[00:00:00] Speaker 04:
4-1074, Takeda Pharmaceutical Company versus TWI Pharmaceuticals.

[00:00:33] Speaker 04:
Yes.

[00:00:33] Speaker 04:
Please proceed.

[00:00:42] Speaker 01:
Good morning.

[00:00:45] Speaker 01:
This appeal presents essentially four issues.

[00:00:50] Speaker 01:
First, whether a 2.7 E2 infringement claim can be made based on a patent that is not listed and submitted to the secretary and listed in the Orange Board.

[00:01:01] Speaker 01:
to whether the district court erred in finding that the 2A2 patent was invalid because it lacked... So let's go back to that first issue.

[00:01:10] Speaker 03:
Section 271 uses the word a patent.

[00:01:14] Speaker 03:
It doesn't say patent listed in the ordinance, correct?

[00:01:18] Speaker 03:
How do you want us to read that into the statute?

[00:01:21] Speaker 01:
Sure, your honor.

[00:01:22] Speaker 01:
If you look at the entire statute, it says it should be an act of infringement to submit an handoff

[00:01:29] Speaker 01:
And then if you read at the end it says, if the purpose of the submission is to obtain approval under the Act to engage in the commercial manufacture of a claim in a patent or the use of which is claimed in a patent before the expiration of such a patent.

[00:01:48] Speaker 01:
That whole phrase is used throughout the Hatch-Waxman Act to refer to the patents that are listed in reference to the

[00:01:59] Speaker 01:
a branded drug for which the generic must submit a certification.

[00:02:05] Speaker 01:
And the certification says, here we certify, we're going to address every single one of those patents that are listed.

[00:02:11] Speaker 03:
Why wouldn't Congress write in those words a patent listed in the Ring Book?

[00:02:17] Speaker 01:
Well, they did.

[00:02:18] Speaker 01:
They said the patent's listed with the secretary.

[00:02:20] Speaker 01:
It's before the expiration of that patent.

[00:02:23] Speaker 01:
If you look at that section and then you look at the section that corresponds to this, which we reference, which is under the circumstances under which the FDA can approve an application, it says explicitly and spells it out that FDA can only approve an application, has to approve it within a certain period of time unless an inaction is filed under 271E2 with respect to a patent submitted by the brand company to the secretary.

[00:02:53] Speaker 01:
And so there is a balance between that.

[00:02:59] Speaker 01:
If you read it the way your honor suggests, which I think that is Takeda's position, that it means any patent, then you would be, I think,

[00:03:09] Speaker 01:
all the case law where we've discussed these issues over the years would have all been for naught because it would have been very simple and Congress could have set any patent.

[00:03:17] Speaker 03:
And in the Momenta case, which I believe Judge Moore wrote... You would argue that all jurisdiction under 271 requires an orange book listing.

[00:03:27] Speaker 01:
I'm requiring that under 271

[00:03:29] Speaker 01:
E2, in order to have jurisdiction or to state a claim under 27E2, the patent that's asserted must be listed in the orange book.

[00:03:38] Speaker 01:
That's exactly what Judge Moore wrote in the AstraZeneca versus Apotex case.

[00:03:44] Speaker 01:
Maybe it wasn't Judge Moore, but you're on the panel, where they said jurisdiction is the only thing required to allege jurisdiction under 27E2 is

[00:03:55] Speaker 01:
that the ANDA infringes a listed patent.

[00:03:59] Speaker 04:
Can you move on to your anticipation argument and explain why Larson is in fact enabled?

[00:04:09] Speaker 01:
What we say, Your Honor, is there's Larson and Barbarich.

[00:04:13] Speaker 01:
Barbarich incorporates the Larson information.

[00:04:16] Speaker 01:
And then it says explicitly that

[00:04:21] Speaker 01:
you have a powder that the dexlansoprazole is in a flowable powder, preferred.

[00:04:29] Speaker 01:
And it was admitted that if it was enabled to make a flowable powder, that powder would in fact be amorphous and therefore it would be invalidating.

[00:04:37] Speaker 01:
That was never disputed by the plaintiffs.

[00:04:39] Speaker 04:
in this case, because they were arguing... No, I know, but the question, it seems to me, in the district court held was that it wasn't enabled, and he rejected Dr. Elder's testimony on that point.

[00:04:49] Speaker 04:
So I'm asking you to tell me why that's wrong.

[00:04:51] Speaker 01:
All right.

[00:04:51] Speaker 01:
It's wrong for, I think, three reasons, Your Honor.

[00:04:54] Speaker 01:
First reason was it was wrong because the district court put the burden on the TWI to prove not enablement of the prior art, of Larson and of

[00:05:08] Speaker 01:
of Barbarich.

[00:05:10] Speaker 01:
Larson claimed, had a specific claim for pharmaceutical salts of Dexlansulfazol.

[00:05:17] Speaker 01:
So under the Antoramedia case and the case decided in our brief, this court has stated that actually the patentee, that someone challenging enablement of any patent is the one who bears the burden to prove it.

[00:05:30] Speaker 01:
It makes no sense for the patentee here to say everybody's patent

[00:05:36] Speaker 01:
or my patent is entitled to the presumption of validity, but nobody else's is.

[00:05:41] Speaker 01:
The patent up is granted, Larson.

[00:05:43] Speaker 01:
It reviewed the Barberage application.

[00:05:46] Speaker 01:
And Larson's explicitly got a claim entered with Dexalant Soprazole and pharmaceutically acceptable salts of Dexalant Soprazole in a claim.

[00:05:56] Speaker 01:
So the burden was on that.

[00:05:57] Speaker 01:
Second, the district court made a fundamental error with respect to Larson.

[00:06:05] Speaker 01:
He got caught up on whether or not you could replicate Larson perfectly to end up with an oil.

[00:06:14] Speaker 01:
When Larson, the chemical reactions that were described in Larson were replicated by Dr. Elder,

[00:06:20] Speaker 01:
And he went through and mixed the exact same amounts of the materials, exact same way, ended up with dexlain solvrazol.

[00:06:28] Speaker 01:
And then he just dried it, it came out.

[00:06:32] Speaker 01:
So his theory, his explanation was that from all the evidence that what you had in Larson was pure dexlain solvrazol with some residual solvent.

[00:06:42] Speaker 01:
Their expert came in and said, well, wait, wait, wait a minute.

[00:06:45] Speaker 01:
We think that what you have here in Larson is some mystery meat that is pure dexlansulfurazole, but magically it's an oil.

[00:06:53] Speaker 01:
And when Dr. Atwood was cornered on this during his cross-examination, we asked him, do you have any support for your theory that something can exist in nature simultaneously

[00:07:06] Speaker 01:
in pure and excellent silver salt, at room temperature, as a salad and as an oil.

[00:07:11] Speaker 01:
And he said no.

[00:07:12] Speaker 01:
And that flew right over the district court's head, didn't address it in his opinion.

[00:07:17] Speaker 01:
And it is an instance where the district court, factual findings, because they didn't appreciate the admission, is totally erroneous.

[00:07:26] Speaker 04:
Unfortunately, I do not totally appreciate it either.

[00:07:29] Speaker 04:
So you might want to go back over it, since you obviously think it's really important.

[00:07:31] Speaker 04:
But before you do that, I guess my question is, Dr. Elder was supposedly attempting to follow the Larson process.

[00:07:39] Speaker 04:
which should have resulted in him getting an oil.

[00:07:42] Speaker 04:
That's what Larson disclosed.

[00:07:44] Speaker 04:
He followed the Larson process and got a solid.

[00:07:48] Speaker 04:
So that left the district court sort of scratching its head a little bit.

[00:07:52] Speaker 04:
And I don't even think Dr. Elder explained why he got a solid.

[00:07:56] Speaker 04:
I think he was sort of surprised to have gotten a solid and not need to.

[00:08:02] Speaker 01:
What Dr. Elder said was, and what the evidence was, is that when I replicated this, I followed those steps, and I got what I got.

[00:08:09] Speaker 01:
I can, since I got a solid, and because dexlansulfurazole is a solid at room temperature in its natural state, what Larson had was dexlansulfurazole with some residual solvent.

[00:08:23] Speaker 01:
So if the issue was only removing residual solvent from dexlansulfurazole, if that's what you had, then it would be a matter of course for anybody to remove additional solvent.

[00:08:35] Speaker 01:
And that's where the theories offered by Professor Atwood

[00:08:38] Speaker 01:
He said, okay, I've looked at all the information.

[00:08:41] Speaker 01:
I'm concluding that Larson had this mystery meat of dextrose oil, and that you couldn't do anything with it.

[00:08:54] Speaker 01:
And we asked him what their support for that was, and he had none.

[00:08:56] Speaker 01:
He said, I can't support that in light of all the facts.

[00:08:58] Speaker 01:
Dr. Elder said, and Dr. Rogers said, and even their own expert, Dr. Meyerson, who they offered during the earlier proceedings on summary judgment, said that Larson is just paradoxical and sole resolve with some residual solvent.

[00:09:17] Speaker 01:
And then the third reason why the district court erred

[00:09:22] Speaker 01:
in not finding anticipation, was that the district court didn't even address whether you could make things directly from Larson's oil.

[00:09:35] Speaker 01:
And the evidence is uncontroverted that you could make the salts that are claimed from Larson's oil, it's pure Dexlansulfurazole, the first step in a salt reaction is to dissolve the material and you can perform the salt and that the disclosures in Barbarich

[00:09:50] Speaker 01:
with respect to salts were identical to the disclosures in the 2A2 patent with respect to salts.

[00:09:55] Speaker 04:
Well, what about the district court's conclusion about solvent?

[00:10:00] Speaker 04:
He said that one skilled near Larson would have had prior publications that taught appropriate solvents for extraction and flash chromatography.

[00:10:08] Speaker 04:
But Dr. Elder didn't use any of the solvents disclosed in the prior art.

[00:10:12] Speaker 04:
He chose completely different solvents and gradients for those solvents and used them in Larson's method.

[00:10:24] Speaker 04:
How do we know in short that the ones that Dr. Elder chose were known in the prior art such that one of Skill in the Art at the relevant time would have used those solvents to arrive at the... Well, I believe that their expert testified that the choices that Dr. Elder used were available to persons of Skill in the Art.

[00:10:45] Speaker 01:
And so these steps that you're describing are steps that are not specified in Larson.

[00:10:52] Speaker 01:
And Dr. Abbott even admitted that he did not specify the ways to perform these steps in his own patents.

[00:11:01] Speaker 01:
And so you have a situation where the person with skill in the art can gap fill on routine things.

[00:11:07] Speaker 01:
Larson didn't think these procedures, how you extract and do these removals and purification steps were at all

[00:11:15] Speaker 04:
I don't remember what precisely did Dr. Atwood say about this, because it's my recollection that he said something like, yes, these solvents were known, but what he didn't say is one of skill and the art would have chosen these.

[00:11:28] Speaker 04:
And this is a very unpredictable field.

[00:11:29] Speaker 04:
It's not something I feel like I know a lot about, that's for sure.

[00:11:32] Speaker 04:
very unpredictable field.

[00:11:34] Speaker 04:
So the fact that there are, I mean there are millions of possible solvents out there.

[00:11:38] Speaker 04:
The fact that this would happen to exist among millions is not the same thing as establishing that one of skill near the relevant time would have used it in this process.

[00:11:46] Speaker 01:
Well, Your Honor, I think that if that's, here there are, the Larson reference discloses from a very experienced people as a patent,

[00:11:54] Speaker 01:
and they disclose a whole series of chemical reactions performed to obtain different chemicals.

[00:12:01] Speaker 01:
And they don't disclose specifically what they use for any of these things in the context of this patent.

[00:12:08] Speaker 01:
And everyone understands that things that are routine or can be gap-filled are okay to leave out of patents.

[00:12:14] Speaker 01:
So that doesn't make Larson not enabled.

[00:12:16] Speaker 04:
But only if Dr. Elder, in producing Larson, since the question is enablement, only if what Dr. Elder did is what one of skill in New York at that time would have done.

[00:12:28] Speaker 04:
Dr. Elder's proof that he established Larson on the second try is meaningful, but only if he established it by virtue of the knowledge, which is hard to divorce yourself from, but that existed back then, not the knowledge he has now.

[00:12:42] Speaker 01:
Well, Your Honor, I think the steps that have been, you know, Dr. Abb would just basically, I think, nitpick at what Dr. Elder did.

[00:12:50] Speaker 01:
And no one ever said that anything was significant or would lead, he would just say, this was different, this was different.

[00:12:55] Speaker 01:
He didn't say that the different choices would have infected the experiment in any way.

[00:13:00] Speaker 01:
He just was arguing that there were differences.

[00:13:03] Speaker 01:
and without saying that there was any consequence to any of those differences.

[00:13:07] Speaker 01:
And all the evidence is that there was no consequence to any of those differences because nobody puts those in any past.

[00:13:12] Speaker 04:
You started by saying there are four things on appeal.

[00:13:14] Speaker 04:
You've got two minutes left and we only covered two.

[00:13:17] Speaker 04:
Do you want to take a quick minute to say something else about one of your other points?

[00:13:20] Speaker 01:
Sure, Your Honor.

[00:13:21] Speaker 01:
With respect to the claim construction of amorphous that the district court adopted, I think it's important to recognize that we said

[00:13:30] Speaker 01:
There was no discussion in the patent of amorphous at all.

[00:13:34] Speaker 01:
It's amorphous compound and the district court read in a solid limitation.

[00:13:38] Speaker 04:
We were recently instructed that we need to give deference to expert testimony and claim construction and we actually have some of that here.

[00:13:46] Speaker 04:
The district court did in fact rely on an expert with regard to what amorphous meant to people in this particular industry.

[00:13:54] Speaker 04:
So what do we do with that?

[00:13:55] Speaker 01:
Well, I think, Your Honor, the factual conclusions of the district court based upon the evidence are what leads you to reject what he did.

[00:14:03] Speaker 01:
He said it's undisputed that the patent makes no mention of amorphous... He said it's undisputed that the term

[00:14:18] Speaker 01:
At A-222, he said the term amorphous compound is not used in the specification much less defined.

[00:14:25] Speaker 01:
At 230, he said the district court found that there are two possible meanings of the term, quote, there are two possible meanings of the term, both of which might be characterized as plain and ordinary meaning of the claimed term.

[00:14:37] Speaker 01:
That should have ended the inquiry under this court's reasoning in Thorner, Judge Schall's opinions in Brook Hill or Texas Digital,

[00:14:47] Speaker 01:
and even Judge Raina's decision in area.

[00:14:51] Speaker 01:
Then the other fact finding he made was that the amorphous compound, that is in examples one and two, was a solid.

[00:15:04] Speaker 01:
That's all that appears.

[00:15:05] Speaker 01:
Otherwise, the application is devoid of any information about this, and he read those limitations

[00:15:12] Speaker 01:
into the claim notation.

[00:15:13] Speaker 01:
I think under the court's rules of claim construction, which were not, as a legal issue, were not disturbed, that it was improper when the court found that there were two meanings, both of which were consistent with the use of the specification.

[00:15:27] Speaker 01:
He was required to adopt something that encompassed both of them.

[00:15:31] Speaker 01:
He did not.

[00:15:31] Speaker 04:
I think we need to give the other side a chance.

[00:15:35] Speaker 04:
Mr. Dane.

[00:15:36] Speaker ?:
Thank you.

[00:15:43] Speaker 02:
Please the court.

[00:15:45] Speaker 02:
I'll begin with addressing the jurisdictional issue briefly.

[00:15:50] Speaker 02:
I think the court is absolutely correct that what TWI is arguing for is a reading of 271E2A that would add language that Congress did not include.

[00:16:01] Speaker 02:
The language of that provision states, it shall be an act of infringement to submit an application under Section 505J of the Federal Food, Drug and Cosmetic Act

[00:16:12] Speaker 02:
for a drug claimed in a patent.

[00:16:15] Speaker 02:
And they stop there.

[00:16:17] Speaker 02:
If the purpose of such submission is to obtain approval under such act to engage in the commercial manufacturer use or sale of the drug claimed in a patent before the expiration of such patent.

[00:16:27] Speaker 02:
That is exactly the situation here.

[00:16:29] Speaker 02:
TWI is seeking approval from the FDA to sell a drug that is claimed in a patent.

[00:16:36] Speaker 02:
And the main reliance that TWI has relied on

[00:16:40] Speaker 02:
for their view that there is no jurisdiction is the Warner-Lambert decision of this court, which is very different because that is a decision that relates to method of use patents.

[00:16:52] Speaker 02:
And it's somewhat coincidental, I guess, that we had a previous argument that talked about the difference between the Article B and the Article A. In the Warner-Lambert decision, the court very carefully construed the statutory language.

[00:17:05] Speaker 02:
And one of the bases for its decision was when Congress talked about use patents.

[00:17:10] Speaker 02:
it used the word the it said to be an act of infringement to submit an application for a drug claimed in a patent the use the use of which is claimed in a patent and the court can find a leading counsel so can you move to the anticipation absolutely wrong uh... first of all with regard to the uh... uh... counsel said that the court

[00:17:37] Speaker 02:
uh... parley heard him in placing the burden upon them to disprove enablement of our bridge correctly expressly said that it didn't matter where it plays the presumption here because this wasn't a case where the evidence was essentially an equipoise the court found that uh... skater had produced sufficient evidence to convince that the barberage was not enabled and even in the engine three cases court recognized why doctor

[00:18:03] Speaker 04:
able to produce the composition on his second try.

[00:18:09] Speaker 04:
The court said, something like, it took him two tries, and I thought, oh, my goodness sakes.

[00:18:14] Speaker 04:
Do you strike oil the first time you draw it?

[00:18:17] Speaker 04:
I mean, two tries doesn't seem like undue experimentation to me.

[00:18:21] Speaker 04:
So why is it such that that is not clearly erroneous?

[00:18:28] Speaker 02:
Well, Your Honor, I think here we have to look at it.

[00:18:30] Speaker 02:
It's an unusual type of anticipation argument.

[00:18:32] Speaker 02:
Because we start with Barbaridge.

[00:18:35] Speaker 02:
Barbaridge has no teaching as how to make dexalenzoprazole.

[00:18:39] Speaker 02:
Barbaridge is basically a formulation of that.

[00:18:41] Speaker 04:
It incorporates Larson.

[00:18:42] Speaker 02:
It incorporates Larson.

[00:18:44] Speaker 02:
So you go to Larson, and Larson doesn't tell you how to make solid form dexalenzoprazole.

[00:18:48] Speaker 02:
It says this is how you get an oil.

[00:18:50] Speaker 02:
And so what Dr. Elder was initially attempting to do was to faithfully replicate Larson and then prove, their theory was, that we can get that oil

[00:19:01] Speaker 02:
We can dry it.

[00:19:01] Speaker 02:
That was Larsen's problem.

[00:19:03] Speaker 02:
He didn't dry it enough.

[00:19:04] Speaker 02:
And if we dry it enough, we'll wind up with a solid.

[00:19:07] Speaker 02:
So the first time that he tried to do the experiment, and this is in the record.

[00:19:12] Speaker 02:
He said, this is when we tried to do the most literal reenactment of the experiment.

[00:19:18] Speaker 02:
They didn't even get the compound.

[00:19:20] Speaker 02:
They didn't even get dexalenzoprazole.

[00:19:22] Speaker 02:
They got the racemic mixture.

[00:19:24] Speaker 02:
So they never even tested it for chemical purity.

[00:19:26] Speaker 02:
They never attempted to isolate it.

[00:19:27] Speaker 02:
They acknowledged that they couldn't have been able to.

[00:19:30] Speaker 02:
They wouldn't have been able to tell what the state of matter was.

[00:19:32] Speaker 04:
We all know.

[00:19:33] Speaker 04:
First try didn't work.

[00:19:34] Speaker 04:
Second try.

[00:19:36] Speaker 02:
So the second try, instead of trying to replicate the example again, the experiment again, they changed.

[00:19:43] Speaker 04:
How did they change?

[00:19:45] Speaker 02:
Okay, well the most significant change that they made, there were several changes that they made.

[00:19:49] Speaker 04:
So you think the drop-wise is the problem?

[00:19:51] Speaker 04:
Yes, yes.

[00:19:52] Speaker 04:
Okay, but the problem is Larson doesn't say doing it in this, for this example, Larson doesn't say do it drop-wise or do it all at once.

[00:19:58] Speaker 04:
First time he did it all at once, second time he did it drop-wise.

[00:20:02] Speaker 04:
Larson, it's not that they deviated from Larson, because on this point, Larson doesn't tell you which way to do it.

[00:20:08] Speaker 04:
Right?

[00:20:08] Speaker 04:
Am I misreading something in Larson?

[00:20:10] Speaker 02:
Larson does not have an explicit instruction?

[00:20:14] Speaker 04:
To do it either way.

[00:20:16] Speaker 04:
And this district court made fact findings that drop-wise introduction was known and regularly used in the art in this field or in this exact purpose.

[00:20:27] Speaker 04:
So given that fact finding, why wasn't it an error of him to then say to the extent that Dr. Elder did it drop-wise, that's a problem.

[00:20:38] Speaker 02:
Precisely because of what Larson

[00:20:41] Speaker 02:
basic teaching is.

[00:20:44] Speaker 02:
Larson was coming up with a new synthetic method to make these enantiomeric compounds.

[00:20:50] Speaker 02:
He reports in his patent that the old way of doing it was to do it at extremely low temperatures, negative 20, negative 40 degrees centigrade.

[00:21:00] Speaker 02:
The reason was other methods of making these enantiomers were incredibly heat sensitive.

[00:21:07] Speaker 04:
And Dr. Elder said, and this is not disputed, I don't think, that there are two ways that he could have modified his first test.

[00:21:16] Speaker 04:
Number one, he could have done it drop-wise, or number two, he could have lowered the temperature.

[00:21:19] Speaker 04:
But because Larson has expressed that it's not going to be the low temperature variety, he did it drop-wise instead.

[00:21:27] Speaker 04:
So why, I don't understand, why is that a problem?

[00:21:30] Speaker 02:
Because he's still violating Larson's teaching.

[00:21:33] Speaker 04:
How?

[00:21:34] Speaker 02:
Because the only reason that you would slowly add the oxidant is to control the temperature.

[00:21:42] Speaker 02:
And that's in the record, there's no dispute.

[00:21:45] Speaker 02:
The only reason you do it is because you understand it to be a heat sensitive reaction and if you add the oxidant all at once,

[00:21:53] Speaker 02:
It's an exothermic reaction that gives off heat.

[00:21:56] Speaker 02:
It might heat things up, and that can interfere with the synthesis.

[00:21:59] Speaker 02:
The very teaching of Larson is that that is not true of his methods.

[00:22:04] Speaker 04:
No, no, no, because this example doesn't describe whether it's all at once or drop-wise.

[00:22:10] Speaker 04:
In other places in the Larson patent, it does actually disclose drop-wise and or all at once, but not on this example.

[00:22:17] Speaker 04:
It doesn't disclose it.

[00:22:18] Speaker 04:
It only says don't reduce the temperature.

[00:22:21] Speaker 04:
Don't do the low temperature variety.

[00:22:23] Speaker 04:
I don't understand why that would exclude somebody from entering it drop-wise, which might give you the same result, but without manually lowering the temperature.

[00:22:35] Speaker 02:
Well, Your Honor, first of all, that's inconsistent with Dr. Elder's own admission.

[00:22:41] Speaker 02:
In his first, he said he was trying to do what his reading was of Larson the first time, and that was adding it all at once.

[00:22:48] Speaker 02:
So it's consistent with how he read Larson.

[00:22:51] Speaker 02:
and with how our experts said one would normally read Larson.

[00:22:54] Speaker 04:
I believe that it's unequivocal that Larson doesn't say do it all at once.

[00:22:58] Speaker 04:
Am I right with this example?

[00:23:00] Speaker 04:
Is there anything that says do it all at once or do it drop by?

[00:23:03] Speaker 04:
Are there other examples in Larson which do specify one or the other?

[00:23:07] Speaker 02:
There are others.

[00:23:09] Speaker 02:
But also it's important to keep in mind the amount that we're talking about here.

[00:23:16] Speaker 02:
It's a teaspoon.

[00:23:18] Speaker 02:
It is a tiny, tiny amount.

[00:23:20] Speaker 02:
And he took, I think in the record he was found it was an hour, an hour and a half.

[00:23:25] Speaker 04:
No, 30 minutes or it was 60 minutes.

[00:23:26] Speaker 04:
I'm sorry, 60 minutes.

[00:23:27] Speaker 04:
And the district court was not clear about which one it was, but he said it didn't matter in the end.

[00:23:31] Speaker 02:
Yeah, there was notation in his notebook that said it was 60 minutes, and the court credited that.

[00:23:37] Speaker 02:
But it would not be the natural thing to do when you've just got a teaspoon, a tiny amount to add, to add it

[00:23:45] Speaker 02:
in this very extracted way.

[00:23:48] Speaker 04:
But that's completely contrary to what the district court expressly found, which is drop-wise additions of these exact sorts of materials were well-known in the prior art as a method to use.

[00:24:00] Speaker 04:
I mean, it's not always the case that you're dumping a ton of it in.

[00:24:02] Speaker 04:
Lots of instances you are using a tiny amount, and that drop-wise was a regular prior art existing method of doing this.

[00:24:10] Speaker 02:
But what the court said is it was a known prior art method for controlling the temperature.

[00:24:15] Speaker 02:
That's the only reason that you do it that way.

[00:24:17] Speaker 02:
It is absolutely the only reason.

[00:24:20] Speaker 02:
Is that when you add it quickly, because it's an exothermic reaction, like putting something volatile into a liquid, all of a sudden it can heat it up, it can boil.

[00:24:29] Speaker 02:
The problem is that used to, in other techniques, it used to affect the synthesis.

[00:24:35] Speaker 02:
And Larsen's express teaching is

[00:24:37] Speaker 02:
Temperature does not affect my methods.

[00:24:40] Speaker 02:
It's an advantage of my methods.

[00:24:42] Speaker 02:
And we're not even talking about a modest change in temperature.

[00:24:45] Speaker 02:
He went from negative 20 to negative 40 degrees in the prior art.

[00:24:48] Speaker 02:
He said, you can do this at room temperature.

[00:24:51] Speaker 02:
The message there to someone with skill in the art is, don't worry about temperature.

[00:24:54] Speaker 02:
You do not need to care about it.

[00:24:56] Speaker 02:
So it is not a routine.

[00:24:59] Speaker 04:
So Larson said you can do it at room temperature.

[00:25:02] Speaker 04:
Did Dr. Elder do his experiment at room temperature?

[00:25:05] Speaker 02:
He did.

[00:25:06] Speaker 02:
He did.

[00:25:07] Speaker 04:
So how is entering it drop-wise somehow contradicting the teaching of Larson's room temperature?

[00:25:14] Speaker 02:
Your Honour, because if there is a heat sensitive reaction and people have two ways to address the heat sensitivity.

[00:25:25] Speaker 02:
One of them is you do the reaction at a very, very cool temperature

[00:25:31] Speaker 02:
The other is you, together with that, separately, you add the oxidant extremely slowly.

[00:25:38] Speaker 02:
And you have Larson telling you, don't worry about that.

[00:25:42] Speaker 02:
Don't worry about the heat sensitivity.

[00:25:45] Speaker 02:
This can be done at room temperature and it's not going to matter.

[00:25:49] Speaker 04:
Then one of skill in the art, back at that time... Does Larson actually say what you just said it is, which is don't worry about the heat sensitivity, or did he just say that this can be done at room temperature?

[00:26:01] Speaker 02:
He says it can be done at room temperature.

[00:26:05] Speaker 04:
It doesn't say don't worry about the heat sensitivity.

[00:26:07] Speaker 04:
It just says that it can be done at room temperature.

[00:26:10] Speaker 04:
Is there anything else that you wanted to, other than dropwise, are there other points that you wanted to do?

[00:26:17] Speaker 03:
Well, in addition... What's the motivation the marshal would provide to do the synthesis dropwise?

[00:26:23] Speaker 02:
Well, I think he teaches a way for him to do the dropwise, Your Honor, in this instance.

[00:26:28] Speaker 02:
I think that's the point.

[00:26:29] Speaker 03:
Does it matter in this situation that Dr. Larson was of extraordinary skill?

[00:26:35] Speaker 03:
Yes, I think that she... Dr. Elder, I'm sorry.

[00:26:38] Speaker 00:
Not Dr. Elder.

[00:26:39] Speaker 00:
I'm sorry, Dr. Elder?

[00:26:40] Speaker 02:
Dr. Elder.

[00:26:41] Speaker 02:
Well, I think that's also a problem here, Your Honors, is that, look, we have Larson, who's wanting to make compounds for pharmaceutical uses.

[00:26:50] Speaker 02:
He'd like to come up with crystals, not only solids, but he'd like to come up with crystals.

[00:26:54] Speaker 02:
Sometimes he's successful in doing that.

[00:26:56] Speaker 02:
Sometimes he comes up with a non-crystalline solid.

[00:26:58] Speaker 02:
Other times he just winds up with an oil.

[00:27:01] Speaker 02:
So he doesn't, with dexonzoprazole, he doesn't achieve an oil.

[00:27:04] Speaker 02:
So that's one data point.

[00:27:05] Speaker 02:
This is the reality of what someone of high skill in the art was able to do.

[00:27:10] Speaker 02:
Then we have Dr. Elder come along, and this is 16 years later from the time of the 2A2 patent filing.

[00:27:18] Speaker 02:
And he's initially trying to do what Larson did to get what Larson got.

[00:27:25] Speaker 02:
And he can't do it.

[00:27:26] Speaker 02:
He doesn't get it.

[00:27:27] Speaker 02:
And so then he changes from that.

[00:27:31] Speaker 02:
And he modifies various parameters.

[00:27:34] Speaker 02:
And in addition, there's the drop-wise change.

[00:27:37] Speaker 02:
He does select particular solvents.

[00:27:41] Speaker 02:
And this is someone sort of with a target.

[00:27:44] Speaker 02:
He's not trying to get what Larson got.

[00:27:46] Speaker 02:
He's trying to get something different 16 years later in litigation and then make the argument that 16 years earlier, this is what somebody of skill would have done.

[00:27:55] Speaker 02:
And I think that's a very dubious proposition for his choices that he's making, what he's doing with the solvents.

[00:28:01] Speaker 02:
He had relied upon literature.

[00:28:05] Speaker 02:
He said he was relying on literature at the time that told him these are the types of solvents you can use here.

[00:28:09] Speaker 02:
He didn't use those.

[00:28:10] Speaker 02:
He picked other ones.

[00:28:12] Speaker 02:
Now, it's true that

[00:28:13] Speaker 02:
picking solvents is something that chemists do.

[00:28:16] Speaker 02:
But he didn't pick the ones that were in the art that would be the natural ones that one of skill would use.

[00:28:21] Speaker 02:
He didn't test chemical purity of what he got.

[00:28:24] Speaker 02:
So we don't know exactly what it is that he got.

[00:28:27] Speaker 02:
He did the purification techniques over and over and over again.

[00:28:32] Speaker 02:
This is, in the context of litigation, this is someone who is, again, has a bullseye of this is where I want to be.

[00:28:40] Speaker 02:
supposedly to show that this is what somebody would have done 16 years earlier.

[00:28:44] Speaker 02:
And he wasn't successful the first time.

[00:28:46] Speaker 02:
He changed parameters the second time.

[00:28:49] Speaker 02:
He changed what he did.

[00:28:50] Speaker 02:
And we think the court properly found that those changes were not what would be deemed routine experimentation.

[00:29:02] Speaker 02:
And I would note that with regard to TWA, this court has recognized or

[00:29:06] Speaker 02:
predecessor court, the Court of Custom and Patent Appeals, previously recognized that when somebody tries to replicate a priority experiment, they may have to modify some of the parameters.

[00:29:14] Speaker 02:
But the important distinction there is they're trying to get what the person who did the previous experiment got.

[00:29:20] Speaker 02:
Here, they're trying to get something different.

[00:29:22] Speaker 02:
And an argument that Barbarich anticipates, solid excellence over result, when Barbarich doesn't tell you how to do it,

[00:29:31] Speaker 02:
refers to Larson, and Larson doesn't tell you how to do it, but that litigation experts 16 years later can fiddle around and they can come up with a solid and then say that therefore Barberage anticipates a solid that comes up as well.

[00:29:47] Speaker 02:
We believe the court properly rejected that.

[00:29:52] Speaker 02:
that conclusion.

[00:29:53] Speaker 02:
I see I'm almost out of time, so just very briefly on the cross appeal, I would say that in our view, the court with regard to the release terms took an unduly restrictive view of those terms.

[00:30:06] Speaker 02:
The court recognized in its original summary judgment hearing that this notion that release is sort of a, I think of it as a digital binary type thing where you can pick a pH

[00:30:21] Speaker 02:
level and there's no release at say 4.9 and then suddenly there's release at 5.0.

[00:30:29] Speaker 02:
That's not science.

[00:30:31] Speaker 02:
It's more of an analog function.

[00:30:33] Speaker 02:
You have a continuum of the amount of release.

[00:30:36] Speaker 02:
And this is recognized in the USP guidelines for testing delayed release products.

[00:30:45] Speaker 02:
And we think the court, I see I'm out of my time.

[00:30:51] Speaker 02:
I see that the USP standards for delayed release products provide industry-wide guidelines that everybody knows that would have been known to one's skill in the art that are objective,

[00:31:03] Speaker 02:
and that tell you how to determine what amount of unwanted release is unacceptable.

[00:31:10] Speaker 02:
And that's an unusual situation because you're normally not dealing with that.

[00:31:13] Speaker 02:
You're dealing with we want to see how much release we want to get.

[00:31:16] Speaker 02:
And those guidelines, in our view, properly should have been considered in determining the amount of release that the claims are talking about when they talk about this range of release of no less than 5.0 to no more than

[00:31:33] Speaker 04:
Okay, thank you Mr. Dane.

[00:31:36] Speaker 04:
Mr. Mazurk, why don't we give you two minutes of rebuttal time and we'll give Mr. Dane an extra minute of rebuttal only on his cross appeal if he needs it.

[00:31:47] Speaker 01:
Thank you, Your Honor.

[00:31:49] Speaker 01:
Let's go back to the claim language on the 755 patent.

[00:31:53] Speaker 01:
Such that the active ingredient is released

[00:31:56] Speaker 01:
in the pH range of no less than 5.0 and no more than 6.0.

[00:32:03] Speaker 01:
That is the claim language.

[00:32:06] Speaker 01:
And it is undisputed that in all tests, the TWI product releases active ingredient below pH 5.0.

[00:32:16] Speaker 01:
Therefore, the district court's summary judgment of no literal infringement was appropriate.

[00:32:22] Speaker 04:
I think the tests that we had in the record were that the plaintiffs put in were at pH's of 4.5, 4.7, 4.9.

[00:32:39] Speaker 01:
For how long?

[00:32:41] Speaker 01:
For whatever duration, but I mean it's different as you approached at 4.9, which is what the plaintiffs offered,

[00:32:51] Speaker 01:
They had tests that released, we had tests that released this... The claim doesn't include a time.

[00:33:05] Speaker 01:
The claim does not include a time.

[00:33:06] Speaker 01:
So in every single one of these tests, below pH 5.0, there is release.

[00:33:11] Speaker 01:
Sometimes it takes a little bit longer, sometimes it doesn't.

[00:33:13] Speaker 01:
But it releases, it's not de minimis, it goes and it goes off like a plane taking off.

[00:33:17] Speaker 01:
And the time of the worst test, the one they relied on, is still a much shorter duration than the only dissolution data that was ever submitted in the context of the case, the Kurosawa Declaration, where they were illustrating what it was like for something to release at pH 6.8.

[00:33:35] Speaker 01:
They ran the test.

[00:33:36] Speaker 01:
And at 6.8, there was no release until over three hours.

[00:33:40] Speaker 01:
And they said that still demonstrated release at 6.8.

[00:33:44] Speaker 01:
So only by adding

[00:33:47] Speaker 01:
a arbitrary cutoff of a time or amount, do you then change the data or begin to something else?

[00:33:56] Speaker 01:
And so now they're not arguing begins anymore.

[00:33:59] Speaker 01:
They're arguing somewhere in the middle, not begins to release, not ends to all release, but somewhere in the middle.

[00:34:04] Speaker 01:
And then as we've made clear, that if you start fudging with this, then the claim term is indefinite.

[00:34:11] Speaker 01:
And I think one of Judge Raina's cases was even after Nautilus said that's a problem then.

[00:34:17] Speaker 01:
Because if you look at page, for example, on page A6988 of the record, we have a list of all the different tests that were performed and whether or not the DexLant or the TWA product will meet the limitations

[00:34:32] Speaker 01:
You know, depending upon what tests you have.

[00:34:35] Speaker 01:
The test then becomes critical and under Honeywell and other cases, then you even, you have to say that there's no guidance and it's indefinite because nobody knows what the heck to do.

[00:34:45] Speaker 01:
The patentee couldn't figure out what to do.

[00:34:47] Speaker 01:
They had to run all sorts of tests on our product, which we got.

[00:34:50] Speaker 01:
They tried to hide from us.

[00:34:51] Speaker 01:
And we found out how they actually came up with 10% two hours, it was that they tried to manipulate the test as best they could to get the best result, and even the best result they can got a job.

[00:35:02] Speaker 04:
Okay, thank you.

[00:35:03] Speaker 04:
Thank you, Your Honor.

[00:35:05] Speaker 04:
Let's let Mr. Dane have, give me two minutes for bottle time, please.

[00:35:09] Speaker 02:
Thank you, Your Honor.

[00:35:12] Speaker 02:
As I said before, it blinks scientific reality to have this idea that you can have a particular pH level above which there will be release, below which there will be

[00:35:21] Speaker 02:
zero measurable release over any infinite amount of time.

[00:35:27] Speaker 02:
That is where the court ultimately came out into claim construction.

[00:35:31] Speaker 02:
So that you could show 1% release over 15 hours at 4.9, then that removed something from the scope of the claims.

[00:35:43] Speaker 02:
And we've submitted in the appellate record examples to show that this isn't how it works with polymeric coatings.

[00:35:51] Speaker 02:
A5786 and A5791 show data for release at the pH of 4.7, 4.9.

[00:35:59] Speaker 02:
And for any release that is 10% at one particular pH, if you go 0.1 pH level below that, you're going to see some release.

[00:36:11] Speaker 02:
And Takeda's data at 150 minutes, TWI's data at 240 minutes reflects that.

[00:36:17] Speaker 02:
Similarly, at pages 8, 5, 9,

[00:36:20] Speaker 02:
5796 and 5801 with releases at PH 5.7 and 5.9 show this same phenomenon for Takeda's release at 120 minutes in TWIs and 150 minutes.

[00:36:33] Speaker 02:
This is the reality of how these work and there is a commonly understood understanding in the industry of what is the release that's not considered to be real release.

[00:36:44] Speaker 02:
The Becker patent even makes reference to the fact that here we want no release

[00:36:49] Speaker 02:
And what it's talking about is less than 5% release or 10% release at a particular pH.

[00:36:57] Speaker 02:
That's where the USP dissolution standards come in.

[00:37:00] Speaker 02:
They tell you if it's 10% or less in two hours, that really doesn't count.

[00:37:05] Speaker 02:
It's the minimum, and you don't consider that to be released.

[00:37:10] Speaker 04:
Thank you.

[00:37:10] Speaker 04:
Thank you, Mr. Shane.

[00:37:11] Speaker 04:
Case is taken under submission.

[00:37:13] Speaker 04:
I thank both counsel for their arguments.