NOVARTIS PHARMACEUTICALS CORPORATION v. MSN PHARMACEUTICALS, INC. — Oral Argument

0:00 Judge Lourie Our next case is Novartis v. MSN, 2024, 22-11.

0:08 Ms. Maynard.

0:10 Appellant Attorney (Deanne E. Maynard) Thank you, Your Honor.

0:12 May it please the Court again?

0:13 My name is Deanne Maynard.

0:15 I'd like to reserve three minutes for rebuttal.

0:17 So this preliminary injunction appeal involves the 918 patent,

0:21 which claims an amorphous complex, which is called TVS for short.

0:25 Judge Lourie Now, this case is going to trial in a few weeks.

0:28 Appellant Attorney (Deanne E. Maynard) Yes, sir.

0:28 However, December 9th, the trial starts on December 9th.

0:31 The patent has, as we mentioned earlier, two years of life left,

0:35 yet MSN wants to launch before next month's trial prematurely.

0:39 And the district court refused to enjoin them by adding limitations to the plain,

0:44 plain language that aren't there and by clearly misinterpreting the evidence.

0:49 So I'd like to start with the claim construction, because claim one is straightforward.

0:54 It just recites an amorphous form of a compound

0:57 and then defines the claim.

1:00 Judge Lourie The amorphous is almost an amorphous term.

1:04 Appellant Attorney (Deanne E. Maynard) Well, the district court recognized, and everyone agreed, this is at A20,

1:08 the district court recognized that a person of skill in the art recognizes an amorphous form

1:13 when they know, when they have it, and can discern it from other forms.

1:17 Judge Prost So is it your view that if you've got everything entirely crystalline

1:20 and you've just got traces of amorphous, that would bring you within the claim language?

1:25 Appellant Attorney (Deanne E. Maynard) The amorphous part of what you described,

1:28 and that's consistent with this court's case law,

1:31 Smith Klein says trace amounts of a drug substance will infringe a claim on that drug substance.

1:37 Judge Prost Well, even assuming you were correct, and I don't know whether you are or not,

1:43 the district court here made findings that are reviewed for abuse of discretion,

1:48 including findings, as I understood them, that weigh in the testimony of the experts.

1:54 You hadn't established any amorphous, even amorphous traces.

1:58 Appellant Attorney (Deanne E. Maynard) And the district court clearly erred in reaching that conclusion.

2:01 And so, well, before you leave the claim construction,

2:04 we would ask that you correct and address the claim construction before next month's trial,

2:08 because that's obviously, like, better for everyone.

2:10 Judge Lourie The claim construction is predominantly, right, predominantly amorphous?

2:15 Appellant Attorney (Deanne E. Maynard) Yes, Your Honor.

2:16 He added a predominance requirement to this claim that's just not supported by the intrinsic record or the claim language.

2:22 Judge Reyna And predominant, that's the error that you see in the construction?

2:26 Appellant Attorney (Deanne E. Maynard) That's right.

2:27 That's right.

2:27 Because he, he, he, there's no need.

2:28 Everybody agrees that a person of skill in the art can recognize when they have an amorphous form of TBS.

2:33 There's no need to compare it to something else.

2:35 Nothing in the claim language would support such a comparison.

2:38 Judge Prost But does this cover Ernesto, the product?

2:41 The product is crystalline, right?

2:45 Appellant Attorney (Deanne E. Maynard) Our product, Ernesto, we have not listed in this orange book, so we don't claim that we practice this patent.

2:52 But this court has made clear under TRIBO that you can get an injunction even if you don't practice a patent.

2:57 But we do claim it's in their product.

2:58 Judge Prost Can I ask you, just, I don't want to skip around too much if you have more to say on likelihood of success on the merits.

3:04 But I don't understand irreparable harm if you're not practice, if you're not practice, this claim doesn't practice the patent.

3:11 Because all of your evidence about harm had to do with the effect on Ernesto and the market for Ernesto.

3:18 And that's, it's, that's not even listed here in issue.

3:22 Why is that evidence relevant to the irreparable harm inquiry?

3:26 Appellant Attorney (Deanne E. Maynard) So, because this court has held in TRIBO.

3:28 That you don't need to practice the patent to show irreparable harm.

3:31 And the reason we will have irreparable harm and the reason they're, it's caused by their using our invention here is because they're going to, 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.

3:46 And this court has held that, that, that is irreparable harm.

3:49 We've, they're going to, they want to, to launch and use the, under, on the facts here.

3:56 Judge Prost But the irreparable harm you say all goes.

3:58 It goes to your sales of Ernesto.

4:02 Appellant Attorney (Deanne E. Maynard) Of Entresto.

4:03 Entresto, I'm sorry.

4:03 Yeah, that's okay.

4:04 So, the, the, the harm, but that's what they want to market, a competing product to Entresto.

4:10 And, and the record shows that under the process that they proposed to the FDA, they can't make their competing product without infringing the patent.

4:18 The way that they've chosen to make their product, our evidence shows, is going to include amorphous TBS.

4:23 So, what they want to do is use the patent and invention in the 918 to, to, to.

4:29 To, to launch prematurely their generic product of Entresto to compete with us.

4:34 And their generic product is going to include an amorphous TBS, which infringes this patent.

4:39 And this court has held, held under those circumstances that we, we, we both have, it's a nexus and we both have irreparable harm in the market for Entresto as a result of that.

4:48 Judge Lourie Now, the specification says that the invention may be in the crystalline, partly crystalline, amorphous or polymorphous state.

4:59 And so, what is claimed is amorphous.

5:02 In other words, not partly crystalline, crystalline, just amorphous.

5:10 Appellant Attorney (Deanne E. Maynard) Exactly, Your Honor.

5:11 And that, that's why there was no need to add any language to the claim.

5:14 The claim is clear on its face.

5:15 And claim two makes that point clear because claim two claims a pharmaceutical composition comprising.

5:21 And so, if there was a need to look out and look at some sort of hole, that shows, you know, that the claim one doesn't do that.

5:27 The question is just, do you have amorphous TBS?

5:29 And in claim two, also reinforces that amorphous TBS can be one component in another mixture, to your example, Judge Prost, and it would still infringe.

5:37 Judge Lourie The, the court found a lack of proof here.

5:39 And isn't, isn't that based, clearly erroneous standard?

5:44 Appellant Attorney (Deanne E. Maynard) Well, once you correct the claim construction, Judge Lurie, his error on assessing the evidence is clear.

5:51 Novartis is the only party that did tests that could show whether or not their finished product contains amorphous TBS.

6:00 We found amorphous TBS.

6:03 The district court faulted that for only one reason, and their expert shows that reason is wrong.

6:08 And so, I, I, I can walk you through where that is.

6:13 So, so our expert did a Raman, tested their finished products, which is, of course, what we accuse of infringement,

6:19 and found amorphous TBS by, by doing what you, what you need to do to look for amorphous TBS,

6:25 and compared it to a reference spectrum for amorphous TBS.

6:29 Judge Lourie Okay.

6:29 What are the facts shown here in terms of the percent amorphous?

6:35 Appellant Attorney (Deanne E. Maynard) Well, we don't, we didn't dispute that, that there might be a small amount of amorphous,

6:40 but as I said to Judge Prost, any amount of amorphous infringes this claim.

6:44 Judge Lourie One percent of amorphous and the rest crystalline would infringe?

6:48 Appellant Attorney (Deanne E. Maynard) Well, so, under, well, that just proves why the district court's construction is wrong,

6:53 because nothing the claim requires like looking at outside the context of what you're, what you're claiming is amorphous.

6:58 But, but if you're...

7:00 If you're getting, if you're getting to the district court's construction and are showing under the district court's construction,

7:04 we also showed, and we were also the only ones that did the appropriate testing to answer the question,

7:08 that their complex is not a complex at all.

7:12 Their...

7:13 Judge Lourie But, but the specification distinguishes amorphous from partially crystalline.

7:20 So, if this is only, the accused is only slightly amorphous, what is it mostly?

7:28 Partially crystalline?

7:30 But the spec indicates that's different from amorphous.

7:33 Appellant Attorney (Deanne E. Maynard) So, the, but the spec, I think the spec actually shows something different, Your Honor,

7:37 which is the spec actually shows that amorphous is its own thing,

7:40 and the parties agree that partially crystalline includes both some amorphous and some crystalline,

7:45 so to answer, so, but all you have to have...

7:47 Judge Lourie That's why the court said predominantly.

7:50 Appellant Attorney (Deanne E. Maynard) Well, but that, there's nothing to warrant reading that into the claim, Your Honor,

7:53 because the claim requires only amorphous, and the spec recognizes that amorphous is a thing.

7:58 Judge Prost Leaving amorphous aside,

8:00 look at Appendix 4 and 5 of the District Court's opinion.

8:02 I read this very long paragraph analyzing the details of both experts' opinions

8:08 to conclude not that it meets the claim construction that the District Court came up with,

8:14 but Novartis has not shown it's likely to succeed in proving MSM's product contains amorphous TBS.

8:20 And that's the last sentence, too.

8:22 I found, I find Novartis has not met its burden likely to succeed in proving MSM's and ANDA products,

8:30 but Novartis has not met its burden likely to succeed in proving MSM's and ANDA products.

8:31 Why is it, unless you can show, you would agree,

8:34 unless you can show clear error in those findings, you lose.

8:38 Appellant Attorney (Deanne E. Maynard) And I can show clear error.

8:40 So only our expert did the test for whether or not their final products have amorphous TBS.

8:45 That was Dr. Matsker's testing.

8:47 The District Court, as you point out, Judge Prost,

8:49 the only fault that the District Court found with that testing was

8:52 that he should have compared his Raman spectra to the reference spectra for MSM's isolated API.

8:58 That's the only objection.

9:00 That objection would be, that test would be, that comparison would be beside the point

9:05 because our view is that it's not the API that has the amorphous,

9:09 it's the finished products that we accuse.

9:11 And it ends up in their, it is created in the tabling process.

9:14 So, but even, but more importantly, MSM did the comparison that the District Court was asking for.

9:21 And so, and that's the overlaid spectrum in our blue brief on 34.

9:32 So, on 34.

9:33 So, the top two lines are, the black line is Dr. Matsker's test of their final tablets.

9:42 And the red line is the reference spectra for amorphous TBS.

9:46 And Dr. Matsker marched through and said these two things have the same peaks,

9:50 the same fingerprint peaks for amorphous TBS.

9:53 What the District Court is saying is, oh, but you should have compared that

9:56 to their reference spectra for amorphous TBS.

9:58 Well, that's the blue line.

10:00 So, they made this comparison.

10:02 And their, the blue line is the reference spectra for amorphous TBS.

10:03 The blue line doesn't match the peaks for amorphous TBS.

10:06 So, if we had compared it, if we, you know, if you do compare it,

10:10 it just bolsters our point that the amorphous TBS Dr. Matsker found matches amorphous TBS

10:16 and isn't like a mistake for their, but you don't have to take my word for it.

10:20 Because their expert on paragraph 187 goes through the characteristic peaks and explains this.

10:26 He catalogs the peaks and says, and he concludes at the end of that paragraph

10:32 that their reference spectra for amorphous TBS is the same as their reference spectra for amorphous TBS.

10:33 And he concludes at the end of that paragraph that their reference spectra does not match the amorphous TBS reference spectra.

10:37 Judge Reyna Were you, did you present any evidence of amorphous TBS as, as a specifically driving demand?

10:46 Appellant Attorney (Deanne E. Maynard) So, this court's cases on, on NEX, I get you're getting at NEXUS, are, are flexible.

10:51 And the, the, the, they, they, the way that they, the what's driving demand is, is the product,

10:58 the interest of generic, right?

11:00 The interest of driving demand, the API.

11:02 Right.

11:03 Right.

11:04 Their product, as I was explaining earlier, do the process they've chosen in their ANDA,

11:09 they are going to infringe this patent.

11:11 So, under this court's decision in Natera, they can't, they can't compete with us in the market without infringing our patent.

11:18 They can't make the thing that consumers want, which is the drug, without infringing our patent.

11:23 And that is sufficient NEXUS under this court's case law.

11:28 unknown So.

11:29 Judge Lourie You want to say something?

11:30 I, I think I will.

11:31 Appellant Attorney (Deanne E. Maynard) Thank you, Your Honor.

11:32 Okay.

11:33 Judge Lourie Mr. McCosey.

11:35 Appellee Attorney (William A. Rakoczy) Yes, Judge.

11:36 William McCosey.

11:37 McCosey again for MSN.

11:38 This court can affirm the denial of the injunction without reaching the claim construction issue,

11:43 precisely because it was a failure of proof.

11:46 Novartis did not carry its burden of showing a likelihood that the product contains any

11:50 amorphous TBS, regardless of construction.

11:54 Judge Prost What do you say to the chart that Ms., I'm sorry.

11:56 Excuse me.

11:57 What did you say, what do you say to the chart Ms. Maynard showed us on page 34 of the movie?

12:01 Appellee Attorney (William A. Rakoczy) Your Honor, I would point you to Dr. Steed's testimony at 6945.

12:07 55, where Dr. Steed testified that if you take a reference spectrum for the 4MAS crystalline

12:13 complex, which everyone agrees is 100% crystalline, so regardless of the dispute of whether 4MAS

12:19 is a complex or not, their expert in Novartis agrees that 4MAS is 100% crystalline.

12:26 Dr. Steed took that and compared it to all of the Raman maps that their expert, Dr. Matzker,

12:31 took.

12:31 And he testified that every single region, including what you just saw, that he colored

12:37 yellow and identified as amorphous is actually crystalline material, every single region.

12:43 And that there was no amorphous found, everything was consistent with and matched up with crystalline

12:49 material.

12:50 And so for that reason alone, the district court did not commit any error, much less

12:54 clear error.

12:55 Dr. Steed presented incredible testimony that all of those regions that were allegedly

13:00 amorphous are crystalline.

13:02 But beyond that, there's a lot more.

13:05 Dr. McCreary testified.

13:07 They didn't even have an amorphous TVS reference vector to use here.

13:11 And I think that's important.

13:12 We shouldn't lose sight of it.

13:14 As your honor knows from this patent, there's absolutely nothing in here about analytical

13:18 testing data or reference standards on amorphous TVS.

13:22 There's absolutely nothing.

13:23 So when you have a mixture that everybody agrees is almost 100% crystalline, you're

13:28 looking for some minuscule amount working on the surface of a tablet somewhere.

13:33 You need an amorphous fingerprint or reference vector so you know what you're looking.

13:37 Judge Lourie Well, how about the fact that the district court added the word predominantly, which

13:43 that's sort of a no-no, isn't it?

13:45 Appellee Attorney (William A. Rakoczy) Well, your honor, that goes to the claim instruction this court doesn't need to reach because if

13:49 there is an amorphous TBS, then it doesn't matter whether predominant is in the construction

13:54 or not, number one.

13:55 Number two, Novara's waived the right to challenge that.

13:59 Judge Lourie You're saying that it's all crystalline that we don't need to worry about predominantly.

14:03 Appellee Attorney (William A. Rakoczy) Correct.

14:03 And the evidence showed we presented...

14:05 Judge Prost They're about to go to trial.

14:07 Well, you're about to go to trial.

14:09 Don't you think it's incumbent upon us to say something about the claim construction

14:12 if we think it's in error?

14:14 Appellee Attorney (William A. Rakoczy) Well, because I believe the evidence shows that it is all crystalline and it doesn't

14:19 matter, then no, I don't believe you do.

14:21 But more fundamentally, your honor, they waived the right to challenge that here.

14:26 Judge Andrews specifically asked Novara's counsel, for this preliminary injunction hearing

14:30 and for an appeal of my ruling, you agree to my claim construction.

14:34 They answered yes.

14:35 Yes.

14:36 This court should not allow them to turn around...

14:38 Is that in the record?

14:39 That is at A9127.

14:42 Judge Andrews asked, quote, this injunction hearing and if there is an appeal by your

14:47 side, the claim construction you accept, question mark.

14:51 Novara's counsel answered yes.

14:54 So far as we're concerned, this court should not reach the claim construction.

14:57 It doesn't need to.

14:58 But again, it doesn't matter because the evidence showed a failure proof to show any amorphous

15:03 in the product, which is enough to affirm.

15:05 But to your point, your honor, on predominates, all the district court did was rightly reject

15:12 this nonsensical notion that an amorphous solid form of a compound means several molecules

15:18 of TVS sitting around on the surface of a tablet that don't have long range order.

15:23 There's nothing in this intrinsic evidence whatsoever that that's what Novara somehow

15:27 invented.

15:28 As your honor pointed to, the specification makes clear, the solid state form of the compound

15:33 comes in crystalline, partially crystalline.

15:36 Everybody agrees, crystalline and amorphous are distinct, mutually exclusive forms.

15:41 And even if there could be overlap with partially crystalline, all the judge did was make clear

15:46 that the skilled person would need to distinguish those two and could easily do that by looking

15:51 to predominantly amorphous.

15:54 The file history or the prosecution history is consistent.

15:56 Novara's made clear crystalline and amorphous are different.

15:59 They have different properties.

16:00 That only makes sense if the amorphous form predominates.

16:04 You can't say.

16:05 It's several molecules of TVS on the surface of a tablet demonstrates new properties.

16:11 So even under the claim construction, which you don't need to reach, we submit that this

16:17 report was correct on the law.

16:18 And there's no clear error on that physical mixture issue either.

16:22 Again, Dr.

16:23 Steen testified credibly that form S is a crystalline complex, not a mixture.

16:29 He looked at Raman.

16:29 He looked at IR.

16:30 He looked at XRPD.

16:32 He looked at DSC.

16:33 Novartis has no answer to that.

16:36 Much less being able to prove that there was clear error.

16:39 So whether the claim construction stands or not, the injunction should be that are affirmed

16:45 as properly denied.

16:47 But I want to get back to the amorphous TVS point, Your Honor, and why the claim construction

16:51 doesn't matter.

16:52 Judge Steen testified again, the product is all crystalline according to the proper test

16:58 and comparison.

16:58 But number two, they didn't have an amorphous fingerprint.

17:02 If you're searching for a few molecules.

17:04 There's no dispute in the record.

17:05 Do you agree to what you're saying?

17:07 No, Your Honor.

17:08 That's the whole point.

17:10 Our expert, Dr.

17:11 McCreary, submitted credible expert testimony that what they have and what they're claiming

17:16 to use as an amorphous reference vector is not actually a reference vector for amorphous

17:20 TVS.

17:22 It was generated because the patent doesn't have one.

17:25 Novartis had to run out and try and generate one and make that glassy solid an example

17:30 one.

17:30 Our expert, Dr.

17:32 McCreary, testified that their expert, Dr.

17:34 Park, who claimed to have generated the patent.

17:35 She didn't follow example one.

17:38 She's protocols not in there.

17:40 The reference.

17:41 Judge Reyna It's not that they didn't present any evidence.

17:44 It's that they presented evidence that she think is not credible.

17:47 Appellee Attorney (William A. Rakoczy) Did the district court found not credible, Your Honor?

17:51 And that's the whole point of the burdens on a preliminary injunction.

17:55 It's their burden alone to show likelihood of proving success on the merits.

18:00 MSN to the extent has any burden at all.

18:02 If they put forward substantial evidence of non-infringement,

18:05 then the injunction.

18:05 It needs to be denied.

18:07 That's the appropriate.

18:08 I'm sorry, Judge.

18:09 I didn't mean to interrupt you.

18:10 Judge Lourie Well, thanks for your sentence.

18:12 No, I hadn't said anything yet.

18:14 Appellee Attorney (William A. Rakoczy) Okay.

18:15 If we present substantial evidence of non-infringement, which we did through Dr.

18:19 Steed and Dr.

18:21 McCreary, that the product's all crystalline and that they didn't even have an amorphous

18:25 reference spectrum, then that is more than enough to deny the injunction.

18:28 And that's what the court found.

18:30 The court found that Dr.

18:31 Steed's testimony undermines their theory that there's any amorphous TVS and that's

18:35 that Dr.

18:36 Steed's testing and valid criticism.

18:38 They were valid criticisms of the rest of the evidence.

18:42 That's enough to deny the injunction.

18:44 Judge Lourie Now, you're not on the market now, even though the preliminary injunction was denied.

18:51 And that was due to our stay and the existence, well, the existence of the other patent.

19:03 But, all right, the existence of the other patent, which was partly upheld.

19:12 Well, not obvious.

19:13 Appellee Attorney (William A. Rakoczy) It was, uh, the 659, you're on.

19:16 Judge Lourie It was invalid for written description.

19:17 Appellee Attorney (William A. Rakoczy) Correct.

19:18 unknown Right.

19:18 Appellee Attorney (William A. Rakoczy) And this court issued injunctions or stays in both appeals.

19:22 Judge Prost And you also have this D.C.

19:24 Circuit issue going.

19:25 That has been lifted.

19:26 And that's been lifted and the district court has ruled in your favor or against, in favor

19:32 of the FDA.

19:32 And I presume that's on appeal, but there's no stay.

19:36 Appellee Attorney (William A. Rakoczy) Correct.

19:37 The D.C.

19:37 Circuit has lifted the stays.

19:39 So MSN, as we sit here today.

19:41 Correct.

19:41 It has final approval.

19:42 It has prepared to launch.

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

19:48 Judge Reyna You're, you're, you're arguing that we should not, uh, address claim construction, right?

19:54 That we don't have to.

19:55 Correct.

19:56 You don't need to.

19:56 What's the danger of, of, of us doing that, not addressing it, and then it becoming a

20:02 big issue at trial or, you know, the parties are here before this court after trial, uh,

20:09 with the claim construction?

20:10 Appellee Attorney (William A. Rakoczy) Well, I wouldn't say it's a, a, a danger, your honor, because my friend has to prove

20:16 amorphous TVS regardless at trial.

20:19 We don't believe they can do that.

20:20 And so regardless of the construction, we believe the evidence will show at trial that

20:26 in fact MSN does not infringe because it doesn't have any amorphous TVS.

20:29 So construction won't be an issue at trial?

20:32 Not based on our evidence and our position, your honor, because whether it predominates

20:36 or not, our position is as Dr.

20:39 Steed and Dr.

20:39 Mercury testified here, there is no amorphous in the product at all, regardless of construction.

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

20:48 There was no clear error.

20:50 Yes, Judge.

20:50 Judge Prost What about irreparable injury?

20:52 Do you agree with your friend's analysis in terms of my question about how odd I think

20:56 this case is because the product that we're dealing with here is not listed and, and connects

21:03 with this patent?

21:04 Appellee Attorney (William A. Rakoczy) I respectfully do not agree with my friend, your honor.

21:07 We are talking about an amorphous.

21:09 This is a solid form patent that no one practices.

21:12 Novartis doesn't commercialize it.

21:13 We're talking about an infringement theory that at best, at best we're talking about

21:18 a product or a tablet that is all crystalline with some tiny, barely detectable amount of

21:23 amorphous working on the surface of the tablet somewhere.

21:26 They have to show a nexus or a link between that feature of amorphous and the alleged

21:32 infringement or some demand.

21:34 And I would, I would submit.

21:35 Judge Prost But the product they're talking about in terms of comparing or an arguing agreement, I don't

21:39 think the one we're talking about now for irreparable injury is a product that's like the one

21:44 you're going to launch, right?

21:46 Appellee Attorney (William A. Rakoczy) Which is 100% crystalline, not amorphous.

21:48 And no one in their right mind, I would submit to be candid, would purchase MSN's product

21:54 or any other product because there's a few molecules of amorphous TVS working on the surface

21:59 of the tablet.

22:00 Judge Lourie But one doesn't have to be selling the patented product to obtain damages from someone else's

22:08 infringement.

22:09 We held in bank, accordingly, in right height many years ago.

22:15 And the question is whether the accused causes damages to what the patentee has said,

22:25 whether the patentee is damaged by someone infringing.

22:29 Appellee Attorney (William A. Rakoczy) I would add to that, Your Honor.

22:31 I know Novartis talks it down and they want to dismiss it.

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

22:42 And that means showing that there is some evidence somewhere hiding that there's some demand

22:48 that this trace amount of amorphous would somehow drive demand in this product.

22:54 And the record is bereft.

22:56 There is no evidence whatsoever of any nexus or connection between that amorphous feature

23:01 and the product we're going to sell, which we believe is 100%.

23:05 But even under their theory, it's 99.9999% crystalline with some trace amount.

23:12 That is no nexus we would submit.

23:14 But beyond that, Your Honor, on harm, again, the district court made fact findings,

23:19 which we believe are not clearly erroneous, on the fact that the harms they allege are all quantifiable.

23:25 The district court credited our expert, Dr. McDuff, over theirs,

23:28 that things like lost sales, market share, profits, price erosion are all quantifiable.

23:33 The court can affirm denial.

23:35 On that basis as well.

23:36 Beyond that, the district court held the other claims were speculative.

23:42 Judge Lourie This is a $3 billion product.

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

23:54 And the market price for the product never comes up.

23:59 Appellee Attorney (William A. Rakoczy) Actually, our expert disputed that, Your Honor.

24:02 And the district court was entitled to credit that.

24:04 Dr. McDuff?

24:05 McDuff testified that the damages Novartis is asserting here are overstated,

24:10 but even to the extent they're not, they're still quantifiable with typical standard damages models,

24:16 that forecasting difficulties are overstated.

24:18 Judge Lourie But you're saying we don't need to go there?

24:21 Appellee Attorney (William A. Rakoczy) You do not need to go there, Your Honor.

24:22 This injunction...

24:23 Judge Lourie Because there's no proof of infringement.

24:25 Appellee Attorney (William A. Rakoczy) Exactly, Your Honor.

24:26 But if the court wants to reach irreparable harm, we believe there's no clear error in any of those findings as well.

24:35 Because damages are quantifiable, we submit there's no evidence of any required nexus.

24:40 The other harms, such as reduced investments, are speculative, haven't been proven.

24:45 And this whole idea of laying this generic jailbreak idea at MSN's feet,

24:50 because Novartis may or may not let other companies into the market, that doesn't transform into harm.

24:55 None of those findings from the district court are error.

24:58 So before I relinquish the podium to my friend, I would like again to request the balance of harms here, we believe,

25:04 tips decidedly in favor of MSN.

25:08 Again, the district court's already found there will be no irreparable harm.

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

25:16 That means we're left with MSN that has devoted substantial time, money, and effort

25:20 to preparing to launch a lower-priced generic medicine for patients.

25:27 Final FDA approval is here.

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

25:32 We respectfully request those be lifted as soon as possible.

25:35 And again, that the court reach a decision on the merits in expedited fashion.

25:40 Judge Lourie Thank you, counsel.

25:42 Appellee Attorney (William A. Rakoczy) Thank you, Judge.

25:43 Judge Lourie Ms. Maynard has a little rebuttal time.

25:46 Appellant Attorney (Deanne E. Maynard) Thank you, Your Honor.

25:47 So on the claim construction, we expressly preserved this issue.

25:50 Judge Prost, I invite you to look at the full colloquy.

25:52 He only read you part of it.

25:54 Judge Prost Well, no, I mean, in the pages he showed us, you say you preserved it for appeal,

25:58 but your lawyer, your attorney said that for purposes of the PI, we'll accept the claim construction.

26:05 Appellant Attorney (Deanne E. Maynard) I think in context, Your Honor, what he's saying is, yes, we're applying your construction now in front of you,

26:10 which is what always happens, because just like we will in the trial next month if you all don't fix it,

26:17 which is we have to go forward in the district court, and then we come up here.

26:21 He expressly preserved the right to appeal, and to the extent you think it's ambiguous,

26:26 there would be no reason to do that.

26:29 So, like, it makes no sense to read it that way.

26:31 And this court, you know, often addresses claim construction.

26:35 When it's necessary, as it is here, to a proper ruling on the PI, and we think you should do that.

26:39 On his evidence, again, only on the presence of amorphous, only Novartis did the testing.

26:45 What he's pointing to with Dr. Steed, Dr. Steed says at most that he's talking about the cyan maps, the blue maps.

26:53 At most, that shows that their final product is predominantly their form S API, whatever that is.

27:00 It doesn't show, it can't show, and doesn't show a lack of amorphous.

27:04 And Dr. Steed admits, and this is at A6950-57, that all it shows is predominantly,

27:13 and that the lighter blue regions are something else.

27:15 And Dr. Masker showed, so it can't show that it's, that there's no amorphous.

27:20 And then, I invite you to look, he pointed to you just some Dr. Steed paragraphs,

27:26 but the paragraph that shows you that the only reason, so he's trotting out reasons the district court did not accept,

27:33 and I can tick through those.

27:34 But the only reason the district court gave was that we should have compared our Raman spectra for amorphous to their,

27:41 and that's the picture that I showed you.

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

27:53 and he concludes with the sentence, simply put, none of the peaks, and he means of their API,

27:59 actually match the alleged amorphous TVFs as claimed by Dr. Masker.

28:03 Well, that proves our point, that what Dr. Masker found is not their API, it's the amorphous reference.

28:08 He trots out.

28:10 Judge Reyna Does that statement, does that statement prove or show that there is amorphous TVFs, the presence of?

28:17 Appellant Attorney (Deanne E. Maynard) So, when you put the evidence together, it, it, what it does is show that the district court clearly erred

28:23 in concluding that comparing our amorph, what we found as amorphous reference spectra to their API,

28:33 would not support, it supports us, because it shows that what we found is not their API, it is amorphous TVFs.

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

28:48 In fact, the same district court held a trial on this patent earlier and concluded,

28:53 after hearing similar complaints about Dr. Park's reference spectra,

28:58 that she had, in fact, made an amorphous, a glassy solid in accordance with example one,

29:03 and that's, and that's, and that's, and that's, and that's, and that's, and that's, and that's, and that's, and that's,

29:04 and that's, and that's, and that's, and that's, and that's, and that's, and that's, and that's, and that's, and that's,

29:04 the district court's findings in that previous trial are right on the record at A3534.

29:11 So, on the irreparable harm point, like, this is not a piece in an iPhone.

29:18 This is a pharmaceutical product where we created this market.

29:24 They're using the ANDA process to try to launch their product, to compete against our product,

29:30 our blockbuster product.

29:33 It will, in the district court,

29:35 the court erred in the irreparable harm analysis because he set aside harms that,

29:40 he just didn't address them, harms that this court has recognized are irreparable,

29:44 including permanent price erosion, lost market share, and this is, this is a growing market.

29:50 The evidence shows that in TRSTO, new, new indications are coming out.

29:54 New patients are being served, and we're the ones educating clinicians, educating patients,

30:00 and if they are allowed to launch, even for a short period before they should,

30:04 that will cause,

30:05 that will cause harm that can't be put back in the bottle.

30:08 Judge Lourie Thank you, counsel.

30:09 Thank you, Your Honor.

30:10 Appellant Attorney (Deanne E. Maynard) May I make one housekeeping request in response to his?

30:13 If you do lift the injunctions in both, we would request 48 hours to seek further relief.

30:18 Thank you, Your Honor.

30:19 Judge Lourie I could say both arguments have been crystalline and not amorphous,

30:24 but I won't carry that further.

30:26 The case is submitted.

30:27 Thank you very much.