[00:00:06] Speaker 03:
We have a busy morning in front of us.

[00:00:11] Speaker 03:
We have four argued cases.

[00:00:16] Speaker 03:
Before we move into arguments this morning, we're going to take care of administrative in-house matter.

[00:00:24] Speaker 03:
Kate, will you stand?

[00:00:32] Speaker 03:
Kate, it's been a year since you started clerking for me, and now it's over.

[00:00:36] Speaker 03:
And I bet that time has flown past pretty fast for you.

[00:00:40] Speaker 03:
It has for me because the older I get, the faster time seems to fly.

[00:00:46] Speaker 03:
But for you, I bet it flew pet.

[00:00:48] Speaker 03:
It went by pretty fast because of the hard work that you've been doing.

[00:00:53] Speaker 03:
And this hard work was exemplified by an excellent work product.

[00:00:59] Speaker 03:
Before me stands an attorney, whom I'm sure will be an extraordinary member of the bar,

[00:01:07] Speaker 03:
and someone that we can look back and continue to thank for her contributions, both to the court, but especially to my chambers.

[00:01:16] Speaker 03:
So with that, my colleagues, I'll turn this over to Judge Toronto as I step aside as I move for the admission of Catherine Marcon, who's a member of the bar in good standing with the highest courts of Texas.

[00:01:29] Speaker 03:
I have knowledge of her credentials and am satisfied that she possesses the necessary qualifications.

[00:01:42] Speaker 01:
Welcome to the Bar of the Court.

[00:01:54] Speaker 01:
Thank you very much.

[00:02:07] Speaker 03:
The first case this morning is Goodenthal GmbH versus Alcom Laboratories Limited, 17-1153.

[00:02:18] Speaker 03:
And we had granted additional time for arguments given the number of issues involved and the number of parties involved.

[00:02:26] Speaker 03:
And I received today the breakdown of the arguments.

[00:02:29] Speaker 03:
I want to make sure that I have this correct.

[00:02:33] Speaker 03:
Mr. Geharsa, you're going to go first.

[00:02:37] Speaker 03:
And you have six minutes, and then you're reserving three for rebuttal?

[00:02:42] Speaker 05:
Yes, Your Honor.

[00:02:42] Speaker 03:
Is that correct?

[00:02:44] Speaker 03:
Mr. Alley?

[00:02:45] Speaker 03:
You have five minutes and one minute for rebuttal.

[00:02:50] Speaker 03:
Is that correct?

[00:02:51] Speaker 03:
Yes, Your Honor.

[00:02:52] Speaker 03:
And Mr. Joffrey, you have five minutes.

[00:02:55] Speaker 03:
You don't get to rebut today.

[00:02:57] Speaker 02:
No, I'm the Apollo.

[00:02:58] Speaker 02:
Okay.

[00:02:58] Speaker 03:
Mr. Stichman, you have 15 minutes and 5 minutes for your cross-claim, is that correct?

[00:03:06] Speaker 04:
Yes, Your Honor, thank you.

[00:03:07] Speaker 03:
Okay, so you all help me out now if I don't get the order calling you up.

[00:03:12] Speaker 03:
So let's get started, Mr. Garson.

[00:03:24] Speaker 05:
Good morning.

[00:03:24] Speaker 05:
May I please the court?

[00:03:25] Speaker 05:
My name is Robert Guyarza from the Legion of Watkins for Hickam and Westford today.

[00:03:29] Speaker 05:
In my opening, I'll be discussing the lack of utility for the 364 patent.

[00:03:33] Speaker 05:
And if there's time or questions, the invalidity of the 130 patent.

[00:03:38] Speaker 05:
The 364 patent lacks an adequate disclosure of utility.

[00:03:41] Speaker 05:
And the district court committed legal error by concluding otherwise based on the known analgesic effect of turpentine hydrochloride and example 16.

[00:03:52] Speaker 05:
The utility of the prior art being improved is not the touchstone of the utility inquiry.

[00:03:59] Speaker 05:
The improvement itself is that touchstone.

[00:04:02] Speaker 05:
And that finds its basis in the statute itself, section 101, where an improvement to a compositional matter is allowable.

[00:04:08] Speaker 05:
However, that improvement itself has to be new and useful.

[00:04:13] Speaker 05:
And this court's predecessor, the CCPA, explained that also in reselling back in 1946.

[00:04:19] Speaker 08:
Is Selmy a 101 case or is Selmy a 103 case?

[00:04:23] Speaker 08:
I mean, it talks about a lack of invention over the prior art, but I think one could read Selmy as fitting quite neatly into a Section 103 context about overlapping claim ranges with the prior art and then determining whether there's a criticality as to the claimed range.

[00:04:44] Speaker 08:
And so to me,

[00:04:46] Speaker 08:
I could easily read SOMIA as being really more about a modern day 103 case than a 101 lack of invention case.

[00:04:54] Speaker 05:
They did use some parlance, your honor, that does speak to 103 in today's terms.

[00:04:59] Speaker 05:
However, they clearly stated that the invention there, the improvement to the alloy steel, the utility that it had, had to be new and materially different than the existing steel.

[00:05:10] Speaker 05:
And that statement came and it found its support in the Dow Chemical versus Halliburton case

[00:05:15] Speaker 05:
of the Supreme Court in 1945.

[00:05:17] Speaker 05:
And in that case, the Supreme Court clearly stated that if you have a known chemical and you simply dilute it, you have to show that the critical improvement there, the advance that you claimed over the prior art, had to be linked to that improvement itself.

[00:05:33] Speaker 05:
The dilution has to have some type of function.

[00:05:36] Speaker 05:
And indeed, that goes back to the one-on-one statute itself that shows that the improvement has to be new and useful.

[00:05:43] Speaker 05:
And it's very clear here that what we're talking about is an improvement to the dipenditol hydrochloride compound.

[00:05:50] Speaker 09:
How do you square that theory with the, I think, equally well-established theory that you can get a patent on something new and different but worse than the prior art?

[00:06:04] Speaker 05:
We're not saying that it has to be superior to the prior art.

[00:06:07] Speaker 05:
It just has to have usefulness.

[00:06:08] Speaker 05:
as the Supreme Court in Brenner said.

[00:06:10] Speaker 09:
So it does what the prior art does, but just not as well.

[00:06:14] Speaker 05:
In that case, you'd have to show that their usefulness to not doing it as well.

[00:06:19] Speaker 09:
I guess I'm struggling to understand how one can frame the question in terms of the word improvement, which suggests something that you can do with this that you couldn't do with the previous thing.

[00:06:37] Speaker 05:
Well, indeed, that comes from the Statute of Self, Your Honor.

[00:06:39] Speaker 05:
In Brenner, the Supreme Court said that the first step to determine what the usefulness is is looking to the intent of Congress.

[00:06:44] Speaker 05:
And we believe the intent is very clear, that it has to be an improvement to the existing composition of matter.

[00:06:50] Speaker 05:
So you'd have to link the worse-off principles in that hypothetical.

[00:06:54] Speaker 09:
And how can something that's worse than the prior art be an improvement?

[00:06:57] Speaker 05:
That's a very good question.

[00:06:59] Speaker 05:
In that context, you'd have to prove that being worse than actually has some function.

[00:07:03] Speaker 05:
For example, in the dilution case, or sorry, in Dow Chemical, the... Cheaper but less efficient, but then I'm not sure you'd say it's worse than that.

[00:07:12] Speaker 05:
Right, there's trade-offs, Your Honor.

[00:07:13] Speaker 05:
So in Dow Chemical, one of the aspects of the fracking liquid that they were using, the reason that they said they were diluting it was because it would be slower to dilute the limestone, and there are advantages to that.

[00:07:25] Speaker 05:
So it was worse in one aspect, but it was better in another.

[00:07:28] Speaker 08:
Are you saying that if a first inventor comes up with a mousetrap, the second inventor that comes up with a different way of trapping mice has to prove that that second mousetrap is functionally somehow better than the first mousetrap?

[00:07:45] Speaker 08:
It can't just merely be a different way of doing it that is novel and non-obvious over the first mousetrap?

[00:07:51] Speaker 05:
That could be a very complex question, Your Honor.

[00:07:53] Speaker 05:
And here, though, the question is whether or not you have an existing mousetrap, for example, and you change one element and claim that's an improvement of the mousetrap.

[00:08:02] Speaker 05:
For example, if you had a simple snap mousetrap with a bar, and then you change the form of that mousetrap by simply... You seem to be arguing a novelty, not utility.

[00:08:12] Speaker 05:
Well, the utility is separate from novelty, and the Supreme Court in Brenner specifically says that utilities forms an essential component

[00:08:20] Speaker 05:
of the quid pro quo exchange for the patent system itself.

[00:08:23] Speaker 05:
And one of those important aspects of it is showing that you have usefulness.

[00:08:27] Speaker 05:
And indeed, the statute itself goes back and says the improvement has to be useful over the prior item.

[00:08:33] Speaker 09:
Am I remembering right?

[00:08:34] Speaker 09:
And there's so many patents here and issues that may get this wrong.

[00:08:38] Speaker 09:
And I remember that this report essentially found two forms of utility.

[00:08:42] Speaker 09:
One, the same as the underlying molecule of the pentadol, is that it?

[00:08:48] Speaker 09:
Yes.

[00:08:48] Speaker 09:
And the second is that this particular crystal structure has greater stability under certain kinds of conditions.

[00:09:00] Speaker 09:
Does your argument require saying the first is legally irrelevant and the second is unsupported by the record?

[00:09:07] Speaker 05:
No, the second is also legal error, Your Honor, because the basis for it was the same.

[00:09:12] Speaker 05:
And I think it's important at this point to step back if we're talking about example 16 to understand what the term stability is, because it's a basic misnomer almost.

[00:09:23] Speaker 05:
In classic abstract sense, stability, of course, could be useful in a pharmaceutical composition.

[00:09:29] Speaker 05:
You could have extended shelf life.

[00:09:30] Speaker 05:
You could have extended resistance to degradation, higher food effects, something like that.

[00:09:36] Speaker 05:
But here, the stability that you're talking about, that word, isn't talking about that classic sense of stability.

[00:09:41] Speaker 05:
It's talking about conversion from one form to the other form, form A to form B and form B to form A. And as the defendants, or sorry, as the cross-appellants themselves state, it doesn't matter which form you have for the analgesic properties.

[00:09:56] Speaker 05:
Indeed, they're expert stated, as Gremethall says on page 55 of his brief and argues the point, it doesn't matter which one you have, because they're both going to be the same.

[00:10:05] Speaker 05:
So what's the point of having form A?

[00:10:07] Speaker 05:
And that's exactly what we asked the district court.

[00:10:10] Speaker 05:
And that's a proof we put on below is that it doesn't have any utility.

[00:10:13] Speaker 05:
And the district court came back and said, as a matter of law, and that's at apex 147 to 148, that as a matter of law, you don't have to prove that this stability makes it a better pharmaceutical composition because it doesn't have to be better than the prior art.

[00:10:27] Speaker 05:
But stepping back, if it's not better than the prior art, what does example 16 show?

[00:10:32] Speaker 05:
It simply shows that at room temperature,

[00:10:35] Speaker 03:
the known tepiditol hydrochloride compound exists in form A. So if form A is very stable at ambient conditions, then my understanding is it's more useful at that point.

[00:10:50] Speaker 03:
That stability makes it more useful to make pharmaceutical compositions.

[00:10:54] Speaker 05:
That's exactly the finding we asked the district court to make, and she didn't reach it.

[00:10:59] Speaker 05:
And we put on evidence showing that it wasn't more useful.

[00:11:02] Speaker 05:
The district court refused to make the finding that stability, in that context, conversion stability, was actually useful.

[00:11:10] Speaker 05:
She didn't make that finding.

[00:11:11] Speaker 05:
She refused to make that finding based on her interpretation of the law, which was saying you don't have to show it's better than the prior art.

[00:11:18] Speaker 05:
But without that finding, there's nothing to show that form A is better than form B. All you're left with is the discovery itself that at room temperature, form A is indeed the form that's prevalent.

[00:11:31] Speaker 05:
It's still, as Grimothal says, the identical chemical compound, regardless of its form A or form B, just a crystalline structure that matters.

[00:11:59] Speaker 00:
Morning, may it please the court.

[00:12:00] Speaker 00:
The one issue that ALKIM is addressing is obviousness of polymorphs.

[00:12:04] Speaker 00:
Polymorphs should be found obvious where the patent does nothing more than follow a published guide for how to screen for polymorphs and then claims the result of that published guide.

[00:12:15] Speaker 00:
That's what happened here, so the district court's conclusion should be reversed.

[00:12:19] Speaker 00:
The reason that we have that obviousness issue here is the prior already had tapentadol hydrochloride and said that it was crystallized out.

[00:12:26] Speaker 00:
In other words, it was a solid that had a crystal form.

[00:12:29] Speaker 00:
Crystal form itself was not disclosed in that patent.

[00:12:32] Speaker 00:
However, a guide was published by Steven Byrne.

[00:12:35] Speaker 00:
Dr. Byrne's guide was how to do a polymorph screen.

[00:12:38] Speaker 00:
The FDA, as of 1995, wanted anybody developing any drug to do a polymorph screen to determine what the crystal criteria and structure would be.

[00:12:47] Speaker 00:
Following that Byrne implementation of the guide, Byrne explicitly identifies nine solvents that one should use to do the crystallization experiments

[00:12:57] Speaker 00:
and then also the evaporation and cooling conditions that a POSA would then implement.

[00:13:02] Speaker 00:
The whole point of the Byrne article, Your Honors, was to determine the answer to the question, are polymorphs possible, yes or no?

[00:13:08] Speaker 00:
So the amount of information that Byrne intended to provide was to get a POSA to implement the polymorph screen.

[00:13:15] Speaker 00:
And at trial, as to that Byrne reference, Dr. Steed, which was Alchem's expert, proposed that, in fact, that is all that anyone needed to do.

[00:13:24] Speaker 00:
In fact, when that was done by SSCI, a third-party outsourced company, SSCI was managed by Dr. Stephen Byrne.

[00:13:33] Speaker 08:
Does SSCI actually follow the Byrne disclosure every step of the way?

[00:13:38] Speaker 08:
And my understanding was that it didn't quite use every single solvent disclosed in Byrne.

[00:13:44] Speaker 08:
And in fact, it may have used one that wasn't disclosed in Byrne.

[00:13:48] Speaker 08:
And maybe there was a lot of overlap.

[00:13:50] Speaker 08:
But it wasn't exactly following Byrne to a T. Is that right?

[00:13:54] Speaker 00:
Two response, Your Honor.

[00:13:55] Speaker 00:
No, the only unrebutted testimony is by Dr. Steed as to burn.

[00:13:58] Speaker 07:
No, it did follow burn to a T. It did.

[00:14:01] Speaker 00:
And then it added, yes, it added, it had eight of the nine solvents, Your Honor.

[00:14:05] Speaker 00:
It didn't have one of the nine solvents, but it did have the conditions that are spelled out in the burn article.

[00:14:10] Speaker 00:
Then there are a lot of other also tests not published in burn in addition to the reference that SSCI did.

[00:14:17] Speaker 00:
But in this case, that distinction really doesn't matter.

[00:14:19] Speaker 08:
But I guess what I'm wondering is to what extent

[00:14:23] Speaker 08:
Can anybody say that there was a very defined set of procedures that one would do to do a polymorph screen?

[00:14:35] Speaker 08:
Was there an answer book already out there that this is what you do, this is the universe of procedures you undertake whenever you do a polymorph screen?

[00:14:45] Speaker 00:
No, Your Honor, it wasn't an encyclopedia of the universe.

[00:14:48] Speaker 00:
However, Byrne had enough information to say the first step, the low-hanging fruit, the easiest path to take is the nine solvents.

[00:14:56] Speaker 08:
The concern I have is the other side put on evidence and testimony that there is some huge number of possibilities that you would do and it would take a lot of time.

[00:15:09] Speaker 08:
And then don't we have case law

[00:15:13] Speaker 08:
Maybe O'Farrell and Kubin that say when there are a large number of possibilities and there's nothing in the art that really suggests going down a particular subset of those large number of choices, then we can't say it's really obvious to just start shooting in the dark or start walking into a dark forest looking for treasure when we don't really have any information as to where in the forest we should start walking down.

[00:15:41] Speaker 08:
And that would be correct if the burn reference was not there.

[00:15:44] Speaker 08:
Now I'm asking about burn because, as I understand it, there's nothing in the record that says burn.

[00:15:50] Speaker 08:
This is the gold standard.

[00:15:51] Speaker 08:
This is what you do.

[00:15:52] Speaker 08:
You do precisely this.

[00:15:54] Speaker 08:
And if you do this, then you're going to get them polymorphs.

[00:15:58] Speaker 08:
It doesn't quite talk like that.

[00:15:59] Speaker 08:
So that's why I'm trying to now understand what was the understanding in the art at the time of how to do a polymorph screen.

[00:16:10] Speaker 08:
as indeterminate, as the other side is saying, that there's just this huge number of choices.

[00:16:15] Speaker 08:
Yes, maybe there's a starting point, but in the end, it's a huge number of choices that you would want to do, that you would need to do to satisfy yourself, as opposed to some very limited set of things, which is what I guess you're trying to advocate.

[00:16:31] Speaker 00:
Your Honor, there are directions that a person or a skill in the art could take, and Dr. Bernstein and

[00:16:36] Speaker 00:
the adversary here is taking the position that, in general, not looking at burn, in general, there are a lot of choices that one could make.

[00:16:44] Speaker 00:
And the district court made the same finding.

[00:16:45] Speaker 00:
In general, there are many choices that one could take.

[00:16:48] Speaker 00:
But the other side did not dispute at trial, and the district court did not make a finding specifically as to burn that said that that was different or that was not narrow enough.

[00:16:58] Speaker 00:
And in fact, burn within the world of possibilities that a person wearing a skill in the art would have, which includes different solvents,

[00:17:05] Speaker 00:
And as you see in the briefing, it includes anti-solvents or slurring.

[00:17:09] Speaker 00:
Those are not discussed in the burn reference.

[00:17:11] Speaker 00:
The burn reference is one technique, crystallization, and has nine solvents, and it gives the evaporation conditions.

[00:17:18] Speaker 00:
So it's possible.

[00:17:19] Speaker 00:
You can continue your rebuttal time now.

[00:17:20] Speaker 00:
Thank you, Your Honor.

[00:17:21] Speaker 00:
I'll just conclude then by saying that this is to show the difference between those polymorphs that are obvious.

[00:17:27] Speaker 00:
Following the one protocol that's published in the prior art and giving that targeted approach,

[00:17:32] Speaker 00:
versus other polymorphs that may not be when there isn't enough guidance.

[00:17:35] Speaker 00:
And that would open the door then to what the other side has explained as a lot of variables that one could look into.

[00:17:40] Speaker 00:
Thank you very much.

[00:18:01] Speaker 04:
You may proceed.

[00:18:01] Speaker 04:
Good morning, and may it please the court.

[00:18:04] Speaker 04:
This case involves three distinct and separate inventions.

[00:18:08] Speaker 04:
The first occurred many years ago when Grunenthal synthesized a new class of opioids that had unusual characteristics that could treat nociceptive pain.

[00:18:19] Speaker 04:
That's the invention that set forth in the 737 patent.

[00:18:24] Speaker 04:
The next occurred when Grunenthal, a separate team at Grunenthal,

[00:18:28] Speaker 04:
synthesized a brand new crystalline form of one of those compounds.

[00:18:33] Speaker 04:
And that form, which had not existed before, was tepentadol form A. And that's the invention claimed in the 364 patent.

[00:18:43] Speaker 04:
The third invention occurred years later.

[00:18:46] Speaker 04:
Another team at Grunenthal discovered that tepentadol had the unusual characteristic of being able to treat polyneuropathic pain without destroying

[00:18:56] Speaker 04:
the nociceptive pain pathway.

[00:18:59] Speaker 04:
That's the invention of the 130 patent.

[00:19:01] Speaker 04:
And that's what led FDA to approve Depentadol as the first and only opioid to treat polyneuropathic pain.

[00:19:11] Speaker 04:
Now, in analyzing the validity of the 364 patent, the district court undertook a highly factual analysis of the 737 patent.

[00:19:19] Speaker 09:
Can you address the obviousness point?

[00:19:24] Speaker 09:
And it seemed to me that the district

[00:19:27] Speaker 09:
different components to the there would be a lot of choices here theory for rejecting obviousness.

[00:19:37] Speaker 09:
But the one that the other side focuses on is the idea that

[00:19:43] Speaker 09:
There clearly was an interest supported by the FDA guidance in figuring out what polymorphs may exist.

[00:19:53] Speaker 09:
And there was, at least at the core, a routine set of procedures to follow, if not to get a complete answer, at least to start.

[00:20:05] Speaker 09:
And whatever would fall out of that process, which the FDA more or less tells you to follow, gives you an incentive to follow, ought to be obvious.

[00:20:17] Speaker 04:
Well, Your Honor, I think the analysis in that capacity starts really back at the question of, is Depentadol even polymorphic?

[00:20:26] Speaker 04:
If we assume that you would go down that path, then the question becomes,

[00:20:31] Speaker 04:
What tests would you apply and how would you apply them, burn being one of them, but there were other articles and other prior articles out there about all kinds of different tests that need to be done.

[00:20:43] Speaker 04:
We don't know whether or not there's hydrates, solvates, polymorphs.

[00:20:47] Speaker 04:
We don't know how many forms of polymorphs we have.

[00:20:50] Speaker 04:
We don't know if we're going to get a polymorph that is more stable or if we get one that's more stable.

[00:20:56] Speaker 04:
We have no idea if it has the same bioavailability

[00:20:59] Speaker 04:
as the crystal that was previously made.

[00:21:02] Speaker 04:
Remember, what happens here, which is sort of overlooked by counsel here, is we not only discover a new crystalline form that happens to be stable at room temperature, but it also happens to have the same analgesic property as the original crystal form.

[00:21:17] Speaker 04:
There's nothing in the prior art that suggests that's going to happen.

[00:21:21] Speaker 04:
In fact, there's lots of science out there to suggest that the more stable form may not be as bioavailable

[00:21:29] Speaker 04:
as the original form that's crystal.

[00:21:32] Speaker 04:
So we have a lot of variables.

[00:21:34] Speaker 04:
The way I look at it is we've got a lot of levers that are out there to move into different combinations to try to even look for a polymorph to begin with.

[00:21:43] Speaker 04:
Bern is helpful, but it's not the answer book.

[00:21:47] Speaker 04:
I like that.

[00:21:48] Speaker 04:
It's not the answer book on what to follow when out pops polymorphs.

[00:21:52] Speaker 04:
That's not what the record shows, and that's certainly not what the evidence was in this case.

[00:21:57] Speaker 04:
There's so many variables here.

[00:21:59] Speaker 04:
And the district court weighed all of that evidence, heard from all the experts.

[00:22:04] Speaker 09:
Did the district court rely on the notion that you articulated as part of your litany that even when you get a bunch of crystals falling out of the process, that you don't know the properties of them, that is, whether they'll be good stuff or not such good stuff?

[00:22:26] Speaker 04:
Yes.

[00:22:27] Speaker 04:
And what the district court cited in that capacity was the disillusion test.

[00:22:33] Speaker 04:
After Form A was identified, they had to analyze Form A compared to Form B. And the disillusion test is what told us that it most likely had the same analgesic property as the original Form B. And that itself wouldn't be routine?

[00:22:52] Speaker 04:
It would be, well, but the results, more importantly, the results would not be known.

[00:22:57] Speaker 04:
In fact, it's sort of counterintuitive given science.

[00:23:00] Speaker 09:
But it's, it is the core of their theory that you can have and maybe even automatically have, but at least can have obviousness when the tests that you conduct are ones as to which you have no idea what the answer will be, but whatever the answer is, you're going to get those answers.

[00:23:20] Speaker 09:
So this may be, in fact, crossing a doctrinal bridge that we have never crossed.

[00:23:28] Speaker 09:
And it certainly goes beyond this language of identified as predictable in the obviousness to try paragraph of KSR.

[00:23:37] Speaker 09:
But why are they wrong?

[00:23:40] Speaker 09:
If everybody would at least start with Bern, run the tests, you either find nothing or you find something, why isn't whatever you find

[00:23:51] Speaker 04:
Well, I think it goes back to the reasonable expectation of success.

[00:23:57] Speaker 04:
What we're doing in that capacity is taking the result of the test and saying we would have had a reasonable expectation looking backwards.

[00:24:05] Speaker 04:
When we start the test, let me assume the extreme of your hypothetical, that everybody knew exactly what the test was going to be.

[00:24:14] Speaker 09:
And everybody would know to start with example 25.

[00:24:16] Speaker 09:
That's a separate point, which I'm putting aside.

[00:24:19] Speaker 04:
Then it's still, there's a real big question out there as to what the reasonable expectation is in coming up with the invention at the time of the invention or time of the work.

[00:24:34] Speaker 04:
We have no idea before we send this thing through the polymorph machine, if that's where the court is, before we send this thing through the polymorph machine, we have no idea what we're going to get on the other side.

[00:24:48] Speaker 04:
We have no idea if we're gonna get polymorphs.

[00:24:50] Speaker 04:
We have no idea if we're gonna get hydrates.

[00:24:52] Speaker 04:
We have no idea we're gonna get solvates.

[00:24:54] Speaker 08:
Why wouldn't it be that getting the information of whether polymorphs exist

[00:25:03] Speaker 08:
and that if you had a reasonable expectation that you would get that information be good enough.

[00:25:09] Speaker 08:
So let me try to crystallize down this hypo even more.

[00:25:14] Speaker 08:
Let's just say that it was well understood in the art and the FDA said so and commanded that

[00:25:22] Speaker 08:
When you develop a new compound, you should go look for polymorphs.

[00:25:27] Speaker 08:
And that it's well defined that the way to get polymorphs is to add water and keep the liquid up to 300 degrees Fahrenheit.

[00:25:38] Speaker 08:
And then you will get whatever polymorphs there are.

[00:25:41] Speaker 08:
They either exist or they don't exist.

[00:25:44] Speaker 08:
And if they do exist, you'll be able to define them.

[00:25:47] Speaker 08:
Are you saying that those resulting polymorphs would in fact be a non-obvious invention that merits a patent under those circumstances?

[00:25:57] Speaker 04:
Under those circumstances and the hypothetical that you gave, which doesn't have any of the variability that I think exists in this case, I think it would be a very difficult case to make of non-obviousness.

[00:26:07] Speaker 08:
Because I understand a lot of your argument to be based on the theory that, well, even under my hypothetical, we would have no idea what structures there would be, if any would exist, and what they would look like, and what kind of properties they would have.

[00:26:21] Speaker 08:
And so therefore, the inventor ought to get credit for that.

[00:26:25] Speaker 08:
But under my hypothetical, it seems like it's just extremely routine automaton-like activities that you would undertake, that you would necessarily undertake.

[00:26:37] Speaker 04:
Yeah, well, and as I understood your hypothetical, it really reduced it to a binary analysis, right?

[00:26:42] Speaker 04:
You send it in and get information.

[00:26:44] Speaker 04:
The one issue I think I might take with your hypothetical as we apply to this is, don't forget the case law here.

[00:26:51] Speaker 04:
We've got to have a reasonable expectation of success of the invention, not the information, not the process, not the machine, not the levers, not anything else, but we have to have a reasonable, the inventor has to have a reasonable expectation success of getting the invention.

[00:27:09] Speaker 04:
The invention here is a brand new crystalline form.

[00:27:14] Speaker 09:
And by the way, without, am I remembering right, this is the patent for which there's no findings of unexpected results?

[00:27:23] Speaker 04:
There's none beyond, no, there's no separate finding in that respect, beyond just the utility.

[00:27:29] Speaker 04:
And I do take issue with Council's comment, by the way, in his opening.

[00:27:32] Speaker 04:
This is not an improvement patent.

[00:27:34] Speaker 04:
There's not an improvement here.

[00:27:36] Speaker 04:
This is a brand new crystalline form that didn't exist before the inventors of the 364 patent made it.

[00:27:44] Speaker 04:
and identified it.

[00:27:45] Speaker 04:
It didn't exist.

[00:27:47] Speaker 04:
The example 25 in the earlier patent made form B. And the appellants put on no evidence, absolutely no evidence.

[00:27:57] Speaker 04:
The district court saw no evidence that if you put anything into a polymorph screen other than form A, that you will get form A. What counsel forgot to tell you in the record is every test they ran, they ran on form A.

[00:28:13] Speaker 04:
So it's not surprising that if you put form A in, you get form A out.

[00:28:19] Speaker 04:
What they didn't put on any evidence of is if you put in form B, like from example 25, that you would get form A. And that makes this novel and non-obvious.

[00:28:30] Speaker 03:
It seems to me when I look at the graph on appendix 57373, that's the Byrne chart.

[00:28:40] Speaker 03:
The text there pretty well describes the entire process and it describes processes that I think that you're saying that's where the variability resides.

[00:28:54] Speaker 03:
But it lists out the entire process.

[00:28:58] Speaker 03:
It says it outlines investigations in the form of polymorphs, the analytical tests that are available for identifying polymorphs, studies of the physical properties,

[00:29:07] Speaker 03:
and controls that are needed to ensure the integrity of drug substance containing either a single morph or a mixture.

[00:29:15] Speaker 03:
What's left?

[00:29:17] Speaker 03:
I mean, that's pretty thorough.

[00:29:21] Speaker 04:
Again, and we don't deny that those tests exist.

[00:29:25] Speaker 04:
By the way, Bern is one of many in the art there.

[00:29:29] Speaker 04:
They're describing what we call it one test called a DSC with lots of variable.

[00:29:33] Speaker 04:
There's other tests out there as well.

[00:29:36] Speaker 04:
But assuming you were to pick out burn and assuming you were to follow that graph that you were looking at, your honor, again, there's a bunch of if-thens.

[00:29:48] Speaker 04:
I mean, this is sort of like an if-then claiming, right?

[00:29:50] Speaker 04:
If this, then that, if this, then that, if this, then that.

[00:29:54] Speaker 04:
But that's not what this patent is.

[00:29:56] Speaker 04:
This patent is not on a polymorph screen.

[00:29:59] Speaker 04:
This patent is on a brand new crystalline form

[00:30:02] Speaker 04:
that had not been made and had not been known prior to the inventor's work.

[00:30:08] Speaker 03:
That form was discovered or made known through this polymorph testing.

[00:30:15] Speaker 04:
Right.

[00:30:16] Speaker 04:
It was made known and identified, but don't forget what we did.

[00:30:20] Speaker 04:
We made it.

[00:30:21] Speaker 04:
We had to make that new crystal and discover it before we could claim it.

[00:30:27] Speaker 04:
And again, I can't emphasize enough that district court had all of this evidence, including the Byrne article, including the flow chart Your Honor's looking at before it, and heard testimony from some of the top polymorph experts in the world on this issue, and made a very detailed factual analysis and concluded that in this case, dipentadol hydrochloride produced or could not have been predicted.

[00:30:54] Speaker 04:
It was non-obvious in this case.

[00:30:57] Speaker 09:
I guess it's sort of that point that from the beginning of what I think is my understanding of the case has intrigued me most doctrinally.

[00:31:06] Speaker 09:
This does seem to be a case in which I think it's actually undisputed, maybe even expressly conceded by the other side, that what would come out of the test was not predictable.

[00:31:19] Speaker 09:
And so the theory is, as long as the test was utterly routine, whatever comes out

[00:31:26] Speaker 09:
is obvious unless there's unexpected results, which there aren't here.

[00:31:30] Speaker 09:
What is wrong with that theory as a matter of obviousness law?

[00:31:35] Speaker 09:
It feels newish.

[00:31:37] Speaker 09:
It feels potentially dangerous.

[00:31:40] Speaker 09:
But I'm not getting much of a sense of how to think about whether that is a significant doctrinal step and whether it's a bad step or a good step.

[00:31:51] Speaker 04:
Well, I would urge the court that I think it's a bad step.

[00:31:54] Speaker 04:
That assumes that

[00:31:56] Speaker 04:
Number one, there is a set number of parameters that are clearly identified as the polymorph test.

[00:32:02] Speaker 04:
And I understand that's the hypothetical the court's working with.

[00:32:05] Speaker 04:
It also assumes that there's something in the prior art, something about tepentadol, something about its molecular structure, something that suggests that this may be polymorphic and there may be more than one form.

[00:32:21] Speaker 04:
Don't forget, when we put this through polymorph screens,

[00:32:25] Speaker 04:
We don't know if there's three forms, four forms, five.

[00:32:28] Speaker 04:
We don't know how many forms there would even be, even if it was polymorphic.

[00:32:33] Speaker 04:
This is a completely unexpected situation when we're talking about, even if there is support to do a polymorph screen, we have no idea, and the inventors of the 364 patent have no idea what they're going to see or get.

[00:32:50] Speaker 04:
There's no level of predictability.

[00:32:52] Speaker 03:
In fact... Does it burn lead you through that?

[00:32:54] Speaker 03:
It's like you said, it's an if.

[00:32:55] Speaker 03:
If you get this and you go here, and if you get that, you go on to the next step.

[00:33:00] Speaker 04:
But whether or not the test is easy or laid out to get to the invention, as section 103 says, doesn't create an obviousness issue.

[00:33:09] Speaker 04:
It doesn't matter how the invention was arrived at.

[00:33:13] Speaker 04:
What matters is whether the invention itself is non-obvious in light of the prior art.

[00:33:19] Speaker 03:
Well, it goes to a reasonable expectation of success, doesn't it?

[00:33:23] Speaker 04:
It does, but if the success is defined by the invention, which is what case law of this court says, the invention here is form A. It's not doing a polymorph screen.

[00:33:32] Speaker 04:
It is having crystalline form A, which is a specialized crystal.

[00:33:39] Speaker 04:
And in this instance, it does have utility.

[00:33:41] Speaker 04:
It is stable at room temperature and has the same pharmacological effect.

[00:33:45] Speaker 08:
What about our case law on result-effective variables?

[00:33:50] Speaker 08:
So we have case law that if there's a claim convention that says you can make a certain composition with the temperature range of this, pressure range of that, and we have case law that says, well, even if those temperature ranges and pressure ranges are different from what was disclosed in the prior art,

[00:34:13] Speaker 08:
if it's recognized that those variables are what we've called result-effective variables, then you don't necessarily have to prove an expectation of success for those particular claim ranges.

[00:34:29] Speaker 08:
We can just recognize the fact that it would be obvious to ultimately land on those claim ranges.

[00:34:35] Speaker 08:
And so there's a potential parallel to this situation.

[00:34:41] Speaker 08:
we recognize that polymorph screening is something one would do.

[00:34:46] Speaker 08:
And then, therefore, whatever comes out of that polymorph screening, why wouldn't that be obvious, like the result-effective variable?

[00:34:55] Speaker 04:
I think a significant difference is in those cases, as I generally refer to them, in the result variable.

[00:35:03] Speaker 04:
We're talking about a new characteristic of something that already exists, right?

[00:35:07] Speaker 04:
There's a new benefit.

[00:35:08] Speaker 04:
There's a new characteristic.

[00:35:09] Speaker 04:
We put it through a test.

[00:35:10] Speaker 04:
We found out that there is some new aspect of this.

[00:35:14] Speaker 04:
It's heat resistant.

[00:35:16] Speaker 04:
It's whatever the result is of the test itself, dealing with the characteristic of something that's already known.

[00:35:24] Speaker 04:
We're not dealing with the same thing here.

[00:35:26] Speaker 09:
I'm not sure that really captures the universe of what Judge Shen was talking about.

[00:35:31] Speaker 09:
You can have result-effective variables that will affect the creation of different things with different percentages of X or percentages of Y. So it can actually be a new thing, not just a

[00:35:50] Speaker 04:
But maybe I'm just misunderstanding that the invention, the creation of some brand new crystalline form, it's not an improvement.

[00:36:01] Speaker 04:
It's not a change.

[00:36:02] Speaker 04:
It's not something that is in the prior art.

[00:36:05] Speaker 04:
It is a new creation of a new crystal that is going through this variability.

[00:36:11] Speaker 04:
And there may be some predictable results, if I understand the hypothetical.

[00:36:16] Speaker 04:
But the crystalline structure is a brand new crystalline structure.

[00:36:20] Speaker 04:
I don't think the court has case law that says when you create a brand new compound or a brand new crystalline structure.

[00:36:29] Speaker 03:
OK, you're into your reserve time, but I'm going to let Judge Chan have a few slides.

[00:36:33] Speaker 08:
OK.

[00:36:34] Speaker 08:
We haven't explored very much the utility part of the argument here.

[00:36:39] Speaker 08:
You know, the other side is saying form A, form B,

[00:36:43] Speaker 08:
There's no difference in terms of utility, and it's not a big deal, because they behave precisely the same.

[00:36:51] Speaker 08:
So even if we get to the question of whether one is more stable than the other, it doesn't matter if one turns into the other at any point in time, because they both have the exact same properties.

[00:37:02] Speaker 08:
It doesn't matter.

[00:37:03] Speaker 08:
They're interchangeable.

[00:37:04] Speaker 08:
Could you give us a little more on your final answer on utility?

[00:37:11] Speaker 04:
Sure.

[00:37:11] Speaker 04:
I guess I'd start with the first part of yours, which is actually itself important.

[00:37:16] Speaker 04:
The fact that form A turns out to be pharmacologically equivalent to form B is not just happenstance, it's important significance because the idea that we've discovered a new polymorph that has that same pharmacological activity and is stable is itself unexpected and it is itself useful in the sense that

[00:37:38] Speaker 04:
We now can shift to form A, keep it stable at room temperature, and know that we're not giving up any of the pharmacological activity that we originally discovered.

[00:37:48] Speaker 04:
The fact that it has pharmacological activity, the fact that it is stable at room temperature, and as the court looked at example 25, we demonstrated that usefulness and utility.

[00:37:58] Speaker 04:
After all, this is a drug that the defendants anxiously want to copy and put on the market.

[00:38:04] Speaker 04:
It is useful in treating both nociceptive pain and polyneuropathic pain.

[00:38:10] Speaker 04:
Unfortunately, I think I may have run out of time, but I'd like to get to infringement maybe in my rebuttal, if that would be all right with the court.

[00:38:16] Speaker 03:
I'd like to bring it up in your rebuttal.

[00:38:17] Speaker 03:
We'll restore you to four minutes in the middle of time.

[00:38:21] Speaker 04:
Thank you.

[00:38:23] Speaker 03:
So who's next here?

[00:38:25] Speaker 03:
Is it Mr. Joffrey?

[00:38:32] Speaker 03:
Ms.

[00:38:32] Speaker 03:
Garrison.

[00:38:37] Speaker 03:
Thank you, Your Honor.

[00:38:38] Speaker 03:
So put him back to three minutes.

[00:38:41] Speaker 05:
I understand that infringement might be addressed in the rebuttal.

[00:38:43] Speaker 05:
Would you like me to address those issues now, or is there a chance to respond to it?

[00:38:50] Speaker 05:
You'd better address them now.

[00:38:52] Speaker 05:
OK.

[00:38:52] Speaker 05:
Well, the infringement analysis itself, what I anticipate he's going to say is that it's pure legal error, but it's not.

[00:38:59] Speaker 05:
It's factual findings straight up.

[00:39:01] Speaker 05:
And there's nothing that's anything different.

[00:39:04] Speaker 05:
Indeed, it's a making of their own case, because

[00:39:06] Speaker 05:
The carve-out tracks their invalidity argument, and Dr. Brown, their expert, admitted that.

[00:39:11] Speaker 05:
And that was at 11-2-10, 11-2-08 of the record, that the anticipation argument tracks their third theory for inducement, which is that the meaning of pain is broad enough.

[00:39:21] Speaker 05:
And that, however, is supplemented by the district court's clear factual findings.

[00:39:26] Speaker 05:
And there's a whole host of them.

[00:39:27] Speaker 05:
That DPN is not covered by indication one.

[00:39:30] Speaker 05:
That CLBP's study is nociceptive or, at most, mononeuropathic.

[00:39:36] Speaker 05:
Those facts alone require affirmance, in addition to the extensive other findings that the treatment of polyneuropathic pain is not on label, and therefore that the label itself would not incur treatment of polyneuropathic pain, that it cannot be reasonably understood to be an instruction to engage in an infringing act, and to the extent that doctors prescribe it,

[00:39:56] Speaker 05:
They would be motivated.

[00:39:57] Speaker 09:
You're making the argument at this point, both for you and for who is the loser on the inducement.

[00:40:04] Speaker 09:
One of the generics was a loser, right?

[00:40:07] Speaker 05:
Wasn't it?

[00:40:07] Speaker 05:
That was for a different patent, Your Honor.

[00:40:09] Speaker 05:
That was the 130 patent.

[00:40:10] Speaker 05:
I'm sorry, that's the same patent, but we're not making that argument for outcome.

[00:40:15] Speaker 09:
OK.

[00:40:16] Speaker 05:
We have a different label.

[00:40:17] Speaker 09:
Right, I know.

[00:40:18] Speaker 09:
But are you standing, are they going to stand up and talk about the same point on

[00:40:25] Speaker 05:
I don't believe they dressed.

[00:40:27] Speaker 05:
So are you?

[00:40:28] Speaker 09:
I mean, they are speaking for Hickam and Westward.

[00:40:30] Speaker 09:
They adopted your brief.

[00:40:32] Speaker 05:
I believe they adopted it for the invalidity.

[00:40:36] Speaker 09:
Their label is different, right?

[00:40:38] Speaker 05:
Yes, there's no carbon.

[00:40:39] Speaker 09:
Do you have anything to say about is there's the label?

[00:40:43] Speaker 09:
No, I'm sorry.

[00:40:44] Speaker 09:
You have two label.

[00:40:45] Speaker 09:
You have two clients, right?

[00:40:46] Speaker 09:
I'm trying to get this.

[00:40:47] Speaker 05:
We have two clients, one label, one label.

[00:40:49] Speaker 09:
I thought one of them had this this reference to the Janssen

[00:40:53] Speaker 05:
That was taken out, Your Honor.

[00:40:55] Speaker 05:
It's been taken out.

[00:40:57] Speaker 09:
Because that was a kind of wink-wink, nod-nod reference in that label.

[00:41:01] Speaker 09:
That's gone.

[00:41:02] Speaker 05:
That is not an issue in the case.

[00:41:03] Speaker 05:
It's not an issue that's been appealed by the... It's no longer there.

[00:41:09] Speaker 05:
So that carve-out, those factual findings are not clear.

[00:41:12] Speaker 05:
They're plausible.

[00:41:13] Speaker 05:
They're based on the classic battle of the experts.

[00:41:15] Speaker 05:
But just going back to utility real quick, Judge Rainnett

[00:41:19] Speaker 05:
Going back to your point about whether or not the district court found it more stable was useful, she did not.

[00:41:23] Speaker 05:
She found that there was a legal bar to even addressing that factual finding.

[00:41:28] Speaker 05:
But you heard my friend from cross-appellants today state that you actually do need dissolution testing to determine whether or not what's the most, quote, stable, the form that exists at room temperature, whether or not it's useful.

[00:41:40] Speaker 05:
And that agrees with Dr. Bernstein's, their expert's testimony at 10-9-11 of the record, where he said, in order to determine what is most suitable,

[00:41:48] Speaker 05:
You can't just know what's the most stable form.

[00:41:50] Speaker 05:
You actually have to do the testing.

[00:41:52] Speaker 05:
And at minimum, we would need remand on that issue for her to make that finding.

[00:41:56] Speaker 05:
But at the end, just relying on the prior art for utility is not enough.

[00:42:00] Speaker 05:
Because even as this court said in Juicy Whip, a case that is relied on by cross-appellants, the invention of the product is what matters.

[00:42:08] Speaker 05:
The improvement is what matters.

[00:42:09] Speaker 05:
And the improvement here is that you have form A instead of form B. And the fact that form A has the same properties as the Supreme Court said in Brenner

[00:42:18] Speaker 05:
is not enough in terms of the quid pro quo to grant it a patent based on utility.

[00:42:23] Speaker 05:
Because you have to show why those properties, why existing at room temperature in form A instead of form B matters.

[00:42:32] Speaker 05:
And it's undisputed here that for pharmacological activity, it doesn't matter.

[00:42:36] Speaker 05:
They have the same.

[00:42:37] Speaker 05:
As their expert even stated, it doesn't matter whether you have form A or form B. So while they're trying to save their patent on obviousness by saying that it's unexpected and you need the dissolution testing,

[00:42:48] Speaker 05:
It wasn't there.

[00:42:49] Speaker 05:
And that's what makes this case unusual for a polymorph patent.

[00:42:53] Speaker 05:
As a polymorph patent, this is not the typical polymorph patent.

[00:42:56] Speaker 05:
Every polymorph patent I've ever seen that claims a new polymorph explains why it's useful.

[00:43:00] Speaker 05:
It says it has a food effect, not just that it exists at room temperature.

[00:43:04] Speaker 05:
And at its heart, that's all the testing here does say, Form 16, that at room temperature, you have Form A. So what?

[00:43:12] Speaker 05:
If you had Form B, it would convert to Form A. That's a natural law.

[00:43:15] Speaker 05:
As the Supreme Court said in Funk Brothers, you have to take that discovery

[00:43:18] Speaker 05:
and apply it.

[00:43:20] Speaker 05:
And they haven't done that here to show that it's useful.

[00:43:22] Speaker 05:
And under Brenner, there is no utility to that because it's still just an object of research.

[00:43:26] Speaker 05:
They left it for someone else to discover.

[00:43:28] Speaker 03:
What about it's used to treat a different form of pain?

[00:43:33] Speaker 03:
A different form of pain?

[00:43:34] Speaker 03:
Yes.

[00:43:36] Speaker 05:
I'm not sure I understand.

[00:43:38] Speaker 05:
OK.

[00:43:38] Speaker 05:
It's admitted by Grimthal in their argument is that it's the identical chemical structure.

[00:43:43] Speaker 05:
It's the same thing.

[00:43:44] Speaker 05:
It's just arranged differently.

[00:43:47] Speaker 05:
And it has the same identical pharmacological effect.

[00:43:50] Speaker 05:
That's what the patent says in column 4, lens 13 to 16, that has the same.

[00:43:55] Speaker 05:
Grunthal says that at page 55 of their brief, that it has the identical same structure and analgesic effect, regardless if you have form A or form B. So then the question still comes back to, why does having form A matter?

[00:44:09] Speaker 05:
What did they give to the public to assure them that they had a useful invention?

[00:44:14] Speaker 05:
And the answer is,

[00:44:15] Speaker 05:
What makes this case even more unusual is that they had the dissolution testing.

[00:44:19] Speaker 05:
They had that testing.

[00:44:21] Speaker 05:
At APEX 9804, the record, that testing was disclosed as DTX 1158, which can be found at 49209 of the record.

[00:44:30] Speaker 05:
They had the dissolution testing, but they didn't disclose it.

[00:44:32] Speaker 05:
So as the Supreme Court said in Brenner, this is not the case where they disclose something useful that is good for the public, that is part of the quid pro quo, but it's still an object of research.

[00:44:42] Speaker 05:
And it doesn't matter if you have form A or form B. OK.

[00:44:44] Speaker 05:
We thank you very much.

[00:44:45] Speaker 05:
Thank you.

[00:44:56] Speaker 03:
We'll put you back to your original minute.

[00:45:00] Speaker 00:
Thank you, Your Honors.

[00:45:01] Speaker 00:
As to the polymorph obviousness, the district court's error is essentially on pages appendix 133 to 145.

[00:45:07] Speaker 00:
It's confusing, reasonable expectation of success with predictability.

[00:45:11] Speaker 00:
and requiring predictability, even though the court had already found the procedures are routine to do the polymorph screen, and that a person already skilled in the art would know how to do that screen.

[00:45:21] Speaker 09:
What case or cases would you cite as stating or holding, if any do, that you can have a reasonable expectation of success as to something you cannot even identify in advance?

[00:45:36] Speaker 00:
Cuban would be the closest case, Your Honor, where there is a sequence for that.

[00:45:40] Speaker 00:
And nobody knows the sequence ahead of time.

[00:45:42] Speaker 00:
But the key quote is, the enabling methodology is disclosed.

[00:45:46] Speaker 00:
And therefore, combining, and it's an obvious to try case, combining the prior art, which had the direction to find out sequences and had prior art compound, but didn't know the result ahead of time.

[00:45:56] Speaker 09:
So we have one in which, among the things you cannot even predict, is whether the thing existed.

[00:46:03] Speaker 09:
That's not true in Cuban, because somehow or other, there are a bunch of codon sequences.

[00:46:09] Speaker 09:
that are going to be the gene, right?

[00:46:11] Speaker 00:
Yes, your honor.

[00:46:12] Speaker 00:
And here, whether there's polymorphs or not, that's a question where it's answered in the 737 that there is at least a crystal form.

[00:46:19] Speaker 00:
And in determining even how to characterize that form, which the FDA would require, that's the step that the polymorph would do.

[00:46:25] Speaker 00:
So at that point, while one does not know how many forms there are, that's the routineness of doing the polymorph screen to find out the result to say, what is the polymorph landscape?

[00:46:36] Speaker 00:
And that's exactly what that Byrne article was intended to address.

[00:46:39] Speaker 00:
So in conclusion, the distinction was between using the routine steps following the prior art versus what the court addressed, which was predictability.

[00:46:48] Speaker 00:
And that's also the expert's response.

[00:46:50] Speaker 00:
Specifically, when asked about SSCI is that Appendix 10907 was asked specifically about SSCI as a reference.

[00:46:58] Speaker 00:
And if one followed that, does that still make it non-obviousness?

[00:47:02] Speaker 00:
And the expert's answer was, it's not predictable.

[00:47:04] Speaker 00:
So it's only distinction here that the judge and their experts relied on is not knowing the answer ahead of time.

[00:47:09] Speaker 00:
And it's not addressed in the opinion whether the pathway would be obvious, specifically in view of burn, as opposed to the general landscape of polymorph patents.

[00:47:17] Speaker 02:
Thank you very much.

[00:47:31] Speaker 02:
Michael Joffrey.

[00:47:32] Speaker 02:
Obviously, I'm the appellee.

[00:47:34] Speaker 02:
And we have not had the benefit of hearing Mr. Sitzman's argument.

[00:47:39] Speaker 02:
But I will address the issue of infringement.

[00:47:44] Speaker 02:
May it please the Court?

[00:47:45] Speaker 02:
A fundamental flaw in DepoMed's cross-appeal is their assertion that polyneuropathic pain is an unlabeled use under the Indication Act of AFC-1.

[00:47:57] Speaker 02:
And that's just not true.

[00:47:58] Speaker 02:
And this was an issue that was disputed at trial.

[00:48:01] Speaker 09:
And the district court.

[00:48:04] Speaker 09:
Why does the label, on label, off label matter, as opposed to whether physicians would understand something in a certain way and would understand that it is being encouraged?

[00:48:17] Speaker 02:
The touchstone is encouragement, Your Honor.

[00:48:20] Speaker 02:
That's true.

[00:48:21] Speaker 02:
But because this is an Anda case, we don't have any benefit of knowing what doctors actually do or

[00:48:27] Speaker 02:
that there is any other type of encouragement of record.

[00:48:31] Speaker 02:
All that exists, because this is an Anda case, is the Anda filing itself, including the label.

[00:48:37] Speaker 02:
So if we're going to look for it.

[00:48:38] Speaker 09:
By the way, is that troublesome little bit about a reference to Jansen?

[00:48:43] Speaker 09:
Is that out of the case?

[00:48:44] Speaker 09:
One of the- Yes.

[00:48:46] Speaker 02:
That was an issue with Westward.

[00:48:48] Speaker 02:
That is out of the case, as I'm understanding.

[00:48:50] Speaker 02:
As to activists as label, it was never an issue.

[00:48:52] Speaker 02:
And in any event, the point being is,

[00:48:54] Speaker 02:
The only thing to look at, the only evidence to look at, is what is in the label.

[00:48:58] Speaker 02:
In an activist's label, what happened was there was a specific carve-out of anything dealing with polyneuropathic pain.

[00:49:06] Speaker 02:
So there was nothing in the indication, and there was no testing within the label showing anything about polyneuropathic pain.

[00:49:13] Speaker 02:
And that matters a lot, because as Depot Med admits in its brief at 10, before 2007, and even continuing today,

[00:49:22] Speaker 02:
there was widespread controversy surrounding the use and efficacy of opioids for treating neuropathic pain.

[00:49:29] Speaker 02:
So if you have a doctor that's looking at a label on an opioid, and it doesn't say anything about polyneuropathic pain, they would naturally not think that it has any ability to treat polyneuropathic pain.

[00:49:41] Speaker 08:
It would solely be about... Are you saying opioids were not being used as a second line of treatment?

[00:49:46] Speaker 02:
I'm saying they were being used... You're not saying that.

[00:49:49] Speaker 02:
No, no, no.

[00:49:50] Speaker 08:
But I am saying...

[00:49:51] Speaker 02:
Yes, but there was, as they admit, a controversy about the use of opioids.

[00:49:57] Speaker 02:
And that continues even to this day, about using it to treat polynorethropathic pain.

[00:50:03] Speaker 02:
So given that fact, given that general reticence in the art about using an opioid to treat polynorethropathic pain, and a label that's absolutely devoid of talking about polynorethropathic pain, a doctor would not read this label and say, oh, this must be for treating polynorethropathic pain.

[00:50:19] Speaker 02:
And so there's therefore no possibility of encouraging the infringing use.

[00:50:24] Speaker 02:
And in fact, Janssen knew that.

[00:50:26] Speaker 02:
So Janssen did not think when it originally sold the branded or got the indication for the branded product that this covered neuropathic pain.

[00:50:37] Speaker 02:
They originally, like activists, had a single indication, and that indication was for severe pain.

[00:50:44] Speaker 02:
Internal Janssen documents describe that the indication was not covering neuropathic pain.

[00:50:49] Speaker 02:
So Janssen then went out, spent $50 million on testing in order to get a second indication that specifically went to a type of neuropathic pain.

[00:50:57] Speaker 02:
That indication that is now on their label is not an activist's label.

[00:51:02] Speaker 02:
So even Janssen knew that this was not, that probably not neuropathic pain could not exist within the scope of activist's label.

[00:51:10] Speaker 02:
And because of that, there can't be any encouragement to infringe.

[00:51:14] Speaker 07:
Is there any difference between your label and your co-counsel's client's label?

[00:51:20] Speaker 02:
So our label, the answer is there's slight different wording.

[00:51:25] Speaker 02:
But I think that there's been no dispute that they're essentially co-extensive.

[00:51:29] Speaker 02:
Westward.

[00:51:29] Speaker 08:
Westward, not Elkham.

[00:51:30] Speaker 08:
Indication 2 has been carved out, all references to a DPN trial study has been carved out.

[00:51:36] Speaker 02:
That's us and Westward.

[00:51:37] Speaker 02:
That would not be the same with Truth for Elkham.

[00:51:40] Speaker 08:
And to what extent would

[00:51:42] Speaker 08:
doctors appreciate the fact that these carve-outs occurred.

[00:51:46] Speaker 08:
Would they somehow understand in a larger context?

[00:51:50] Speaker 08:
Okay, for the patent owner's label, they see and know that there's indication one, there's indication two, and underneath indication one, there's a discussion of the DPN study to support indication one.

[00:52:05] Speaker 08:
But now I have these ANDA people's labels, and I see, ah, they've

[00:52:12] Speaker 08:
removed indication two, and they've removed any discussion of the DPN study to support their indication one.

[00:52:19] Speaker 08:
Would the doctors somehow see and read and understand the overall context of what's going on?

[00:52:24] Speaker 02:
Doctors would understand the context, but they would also see specifically what activists did.

[00:52:29] Speaker 02:
And the only thing activists did was include indication one in their label.

[00:52:33] Speaker 02:
They didn't include the studies or anything else.

[00:52:36] Speaker 02:
So you

[00:52:37] Speaker 08:
The thing that you can't do is... I guess what I'm wondering is maybe would they understand, would they have a baseline understanding of what the other side's label actually says and does in the NDA?

[00:52:50] Speaker 02:
So there may be doctors that know that.

[00:52:53] Speaker 02:
The problem, of course, is that you can't combine what some doctor knows about something else and do some sort of literature hunt, where you combine something that

[00:53:04] Speaker 02:
some other label with what activist does, and then say, oh, from that we can infer that activist is doing an infringing conduct.

[00:53:11] Speaker 08:
In fact, what you have to look at is- No, my inference would be the converse of that.

[00:53:17] Speaker 08:
They'd be assuming, oh, activist is trying to run away from using their particular generic for polyneuropathic things.

[00:53:26] Speaker 02:
And we did.

[00:53:27] Speaker 02:
We specifically carved out, and then we filed a section 8 in our ANDA notice letter saying we don't infringe this.

[00:53:34] Speaker 02:
And so therefore, altogether, that would lead to the assumption that not only were we not acting to encourage infringement, we were doing everything we could to avoid infringement.

[00:53:43] Speaker 09:
Could the answer to the question of what your label is tends to suggest you intend to encourage change over time as the world of research changes?

[00:53:59] Speaker 09:
So that, for example, here, assume that, you know,

[00:54:03] Speaker 09:
nothing happens till 2025.

[00:54:06] Speaker 09:
We're talking here now about the difference between 25 and 28, right?

[00:54:10] Speaker 09:
2025 and 28, just on that assumption.

[00:54:14] Speaker 09:
So by seven years from now, there's new research and everybody now understands that the chronic form of pain covered by the only explicitly stated indication is understood by everybody to include

[00:54:28] Speaker 09:
polymorphic and the diabetic peripheral pain.

[00:54:32] Speaker 09:
If you kept the label this way, Mike, you'd newly be accused of inducing.

[00:54:38] Speaker 02:
I think that the issue, though, is what is the act that is actually being performed.

[00:54:45] Speaker 09:
So there has to be an act.

[00:54:47] Speaker 09:
Marketing with this label.

[00:54:48] Speaker 02:
At some point, if marketing comes along, perhaps there would be some issue of intent that could clearly be inferred.

[00:54:54] Speaker 02:
For example, if contrary to law, activists were to

[00:54:58] Speaker 02:
to market off-label uses, which can't really do.

[00:55:03] Speaker 02:
It wouldn't happen for long.

[00:55:04] Speaker 02:
Theoretically, that kind of activity could be used to show an intent to actually encourage infringement despite the label.

[00:55:11] Speaker 02:
But here, we have a label that was produced a little while ago.

[00:55:15] Speaker 02:
And you also have the admission.

[00:55:17] Speaker 09:
I guess the question is, legally, is the inquiry fixed as of what time?

[00:55:24] Speaker 09:
Isn't it as of the marketing, whether you would be

[00:55:27] Speaker 09:
will be inducing when you market?

[00:55:29] Speaker 02:
Well, it has to surely be the act of, there has to be an intent and an act of encouragement at a given time.

[00:55:34] Speaker 02:
And the only action, there's only one action, and that one action was filing an ANDA at this point in time.

[00:55:40] Speaker 02:
Now later on in time, there will be marketing, et cetera.

[00:55:43] Speaker 02:
But at this point in time, you're somewhat fixed because you only have an intent and one action, which is the filing of the ANDA, which would trigger 271.

[00:55:52] Speaker 09:
But you're going to sit there for seven years, on my assumption, and do nothing.

[00:55:57] Speaker 09:
And then in 2025, you're going to say, OK, there's only the one thing left, the 130, and now I'm going to market, assuming that.

[00:56:08] Speaker 09:
And at that point, why doesn't your intent count with all the knowledge existing in the world then?

[00:56:15] Speaker 02:
Because then it becomes a pure speculation about what we might do in 10 years, which seems both problematic, just as a legal matter, but also it is also the problem is that we

[00:56:27] Speaker 02:
There's no evidence in the record, obviously, of what we're going to do in 10 years.

[00:56:31] Speaker 02:
So by necessity, you have to be fixed at the time and look at the only action that activists took.

[00:56:39] Speaker 02:
And the only action is the filing of the end.

[00:57:00] Speaker 04:
Before I jump right into infringement, I wanted to respond to Judge Taranto.

[00:57:05] Speaker 04:
You asked for a case site.

[00:57:06] Speaker 04:
I wanted to give you one.

[00:57:08] Speaker 04:
Pfizer v. on the 364, Pfizer v. Teva, 555, Fed Appendix 961 at 971.

[00:57:22] Speaker 04:
Activists in Westward's labels induce infringement of the 130 patent.

[00:57:28] Speaker 04:
All the experts agreed in this case, all three medical experts in this case agreed that the indicated use on defendants proposed labels includes polyneuropathic pain.

[00:57:42] Speaker 04:
Council did not tell you that the medical expert that they hired agreed with all of the other medical experts that indication one that's on their label includes polyneuropathic pain.

[00:57:58] Speaker 04:
In fact, as the district court found, 95% of the time will be used for the treatment of polyneuropathic pain.

[00:58:05] Speaker 04:
Now that evidence was undisputed and in the record.

[00:58:09] Speaker 04:
The instruction here appears in the indication section, which is where FDA requires parties to put down their intended use.

[00:58:18] Speaker 04:
This is induced infringement.

[00:58:21] Speaker 04:
The district court committed legal error

[00:58:24] Speaker 04:
when it used non-infringing uses to negate the finding of intent and induced infringement.

[00:58:32] Speaker 04:
And that's contrary to this court's precedent.

[00:58:35] Speaker 04:
On at least three occasions in the last 18- Are we talking 271B or 271C?

[00:58:40] Speaker 04:
271B.

[00:58:41] Speaker 04:
OK.

[00:58:42] Speaker 04:
On at least three different occasions in the last 18 months, this court has said using non-infringing uses or substantial non-infringing uses to negate a finding of inducement

[00:58:53] Speaker 04:
is improper.

[00:58:55] Speaker 04:
As the Court said in Sanofi, there is no legal or logical basis for the suggested limitation on inducement.

[00:59:02] Speaker 04:
Section 271b on inducement does not contain

[00:59:05] Speaker 04:
substantial non-infringing use restriction of 271C on contributory infringement.

[00:59:11] Speaker 09:
I'm going to assume, maybe hope, but assume that Santa Fe doesn't say that that evidence is irrelevant, only that it's not required.

[00:59:20] Speaker 09:
Why would it not, in the real world, be relevant to assessing intent as manifested in some sort of encouragement, whether

[00:59:34] Speaker 09:
there actually is anything else that anybody could use the thing for.

[00:59:38] Speaker 09:
Of course, it's relevant.

[00:59:39] Speaker 04:
Well, I, I, I, it may be relevant, but.

[00:59:43] Speaker 09:
Well, that's the question, right?

[00:59:44] Speaker 09:
The district judge made a factual finding about intent as manifested in, in words of encouragement.

[00:59:52] Speaker 04:
But the court, but the district court cannot use that finding to negate the induced infringement as per AstraZeneca.

[01:00:00] Speaker 04:
This court said,

[01:00:01] Speaker 04:
that as long as some users will be instructed to use this in an infringing manner, that non-infringing uses could not or would not negate the finding of induced infringement.

[01:00:14] Speaker 04:
It was, in fact, irrelevant in that case whether or not there were non-infringing uses on label or off label.

[01:00:24] Speaker 09:
What do you do about the significance of

[01:00:30] Speaker 09:
the sequenced way in which it was at Janssen, I guess, went to the FDA and said, and in fact got approval for what extended release in 2011 was it, and then later extended release in 2012.

[01:00:44] Speaker 09:
I may have the dates wrong.

[01:00:46] Speaker 09:
First with indication one, second with indication two.

[01:00:48] Speaker 09:
Doesn't that tell you that the world of providers would not automatically assume that indication one

[01:01:00] Speaker 09:
is an encouragement of indication two, otherwise what was the need?

[01:01:04] Speaker 04:
Well, as the record reflects, the need was a marketing one by FDA.

[01:01:09] Speaker 04:
FDA required that second DPN study in order to say that this has been approved for DPN.

[01:01:15] Speaker 04:
But the record is unequivocal on what doctors will do.

[01:01:20] Speaker 04:
We had three medical experts, including the experts from the defendants, who testified very clearly that indication one

[01:01:27] Speaker 04:
includes polyneuropathic pain.

[01:01:30] Speaker 04:
There was no equivocation on that.

[01:01:32] Speaker 04:
And the district court made a factual finding that some users will infringe.

[01:01:38] Speaker 04:
The problem is she committed legal error when the district court used non-infringing alternatives, non-infringing uses, to take that away.

[01:01:48] Speaker 04:
And that is what was improper.

[01:01:50] Speaker 04:
That's the error here.

[01:01:55] Speaker 04:
Unless the court has any further questions,

[01:01:58] Speaker 03:
Thank you.