[00:00:03] Speaker 02:
Rubicon Research, Private, Limited, 2023, 2386.

[00:00:09] Speaker 02:
Mr. Zapata.

[00:00:14] Speaker 04:
Can I quickly ask the parties, to what degree are we still truly limited in how we can describe what's in the label?

[00:00:24] Speaker 01:
Your Honor, the drug is now, the Rubicon product is now on the market, so we're free.

[00:00:31] Speaker 03:
So we can say room temperature?

[00:00:33] Speaker 03:
Yes.

[00:00:34] Speaker 04:
OK.

[00:00:34] Speaker 04:
We can say refrigerated?

[00:00:36] Speaker 04:
Yes.

[00:00:38] Speaker 01:
Oh, right then.

[00:00:40] Speaker 01:
It would have been helpful to know that.

[00:00:42] Speaker 01:
Good morning, Your Honors.

[00:00:47] Speaker 00:
May it please the Court.

[00:00:50] Speaker 00:
The district court's decision here should be overturned for at least two reasons.

[00:00:55] Speaker 00:
First.

[00:00:56] Speaker 00:
The district court abused its discretion by allowing Rubicon to advance a late theory at summary judgment, which is not timely disclosed during discovery or in its non-infringement contentions.

[00:01:06] Speaker 00:
Second, the district court improperly granted summary judgment over genuine issues of material fact and through improper application of the case law.

[00:01:15] Speaker 00:
Turning to the first issue, Rubicon's untimely presentation of its non-infringement theory warrants reversal.

[00:01:21] Speaker 00:
Rubicon first disclosed its non-infringement theory.

[00:01:24] Speaker 02:
So why don't you get to the merits rather than

[00:01:26] Speaker 02:
arguing procedure.

[00:01:27] Speaker 00:
OK.

[00:01:29] Speaker 00:
So I will turn to the merits then.

[00:01:32] Speaker 00:
So here, the district court essentially relied on Rubicon's label itself and nothing else to come to its conclusion that there was no induced infringement.

[00:01:48] Speaker 00:
The court concluded that

[00:01:50] Speaker 00:
based upon the option to store this at room temperature, that that was insufficient to rise to showing induced infringement, or at least the intent for that.

[00:02:00] Speaker 00:
Now Rubicon has characterized this as being a permissive usage along the way.

[00:02:06] Speaker 00:
And to support that and find for no induced infringement, the court pointed to HZMP, which I think is probably Rubicon's strongest case here.

[00:02:15] Speaker 00:
But I think there are distinctions.

[00:02:17] Speaker 00:
So in HCMP, we had a situation where the claims called for applying a topical, waiting for the area to dry, and then applying a second topical once the area was dry.

[00:02:32] Speaker 00:
The generic label in that case had

[00:02:34] Speaker 00:
instructed users to apply a material and wait for it to dry until you put on clothing or some other topical.

[00:02:43] Speaker 00:
And so this court characterized that situation as conditional, as an if and when.

[00:02:50] Speaker 02:
Let's focus on this case.

[00:02:52] Speaker 02:
The claim says 2 to 8 degrees.

[00:02:55] Speaker 02:
That's refrigeration.

[00:02:59] Speaker 02:
The label of the accused product is 20 to 25.

[00:03:03] Speaker 02:
And yes, it mentions

[00:03:04] Speaker 02:
can be stored, but in terms of inducement, that's not an inducement.

[00:03:10] Speaker 02:
That's just saying what can occur.

[00:03:15] Speaker 00:
Yes, but when you look at the opinion of Dr. Savello, who looked at this label and he said, I've never seen a label quite like this.

[00:03:22] Speaker 00:
And Dr. Savello was a pharmacist for many years and was a meta-cells expert in this case.

[00:03:26] Speaker 00:
He said, I've never seen an instance where I have conflicting storage conditions stated on a label.

[00:03:32] Speaker 00:
And often, there are benefits to just refrigerating things.

[00:03:36] Speaker 00:
So he said you might defer.

[00:03:37] Speaker 02:
We're not really conflicting.

[00:03:39] Speaker 02:
The label doesn't say it can be stored at 20 to 25 degrees or 2 to 8.

[00:03:46] Speaker 02:
That's not what it says.

[00:03:48] Speaker 00:
Yes, and I don't disagree with that.

[00:03:51] Speaker 00:
But we also are presented with a situation where Rubicon's own expert calls these opposite storage conditions.

[00:03:56] Speaker 00:
So to the extent they are conflicting, that comes from their expert.

[00:04:01] Speaker 03:
And I would remind the court that when Rubicon... It's not just that your expert says, in front of this, I would choose to do that.

[00:04:11] Speaker 03:
confronted with this label, I would read this as instructing me to do the infringing act.

[00:04:18] Speaker 03:
I've read his testimony.

[00:04:20] Speaker 03:
It doesn't seem to say that.

[00:04:21] Speaker 03:
It seems to say that in his experience as a pharmacist, if he sees room temperature or refrigeration, he would store it refrigeration.

[00:04:29] Speaker 03:
That doesn't go enough to say that the label induced me to store it refrigeration.

[00:04:35] Speaker 00:
I think that's a fair point, Your Honor.

[00:04:36] Speaker 00:
And to the extent that it wasn't.

[00:04:38] Speaker 03:
I don't see why this isn't on all fours with HCMP.

[00:04:41] Speaker 03:
HCMP had a label that specifically instructed to do one thing and permitted something, but did not require the infringing act.

[00:04:51] Speaker 03:
This one has something that's not infringing and permits, but does not require the infringing act.

[00:04:57] Speaker 00:
Well, I think it's an extension of HCMP because this is where I was driving to a moment ago where HCMP was characterized as kind of conditional situation where it was if a user was going to eventually do something, this is what they do.

[00:05:11] Speaker 00:
But here I think we're left with a situation where

[00:05:13] Speaker 00:
Pharmacists are going to look at this label and refrigerate it.

[00:05:17] Speaker 00:
And again, this goes back to Dr. Savello's opinion.

[00:05:19] Speaker 03:
You still have to have something that would support a genuine issue of material effect and that the label would tell the pharmacist to infringe.

[00:05:28] Speaker 03:
Not that they have a choice, but that the label read as a whole suggests that they should do the infringing act.

[00:05:36] Speaker 03:
That's hard to read into this label when it doesn't say that on its face.

[00:05:40] Speaker 00:
Well, that's true.

[00:05:41] Speaker 00:
But I think if we zoom out and look at this more generally for just a moment, and we take this in the context of patent inducement generally, or more specifically in ANDA cases, if you look at, say, Section 8 carve-out cases, for example, you could be presented, if this is affirmed on this basis, you have a situation where generic brands could simply say,

[00:06:01] Speaker 00:
I'm going to recite an indication that is not infringing.

[00:06:04] Speaker 00:
And then below that, every alternative that could be an infringing use.

[00:06:08] Speaker 00:
I'm simply stating on that label that those are permissive.

[00:06:10] Speaker 00:
So thereby, I escape all infringement.

[00:06:13] Speaker 00:
And I don't think that that's what HCSP stands for.

[00:06:16] Speaker 03:
Well, it might not infringe.

[00:06:17] Speaker 03:
But if it's actually to be used for the composition to be used for treatment, then the fact that it's to be used for those conditions is infringing, probably.

[00:06:28] Speaker 03:
This is a little strange because it's a method claim.

[00:06:32] Speaker 03:
It also showed that the label says to use the product in an infringing way, not just permit its use under HCMP.

[00:06:42] Speaker 00:
And we're frequently faced with method claims of this very nature in these ANDA cases.

[00:06:46] Speaker 00:
In fact, most of the ones that we've cited and looked at in this case are framed in this same way.

[00:06:51] Speaker 00:
So if we turn to Vanda for example, I think that's perhaps MetaCell's strongest case in its favor here, where in that instance you had a label that said, well let me back up, the patent claim called for a certain type of genotyping assay as part of the patent claim.

[00:07:06] Speaker 00:
The generic label simply said, laboratory tests are available.

[00:07:11] Speaker 00:
Now that's a pretty broad statement, and that certainly says

[00:07:15] Speaker 00:
that's permissive in the sense that you could go get genotyping assays conducted.

[00:07:19] Speaker 00:
It does an instructor user to do that.

[00:07:21] Speaker 00:
And yet this court found that there was induced infringement there.

[00:07:24] Speaker 00:
And so I think there's some factual distinctions here.

[00:07:27] Speaker 00:
And I don't think HCMP is on all fours for that reason.

[00:07:31] Speaker 00:
And when we look at, and turning back to Dr. Sabella's opinion for a moment,

[00:07:37] Speaker 00:
Dr. Savello said that, while I find this confusing and I recognize there are certain advantages with refrigerating things generally, so sometimes it's for improved taste, it's because patients tend to do what they did when they were using the branded product, or it can prolong the shelf life of a product.

[00:07:54] Speaker 00:
In his declaration in support of the Motion 3 consideration, Dr. Savello also cited reports from the AHPSA, I believe is the acronym,

[00:08:08] Speaker 00:
of a trade association of approximately 60,000 pharmacists who said, we often see issues with generic labeling where they're not looking properly at the safety considerations or other items, and so they're often consulting the reference label drug, which is exactly what Dr. Savello suggested you would do here and store it in that same manner.

[00:08:30] Speaker 03:
Does any of that relate to what the label told him to do rather than what his own experience as a pharmacist told him to do?

[00:08:39] Speaker 00:
Well, because this is the viewpoint of what pharmacists would do across the board.

[00:08:43] Speaker 00:
The point is he's confronted with a label that says two different things and how it should be stored.

[00:08:49] Speaker 00:
And he is saying, I, and on behalf of what I believe other pharmacists would do, I would look at this label and I would refrigerate it on that basis.

[00:08:57] Speaker 00:
I think that's a very reasonable outcome here, particularly when you consider how the reference label, the branded drug, is stored.

[00:09:04] Speaker 00:
And there was evidence that, or at least Dr. Savello's opinion, was that we often tend to treat Trinarex in the same way we did with the brand.

[00:09:14] Speaker 00:
So that's how he gets down to that point of saying, I will look at this label.

[00:09:17] Speaker 03:
That seems to go a little too far, because we didn't have this optional phrase store that could be stored at refrigeration.

[00:09:26] Speaker 03:
Yet the pharmacists knew that the branded drug was always stored at refrigeration.

[00:09:32] Speaker 03:
Based on their experience, wouldn't they store the generic at refrigeration anyway?

[00:09:36] Speaker 03:
But that nonetheless couldn't even possibly be inducement, because that wasn't in the label at all.

[00:09:43] Speaker 03:
I mean, you're relying on this reference to the name brand drug and the way they would store it and saying, well, they would just do it the same way as the generic.

[00:09:53] Speaker 03:
But that can't be a ground for inducement, because otherwise you could not have anything about refrigeration on the label, but you would still be here arguing inducement.

[00:10:04] Speaker 00:
But I think that intent can be inferred on the basis that Rubicon chose to include that storage condition at all.

[00:10:12] Speaker 03:
It's not very HCMP.

[00:10:13] Speaker 03:
You need something more than that.

[00:10:16] Speaker 03:
That's the problem.

[00:10:17] Speaker 03:
The evidence you're relying on doesn't go to their intent to induce.

[00:10:23] Speaker 03:
It goes to what a pharmacist, who clearly is skilled in the art, what they would do, not what the generic intended them to do.

[00:10:32] Speaker 00:
I think the generic entirely understands that this is going to be refrigerated.

[00:10:36] Speaker 00:
I think that is the point of Dr. Savello's opinion.

[00:10:39] Speaker 00:
I think that is the point of when we reference the statements made to the FDA,

[00:10:43] Speaker 00:
Rubicon understood to be the case.

[00:10:45] Speaker 00:
When asked how this was going to be stored, Rubicon told the FDA it would be stored in refrigerated temperatures in the same manner as the reference listed drug.

[00:10:54] Speaker 00:
And again, I don't think Rubicon had to include that storage statement at all.

[00:10:59] Speaker 00:
If they wanted to get rid of this issue altogether, if they wanted no possibility that it would be refrigerated,

[00:11:04] Speaker 00:
then they didn't have to include that on the label, according to their expert who says that this condition is not required.

[00:11:10] Speaker 00:
So why else include it unless you expect or intend that it may be refrigerated?

[00:11:15] Speaker 00:
I think that's a strong showing of intent.

[00:11:18] Speaker 04:
Do you have evidence that Rubicon understood that pharmacists would go ahead and refrigerate it based on the, what I'll call, optional instruction to refrigerate?

[00:11:28] Speaker 00:
We do not have direct evidence of it having been stored because we're still sort of left with the hypothetical of what we've got based upon the label and the record in front of us and the opinions of the experts.

[00:11:38] Speaker 00:
We have testimony from a 30B6 witness from Rubicon who explained that they included those storage conditions because they needed to match up with what the FDA was telling them to do.

[00:11:48] Speaker 00:
But to your point, Your Honor, we do not have direct evidence that it has been stored, one way or another.

[00:11:55] Speaker 02:
Counsel, you're into your rebuttal time.

[00:11:57] Speaker 02:
You can continue or save it as you wish.

[00:11:59] Speaker 00:
I will save my rebuttal time, Your Honor.

[00:12:09] Speaker 02:
Mr. Krauss.

[00:12:11] Speaker 01:
Thank you, Your Honor.

[00:12:12] Speaker 01:
May it please the Court.

[00:12:15] Speaker 01:
Sometimes a case is as simple as it appears.

[00:12:18] Speaker 01:
I don't think you can reverse this case without reversing HZNP.

[00:12:24] Speaker 01:
They don't advocate that you do that.

[00:12:27] Speaker 04:
Why did you write into the label the idea of refrigerating at 2 to 8 degrees Celsius?

[00:12:32] Speaker 01:
It's as an optional storage condition.

[00:12:35] Speaker 04:
I mean, as soon as you write in the infringing act, you're playing the fire.

[00:12:42] Speaker 01:
Your Honor, we actually had established that the product was stable at both room temperature and at refrigerated conditions.

[00:12:53] Speaker 01:
When you do that, you can then put in the label both options.

[00:12:57] Speaker 01:
And the label clearly said.

[00:13:00] Speaker 04:
At the same time, you need to avoid 271B liability.

[00:13:03] Speaker 01:
Well, I understand that.

[00:13:05] Speaker 01:
But the point being that in terms of the label, the label instructs the pharmacist to store it room temperature unless they want to put it in the refrigerator.

[00:13:16] Speaker 01:
And they can do that.

[00:13:17] Speaker 01:
We've told them that if they do that, we're also stable at that condition.

[00:13:23] Speaker 01:
And so it's not a recognition or an expectation that they're going to do that.

[00:13:27] Speaker 01:
It's definitely not an inducement that they're going to do that.

[00:13:30] Speaker 03:
What if the label, and some of the way it's worded it,

[00:13:34] Speaker 01:
I think if it did that, it would actually be closer to HCMP case.

[00:13:40] Speaker 01:
I think our case is further away from inducement than in HCMP.

[00:13:44] Speaker 03:
I don't understand that.

[00:13:45] Speaker 03:
If you're telling the pharmacist to store at one of these or the other one and one of them is infringing,

[00:13:53] Speaker 03:
I think that's inducement, isn't it?

[00:13:55] Speaker 03:
I mean, isn't that what GlaxoSmithKline said?

[00:13:57] Speaker 01:
No, I don't think so.

[00:13:59] Speaker 01:
I think GlaxoSmithKline, if it's the Tubbitt case, that's dealing with different indications.

[00:14:05] Speaker 01:
And if the evidence in that case suggested that, well, we also might sell for these indications that aren't in the label, but we put it on our website and the like, then sure, then that's evidence of inducement that the court in this court found was sufficient to at least make a case for infringement.

[00:14:23] Speaker 03:
I really don't understand your answer here.

[00:14:25] Speaker 01:
OK, well, I'd like to back up.

[00:14:28] Speaker 03:
If the label instructs the user to store at either a non-infringing or an infringing use, you're telling them,

[00:14:40] Speaker 03:
to store an infringing use.

[00:14:43] Speaker 03:
The fact that you're also giving them a non-infringing option, I don't understand how they get you out of it.

[00:14:49] Speaker 01:
I think under HCMP it does, because in HCMP... HCMP is different.

[00:14:53] Speaker 03:
That's the whole point of this question, is HCMP doesn't tell them to do the infringing act at all.

[00:15:00] Speaker 03:
It permits it.

[00:15:02] Speaker 03:
But if it's a single storage and says do it either A or B,

[00:15:09] Speaker 01:
Okay, so first I want to be clear that this is a hypothetical Right, okay, so so let's let's let's say this is the hypothetical our label itself doesn't do that our label itself instructs room temperature and says but you can also do it refrigerated but under that hypothetical

[00:15:32] Speaker 01:
I think perhaps it's a fair question.

[00:15:34] Speaker 01:
I think our argument would be that we're not telling them to do one or the other.

[00:15:37] Speaker 01:
They can do it if they want to do it under that hypothetical.

[00:15:41] Speaker 03:
On your label, you're telling them to do the non-pringing use.

[00:15:45] Speaker 03:
Yeah, exactly.

[00:15:45] Speaker 03:
But it says, you know, you can also store it at refrigeration.

[00:15:51] Speaker 03:
Exactly.

[00:15:51] Speaker 03:
What do you do with all your, I mean, what happens, I'm a little troubled by the fact that you went to the FDA and told them, oh yeah, you'd store it at refrigeration.

[00:16:00] Speaker 01:
That's actually not what happened.

[00:16:04] Speaker 01:
And the evidence is exaggerated and is not correct.

[00:16:08] Speaker 01:
There's non-public portions of the submission that go to the FDA.

[00:16:12] Speaker 01:
There's a Q&A section of that non-public portions.

[00:16:16] Speaker 01:
So right away, we're not dealing with inducement.

[00:16:20] Speaker 01:
It's almost another hypothetical that doesn't exist.

[00:16:23] Speaker 01:
But in that Q&A section,

[00:16:25] Speaker 01:
And the court found this to be true.

[00:16:27] Speaker 01:
And they looked at it.

[00:16:27] Speaker 01:
And the court found that that Q&A dealt with, is there a difference between the way you handle this product if you're going to refrigerate?

[00:16:37] Speaker 01:
And it's basically a Q&A that goes over a comprehensive discussion between what are the differences between these products?

[00:16:46] Speaker 01:
Because as you know, the last day.

[00:16:48] Speaker 04:
Which J&A side are we talking about?

[00:16:49] Speaker 04:
Do you have the page?

[00:16:50] Speaker 01:
On the page of the court's opinion?

[00:16:52] Speaker 04:
In the JA, in the joint appendix?

[00:16:54] Speaker 01:
Yeah.

[00:16:55] Speaker 04:
The non-public colloquy you're talking about, the FDA.

[00:16:59] Speaker 01:
Yeah.

[00:17:00] Speaker 01:
The non-public appendix 1985 is my little site for this, which I think may be

[00:17:24] Speaker 01:
That is, in fact, the non-public portion.

[00:17:27] Speaker 01:
1985.

[00:17:30] Speaker 01:
I actually wrote that down correctly.

[00:17:33] Speaker 04:
So there's a column for Rubicon's storage statement.

[00:17:38] Speaker 04:
and it comes right out saying store at 2 degrees Celsius to 8 degrees Celsius.

[00:17:44] Speaker 04:
It can be stored at 20 degrees to 25 degrees Celsius.

[00:17:49] Speaker 04:
That's basically the reverse of what the label says, right?

[00:17:54] Speaker 04:
Right.

[00:17:55] Speaker 04:
So what's going on here?

[00:17:56] Speaker 04:
It seems a little peculiar that in your submission to the FDA, you've got opposite statements.

[00:18:06] Speaker 01:
But you also have to understand the label itself was submitted to the FDA.

[00:18:09] Speaker 01:
The FDA approved it as the label being, we want to instruct the downstream user to store at room temperature, but optionally at refrigerated conditions.

[00:18:21] Speaker 01:
It is possible during this Q&A portion of the hand to submission that it was flipped.

[00:18:28] Speaker 01:
But by the time we got to the label and what was going to be put into the public stream as to the instructions for storage, then it did change.

[00:18:38] Speaker 01:
And it changed to reversal so that it's good that they did that because then we don't need French.

[00:18:44] Speaker 04:
Does the FDA require you to have the refrigeration statement in the label?

[00:18:48] Speaker 01:
I think that there was no discussion about whether to take out the optional refrigeration portion of the label.

[00:18:59] Speaker 01:
It's not a carve-out situation where you're dealing with an indication.

[00:19:03] Speaker 01:
Instead the label, which all generics try to make it as close to the brand as possible.

[00:19:09] Speaker 01:
But here, frankly, this is a situation where we've improved the product.

[00:19:13] Speaker 01:
We're stable at room temperature.

[00:19:15] Speaker 01:
The fact is, whether or not the downstream user follows this expert and puts it all in the refrigerator, the fact is it doesn't have to be.

[00:19:24] Speaker 01:
And that's a benefit.

[00:19:26] Speaker 01:
Well, there's actually

[00:19:28] Speaker 01:
I mean, there's thought about that, right?

[00:19:31] Speaker 01:
Because we created, you have to understand, this entire patent is not, this is barely invented.

[00:19:39] Speaker 01:
It took a known drug.

[00:19:40] Speaker 04:
It looks like the PTO is handing out patents on these storage limitations.

[00:19:44] Speaker 01:
Well, you can get me talking.

[00:19:46] Speaker 04:
This particular patent, they issued seven months after the filing date.

[00:19:52] Speaker 01:
Your Honor, that is correct.

[00:19:54] Speaker 01:
We did make a validity argument, which we didn't pursue.

[00:19:58] Speaker 01:
don't need to pursue.

[00:19:59] Speaker 01:
But the fact is, it was a known drug.

[00:20:01] Speaker 01:
The treatment, it's a method of treating spasticity for patients that have multiple sclerosis, I believe.

[00:20:12] Speaker 01:
But that was known.

[00:20:14] Speaker 01:
All they did was take it and put an oral solution for it.

[00:20:17] Speaker 01:
But they made their oral solution with this citric acid buffer, which is one of the steps required in the patent that we don't meet.

[00:20:25] Speaker 01:
And then they had to test for this particular impurity that they created by using the citric acid buffer, which we don't have to test for because we don't use citric acid.

[00:20:36] Speaker 01:
And then you have to put it in the refrigerator.

[00:20:38] Speaker 01:
So they made a solution, and they got a patent on it.

[00:20:41] Speaker 01:
And the patent then has the three steps, to use the citric acid buffer, to test for this impurity that they created, and then to put it in the refrigerator.

[00:20:51] Speaker 03:
But those first two, I mean, it seems like you have really good arguments, but they're not before us.

[00:20:55] Speaker 03:
Exactly.

[00:20:56] Speaker 03:
Because you can't pursue them.

[00:20:57] Speaker 01:
Exactly.

[00:20:57] Speaker 01:
And if we get into the, well, we haven't given them up.

[00:21:01] Speaker 01:
But what we did.

[00:21:02] Speaker 03:
Well, I understand.

[00:21:03] Speaker 03:
But it seems like you, I don't understand why you went with what seems to be the most complex of the issues, because the label is tricky, whereas those two things are not.

[00:21:16] Speaker 01:
In our estimation,

[00:21:19] Speaker 01:
The exact opposite reason is why we did what we did, which is the HCMP case absolutely controls the fact that we gave a direction not to infringe with an option.

[00:21:33] Speaker 01:
If they want to put in the refrigerator, they can.

[00:21:35] Speaker 01:
It's not our inducement at all.

[00:21:37] Speaker 03:
Have you read our other label cases?

[00:21:39] Speaker 03:
Because they may support their argument.

[00:21:43] Speaker 04:
Yeah, they cited Vanda.

[00:21:45] Speaker 04:
Could you discuss that case?

[00:21:46] Speaker 01:
Vanda, there was an instruction to do the testing that was on top of it.

[00:21:53] Speaker 04:
The genotyping assay that the Rosen Council refers to?

[00:21:57] Speaker 01:
The holding, at least in Vanda, was that that testing was being induced by the label.

[00:22:02] Speaker 01:
And so it's in a box.

[00:22:04] Speaker 04:
But did the label actually say genotyping assay?

[00:22:07] Speaker 01:
I, the court held that it was, it was specific enough to be an inducement for it.

[00:22:13] Speaker 01:
Where here it's different because here we said, don't do it.

[00:22:16] Speaker 01:
And then put it in.

[00:22:18] Speaker 03:
I understand.

[00:22:21] Speaker 03:
Right.

[00:22:21] Speaker 03:
I mean, I think you're both overseeing your cases both ways.

[00:22:26] Speaker 03:
Yes.

[00:22:28] Speaker 01:
Do it a non-infringing way.

[00:22:30] Speaker 01:
There's no instruction in Vanda in the label.

[00:22:34] Speaker 01:
I understand.

[00:22:35] Speaker 01:
I understand and I apologize to the court.

[00:22:37] Speaker 01:
I will.

[00:22:39] Speaker 01:
But it absolutely, we had a non-infringing direction.

[00:22:42] Speaker 01:
The only inducement that's taking place with respect to storage conditions in our label, the only inducement is to not infringe.

[00:22:51] Speaker 03:
So we said... And if there is an infringing

[00:22:55] Speaker 03:
It's permitted by the label, but not required by the label.

[00:22:59] Speaker 03:
And your view under HCMP.

[00:23:01] Speaker 01:
That's our view under HCMP, and Vanda doesn't address that at all.

[00:23:04] Speaker 04:
If I were to say to you, do your homework, but you can also practice the piano.

[00:23:10] Speaker 04:
And then you go off to the piano and start practicing.

[00:23:13] Speaker 04:
Have I induced you to play the piano?

[00:23:16] Speaker 01:
I don't believe so.

[00:23:17] Speaker 01:
Under the HCMP analysis, under, and I think even in a family.

[00:23:21] Speaker 04:
You were sitting there watching TV.

[00:23:25] Speaker 04:
You're watching a sitcom, and then I come into the room and I say, do your homework.

[00:23:29] Speaker 04:
or you can play the piano?

[00:23:31] Speaker 01:
The hypothetical is interesting because it's as if there's something exciting about putting this product in the refrigerator.

[00:23:40] Speaker 01:
It's exciting to play the piano.

[00:23:42] Speaker 01:
And so permitting someone to play the piano as a wink and a nod might be something that you're thinking about as a parent.

[00:23:51] Speaker 01:
But here, it's

[00:23:56] Speaker 01:
stored in room temperature, which most drugs are stored at room temperature.

[00:24:00] Speaker 01:
And pharmacists know how to do that.

[00:24:02] Speaker 01:
And so the idea that they're permitted and instructed to put it in room temperature, that's a good thing.

[00:24:10] Speaker 01:
And the fact that you can also put it in the refrigerator and it's stable

[00:24:14] Speaker 01:
if you put it in the refrigerator, which we've had to prove in order to get our ANDA submitted, and there you go.

[00:24:20] Speaker 01:
And so the case starts and ends at HZNP, and it starts and ends with our label.

[00:24:27] Speaker 01:
Their expert doesn't matter.

[00:24:29] Speaker 01:
This non-public portion of the ANDA doesn't matter.

[00:24:32] Speaker 01:
The deposition that they claim was our expert, which we don't have an expert, doesn't matter, because none of it relates to the label itself.

[00:24:41] Speaker 01:
And the label could not be more clear.

[00:24:43] Speaker 01:
It says,

[00:24:44] Speaker 01:
store it at room temperature and if you want to put it in the refrigerator.

[00:24:50] Speaker 01:
Now, they do have the secondary argument with respect to our timing.

[00:24:55] Speaker 01:
When we made the argument regarding this non-infringement position, Your Honor suggested that they move from that.

[00:25:03] Speaker 01:
We have answers to that in our briefing.

[00:25:05] Speaker 01:
I'm happy to answer any questions as to why we did what we did.

[00:25:09] Speaker 01:
Judge Hughes, you asked about why we didn't go for these other arguments.

[00:25:13] Speaker 01:
I can explain that as well.

[00:25:15] Speaker 01:
The point is we were first to file in this case.

[00:25:17] Speaker 01:
We were running against the clock to get this product out of the district court because we had tentative approval midway through this case.

[00:25:28] Speaker 01:
And so it was critical for us to get to summary judgment from this court in New Jersey to give us summary judgment.

[00:25:36] Speaker 01:
This was what we figured out to be a rifle shot to apply HCMP.

[00:25:42] Speaker 01:
We would just like that affirmed at this point as well.

[00:25:46] Speaker 02:
Thank you, counsel.

[00:25:49] Speaker 02:
Mr. Zapata has the floor.

[00:26:01] Speaker 00:
Mr. Schroener, I'd like to address a few points raised by the panel and Mr. Kratz.

[00:26:07] Speaker 00:
So your panel pointed to the Q&A section that Rubicon conducted with the FDA.

[00:26:13] Speaker 00:
And what I would direct the panel to is several pages of that ANDA.

[00:26:18] Speaker 00:
While they are not sequential in the appendix themselves because of the removal of pages, you will, however, see that they represent the sequence of events of what Rubicon submitted at what time to the FDA.

[00:26:29] Speaker 00:
So at APPX 1876, Rubicon submitted an additional statement which started off with the instruction to store at 20 to 25 degrees.

[00:26:39] Speaker 00:
At 8PPX1880, you then have the label for Rubicon's product, which starts with storing the label at 20 degrees.

[00:26:48] Speaker 00:
However, when we get slightly further in that, Anda, and we get to 8PPX1985, you have a storage statement that is the one that's at issue here, where it is then flipped.

[00:26:58] Speaker 00:
And Rubicon tells the FDA to store this at refrigerated temperatures or to store it at room temperature.

[00:27:05] Speaker 00:
And I think there's somewhat of a distinction without a difference here.

[00:27:09] Speaker 00:
And one thing that's important, turning to the procedural aspects, is how Rubicon characterized this condition very early in its non-infringement contentions.

[00:27:18] Speaker 00:
It referred to this limitation as instructing users to store this under a temperature-controlled condition.

[00:27:24] Speaker 00:
Both refrigerated conditions and room temperature conditions are temperature-controlled conditions.

[00:27:30] Speaker 00:
So I think when a pharmacist is looking at this label, we look at all of the totality of information here, there is an

[00:27:38] Speaker 00:
induce infringement.

[00:27:40] Speaker 00:
And to that same end, Mr. Crouch just said that they do not have an expert in this case, but if their expert did submit a rebuttal opinion, which Dr. Savello addressed, which of course all arose after the close of reply briefing.

[00:27:55] Speaker 00:
I would point to one other thing that I would think helped this panel address some of the issues here.

[00:27:59] Speaker 00:
APPX 6057 to 6058.

[00:28:03] Speaker 00:
There is a report in there from the first data bank, which was attached to Dr. Savello's declaration.

[00:28:11] Speaker 00:
Now, Mr. Kratz explained that most drugs are stored at room temperature.

[00:28:15] Speaker 00:
And while this may be true, it's going to be dependent upon the type of drug.

[00:28:19] Speaker 00:
You may see pills or things like that often stored on shelves.

[00:28:23] Speaker 00:
But the first data bank report that Dr. Savello referenced includes instructions, including ones from Cigna,

[00:28:29] Speaker 00:
where if you actually look at a QR code on that database, you are directed to a place that says, for Baclofen solutions, these should be refrigerated.

[00:28:38] Speaker 00:
If you don't have an oral suspension, then you should refrigerate it.

[00:28:41] Speaker 00:
Here we're dealing with an oral solution.

[00:28:43] Speaker 00:
So this is the reason why when we cast broad strokes about how all drugs are stored, that isn't what's applicable here.

[00:28:50] Speaker 00:
And this is why it's important to think about what Dr. Savello said, how one would view this label in the context of these kinds of drugs in the totality of information.

[00:29:00] Speaker 00:
And we spent a lot of time with HCMP, but I would have made one more reference that there is other jurisprudence from this court.

[00:29:06] Speaker 00:
And again, I think Vanda is the one that's most on point here.

[00:29:10] Speaker 00:
In Vanda, as I described when I first came up here, the patent claim said conducted genotyping assay.

[00:29:17] Speaker 00:
The generic label said, laboratory tests are available.

[00:29:22] Speaker 00:
I think that is a far broader, more abstract or ambiguous position than what we have on this label, which says, go do your homework or play the piano.

[00:29:31] Speaker 00:
I'm going to choose the piano.

[00:29:32] Speaker 00:
And with that, I will conclude my time, unless Your Honors have any further questions.

[00:29:37] Speaker 02:
Thank you, Counsel.

[00:29:38] Speaker 02:
The case is submitted, and that concludes today's argument.