[00:00:00] Speaker 04:
Our next case is Delgadis versus MSN, 2024-22-11.

[00:00:09] Speaker 04:
Ms.

[00:00:09] Speaker 04:
Maynard.

[00:00:10] Speaker 01:
Thank you, Your Honor.

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

[00:00:14] Speaker 01:
My name is Deanne Maynard.

[00:00:15] Speaker 01:
I'd like to reserve three minutes for rebuttal.

[00:00:17] Speaker 01:
So this preliminary injunction appeal involves the 918 patent, which claims an amorphous complex, which is called TVS for short.

[00:00:25] Speaker 04:
Now this case is going to trial in a few weeks.

[00:00:28] Speaker 01:
Yes, sir.

[00:00:28] Speaker 01:
December 9th, the trial starts on December 9th.

[00:00:32] Speaker 01:
The patent has, as we mentioned earlier, two years of life left, yet MSN wants to launch before next month's trial prematurely.

[00:00:39] Speaker 01:
And the district court refused to enjoin them by adding limitations to the plain claim language that aren't there, and by clearly misinterpreting the evidence.

[00:00:50] Speaker 01:
So I'd like to start with the claim construction, because claim one

[00:00:53] Speaker 01:
is straightforward.

[00:00:54] Speaker 01:
It just recites an amorphous form of a compound and then defines the TVS complex.

[00:01:01] Speaker 04:
Amorphous is almost an amorphous term.

[00:01:04] Speaker 01:
Well, the district court recognized, and everyone agreed, this is at A20, the district court recognized that a person of skill in the art recognizes an amorphous form when they know, when they have it, and can discern it from other forms.

[00:01:17] Speaker 02:
So is it your view that if you've got everything entirely crystalline and you've just got traces of amorphous, that would bring you within the claim language?

[00:01:26] Speaker 01:
The amorphous part of what you described would infringe this claim, and that's consistent with this court's case law.

[00:01:31] Speaker 01:
Smith Klein says trace amounts of a drug substance will infringe a claim on that drug substance.

[00:01:39] Speaker 02:
Even assuming you were correct, and I don't know whether you are or not, the district court here made findings that are a review for abuse of discretion, including findings, as I understood them, that weighing the testimony of the experts, you hadn't established any amorphous, even amorphous traces.

[00:01:59] Speaker 01:
And the district court clearly erred in reaching that conclusion.

[00:02:02] Speaker 01:
And so, well, before you leave the claim construction, we would ask that you react

[00:02:06] Speaker 01:
correct and address the claim construction before next month's trial, because that's obviously better for everyone to do.

[00:02:11] Speaker 04:
The claim construction is predominantly, right?

[00:02:13] Speaker 04:
Predominantly amorphous?

[00:02:15] Speaker 01:
Yes, Your Honor.

[00:02:16] Speaker 01:
He added a predominance requirement to this claim that's just not supported by the intrinsic record or the claim language.

[00:02:22] Speaker 03:
And predominant, that's the error that you see in the construction?

[00:02:26] Speaker 01:
That's right.

[00:02:27] Speaker 01:
Because there's no need.

[00:02:28] Speaker 01:
Everybody agrees that a person of skill in the art can recognize when they have an amorphous form of TBS.

[00:02:33] Speaker 01:
There's no need to compare it to something else.

[00:02:35] Speaker 01:
Nothing in the claim language would support such a comparison.

[00:02:38] Speaker 02:
So does this cover Ernesto, the product?

[00:02:41] Speaker 02:
The product is crystalline, right?

[00:02:45] Speaker 01:
Our product in Tresto, we have not listed in this orange book, so we don't claim that we practiced this patent.

[00:02:52] Speaker 01:
But this court has made clear under Tribbo that you can get an injunction even if you don't practice a patent.

[00:02:57] Speaker 01:
But we do claim it's in their product.

[00:02:59] Speaker 02:
Can I ask you?

[00:03:00] Speaker 02:
I don't want to skip around too much if you have more to say on likelihood of success on the merits.

[00:03:04] Speaker 02:
But I don't understand irreparable harm if you're not practicing this claim doesn't practice the patent.

[00:03:11] Speaker 02:
Because all of your evidence about harm had to do with the effect on UNESCO and the market for UNESCO.

[00:03:20] Speaker 02:
that's not even listed here, an issue.

[00:03:22] Speaker 02:
Why is that evidence relevant to the irreparable harm inquiry?

[00:03:26] Speaker 01:
So because this court has held in Trebro that you don't need to practice the patent to show irreparable harm.

[00:03:32] Speaker 01:
And the reason we will have irreparable harm and the reason it's caused by their using our invention here is because they want to enter the market to compete head to head with Novartis in the market that we created using our invention of this patent.

[00:03:46] Speaker 01:
And this court has held that that is irreparable harm.

[00:03:50] Speaker 01:
We've, they're going to, they want to, to launch and use the under on the facts here.

[00:03:56] Speaker 02:
But the irreparable harm you say all goes to your seals of Ernesto.

[00:04:02] Speaker 01:
Oh, of Entresto.

[00:04:03] Speaker 01:
Entresto.

[00:04:03] Speaker 01:
That's okay.

[00:04:04] Speaker 01:
So the, the, um,

[00:04:06] Speaker 01:
But that's what they want to market, a competing product to entrust it.

[00:04:10] Speaker 01:
And the record shows that under the process that they propose to the FDA, they can't make their competing product without infringing the patent.

[00:04:19] Speaker 01:
The way that they've chosen to make their product, our evidence shows, is going to include amorphous TBS.

[00:04:24] Speaker 01:
So what they want to do is use the patent and invention in the 918 to

[00:04:29] Speaker 01:
to launch prematurely their generic product of Entresto to compete with us.

[00:04:34] Speaker 01:
And their generic product is going to include an amorphous TVS, which infringes this patent.

[00:04:39] Speaker 01:
And this court has held under those circumstances that it's a nexus, and we both have irreparable harm in the market for Entresto as a result of that.

[00:04:48] Speaker 04:
Now, the specification says that the invention may be in the crystalline, partly crystalline amorphous or polymorphous state.

[00:04:59] Speaker 04:
And so what is claimed is amorphous.

[00:05:03] Speaker 04:
In other words, not partly crystalline, crystalline, just amorphous.

[00:05:10] Speaker 01:
Exactly, Your Honor.

[00:05:11] Speaker 01:
And that's why there was no need to add any language to the claim.

[00:05:14] Speaker 01:
The claim is clear on its face.

[00:05:16] Speaker 01:
And claim two makes that point clear because claim two claims a pharmaceutical composition comprising.

[00:05:22] Speaker 01:
And so if there was a need to look out and look at some sort of hole,

[00:05:25] Speaker 01:
That shows that the claim one doesn't do that.

[00:05:27] Speaker 01:
The question is just, do you have amorphous TDS?

[00:05:30] Speaker 01:
And in claim two, also reinforces that amorphous TDS can be one component in another mixture, to your example, Judge Pros.

[00:05:36] Speaker 01:
And it would still infringe.

[00:05:37] Speaker 04:
The court found a lot of proof here.

[00:05:40] Speaker 04:
And isn't that based clearly around the standard?

[00:05:44] Speaker 01:
Well, once you correct the claim construction, Judge Lurie, his error on assessing the evidence is clear.

[00:05:51] Speaker 01:
Novartis is the only party that did tests.

[00:05:54] Speaker 01:
that could show whether or not their finished product contains amorphous TBS.

[00:05:58] Speaker 01:
The only one who tested the finished products for amorphous TBS, we found amorphous TBS.

[00:06:03] Speaker 01:
The district court faulted that for only one reason, and their expert shows that reason is wrong.

[00:06:09] Speaker 01:
And so I can walk you through where that is.

[00:06:13] Speaker 01:
So our expert did a ramen, tested their finished products, which is of course what we accuse of infringement.

[00:06:20] Speaker 01:
found amorphous TBS by doing what you need to do to look for amorphous TBS.

[00:06:25] Speaker 01:
He compared it to a reference spectrum for amorphous TBS.

[00:06:29] Speaker 04:
What were the facts shown here in terms of the percent amorphous?

[00:06:36] Speaker 01:
Well, we didn't dispute that there might be a small amount of amorphous, but as I said to Judge Prost, any amount of amorphous infringes this claim.

[00:06:44] Speaker 04:
One percent of amorphous and the rest crystalline would infringe?

[00:06:50] Speaker 01:
Well, that just proves why the district court's construction is wrong, because nothing the claim requires looking outside the context of what you're claiming is amorphous.

[00:06:59] Speaker 01:
But if you're getting to the district court's construction and are showing under the district court's construction, we also showed, and we were also the only ones that did the appropriate testing to answer the question, that their complex is not a complex at all.

[00:07:14] Speaker 04:
But the specification distinguishes amorphous from partially crystalline.

[00:07:20] Speaker 04:
So if the accused is only slightly amorphous, what is it mostly?

[00:07:28] Speaker 04:
Partially crystalline?

[00:07:30] Speaker 04:
But the spec indicates that's different from amorphous.

[00:07:33] Speaker 01:
So I think the spec actually shows something different, Your Honor, which is the spec actually shows that amorphous is its own thing.

[00:07:40] Speaker 01:
And the parties agree that partially crystalline includes both some amorphous and some crystalline.

[00:07:46] Speaker 01:
So with all you have to have.

[00:07:48] Speaker 04:
That's why the court said predominantly.

[00:07:50] Speaker 01:
But there's nothing to warrant reading that into the claim, Your Honor, because the claim requires only amorphous.

[00:07:56] Speaker 01:
And the spec recognizes that amorphous is a thing.

[00:07:58] Speaker 02:
Leaving amorphous aside, look at appendix 4 and 5 of the district court's opinion.

[00:08:03] Speaker 02:
I read this very long paragraph analyzing the details of both experts' opinions to conclude not that it meets the plain construction that the district court came up with, but the virus has not shown it's likely to succeed in proving MSM's product contains amorphous TBS.

[00:08:21] Speaker 02:
And that's the last sentence, too.

[00:08:23] Speaker 02:
I find Novartis has not met its burden likely to succeed in proving MSN's and ANDA products contain amorphous TBS.

[00:08:32] Speaker 02:
Why is it, unless you can show, you would agree, unless you can show clear error in those findings, you lose.

[00:08:39] Speaker 01:
And I can show clear error.

[00:08:40] Speaker 01:
So only our expert did the test for whether or not their final products have amorphous TBS.

[00:08:45] Speaker 01:
That was Dr. Matzker's testing.

[00:08:47] Speaker 01:
The district court, as you point out, Judge Prost, the only

[00:08:50] Speaker 01:
fault that the district court found with that testing was that he should have compared his Raman spectra to the reference spectra for MSN's isolated API.

[00:08:58] Speaker 01:
That's the only objection the district court had.

[00:09:03] Speaker 01:
That comparison would be beside the point, because our view is that it's not the API that has the amorphous.

[00:09:09] Speaker 01:
It's the finished products that we accuse, and it is created in the tabling process.

[00:09:15] Speaker 01:
But more importantly, MSN did the comparison that the district court was asking for.

[00:09:22] Speaker 01:
And that's the overlaid spectrum in our blue brief on 34.

[00:09:26] Speaker 01:
So on 34, so the top two lines are, the black line is Dr. Madder's test of their final tablets.

[00:09:43] Speaker 01:
And the red line is the reference spectra for amorphous TVS.

[00:09:46] Speaker 01:
And Dr. Maddox remarks through and said, these two things have the same peaks, the same fingerprint peaks for amorphous TVS.

[00:09:53] Speaker 01:
What the district court is saying is, oh, but you should have compared that to their reference spectra for amorphous TVS.

[00:09:59] Speaker 01:
Well, that's the blue line.

[00:10:00] Speaker 01:
So they made this comparison.

[00:10:02] Speaker 01:
And the blue line doesn't match the peaks for amorphous TVS.

[00:10:06] Speaker 01:
So if we had compared it, if you do compare it, it just bolsters our point.

[00:10:12] Speaker 01:
that the amorphous TBS Dr. Matsker found matches amorphous TBS and isn't like a mistake for their, but you don't have to take my word for it because their expert on paragraph 187 goes through the characteristic peaks and explains this.

[00:10:26] Speaker 01:
He catalogs the peaks and says, and he concludes at the end of that paragraph that their reference vector does not match the amorphous TBS reference vector.

[00:10:37] Speaker 03:
Were you, did you present any evidence of amorphous TVS as, as it specifically driving demand?

[00:10:46] Speaker 01:
So this court's cases on, on next, I get you're getting at Nexus are flexible and the, the, the, they, they, the way that they, the, what's driving demand is, is the product, the interest of generic, right?

[00:11:00] Speaker 01:
The interest of driving demand, the API.

[00:11:02] Speaker 01:
In order to make their product, as I was explaining earlier, do the process they've chosen in their ANDA, they are going to infringe this patent.

[00:11:11] Speaker 01:
So under this court's decision in Matera, they can't compete with us in the market without infringing our patent.

[00:11:19] Speaker 01:
They can't make the thing that consumers want, which is the drug, without infringing our patent.

[00:11:24] Speaker 01:
And that is sufficient nexus under this court's case law.

[00:11:29] Speaker 04:
You want to say something?

[00:11:30] Speaker 01:
I think I will.

[00:11:31] Speaker 01:
Thank you, Your Honor.

[00:11:33] Speaker 04:
Mr. Roccozi.

[00:11:36] Speaker 00:
Yes, Judge.

[00:11:37] Speaker 00:
William Roccozi again for MSN.

[00:11:39] Speaker 00:
This court can affirm the denial of the injunction without reaching the claim construction issue, precisely because it was a failure of proof.

[00:11:46] Speaker 00:
Novartis did not carry its burden of showing a likelihood that the product contains any amorphous TBS, regardless of construction.

[00:11:54] Speaker 02:
What do you say to the chart that Ms.

[00:11:56] Speaker 02:
I'm sorry.

[00:11:57] Speaker 02:
Excuse me.

[00:11:57] Speaker 02:
What do you say to the chart Ms.

[00:11:59] Speaker 02:
Maynard showed us on page 34 of the rule?

[00:12:01] Speaker 00:
Your honor, I would point you to Dr. Steed's testimony at 6945 through 55, where Dr. Steed testified that if you take a reference spectrum for the 4-mass crystalline complex, which everyone agrees is 100% crystalline.

[00:12:17] Speaker 00:
So regardless of the dispute of whether 4-mass is a complex or not, their expert in Novartis agrees that 4-mass is 100% crystalline.

[00:12:26] Speaker 00:
Dr. Steed took that and compared it to all of the ramen maps that their expert Dr. Matsker took.

[00:12:32] Speaker 00:
And he testified that every single region, including what you just saw, that he colored yellow and identified as amorphous, is actually crystalline material.

[00:12:41] Speaker 00:
Every single region.

[00:12:44] Speaker 00:
And that there was no amorphous found.

[00:12:46] Speaker 00:
Everything was consistent with and matched up with crystalline material.

[00:12:50] Speaker 00:
And so for that reason alone, the district court did not commit any error, much less clear error.

[00:12:55] Speaker 00:
Dr. Steed presented credible testimony that all of those regions where allegedly amorphous are crystalline.

[00:13:02] Speaker 00:
But beyond that, there's a lot more.

[00:13:05] Speaker 00:
Dr. McCreary testified that they didn't even have an amorphous TVS reference factor to use here.

[00:13:11] Speaker 00:
And I think that's important.

[00:13:12] Speaker 00:
We shouldn't lose sight of it.

[00:13:14] Speaker 00:
As your honor knows from this patent, there is absolutely nothing in here

[00:13:18] Speaker 00:
about analytical testing data or reference standards on amorphous TBS.

[00:13:22] Speaker 00:
There's absolutely nothing.

[00:13:23] Speaker 00:
So when you have a mixture that everybody agrees is almost 100% crystalline, you're looking for some minuscule amount working on the surface of a tablet somewhere.

[00:13:33] Speaker 00:
You need an amorphous fingerprint or reference vector so you know what you're looking at.

[00:13:37] Speaker 04:
Well, how about the fact that the district court added the word predominantly, which that's sort of a no-no, isn't it?

[00:13:45] Speaker 00:
Your Honor, that goes to the claim destruction this court doesn't need to reach.

[00:13:48] Speaker 00:
Because if there is an amorphous TBS, then it doesn't matter whether predominant is in the construction or not, number one.

[00:13:56] Speaker 00:
Number two, Novara's waived the right to challenge that.

[00:13:59] Speaker 04:
You're saying that it's all crystalline that we don't need to worry about predominantly.

[00:14:03] Speaker 00:
Correct.

[00:14:04] Speaker 00:
And the evidence showed we presented it.

[00:14:06] Speaker 02:
But you're about to go to trial.

[00:14:07] Speaker 02:
You're about to go to trial.

[00:14:09] Speaker 02:
Don't you think it's incumbent upon us to say something about the claims instruction if we think it's in error?

[00:14:15] Speaker 00:
Well, because I believe the evidence shows that it is all crystalline and it doesn't matter, then no, I don't believe you do.

[00:14:21] Speaker 00:
But more fundamentally, Your Honor, they waive the right to challenge that here.

[00:14:26] Speaker 00:
Judge Andrews specifically asked Novartis's counsel for this preliminary injunction hearing and for an appeal of my ruling

[00:14:33] Speaker 00:
You agree to my claim construction?

[00:14:35] Speaker 00:
They answered yes.

[00:14:36] Speaker 00:
This court should not allow them to turn around.

[00:14:38] Speaker 00:
Is that in the record?

[00:14:39] Speaker 00:
That is at A9127.

[00:14:42] Speaker 00:
Judge Andrews asked, quote, this injunction hearing and if there is an appeal by your side, the claim construction you accept?

[00:14:50] Speaker 00:
Question mark.

[00:14:51] Speaker 00:
Novartis counsel answered yes.

[00:14:53] Speaker 00:
So far as we're concerned, this court should not reach the claim construction.

[00:14:58] Speaker 00:
It doesn't need to.

[00:14:59] Speaker 00:
But again, it doesn't matter because the evidence showed a failure proof to show any amorphous in the product, which is enough to affirm.

[00:15:06] Speaker 00:
But to your point, Your Honor, on predominates, all the district court did was rightly reject this nonsensical notion that an amorphous solid form of a compound means several molecules of TVS sitting around on the surface of a tablet.

[00:15:21] Speaker 00:
that don't have long range order.

[00:15:23] Speaker 00:
There's nothing in this intrinsic evidence whatsoever that that's what Novartis somehow invented.

[00:15:29] Speaker 00:
As your honor pointed to, the specification makes clear.

[00:15:32] Speaker 00:
The solid state form of the compound comes in crystalline, partially crystalline, and amorphous.

[00:15:36] Speaker 00:
Everybody agrees, crystalline and amorphous are distinct mutually exclusive forms.

[00:15:41] Speaker 00:
And even if there could be overlap with partially crystalline, all the judge did was make clear that the skilled person would need to distinguish those two and could easily do that by looking to predominantly amorphous.

[00:15:54] Speaker 00:
The file history or the prosecution history is consistent.

[00:15:57] Speaker 00:
Novartis made clear, crystalline and amorphous are different, they have different properties.

[00:16:01] Speaker 00:
That only makes sense if the amorphous form predominates.

[00:16:05] Speaker 00:
You can't say that several molecules of TBS on the surface of a tablet demonstrates new properties.

[00:16:11] Speaker 00:
So even under the claim construction, which you don't need to reach, we submit the district court was correct on the law, and there's no clear error on that physical mixture issue either.

[00:16:23] Speaker 00:
Again, Dr. Steed testified credibly

[00:16:26] Speaker 00:
That Form S is a crystalline complex, not a mixture.

[00:16:29] Speaker 00:
He looked at Raman.

[00:16:30] Speaker 00:
He looked at IR.

[00:16:31] Speaker 00:
He looked at XRPD.

[00:16:32] Speaker 00:
He looked at DSC.

[00:16:33] Speaker 00:
Novartis has no answer to that, much less being able to prove that there was clear error.

[00:16:39] Speaker 00:
So whether the claim construction stands or not, the injunction should be affirmed as properly denied.

[00:16:48] Speaker 00:
But I want to get back to the amorphous TVS point, Your Honor, and why the claim construction doesn't matter.

[00:16:53] Speaker 00:
Judge Seed testified again.

[00:16:54] Speaker 00:
The product is all crystalline according to the proper testing comparison.

[00:16:59] Speaker 00:
But number two, they didn't have an amorphous fingerprint.

[00:17:02] Speaker 00:
If you're searching for a few molecules... There's no dispute in the record to what you're saying?

[00:17:08] Speaker 00:
No, Your Honor.

[00:17:08] Speaker 00:
That's the whole point.

[00:17:10] Speaker 00:
Our expert, Dr. McCreary, submitted credible expert testimony

[00:17:14] Speaker 00:
that what they have and what they're claiming to use as an amorphous reference vector is not actually a reference vector for amorphous TBS.

[00:17:22] Speaker 00:
It was generated because the patent doesn't have one.

[00:17:26] Speaker 00:
Novartis had to run out and try and generate one and make that glassy solid an example one.

[00:17:31] Speaker 00:
Our expert, Dr. Mercuri, testified

[00:17:33] Speaker 00:
that their expert, Dr. Park, who claimed to have generated this reference spectra, she didn't follow example one.

[00:17:39] Speaker 00:
She used protocols not in there.

[00:17:41] Speaker 03:
The reference spectra... It's not that they didn't present any evidence, it's that they presented evidence that she think is not credible.

[00:17:48] Speaker 00:
That the district court found not credible, Your Honor, and that's the whole point of the burdens on a preliminary injunction.

[00:17:55] Speaker 00:
It's their burden alone

[00:17:57] Speaker 00:
to show a likelihood of proving success on the merits.

[00:18:00] Speaker 00:
MSN, to an extent, has any burden at all.

[00:18:02] Speaker 00:
If they put forward substantial evidence of non-infringement, then the injunction needs to be denied.

[00:18:07] Speaker 00:
That's the appropriate... I'm sorry, Judge, I didn't mean to interrupt you.

[00:18:10] Speaker 04:
Well, thanks for your sentence.

[00:18:12] Speaker 04:
No, I hadn't said anything yet.

[00:18:14] Speaker 00:
OK.

[00:18:16] Speaker 00:
If we present substantial evidence of non-infringement, which we did through Dr. Steed and Dr. McCreary, that the product's all crystalline and that they didn't even have an amorphous reference spectrum, then that is more than enough to deny the injunction.

[00:18:29] Speaker 00:
And that's what the court found.

[00:18:30] Speaker 00:
The court found that Dr. Steed's testimony undermines their theory that there's any amorphous TBS and that Dr. Steed's testing invalid criticism.

[00:18:39] Speaker 00:
They were valid criticisms of the rest of the evidence.

[00:18:42] Speaker 00:
That's enough to deny the injunction.

[00:18:45] Speaker 04:
Now, you're not on the market now, even though the preliminary injunction was denied.

[00:18:52] Speaker 04:
And that was due to our stay and the existence, well,

[00:19:00] Speaker 04:
The existence of the other patent, which was partly upheld.

[00:19:12] Speaker 04:
It's now not obvious.

[00:19:14] Speaker 04:
It was invalid for written description.

[00:19:17] Speaker 00:
Correct.

[00:19:19] Speaker 00:
And this court issued injunctions or stays in both appeals.

[00:19:23] Speaker 02:
And you also have this DC Circuit issue going.

[00:19:25] Speaker 00:
That has been lifted.

[00:19:26] Speaker 02:
And that's been lifted.

[00:19:27] Speaker 02:
And the district court has ruled in your favor or against in favor of the FDA.

[00:19:33] Speaker 02:
And I presume that's on appeal, but there's no stay.

[00:19:37] Speaker 00:
Correct.

[00:19:37] Speaker 00:
The DC Circuit has lifted the stays.

[00:19:39] Speaker 00:
So MSN, as we sit here today, it has final approval.

[00:19:43] Speaker 00:
It has prepared to launch.

[00:19:44] Speaker 00:
The only thing holding it up are this court's injunctions.

[00:19:48] Speaker 03:
You're arguing that we should not address claim construction, right?

[00:19:54] Speaker 03:
That we don't have to.

[00:19:55] Speaker 00:
Correct.

[00:19:56] Speaker 03:
You don't need to.

[00:19:57] Speaker 03:
What's the danger of us doing that, not addressing it, and then it becoming a big issue at trial or, you know, the parties are here before this court after trial with the claim construction?

[00:20:11] Speaker 00:
Well, I wouldn't say it's a danger, Your Honor, because my friend has to prove amorphous TVS regardless at trial.

[00:20:19] Speaker 00:
We don't believe they can do that.

[00:20:21] Speaker 00:
And so regardless of the construction, we believe the evidence will show at trial that in fact MSN does not infringe because it doesn't have any amorphous TVS.

[00:20:29] Speaker 00:
So construction won't be an issue at trial?

[00:20:32] Speaker 00:
Not based on our evidence and our position, Your Honor.

[00:20:35] Speaker 00:
Because whether it predominates or not, our position is, as Dr. Steed and Dr. McCurry testified here, there is no amorphous in the product at all, regardless of construction.

[00:20:45] Speaker 00:
And so that's why the district court properly denied the injunction.

[00:20:48] Speaker 00:
There was no clear error.

[00:20:50] Speaker 02:
Yes, Judge McCurry.

[00:20:50] Speaker 02:
What about irreparable injury?

[00:20:52] Speaker 02:
Do you agree with your friend's analysis in terms of my question about how odd I think this case is because the product that we're dealing with here is not listed in connection with this patent?

[00:21:04] Speaker 00:
I respectfully do not agree with my friend, Your Honor.

[00:21:08] Speaker 00:
We are talking about an amorphous solid form patent that no one practices.

[00:21:12] Speaker 00:
Novartis doesn't commercialize it.

[00:21:14] Speaker 00:
We're talking about an infringement theory that at best, at best we're talking about a product or a tablet that is all crystalline with some tiny, barely detectable amount of amorphous working on the surface of the tablet somewhere.

[00:21:27] Speaker 00:
They have to show a nexus or a link between that feature of amorphous

[00:21:31] Speaker 00:
and the alleged infringement or some demand.

[00:21:34] Speaker 02:
And I would, I would submit- The product they're talking about in terms of comparing or arguing for irreparable injury is a product that's like the one you're going to launch, right?

[00:21:46] Speaker 00:
Which is a hundred percent crystalline, not amorphous.

[00:21:49] Speaker 00:
And if no one in their right mind, I would submit to be candid, would purchase MSN's product or any other product because there's a few molecules of amorphous TBS working on the surface of the tablet.

[00:22:00] Speaker 04:
But one doesn't have to be selling the patented product to obtain damages from someone else's infringement.

[00:22:09] Speaker 04:
We held in bank, accordingly, in right height many years ago.

[00:22:15] Speaker 04:
And the question is whether the accused causes damages to what the patentee has said, whether the patentee is damaged by someone infringing.

[00:22:29] Speaker 00:
I would add to that, Your Honor, I know Novartis talks it down and they want to dismiss it.

[00:22:35] Speaker 00:
They still have the burden, Novartis alone, to show some nexus between the alleged harm and the alleged infringement.

[00:22:43] Speaker 00:
And that means showing that there is some evidence somewhere hiding that there's some demand that this trace amount of amorphous would somehow drive demand in this product.

[00:22:54] Speaker 00:
And the record is bereft.

[00:22:56] Speaker 00:
There is no evidence whatsoever.

[00:22:58] Speaker 00:
of any nexus or connection between that amorphous feature and the product we're going to sell, which we believe is 100% crystalline, but even under their theory, it's 99.9999% crystalline with some trace amount.

[00:23:12] Speaker 00:
That is no nexus we would submit.

[00:23:15] Speaker 00:
But beyond that, Your Honor, on harm, again, the district court made fact findings, which we believe are not clearly erroneous on the fact that the harms they allege are all quantifiable.

[00:23:25] Speaker 00:
The district court credited our expert, Dr. McDuff, over theirs, that things like lost sales, market share profits, price erosion are all quantifiable.

[00:23:33] Speaker 00:
The court can affirm denial on that basis as well.

[00:23:37] Speaker 00:
Beyond that, the district court held the other claims were speculative.

[00:23:42] Speaker 04:
And that... This is a $3 billion product.

[00:23:45] Speaker 04:
And if a competitor wrongfully went on the market even for two months, that's a lot of money.

[00:23:54] Speaker 04:
And the market price for the product never comes up.

[00:23:59] Speaker 00:
Actually, our expert disputed that, Your Honor.

[00:24:02] Speaker 00:
And the district court was entitled to credit that.

[00:24:04] Speaker 00:
Dr. McDuff testified that the damages Novartis is asserting here are overstated, but even to the extent they're not, they're still quantifiable with typical standard damages models, that forecasting difficulties are overstated.

[00:24:19] Speaker 04:
But you're saying we don't need to go there.

[00:24:21] Speaker 00:
You do not need to go there, Your Honor.

[00:24:23] Speaker 04:
This injunction... Because there's no proof of infringement.

[00:24:26] Speaker 00:
Exactly, Your Honor.

[00:24:27] Speaker 00:
But if the court wants to reach irreparable harm, we believe there's no clear error in any of those findings as well, because damages are quantifiable.

[00:24:37] Speaker 00:
We submit there's no evidence of any required nexus.

[00:24:40] Speaker 00:
Other harms such as reduced investments are speculative, haven't been proven.

[00:24:45] Speaker 00:
And this whole idea of laying this generic jailbreak idea at MSN's feet, because Novartis may or may not let other companies into the market,

[00:24:53] Speaker 00:
That doesn't transform into harm.

[00:24:55] Speaker 00:
None of those findings from the district court are error.

[00:24:58] Speaker 00:
So before I relinquish the podium to my friend, I would like again to request the balance of harms here, we believe, tips decidedly in favor of MSN.

[00:25:08] Speaker 00:
Again, the district court's already found there will be no reprehensible harm.

[00:25:11] Speaker 00:
We submit Novartis has not shown a substantial likelihood of success on appeal.

[00:25:16] Speaker 00:
That means we're left with MSN that is devoted substantial time, money, and effort to preparing to launch

[00:25:23] Speaker 00:
a lower price generic medicine for patients.

[00:25:27] Speaker 00:
Final FDA approval is here.

[00:25:29] Speaker 00:
The only thing holding that up are this court's injunctions.

[00:25:32] Speaker 00:
We respectfully request those be lifted as soon as possible.

[00:25:36] Speaker 00:
And again, that the court reach a decision on the merits in expedited fashion.

[00:25:41] Speaker 04:
Thank you, counsel.

[00:25:42] Speaker 00:
Thank you, judge.

[00:25:43] Speaker 04:
Ms.

[00:25:43] Speaker 04:
Maynard has a little bit of time.

[00:25:46] Speaker 01:
Thank you, Your Honor.

[00:25:47] Speaker 01:
So on the claim construction, we expressly preserved this issue.

[00:25:50] Speaker 01:
Judge Prost, I invite you to look at the full colloquy.

[00:25:52] Speaker 01:
He only read you part of it.

[00:25:54] Speaker 02:
In the pages he showed us, you say you preserved it for appeal, but your lawyer or your attorney said that for purposes of the P.I., we'll accept the claim construction.

[00:26:05] Speaker 01:
I think in context, Your Honor, what he's saying is, yes, we're applying your construction now in front of you, which is what always happens.

[00:26:12] Speaker 01:
Because just like we will in the trial next month, if you all don't fix it, which is we have to go forward in the district court, and then we come up here.

[00:26:22] Speaker 01:
He expressly preserved the right to appeal.

[00:26:24] Speaker 01:
And to the extent you think it's ambiguous, there would be no reason to do that.

[00:26:29] Speaker 01:
So it makes no sense to read it that way.

[00:26:32] Speaker 01:
And this court often addresses claim construction when it's necessary, as it is here, to a proper ruling on the PI.

[00:26:38] Speaker 01:
And we think you should do that.

[00:26:39] Speaker 01:
On his evidence, again, only on the presence of amorphous, only Novartis did the testing.

[00:26:46] Speaker 01:
What he's pointing to with Dr. Steed, Dr. Steed says at most that he's talking about the cyan maps, the blue maps, at most that shows that their final product is predominantly their form SAPI, whatever that is.

[00:27:01] Speaker 01:
It can't show and doesn't show a lack of amorphous.

[00:27:04] Speaker 01:
And Dr. Steed admits, and this is it,

[00:27:07] Speaker 01:
at A6950 to 57, that all it shows is predominantly, and that the lighter blue regions are something else.

[00:27:16] Speaker 01:
And Dr. Masker showed, so it can't show that there's no amorphous.

[00:27:20] Speaker 01:
And then I invite you to look, he pointed you to some Dr. C paragraphs, but the paragraph that shows you that the only reason, so he's trotting out reasons the district court did not accept, and I can tick through those, but the only reason the district court gave was that we

[00:27:37] Speaker 01:
we should have compared our ROM inspector for amorphous to their.

[00:27:41] Speaker 01:
And that's the picture that I showed you.

[00:27:44] Speaker 01:
And at paragraphs 186 to 187, Dr. Steed, their expert, goes through and catalogs those peaks in that figure in our brief.

[00:27:53] Speaker 01:
And he concludes with the sentence, simply put, none of the peaks, and he means of their API, actually match the alleged amorphous TBS as claimed by Dr. Masker.

[00:28:03] Speaker 01:
Well, that proves our point.

[00:28:04] Speaker 01:
that what Dr. Matsker found is not their API, it's the amorphous reference.

[00:28:09] Speaker 03:
Does that statement prove or show that there is amorphous TBS, the presence of?

[00:28:18] Speaker 01:
So when you put the evidence together, what it does is show that the disreport clearly aired in concluding that comparing what we found as amorphous reference spectra to their API would not support

[00:28:35] Speaker 01:
it supports us because it shows that what we found is not their API.

[00:28:39] Speaker 01:
It is amorphous TBS.

[00:28:42] Speaker 01:
And he's challenging Dr. Park's amorphous reference spectrum, but the judge didn't make findings about that.

[00:28:48] Speaker 01:
In fact, the same district court held a trial on this patent earlier and concluded after hearing similar complaints about Dr. Park's reference spectrum that she had, in fact, made an amorphous glassy solid in accordance with example one.

[00:29:04] Speaker 01:
And that's the district court's findings in that previous trial are right on the record at A3534.

[00:29:09] Speaker 01:
So on the irreparable harm point, this is not a piece in an iPhone.

[00:29:19] Speaker 01:
This is a pharmaceutical product where we created this market.

[00:29:25] Speaker 01:
They're using the ANDA process to try to launch their product, to compete against our product, our blockbuster product.

[00:29:33] Speaker 01:
It will, and the district court aired in the irreparable harm analysis because he set aside harms that, he just didn't address them, harms that this court has recognized are irreparable, including permanent price erosion, lost market share, and this is a growing market.

[00:29:50] Speaker 01:
The evidence shows that, in trust of, new indications are coming out, new patients are being served

[00:29:56] Speaker 01:
And we're the ones educating clinicians, educating patients.

[00:30:01] Speaker 01:
And if they are allowed to launch, even for a short period before they should, that will cause harm that can't be put back in the bottle.

[00:30:08] Speaker 04:
Thank you, counsel.

[00:30:09] Speaker 01:
Thank you, your honor.

[00:30:10] Speaker 01:
May I make one housekeeping request in response to his?

[00:30:14] Speaker 01:
If you do lift the injunctions in both, we would request 48 hours to seek further relief.

[00:30:18] Speaker 01:
Thank you, your honor.

[00:30:19] Speaker 04:
I could say both arguments have been crystalline and not amorphous.

[00:30:25] Speaker 04:
But I don't carry that further.

[00:30:26] Speaker 04:
The case is submitted.

[00:30:27] Speaker 04:
Thank you very much.