaker 02:
I disagree that the district court didn't look at that, Your Honor, but also the record.

[00:22:02] Speaker 02:
Oh, he never discussed in the opinion at all.

[00:22:06] Speaker 02:
Is that correct?

[00:22:08] Speaker 02:
No, that's not correct.

[00:22:09] Speaker 02:
Where did he discuss it in the opinion?

[00:22:11] Speaker 02:
He discussed the fact that there's a balancing, Your Honor.

[00:22:15] Speaker 03:
Where did he discuss that there was a powerful motivation to combine cellotriptin with a nasal spray because of the difficulties with an oral formulation?

[00:22:27] Speaker 02:
He found the opposite, Your Honor, than what I read before.

[00:22:30] Speaker 03:
Remember, but where does he discuss the evidence?

[00:22:33] Speaker 03:
For which part, Your Honor?

[00:22:35] Speaker 03:
For the evidence providing the motivation to combine Zolotriptan with a nasal spray because it avoids the vomiting.

[00:22:45] Speaker 02:
Here's what, let me, I'm not going to have a specific page reference for your honor.

[00:22:49] Speaker 02:
I want a specific, is there?

[00:22:52] Speaker 02:
I'm going to find one.

[00:22:53] Speaker 02:
Tell me where it is.

[00:22:56] Speaker 02:
Let me tell you what he did discuss.

[00:22:57] Speaker 02:
No, I want to see where he discussed it.

[00:22:59] Speaker 02:
He's going to talk about the fact that I'm going to give a hint to my colleagues.

[00:23:03] Speaker 02:
Okay.

[00:23:03] Speaker 02:
The, the, he talked about the fact that look in the history of migraines, only two nasal sprays were created.

[00:23:10] Speaker 03:
One of which I want you to answer my question.

[00:23:12] Speaker 03:
Did he discuss the,

[00:23:15] Speaker 03:
reason to combine Zolotriptan with a nasal spray because of the vomiting problem?

[00:23:21] Speaker 03:
Did you discuss that?

[00:23:22] Speaker 02:
The answer is yes, indirectly.

[00:23:24] Speaker 02:
He discussed that because... Not directly.

[00:23:28] Speaker 02:
Because... Answer my question.

[00:23:30] Speaker 02:
I do not remember whether he said Zolotriptan would solve the throw-up problem.

[00:23:37] Speaker 02:
When he did so, he talked about the only, in 40 years,

[00:23:41] Speaker 02:
of migraine treatment, despite this incentive you talked about to try to get faster acting treatment from nasal sprays, only two nasal sprays in the history, even to this day, in the history of migraine treatments have been, were created before Zolmitriptan, one of which caused throw-up, Your Honor.

[00:23:58] Speaker 01:
Sumitriptan.

[00:23:59] Speaker 01:
Mr. Hurst, why doesn't, why isn't Pankler in anticipation?

[00:24:04] Speaker 01:
It disposes a small group of Zolmitriptans, including Zolmitriptan, and

[00:24:10] Speaker 01:
It says an intranasal administration is preferable.

[00:24:22] Speaker 01:
Why isn't that an anticipation?

[00:24:24] Speaker 02:
And Judge Lurie, I hate to do this, but because it's such an important point to Judge Dyke, can I just finish the thought?

[00:24:29] Speaker 02:
You have about five minutes to answer it.

[00:24:31] Speaker 02:
I'm sorry.

[00:24:32] Speaker 02:
Why don't you go ahead and answer, Judge Lurie?

[00:24:33] Speaker 02:
My point is the only tryptan ever used in a nasal strain before exasperated throwing up.

[00:24:39] Speaker 02:
exasperated nausea.

[00:24:41] Speaker 03:
So that's what the art was at the time.

[00:24:46] Speaker 02:
They're both tryptans.

[00:24:47] Speaker 02:
They would both be expected to taste nasty and cause more nausea, to your point, Your Honor.

[00:24:52] Speaker 02:
Pankler and Robertson, and I think counsel conceded this, there are two references that are discussed mostly in the reply brief.

[00:25:02] Speaker 02:
Down below, and in their post-trial brief, they did not rely on either Pankler or Robertson as it was waived.

[00:25:09] Speaker 02:
Because all they have done, even in their opening brief in this case... And did the district court discuss Pinkler?

[00:25:14] Speaker 02:
I don't think the district court referenced Pinkler in any meaningful way, to the best of my knowledge, because neither did counsel in their brief.

[00:25:20] Speaker 02:
In their post-trial brief, they have literally one paragraph on each in the background fact section.

[00:25:26] Speaker 02:
And they never make any invalidity arguments in the argument section of the post-trial brief, just as they did in the opening brief to this court.

[00:25:34] Speaker 01:
So we should uphold the patent if there is a reference out there, against a reference out there, because it wasn't really cited and argued and decided.

[00:25:47] Speaker 02:
Yes, for one reason.

[00:25:48] Speaker 02:
But another reason is that if we had litigated them, neither helps them at all.

[00:25:52] Speaker 02:
That's why they said Chabot was their very best reference.

[00:25:56] Speaker 02:
Both Robertson and Pankler, both Robertson and Pankler have a huge class of potential compounds with no reference about which ones are more likely to be successful than the other.

[00:26:07] Speaker 02:
So it's like the case that you referenced before, Judge Dyke, and just like Chabot.

[00:26:12] Speaker 02:
There's a large class of compounds with no direction over which ones would be successful or wouldn't be successful.

[00:26:17] Speaker 02:
But just to give you a couple things about Pankler and Robertson.

[00:26:20] Speaker 02:
Robertson, here's what it says about nasal sprays.

[00:26:24] Speaker 02:
It says,

[00:26:25] Speaker 02:
They have a large genus of compounds, indulce, and it says, you can use these with oral, sublingual, buccal, parental, for example, subcutaneous, intramuscular, or intravenous, rectal, topical, and intranasal administration, and where possible, oral administration is preferred.

[00:26:42] Speaker 02:
Pankler?

[00:26:43] Speaker 02:
Pankler teaches a way.

[00:26:45] Speaker 02:
What Pankler teaches is that there's a large class of compounds that have absorption problems.

[00:26:51] Speaker 02:
And so what they suggest is their invention is to create a chemical complex as sort of a new chemical complex as a cage around the active ingredient to try to increase absorption.

[00:27:02] Speaker 02:
And so that's what Penkler teaches, that there's problems with trying to use these compounds in this long list, which would include zomatryptin, because they have absorption problems.

[00:27:11] Speaker 00:
And that's why they were never litigated or relied on below, because... Do the claims here preclude the kind of complex that Pankler wants to surround some of these substances?

[00:27:22] Speaker 02:
I believe that they do, and I'm not positive, but the chemical complex, as I read Pankler, and I'm not a chemist, it actually talks about a bonding occurring between the active ingredient and the chemical complex, and it's on page...

[00:27:36] Speaker 02:
I know I just have the beginning page of Pankler.

[00:27:37] Speaker 02:
But my point is this.

[00:27:38] Speaker 02:
It's in Pankler.

[00:27:41] Speaker 02:
When they talk about the claimed invention, they have substitutions.

[00:27:44] Speaker 02:
And the substitutions would include attaching the chemical compounded issue to the chemical complex to help create the formulation.

[00:27:52] Speaker 02:
But the point is that none of this is in the record, because they didn't rely on Pankler and Robertson below.

[00:27:57] Speaker 02:
And now is not the time.

[00:28:00] Speaker 02:
but not as a basis for an invalidity argument.

[00:28:05] Speaker 02:
If you read their opening brief where they have reference to both of these, that's how they argued it below, just as background information.

[00:28:11] Speaker 02:
And they never said, hey, here's why Pinkler and Robertson solve our problem with Chauvet having just a huge long list.

[00:28:19] Speaker 02:
In the end here, the district court made seriously applicable factual findings that we think make the insight case directly on point.

[00:28:29] Speaker 02:
What the court said was a skilled artisan would look to any other tryptan so that if they had Chevelle in front of them, they would choose any other tryptan before looking at Zoma tryptan because you would lose the effect of this more potent metabolite, the one that's two to eight times more potent.

[00:28:48] Speaker 02:
In the Insight case, they have a very similar circumstance.

[00:28:52] Speaker 02:
What we think that Lynette is doing is they're sort of defining the problem with hindsight.

[00:28:57] Speaker 02:
They're saying the only candidate, they're assuming the only candidate is Zomatryptin, and that's not correct.

[00:29:03] Speaker 02:
None of the prior references that they actually argued list Zomatryptin as the only candidate.

[00:29:08] Speaker 02:
Chabot has a huge long category list.

[00:29:12] Speaker 02:
And so what happened in, what happened in Insight v. Sandoz in 2015 is they, the alleged infringer just assumed away the problem by assuming the active ingredient would be

[00:29:25] Speaker 02:
the one to choose.

[00:29:27] Speaker 02:
And the district court in this Court said defining the problem in terms of its solution reveals improper hindsight.

[00:29:33] Speaker 02:
That case talked about converting an oral medication into a topical treatment for conjunctivitis.

[00:29:40] Speaker 02:
And a related compound had been converted from an oral medication into a topical treatment.

[00:29:47] Speaker 02:
The World Health Organization had suggested using that specific compound as a topical treatment for a different eye infection.

[00:29:54] Speaker 02:
Well, what did the district court do, Your Honors?

[00:29:57] Speaker 02:
Looked at the characteristics of the drug itself.

[00:30:00] Speaker 02:
Didn't just stop at the surface, looked at the characteristics of the drug itself, and the district court found an insight that it would be a poor choice and not a good candidate for topical treatment.

[00:30:12] Speaker 02:
This Court upheld that ruling for a lack of clear error.

[00:30:15] Speaker 02:
That's what our judge did.

[00:30:17] Speaker 02:
Our judge didn't stop at the surface, the one snippet in Cheveau or the one snippet in any reference.

[00:30:23] Speaker 02:
that our judge dug down and said, made factual findings.

[00:30:26] Speaker 02:
There was no reasonable expectation of success.

[00:30:29] Speaker 02:
And that one of ordinary skill in the art would have found it absolutely counterintuitive to choose Zoma tryptin.

[00:30:35] Speaker 02:
They would have went a different direction, a different tryptin, even if they wanted to make a nasal spray to try to solve the nausea problem, which had been tried and failed before.

[00:30:45] Speaker 02:
The only other tryptin that had been used actually made the nausea problem worse, not better.

[00:30:52] Speaker 02:
And let me just, I see my time is running out.

[00:30:54] Speaker 02:
I just want to make one last point.

[00:30:56] Speaker 02:
If this court were to find that the district court erred in finding no motivation, the proper remedy here would be to remand the case for a finding on whether or not there were surprising results to uphold the validity of the patent.

[00:31:11] Speaker 02:
Why?

[00:31:12] Speaker 02:
Because the only reason the district court did not address our surprising results arguments is because he said,

[00:31:18] Speaker 02:
we were just reframing our lack of motivation argument.

[00:31:21] Speaker 02:
So he found lack of motivation, that was good enough to hold the patent.

[00:31:25] Speaker 02:
But if you were to say there was a motivation, then the proper thing would be to go back to the district court and now evaluate surprising results, because it's all the same evidence, because we think this was a truly surprising and the very first fast-acting migraine nasal spray in the history of migraine medicines.

[00:31:42] Speaker 02:
Thank you, Your Honors.

[00:31:43] Speaker 01:
Thank you, Mr. Hearst.

[00:31:44] Speaker 01:
Mr. Pasilico has some rebuttal time to...

[00:31:48] Speaker 01:
Thank you, Your Honor.

[00:31:50] Speaker 04:
A couple of points.

[00:31:51] Speaker 04:
There's another piece of prior art which I think is important, but let me back up and say this first.

[00:31:57] Speaker 04:
I disagree with opposing counsel on this question of whether there's been waiver of Pankler and Robinson.

[00:32:01] Speaker 04:
That's dead wrong.

[00:32:03] Speaker 04:
There's citation in our post file brief to both of them, and they were cited specifically for the purpose of showing that as cumulative in this sense of Chauvet,

[00:32:14] Speaker 04:
It was known in the prior art to combine some of it.

[00:32:17] Speaker 01:
But what about the purchase?

[00:32:18] Speaker 01:
$130 million was paid for this product.

[00:32:22] Speaker 01:
People don't pay that kind of money to buy a product that was covered only by an invalid patent.

[00:32:31] Speaker 01:
And then you have the testimony of an expert.

[00:32:35] Speaker 04:
Yeah, there was no expert testimony, Your Honor, on that.

[00:32:38] Speaker 04:
It was the judge.

[00:32:39] Speaker 01:
Dr. Rappaport, didn't you say it was counterintuitive and surprising?

[00:32:43] Speaker 04:
Oh, yes.

[00:32:44] Speaker 04:
But there was no testimony on the reason why the license had any nexus to the claim.

[00:32:49] Speaker 01:
Right.

[00:32:49] Speaker 01:
The license stands by itself.

[00:32:51] Speaker 04:
Well, except that, no, because there's no nexus.

[00:32:54] Speaker 04:
The license, first of all, Your Honor, and it's in the briefs, in the appendix.

[00:32:59] Speaker 01:
No nexus.

[00:33:00] Speaker 01:
The licensed product was the intranasal

[00:33:03] Speaker 04:
One of the licensed products was they sold the brand and the business.

[00:33:07] Speaker 04:
That agreement is like that thick, and there's two pages in that agreement that say anything about a patent.

[00:33:14] Speaker 04:
That's it.

[00:33:15] Speaker 04:
And whatever they paid, all the rest of that agreement has nothing to do with the patents because they sold the business, they sold the brand.

[00:33:24] Speaker 04:
Impact's own testimony was that they were buying a strong brand.

[00:33:28] Speaker 04:
It has nothing to do with the patents.

[00:33:30] Speaker 04:
They were buying an ongoing business.

[00:33:32] Speaker 04:
And there's no evidence to the contrary.

[00:33:33] Speaker 04:
There's not a single shred of evidence that Impacts paid even, you know, any amount of money for the patent protection or because they thought the patents were valid.

[00:33:47] Speaker 04:
They were selling a brand.

[00:33:49] Speaker 04:
Number one.

[00:33:50] Speaker 04:
Number two, all of this argumentation about the unexpected result because of the metabolite

[00:33:58] Speaker 04:
doesn't apply.

[00:33:59] Speaker 04:
First of all, it doesn't apply because it's comparing to Zolmitriptan in an oral tablet, which is not the closest art.

[00:34:07] Speaker 04:
We already have Zolmitriptan in a nasal spray.

[00:34:11] Speaker 04:
And so if you're going to establish that there's some unexpected result, it has to be that something unexpected was done by Dern compared to what's taught in Cheveau.

[00:34:23] Speaker 04:
And there's no evidence at all

[00:34:25] Speaker 04:
that there's anything unexpected.

[00:34:27] Speaker 04:
The only argument that was ever made, and this was in the prosecution, was that the PH created an unexpected result, and the judge, and they made that argument at trial, and the judge knocked it down, said there's no such unexpected result.

[00:34:39] Speaker 00:
Well, what about Mr. Hearst's point that the district court sentence saying, I don't find unexpected results, follows a little paragraph that says,

[00:34:50] Speaker 00:
Because even though there are actually unexpected results, I already took care of that in the first part of the analysis.

[00:34:56] Speaker 00:
The unexpected result being that it might be worthwhile to lose the metabolite effect, the very fast metabolite effect of zomatryptin taken orally.

[00:35:11] Speaker 04:
And so, yes, the judge said this, and the judge equated it with the lack of motivation.

[00:35:17] Speaker 04:
But again, that he equated it based upon an error of fact.

[00:35:22] Speaker 04:
And the error was this, that he read the record as saying Zolmitriptan by itself doesn't have effect.

[00:35:30] Speaker 04:
Okay?

[00:35:30] Speaker 04:
And that's what Penckler and Robinson specifically say.

[00:35:33] Speaker 04:
These drugs were designed, forgetting about a metabolite, were designed to have effect.

[00:35:40] Speaker 04:
And so they would have effect.

[00:35:41] Speaker 04:
And by using them in a nasal spray, you would get their effect, plus all the benefits of them being in a nasal spray.

[00:35:47] Speaker 04:
A couple of other quick points.

[00:35:49] Speaker 01:
This question about... One quick point, since your time has expired.

[00:35:52] Speaker 04:
OK, let me figure out the best one.

[00:35:55] Speaker 04:
OK.

[00:35:55] Speaker 04:
The question of counterintuitive, I think that also actually suggests that this is not patentable.

[00:36:03] Speaker 04:
Because there's not a single shred of evidence to... That's a counterintuitive comment.

[00:36:09] Speaker 04:
And I'll explain why.

[00:36:11] Speaker 04:
Because, first of all, it's not a standard for obviousness.

[00:36:13] Speaker 04:
But if it were, there's not a single shred of evidence to indicate that Dern counterintuited this before Chauvet.

[00:36:22] Speaker 04:
Not a single shred.

[00:36:24] Speaker 04:
The information about the metabolite was known before Chauvet made his invention.

[00:36:31] Speaker 04:
And he said you can get fast mi- and he specifically refers to fast migraine relief.

[00:36:37] Speaker 04:
He says, you can get fast migraine relief using my nasal spray and Zoma Triptan.

[00:36:42] Speaker 01:
Thank you, counsel.

[00:36:42] Speaker 01:
Let's hope none of us need this product.

[00:36:44] Speaker 04:
Thank you.