[00:00:13] Speaker 01: Good morning. [00:00:13] Speaker 00: I think we're ready to go. [00:00:14] Speaker 00: Yes, Your Honor. [00:00:15] Speaker 00: Please proceed. [00:00:16] Speaker 00: Thank you. [00:00:17] Speaker 00: May it please the court. [00:00:18] Speaker 00: After a seven-day trial, a jury returned a verdict on behalf of my client, GlaxoSmithKline, finding that Teba had willfully induced infringement of Glaxo's method of use patent using Carvitolol to treat congestive heart failure. [00:00:36] Speaker 01: With respect, certain limitations are included in that. [00:00:39] Speaker 01: Correct, Your Honor. [00:00:41] Speaker 00: And it can be found at page 7 of the blue brief, if Your Honors would like to follow along, all of the elements of the claim. [00:00:51] Speaker 00: Despite overwhelming proof of Teva's intent to induce an actual acts of inducement, the district court granted Jamal. [00:01:02] Speaker 00: And this, of course, [00:01:05] Speaker 00: the district court accomplished by not following the law of ACUMED or MARA, where all of the evidence has to be viewed in the light most favorable to the non-moving party, i.e. [00:01:17] Speaker 00: GSK, and that it is a remedy that is sparingly invoked. [00:01:21] Speaker 00: The reason the district court granted Jamal is the district court found that somehow the burden had shifted and that the burden had gone to [00:01:33] Speaker 00: GlaxoSmithKline to eliminate any other possible causes for doctors to be prescribing carbidolol to treat congestive heart failure. [00:01:43] Speaker 01: I mean, that's probably a major portion of this case. [00:01:47] Speaker 01: And it's very much, and I think you would concede, it's very much a circumstantial case. [00:01:52] Speaker 01: But your view is that applying that [00:01:56] Speaker 01: and inferences towards your side, you should have prevented the jury verdict should stand. [00:02:01] Speaker 01: Absolutely, Your Honor. [00:02:03] Speaker 01: As I understand what the district court's view of it was, and obviously it's an experienced district court judge who sat through a lot of trials and a lot of jury trials, even if we counsel, nobody's disputing circumstantial evidence counts. [00:02:18] Speaker 01: But this is not a criminal case where there's no eyewitness, and so we have to rely on it. [00:02:23] Speaker 01: We usually see it come up in our [00:02:27] Speaker 01: inequitable conduct cases, where there's no smoking gun, no admission by the party, so you need circumstantial evidence. [00:02:33] Speaker 01: Here, you did have doctors, and presumably a lot of them given the size of the damage award. [00:02:38] Speaker 01: And you did very much rely and try to suggest or think that you relied on your doctor, having said he read the label, even though that turned out not to be so true. [00:02:52] Speaker 01: But in this case, based on the circumstantial evidence, [00:02:55] Speaker 01: I think what the district court was concluding was that all of the circumstantial evidence and the inferences largely went against you. [00:03:07] Speaker 01: And that was for several reasons, because your doctor's testimony was he lied on a whole bunch of other stuff outside of anything Teva did. [00:03:16] Speaker 01: The testimony was it didn't matter what Teva was doing. [00:03:24] Speaker 01: prescribe anything with regard to Teva. [00:03:27] Speaker 01: It was the pharmacies that did it. [00:03:29] Speaker 01: He even had no idea if it was going to a generic, which generic it would go to. [00:03:35] Speaker 01: So I think Chief Judge Stark, looking at that, said all of the inferences that exist point the opposite. [00:03:42] Speaker 01: So why don't you respond? [00:03:43] Speaker 00: I will, Your Honor, to be very respectful. [00:03:47] Speaker 00: Chief Judge Stark was wrong as to what our evidence was. [00:03:50] Speaker 00: Our evidence was actually that Dr. McCullough testified. [00:03:53] Speaker 00: We've got two periods here, the partial label period and the full label period. [00:03:58] Speaker 00: Dr. McCullough testified that he hadn't read Teva's partial label. [00:04:03] Speaker 00: And the reason he hadn't read it is that Teva had advertised to him [00:04:07] Speaker 00: in a press release that they had been approved for all uses. [00:04:11] Speaker 01: You're talking about the 2000 press release. [00:04:13] Speaker 00: The 2004 press release. [00:04:15] Speaker 01: And then in 2007... No, the 2004 didn't say it had been approved. [00:04:19] Speaker 01: It said it had been tentatively approved. [00:04:21] Speaker 01: The only press release that went to the approval of Teva's generic was the 2000 press release, right? [00:04:27] Speaker 00: Well, I would beg to differ. [00:04:29] Speaker 00: The 2004 said they had been tentatively approved for all uses and expected final approval in 2007. [00:04:34] Speaker 00: In 2007, they issued a press release saying, we have now final approval to market a generic version of GSK's cardiovascular drug, Coric, which led Dr. McCullough to believe, and this is direct evidence, not circumstantial, that Teba had been approved for all uses because they had previously said they had gotten approval for all uses. [00:04:55] Speaker 00: Teva did nothing to disabuse him of that, and in fact, actually in their product catalogs, which our regulatory experts said would be viewed as a statement that they had been approved for all uses, they directly compared themselves, their generic carbidolol [00:05:13] Speaker 01: wasn't the testimony with regard to the catalogs? [00:05:17] Speaker 01: The catalogs weren't submitted to the physicians. [00:05:20] Speaker 01: The catalogs, I think your witness said, it's possible. [00:05:24] Speaker 01: I think that was the word. [00:05:25] Speaker 01: It's a possibility that a doctor would ultimately read something in the catalog, but not that the catalogs were submitted to physicians. [00:05:33] Speaker 01: Am I missing something? [00:05:34] Speaker 01: Yes, Your Honor. [00:05:35] Speaker 00: Actually, Dr. McCullough stated rather unequivocally that doctors were completely reliant on [00:05:42] Speaker 00: what they received from Teva. [00:05:45] Speaker 00: And if we look at appendix 10.6.10, 10.6.11, 10.6.12, he states that doctors have to rely on what the generics send to them, and that specifically Teva, he said, [00:06:01] Speaker 00: I said, Teva, I'm showing him something Teva said, where it says the clinician must be familiar with the full product labeling provided by the manufacturer or distributor. [00:06:09] Speaker 01: Are we talking about the catalog still in the context of catalog? [00:06:12] Speaker 00: And also the catalogs. [00:06:13] Speaker 00: He said. [00:06:14] Speaker 01: OK, I was talking about the catalogs, because I'm looking at 685, 686. [00:06:17] Speaker 01: So the catalog lists products. [00:06:27] Speaker 01: And the people at Teva sells to are, as we talked about, the middlemen, the pharmacies, and whoever is in the supply chain. [00:06:35] Speaker 01: So Teva doesn't give this catalog to doctors, do they? [00:06:39] Speaker 01: And then he says, I think it does end up with doctors. [00:06:42] Speaker 01: This looks like a circular product catalogs, yada da. [00:06:46] Speaker 01: And the question is, you think it is directed to doctors? [00:06:49] Speaker 01: The answer, I think it clearly could have been seen by doctors. [00:06:52] Speaker 01: So you were testifying this is actually given to doctors? [00:06:55] Speaker 01: You just don't know. [00:06:55] Speaker 01: I don't know that. [00:06:57] Speaker 01: I think it's possible. [00:06:58] Speaker 01: That's the testimony I was referring to on catalog. [00:07:00] Speaker 00: And then on top of that, Your Honor, there is, and I'm looking for my module on the full label, there is an actual book that Teva sends directly to doctors. [00:07:09] Speaker 00: And it's a fact that says, Dear Health Care Provider. [00:07:12] Speaker 00: And in that book, it specifically compares [00:07:16] Speaker 00: its generic carbonyl to pour it. [00:07:18] Speaker 01: So that's the full label. [00:07:19] Speaker 01: That would have been as of 2011. [00:07:20] Speaker 01: When was the switch from the skinny label to the full label? [00:07:25] Speaker 00: 2011 is when they went to full label. [00:07:27] Speaker 00: And in fact, if we look at appendix [00:07:33] Speaker 02: But what's the date on the book that they're sending it to doctors? [00:07:36] Speaker 00: We had 2011, and we had another one, I think, in 2012. [00:07:40] Speaker 00: So that's the full label, which, by the way, even the judge found that that was not an inducement, when you had a full label teaching the doctor how to practice the method. [00:07:49] Speaker 01: Yeah, and that's confusing to me in reviewing this whole case, because normally my own personal view would come to this thinking there's [00:07:57] Speaker 01: Maybe there's some distinction to be drawn between the skinny label and the full label But having read as much as I have on the case. [00:08:04] Speaker 01: That's not the case the way the case ran, right? [00:08:07] Speaker 01: It wasn't your view that When you did say the label matters, but you didn't draw this you weren't basing your case on the distinction If not, you would have lost the first part of it [00:08:18] Speaker 00: Your Honor, correct. [00:08:20] Speaker 00: What we said is, let's start with the partial label, that the partial label in and of itself contained enough information, just like in AstraZeneca, to induce doctors to infringe. [00:08:33] Speaker 01: But was there any, please tell me the testimony that the doctors did use that label, we're talking skinny label now, that the doctors relied on the skinny label in their prescribing the drug that they prescribed. [00:08:47] Speaker 00: We have no direct testimony. [00:08:49] Speaker 00: We have circumstantial evidence. [00:08:51] Speaker 01: Again, so this is why I started. [00:08:52] Speaker 01: The circumstantial evidence that I know about is really, McCullough was the main doctor here. [00:08:58] Speaker 01: And he's talking about what he used. [00:09:01] Speaker 01: But most compellingly, and I'll find it in a minute, that when the generics launched, you switched your patients over, right, to the generic. [00:09:14] Speaker 01: answer. [00:09:15] Speaker 01: No, I didn't actively switch. [00:09:17] Speaker 01: I continued to prescribe her. [00:09:19] Speaker 01: It was automatically switched. [00:09:20] Speaker 01: And he goes on to say, I did nothing different. [00:09:24] Speaker 01: The pharmacies, I don't know which generic they prescribed it to, but whatever it is, there's state law, there's pharmacy practices, and they'll take the same prescription that I had before and after their patent, which was 2008. [00:09:38] Speaker 01: after the generic swan, right? [00:09:40] Speaker 00: Is that the testimony? [00:09:43] Speaker 00: Yes, but what the district court ignored and what apparently we didn't do well enough in our brief is point out the key language from Dr. McCullough. [00:09:52] Speaker 00: Dr. McCullough specifically testified at 11662 and 11663 that he didn't look at Teva's partial label because Teva told him, prescribe our generic carbidolol just like correct. [00:10:08] Speaker 00: Well, pouring was approved to treat congestive heart failure. [00:10:13] Speaker 01: I'm sorry. [00:10:14] Speaker 01: I have this testimony marked. [00:10:16] Speaker 01: Now, before you started, Minister. [00:10:20] Speaker 01: So he says he didn't read. [00:10:22] Speaker 01: This is where he says explicitly, notwithstanding your calling him back to say that he read the label, that he didn't read the label. [00:10:31] Speaker 01: And he says, no, I didn't. [00:10:32] Speaker 01: Why not? [00:10:33] Speaker 01: I just assume they were the same. [00:10:36] Speaker 01: And then he says, what made you assume that? [00:10:39] Speaker 01: Firstly, the same as what? [00:10:41] Speaker 01: The same as Corig, because Teva, you see, with the judges. [00:10:44] Speaker 01: Well, the compound was the same, right? [00:10:46] Speaker 01: I mean, that's why they got AB rated and therapeutic. [00:10:51] Speaker 01: Yeah, so. [00:10:52] Speaker 01: Correct. [00:10:52] Speaker 01: But here's what happened. [00:10:54] Speaker 01: We need to back up. [00:10:55] Speaker 01: Because he didn't read. [00:10:56] Speaker 01: But he didn't read. [00:10:56] Speaker 01: I'm sorry. [00:10:57] Speaker 01: I'll let you do this. [00:10:58] Speaker 01: But he didn't read the generic label. [00:11:01] Speaker 01: Isn't it kind of on him? [00:11:03] Speaker 01: I mean the generic label, there were three indications for this drug historically and only one of them was congestive heart failure. [00:11:10] Speaker 01: The label didn't cover congestive heart failure. [00:11:13] Speaker 01: Somewhere else he also says, well if I had read the label I wouldn't have prescribed it because it was missing too much information. [00:11:21] Speaker 00: Right. [00:11:21] Speaker 00: So we need to back up, Your Honor. [00:11:23] Speaker 00: He said he didn't read the generic label, because Teva had said, prescribe our drug just like Correg. [00:11:30] Speaker 00: And what, unfortunately, the district court judge was conflating teaching a method of use, which is licensed. [00:11:37] Speaker 00: If you use Correg to treat congestive heart failure, you're not infringing. [00:11:41] Speaker 00: And so what the district court said is, well, that the innovator taught the industry [00:11:46] Speaker 00: how to practice this method of use. [00:11:49] Speaker 00: But that's not infringing. [00:11:51] Speaker 00: It's only when you have an unlicensed sale that you now get into infringement. [00:11:55] Speaker 00: The district court seemed to think that GSK had somehow induced doctors to infringe. [00:12:02] Speaker 00: Of course they couldn't. [00:12:02] Speaker 00: They wouldn't. [00:12:03] Speaker 00: They would never say, and by the way, use generic carbidolol to treat congestive heart failure. [00:12:08] Speaker 00: That was Teva who said, and use generic carbidolol just like you use Poreg. [00:12:14] Speaker 00: And doctors had already been taught to use Poreg to treat congestive heart failure. [00:12:19] Speaker 01: But can I look at the testimony you were just turning us to? [00:12:23] Speaker 01: Because the answer was, he says, I assume they were the same. [00:12:27] Speaker 01: And the next question, your question, what made you assume that? [00:12:32] Speaker 01: And the answer is, well, we have lots of information as we have gone over that indicated that you know it was a complete replacement. [00:12:40] Speaker 01: That, in fact, the two. [00:12:43] Speaker 01: The drug was the same. [00:12:45] Speaker 01: Well, the drug was the same, right? [00:12:46] Speaker 01: I mean, the patent was off the compound. [00:12:48] Speaker 01: The drug was the same. [00:12:49] Speaker 01: That's a correct assumption. [00:12:51] Speaker 01: And all the information regarding it was the same. [00:12:54] Speaker 01: I don't know what that means. [00:12:56] Speaker 01: So what does that mean? [00:12:58] Speaker 00: What that means is, and what Dr. McCullough was referring to when he said we've already gone over it, is that he had been led to believe, and this is direct evidence of inducement. [00:13:07] Speaker 00: He, Dr. McCullough, had been led during the partial label period by Teva to believe that [00:13:13] Speaker 00: How and why? [00:13:15] Speaker 01: Are we referring to the press releases now? [00:13:17] Speaker 00: The press releases, the product catalogs? [00:13:19] Speaker 01: Well, the press release was 2007, so that was before the patent we're talking about in this case was even reissued, right? [00:13:27] Speaker 00: They put those press releases up on their website and they're still there today. [00:13:31] Speaker 02: Is there evidence of that in this record that was in front of the jury? [00:13:35] Speaker 00: There was evidence that Teba put the press releases up on the website, yes. [00:13:43] Speaker 00: Obviously, we had to check before we wrote the briefs, but we couldn't check at that point in time. [00:13:48] Speaker 02: They specifically objected in their brief to your citation of that and said that the jury had never been told. [00:13:54] Speaker 02: that these things were still on the website, or had continued to be on the website. [00:13:58] Speaker 00: Or were they on the website in 2007? [00:13:59] Speaker 00: They were put on the website, certainly in 2007. [00:14:02] Speaker 00: And Dr. McCullough testified that he did look at Teva's website. [00:14:06] Speaker 01: Well, except but not when. [00:14:08] Speaker 01: And in fact, wasn't the discussion there, the download of whatever was on the website, was a 2015 date. [00:14:15] Speaker 01: So I didn't see any testimony about what he saw in 2007. [00:14:21] Speaker 01: And I don't know that he had [00:14:22] Speaker 01: There was any testimony about that. [00:14:24] Speaker 00: Well, see, this is how Teva is playing games here, that what we introduced through Dr. McCullough. [00:14:29] Speaker 01: Well, let me assure you, I'm not playing games. [00:14:31] Speaker 01: I'm just trying to get to the heart of the record. [00:14:33] Speaker 00: Oh, no, no. [00:14:33] Speaker 00: I'm sorry. [00:14:34] Speaker 00: No. [00:14:34] Speaker 00: What Teva did was they objected, as Judge Moore said, they objected about us saying that it was on the website. [00:14:42] Speaker 00: And at the trial, what we introduced was a screenshot from the website from 2015. [00:14:49] Speaker 00: And so they objected and said, well, this doesn't show what was on the website in 2007. [00:14:52] Speaker 00: And Dr. McCullough said, but the press release was in 2007. [00:14:55] Speaker 00: And I read the press release, and it led me to believe that Teller had been approved for all uses. [00:15:01] Speaker 00: I'm not saying that. [00:15:01] Speaker 01: I mean, I'm looking. [00:15:02] Speaker 01: You must be referring to 10-687. [00:15:04] Speaker 01: I just want to specifically understand what you're saying. [00:15:15] Speaker 01: And I just want to make sure I'm looking at the same thing you're relying on in the record for what? [00:15:22] Speaker 01: You are, Your Honor. [00:15:25] Speaker 01: You didn't present any evidence to this jury about the website in 2007, did you? [00:15:30] Speaker 01: You know, I can't recall. [00:15:31] Speaker 01: I went over quite a bit. [00:15:33] Speaker 01: Well, this is the only picture of the website you put up right. [00:15:36] Speaker 01: I believe that's correct. [00:15:37] Speaker 01: The only picture of the website is from April 2015. [00:15:42] Speaker 01: Right? [00:15:44] Speaker 01: You don't know when it was edited before that. [00:15:46] Speaker 01: Do you answer? [00:15:47] Speaker 01: No. [00:15:48] Speaker 01: I don't know how long it was up before 2015. [00:15:51] Speaker 01: Question. [00:15:51] Speaker 01: Right. [00:15:52] Speaker 01: They may not have had a website in 2007. [00:15:54] Speaker 01: Right? [00:15:55] Speaker 01: Answer. [00:15:56] Speaker 01: They may or may not have. [00:15:57] Speaker 01: You don't know. [00:15:58] Speaker 01: I don't know. [00:16:00] Speaker 01: So what are we supposed to take away from that? [00:16:02] Speaker 00: What we're supposed to take away from it, and this answers Judge Moore's question, at the trial, the screenshot was from 2015. [00:16:08] Speaker 00: That that 2007 press release was still [00:16:12] Speaker 00: on the website as of 2015. [00:16:14] Speaker 00: And I didn't mean to say Your Honor was playing games. [00:16:17] Speaker 00: What Teva tried to do is say, well, how do you know it hasn't been edited since 2007? [00:16:21] Speaker 00: Well, because the press release was issued in 2007. [00:16:26] Speaker 00: It says on the press release, issue date 2007. [00:16:29] Speaker 00: That's when they received their final approval. [00:16:32] Speaker 01: OK, but we're talking about the website. [00:16:34] Speaker 01: And this was your witness's testimony about the website not knowing whether they even had a website in 2007. [00:16:41] Speaker 00: He certainly had to concede that, but now recall the jury heard all of this and they chose to find that we met our burden and were instructed by the court as to what they needed to find in order to find that we met our burden. [00:16:56] Speaker 00: The district court may have found Dr. McCullough less than credible. [00:17:00] Speaker 00: That's not what one does in a JMOC, which is to weigh the evidence. [00:17:04] Speaker 00: But more importantly, and this is uncontested, Dr. McCullough said that had he known during the partial label period that Teva had not been approved for all indications, and he'd been led to believe by Teva that it had been approved for all indications, had he known it hadn't, he would have written dispensed as written, meaning there would not have been any infringing sales. [00:17:26] Speaker 00: because then the pharmacy couldn't have substituted. [00:17:29] Speaker 00: And then they would have had to have given the doctor or the patient the actual innovator product of Cori. [00:17:37] Speaker 00: And we had multiple experts testify to that. [00:17:40] Speaker 00: Teva's expert, Dr. Kinsey, testified to that. [00:17:43] Speaker 00: Our survey expert, Dr. Riester, testified to that. [00:17:46] Speaker 00: And so what would he have written in the prescription? [00:17:49] Speaker 00: Dispense as written. [00:17:50] Speaker 00: And that would have prevented generic substitution. [00:17:53] Speaker 01: And so he said... But what is dispense has written? [00:17:56] Speaker 01: So we're sure his prescription would have included all the limitations on the patent and dispute? [00:18:00] Speaker 01: No. [00:18:01] Speaker 01: Dispense has written means you write Correg and then you say dispense has written. [00:18:05] Speaker 01: But the only inducement or infringement here is with respect to the claim... [00:18:09] Speaker 01: The claim and the claim is quite limited and specific as you know it had to go through reissue with further limitations, right? [00:18:17] Speaker 01: So that's that the infringement here is only with respect. [00:18:21] Speaker 01: It's a method of you This is a method of use patent. [00:18:23] Speaker 01: We're talking about the compound pattern has already expired, right? [00:18:26] Speaker 00: Correct. [00:18:26] Speaker 00: And so, dispense as written, just to be technical, when a doctor writes COREG for congestive heart failure, DAW, dispense as written, it means to the pharmacy, you can't swap it out. [00:18:38] Speaker 00: And Teva's expert testified to that at 11076. [00:18:41] Speaker 00: Dr. McCullough testified to that at 11662. [00:18:44] Speaker 00: Our survey expert testified to that at 10750 through 751. [00:18:49] Speaker 00: And most importantly, Teva's 30B6 witness. [00:18:53] Speaker 00: And this is really important. [00:18:54] Speaker 00: She was asked this question. [00:18:56] Speaker 00: It's Ms. [00:18:56] Speaker 00: King at 10488. [00:18:58] Speaker 00: And so to make it specific to the issues here, if Teva has carved out congestive heart failure, but not hypertension and not post-MILVD, [00:19:07] Speaker 00: Teva still expects to get sales where the doctor prescribed parfidolol for congestive heart failure, correct. [00:19:14] Speaker 00: Answer, yes, unless the doctor feels strongly. [00:19:18] Speaker 00: Question writes brand only. [00:19:20] Speaker 00: Answer, yes. [00:19:21] Speaker 00: So Teva knew. [00:19:23] Speaker 00: that if the doctor wrote DAW, they weren't going to get that sale. [00:19:27] Speaker 00: GSK was going to get that sale. [00:19:29] Speaker 00: And so they did everything in their power. [00:19:32] Speaker 01: Or any other generic, right? [00:19:34] Speaker 01: I mean, there were the FDA press release in 2007 said there were 14 generics. [00:19:41] Speaker 01: I can only count seven right on the record. [00:19:43] Speaker 01: But it wasn't, I mean, as Dr. McCulloch said, [00:19:47] Speaker 01: The pharmacy switched to a generic, and he has no idea whether it was Teva or another generic. [00:19:53] Speaker 00: Correct. [00:19:53] Speaker 00: Unless he wrote dispensed as written. [00:19:55] Speaker 00: So my point is not that Teva versus another generic. [00:19:58] Speaker 00: Teva has like 45% of the market. [00:20:00] Speaker 00: The point isn't that Teva versus another generic would get the sale. [00:20:05] Speaker 00: The point is GSK would get the sale if [00:20:08] Speaker 00: the doctors had not been misled by Teva into believing that it had been approved. [00:20:14] Speaker 00: Their generic carbidolol had been approved for all uses. [00:20:16] Speaker 01: Is there testimony about whether or not doctors read FDA press releases? [00:20:21] Speaker 00: Yes. [00:20:21] Speaker 00: Dr. McCullough said he does. [00:20:23] Speaker 00: Dr. Zussman said he doesn't read anything. [00:20:27] Speaker 00: That's Teva's expert. [00:20:29] Speaker 00: Well, remind me not to go to him. [00:20:31] Speaker 00: Well, interestingly, Your Honor, in the Sanofi case, which was before this court, [00:20:37] Speaker 00: That same Dr. Sussman is testifying that doctors do look to drug labels for information about the use of the drug in special or specific populations, that it's important to look at the label's indications. [00:20:50] Speaker 00: This is the same Dr. Sussman. [00:20:51] Speaker 01: Well, we know the labels are important. [00:20:53] Speaker 01: You said to Judge Stark, no label, no inducement. [00:20:56] Speaker 01: So we can all agree with that. [00:20:59] Speaker 01: Let me ask you, the FDA press release comes out like one day before Teva's press release in 2007. [00:21:05] Speaker 01: Now, all of this press release activity occurs before the patent even comes out of reissue. [00:21:11] Speaker 01: So in order to even be considered as legally sufficient, it would have to be part of a pattern that existed after the patent issue. [00:21:18] Speaker 01: But let me ask you, was there anything in Teva's press release? [00:21:23] Speaker 01: My reading of the FDA press release is that it had a lot more stuff. [00:21:27] Speaker 01: Now, it didn't refer just Teva specifically, it referred to 14 generics that have this. [00:21:33] Speaker 01: But all of the stuff that you're concerned about, AB-related, Corig, all this stuff, that's all in the FDA press release too, right? [00:21:41] Speaker 00: I don't recall. [00:21:41] Speaker 00: I'd have to look at it. [00:21:43] Speaker 00: But I must say that Teva continued their marketing, very extensive marketing efforts, well into after the patent issue. [00:21:50] Speaker 00: But there's another point I would like to get at, because I'm concerned that we're- Because we are running out of time, but sure. [00:21:57] Speaker 00: The partial label. [00:21:59] Speaker 00: The partial label itself, following the AstraZeneca opinion, contains enough information to induce doctors to practice the claimed method. [00:22:10] Speaker 02: Why do you need it? [00:22:10] Speaker 02: Why can't you just rely on the releases? [00:22:12] Speaker 00: We can. [00:22:13] Speaker 00: We absolutely can. [00:22:14] Speaker 00: But we also do have the partial label, and we can't forget that. [00:22:17] Speaker 00: And this isn't a case like Takeda, where we're talking about, oh, it doesn't really. [00:22:22] Speaker 00: The partial label, 1.1, is heart failure. [00:22:27] Speaker 00: So Teva had carved that out. [00:22:28] Speaker 00: Now remember, up until two weeks before launch, they intended to capture the whole market. [00:22:33] Speaker 00: They intended to capture everything, including sales of congestive heart failure. [00:22:36] Speaker 00: Then they found out the other generics were going to do a carve out and get rid of 1.1. [00:22:41] Speaker 00: So they did too. [00:22:43] Speaker 00: They didn't change their intent. [00:22:45] Speaker 00: They still intended to capture the whole market. [00:22:47] Speaker 01: And if we look at- They took congestive heart failure off the light. [00:22:50] Speaker 00: Correct. [00:22:50] Speaker 00: They left on 1.2. [00:22:52] Speaker 00: 1.2 is left ventricular dysfunction, and this is at appendix 7665. [00:22:58] Speaker 00: Left ventricular dysfunction following myocardial infarction. [00:23:01] Speaker 00: Now if we track it with the claim language, it says COREG is indicated to reduce cardiovascular mortality in clinically stable patients who have survived a myocardial infarction, have left ventricular ejection fraction of less than or equal to 40% with [00:23:19] Speaker 00: And in this case, or without systemic heart failure. [00:23:22] Speaker 00: Now, Teva's own expert, Dr. Zussman, at appendix 11226 said, I asked him, is it your testimony that a patient who has left ventricular ejection fraction of less than or equal to 40% with systemic heart failure [00:23:38] Speaker 00: Would they be diagnosed as suffering from congestive heart failure? [00:23:41] Speaker 00: Answer, yes, is construed by the court. [00:23:43] Speaker 01: OK, so this is about your overlap argument, that there was some overlap. [00:23:46] Speaker 01: Correct, Your Honor. [00:23:47] Speaker 01: The problem with that is there was no testimony about what those numbers were at all. [00:23:52] Speaker 01: Was there? [00:23:53] Speaker 01: What percentage of people were overlapping or not overlapping? [00:23:59] Speaker 00: I don't know that there was an actual percentage, but all experts agreed that there was an overlap of some percentage. [00:24:09] Speaker 01: Correct. [00:24:10] Speaker 00: It would be patients who were suffering, who were symptomatic. [00:24:14] Speaker 00: They would be diagnosed as having congestive heart failure. [00:24:17] Speaker 00: And all of the uptitration and the use with ace inhibitors and so on, that was all on the partial label. [00:24:24] Speaker 00: It all stayed there. [00:24:25] Speaker 00: And Dr. McCullough walked the jury through it very carefully. [00:24:28] Speaker 00: And I can give the court the appendix citations, but they are in our brief. [00:24:32] Speaker 00: So that's the partial label. [00:24:33] Speaker 00: It's enough. [00:24:34] Speaker 00: The partial label alone is enough. [00:24:36] Speaker 00: But on top of that, we have the press releases. [00:24:38] Speaker 00: We had the marketing materials. [00:24:39] Speaker 00: We had the AB rated. [00:24:41] Speaker 00: We had to have it telling the industry, use our generic carbidolol just like Coric. [00:24:47] Speaker 00: Just like Coric means, use it to treat patients with congestive heart failure. [00:24:51] Speaker 00: So we have all of those together. [00:24:52] Speaker 00: And then we get to the full label, which, of course, is an exact copy of ours, which should have been more than enough to prove inducement. [00:25:00] Speaker 00: And yet, the court found no inducement there either. [00:25:04] Speaker 01: Okay, I'll exceed our time when we start. [00:25:06] Speaker 01: Thank you. [00:25:07] Speaker 01: Thank you very much. [00:25:17] Speaker 03: Good morning, Your Honor. [00:25:18] Speaker 03: May it please the Court? [00:25:20] Speaker 03: You heard my friend on the other side say, I think five times, that Teva instructed doctors to use its generic product just like Correg. [00:25:30] Speaker 03: That statement does not appear anywhere in the record. [00:25:32] Speaker 03: It doesn't appear in the [00:25:34] Speaker 03: materials that my friend discussed this morning. [00:25:36] Speaker 01: Well, if it's just like Corig, why is it one making the next leap into and therefore patients and doctors are going to use it exactly the same way. [00:25:46] Speaker 03: You say, I'm sorry, you said if they said it's just like Corig. [00:25:51] Speaker 03: That's not what any of the materials of the records say. [00:25:56] Speaker 03: Let me start with the press releases from before the patent had issued. [00:26:03] Speaker 03: Even they don't say use just like Correg. [00:26:05] Speaker 03: My friend is drawing an inference from [00:26:08] Speaker 03: the 2004 press release in which, at the time, Teva had said that when it launched, it intended to launch with a label for heart failure. [00:26:15] Speaker 03: Of course, it didn't do that. [00:26:17] Speaker 02: OK, so hold on. [00:26:18] Speaker 02: The press release is on page 6347, so we're all looking at the same document. [00:26:23] Speaker 02: And that press release says, Carvedilal tablets are the AB-rated generic equivalent of GlaxoCORIG tablets. [00:26:33] Speaker 02: So what does it mean to be AB rated? [00:26:35] Speaker 03: To be AB rated. [00:26:36] Speaker 02: Generic equivalent. [00:26:38] Speaker 03: To be an AB rated generic equivalent, which is the same language that FDA uses. [00:26:41] Speaker 03: AB rating means that it has been proven through studies to be therapeutically equivalent, meaning that it behaves the same way in the body within certain tolerances. [00:26:51] Speaker 02: OK, well, they say it's the generic equivalent. [00:26:53] Speaker 02: So then it goes on and says, and are indicated for treatment of heart failure and hypertension. [00:27:00] Speaker 02: Hypertension was the earlier use. [00:27:02] Speaker 02: Heart failure is the new claim to use in the reissue patent, is that correct? [00:27:09] Speaker 03: Heart failure with some additional limitations. [00:27:11] Speaker 02: Congestive heart failure, yes. [00:27:13] Speaker 03: More than that. [00:27:15] Speaker 03: Reduced to reduced mortality with co-administration for more than six months. [00:27:19] Speaker 03: I'm sorry. [00:27:20] Speaker 01: I think we're looking at the, are we looking at the [00:27:23] Speaker 01: 2004 press release. [00:27:26] Speaker 01: Okay, I thought we were due in the 2007. [00:27:27] Speaker 01: I'm sorry. [00:27:28] Speaker 02: No, that's okay. [00:27:29] Speaker 02: The 2004 press release. [00:27:30] Speaker 01: In 2004, they did include the other, all the uses. [00:27:34] Speaker 03: Right. [00:27:35] Speaker 03: At the time, they had obtained tentative approval and said that they intended to market it in the future after the compound patents expired. [00:27:43] Speaker 02: And Dr. McCullough expressly testified that doctors receive these releases and read them. [00:27:48] Speaker 03: respectfully know your honor first of all they didn't he testified generally about press releases but not about and I want to make sure I'm understanding your question correct the doctors receive press releases and read them from generic press releases generally from the from generics and from the FDA in order to and he said this is what he said in order to determine when a product is going generic that's right [00:28:10] Speaker 03: What he didn't say is that they use press releases to determine how to prescribe their medications or what prescriptions to write. [00:28:19] Speaker 03: He did not say that it changes, that press releases are what determine doctors prescribing. [00:28:23] Speaker 02: Really? [00:28:23] Speaker 02: Just out of curiosity, what was Teva's intent then when they issued this press release? [00:28:27] Speaker 02: Just goodwill, let the world know? [00:28:29] Speaker 02: Or to let doctors know so that they could prescribe this drug? [00:28:33] Speaker 03: It was letting the world know that it had received this. [00:28:37] Speaker 02: Letting the world know that there is a new generic that can be prescribed for all of the identical uses that Correg has been approved. [00:28:43] Speaker 03: No, Your Honor, because this is 2004 and Teva was not launching its product. [00:28:47] Speaker 03: This is three years before Teva launched its product. [00:28:49] Speaker 02: Okay, that we are attempting to seek and expect final approval in 2007 of a generic version of Correg which will be expected to be approved for all the same uses. [00:28:59] Speaker 03: Yes, at the time. [00:29:01] Speaker 03: That's what they expected. [00:29:02] Speaker 02: Okay, so this is what they've informed doctors if I accept dr. McCullis testimony which since this is a jury verdict I have to do so if I accept dr. McCullis testimony that doctors get releases and read releases in 2004 doctors would have gotten this release according to his testimony and read it and [00:29:22] Speaker 03: According to his testimony, doctors also would have received in 2007 the FDA press release at Appendix 7116, which explained that the generics were not being approved for all of the indications in the label of the brand. [00:29:35] Speaker 03: And Dr. McCullough also said that if he'd read the label at that time, the carved out label, then he would have concluded that it was, as he said, missing too much information to prescribe Tevis Generic for that. [00:29:48] Speaker 02: In 2007 there was another press release correct correct Ateba and that one says we have been approved Doesn't it does so we've been approved and what have we been approved for? [00:30:00] Speaker 03: It says to market its generic version of GSK's cardiovascular agent correct tablets shipment will begin immediately [00:30:08] Speaker 02: So to market its generic version, what does generic mean? [00:30:12] Speaker 03: A generic version means it's an ANDA. [00:30:15] Speaker 03: So it has been approved based on its bioequivalence to an already approved product. [00:30:21] Speaker 02: So it means it is therapy. [00:30:22] Speaker 02: So they're now marketing a bioequivalent product of Glaxo's cardiovascular agent, Corig. [00:30:33] Speaker 02: So they previously articulated [00:30:36] Speaker 02: expressly what uses in the cardiovascular family it could be used for in 2004, heart failure as well as hypertension. [00:30:44] Speaker 02: Now they get a little bit more ambiguous, but they still say cardiovascular agent coric. [00:30:49] Speaker 02: So your language was equivalent, can be used as an equivalent for the cardiovascular agent coric. [00:30:56] Speaker 02: How would this not continue to potentially inform doctors [00:31:02] Speaker 02: that this drug could be a substitute for cardiovascular agent Corig Full Stop. [00:31:07] Speaker 03: So let me start with cardiovascular agent. [00:31:09] Speaker 03: A treatment for hypertension is a cardiovascular agent as well. [00:31:13] Speaker 02: That's why I said they got a little more ambiguous. [00:31:15] Speaker 03: Sure. [00:31:17] Speaker 03: The other side places more weight on that phrase than your question does. [00:31:22] Speaker 03: So in conjunction with this press release... Well, it certainly could be interpreted by someone. [00:31:28] Speaker 02: Couldn't congestive heart failure be understood to be a cardiovascular condition? [00:31:34] Speaker 02: I think the answer to that's got to be yes. [00:31:36] Speaker 03: Sure. [00:31:36] Speaker 03: But for the other side to place any reliance on this, they have to show. [00:31:41] Speaker 02: So if congestive heart failure could be understood to be a cardiovascular condition, then when someone says, you can use my cardiovascular agent, your point is lost on me. [00:31:51] Speaker 02: This is a jury trial. [00:31:52] Speaker 02: The jury had all this in front of it. [00:31:54] Speaker 02: It got to make a fact finding. [00:31:56] Speaker 02: We don't step in the shoes of the jury. [00:31:59] Speaker 03: Indeed not, Your Honor. [00:32:00] Speaker 03: But what you take is all of the evidence [00:32:03] Speaker 03: all of the evidence, including the admissions made by GSK and all of the failures of proof that the district court pointed out. [00:32:11] Speaker 03: So GSK had said to the district court in mid trial that it would recall the doctor to testify that he [00:32:19] Speaker 03: I read generic labels. [00:32:20] Speaker 02: This is labeling. [00:32:21] Speaker 02: I haven't even mentioned labeling. [00:32:23] Speaker 02: I'll tell you what. [00:32:24] Speaker 02: One thing Chief Judge Post said earlier is, well, labels are important. [00:32:26] Speaker 02: We can all agree on that. [00:32:27] Speaker 02: I don't agree. [00:32:28] Speaker 02: I do think they can be important, but I don't agree they always have to be. [00:32:31] Speaker 02: I'll tell you right now, I think the releases are enough. [00:32:33] Speaker 02: I think the releases present enough evidence when presented to a jury that could have sufficed, even if the label had never said heart failure. [00:32:43] Speaker 02: Never, at any point. [00:32:44] Speaker 02: I don't care what the skinny label even says. [00:32:47] Speaker 02: I think the releases are enough in a jury trial for the jury after Dr. McCullough says, I read releases and then I act on them. [00:32:55] Speaker 03: Respectfully, Your Honor, he did not say, and then I act on them. [00:32:58] Speaker 03: That's not what he testified to. [00:32:59] Speaker 03: That's what the other side would like you to get out of this. [00:33:02] Speaker 03: That is not his testimony. [00:33:04] Speaker 03: His testimony was that he read press releases to determine when products were going generic. [00:33:10] Speaker 03: And he also said, I believe in the very same page, referring to the FDA press release at 7-1-1-6 of the appendix. [00:33:17] Speaker 03: that doctors also read FDA press releases. [00:33:20] Speaker 03: And here the FDA press release makes clear so that you can't just take the Teva press release in isolation without the same day. [00:33:28] Speaker 02: I understand. [00:33:28] Speaker 02: That's called competing evidence. [00:33:30] Speaker 02: And that's what a jury gets to look at and make a determination about how a doctor would be influenced. [00:33:36] Speaker 03: I don't think, first of all, it has to be that Teva influenced doctors during the life of this patent. [00:33:43] Speaker 02: And I think your question, in the top side of the argument, is there any evidence in the record that they... A screenshot was presented to the jury that in 2015, these press releases were still on the Teva website. [00:33:55] Speaker 03: That's not correct, Your Honor. [00:33:56] Speaker 03: That's not correct? [00:33:57] Speaker 03: That screenshot is not of the press release. [00:33:59] Speaker 03: So what is it a screenshot of? [00:34:00] Speaker 03: It's a screenshot of another thing from Teva's website, a different exhibit that refers to generic carbidolol. [00:34:10] Speaker 02: So are you saying the jury was never made aware that Teva put press releases on its website? [00:34:16] Speaker 03: I am saying that. [00:34:17] Speaker 02: The jury was never told Teva puts press releases on its website in any way, shape, or form? [00:34:21] Speaker 03: Never. [00:34:23] Speaker 02: But even if the jury wasn't told that Teva puts press releases on its website, you've got a doctor that says we read them. [00:34:29] Speaker 02: that it influences us, why can't the influence that occurred right beforehand, if not retracted later, especially when combined with all the future marketing efforts by Teva, which touted its AB rating, which you and I both agreed means therapeutically equivalent, without condition, without limitation. [00:34:51] Speaker 03: I didn't say that without condition, Your Honor, because that's not correct. [00:34:54] Speaker 03: It's AB rated. [00:34:55] Speaker 03: It's very clearly equivalent as labeled. [00:34:57] Speaker 03: As labeled. [00:34:58] Speaker 03: That's what it means. [00:34:59] Speaker 02: Therapeutically equivalent of the label? [00:35:01] Speaker 02: OK, so then how about the full label period? [00:35:03] Speaker 03: So that would be a different case. [00:35:06] Speaker 03: And I'm happy to turn to the full label. [00:35:08] Speaker 03: No, that's this case. [00:35:08] Speaker 03: Well, respectfully, Your Honor, I'm not sure what you wanted to talk about the press releases. [00:35:12] Speaker 03: If we want to turn to the full label, GSK had an opportunity to prove. [00:35:17] Speaker 03: And I think as the chief judge's question brought out. [00:35:20] Speaker 02: To the jury. [00:35:20] Speaker 02: They had an opportunity to prove. [00:35:21] Speaker 03: Yes, they had an opportunity to prove to the jury. [00:35:24] Speaker 02: And they did, based on the jury verdict. [00:35:26] Speaker 03: We're not sure. [00:35:27] Speaker 03: What do you mean you're not sure? [00:35:28] Speaker 02: The jury found for them. [00:35:30] Speaker 03: Sure, the jury returned a verdict in their favor. [00:35:31] Speaker 03: Yes, I'm not here to dispute that. [00:35:35] Speaker 03: Seems like a good choice. [00:35:36] Speaker 03: The evidence was from all sides experts, including Dr. McCullough, that nobody's prescribing behavior changed when the label was changed in 2011 because the doctors had had the benefit of not only 10 years with GSK's product, which had become the standard of care, and Dr. McCullough agreed that the American College of Cardiology guidelines and the other professional... I'm quite frankly baffled. [00:36:02] Speaker 02: I can't imagine a stronger case for induced infringement. [00:36:06] Speaker 02: You've got a label telling doctors to give it for congestive heart failure. [00:36:11] Speaker 02: You've got press releases by the company repeatedly saying either give it for heart failure or it's equivalent to things you should give for heart failure. [00:36:20] Speaker 02: You've got product catalogs that say we are AB rated with core egg, which means we are equivalent. [00:36:25] Speaker 02: I can't for the life of me, at least for the full label period, imagine a stronger case for inducement. [00:36:31] Speaker 02: And so the jury found, not at all to my surprise that there was inducement here, [00:36:36] Speaker 02: And it got flipped on Gmail. [00:36:37] Speaker 02: And I'm bewildered as to how you accomplished that. [00:36:40] Speaker 03: So a couple of things, Your Honor. [00:36:41] Speaker 03: So first on the full label, this would have been a different case if Teva had launched with the full label, as opposed to switching to the full label four years. [00:36:50] Speaker 02: The jury was given both periods separately on interrogatories. [00:36:54] Speaker 03: That's right. [00:36:56] Speaker 03: And it was instructed for both periods that it had to establish that TEVA, as opposed to other factors, that's the language of the jury instruction, had caused the infringing behavior by the doctors. [00:37:09] Speaker 03: And the evidence for the full label period was that doctors did not change their prescribing behavior. [00:37:15] Speaker 03: TEVA's market share did not go up at the time it changed its label. [00:37:18] Speaker 03: It went down. [00:37:19] Speaker 03: GSK's market share did not change at the time that Teva and another generic switched to a full label in 2011. [00:37:26] Speaker 03: So I think it would have been a different case if Teva had launched with the full label, but it didn't. [00:37:30] Speaker 03: You said 2001 meant 2011. [00:37:31] Speaker 03: I did. [00:37:32] Speaker 03: I did, Your Honor. [00:37:33] Speaker 03: Thank you. [00:37:36] Speaker 03: And the other point I wanted to make in response to your point about this being a strong case because it was AB rated, everyone concedes [00:37:46] Speaker 03: Both sides agree. [00:37:47] Speaker 03: And Ms. [00:37:48] Speaker 03: Brooks conceded this in her argument to the district court at J-Mall five times that launching with just hypertension, so labeled just for hypertension, would not be inducing, would not violate anything. [00:38:01] Speaker 03: And the AB rated language would have been exactly the same for products labeled for hypertension. [00:38:07] Speaker 03: They would still have been AB rated. [00:38:08] Speaker 02: But when you say she said this to the district, she didn't say this to the jury. [00:38:11] Speaker 02: She never told the jury, did she, that launching with just [00:38:16] Speaker 02: A label that doesn't say hyper, that doesn't say CHF would have not been an inducement. [00:38:24] Speaker 02: Did she? [00:38:24] Speaker 02: Did she say that to the jury? [00:38:26] Speaker 02: You said she said it five times to the district court. [00:38:28] Speaker 02: She never said it to the jury, did she? [00:38:29] Speaker 03: Right. [00:38:29] Speaker 03: They've taken the legal position that an- It's not a legal position. [00:38:32] Speaker 02: I think that's where we differ. [00:38:33] Speaker 02: It's a factual position. [00:38:34] Speaker 02: The factual position is, is there substantial evidence upon which a jury could have concluded there's inducement? [00:38:39] Speaker 02: And inducement is a question of fact. [00:38:41] Speaker 02: So the question of fact that went to the jury is, is there inducement? [00:38:44] Speaker 02: I think the jury could have concluded it based on the releases alone. [00:38:47] Speaker 02: It does not matter to me that she argued her position poorly to the district court judge in a legal discussion. [00:38:53] Speaker 02: because this is a fact question and the jury was free based on the jury instructions jury instruction didn't say it has to be in the label did it the jury instruction no correct so the jury could have rightly concluded under my view of the law which we'll say is the correct one the jury could have rightly concluded [00:39:11] Speaker 02: that there was inducement presented based on all of these facts. [00:39:14] Speaker 02: And it's pretty much irrelevant what she argued to the judge in Jane Maul. [00:39:17] Speaker 03: Well, but Your Honor, I would just point out, in your question, you pointed on your view of the law. [00:39:21] Speaker 03: And I guess I'm pointing out that that's not GSK's view of the law or our view of the law, because the law of how carve-outs operate is that- Wait, your view of the law is for someone to prove induced infringement, there has to be a label. [00:39:33] Speaker 02: It wouldn't be enough. [00:39:34] Speaker 02: Suppose there were 10 press releases, all say, use it for hypertension. [00:39:37] Speaker 02: There still has to be a label that, I mean, use it for CHF. [00:39:40] Speaker 02: There still has to be a label that says it? [00:39:42] Speaker 03: No, I'm not saying that. [00:39:44] Speaker 02: OK, so the label doesn't have to be present for a fact finder to conclude there's inducement if there's other evidence. [00:39:48] Speaker 03: I'm zeroing in respectfully, Your Honor, on the point that you made about AB rated generic equivalent. [00:39:54] Speaker 03: And all of that would have been exactly the same under a label. [00:39:59] Speaker 03: Set the press releases aside for a moment. [00:40:00] Speaker 03: I understand why that's different. [00:40:02] Speaker 03: But all of the evidence that actually is from the period of time when the patent was in force, [00:40:09] Speaker 03: All of that, referring to A-B rated generic equivalent, all of that would have been exactly the same under a label, a partial label, that everyone would have agreed is not inducing. [00:40:22] Speaker 03: And that all of the same sales. [00:40:24] Speaker 02: You say everyone would have agreed. [00:40:26] Speaker 02: Yes. [00:40:27] Speaker 02: First up, she does not agree that the skinny label is not inducing. [00:40:30] Speaker 03: No, a hypertension only label. [00:40:33] Speaker 03: I've never heard, GSK doesn't, literally doesn't. [00:40:37] Speaker 02: Would the label have the words only? [00:40:39] Speaker 03: It would have the only indication in that label would have been hypertension. [00:40:45] Speaker 03: In other words, everything else would have been carved out. [00:40:47] Speaker 02: Well, you guys can all agree to that, but that's not the law. [00:40:50] Speaker 03: and agree to what's not the law, Your Honor? [00:40:52] Speaker 02: You can agree if you want that if the label only says the word hypertension, not only hypertension, that maybe that wouldn't have amounted to inducement, but that's not the law. [00:41:01] Speaker 02: That's not the law. [00:41:01] Speaker 02: The law is inducement can be determined based on circumstantial evidence, which can go to a jury. [00:41:07] Speaker 02: And if there was no label, or if the label just said hypertension, but yet all of the press releases and Teva's clearly expressed intent was to tell the world, oh, you can also use it for heart failure. [00:41:17] Speaker 02: That could have been enough, even if the label just said the word hypertension. [00:41:21] Speaker 03: As I said, Your Honor, I agree that the press releases are different, but let's go step by step. [00:41:26] Speaker 02: But we have the press releases here, so you can't sort of exclude them from the body of evidence. [00:41:31] Speaker 03: Respectfully, Your Honor, I absolutely can, because they are not from the time period when GSK had the patent. [00:41:36] Speaker 03: This patent issued in 2008. [00:41:37] Speaker 03: There is not a shred of evidence that anyone saw these press releases during the [00:41:42] Speaker 03: time period when the patent was enforced. [00:41:45] Speaker 03: None. [00:41:46] Speaker 02: None at all. [00:41:46] Speaker 02: I'm sorry. [00:41:46] Speaker 02: What was the time period you said? [00:41:48] Speaker 03: These press releases are from 2004 and 2007. [00:41:51] Speaker 03: This patent issued in 2008 and expired in 2015. [00:41:56] Speaker 03: So this trial occurred after that. [00:42:00] Speaker 02: So why couldn't these press releases, which doctors read and influence their prescribing descriptions, when not recanted at all, [00:42:11] Speaker 02: When there's product catalogs that come out and advertising thereafter talking about how we're AB rated and we're a generic equivalent of Core Egg in the abstract, why isn't that enough? [00:42:23] Speaker 03: The AB rated is not enough, I think, for the reasons that I've been trying to give, that any therapeutically equivalent product, whether or not anyone is trying to get it to be marketed for the carved out use, that's still AB rated. [00:42:38] Speaker 03: Marketing something. [00:42:38] Speaker 02: But we know here Teva's trying to get it to be used for the carved out use, because there's a mountain of evidence that says so. [00:42:44] Speaker 02: So then when they further say AB rated on top of it, [00:42:48] Speaker 02: Maybe AB rated standing alone all by itself with nothing else wouldn't be enough. [00:42:52] Speaker 02: Maybe a jury would reject that. [00:42:54] Speaker 02: That would, of course, be up to a jury, not up to me. [00:42:56] Speaker 03: I don't think so, Your Honor. [00:42:57] Speaker 03: I don't think it would be sufficient for – I don't think a reasonable jury confronted only with a skinny label and AB rating could return the verdict. [00:43:04] Speaker 03: That would not be within the bounds of what a reasonable jury could do. [00:43:07] Speaker 03: with nothing else. [00:43:08] Speaker 03: Now, GSK, I think, decided to put on a case that was not focused just on that. [00:43:15] Speaker 03: They decided to add all these extrinsic things. [00:43:18] Speaker 03: And I think your question's appropriately focused on those. [00:43:22] Speaker 03: You mentioned the catalogs. [00:43:23] Speaker 03: GSK attempted to, but did not show that doctors rely on the catalogs. [00:43:28] Speaker 03: I think the chief judge's questioning brought this out in the top half of the argument. [00:43:31] Speaker 02: That's just not what they did. [00:43:32] Speaker 02: I have your argument. [00:43:33] Speaker 02: Why don't you, for just a minute, talk about the lost profits case, please? [00:43:36] Speaker 02: Sure. [00:43:37] Speaker 02: Is that OK? [00:43:38] Speaker 02: Yes, sorry. [00:43:39] Speaker 03: Be happy to, Your Honor. [00:43:40] Speaker 03: So my friend on the other side said in the top half of the argument that this is basically about whether GSK would have captured these sales. [00:43:51] Speaker 02: Assuming that they've shown that... But your argument, as I understand it, is GSK wouldn't have captured the sales. [00:43:58] Speaker 02: They would have gone to other generics, not Teva. [00:44:01] Speaker 02: if Teva had been pulled off the market. [00:44:04] Speaker 02: But if the argument is that those other generics would have been infringing alternatives when they were being prescribed for CHF, then how is that relevant under Panduit? [00:44:18] Speaker 03: so under grain processing you look at what can what steps can be taken to avoid infringement and The step that I think as we as you and I have been talking about your honor That every every one of those generics could do to avoid infringement is simply to launch with a hypertension only label if GSK had asserted that its position that this that a a [00:44:43] Speaker 03: carve out that included the post-MILVD indication infringes, then they could have carved out further. [00:44:49] Speaker 03: They could have carved out down to hypertension. [00:44:51] Speaker 03: And as a consequence, all of the sales, when a doctor writes either Corig or Corvidolol on a prescription pad, and that goes to the pharmacy, under generic substitution laws, those would all have been filled by the available generics. [00:45:08] Speaker 02: And that would be an active infringement? [00:45:10] Speaker 03: No, Your Honor. [00:45:11] Speaker 02: Really, they have a patent. [00:45:13] Speaker 02: They're the exclusive use of this drug for congestive heart failure. [00:45:18] Speaker 02: So if a doctor prescribes a generic for congestive heart failure, isn't that in direct infringement? [00:45:25] Speaker 02: An act of direct infringement. [00:45:27] Speaker 03: So GSK would be in touch? [00:45:28] Speaker 02: It's a yes or no question. [00:45:29] Speaker 02: If they have a patent, [00:45:31] Speaker 02: exclusive rights on the use of this drug for congestive heart failure. [00:45:35] Speaker 02: If a doctor then prescribes a generic for congestive heart failure, is the doctor directly infringing their patent? [00:45:46] Speaker 03: So it doesn't have to be prescribing a generic because doctors don't prescribe generics. [00:45:50] Speaker 02: No, they just use the word carbiterol, and that would be sufficient. [00:45:53] Speaker 03: Yeah, so that would be an act of infringement. [00:45:55] Speaker 03: But the question is whether GSK is entitled to any more than a reasonable royalty for that infringement. [00:46:07] Speaker 02: So therefore, every sale by a generic which has been prescribed for the purposes of congestive heart failure amounts to an infringing sale. [00:46:16] Speaker 02: Every sale, you just admitted that if a doctor writes a prescription to use carbidrol for congestive heart failure, and if a generic is used to fill that prescription, that amounts to infringement. [00:46:29] Speaker 02: So every sale by the generic [00:46:31] Speaker 02: for that use amounts to infringement. [00:46:33] Speaker 02: So those are all infringing sales under Panduit. [00:46:37] Speaker 02: Those are not to be considered when you're assessing lost profits. [00:46:40] Speaker 02: Look, the fact that GSK only has a small percentage of this market compared to 100%, and I mean for the CHF use, obviously. [00:46:48] Speaker 02: All the other uses were long since off patent. [00:46:50] Speaker 02: So the fact that they only have a small percentage because eight or 13 generics infringed their patent, I don't see how in the world [00:46:59] Speaker 02: The argument by you could be, other people were infringing too, so we shouldn't be liable to them for their lost sales by us. [00:47:06] Speaker 03: So a couple of points, Your Honor. [00:47:08] Speaker 03: So you asked, would it be an infringing sale? [00:47:11] Speaker 03: So the doctor is committing an act of infringement by writing the prescription. [00:47:14] Speaker 03: But of course, the doctor isn't selling the drug, right? [00:47:17] Speaker 03: So the question is, [00:47:19] Speaker 03: Are any of those sales caused by inducement and is there, in order to avoid overcompensating GSK, so under grain processing. [00:47:31] Speaker 02: How are they overcompensated when you have to pay them 100% of their lost profits on only the drugs you sold wrongly? [00:47:39] Speaker 02: How are they overcompensated? [00:47:40] Speaker 03: They're overcompensated, Your Honor, because as the statute says, they're entitled to compensation for the infringing use. [00:47:47] Speaker 02: Correct, as defined by, and we went further, we then have Panduit and a million cases thereafter that have articulated a four-part test for how we assess lost profits. [00:47:56] Speaker 03: So what the court has also said, first, that Panduit is not used in all cases. [00:48:01] Speaker 02: Second, that Panduit is ideal for- Did you object to its use in this case? [00:48:05] Speaker 02: Did you object to the jury instructions? [00:48:06] Speaker 02: And did you appeal that objection? [00:48:08] Speaker 03: Yes, yes, and yes. [00:48:09] Speaker 03: So we moved for summary judgment. [00:48:13] Speaker 03: this discussion that you and I are having in order that that could be hashed out before the jury through competing experts. [00:48:20] Speaker 03: The district court excluded our evidence and denied our motion for partial summary judgment. [00:48:27] Speaker 03: We preserved an objection to all of the jury instructions based on the positions that we had taken at summary judgment. [00:48:32] Speaker 03: And we filed a notice of cross-appeal and a brief in this court. [00:48:35] Speaker 03: So yes, yes, and yes to all of your questions. [00:48:38] Speaker 02: But I understood your cross-appeal to be [00:48:41] Speaker 02: that the infringing sales by generics somehow don't affect loss profits analysis. [00:48:51] Speaker 03: So when generics have a product on the market that is lawfully labeled for a non-infringing use. [00:49:02] Speaker 02: What about the ones on the market during the time period of the full label? [00:49:05] Speaker 03: So that's not the question. [00:49:10] Speaker 02: You presuppose it is lawfully labeled for other uses. [00:49:16] Speaker 02: No. [00:49:17] Speaker 03: I'm not. [00:49:18] Speaker 03: We're talking about the but for world. [00:49:20] Speaker 03: We're talking about what would have happened but for the circumstance that labeling your product as the generics did either during the partial label period or during the full label period is infringing. [00:49:32] Speaker 03: And under green processing, what you look to is what steps the generics could have taken, here the accused infringer could have taken, to avoid infringement. [00:49:42] Speaker 03: And simply by changing a label, [00:49:44] Speaker 03: And we're not just talking about Teva. [00:49:46] Speaker 03: We're talking literally about any one of the eight generics that launched during this period By if GSK had asserted its patent Everyone had carved out even further down to a hypertension level GSK would not have captured any any of those sales That's why what GSK is entitled to a reasonable role. [00:50:04] Speaker 02: Why wouldn't GSK capture any sales of the product? [00:50:09] Speaker 02: for CHF [00:50:10] Speaker 03: Because if a doctor writes a prescription for take this twice a day for CHF and gives the how many milligrams and so on, they take it to the pharmacy and it's filled. [00:50:25] Speaker 03: Even if a generic, let's take Teva out of the case, even if one of the other generics has labeled each product. [00:50:32] Speaker 02: Each of those would be an active infringement. [00:50:33] Speaker 03: No, Your Honor. [00:50:35] Speaker 02: I mean, it wouldn't, because that other generic is not- Whether the act of infringement is by the pharmacist who substitutes the drug he's not allowed to give because there's patent protection, whether the act of his infringement is by the doctor who writes the prescription in a manner to cause the generic to be substituted, or whether the act of infringement is by the company that is selling it, encouraging people to use it for this purpose. [00:51:02] Speaker 02: All of those amount to acts of infringement. [00:51:04] Speaker 02: So none of them should be carved out when you're considering what the pool is for damages. [00:51:10] Speaker 02: I don't understand. [00:51:11] Speaker 02: Your argument boils down to you want other generics who are also infringing. [00:51:18] Speaker 02: You're saying they would have gotten the sales, not Glaxo. [00:51:21] Speaker 02: I don't doubt you that that's what would have happened in the world. [00:51:24] Speaker 02: But all of those are infringing sales. [00:51:27] Speaker 02: So they're not relevant for lost profits. [00:51:30] Speaker 03: They're not infringing sales, Your Honor, because a sale, no one is being sued for infringing for selling or offering to sell, to use the words of the Patent Act. [00:51:42] Speaker 03: The act of infringement is practicing steps of the method. [00:51:45] Speaker 03: So there is not an infringing sale. [00:51:47] Speaker 03: The question is whether [00:51:49] Speaker 03: the sellers of the product that wind up being administered to the patient, whether they are complicit in the infringement, either from contributory infringement, which we know doesn't work here because only 17% at the maximum of uses are infringing, or through inducement. [00:52:07] Speaker 03: And so when you have generics on the market that have not been accused of inducement, [00:52:11] Speaker 03: that didn't issue press releases or anything of that sort. [00:52:17] Speaker 03: But that's the but for world that we wanted to prove to the jury existed. [00:52:21] Speaker 03: And we were not allowed to do that because of the perception, as you're asking me about, that every- Because the district court judge had the same misperception that I do about what Panduit says and what the law is. [00:52:35] Speaker 02: That's why you weren't allowed to do it. [00:52:37] Speaker 03: The district court relied exclusively on Panduit. [00:52:40] Speaker 03: And we are asking the court to look to its own cases, including BIC, that say that Panduit is not the beginning and end of the analysis. [00:52:48] Speaker 01: Thank you. [00:52:54] Speaker 00: Thank you. [00:52:54] Speaker 00: Very briefly, let's start with the website, appendix 10991. [00:53:00] Speaker 00: Teva's witness Collier was asked the following question. [00:53:02] Speaker 00: So OK, so Teva had a website in 2007. [00:53:06] Speaker 00: Is that correct? [00:53:07] Speaker 00: answer correct and as part of the launch in 2000. [00:53:09] Speaker 00: Sorry, but you got a 10 what? [00:53:11] Speaker 00: 10, I'm sorry, Your Honor, 10-9-9-1. [00:53:13] Speaker 00: Appendix 10-9-9-1. [00:53:19] Speaker 00: And as part of the launch in 2007, you added Carbitolol product information to the website. [00:53:24] Speaker 00: Answer, that is correct. [00:53:25] Speaker 00: Question, and it's also true that that would have said that Carbitolol is a generic to Correg, right? [00:53:31] Speaker 00: That information would have been there. [00:53:33] Speaker 00: Answer, yes. [00:53:34] Speaker 00: Question, all right. [00:53:35] Speaker 00: And it would have said that Correg is AB rated, right? [00:53:37] Speaker 00: Answer, yes. [00:53:39] Speaker 00: Question, and it's also true that that website would not have said that Correg or Carbitolol was not indicated for congestive heart failure. [00:53:47] Speaker 00: Answer, that was not one of the improved indications in 2007. [00:53:51] Speaker 00: Question, but the website did not say that, did it? [00:53:53] Speaker 00: Answer, it did not. [00:53:55] Speaker 00: The jury heard that testimony. [00:53:56] Speaker 00: They heard the testimony of Dr. Litson. [00:53:58] Speaker 02: Yes, but I'm sorry, but I'm going to derail you, because you told me that there was a snapshot from 2015 that was presented to the jury that indicated these releases. [00:54:11] Speaker 02: That's what we were talking about. [00:54:12] Speaker 02: We're still on the Teva website, at least as of 2015. [00:54:16] Speaker 02: Were you mistaken? [00:54:17] Speaker 02: Did I misunderstand you? [00:54:18] Speaker 00: No, I'm not mistaken. [00:54:19] Speaker 00: We're still looking for it, Your Honor, because the cross of Dr. McCullough was, well, look, this snapshot was from 2015. [00:54:26] Speaker 00: How do you know it hasn't been edited since the press release came out in 2007? [00:54:30] Speaker 00: So we are continuing to look for that. [00:54:33] Speaker 02: Because he said that you were unequivocally misspeaking or wrong when you said that. [00:54:38] Speaker 00: I know that I'm not because we in our brief showed the court that obviously is not trial record. [00:54:44] Speaker 00: In our brief, we showed the court that those press releases are still on the website. [00:54:48] Speaker 00: And we add a link to our brief to that effect. [00:54:51] Speaker 00: So the court or showed the jury? [00:54:54] Speaker 00: Both. [00:54:54] Speaker 00: We showed the jury in 2015, and we're looking for that site, Your Honor. [00:54:58] Speaker 00: And in our brief, we showed this court that they're still on the website, as at the time of the writing of the brief. [00:55:03] Speaker 00: And we attached a link. [00:55:03] Speaker 02: But that's not relevant if it wasn't before the record. [00:55:06] Speaker 00: Understood, Your Honor. [00:55:06] Speaker 00: That's why we're looking for the other citation. [00:55:08] Speaker 00: But to go back, and my colleague here is, we'll find it before I finish, and I have very little time. [00:55:16] Speaker 00: What also the jury heard, Dr. Liston testified at 10-545. [00:55:20] Speaker 00: Does the FDA take any positions about product comparison? [00:55:23] Speaker 00: Answer, yes. [00:55:24] Speaker 00: The agency's general position is that if you compare one product to another by name, you are implying the use of the product. [00:55:31] Speaker 00: The jury also heard evidence at appendix 11659 and appendix 11660 about the 2007 press release. [00:55:41] Speaker 00: Dr. McCullough was specifically asked [00:55:43] Speaker 00: Now, what did that tell you, referring to the press release Dr. McCullough and your colleagues as a physician, about what Teva's generic carbidolol, what indications it could have been used for, answer? [00:55:54] Speaker 00: It could be used for all indications. [00:55:57] Speaker 00: Question, would that include heart failure in your mind? [00:55:59] Speaker 00: Answer, sure. [00:56:00] Speaker 00: Question, well, I don't see the words heart failure in this particular press release. [00:56:04] Speaker 00: What made you think that Teva's generic carbidolol had been approved for the treatment of congestive heart failure? [00:56:09] Speaker 00: Answer, the use of the term cardiovascular agent. [00:56:13] Speaker 00: And then if we go to appendix 11661 and 11662, Dr. McCullough was asked, so do you or do you not rely on the information you get from the generic as to whether or not they are truly a generic equivalent of the original brand? [00:56:32] Speaker 00: Answer, we are completely reliant on what they provide to us. [00:56:35] Speaker 00: That's what the jury heard. [00:56:37] Speaker 00: The jury also heard at appendix 11656, as far as the 2004 press release, [00:56:43] Speaker 00: I said, we don't want to reinvent the wheel here. [00:56:46] Speaker 00: Is your testimony that you actually saw this press release, is that right? [00:56:51] Speaker 00: Answer, yes. [00:56:53] Speaker 00: Then we go to appendix 10670 on cross-examination. [00:56:58] Speaker 00: Dr. McCullough was asked, and you think that doctors would have seen this press release, right? [00:57:03] Speaker 00: Answer, yes. [00:57:05] Speaker 00: Question, because doctors care when generics get launched because it saves [00:57:10] Speaker 00: their patient's money, right? [00:57:11] Speaker 00: Answer, yes, I agree with that. [00:57:13] Speaker 00: Jury heard all of that, hence why they returned the verdict they did. [00:57:17] Speaker 00: Counsel then switches to the full label. [00:57:20] Speaker 00: And the explanation for why that's not inducing is because Tebbit's market share did not change when they went to full label in 2011. [00:57:28] Speaker 00: That actually just shows you that Tebbit had already induced doctors to prescribe genericarbitolol for the treatment of Pinchessa. [00:57:34] Speaker 01: This is about the labels? [00:57:36] Speaker 01: OK, so I just got your way ahead of me, which is fine, because you've got limited time. [00:57:40] Speaker 01: But I'm looking at 10670 and 10671. [00:57:44] Speaker 01: And 10671 looks to me like Dr. McCullough is saying he looked for Teva's product, right? [00:57:54] Speaker 01: You haven't analyzed the labels of any of these other generics. [00:57:57] Speaker 01: You don't know what they say, right? [00:57:59] Speaker 01: Well, in the context of my work in this case, Teva is the generic company. [00:58:04] Speaker 01: So I have reviewed your label, right? [00:58:06] Speaker 00: Yeah, but I was actually citing the press release testimony on the previous page. [00:58:10] Speaker 01: I'm sorry. [00:58:10] Speaker 00: I thought you were telling me. [00:58:12] Speaker 00: Yes, at page 10669. [00:58:14] Speaker 00: This is on cross examination. [00:58:16] Speaker 00: He's shown the press release from 2007 on cross and He's asked and you think on 106 70 and you think the doctors would have seen this press release right answer Yes, because doctors care when generics get launched because it saves their patients money right answer. [00:58:33] Speaker 00: Yes I agree with that and so even on cross he said doctors look at press releases including him [00:58:39] Speaker 00: To just address the last comment by council as to why Teva's market share did not increase when it went full label in 2011, that is proof actually that they had already successfully induced physicians to prescribe generic carvitalol to treat congestive heart failure as early as 2008, which is when the patent issued. [00:58:59] Speaker 00: Thank you. [00:59:00] Speaker 00: Oh, and Your Honor, here we go. [00:59:02] Speaker 00: Thank you. [00:59:04] Speaker 00: It's appendix, as far as it being up on the website, it's appendix 6353. [00:59:11] Speaker 00: And it's September 6, 2007. [00:59:15] Speaker 00: So I'll let the court get to that so everybody can be on the same page. [00:59:21] Speaker 00: Your Honors, don't mind that I'm into my time here. [00:59:25] Speaker 00: It's appendix 6353. [00:59:27] Speaker 02: That's the 2007 release. [00:59:30] Speaker 00: Yes, Your Honor. [00:59:30] Speaker 00: And if you look at the appendix [00:59:34] Speaker 00: Bottom right, it shows April 14, 2015. [00:59:37] Speaker 00: I see. [00:59:38] Speaker 02: So that is the evidence. [00:59:41] Speaker 02: This is the actual document that was presented to the jury, and it shows that it was pulled from the Teble website on April 14, 2015. [00:59:49] Speaker 02: Yes, Your Honor. [00:59:50] Speaker 02: So the jury had in front of it, very clearly, the idea that as of 2015, this release was still accessible on the Teble website. [00:59:57] Speaker 00: Correct, Your Honor. [00:59:58] Speaker 00: Got it. [00:59:59] Speaker 00: Thank you. [01:00:00] Speaker 00: And I think the exhibit number actually is in the preceding page at 6352, is the actual exhibit number. [01:00:06] Speaker 00: Thank you. [01:00:06] Speaker 01: Thank you. [01:00:08] Speaker 01: So since, as far as I can tell, we haven't heard anything on the cross-appeal, that time's gone. [01:00:15] Speaker 01: Thank both sides and the cases.