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

[00:01:06] Speaker 02:
Okay.

[00:01:29] Speaker ?:
Okay.

[00:01:29] Speaker ?:
Okay.

[00:01:41] Speaker 02:
Thank you.

[00:01:49] Speaker 02:
Be seated.

[00:01:53] Speaker 03:
Good morning, everyone.

[00:02:09] Speaker 03:
Hearing an argument on motions this morning.

[00:02:12] Speaker 03:
Case number 15, 1139, Takeda Pharmaceuticals USA against Hickman Americas, Incorporated.

[00:02:21] Speaker 03:
Mr. Weinberger.

[00:02:28] Speaker 05:
May I please start?

[00:02:30] Speaker 05:
This is not a typical off-label or carve-out case, which this court has considered on a number of occasions.

[00:02:37] Speaker 00:
it's quite different because of congress really confident in the car about legislation that there would be situations in which the generic would be selling a drug for one method of use but at the same time there might be off-label uses for that which were covered by a patent, correct?

[00:03:00] Speaker 05:
Absolutely correct your honor and that's why I started the way I have to try and show that this case is not

[00:03:06] Speaker 05:
the kind of case that your honor is referring to.

[00:03:09] Speaker 00:
Well, it seems to me to follow from that, that the mere fact that there are off-label uses prescribed does not result in inducement.

[00:03:18] Speaker 00:
You would agree with that?

[00:03:19] Speaker 05:
I do agree with that.

[00:03:21] Speaker 05:
I think the key difference is that in those cases, the label, as well as the application, was silent with respect to any off-label use.

[00:03:32] Speaker 05:
There was nothing in an AstraZeneca 2012 case

[00:03:36] Speaker 05:
The court found that the label expressly and indisputably carved out all approved uses.

[00:03:44] Speaker 00:
Well, what should the label, in your view, have said here to avoid the inducement problem that you say exists?

[00:03:53] Speaker 05:
Of taking both sets of patents separately with respect to the acute flares, the label clearly should have said, do not use Mitigare for treatment of acute flares.

[00:04:03] Speaker 05:
But having said, consult your doctor, they're basically saying it can be used if your doctor says it can be used.

[00:04:11] Speaker 05:
And the doctor knows how to prescribe it, knows how to instruct it, because the dosing regimen and the patents are the only approved dosing regimens that are available.

[00:04:20] Speaker 00:
Well, didn't the label come close to that in saying that this hasn't been approved, approved only for prophylactic use?

[00:04:29] Speaker 05:
No, actually what it said was that it hadn't been studied for

[00:04:33] Speaker 05:
for acute gout fliers.

[00:04:36] Speaker 05:
It did not say anything about not using it.

[00:04:40] Speaker 05:
And let me direct the court to one item in the record that could help on this.

[00:04:45] Speaker 05:
At 82578, the FDA, during the application process, told Hickmore, I think it was Westward at the time, told them, your label could clearly state, don't use Mitigare for treatment of acute gout fliers.

[00:05:03] Speaker 05:
And then we wouldn't be here, but they resisted.

[00:05:06] Speaker 05:
They didn't want to do that.

[00:05:07] Speaker 05:
They said, well, you know, we think there's literature that supports what we're saying and we want to be able to say consult your doctor and the FDA went along with that.

[00:05:17] Speaker 05:
So they made a choice.

[00:05:19] Speaker 05:
They made a choice to have a watered down statement, not a clear disclaimer, not a clear statement that it couldn't be used, but an instruction that if a patient while taking Mitigare for a treatment,

[00:05:32] Speaker 05:
suffers a flare, then he should consult the doctor.

[00:05:36] Speaker 05:
And the doctor, the key thing here to understand is... I think that's the wrong standard, that they have to have a clear disclaimer to avoid inducements the other way around.

[00:05:49] Speaker 00:
There has to be a statement in the label that constitutes an inducement.

[00:05:53] Speaker 00:
And I'm having trouble seeing what it is in this label that constitutes an inducement

[00:06:00] Speaker 00:
for a patented use.

[00:06:01] Speaker 00:
You have the statement that this isn't been studied for anything other than prophylaxis and that you should consult your doctor.

[00:06:12] Speaker 00:
How does that suggest to anybody that it should be used for a patented use?

[00:06:18] Speaker 05:
I think in the context of this product and what is known by the providers and the participants in the industry, it is an instruction because

[00:06:26] Speaker 05:
I think unlike these other off-label cases, these two indications are inextricably related.

[00:06:34] Speaker 05:
When a patient goes on prophylactics, he's already had gout flares.

[00:06:39] Speaker 05:
You don't put someone on prophylactics of a potentially toxic drug unless there's a reason for it, and the reason is that they've had acute gout flares that

[00:06:49] Speaker 05:
have been controllable.

[00:06:50] Speaker 05:
So they go on prophylactics.

[00:06:52] Speaker 05:
And as the ACR, the rheumatology college noted, and the site for this is at 394 and 389, once you go on prophylactics, you will have gout flares.

[00:07:06] Speaker 05:
Usually in the first six to eight months, you're going to have gout flares.

[00:07:09] Speaker 05:
And that means that that patient is going to call his... How often does that happen?

[00:07:13] Speaker 05:
Why?

[00:07:14] Speaker 00:
How often does it happen?

[00:07:16] Speaker 05:
It happens six to eight times in the first six months.

[00:07:18] Speaker 05:
is what the study shows.

[00:07:20] Speaker 05:
And obviously it's different for each patient, but it happens a substantial number of times.

[00:07:26] Speaker 05:
And I can give the court a site for that.

[00:07:28] Speaker 05:
At A394, the American College said, importantly, recent clinical trials have shown substantial rates of acute gout attacks in the first six or eight months after initiation of prophylactics, even where you're being treated with

[00:07:42] Speaker 05:
with coach staff.

[00:07:44] Speaker 05:
So this is going to happen.

[00:07:46] Speaker 05:
It's inevitable.

[00:07:47] Speaker 01:
But this stuff you're pointing us to is all stuff that's not in the label.

[00:07:51] Speaker 01:
This is all knowledge of how these scouts might work, what their alternative courses of treatment are.

[00:07:59] Speaker 01:
What particular language in the label are you suggesting induces infringement?

[00:08:05] Speaker 01:
Is it just contact your doctor?

[00:08:07] Speaker 05:
Well, I think that it's kind of a wink and nod situation where

[00:08:11] Speaker 05:
You don't want to lay out the specifics.

[00:08:14] Speaker 05:
So you say, if you have an acute flare, which they know you're going to have, then contact your doctor.

[00:08:20] Speaker 01:
In this situation, the FDA has recommended... If the label didn't have that language, if you have an acute flare, contact your doctor, would there be any question of inducement?

[00:08:34] Speaker 05:
No.

[00:08:35] Speaker 01:
And that's the distinction that I'm... So you agree that we can't get to all this outside evidence of protocols and things like that for treating acute gout players with Mitigare without the contact your doctor language?

[00:08:50] Speaker 05:
Yes, I think that the point here is that the label is what contains the implicit instruction.

[00:08:57] Speaker 05:
And then to understand what that instruction means and how it's going to be interpreted by those who are forgetting it

[00:09:04] Speaker 05:
And what it tells you about the intent of the defendant, then you have to look at all of the context to see what is understood, what is known, et cetera.

[00:09:12] Speaker 05:
And when you do that, you realize that here's a doctor is going to get a call from a patient who's suffering an acute flare while he's being treated with 0.6 cultucine.

[00:09:23] Speaker 05:
And immediacy of treatment of these flares, as the FDA has said, is critical.

[00:09:28] Speaker 05:
You need to treat them right away.

[00:09:30] Speaker 05:
And a substantial number of doctors

[00:09:32] Speaker 05:
going to say, well, the colchicine is sitting in your medicine cabinet.

[00:09:36] Speaker 05:
Take it, and it's going to relieve your gout flares.

[00:09:40] Speaker 05:
And take it is only one way to take it for gout flares.

[00:09:43] Speaker 05:
The FDA has laid that out.

[00:09:44] Speaker 05:
The ACR has laid that out.

[00:09:46] Speaker 05:
So inevitably, the instruction to consult your doctor for someone who's on prophylactics and is going to suffer an acute gout flare is going to be to take the colchicine in accordance with the patented dosing regime.

[00:10:01] Speaker 01:
If that were true in 100% of the cases and you had proven that and the district court had made a factual finding or made a clearly erroneous factual finding, to your point, but isn't the problem here that there's no definitive proof that that would be the automatic or nearly automatic result here, that there's evidence that there could be other non-impringing avenues to the consult or doctor phrase?

[00:10:30] Speaker 05:
Yes, let me address that, Your Honor.

[00:10:31] Speaker 05:
I think that as the AstraZeneca 2010 case made clear, the fact that not all doctors or patients would infringe, that only some would infringe, does not prevent the finding of active inducement.

[00:10:45] Speaker 05:
And I think the other point is that the existence of a substantial non-infringing use does not relieve a defendant from active inducement if there's other evidence of intent to

[00:10:57] Speaker 01:
The AstraZeneca case only gets you so far because the label there didn't have this generic consult your doctor phrase.

[00:11:06] Speaker 01:
It had more specific instructions that if you followed through the logic and the protocols would essentially result in infringement in almost every case.

[00:11:18] Speaker 01:
Like I said, if that was the argument or making evidence in the record here, it seems like it would fall more explicitly within AstraZeneca.

[00:11:27] Speaker 01:
It seemed, I thought, that the district court had found that there were substantial non-infringing uses of this.

[00:11:35] Speaker 01:
And that seems to me to be, at least in some ways, a factual question that you have a pretty hard hill to get over.

[00:11:43] Speaker 05:
In AstraZeneca, actually, the federal circuit, this court, made no finding of substantial non-infringing use.

[00:11:52] Speaker 05:
There was a lot of confusion and controversy at the district court about how much the

[00:11:57] Speaker 05:
infringing use was and how much it wasn't.

[00:11:59] Speaker 05:
And there was no specific finding.

[00:12:01] Speaker 05:
But certainly, the court said that you could have infringement even with the substantial non-infringing use.

[00:12:09] Speaker 00:
But the substantial infringing use, if there is one, is under the legislation simply not relevant to the issue of inducing.

[00:12:21] Speaker 00:
Because Congress wanted people to carve out

[00:12:24] Speaker 00:
and sell it for other things, even though, as you've admitted, there is a risk that some doctors will prescribe it for off-label use.

[00:12:34] Speaker 00:
So the question is here, by sending consult your doctor, what does that mean?

[00:12:40] Speaker 00:
I thought the record was pretty clear that there are a lot of other treatments for acute gout flare-ups that don't even involve this drug.

[00:12:53] Speaker 00:
And of course, there's the possibility that the doctor would prescribe your own client's product for that purpose, right?

[00:13:03] Speaker 00:
I mean, it doesn't automatically follow.

[00:13:05] Speaker 00:
Consult your doctor that he's going to tell you to continue to take a different dose of the generic, right?

[00:13:13] Speaker 05:
It doesn't automatically follow.

[00:13:14] Speaker 05:
But remember that these alternatives that your honor is referring to exist for prophylaxis as well.

[00:13:20] Speaker 05:
The same alternatives, the NSAIDs, the corticosteroids,

[00:13:24] Speaker 05:
and the colchicine.

[00:13:27] Speaker 05:
So we're dealing now with a doctor who's already decided to put his patient on the colchicine.

[00:13:32] Speaker 05:
And then he substituted the Mitigare for my client's product, the Colchris.

[00:13:38] Speaker 05:
And then he's now faced with a patient who says, I have an acute flare while I'm on it.

[00:13:44] Speaker 05:
So the likelihood that he's going to tell him to go get some different drug, having already selected this drug for the prophylactics,

[00:13:52] Speaker 05:
we submit is low.

[00:13:54] Speaker 05:
It's not a very likely scenario.

[00:13:56] Speaker 05:
What's the evidence of that?

[00:13:58] Speaker 05:
Well, the evidence of that is, as I mentioned, that the acute flares will come, that they're going to have them, that the colchicine is one of the primary modalities that is recommended.

[00:14:08] Speaker 00:
Is there any evidence of survey of doctors, or what have they done?

[00:14:13] Speaker 00:
How do we know about that?

[00:14:16] Speaker 05:
Well, we know that we put in evidence of a survey that showed that

[00:14:21] Speaker 05:
about 56% of Colchris prescriptions were for acute gout flares.

[00:14:26] Speaker 05:
So the majority of uses for the product that this is being substituted for were for acute gout flares.

[00:14:32] Speaker 00:
Well, wait, but that's different than someone who's taking it for prophylaxis and then has an acute gout flare.

[00:14:39] Speaker 00:
It may be that there are prescriptions for this drug for the patented use, but as we talked about before, the fact that that happens is irrelevant to inducement, which you have to

[00:14:50] Speaker 00:
address yourself to is a situation where somebody is taking it for prophylaxis.

[00:14:55] Speaker 00:
There's an acute flare-up, and then the consultant doctor and the doctor says, well, take a different dose of the generic that you're already taking.

[00:15:06] Speaker 00:
We don't know how often that happens, right?

[00:15:08] Speaker 05:
We don't know exactly how it happens, but we do know that the colchicine is used on a widespread basis and has been for years to treat acute gout flurs.

[00:15:18] Speaker 05:
We do know that

[00:15:20] Speaker 05:
A majority of the prescriptions of Colchris are written for acute gout fluidism.

[00:15:23] Speaker 00:
But that's irrelevant.

[00:15:24] Speaker 00:
That's the wrong question.

[00:15:26] Speaker 00:
The question is, to what extent are doctors telling people to have acute gout fluids during prophylaxis to take a different dose of the generic that they're already taking?

[00:15:38] Speaker 05:
Well, we don't have a survey, but there's certainly evidence in the record from the expert witnesses we put in that that is the practice.

[00:15:47] Speaker 05:
Dr. Morton said that, Dr. Bumershein.

[00:15:49] Speaker 05:
said that.

[00:15:50] Speaker 05:
And that's basically what they said, that if they have patients who are on prophylactics using colchicine and they get acute gout clearance, they're going to tell them to use the medicine that they have in their cabinet that's FDA approved, that is recommended by one of the primary recommendations.

[00:16:09] Speaker 05:
Two doctors.

[00:16:10] Speaker 05:
Sorry?

[00:16:11] Speaker 05:
Two doctors.

[00:16:12] Speaker 05:
Two doctors talking about the general practice of the industry, yes.

[00:16:17] Speaker 05:
And as well as all the other information that I mentioned, that this is a primary drug for gout treatment.

[00:16:23] Speaker 00:
What's their basis for knowing what would happen with doctors general?

[00:16:28] Speaker 00:
Do they say that?

[00:16:29] Speaker 00:
Do they say that doctors generally?

[00:16:30] Speaker 00:
Yes.

[00:16:32] Speaker 00:
Where is that statement?

[00:16:35] Speaker 05:
It's Dr. Morton's declaration.

[00:16:37] Speaker 05:
I think it's 2656.

[00:16:54] Speaker 05:
So on paragraph 22, in my experience, in the top of 2659, in my experience, physicians will not recommend that a patient suffering a gout failure have two very similar culture scene products on hand.

[00:17:09] Speaker 05:
Critical concern is treating and relieving patients.

[00:17:15] Speaker 05:
And then paragraph 20, because a gout patient will first experience an acute attack and then suffer additional attacks, attacks that is easier

[00:17:23] Speaker 05:
for a patient to take a single CO2C product.

[00:17:26] Speaker 00:
That's not a statement that he knows what other doctors would do.

[00:17:34] Speaker 05:
Yes.

[00:17:36] Speaker 05:
Well, I think that the record-taking as a whole, and just common sense tells you that.

[00:17:43] Speaker 05:
If you've got a treatment that is recommended, the patient is on it, for prophylactics, and you're suffering a pain,

[00:17:53] Speaker 05:
I think my lie is out.

[00:17:54] Speaker 05:
Should I stop?

[00:17:56] Speaker 00:
I didn't even answer the question.

[00:18:00] Speaker 05:
That it's natural and inevitable that that will happen.

[00:18:05] Speaker 05:
And I don't think it's a question that's contrary at all to congressional intent.

[00:18:09] Speaker 05:
Because again, we're dealing with a situation where the label is discussing the use and directing the patient what to do for this use.

[00:18:16] Speaker 05:
The carve-out cases, the other cases we discussed, don't do that.

[00:18:20] Speaker 05:
They don't provide any information at all about the

[00:18:23] Speaker 05:
other indication.

[00:18:24] Speaker 05:
They simply are silent.

[00:18:26] Speaker 05:
And I think that's the major difference between these cases.

[00:18:30] Speaker 03:
Okay, for the moment.

[00:18:33] Speaker 03:
All right, let's hear from the other side.

[00:18:34] Speaker 03:
We'll save you rebuttal time, Mr. Weinberger.

[00:18:45] Speaker 03:
Thank you.

[00:18:45] Speaker 03:
Mr. Klein.

[00:18:47] Speaker 04:
Thank you, and may it please the court

[00:18:50] Speaker 04:
I would like to start with Mr. Weinberger's concession about theory of inducement being alleged here.

[00:18:57] Speaker 04:
He said earlier that he's relying on one statement in the label, consult your doctor.

[00:19:02] Speaker 04:
And he said that that is an implicit instruction that induces infringement.

[00:19:10] Speaker 04:
Decada's own case, the AstraZeneca 2010 case, makes it very clear that where a product has substantial non-infringing uses.

[00:19:17] Speaker 04:
And Mr. Weinberger conceded that fact.

[00:19:20] Speaker 04:
before the district court, intent to induce infringement cannot be inferred when the alleged inducer has actual knowledge that some users of its product may be infringing.

[00:19:31] Speaker 04:
You need direct evidence.

[00:19:34] Speaker 04:
The case goes on to say you need statements or actions directed to promoting infringement.

[00:19:40] Speaker 04:
And the court went on, this is their case, to say the pertinent question is whether the proposed label instructs users to perform the penitent method.

[00:19:49] Speaker 04:
In their own brief, they answered that question.

[00:19:53] Speaker 04:
Page 37, they said, HICMA's label does not explicitly instruct users to practice the claim methods.

[00:20:01] Speaker 04:
They answered the question that is posed by their very same case in the negative.

[00:20:07] Speaker 04:
Their own concessions to the district court about substantial non-infringing uses that the... Can I just ask you hypothetically, though?

[00:20:15] Speaker 01:
Because it seems to me what they're turning that consultant doctor language on is that

[00:20:19] Speaker 01:
that the industry practice and standard protocols and everything is if you're on this drug as a prophylactic means that automatically or almost automatically, if you have an acute flare-up, your doctor is going to tell you to use this in a way that would infringe the patent.

[00:20:39] Speaker 01:
If that's the case, I know you're gonna disagree with that in a minute.

[00:20:42] Speaker 01:
Let's assume that's the case, that the only course of treatment for an acute gout flare-up if you're taking

[00:20:49] Speaker 01:
this drug prophylactically is to infringe the patent.

[00:20:54] Speaker 01:
Would then the consult your doctor phrase be enough for inducement?

[00:20:58] Speaker 04:
No, for three reasons.

[00:21:01] Speaker 04:
First of all, the 2012 case, the Bayer v. Lupin case says, based on Warner-Lambert and Allergan, the defendant's conduct would constitute inducement of infringement under 271B

[00:21:15] Speaker 04:
only if the defendant's and is sought approval for the use protected by the patent.

[00:21:21] Speaker 04:
The patented methods, they are off-label uses.

[00:21:24] Speaker 04:
We do not have approval for acute flares.

[00:21:27] Speaker 04:
For the DDIs, we don't have approval for any drug-drug interaction.

[00:21:32] Speaker 00:
That sounds like an argument that no matter what you said on the label, you couldn't be liable.

[00:21:37] Speaker 00:
The question, obviously, are some circumstances in which a label

[00:21:42] Speaker 00:
would induce infringement.

[00:21:43] Speaker 00:
For example, if the label said, if you have an acute gout flare-up, you may want to consult your doctor and ask him to prescribe this product.

[00:21:55] Speaker 00:
That would be inducement, right?

[00:21:56] Speaker 04:
That would certainly get closer, but that would not be in the label unless FDA approved the product for that use, which did not happen here.

[00:22:04] Speaker 00:
Well, you're saying that couldn't be on the label, but I hypothetically assume that it is on the label.

[00:22:11] Speaker 00:
That would probably be sufficient, right?

[00:22:13] Speaker 04:
You're certainly getting much closer to inducement in that circumstance.

[00:22:17] Speaker 04:
But there are additional reasons.

[00:22:19] Speaker 00:
So I think what Judge Hughes was asking you is everybody knows that this is the only treatment the doctors will use when you're already taking the pen for prophylaxis.

[00:22:33] Speaker 00:
Let's say that's some of the other alternatives

[00:22:37] Speaker 00:
aren't medically appropriate where you've been taking the generic Coltrane or Coltrane, whatever it's called, for prophylaxis so that you know that if somebody consults the doctor that sure enough they're going to prescribe the generic.

[00:22:56] Speaker 04:
Would that be sufficient?

[00:23:00] Speaker 04:
to make sure I understand your hypothetical.

[00:23:02] Speaker 04:
The label does say consult your doctor and ask if you can use.

[00:23:05] Speaker 00:
No, the label says consult your doctor, but you know that in 100% of the cases when the doctor is consulted, he will prescribe the generic that you're already using.

[00:23:15] Speaker 04:
That is not enough, because this court in the DSU case, quoting the Supreme Court in Grokster, said very clearly, knowledge of infringement is not enough.

[00:23:26] Speaker 04:
After all, the statute.

[00:23:27] Speaker 04:
But we can't read.

[00:23:29] Speaker 01:
To me, this seems like a little bit of, I don't know how to characterize it, but are you saying that even if we know when somebody puts the language consult your doctor on, what they're really saying is, by telling them consult your doctor, you know that the doctor is going to prescribe a method that infringes.

[00:23:54] Speaker 01:
That's still not enough for inducement,

[00:23:56] Speaker 04:
It's not enough.

[00:23:56] Speaker 04:
You need affirmative steps.

[00:23:58] Speaker 04:
And keep in mind, of course, our label.

[00:24:00] Speaker 01:
Why isn't a consult your doctor when you know that consulting your doctor is in 100% of the cases going to result in infringement inducement?

[00:24:08] Speaker 04:
Because there are no affirmative steps.

[00:24:11] Speaker 04:
The label, the Mitigar label, says the maximum dose is 1.2 milligrams per day.

[00:24:17] Speaker 04:
To infringe their acute flare patents, you need to prescribe 1.8 milligrams in an hour.

[00:24:23] Speaker 04:
It's impossible to follow the instructions in the Mitigar label and infringe the acute flare pattern.

[00:24:29] Speaker 04:
It's impossible.

[00:24:30] Speaker 04:
You can't do it.

[00:24:31] Speaker 04:
So you have to prescribe the drug.

[00:24:33] Speaker 04:
off-label.

[00:24:34] Speaker 04:
And this court has said doctors can prescribe drugs off-label, but if they do, and even if you know that they're going to do it.

[00:24:41] Speaker 01:
It seems to me you're staking out a decision.

[00:24:42] Speaker 01:
You don't need to to win this case.

[00:24:46] Speaker 01:
But could you go back to the factual question here about, because your friend has pointed to evidence in the declaration of why this is the standard industry practice to do this.

[00:24:58] Speaker 01:
Do you have evidence

[00:24:59] Speaker 01:
to suggest that there are other ways to treat acute flare-ups for people that are on colchicine prophylactically?

[00:25:08] Speaker 04:
I do, Your Honor.

[00:25:09] Speaker 04:
And perhaps the best evidence is from the amicus brief filed by the American College of Rheumatology, an organization that Takeda cited to repeatedly in its own brief.

[00:25:22] Speaker 04:
And the American College of Rheumatology, on page 13 of its brief, said that insects were talking about

[00:25:28] Speaker 04:
drug that include Aleve, Motrin, Advil, they have become the treatment choice for most acute attacks of gout.

[00:25:38] Speaker 04:
So, what happens when, if a doctor were to look at the label, see... But that's not in the record, is it?

[00:25:46] Speaker 04:
It is in the record.

[00:25:47] Speaker 00:
Oh, the... The record for the District Court on the preliminary injunction.

[00:25:54] Speaker 00:
It seems to me that there's an absence of records on this point, that their doctor advocates don't say that this is standard practice or happens all the time or even almost all the time, and there's no evidence to the contrary anywhere else either.

[00:26:13] Speaker 00:
In other words, the record is pretty much silent as to how often it happens that a doctor would say, take a different dose of the generic.

[00:26:23] Speaker 04:
There are record sites for two related points.

[00:26:28] Speaker 04:
The first point is that the NSAIDs I talked about are alternatives.

[00:26:33] Speaker 04:
There are multiple record sites, A384, A93.

[00:26:35] Speaker 04:
384.

[00:26:38] Speaker 00:
384.

[00:26:39] Speaker 00:
We're on 384.

[00:27:08] Speaker 04:
Oh, in the box, the last bullet point.

[00:27:12] Speaker 03:
Which box?

[00:27:14] Speaker 04:
If you look at the significance and innovations box.

[00:27:18] Speaker 00:
Low dose, that's non-steroidal, anti-inflammatory.

[00:27:25] Speaker 04:
Right, so low dose.

[00:27:26] Speaker 00:
Of this coltrine or whatever it is.

[00:27:31] Speaker 00:
Coltrine is not a non-steroidal, anti-inflammatory, right?

[00:27:37] Speaker 04:
Well, it says low-dose NSAID therapy, which, you know, that includes over-the-counter medications such as Aleve and Motrin.

[00:27:44] Speaker 00:
But it's not cultured?

[00:27:47] Speaker 04:
It's not cultured, no.

[00:27:49] Speaker 04:
That's an alternative.

[00:27:50] Speaker 01:
You're relying on this lesson from the bottom to suggest a treatment for flares, because it doesn't say anything about that.

[00:27:58] Speaker 01:
Oh, it's a flair?

[00:27:58] Speaker 04:
It's not galactic.

[00:28:00] Speaker 04:
OK.

[00:28:03] Speaker 04:
If you look at A389, I believe

[00:28:10] Speaker 04:
Yes, if you look at Table 1, it talks about NSAID therapy there.

[00:28:54] Speaker 00:
It may be that the record shows that there are alternative therapies, but nobody has come up with evidence of what doctors do with practice here, right?

[00:29:08] Speaker 00:
Other than perhaps two doctors who say that they, what they would have done.

[00:29:13] Speaker 04:
Well, there is some evidence to that effect.

[00:29:15] Speaker 04:
We have submitted declarations saying that

[00:29:23] Speaker 04:
The doctors, these are the declarations of health got enhanced and the doctors, I don't have record sites on hand for this, that they prescribe cultucine for acute therapy rarely, less than 5% of the time.

[00:29:40] Speaker 04:
And we also have, this is important, we have... But that's still not an answer to the point.

[00:29:47] Speaker 01:
And I suspect the answer is there really isn't.

[00:29:49] Speaker 01:
Maybe we're looking for something more specific.

[00:29:52] Speaker 01:
is there, but the question seems to be that if somebody has already been assigned colchicine prophylactically, then is the standard and or only course of treatment for an acute flare-up once you're taking it prophylactically colchicine?

[00:30:10] Speaker 01:
There, doctors say that's what they would do.

[00:30:13] Speaker 01:
I don't find anything in the record to say that there's any other courses of treatment, but neither side

[00:30:21] Speaker 01:
seems to have any definitive proof of that.

[00:30:24] Speaker 04:
Well, again, there's the record sites that I just cited suggest and say that the NSAID treatment is an alternative.

[00:30:32] Speaker 01:
But all of your record sites, I don't mean to take up too much of your time, they suggest alternative therapies in the first place, not once you're on culture scene as a prophylactic, that the normal course wouldn't be to treat with more culture scene for a flare-up.

[00:30:53] Speaker 04:
I'm not sure if that might be in the declarations of our physicians.

[00:30:57] Speaker 04:
I don't know offhand, but I do know that there are record sites for the proposition that these acute flare-ups are exceptionally rare, especially when you're on prophylactic treatment.

[00:31:07] Speaker 04:
If you think about it, the purpose of this treatment is to prevent the flare-ups, and the record A1512 talks about how in 97% of the cases

[00:31:22] Speaker 04:
of 97 percent of patients who have gout.

[00:31:29] Speaker 04:
They get a flare-up once every other year.

[00:31:32] Speaker 04:
The other three percent, they get a flare-up on average about three times, three and a half times a year.

[00:31:39] Speaker 04:
These are very rare, very rare events.

[00:31:42] Speaker 04:
So number one, there are alternatives.

[00:31:46] Speaker 04:
And so it is their burden to prove.

[00:31:50] Speaker 04:
at the district court level that the doctor would necessarily take the culture scene off label.

[00:31:59] Speaker 04:
Of course, our position is even if that were true, it's not enough for inducement, but even if you go to the next step, it's not going to inevitably lead to infringement because you have alternatives.

[00:32:09] Speaker 04:
But then, given that these occur very rarely, it ties directly to irreparable harm.

[00:32:16] Speaker 04:
an independent basis to affirm here that Mr. Weinberger did not address in his opening presentation.

[00:32:24] Speaker 04:
And there was no, so in order, of course, in order for Ficata to succeed here, it must show abusive discretion not once but twice, both as to the merits and as to irreparable harm.

[00:32:38] Speaker 03:
Do you want to talk about your cross appeal or leave that on the brief?

[00:32:42] Speaker 04:
uh... very very briefly on the cross appeal your honor and and i don't repeat what's in the brief uh... uh... the two quick point that we obviously needed a cross appeal to prevent a situation where this court issued a decision affirming and then the injunction is still in place until the mandate issues and we ask if the court does affirm to dissolve the injunction immediately and and of course we ask that the injunction can and should be dissolved even before a decision comes out

[00:33:11] Speaker 04:
but also that the injunction that is currently in place is causing harm to HICMA in the sense that HICMA did ship product shortly before the TRO was entered and that product is sitting in warehouses and we understand that

[00:33:30] Speaker 04:
at least some of this product is going to be returned in the next couple of weeks if it cannot be sold.

[00:33:36] Speaker 04:
And if it's returned, it's then destroyed and wasted.

[00:33:39] Speaker 04:
And of course, the longer the injunction lasts, the longer patients are harmed, as the American College of Rheumatology pointed out.

[00:33:46] Speaker 03:
Okay.

[00:33:47] Speaker 03:
Thank you, Mr. Klein.

[00:33:53] Speaker 03:
Mr. Weinberger.

[00:34:02] Speaker 05:
A client said that acute gout flares were extremely rare in prophylactics.

[00:34:07] Speaker 05:
I think that's completely unsupported by the record.

[00:34:10] Speaker 05:
For example, at page 3, record 8384, the task force of the American College of Rheumatology said, urate lowering therapy is a cornerstone.

[00:34:21] Speaker 05:
That's prophylactics of management of gout.

[00:34:26] Speaker 05:
However, during the initial phase of UOT, there is an increase in acute gout attacks.

[00:34:30] Speaker 05:
which has been hypothesized due to remodeling of articular urate, crystal deposits, et cetera.

[00:34:36] Speaker 05:
Acute gout attacks attributable to the initiation of ULT may contribute to non-inherence in long-term gout treatment.

[00:34:42] Speaker 05:
And then again, as I mentioned earlier, the ACR refers to clinical studies which show substantial rates of acute gout attacks during propolyptics.

[00:34:52] Speaker 00:
Mr. Klein also... What we don't know is how often

[00:34:57] Speaker 00:
sales are diverted from you because somebody is taking it for prophylaxis and then has an acute gout attack and it's prescribed to use a different dose of this for the acute gout attack, right?

[00:35:09] Speaker 00:
We just don't know how often that happens.

[00:35:11] Speaker 05:
Well, right now, it wouldn't be because Cochras is approved for both indications.

[00:35:16] Speaker 05:
So it's being used, it's being treated, it's being prescribed for prophylaxis.

[00:35:20] Speaker 05:
What would happen?

[00:35:21] Speaker 05:
What would happen, right?

[00:35:23] Speaker 05:
Well, we don't know.

[00:35:24] Speaker 05:
Well, it said it would be prescribed for prophylactics.

[00:35:29] Speaker 05:
And then they're saying, oh, by the way, if you get an acute flare, consult your doctor.

[00:35:34] Speaker 05:
Now, the evidence is clear that this is the same product.

[00:35:36] Speaker 05:
It's a capsule.

[00:35:38] Speaker 05:
But FDA has said the capsule and the tablet are the same.

[00:35:42] Speaker 05:
And it previously said that any 0.6-coltestine tablet is a duplicate of Cochris.

[00:35:48] Speaker 05:
So here's a doctor that was previously using Cochris for both prophylactics and for

[00:35:55] Speaker 05:
treatment, the flares, and now he's substituted Mitigare because it's a generic for Colchris for prophylactics, and are we really going to believe that when the patient calls him up and says, I have a flare, that he's going to say, oh, you know what, I'm going to go send you to CVS and take a few hours to go get another prescription and treat your flare.

[00:36:15] Speaker 05:
We're saying the reality of that is that that's not going to happen.

[00:36:20] Speaker 00:
Not much more than lawyer argument, because you just don't have any support for what the medical community would do under those circumstances, other than a couple of doctors saying that they personally would do that.

[00:36:33] Speaker 05:
They're saying this is what would logically and rationally happen.

[00:36:36] Speaker 05:
This is the way a rational doctor would act.

[00:36:39] Speaker 00:
Well, I don't see even that in there.

[00:36:43] Speaker 05:
I think they say that that's what a physician would do under these circumstances.

[00:36:47] Speaker 05:
I think it's there in Dr. Morton's declaration.

[00:36:50] Speaker 05:
If I could, I'm not sure I have much more I can point the court to on that question.

[00:36:54] Speaker 05:
I just want to spend a few seconds on the other patents which we haven't mentioned, which is the concomitant administration, the patents that deal with interactions with other inhibitors.

[00:37:06] Speaker 05:
And there, the instruction and the label clearly says, if you have to take colchicine with these inhibitors, reduce the dosing frequency or reduce the amount.

[00:37:17] Speaker 05:
And so they're specifically instructing patients

[00:37:20] Speaker 05:
to take Colchicine in a reduced dosage amount.

[00:37:23] Speaker 05:
And the only issue is, what's the exact dosing?

[00:37:25] Speaker 05:
And there, the evidence is undisputed that there's only one dosing regimen that's permitted, that's allowed, that's approved by FDA and recognized by the industry.

[00:37:35] Speaker 05:
And that is the patented dosing regimen.

[00:37:37] Speaker 05:
So we don't even get into these other issues about what would a doctor do.

[00:37:41] Speaker 05:
It's very clear that they're instructing people what to do and that that infringes the patent.

[00:37:47] Speaker 05:
One other issue I wanted to mention, I think I have a few seconds.

[00:37:50] Speaker 03:
Anything else that you need to tell us to take another couple of minutes?

[00:37:55] Speaker 05:
Just one point, if I may, on the injunction.

[00:38:00] Speaker 05:
That is, if the injunction turns out to be vacated by this court, there is a provision that we addressed in our brief that we feel is just beyond the court's power, which enjoins Takeda from launching an authorized genera for 10 days after the injunction.

[00:38:17] Speaker 05:
In other words, if the injunction were to be vacated immediately, they would be free to launch an authorized generic of their product, but we would have to wait for 10 days before we could launch one of ours.

[00:38:30] Speaker 05:
For the reasons we set forth in our brief, that the wrong standard was being used for status quo, that they already had a head start, that there's no precedent supporting that kind of an injunction, restraint against the moving party after the injunction is vacated, we would ask that that 10-day provision be stricken.

[00:38:47] Speaker 03:
Okay.

[00:38:48] Speaker 03:
Anything else Mr. White?

[00:38:52] Speaker 03:
Thank you very much.

[00:38:53] Speaker 03:
I think that we have exhausted the issues.

[00:38:56] Speaker 03:
Do you want a minute to reply to the point about the 10 day delay?

[00:39:04] Speaker 04:
Very briefly, the district court here under the Patent Act had very broad discretion

[00:39:12] Speaker 04:
preserve the status quo on such terms as the court deems reasonable, Section 283, very broad discretion.

[00:39:19] Speaker 04:
And here it was very reasonable to include the 10-day provision.

[00:39:23] Speaker 00:
Well, how do you read the district court's order?

[00:39:26] Speaker 00:
If we were to vacate the injunction pending appeal, would the 10-day provision survive?

[00:39:33] Speaker 04:
Yes.

[00:39:35] Speaker 00:
So that's the dispute.

[00:39:36] Speaker 04:
That is the dispute.

[00:39:37] Speaker 04:
And then Decatur would have to give notice that they plan to launch

[00:39:41] Speaker 04:
an authorized generic and couldn't do so for 10 business days.

[00:39:44] Speaker 04:
That gives the parties time to go back to the district court and litigate whether that injunction on Takeda should be extended or whether a bond should be increased to account for the first mover advantage that HICMA had before the TRO was entered.

[00:40:00] Speaker 04:
So the court understands the context here.

[00:40:04] Speaker 04:
When the TRO was entered,

[00:40:06] Speaker 04:
Hickman's generic product was going to be on the shelves the very next day.

[00:40:14] Speaker 04:
There is no evidence that Takeda could have had an authorized generic on the market the very next day.

[00:40:21] Speaker 04:
It would have taken at least 10 days, our position, as it would have taken them 30 days to get an authorized generic to the market.

[00:40:27] Speaker 03:
I think we have the argument.

[00:40:28] Speaker 03:
Thank you, Mr. Klein.

[00:40:30] Speaker 03:
Thank you, Mr. Weinberger.

[00:40:31] Speaker 03:
The case is taken under submission.

[00:40:34] Speaker ?:
All right.

[00:40:36] Speaker 02:
Our report is adjourned from day to day.