[00:00:00] Speaker 02:
Our next case for argument is 23-1169, Amarin Pharmaceuticals versus HICMA Pharmaceuticals.

[00:00:07] Speaker 02:
Mr. Kelly, please proceed.

[00:00:09] Speaker 00:
Good morning, Your Honors.

[00:00:10] Speaker 00:
May it please the Court.

[00:00:12] Speaker 00:
The District Court demanded too much of Amarin's complaint in this case.

[00:00:15] Speaker 00:
Under the governing pleading standards, a plaintiff need only plead a plausible theory of its case.

[00:00:22] Speaker 00:
And Amarin did just that in its theory of induced infringement against HICMA.

[00:00:27] Speaker 00:
Now, induced infringement requires three components.

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

[00:00:31] Speaker 02:
So for me, Mr. Kelly, the issue here, correct me if I'm wrong, the label in this case does not have an infringing use, correct?

[00:00:44] Speaker 02:
Unlike GSK, where there was finding by the jury that the label played out infringement.

[00:00:50] Speaker 02:
Here, that's not the case.

[00:00:51] Speaker 02:
It's undisputed.

[00:00:52] Speaker 02:
The label itself does not play out infringement.

[00:00:54] Speaker 00:
Your Honor, the indication in HICMA's label does not lay it out.

[00:00:59] Speaker 00:
We have theories in the case about different parts of the label and how they contribute to our infringement case.

[00:01:07] Speaker 02:
But all I've asked is, is it true that there's no dispute here that the label itself does not lay out or instruct as to all the elements necessary for infringement?

[00:01:19] Speaker 00:
Your honor, our complaint does allege that there are parts of their label that do lay out components of the infringement.

[00:01:29] Speaker 02:
But your honor, I'm asking a simple question.

[00:01:36] Speaker 02:
I actually thought this wasn't something I was going to get caught on.

[00:01:39] Speaker 02:
So help me understand why are you being

[00:01:44] Speaker 02:
I don't mean that in a bad way, but I don't understand.

[00:01:48] Speaker 02:
I thought that it was undisputed, and it was found, and I didn't understand you to appeal that the label itself does not set out instructions that amount to infringement.

[00:01:59] Speaker 00:
Well, Your Honor, our complaint does allege that there are portions of the label that do amount to instructions as they would be understood.

[00:02:06] Speaker 01:
Standing alone.

[00:02:08] Speaker 01:
The label standing alone is a question.

[00:02:10] Speaker 00:
The label, our case is not about the label standing alone.

[00:02:12] Speaker 00:
So if that's Your Honor's question.

[00:02:14] Speaker 00:
That's your question.

[00:02:14] Speaker 00:
Yes.

[00:02:14] Speaker 00:
Our case is not about the label standing alone.

[00:02:16] Speaker 00:
But to be clear, we do rely on portions of the label.

[00:02:20] Speaker 00:
For example, HICMA has raised the issue with the warning in the label and how it can be that the warning has absolutely nothing to do with infringement.

[00:02:28] Speaker 00:
Well, there's a claim limitation that talks about not prescribing the drug to a patient.

[00:02:33] Speaker 01:
But your claims also require extra label statements.

[00:02:37] Speaker 01:
I mean, your inducement claims.

[00:02:39] Speaker 00:
Yes, Judge Albright.

[00:02:40] Speaker 00:
Our theory of the case has to do with additional factors as well.

[00:02:45] Speaker 00:
We do rely on the label for certain components of the claim, certain limitations.

[00:02:50] Speaker 00:
But the disputed issue, to bring it back to this case, is the CV indication.

[00:02:56] Speaker 00:
That is, the cardiovascular risk reduction indication on the label.

[00:03:02] Speaker 04:
And listen, number one, the context of this case is 12b6, right?

[00:03:07] Speaker 00:
Correct, Your Honor.

[00:03:08] Speaker 00:
And so all we had to do is lay out a plausible theory of induced infringement, which requires actual infringement.

[00:03:15] Speaker 00:
That's not disputed.

[00:03:16] Speaker 00:
It requires intent to induce.

[00:03:19] Speaker 00:
The district court agreed with us that our evidence went to intent.

[00:03:21] Speaker 00:
And finally, active actions in support of that theory.

[00:03:25] Speaker 00:
And we have those here.

[00:03:27] Speaker 00:
We have those with statements that are outside of the label.

[00:03:31] Speaker 00:
We have them with the press releases and the website.

[00:03:35] Speaker 00:
Yes.

[00:03:35] Speaker 02:
OK, so why don't we start with the website?

[00:03:37] Speaker 02:
Because that one, I feel like, is for sure your biggest argument.

[00:03:42] Speaker 02:
When you look at page 820, is that the website?

[00:03:44] Speaker 02:
Am I missing it?

[00:03:46] Speaker 02:
Is that the right page?

[00:03:46] Speaker 00:
Yes.

[00:03:48] Speaker 02:
Well, I mean, Lord knows it's tiny.

[00:03:50] Speaker 02:
It's so tiny, I couldn't even read it.

[00:03:52] Speaker 02:
I probably can't even read it with my reading glasses.

[00:03:55] Speaker 02:
But doesn't it say there something to the effect of?

[00:03:57] Speaker 02:
Incompetence generic is not approved for everything.

[00:04:01] Speaker 00:
Yes, it says HICMA's generic version is indicated for fewer than all approved indications.

[00:04:08] Speaker 02:
And also, it says that this is an AB rating.

[00:04:13] Speaker 02:
And my understanding of AB rating is that that means it's generic, but only for what's on the label, correct?

[00:04:20] Speaker 00:
It means it's therapeutically effective for what it's labeled for, Your Honor.

[00:04:24] Speaker 02:
Right.

[00:04:25] Speaker 02:
So if the infringing product, the allegedly infringing product, I don't know if that's

[00:04:31] Speaker 02:
If the generic that's being sold, if their website simply says A-B rated, and we've also been through the fact that their label itself does not teach infringement standing alone, so how can calling them A-B related be an active inducement, especially when they've got that little disclaimer on it?

[00:04:53] Speaker 00:
because, Your Honor, the website says more than that.

[00:04:55] Speaker 00:
It says that the therapeutic category is hypertriglyceridemia.

[00:05:00] Speaker 00:
And it's the combination of that therapeutic category and the statement of equivalency that we say, combined with everything else, is at least plausible that somebody in this field would read that as an indication that this could be used for treating the off-label use

[00:05:15] Speaker 00:
the patented use for which only Amarin has authority to distribute the drug, and that's for treating cardiovascular risk in patients that do not suffer from severe hypertriglyceridemia.

[00:05:27] Speaker 00:
In fact, if a physician were to prescribe this drug to a patient in the hypertriglyceridemia category,

[00:05:34] Speaker 00:
they would necessarily be practicing, if they were prescribing under any indication, they would necessarily be practicing the patented invention because they would be prescribing it for the only indication for which it can be prescribed to people with hypertriglyceridemia, and that's to reduce their cardiovascular risk.

[00:05:51] Speaker 00:
So, Chief Judge Moore, to bring it back to your question, yes, they have this tiny little disclaimer at the bottom, which, by the way, doesn't say what they're not indicated for, and yes, they refer to AB rating,

[00:06:01] Speaker 00:
But most significantly, they refer to a therapeutic category for which they simply do not have approval to market throughout that entire category, hypertriglyceridemia.

[00:06:13] Speaker 00:
Now, I would also point, Your Honor, to the press releases, which we contend are part of the factual foundation in this case, part of our plausible pleading.

[00:06:23] Speaker 00:
And in those press releases, they refer to the fact that their drug is the equivalent

[00:06:30] Speaker 00:
of Basipa, that it's the generic version of Basipa.

[00:06:35] Speaker 00:
And they refer obliquely to multiple uses of Vespa.

[00:06:38] Speaker 00:
Yes, the press releases the March and September 2020 press releases.

[00:06:43] Speaker 00:
They do refer to treating severe hypertriglyceridemia.

[00:06:46] Speaker 00:
But they also say that Vespa is indicated only in part for those treatments.

[00:06:51] Speaker 00:
And they don't demarcate in those press releases between the treatments for which it is indicated and the treatments for which it is not.

[00:06:57] Speaker 00:
And Your Honor, that is very similar to the press releases in GSK.

[00:07:02] Speaker 04:
What is the obligation on a generic manufacturer who's selling a product that may or may not infringe existing patents?

[00:07:14] Speaker 04:
Is there any kind of duty or should there be a duty of clarity to make clear in all of one's advertising plus releases what is and is not infringing?

[00:07:31] Speaker 00:
Well, Your Honor, they certainly should, when they make those press releases, consider the effect on the listener.

[00:07:36] Speaker 00:
And if they're going to say things that encourage or obliquely point to the indication for which they don't have approval, they're running the risk of a case just like this.

[00:07:46] Speaker 04:
Is there a fact question here as to what a reasonable physician would understand that the product could be marketed for?

[00:07:56] Speaker 00:
Yes, that is the fact question in this case.

[00:07:59] Speaker 00:
And that's what Magistrate Judge Hall recognized when she recommended that the motion to dismiss be denied.

[00:08:06] Speaker 00:
Because the question isn't how Judge Andrews would read these labels, or how he would read the press releases, or what any of us think they mean.

[00:08:15] Speaker 00:
The question is what a physician, what a health care professional would do with those press releases.

[00:08:21] Speaker 00:
with that website.

[00:08:24] Speaker 01:
How would the question be framed to the jury for them to resolve in this case?

[00:08:32] Speaker 00:
Well, Your Honor, it would come in through testimony, for example, of people in the health care industry.

[00:08:37] Speaker 00:
And that's exactly what happened in GSK.

[00:08:40] Speaker 00:
In GSK, if you look through that opinion, you'll see detailed discussions of testimony by Dr. McCullough.

[00:08:46] Speaker 00:
And that testimony was about how physicians read press releases, what they do with that information.

[00:08:52] Speaker 00:
And perhaps in this case, it would be about treatments in this field.

[00:08:56] Speaker 00:
particularly when it comes to treating cardiovascular risk, for which there really were no treatments like this until this approval.

[00:09:03] Speaker 01:
Specifically, what is the question you think the jury would have to answer that, in essence, Judge Andrews answered by granting the motion to dismiss?

[00:09:14] Speaker 01:
Well, that's what I'm trying to get to, is I understand the factual issue, but what question should a survivor motion be dismissed and should be answered by a jury?

[00:09:27] Speaker 00:
whether or not the public statements in the website, in the press releases, would have suggested or conveyed to a health care professional the patented use.

[00:09:37] Speaker 01:
And all of that was in your complaint in terms of your allegations of infringement?

[00:09:42] Speaker 00:
Oh, absolutely, Your Honor.

[00:09:43] Speaker 00:
We referred to how physicians would read it and what it would convey to those in that field.

[00:09:48] Speaker 04:
What it would convey concerning the intent of the assault.

[00:09:54] Speaker 00:
No, Your Honor.

[00:09:55] Speaker 04:
Well, intent is relevant to inducement.

[00:09:59] Speaker 00:
It is, Your Honor.

[00:09:59] Speaker 00:
And the district court, and this is at Appendix Page 8, the district court acknowledged that our evidence did go to intent.

[00:10:05] Speaker 00:
And that's that chart that shows that the vast majority of prescriptions written for Visipa are for the off-label use for HICMA's label, the patented use

[00:10:18] Speaker 00:
for Ameren's indication, which is treating cardiovascular risk.

[00:10:21] Speaker 00:
They understood that.

[00:10:22] Speaker 00:
That's their demonstrative from the earlier case.

[00:10:25] Speaker 00:
So the district court said that that understanding by HICMA, along with their statements in their press release about the US total sales of ASEPA approaching $1 billion, that they understood what would happen and that that was evidence of intent.

[00:10:43] Speaker 00:
So we don't think that this dispute right now is about intent and that whether Judge Andrews thought that we hadn't plausibly pled intent.

[00:10:50] Speaker 00:
It's simply whether we had plausibly pled affirmative actions that would have conveyed or demonstrated this potential use to health care professionals.

[00:11:01] Speaker 00:
That's exactly the type of evidence that was considered in GSK.

[00:11:06] Speaker 00:
And I see that I am into my rebuttal time, so unless the court has additional questions.

[00:11:11] Speaker 02:
That's fine.

[00:11:12] Speaker 02:
Thank you, Mr. Kelly.

[00:11:24] Speaker 03:
Good morning, may it please the court.

[00:11:26] Speaker 03:
Amarin argues that physicians may infer inducing conduct from vague statements.

[00:11:34] Speaker 03:
That's not the law.

[00:11:36] Speaker 03:
The Patent Act does not impose liability for inferred inducement.

[00:11:42] Speaker 03:
The statute expressly requires actively induced infringement.

[00:11:48] Speaker 03:
And this court, held in Takeda,

[00:11:50] Speaker 03:
the Horizon case and many other cases that active inducement, this doesn't relate to intent, it's conduct, it's culpable conduct, active inducement requires affirmative steps in this context to tell health care providers that they should perform, not even may perform, should perform each and every element of an asserted patent claim.

[00:12:16] Speaker 03:
Takeda, which was not a Hatch-Waxman case, it was a 271B case, said merely describing an infringing mode is not the same as recommending, encouraging, or promoting an infringing use, or suggesting that an infringing use should be performed.

[00:12:33] Speaker 03:
Vague language, this is quoting from Takeda, vague language cannot be combined with speculation about how physicians may act to find inducement.

[00:12:42] Speaker 03:
Mere knowledge of direct infringement or off-label use cannot be used to establish induced infringement.

[00:12:50] Speaker 04:
But Hickman said in his press release at least twice that this is a generic equivalent.

[00:12:57] Speaker 04:
It seems to be a fact that 75%

[00:13:01] Speaker 04:
of the usage is or is expected to be covered by the patent.

[00:13:08] Speaker 04:
And obviously Hickman knew that.

[00:13:13] Speaker 04:
So I know you said inducement needs to be expressed, but couldn't a reasonable fact finder find that that was expressed?

[00:13:27] Speaker 03:
Your Honor, that type of evidence could go to knowledge.

[00:13:31] Speaker 03:
But it doesn't go to the conduct element of induced infringement.

[00:13:35] Speaker 03:
And this court in GSK took pains to explain that.

[00:13:39] Speaker 03:
And I'll quote, because this holding, I believe, is directly on point.

[00:13:43] Speaker 03:
The court in GSK agreed, generics could not be liable for merely marketing and selling under a skinny label, omitting all patented indications.

[00:13:53] Speaker 03:
That's what we have.

[00:13:54] Speaker 03:
or for merely noting, without mentioning any infringing use, press release in the website, don't mention any infringing use, that FDA had rated a product as therapeutically equivalent to a brand name drug.

[00:14:08] Speaker 03:
That's directly on point.

[00:14:10] Speaker 02:
Well, that's because those press releases talked about AB rating.

[00:14:14] Speaker 02:
And that's why I was questioning Mr. Kelly about the website, which is AB rated.

[00:14:21] Speaker 02:
concerned with your website, but I am concerned with your press releases.

[00:14:27] Speaker 02:
Because it's different to say something is AB rated, because I understand the industry, that means equivalent for the uses on HICMA's label.

[00:14:35] Speaker 02:
But that's not what you say on the press releases.

[00:14:37] Speaker 02:
You say it's a generic version of Amarin, this Amarin's drug.

[00:14:44] Speaker 02:
So that's different.

[00:14:45] Speaker 02:
That's a much broader statement.

[00:14:47] Speaker 03:
Your Honor, in GSK on page 1336,

[00:14:52] Speaker 03:
The comment was that the dissent criticizes our analysis, claiming we have weakened intentional encouragement because simply calling a product a generic version or generic equivalent is now enough.

[00:15:06] Speaker 03:
And the court said, no, that's not enough.

[00:15:09] Speaker 03:
It's literally the same phrase that's used in the press releases.

[00:15:12] Speaker 02:
On those press releases, they said AD rated, which directed one of Skill in the Arc to look at the label.

[00:15:21] Speaker 03:
That's right, but our label, unlike in GSK, does not actively induce infringement.

[00:15:27] Speaker 02:
In GSK... But that's the difference between their press release and your press release is their press releases, when they said it was generic equivalent, they also said it for AB rated purposes.

[00:15:40] Speaker 02:
Your press release doesn't do that.

[00:15:42] Speaker 02:
It doesn't have that limitation in it.

[00:15:45] Speaker 03:
I have two responses.

[00:15:46] Speaker 03:
The first response is the press release in GSK referred to the product as a cardiovascular agent, which gets pretty close to the patent claims.

[00:15:58] Speaker 03:
We don't refer.

[00:15:59] Speaker 03:
Our press releases don't call Hickman's product a cardiovascular agent.

[00:16:03] Speaker 03:
And it doesn't even talk about cardiovascular in the press release.

[00:16:07] Speaker 03:
All it says is it's a generic version, which this court in GSK said, that's not enough.

[00:16:12] Speaker 02:
Your problem is this is 12b6.

[00:16:17] Speaker 02:
That was following a jury trial.

[00:16:20] Speaker 02:
So we're here at the 12b6 standard stage to say, could somebody think that this is plausibly enough?

[00:16:28] Speaker 02:
Not it is enough, but plausibly.

[00:16:32] Speaker 03:
It's not plausible.

[00:16:34] Speaker 03:
for two reasons.

[00:16:35] Speaker 03:
One, and this goes to, I think it was Judge Laurie's question, the Takeda case made it clear that

[00:16:47] Speaker 03:
the generic or the defendant has no obligation to disclaim infringement.

[00:16:54] Speaker 03:
The quote on footnote four, Stakata needs to show that Hickman took affirmative steps to induce, not affirmative steps to make sure others avoid infringement.

[00:17:03] Speaker 02:
That turns legal.

[00:17:04] Speaker 02:
Well, yes, and that's their allegation, whether correct or not, favorable at trial or not, but I have to accept as true, is that by calling it a generic version in this press release,

[00:17:17] Speaker 02:
it would cause health care providers and patients to believe that this should be prescribed for all of the equivalent uses.

[00:17:26] Speaker 03:
Isn't that a fact question?

[00:17:28] Speaker 03:
It is not a fact question because you can't look at this press release.

[00:17:32] Speaker 03:
The press release doesn't even describe the cardiovascular patented uses, much less induce infringement.

[00:17:40] Speaker 03:
In order to infer

[00:17:42] Speaker 03:
inducing conduct, you would have, the reader would have to go to a document outside the press release, the Vespa label, and make assumptions that, well, now I can use Hickman's product for any indication in the Vespa label.

[00:18:01] Speaker 03:
That's not what the press release does.

[00:18:03] Speaker 02:
I don't think it's inferential.

[00:18:05] Speaker 02:
I think on page 709, you all say Hickman's a generic version.

[00:18:10] Speaker 02:
Full stop, and then at the bottom you point out

[00:18:12] Speaker 02:
the number of sales that the brand has had, which includes the non-severe HTG sales, 75% of which are in fact the non-severe HTG sales.

[00:18:23] Speaker 02:
So, I mean, maybe the point about the sales figures is inferential, but the earlier statement about Hickman's product can be sold as a generic version of Amarin doesn't seem inferential to me.

[00:18:37] Speaker 02:
It seems like an actual statement encouraging use

[00:18:41] Speaker 02:
for the broad sweep of things that this generic can be used for instead of the brand without any narrowing.

[00:18:51] Speaker 02:
So I don't know.

[00:18:53] Speaker 02:
I don't know the validity of the day, but I'm really struggling with how I'm supposed to say at the 12b6 stage that this isn't enough.

[00:19:00] Speaker 01:
What I care about, see, to follow up is why should the judge, it sounds to me like the district judge has made the decision that it would support what you say when it should be a jury that hears evidence from both sides that decides whether you're right in your position or not.

[00:19:20] Speaker 03:
Well, two responses.

[00:19:22] Speaker 03:
The first one is there's no plausible allegation.

[00:19:25] Speaker 03:
There's no plausible allegation that HICMA is actively encouraging a health care provider to actually perform every step of the patented method.

[00:19:35] Speaker 03:
The patented methods are very specific.

[00:19:37] Speaker 03:
Very specific.

[00:19:39] Speaker 03:
And the patented methods are not even described.

[00:19:41] Speaker 03:
And in the Horizon case, the label literally described the entire patented method.

[00:19:48] Speaker 03:
And the court said expert testimony is irrelevant because the label itself doesn't instruct health care providers to actually perform each and every step.

[00:19:58] Speaker 03:
There's not even a description of the patented methods in the press release.

[00:20:02] Speaker 03:
And the second point, and in a sense this is the elephant in the room, is that this is not just a typical 12b6 case.

[00:20:09] Speaker 03:
The entire industry is watching this case.

[00:20:12] Speaker 03:
It's a test case.

[00:20:13] Speaker 03:
It goes back to the entire controversy with GSK.

[00:20:16] Speaker 03:
And if merely calling a generic product a generic version is sufficient to get past the pleading stage, Section 8 is dead.

[00:20:27] Speaker 03:
It would be economically irrational.

[00:20:29] Speaker 02:
This isn't a Section 8 case.

[00:20:30] Speaker 03:
Well, it is.

[00:20:31] Speaker 03:
We filed a Section 8.

[00:20:33] Speaker 02:
No, this is not.

[00:20:34] Speaker 02:
But it's not a Section 8 case anymore.

[00:20:36] Speaker 03:
Well, that's the point.

[00:20:37] Speaker 02:
It's not.

[00:20:37] Speaker 02:
This is not a Section 8 case.

[00:20:39] Speaker 03:
Your Honor, the point is we weren't sued under 271E because of this Section 8.

[00:20:44] Speaker 02:
And what's going to happen is brains are going to... So this isn't going to unravel Section 8.

[00:20:48] Speaker 02:
How is this going to unravel Section 8?

[00:20:49] Speaker 02:
This is not a Section 8 case.

[00:20:51] Speaker 03:
It will absolutely unravel Section 8 because brands will lie in wait when there's a Section 8 carve-out and not sue under 271E and instead wait until the launch and then sue under 271B for damages based on statements like, oh, you called it a generic version.

[00:21:08] Speaker 03:
Now they can get past the motion to dismiss.

[00:21:10] Speaker 03:
It would be economically irrational for any generic to rely on the Section 8 carve-out if they could get sued, if they could get past

[00:21:17] Speaker 03:
They can survive 271e, but then they can't get past 271b.

[00:21:21] Speaker 02:
And then all you will have to do if you want to avoid future litigation is in your press release be more specific.

[00:21:29] Speaker 02:
We have a generic version which can be used to create severe HTG in the same fashion as the branded version, the SEPA.

[00:21:40] Speaker 02:
And then you're off the hook.

[00:21:41] Speaker 02:
It doesn't unravel Section 8.

[00:21:43] Speaker 02:
It doesn't make it so generics can't sell.

[00:21:46] Speaker 02:
It just makes it so generics, when they're claiming they're generic, have to explain what they're generic for.

[00:21:51] Speaker 03:
Takeda.

[00:21:52] Speaker 02:
How hard is that?

[00:21:53] Speaker 02:
Doesn't feel like a hard burden.

[00:21:54] Speaker 02:
Feels like you had two words to your press release.

[00:21:57] Speaker 02:
Two words.

[00:21:58] Speaker 03:
The Takeda case makes it clear.

[00:22:00] Speaker 03:
That's not our burden.

[00:22:02] Speaker 02:
Oh, no.

[00:22:02] Speaker 02:
I didn't say you have to say you have to discourage people from using it for the other things.

[00:22:08] Speaker 02:
I'm just saying, when you say you're a generic equivalent, say what you are a generic equivalent for.

[00:22:16] Speaker 03:
But the only indication described in the press releases is Hickman's indication.

[00:22:22] Speaker 02:
There's no way to get from- You point to the total sales, 919 million, 75% of which are for things you're not supposed to be doing.

[00:22:32] Speaker 02:
So the question there is, would a health care provider?

[00:22:35] Speaker 02:
I have no idea.

[00:22:36] Speaker 02:
And you may win this on summary judgment.

[00:22:38] Speaker 02:
I don't agree with Judge Albright.

[00:22:39] Speaker 02:
This has to go to a jury.

[00:22:40] Speaker 02:
Because I don't know that they're going to be able to come up with proof to establish, for example, paragraph 122 in their complaint, that health care providers would have read this and would have been inspired by it to actually prescribe.

[00:22:55] Speaker 02:
for uses beyond severe HTG.

[00:22:58] Speaker 02:
I don't know that they can come up with evidence to survive a summary judgment on that point.

[00:23:03] Speaker 02:
But the plausibility question for me is a different question.

[00:23:06] Speaker 01:
And actually, I was about to say, or I think we're all struggling at the 12-26 stage.

[00:23:12] Speaker 01:
I was about to say, this seems to me like a summary judgment.

[00:23:17] Speaker 01:
I was saying a jury question.

[00:23:19] Speaker 01:
But you could eliminate that by having a summary judgment.

[00:23:22] Speaker 01:
down the road, as opposed to which would be reviewed by this panel in a completely different way than a Rule 12b6 motion.

[00:23:32] Speaker 03:
I disagree that summary judgment in this case would be any different than what we're looking at now.

[00:23:37] Speaker 03:
Because the statements, this is not a situation like GSK or Grunenthal where there's ambiguity in a statement and the statement could plausibly be construed broadly as encouraging each and every step of a patented method.

[00:23:50] Speaker 03:
There's no such statement here.

[00:23:52] Speaker 03:
So the statements aren't going to change.

[00:23:54] Speaker 03:
They're not oral representations, you know, and a debate as to whether they were said or not.

[00:24:00] Speaker 03:
We know what the statements are.

[00:24:01] Speaker 03:
They're not going to change between now and summary judgment.

[00:24:04] Speaker 03:
Judge Andrews told Ameren, if you want to amend your complaint, go ahead.

[00:24:08] Speaker 02:
What will change between now and summary judgment is I'm assuming that you'll find a bunch of doctors that say either, hey, we don't read press releases.

[00:24:25] Speaker 02:
will prescribe Hikmah for all the same indications as the Sefa.

[00:24:30] Speaker 02:
Or you would have them say, despite the word generic version, hey, I read labels.

[00:24:35] Speaker 02:
And I wouldn't have gone beyond what's on the label.

[00:24:37] Speaker 02:
There are a million ways in which you can present evidence that, on summary judgment, could disprove this allegation.

[00:24:44] Speaker 02:
But right now, it's an allegation I have to accept is true.

[00:24:46] Speaker 02:
And their allegation is that this word, generic version,

[00:24:50] Speaker 02:
quote, communicates to and instructs health care providers that it should be used for all indications.

[00:24:57] Speaker 02:
How do I not accept that?

[00:24:58] Speaker 02:
How do I accept that as true?

[00:25:00] Speaker 02:
How do I keep their complaint?

[00:25:02] Speaker 03:
Your Honor, you don't have to accept as true.

[00:25:04] Speaker 03:
You can accept what the document says.

[00:25:07] Speaker 03:
The case law is clear.

[00:25:08] Speaker 03:
You don't have to accept conclusory allegations if they attach the document.

[00:25:11] Speaker 03:
So you know what the statement is, and you compare the statement to the claims, and it doesn't plausibly, the statements don't plausibly tell doctors, use this product to reduce cardiovascular death.

[00:25:22] Speaker 03:
Use this product in combination therapy with a different product, a step.

[00:25:25] Speaker 02:
How do I know?

[00:25:26] Speaker 02:
How do I know any of that?

[00:25:27] Speaker 02:
Why do you assume that I have any knowledge about how a doctor would understand the words, generic version of the CEPA, and what it means in terms of what

[00:25:39] Speaker 02:
indications just generic can and cannot be used for.

[00:25:43] Speaker 02:
How in the world do you think I have knowledge of that?

[00:25:46] Speaker 03:
That's the Horizon case.

[00:25:47] Speaker 03:
The Horizon case.

[00:25:48] Speaker 02:
You think because I maybe read the Horizon case, which by the way I didn't, you think maybe because I read the Horizon case I should know what doctors do and don't do?

[00:25:55] Speaker 03:
No, no.

[00:25:55] Speaker 03:
The point is whatever doctors do and don't do isn't relevant to whether the alleged statements plausibly and actively encourage each and every step of the patented method.

[00:26:07] Speaker 03:
And that's what the Horizon said.

[00:26:08] Speaker 03:
Horizon said, I don't care what experts have said.

[00:26:11] Speaker 03:
This was summary judgment.

[00:26:13] Speaker 03:
And so the, yeah, and the Ryzen case addressed the same type of situation we're dealing with here.

[00:26:26] Speaker 03:
In fact, it was closer, it was a closer call because in Ryzen, they literally described every step of the patented method.

[00:26:33] Speaker 03:
They didn't actively encourage it.

[00:26:35] Speaker 03:
I see I'm out of time.

[00:26:44] Speaker 00:
Thank you, Your Honor.

[00:26:45] Speaker 00:
Just a few quick points.

[00:26:47] Speaker 00:
First of all, it's striking how thin HICMA is trying to slice this.

[00:26:52] Speaker 00:
Because in GSK, the advertisement which said the drug was a generic equivalent and referred broadly to there being multiple uses was found to be sufficient evidence for a jury to actually find inducement.

[00:27:06] Speaker 00:
And what they're saying

[00:27:07] Speaker 00:
is that a press release that calls something a generic equivalent and refers to multiple uses by calling one only in part

[00:27:17] Speaker 00:
that that is not even plausible.

[00:27:19] Speaker 00:
So they're taking something that was enough for a jury to find inducement, and they're going all the way to it wasn't even plausible just because of a little tweak in the fact that in one press release, they broadly referred to multiple uses, and in their press release, they referred to multiple uses in a different way.

[00:27:35] Speaker 00:
That just can't be.

[00:27:37] Speaker 01:
Let me follow up on something.

[00:27:39] Speaker 01:
Opposing counsel said, yeah, I was going to ask about, Judge Andrews, when he was either about to or granted 12-6, said, would you like to amend your complaint?

[00:27:50] Speaker 01:
They were arguing that it's missing what he said.

[00:27:54] Speaker 01:
It's missing allegations that they practiced each element or whatever it is.

[00:27:58] Speaker 01:
And you all said no.

[00:27:59] Speaker 01:
How does that impact our concern that this was a 12-6 rather than a summary judgment motion just procedurally?

[00:28:08] Speaker 01:
And the district court gave you a chance to add anything you wanted into the complaint and make it more robust.

[00:28:18] Speaker 01:
And how does that impact our decision about whether what Judge Andrews did was correct or not at this procedural stage?

[00:28:26] Speaker 00:
Your honor, it shouldn't impact your decision at all.

[00:28:29] Speaker 00:
The question in this case is whether our amended complaint plausibly pled induced infringement.

[00:28:34] Speaker 00:
And it did.

[00:28:35] Speaker 00:
Whether or not we could have filed a different complaint that I guess in Judge Andrew's view actually proved infringement, that's a separate question.

[00:28:42] Speaker 00:
We didn't have to do that.

[00:28:44] Speaker 00:
This complaint was good enough.

[00:28:45] Speaker 00:
It had plausibly laid out our theory of induced infringement.

[00:28:50] Speaker 00:
Counselor Hickman has referred a couple of times this morning to how complicated the claims are and to how many different limitations are.

[00:28:58] Speaker 00:
And I'd like to just direct the court's attention to, for example, claim one of the 861 patent, which is on the inside cover of our blue brief.

[00:29:05] Speaker 00:
There's only one step in this claim, and that's administering four grams of the SEPA to reduce cardiovascular risk.

[00:29:14] Speaker 00:
The only difference between this claim

[00:29:17] Speaker 00:
and what is indicated on the HICMA label is the purpose for which they are prescribing the CIPA.

[00:29:25] Speaker 00:
That's the difference.

[00:29:26] Speaker 00:
So the question is not whether or not they hit every detail.

[00:29:29] Speaker 00:
For example, the 537 patent, claim one, which is also on the inside cover, that does have additional details.

[00:29:34] Speaker 00:
And that's why, when this argument began, I pushed back a little bit on Chief Judge Moore, because there are some additional limitations in that claim.

[00:29:40] Speaker 00:
And we did need some stuff in the label to get to some of those limitations.

[00:29:44] Speaker 00:
But the issue now,

[00:29:46] Speaker 00:
is simply the use of vasipa to treat cardiovascular risk.

[00:29:51] Speaker 00:
Physicians knew what vasipa was approved for.

[00:29:54] Speaker 00:
They knew about both indications.

[00:29:56] Speaker 00:
They saw a press release that said it was the generic equivalent.

[00:30:00] Speaker 02:
They saw the press release refer to the... Out of curiosity, does the HICMA label tell you if you administer poor brainings?

[00:30:10] Speaker 04:
I believe it does.

[00:30:16] Speaker 00:
Yes, so Your Honor, on page 696, you'll see the dosage and administration.

[00:30:30] Speaker 00:
The daily dose of icosapent ethyl is four grams per day.

[00:30:35] Speaker 00:
It's about midway down.

[00:30:36] Speaker 02:
This is the HICMA label?

[00:30:38] Speaker 02:
Yes.

[00:30:41] Speaker 00:
Right, and if you go back to 694, you'll see it says, IcoStatement, Ethyl, excuse me, Hicma Pharmaceuticals, at the top of the page.

[00:30:50] Speaker 02:
I don't understand, then, why then is the label not actually encouraging encouragement directly?

[00:31:05] Speaker 00:
Because of the purpose of the... But that's just the statement of intent it used.

[00:31:11] Speaker 02:
or was it construed as a limitation?

[00:31:16] Speaker 00:
He keeps nodding there behind me, but I'll answer the question.

[00:31:18] Speaker 00:
Yes, the parties agreed that the preamble was limited.

[00:31:22] Speaker 02:
Oh, you agreed the preamble was limited?

[00:31:23] Speaker 04:
Yes.

[00:31:24] Speaker 04:
Okay.

[00:31:24] Speaker 04:
The parties agreed what?

[00:31:25] Speaker 00:
That the preamble was limited.

[00:31:29] Speaker 02:
So if there are no further questions, thank you.