[00:00:00] Speaker 01: The United States Court of Appeals for the Federal Circuit is now open and in session. [00:00:05] Speaker 01: God save the United States and this honorable court. [00:00:09] Speaker 04: The case for argument this morning is 18-1976, GlaxoSmithKline versus Teva Pharmaceuticals. [00:00:18] Speaker 04: Ms. [00:00:18] Speaker 04: Brooks, welcome back. [00:00:21] Speaker 04: I was recalling this morning that we were all in the same courtroom the last time we heard this case, so we can guess about how long ago that was. [00:00:29] Speaker 04: In any event, please proceed. [00:00:31] Speaker 03: Thank you very much, Your Honor, and good morning, everyone. [00:00:36] Speaker 03: May it please the court? [00:00:37] Speaker 03: On Friday, Teva filed a notice of supplemental authority citing two additional cases. [00:00:43] Speaker 03: Neither of those cases are applicable here. [00:00:45] Speaker 03: The HZNP case is a paragraph four case where the patented method of use had never been approved by FDA, so it had never been on the label. [00:00:56] Speaker 03: Grunenthal is inapplicable because it deals with a true Section 8 carve out. [00:01:02] Speaker 03: That is, the generic had carved out all the patented uses from the label and the only uses remaining on the label were unpatented. [00:01:12] Speaker 03: That is not our case. [00:01:14] Speaker 03: Teva never did that. [00:01:17] Speaker 04: Well, let me ask you about if I could just follow up with that. [00:01:19] Speaker 04: I'm sorry to interrupt. [00:01:20] Speaker 04: But so your position is this case might very well be extremely different if this were a true skinny label. [00:01:28] Speaker 04: So what makes this case different is it's not a skinny label. [00:01:31] Speaker 04: It's a partial label. [00:01:33] Speaker 04: Correct, Your Honor. [00:01:34] Speaker 03: That is absolutely right. [00:01:36] Speaker 03: That's why we've never referred to the label as the skinny label, because it's not. [00:01:40] Speaker 03: It is a partial label. [00:01:42] Speaker 04: And just to reemphasize, so the issue and the outcome might well be different in the analysis if it were a skinny label case. [00:01:50] Speaker 04: Correct, Your Honor. [00:01:52] Speaker 04: Okay, let me ask you then about, I'm sorry, go ahead. [00:01:55] Speaker 03: I was just going to try to explain to the court how we got here. [00:01:58] Speaker 03: So on GSK's label, there were two heart failure indications, indication 1.1 and indication 1.2. [00:02:07] Speaker 03: TEVA, on its partial label, [00:02:10] Speaker 03: only carved out the first one and not the second one. [00:02:15] Speaker 03: Well, let me ask you about that. [00:02:16] Speaker 04: Just to be clear, I'm looking at JA 6881 and 6882, which is what I understand to be the declaration you submitted to the FDA in 2008 under penalty of perjury when you listed the triple O reissue in the Orange Book and delisted the 69 patent. [00:02:39] Speaker 04: Is that correct? [00:02:40] Speaker 03: That is correct, Your Honor. [00:02:42] Speaker 04: And if you compare that to JA7992, which is the 2003 GSK label, that includes at 7992 three separate indications listed. [00:03:03] Speaker 04: I don't understand, and your position in the briefs was that the use code, decreasing mortality caused by congestive heart failure, meant both indications and two, wasn't tied to any particular indication. [00:03:19] Speaker 04: I don't understand how that's even plausible. [00:03:22] Speaker 04: If you look at the bottom of 6881, I'll give you a chance to respond, I just want to get it. [00:03:27] Speaker 04: If you look at 6881, box 42A, [00:03:32] Speaker 04: And this is dealing with the FDA 2008 000 reissue. [00:03:38] Speaker 04: That box asks you to identify the use with specific reference to the approved labeling. [00:03:44] Speaker 04: And then you write this long sentence, which you'll see. [00:03:47] Speaker 04: And it seems to me that the answer in box 4.2a, the language is extremely specific. [00:03:57] Speaker 04: And it differs from what you filed in 2003. [00:04:02] Speaker 04: So you had enough room to put the LVD stuff in that box, and you didn't. [00:04:10] Speaker 04: You listed one indication, but not the other two indications that you had previously listed. [00:04:16] Speaker 04: Why isn't that sufficient to take away that this is a section or a carve out? [00:04:22] Speaker 04: If you hadn't written your use code, if you had written your use code to expressly include the post-MILVD indication, I don't think we'd be here today because Teva would have either had to bring a paragraph four for the full label and sorted out all the stuff pre-launch, or it could have carved out only hypertension. [00:04:44] Speaker 04: So now I'll let you respond. [00:04:45] Speaker 04: I'm sorry to interrupt. [00:04:46] Speaker 03: Thank you, Your Honor. [00:04:47] Speaker 03: No problem. [00:04:47] Speaker 03: So Ashley, Your Honor, [00:04:49] Speaker 03: the indication that is listed at 6881 covers both indications 1.1 and 1.2 because it is missing critical language that appears only in indication 1.2 that would not apply to, I'm sorry, [00:05:08] Speaker 03: appears only in Indication 1.1 that would not apply to Indication 1.2. [00:05:14] Speaker 03: So if we look, for example, at Appendix 5532, that's Keva's full label where they put the carved out indication back on. [00:05:25] Speaker 03: And you see Indication 1.1, it talks about heart failure. [00:05:29] Speaker 03: And it talks about how carbidolol tablets are indicated for the treatment of mild to severe chronic heart failure. [00:05:37] Speaker 03: So let me stop right there and go back to Appendix 6881. [00:05:42] Speaker 03: The word chronic is missing from that. [00:05:44] Speaker 03: And there's a specific reason why, because indication 1.2, the left ventricular dysfunction following myocardial infarction, is not talking about chronic heart failure, because these patients are just beginning to suffer from heart failure as a result of having had a heart attack. [00:06:03] Speaker 03: So that word chronic does not appear on the use code form. [00:06:09] Speaker 03: More importantly, if we look back... Well, let me ask you about that just before we lose that point. [00:06:14] Speaker 04: But I started off with comparing this to your 2003 submission. [00:06:19] Speaker 04: And in that submission where you list three separate indications, aren't the words the same? [00:06:25] Speaker 03: I would have to go back and look, Your Honor, but what... I'll tell you where it is. [00:06:33] Speaker 04: Sorry. [00:06:38] Speaker 04: 7992. [00:06:40] Speaker 04: That's where you listed in 2003. [00:06:50] Speaker 04: It's the label. [00:06:52] Speaker 04: And I think what you listed under congestive heart failure for that indication is precisely the language you listed under the 42A that we're talking about. [00:07:07] Speaker 03: So I'm having trouble finding that your honor, but I know this appendix is terrible because it doesn't go in chronological order. [00:07:15] Speaker 03: It's a horrible time to your honor, perhaps I can clear this up by not just focusing on the word chronic. [00:07:22] Speaker 03: There's another phrase that is left off at six, eight, eight, one, which is where your honor referred me to look at. [00:07:30] Speaker 03: Okay. [00:07:30] Speaker 03: It says it ends with to increase survival. [00:07:34] Speaker 03: Now, if we go back again to look at the heart failure indication 1.1, we see yet more words at the end. [00:07:42] Speaker 03: It says to reduce the risk of hospitalization. [00:07:46] Speaker 03: That is not on this form, the use form. [00:07:49] Speaker 03: And again, there's a reason for that. [00:07:51] Speaker 03: If I could just give the court a quick background of how we got here. [00:07:55] Speaker 03: GSK performed three studies to get approval for two heart failure indications. [00:08:02] Speaker 03: For the heart failure indication 1.1, they conducted a study called COMET and a study called Copernicus. [00:08:09] Speaker 03: And that was on patients who were suffering from mild to severe chronic heart failure. [00:08:15] Speaker 03: And it showed that it not only increased survival, which is the language that you can find in the heart failure indication, but it also reduced the risk of hospitalization. [00:08:26] Speaker 03: Then GSK conducted a third clinical trial called Capricorn. [00:08:32] Speaker 03: And Capricorn was done on patients who had recently suffered a heart attack. [00:08:38] Speaker 03: And as a result, their left ventricle was damaged, causing heart failure. [00:08:43] Speaker 03: Now, those patients had been excluded from Comet and Copernicus. [00:08:47] Speaker 03: So now they did the Capricorn study. [00:08:50] Speaker 03: And what they found in the Capricorn study that using carbidolol to treat these heart failure patients did reduce the risk of mortality from cardiovascular failure, but it did not reduce the risk of hospitalization. [00:09:06] Speaker 03: So if we look at the use code, that language is left off because it did have been put on, then it wouldn't have applied to the Capricorn study, and it wouldn't have applied [00:09:17] Speaker 03: to the 1.2 indication. [00:09:21] Speaker 04: So these studies done before 2003, I assume. [00:09:26] Speaker 03: Yes, if we could turn so that we can get from the record. [00:09:30] Speaker 03: Because remember, the question we're trying to answer here is, did the jury have substantial evidence to support its verdict? [00:09:37] Speaker 03: And I certainly, you know, it's not like it didn't show up. [00:09:40] Speaker 03: They put on some rebuttal evidence. [00:09:42] Speaker 03: But the question is, what was the substantial evidence the jury heard? [00:09:46] Speaker 03: So if we could turn, Your Honor, to the very first witness at the trial, that was Dr. Mary Ann Lucas, who testified about how these trials were conducted. [00:09:56] Speaker 03: And so if we look at Appendix 10381, that is Dr. Lucas' testimony, the first witness the jury heard. [00:10:05] Speaker 03: And we look at line 22. [00:10:08] Speaker 03: She's asked the question, now we see a trial called Capricorn from 1997 to 2002. [00:10:14] Speaker 03: What was the Capricorn trial? [00:10:16] Speaker 03: Her answer, so I guess I should have said this before, but probably, not probably clearly enough, that heart failure is continuing. [00:10:27] Speaker 03: Something happens that damages the heart. [00:10:30] Speaker 03: It doesn't necessarily happen suddenly. [00:10:32] Speaker 03: You don't start with severe heart failure, typically, and patients start with mild symptoms, then go to moderate, then go to severe. [00:10:39] Speaker 03: So the Copernicus trial we talked about was to do things that were more severe. [00:10:45] Speaker 03: And the Capricorn trial was intended to further study the earlier end. [00:10:49] Speaker 03: So these were patients whose heart failure was at the time or shortly after they actually had a heart attack, an MI, and had damaged left ventricle. [00:10:59] Speaker 03: And then, most importantly, she is shown indication 1.2, the one that Teva left on their label at all times. [00:11:08] Speaker 03: And she's asked, [00:11:09] Speaker 03: What is this? [00:11:10] Speaker 03: And she says, so this is the indication section of the prescribing information that now specifically talks about the results of the Capricorn trial. [00:11:17] Speaker 03: So it's to reduce, again, cardiovascular mortality, which is what the claim requires, describes the patients. [00:11:25] Speaker 03: They had an MI. [00:11:27] Speaker 03: They had a low ejection fraction, which again is what the claim requires. [00:11:32] Speaker 03: and they either did or didn't have symptoms. [00:11:35] Speaker 03: And I would take the court back very quickly to the court's construction in the claim term itself of congestive heart failure. [00:11:44] Speaker 03: It can be found at Appendix 6.0. [00:11:50] Speaker 03: I'm not quite sure what that meant. [00:11:52] Speaker 04: No, I'm sorry. [00:11:53] Speaker 04: That was my other phone ringing. [00:11:55] Speaker 03: Oh, yeah. [00:11:55] Speaker 03: I wasn't sure if that meant my time was up or... I'd yell at myself if we were on the bench. [00:12:00] Speaker 03: So your honor says, it's the court's construction of congestive heart failure using claim one. [00:12:06] Speaker 03: And it says the condition that occurs as a result of impaired pumping capability of the heart, which we see is 1.2, the heart has been impaired as a result of a heart attack and it's associated with abnormal retention of water and sodium. [00:12:22] Speaker 03: This was best explained again. [00:12:24] Speaker 03: What is the jury here? [00:12:25] Speaker 03: The jury heard from Teva's expert Dr. Zussman at appendix 1132, lines 10 through 16. [00:12:32] Speaker 03: He's talking about the court's construction. [00:12:35] Speaker 03: He says, here we depict the type of heart failure defined by the court. [00:12:39] Speaker 03: This is with an impaired pumping function less than 40%. [00:12:43] Speaker 03: These are the patients that's construed by the court to have congestive heart failure. [00:12:49] Speaker 03: Now we go back to indication 1.2. [00:12:52] Speaker 03: And those words are literally in that indication. [00:12:56] Speaker 03: It says for patients who have an injection fraction of less than or equal to 40%. [00:13:03] Speaker 03: So we have every limitation [00:13:06] Speaker 03: of the asserted claim can be found in the indication that Teba left on its label at all times. [00:13:13] Speaker 03: And I could walk the court through if we had more time where all the other limitations can be found. [00:13:18] Speaker 04: Well, can I, let me just, I'm certainly going to obviously ask my colleagues if they have any information because we've kind of monopolized this portion of the argument, but let me ask you one more [00:13:28] Speaker 04: completely other question which was just coming out of our first argument and I know there was some discussion in that argument and clarification on the 2000 press release. [00:13:39] Speaker 04: I think Judge Moore had asked about it and you showed us or you turned us to where in the record it was clear that that was printed out off of the computer on 2015. [00:13:51] Speaker 04: Do you recall that? [00:13:52] Speaker 04: So it was clear that it was on the computer. [00:13:55] Speaker 04: I'm just wondering, I scoured the record, and so maybe you can point me to anything in the record with regard to the 2004 press release, any evidence to show that that was remained on Teva's computer during the time of the 000 patent? [00:14:15] Speaker 04: I couldn't find anything in the record about that having remained on the computer. [00:14:20] Speaker 03: But no, Your Honor, we don't have the record evidence that the 2004 press release was still on, other than obviously we showed it to the jury and we sure didn't get it in 2004. [00:14:32] Speaker 03: But there's no, there's no exhibit like the one from 2007 press release that has a footer that shows it was on there as late as 2015. [00:14:41] Speaker 03: So Your Honor's record. [00:14:43] Speaker 03: Or as late as... Go ahead, Judge Moore. [00:14:47] Speaker 02: Can I ask a couple of questions? [00:14:48] Speaker 02: This is Judge Moore. [00:14:49] Speaker 02: My first question is, you had a witness that you cross-examined Dr. Woodford, who was the Director of Marketing. [00:14:58] Speaker 02: And is it correct that Dr. Woodford testified that Teva put all of its Carvitolol information on the website, the fact that it was AV-rated, the fact that it was equivalent to Correg, and all of that, that they put? [00:15:12] Speaker 02: She didn't specifically mention the press release, but didn't she answer your questions and indicate that they put all of their information on the website? [00:15:20] Speaker 03: Correct, your honor. [00:15:21] Speaker 02: Okay. [00:15:22] Speaker 02: And I'm sorry, please finish. [00:15:24] Speaker 03: I was just going to say as a result of that, that's how we were able to access it for the trial that occurred in 2015 is we went on to have his website and downloaded it and turned them into exhibits. [00:15:34] Speaker 03: Obviously we didn't know back in 2004 that we were going to need to keep that press release. [00:15:38] Speaker 03: So we obviously accessed it in real time in 2015. [00:15:42] Speaker 02: And in fact, Council, again, relevant to the 2004 website, the jury was presented with a press release from 2004, a press release from 2007, evidence that the 2007 press release remained on the website in 2015, and TEVA never refuted in front of the jury that either the 2004 or 2007 press releases remained on their website at any point [00:16:11] Speaker 02: Would it be fair under a substantial evidence standard for the jury to infer that Teva put its press releases on the website and remains there? [00:16:21] Speaker 03: Absolutely, Your Honor. [00:16:22] Speaker 03: And I think that's exactly what the jury did. [00:16:25] Speaker 03: I'm sorry, Your Honor, I didn't mean to interrupt. [00:16:28] Speaker 02: I know. [00:16:28] Speaker 02: I know I want to back you up for a second. [00:16:30] Speaker 02: In the very beginning, the Chief Judge asked you a couple of very quick questions, and you answered very quickly, and then she quickly moved on. [00:16:37] Speaker 02: And I just want to make sure I understand your answers to those questions. [00:16:40] Speaker 02: In the very beginning she asked, would this be a different case with a different outcome if you still did not have an infringing indication on the TEVA partial label? [00:16:51] Speaker 02: And I understood you to say yes. [00:16:53] Speaker 02: And I guess I want to give you a chance to think about that question for a minute. [00:16:57] Speaker 02: and make sure that that really was the answer you meant to give the Chief Judge, because I didn't find that answer to be completely consistent with your briefs. [00:17:05] Speaker 02: I understood your briefs to argue that the combination of product material, press releases, and everything else could amount to support for a conclusion of induced infringement, even of the partial label [00:17:19] Speaker 02: And I guess I didn't understand your answer to hinge exclusively on us concluding that the MILVD indication amounted to infringement. [00:17:28] Speaker 02: Did it? [00:17:28] Speaker 02: Do you believe there is sufficient evidence for a jury to find inducement even if we conclude that the MI, like the district court did in his footnote, that the MILVD indication does not amount to an infringement? [00:17:44] Speaker 03: No, Your Honor, and I perhaps misunderstood the Chief Judge's question. [00:17:49] Speaker 03: I thought the question was, if the post-MI LVD indication did not meet all of the limitations of the asserted claim, would this be a true skinny label case? [00:18:03] Speaker 03: And the answer, yes. [00:18:05] Speaker 03: And not that it would necessarily turn out differently, because in fact, if Teva, let's say Teva had carved even that out. [00:18:12] Speaker 03: and had just left on hypertension on the label, but had gone around to physicians, as it did, and said, we have a generic version of GSK's cardiovascular drug, Correg. [00:18:25] Speaker 03: And by the way, this is how card pill law has been used in the past. [00:18:29] Speaker 03: It's been used to treat congestive heart failure in this fashion. [00:18:33] Speaker 03: And the only thing they had on their label was hypertension. [00:18:36] Speaker 03: That's still inducement. [00:18:37] Speaker 03: Absolutely. [00:18:38] Speaker 03: And I'm sorry if I misspoke or I misunderstood the chief judge question. [00:18:43] Speaker 03: But what I was trying to point out is we have all of that evidence, which is more than substantial. [00:18:49] Speaker 03: When I say that evidence, I mean the press releases, what was on the website, the A-B rating, not in and of itself, but it's part of the evidence. [00:18:57] Speaker 03: That's one bucket. [00:18:59] Speaker 03: But another bucket is the partial label itself, which I'm afraid has gotten lost because the amici, they all seem to be concerned that this [00:19:09] Speaker 03: is a true skinny label case, and that the sky is going to fall on section 8 carve-outs because of it. [00:19:17] Speaker 03: And it's not a true skinny label case. [00:19:20] Speaker 03: At all times, this is AstraZeneca, where the court found that this wasn't a full carve-out. [00:19:28] Speaker 03: And because of that, AstraZeneca was correct, that there was going to be infringement in that case based on the label alone, because there hadn't yet been a launch. [00:19:38] Speaker 03: And that was 10 years ago. [00:19:40] Speaker 03: And nothing bad happened. [00:19:41] Speaker 03: We still have... Okay. [00:19:42] Speaker 02: Ms. [00:19:42] Speaker 02: Brooks, let me ask you something else. [00:19:45] Speaker 02: I don't know what to do with this AB rating evidence. [00:19:49] Speaker 02: The fact that Carbidrol and the generic equivalent or the Teva generic is AB rated to Correg, why [00:20:00] Speaker 02: isn't it fair for them to, why should a statement like that ever amount to induced infringement when that's in fact the way that it is referred to by the FDA and when I understand that means as labeled. [00:20:14] Speaker 02: So certainly, I mean, assuming this was a true skinny label case and there was an effective carve out, when they're holding themselves out as AB rated at that point in time, if this were a true skinny label case, [00:20:30] Speaker 02: Would you agree that can't amount to induced infringement, just a true skinny label and a claim that they're A-B rated, given my understanding that A-B rating means equivalent as label? [00:20:44] Speaker 03: I would agree with that. [00:20:46] Speaker 03: Here's what I would agree with, Your Honor, that the jury was instructed that that isn't enough. [00:20:50] Speaker 03: So if this was a true skinny label and all Teva said is we're A-B rated, the jury was instructed that's not enough. [00:20:57] Speaker 03: But we need to come back to what the question is here. [00:21:02] Speaker 03: Was there substantial evidence to support the jury's verdict? [00:21:05] Speaker 03: And the answer is yes. [00:21:06] Speaker 03: One component was the AB rating, but the other was the press releases. [00:21:11] Speaker 03: And again, if I could just go back for a moment to the label, it's very telling here. [00:21:16] Speaker 03: We keep asking, was the jury's verdict supported by substantial evidence? [00:21:22] Speaker 03: So if we could look at the verdict itself, it's in Appendix 205. [00:21:27] Speaker 03: And there were seven claims that were asserted. [00:21:31] Speaker 03: In the partial label period, the jury only found three of those seven claims to be infringed. [00:21:39] Speaker 03: During the full label period, the jury found all seven of the claims to be infringed. [00:21:44] Speaker 03: Now, the difference in proof between the partial label period and the full label period, the only difference was the content of the labels. [00:21:54] Speaker 03: And if we look, the claims the jury found were not infringed during the partial label period contained limitations that could not be found on the partial label itself. [00:22:06] Speaker 03: Whereas the three claims the jury found were infringed, every single one of those limitations of those three claims could be found on the partial label. [00:22:16] Speaker 03: And GSK's expert walked the jury through that exercise [00:22:21] Speaker 03: at Appendix 10-622 through Appendix 10-631. [00:22:27] Speaker 03: And so was there substantial evidence to support the jury's verdict during the partial label that claims 1, 2, and 3 were infringed? [00:22:35] Speaker 03: Absolutely. [00:22:36] Speaker 03: We can just look at the label itself. [00:22:38] Speaker 03: Every limitation is on the label, and we can stop right there. [00:22:41] Speaker 03: But we did, in fact, introduce additional evidence [00:22:46] Speaker 03: of Tevin's inducement. [00:22:48] Speaker 03: And so we have, I don't know if there's such a thing as more than substantial evidence, but there's certainly more than substantial evidence to support the jury's verdict. [00:22:59] Speaker 04: All right. [00:23:00] Speaker 04: I think that time has expired. [00:23:02] Speaker 04: We will, of course, restore some rebuttal time to you, Ms. [00:23:05] Speaker 04: Brooks, and let's hear from Mr. Jay. [00:23:09] Speaker 01: Thank you, Your Honor. [00:23:10] Speaker 01: May it please the court? [00:23:11] Speaker 01: As this court said in Takeda, Hatch-Waxman was designed to enable the sale of drugs for non-patented uses. [00:23:18] Speaker 01: And the carve-out provision of Hatch-Waxman was designed for just this situation where the drug is not patented and the vast majority of uses, more than 80%, are not patented. [00:23:26] Speaker 00: Let me interrupt you there because, this is Judge Newman, because the policy aspects, the interpretation of Hatch-Waxman [00:23:37] Speaker 00: and the purpose of the Section 8 carve out really I think have to underlie how these various facts are interpreted. [00:23:49] Speaker 00: And undoubtedly Hatch Waxman had a complex of interests that needed to be balanced. [00:24:01] Speaker 00: But when I interrupted you, [00:24:04] Speaker 00: you were saying that it was designed to allow the sale of drugs for non-patented uses. [00:24:12] Speaker 00: And what has concerned at least some of the amici in the briefs, in fact concerned all of them with opposing viewpoints, was how do we get there? [00:24:24] Speaker 00: And one of the things, one of the concerns that's been raised has been to be sure that we don't cut off at the pass [00:24:34] Speaker 00: the kinds of research that would develop a new use of an old drug. [00:24:41] Speaker 00: The Copernicus study and the studies that were done after the initial impact on the heart were discovered. [00:24:50] Speaker 00: If it were known that there could be no protection, I'll call it, at least through the patent system for whatever additional discoveries were made [00:25:04] Speaker 00: Would that work be done at all? [00:25:06] Speaker 00: I think it would start from the assumption that it's here, so let's not put any burdens on the use. [00:25:13] Speaker 00: But Hatch-Waxman was very much concerned with the threshold of doing the research in the first place. [00:25:20] Speaker 00: You remember Hatch-Waxman started out with the patent term extension premise because of the absence of adequate term. [00:25:31] Speaker 00: was discouraging research in some areas. [00:25:35] Speaker 00: So I think it would be very helpful to me if you would help focus on the public interest that's involved as well as the private interest of the generic producer. [00:25:49] Speaker 01: Absolutely, Your Honor, and your question is exactly right that Hatch-Waxman strikes a balance. [00:25:55] Speaker 01: It strikes a balance between the interests of the patent owner and the interests of the public in getting access to the unpatented molecule for the unpatented uses. [00:26:05] Speaker 01: And the way it strikes that balance, I think, is reflected in this court's case law about induced infringement in the carve-out context. [00:26:12] Speaker 00: Now, I was concerned about not access to an unpatented use that's been discovered and approved by the FDA, but access to the research [00:26:23] Speaker 00: that might lead to such discovery, that is, the Copernicus and Capricorn studies, whether they would have been conducted at all if it were known that the position that the generics are now taken, that it can't be protected, whether that work in the enormous investment that we're told is involved in going through phase three. [00:26:47] Speaker 01: Well, if I may, Judge Newman, the studies were conducted at a time when the [00:26:52] Speaker 01: skinny label and carve out portions of the statute worked exactly as they work today. [00:26:58] Speaker 01: And the reason that an innovator can get a patent on a new method for using an old drug, they are able to enforce that if they are able to show that the generic encourages, promotes, or recommends that patented use. [00:27:16] Speaker 01: That's the protection that the new method patent gains. [00:27:20] Speaker 01: But what my friend on the other side has not given the court this morning is anything in Teva's skinny label that encourages, promotes, or recommends every step of the method patent. [00:27:31] Speaker 01: And that is why this is a true skinny label case. [00:27:34] Speaker 04: That is why... Well, Mr. Day, just can you, in your answer, can you include a response to what Ms. [00:27:39] Speaker 04: Brooks told us this morning about GSK's patent declaration at JA 6881 and the discussion we had there? [00:27:47] Speaker 01: Absolutely, Your Honor, and I think that [00:27:50] Speaker 01: The best place to see the comparison is between 6881 and the red line on 6913 of the appendix, which is the red line prepared by FDA based on what GSK had told it were the patent protected aspects of its labeling. [00:28:11] Speaker 01: And this is what FDA communicated to TEVA to carve out. [00:28:14] Speaker 01: And you'll see that that whole indication 1.1 is struck through, including the risk of hospitalization, to reduce the risk of hospitalization language that my friend on the other side referred to. [00:28:28] Speaker 01: And as for the chronic, that was not in the label at that time. [00:28:37] Speaker 01: So you'll see that TEVA's, this red line reflects what TEVA carved out in its partial label. [00:28:44] Speaker 01: And the entirety of what GSK said were the protected aspects of its labeling are carved out from 1.1 and more. [00:28:55] Speaker 01: Other references to treating congestive heart failure are stricken out throughout the skinny label. [00:29:06] Speaker 01: So what they're left with is, and what I was about to say on page 69 and 13, [00:29:12] Speaker 01: is the 1.1 post-MILVD indication. [00:29:17] Speaker 01: And the key parenthetical is with or without symptomatic heart failure. [00:29:25] Speaker 01: So the Teva Skinny label told doctors who were treating patients who'd had a heart attack and had left ventricular dysfunction after that heart attack that this is how to treat that disorder whether or not they have symptomatic heart failure. [00:29:40] Speaker 01: And what my friends on the other side have relied on is a statement that Dr. Zussman made at trial about symptomatic heart failure. [00:29:52] Speaker 01: They tried to get him to say that everybody with a reduced ejection fraction has symptomatic heart failure. [00:30:01] Speaker 01: Sorry, has congestive heart failure. [00:30:02] Speaker 01: But he disagreed with that. [00:30:04] Speaker 01: And so what they've cited is an exchange on page 11226 [00:30:08] Speaker 01: in which the question builds in, does someone with symptomatic heart failure have congestive heart failure? [00:30:16] Speaker 01: And so he says, yes, as construed by the court. [00:30:19] Speaker 01: But that is just the tautology. [00:30:21] Speaker 02: Someone with... Mr. Jay, so he said on that page, a patient who has less ventricular ejection fraction of less than or equal to 40% with symptomatic heart failure, would they be diagnosed as suffering from congestive heart failure? [00:30:36] Speaker 02: And he says, yes. [00:30:37] Speaker 02: So is it your view that the indication, if it, suppose it didn't say with or without heart failure, suppose it just said with symptomatic heart failure on the actual indication on the Teva label, would you agree then that there's infringement? [00:30:59] Speaker 01: Well, that's not the only element of the patented method, Your Honor. [00:31:03] Speaker 02: So... Would you agree that there is infringement of that element of the claim? [00:31:09] Speaker 02: I don't think so, but... But your expert said there was. [00:31:14] Speaker 01: No, Your Honor. [00:31:16] Speaker 02: Is it your testimony that a patient who has less ventricular ejection fraction of less than or equal to 40% with symptomatic heart failure, would they be diagnosed as suffering from congestive heart failure? [00:31:27] Speaker 02: Yes, as construed by the court. [00:31:29] Speaker 01: And the reason that my answer is still no, Your Honor, is the construction of congestive heart failure at page 130 of the appendix. [00:31:36] Speaker 01: A congestive heart failure for purposes of this patent and specifically treating congestive heart failure requires that the patient have been diagnosed with congestive heart failure. [00:31:48] Speaker 01: That's at page 130. [00:31:49] Speaker 01: It's built into the claim construction and GSK agreed that that was built into the claim construction. [00:31:55] Speaker 01: So the limitation is not to treat [00:32:01] Speaker 01: symptoms of congestive heart failure or to treat a patient who is suffering from congestive heart failure. [00:32:07] Speaker 01: The limitation is to reduce a risk of mortality from congestive heart failure. [00:32:12] Speaker 01: And that requires that the patient be have been diagnosed with congestive heart failure and that the purpose of administering carbidolol is to reduce the risk of mortality from congestive heart failure, not from a heart attack, not from hypertension, not cardiovascular mortality generally. [00:32:27] Speaker 01: So that's why my answer to your question is no. [00:32:29] Speaker 01: Of course, there are the other limitations as well. [00:32:32] Speaker 02: I guess, Mr. Jay, one of my problems with this argument, and I would love to hear your response to it, is that GSK methodically walked through the patent claims with regard to this indication in particular in Dr. McCullough's testimony. [00:32:48] Speaker 02: They walked through limitation by limitation, and he concluded unequivocally that this indication, the MILVD indication on your label, was [00:32:59] Speaker 02: a direction to directly infringe the patent. [00:33:02] Speaker 02: Now, you may disagree with that testimony. [00:33:04] Speaker 02: Clearly, in fact, you do. [00:33:06] Speaker 02: And then Dr. Zussman stood up and said something which, with all due respect, supports Dr. McCullough, but at a minimum doesn't contradict Dr. McCullough. [00:33:17] Speaker 02: And that's my problem, is I failed to see any contrary evidence that you presented anywhere in this trial that the MILVD indication did not amount to infringement. [00:33:29] Speaker 01: Well, that is two responses, Your Honor. [00:33:34] Speaker 01: So first, your question asked me to assume that Dr. McCullis said that this added up to inducement, which is not what he said. [00:33:42] Speaker 01: But second, you asked for contrary evidence at page 11188. [00:33:46] Speaker 01: Dr. Zussman specifically said that these mentions of heart failure would not induce [00:33:51] Speaker 01: a doctor to perform the patented method. [00:33:53] Speaker 01: And let me explain that point. [00:33:56] Speaker 01: Dr. McCullough had said, here is where you can find this one limitation in the label. [00:34:01] Speaker 01: Here is where you can find this other limitation. [00:34:04] Speaker 01: What he used five or six times was the word mention. [00:34:08] Speaker 01: This limitation is mentioned in the label. [00:34:10] Speaker 01: The use of ACE inhibitors is mentioned in the label heart failure is mentioned in the label that does not encourage promote or recommend the use of this. [00:34:20] Speaker 01: The doctors to perform the patented method and that's particularly true because, you know, as we were just discussing a moment ago, your honor. [00:34:28] Speaker 01: The label doesn't say with heart failure. [00:34:30] Speaker 01: It says with or without heart failure. [00:34:32] Speaker 01: It's indifferent. [00:34:33] Speaker 02: But, Council, this is like you're testifying in court, and you're not testifying in court. [00:34:38] Speaker 02: Dr. McCullough, who was an expert, did testify. [00:34:41] Speaker 02: And look on page 10656 of this testimony. [00:34:45] Speaker 02: So does TEVA's partial label meet for direct infringement purposes and this limitation? [00:34:53] Speaker 02: Right. [00:34:54] Speaker 02: So all three parts of the claim were met, is his answer. [00:34:57] Speaker 02: And in your expert opinion, did Teba induce that infringement? [00:35:00] Speaker 02: Yes. [00:35:01] Speaker 02: So you're not a testifying expert. [00:35:03] Speaker 02: And what I can't find, so Dr. McCullough has testified that the Teva label amounted to direct infringement. [00:35:10] Speaker 02: You're arguing now that he did so by piecing together different parts of the label. [00:35:15] Speaker 02: But that goes to the weight to give his evidence, and that was for the jury to decide. [00:35:20] Speaker 02: That wasn't, isn't for me to decide. [00:35:23] Speaker 02: So how, where is your evidence? [00:35:25] Speaker 02: that directly contradicts Dr. McCullough's testimony that the TEVA label amounts to direct infringement by virtue of the MILDZ indication. [00:35:35] Speaker 01: Well, a couple things, Your Honor. [00:35:37] Speaker 01: So I gave you a citation for our evidence that directly contradicts what you've asked me to. [00:35:42] Speaker 02: Okay, go ahead. [00:35:43] Speaker 02: Give it to me again. [00:35:44] Speaker 02: 11 what? [00:35:44] Speaker 02: 11-188. [00:35:45] Speaker 02: 11-188. [00:35:55] Speaker 01: Oh, I apologize, Your Honor. [00:35:56] Speaker 01: This is... Not in the appendix. [00:35:59] Speaker 01: Yeah, this is not in the appendix. [00:36:00] Speaker 01: It's trial transcript 1188 because the numbers correspond to the trial transcript. [00:36:05] Speaker 02: Okay. [00:36:06] Speaker 02: You didn't give it to us. [00:36:07] Speaker 02: So why don't you tell me what it says, then? [00:36:09] Speaker 01: Right. [00:36:12] Speaker 01: So at that page, Dr. Zussman, who is our... Please don't help him. [00:36:17] Speaker 02: I know who he is. [00:36:18] Speaker 02: Just read it. [00:36:20] Speaker 01: Okay. [00:36:21] Speaker 01: No. [00:36:22] Speaker 01: No, I don't agree with his interpretation. [00:36:23] Speaker 01: Why is that? [00:36:24] Speaker 01: Because these mentions of heart failure, first of all, don't teach the method. [00:36:27] Speaker 01: They do not induce doctors to infringe the patent. [00:36:29] Speaker 01: And if anything, they are talking about warnings and precautions. [00:36:31] Speaker 01: These are things that could go wrong if you're using Corvidolol in the treatment of a patient. [00:36:35] Speaker 01: So these are discouraging statements rather than encouraging statements. [00:36:38] Speaker 01: Okay. [00:36:38] Speaker 02: Well, so unfortunately, since I don't have that page or the pages preceding it or the pages after it, [00:36:45] Speaker 02: I can't read it in context. [00:36:47] Speaker 02: I will go back and look. [00:36:49] Speaker 02: I will find all of the trial transcript and I'll find whatever it is that you're now referring to for the first time in oral argument as contradictory evidence. [00:36:57] Speaker 02: But even if there is in fact contradictory evidence, isn't it for the jury to make the determination of whether or not the label contains an infringing directive, a direct infringement? [00:37:11] Speaker 02: Isn't that for the jury to determine? [00:37:13] Speaker 01: So, Your Honor, this court has a number of cases at summary judgment and even at motion to dismiss at which experts have come in to try to argue that a label encourages, promotes, or recommends a patented method, and this court has found no [00:37:31] Speaker 01: found beyond factual dispute that the label did not teach the steps of the patented method. [00:37:37] Speaker 01: So, HZNP is just the most recent example of that at summary judgment where, of course, the same standard applies as at J-Mall, which we have here. [00:37:45] Speaker 02: Yes, but if HZNP, unless I'm misremembering the case, that was the one that said you apply [00:37:52] Speaker 02: is it sunscreen? [00:37:53] Speaker 02: You apply the sunscreen after you wait a time and the claim requires the application of sunscreen. [00:38:00] Speaker 02: But the label in the HD, ZM, whatever it was case, actually didn't ever tell you to apply sunscreen. [00:38:07] Speaker 02: It just said if you ever want to apply sunscreen, wait a period of time. [00:38:11] Speaker 02: But the claim to method requires the application of sunscreen and the label in that case did not. [00:38:16] Speaker 01: And the analogy here is twofold. [00:38:21] Speaker 01: One, the claimed method here requires [00:38:23] Speaker 01: that Carvitolol be administered for the purpose of reducing mortality from congestive heart failure, not for treating symptoms of congestive heart failure. [00:38:32] Speaker 01: That's part of the claim construction, page A138, but also on the co-administration, which is an awful lot like HZNP. [00:38:42] Speaker 01: There's nothing in this label that tells you to take Carvitolol with an ACE inhibitor [00:38:47] Speaker 01: or a diuretic. [00:38:49] Speaker 01: All there is is a report of a study, and in that study, some people, less than the majority, had taken diuretics. [00:38:57] Speaker 01: And as for ACE inhibitors, all Dr. McCullough said, again, Your Honor, was that ACE inhibitors are mentioned. [00:39:04] Speaker 01: That is not enough to encourage, promote, or recommend, especially if you look at what it says. [00:39:10] Speaker 01: Patients were taking either an ACE inhibitor or an ARB, an angiotensin receptor blocker. [00:39:17] Speaker 01: And an ARB, co-administration with an ARB does not infringe. [00:39:21] Speaker 01: So you just can't read the label in a way that a reasonable fact finder could credit in a way that encourages, promotes, or recommends [00:39:31] Speaker 01: the co-administration step, and for the same reason I said before, it also doesn't encourage, promote, or recommend the treatment to reduce mortality, risk of mortality from congestive heart failure, as opposed to heart disease more generally. [00:39:45] Speaker 02: Mr. Jay, the actual indication on the label says the tablets are indicated to reduce cardiovascular mortality [00:39:56] Speaker 02: in clinically stable patients who survived the acute phase of a myocardial infarction and have a less ventricular ejection fraction of less than or equal to 40% with or without symptomatic heart failure. [00:40:10] Speaker 02: So I guess I don't understand the cobbled together argument that you're making. [00:40:15] Speaker 02: The indication itself says the purpose of the use of this tablet is to reduce cardiovascular mortality. [00:40:23] Speaker 02: I mean, what am I missing? [00:40:25] Speaker 02: What am I missing? [00:40:26] Speaker 02: I guess I'm just not following your argument. [00:40:28] Speaker 01: What you're missing, Your Honor, is that reducing cardiovascular mortality does not infringe. [00:40:33] Speaker 01: It has to be to reduce mortality from congestive heart failure. [00:40:37] Speaker 02: Wait, but isn't congestive heart failure a cardiovascular mortality? [00:40:42] Speaker 02: I mean, isn't it? [00:40:43] Speaker 02: I don't understand. [00:40:43] Speaker 02: Isn't death from congestive heart failure a subset of cardiovascular mortality? [00:40:49] Speaker 01: Yes, it is. [00:40:51] Speaker 01: And as the court's cases that I referred to a moment ago, including HZMP and Grunenthal, make clear, a subset is not enough. [00:41:00] Speaker 01: So the example we gave in our brief is... But this is a subset of actual infringement. [00:41:09] Speaker 02: In HZMP, it's a subset... No, no. [00:41:11] Speaker 02: ...a subset of the same limitations. [00:41:14] Speaker 02: Assuming I find that there is sufficient evidence that this indication is directly infringing, is recommending a method that would directly infringe, if that is the case, then this is a radically different scenario than these other cases you cited, because while this indication might [00:41:36] Speaker 02: actually encourage the use of carviterol tablets to people who wouldn't be infringing because it would include people without symptomatic heart failure. [00:41:47] Speaker 02: It would include people with symptomatic heart failure. [00:41:50] Speaker 02: So isn't that just a question maybe of damages or something else? [00:41:54] Speaker 02: But why does that make it such that if I tell you infringe with group A and infringe with group B and it turns out group B is not infringing, you still have infringement with group A, right? [00:42:04] Speaker 01: No, not right, Your Honor. [00:42:06] Speaker 01: So let me agree with one part of your question, which is the point that their damages theory does not match up with their theory that the post-MILVD indication is what teaches the infringement. [00:42:16] Speaker 01: But let's bracket that for a moment. [00:42:18] Speaker 01: Because Grunenthal is exactly the scenario that Your Honor has posited, where it teaches you to prescribe this medicine to treat chronic pain. [00:42:29] Speaker 01: One kind of chronic pain is the infringing kind. [00:42:32] Speaker 01: Another kind of chronic pain is the non-infringing kind. [00:42:35] Speaker 01: And this court said in that case that teaching the method for, you know, recommending the method for the broader set, which includes some infringing and some not infringing, does not require infringement. [00:42:47] Speaker 01: It therefore does not encourage, promote, or recommend that step of the patent. [00:42:51] Speaker 01: So it's just not correct that reducing cardiovascular mortality [00:42:57] Speaker 01: is infringing. [00:42:58] Speaker 01: It has to reduce mortality from congestive heart failure in a patient diagnosed with congestive heart failure. [00:43:04] Speaker 01: That's black and white from the claim construction, and it reflects agreement by GSK that the patient must have congestive heart failure, and even treating symptoms of congestive heart failure don't infringe. [00:43:15] Speaker 02: Mr. Jay, I know that your time is short and probably actually over, but I want to give you a chance to respond to the discussion we had about the press releases. [00:43:25] Speaker 02: And in particular, [00:43:27] Speaker 02: Was there any evidence in this record from TEVA that would refute an inference that could be reached by the jury that the press releases were on the TEVA website? [00:43:39] Speaker 01: So, of course, you'll allow me to begin my answer by saying it's not our burden to refute any evidence by GSK. [00:43:47] Speaker 01: And there's also no basis for such an inference, Your Honor. [00:43:51] Speaker 01: What you asked my friend about in your colloquy with her about questions by Attorney Woodford to Ms. [00:43:58] Speaker 01: Collier, who was the Teva witness. [00:44:00] Speaker 01: And all that says is that there was product information, Carbidolol product information on the Teva website. [00:44:07] Speaker 01: Doesn't say anything about press releases. [00:44:09] Speaker 02: Yes, but Council, the 2004 press release, the 2007 press release, the idea that Ms. [00:44:16] Speaker 02: Woodford testified that information regarding Carvitalol was being put on the website in 2004 and combine that with the thing that's shown to the jury that shows the Teva website was still containing the press release as of 2015 or whatever. [00:44:34] Speaker 02: It's fair, isn't it, for the jury to infer that information was on the website the whole time? [00:44:39] Speaker 01: I don't think so, Your Honor, given Dr. McCullough's testimony, and there's another point from Dr. McCullough that's relevant to our previous colloquy that I want to get back to as well. [00:44:48] Speaker 01: So where Dr. McCullough said that he wasn't suggesting that the Teva website was relevant to the skinny label period, and he didn't even know if there was a website in 2007, right? [00:44:58] Speaker 02: That's not relevant to whether it was there or not. [00:45:02] Speaker 02: Dr. McCullough saying he didn't know doesn't necessarily undermine the ability of the jury to infer that there was a website and that it contained this information. [00:45:13] Speaker 01: And my second point, Your Honor, is, well, I guess I have two. [00:45:16] Speaker 01: One is that the jury was never asked to draw that inference, not in closing argument, not at all. [00:45:22] Speaker 01: And then the second point is just that even if all of that, even if the press releases are properly probative of keva, this is what the jury instruction says, continuing to take an action during the life of the patent, [00:45:39] Speaker 01: All they say is that Carbitolol is the, Teva's Carbitolol is the generic equivalent. [00:45:45] Speaker 02: No, that's not true, Counsel. [00:45:46] Speaker 02: The 2004 press release says expressly that it should be used for heart failure. [00:45:52] Speaker 01: I understand, Your Honor, that that's when Teva received tentative approval. [00:45:57] Speaker 01: And then before it issued the next press release, the FDA had issued its press release saying that the generics labels differed from [00:46:05] Speaker 01: GSKs because of patent information, Dr. McCullough agreed that doctors would see that FDA press release and understand it. [00:46:16] Speaker 02: I want to ask you a question. [00:46:17] Speaker 02: Suppose that we were trying to decide whether Teva was inducing infringement today of this patent, suppose it was still alive today. [00:46:26] Speaker 02: And suppose Teva resurrected its 2004 press release which said use this to treat congestive heart failure. [00:46:33] Speaker 02: And suppose that when you went to the Teva website today and search for carbidryl, this is the very first thing that popped up was Teva's press release that said use this for congestive heart failure. [00:46:45] Speaker 02: I understand these are not the facts of this case. [00:46:47] Speaker 02: Don't worry. [00:46:48] Speaker 02: But suppose that were the case. [00:46:50] Speaker 02: Do you think the fact that the 2004 press release was prominently on the Teva website today could be a basis for finding some sort of continuity of action that amounts to inducement to infringe under those circumstances? [00:47:04] Speaker 02: I know those are not the facts of this case. [00:47:06] Speaker 02: I just want to know if you think putting the Teva press release on the website would amount to that sort of inducement. [00:47:16] Speaker 01: So what I'm having trouble with in your question, Your Honor, is the continuity of action point. [00:47:22] Speaker 01: There would be no requirement of continuity of action if the patent were allotted today. [00:47:26] Speaker 02: So if I'm understanding your question right, it is... There would be a need for continuity of action, Counsel, because one of the arguments you could make is this was a press release in 2004 prior to the patent issuing, right? [00:47:39] Speaker 02: And so an argument that could be made is that a press release from 2004 that was prior to the patent issuing can't amount to inducement because there wasn't actually a patent at the time we did it. [00:47:49] Speaker 02: And so I'm just trying, I'm sorry, I just wanted to make clear why I'm asking you this point. [00:47:52] Speaker 02: So if Teba had it on their website today, even though it was a press release from 2004, do you understand my point why I'm trying to ask you this question now? [00:48:02] Speaker 01: I do, Your Honor, and I had thought you meant if they issued the press release today. [00:48:07] Speaker 01: No, a press release from 2004 announcing tentative approval with different indications would not induce today. [00:48:16] Speaker 01: Number one, because of its content. [00:48:18] Speaker 01: Number two, because there's no evidence in this record whatsoever that doctors [00:48:24] Speaker 01: Although they might see press releases when they come out, there's no evidence whatsoever that doctors would go back and dig out archived press releases. [00:48:33] Speaker 01: And then the third point really takes it back. [00:48:35] Speaker 02: Mr. Claire Council, dig out archived press releases. [00:48:37] Speaker 02: You say that as though there is evidence that that is in the record. [00:48:40] Speaker 02: Did you present any evidence about how easy or how hard it would be to find this press release? [00:48:46] Speaker 01: No one presented any evidence that this press release was on any website, so there's no evidence about how difficult or how easy it would be to find it. [00:48:55] Speaker 02: Just in case you're curious, and I realize this is not record evidence, but I was curious, just kind of curious, and since Teva never suggested this was unavailable, I checked your website, and guess what the very first thing that pops up is when I search on Google for carbiterol [00:49:11] Speaker 02: and Teva. [00:49:13] Speaker 02: This damn press release, it's number one on the Google hits, just so you know. [00:49:17] Speaker 02: I mean, perhaps Teva doesn't know that. [00:49:19] Speaker 02: Perhaps Teva doesn't take any action to control what search engines produce results or not. [00:49:25] Speaker 02: But when you said archived, it just made me think maybe I'm missing evidence in the record that suggests this press release wasn't readily available. [00:49:32] Speaker 01: Well, of course, today we are five years after the patent expiring, and we've had a whole trial. [00:49:37] Speaker 02: And what Judge Moore does in her chambers is an evidence to begin with, and I would never treat it as such. [00:49:42] Speaker 02: I'm just wondering if there is any evidence in the record because you said an archived press release as though that were a thing, as though there was record evidence that this press release was archived in the basement of a shoebox written in German in Teva, in a building in Teva somewhere. [00:50:01] Speaker 01: There is no evidence that this press release ever appeared on the website before or during the infringement period. [00:50:08] Speaker 01: The other point that I wanted to bring up, which is related to this, is that even with, even supposing that there are these press releases, right, Dr. McCullough said that there is too much information missing from the skinny label for him to prescribe [00:50:24] Speaker 01: to treat congestive heart failure. [00:50:27] Speaker 01: Too much information missing. [00:50:29] Speaker 01: Now, he said that he didn't read the label. [00:50:32] Speaker 01: He just assumed that the labels were the same, but that if he had read the label, he would not have allowed his patients to take it for congestive heart failure because too much information was missing. [00:50:43] Speaker 01: from the label. [00:50:44] Speaker 01: And that's relevant both to the colloquy that we're having right now about whether the press release would induce and also to our previous colloquy, which is whether the skinny label itself can be said to have induced doctors. [00:50:57] Speaker 01: And Dr. McCullough, the only doctor who testified on this point, said that it wouldn't induce him because the label was missing too much information. [00:51:05] Speaker 01: And what matters is not whether you can find a half a dozen mentions. [00:51:09] Speaker 02: I really want to go back to one other point that you made [00:51:12] Speaker 02: You were talking to us about the FDA filings and the fact that GSK didn't include the second limitation or indication, I should say, the MILVD as one of the things on its FDA filing that should be carved out, right? [00:51:34] Speaker 02: Did I get that right? [00:51:36] Speaker 05: Yes. [00:51:37] Speaker 02: Yes. [00:51:38] Speaker 02: Okay. [00:51:38] Speaker 02: So here's my question to you. [00:51:41] Speaker 02: I'm going to say, does that matter for patent infringement? [00:51:45] Speaker 02: And I don't mean audit to matter in some policy sense. [00:51:49] Speaker 02: Do we want full and complete disclosure to the FDA? [00:51:53] Speaker 02: I mean, of course we do. [00:51:54] Speaker 02: But this isn't a case about whether all FDA rules and regulations were complied with. [00:51:59] Speaker 02: And in fact, there's an FDA rule that says it's your obligation, generic, to figure out patent infringement and that you can't rely upon the FDA documents. [00:52:07] Speaker 02: But let's put that aside. [00:52:09] Speaker 02: Put aside, we're not here to debate whether an FDA rule was violated or not and what consequence that ought to have. [00:52:17] Speaker 02: We're here to resolve whether there's patent infringement in this case. [00:52:21] Speaker 02: So what if any consequence to a patent infringement claim exists by virtue of GSK not having carved out the LMI LVD indication on that form? [00:52:36] Speaker 01: I want to respond to your question on the assumption that you asked me to assume, but I also want to respond to your quote from what the FDA said about what the purposes of this declaration is. [00:52:48] Speaker 01: And so on the first point, GSK was in the best position to tell the FDA what portions of the labeling are claimed. [00:52:56] Speaker 01: And if you look at the instructions, and again, I'm not trying to make an argument that they broke FDA rules. [00:53:01] Speaker 01: I'm trying to make an argument about what GSK is telling not only FDA, but the world about what aspects of its labeling. [00:53:09] Speaker 02: But I guess the problem is, so GSK, even if GSK originally said, [00:53:16] Speaker 02: you know, something ambiguous about MILVD and whether it infringes or not, what impact does that have on whether there actually is patent infringement? [00:53:30] Speaker 01: I think my answer, Your Honor, is that it is, it highlights [00:53:35] Speaker 01: the cobbled together post-hoc nature of the skinny label inducement theory. [00:53:42] Speaker 02: Yeah, but the problem is, even if it's cobbled together, if it really does amount to infringement, it amounts to infringement. [00:53:48] Speaker 02: Like cobbled together or not, there would be, if it creates direct infringement, it creates direct infringement. [00:53:55] Speaker 02: I feel like these FDA filings are a bit of a sideshow. [00:53:59] Speaker 04: Well, does it affect, and this is Judge Prost, does it affect intent? [00:54:04] Speaker 01: I think it definitely affects intent. [00:54:06] Speaker 01: It affects whether there is, whether GSK would be equitably stopped from changing its position. [00:54:14] Speaker 01: And it also affects what doctors would understand as well. [00:54:19] Speaker 01: Ultimately, I take your point, Judge Moore, that infringement is an infringement question and not an FDA question. [00:54:27] Speaker 01: But in all of these allegedly incomplete skinny label cases, [00:54:31] Speaker 01: The question is still, as the court said in AstraZeneca, the pertinent question is whether the proposed label instructs users to perform the patented method. [00:54:40] Speaker 01: And the court has generally looked at the indications section, not all over the label, at the indications section, and here the indication that GSK claimed is carved out. [00:54:50] Speaker 01: And to respond to the second aspect of Your Honor's question, they're certainly right that there is a quote in the Federal Register, which is in our friend's reply brief, [00:55:00] Speaker 01: that says that use codes are not meant to substitute for the applicant's review of the patent and the approved labeling. [00:55:06] Speaker 01: But then if you read the next two sentences, you'll see that what the FDA is talking about is the use code and not the part of the declaration that we've all been discussing this morning. [00:55:16] Speaker 01: To the contrary, the declaration, which includes the complete description of the method of use claim and the corresponding language in the labeling of the approved drug, [00:55:25] Speaker 01: is publicly available after NDA approval. [00:55:27] Speaker 01: That is what both the FDA and generic... I'm just out of curiosity. [00:55:31] Speaker 02: Is there some consequence if somebody files false information to the FDA, like incomplete or inaccurate information? [00:55:39] Speaker 01: Sure. [00:55:40] Speaker 01: The submission is made under penalty of perjury, and so everything from 18 USC 1001 to potential rejection of the NDA. [00:55:51] Speaker 02: Okay, so there are, if someone misrepresents something to the FDA, then there are consequences at the FDA. [00:55:58] Speaker 02: But do you agree with me that those consequences don't automatically carry over into an infringement suit? [00:56:03] Speaker 02: I mean, we are not arbiters of FDA rules. [00:56:06] Speaker 02: I mean, it's not for me to dole out punishment in an infringement case for a possible mis- or non-disclosure to the FDA. [00:56:14] Speaker 01: So I agree with the absolute statement that your honor has just said that it's not absolutely dispositive of infringement, but you also would take into account how the process works in the Section 8 context that this declaration is what tells FDA what to carve out [00:56:31] Speaker 01: and that FDA in turn tells the generics what to carve out. [00:56:35] Speaker 01: So if that carve out leaves something, leaves behind something in the indication statement that encourages, promotes, or recommends the patented method, then I take your point that the FDA is not enforcing the patent laws, but it certainly is relevant [00:56:52] Speaker 01: in an infringement case where the allegation is that the skinny label is what induces is that Keva carved out everything that GSK told the FDA and the public should be carved out to protect its patented use. [00:57:09] Speaker 04: Okay. [00:57:11] Speaker 04: Anything further from the panel? [00:57:14] Speaker 00: No. [00:57:15] Speaker 04: Thank you. [00:57:15] Speaker 04: Thank you. [00:57:16] Speaker 04: Let's restore three minutes or if you need a little more time Ms. [00:57:21] Speaker 04: Brooks, [00:57:23] Speaker 04: Thank you. [00:57:24] Speaker 03: Thank you, Your Honor. [00:57:24] Speaker 03: Let me start with where the questioning left off about how FDA told Teva what to carve out, and they did it based on what GSK said, et cetera. [00:57:38] Speaker 03: Here's what the jury heard. [00:57:39] Speaker 03: And again, the question is, was there substantial evidence to support the jury's verdict? [00:57:43] Speaker 03: So Professor Leitzin, FDA regulatory expert, testified at 10 [00:57:50] Speaker 03: She was asked the question first, does the fact that FDA approved TEVA's label in 2007 mean that TEVA has been found not to infringe any of GSK's patents? [00:58:02] Speaker 03: Answer, no, it has no relation at all. [00:58:06] Speaker 03: On that same page, she was asked about the mock-up label that FDA has sent to TEVA. [00:58:14] Speaker 03: She was asked, so you were asked on cross-examination whether you'd agree that FDA decided what came out of Teva's label. [00:58:23] Speaker 03: Do you remember that? [00:58:24] Speaker 03: Yes. [00:58:25] Speaker 03: And you disagreed. [00:58:26] Speaker 03: I did. [00:58:26] Speaker 03: Why did you disagree? [00:58:27] Speaker 03: Answer. [00:58:28] Speaker 03: I disagreed because it is the manufacturer, ultimately, that is responsible for its own package insert. [00:58:36] Speaker 03: And she goes on to explain why, and at the end she says, they're responsible for taking into account a patent. [00:58:42] Speaker 03: It needed it, meaning Teva, needed to take that responsibility on itself. [00:58:47] Speaker 03: It's the one responsible for the label at the end of the day. [00:58:51] Speaker 03: So going to the next point, which had come up, [00:58:55] Speaker 03: where I think counsel argued that there's this diagnosis requirement somehow that the patient has to be diagnosed with congestive heart failure in order for there to be infringement. [00:59:06] Speaker 03: I would point the court again to Teva's expert, Dr. Zestman, appendix 11.266 at line 14, cross-examination. [00:59:16] Speaker 03: Is it your testimony that a patient who has a left ventricular ejection fraction of less than or equal to 40% [00:59:25] Speaker 03: with symptomatic heart failure, would they be diagnosed as suffering from congestive, diagnosed as suffering from congestive heart failure? [00:59:34] Speaker 03: Answer, yes, is construed by the court. [00:59:37] Speaker 03: So that's what the jury heard. [00:59:38] Speaker 03: Now let's go back to the indication itself at 5508. [00:59:43] Speaker 03: Council has made it sound like this indication says with or without heart failure. [00:59:48] Speaker 03: No, it says with or without [00:59:51] Speaker 03: symptomatic heart failure. [00:59:53] Speaker 03: So everyone agrees that a patient with an injection fraction of less than 40% has heart failure. [01:00:00] Speaker 03: They are suffering from congestive heart failure with symptoms or maybe without symptoms, but they are suffering from congestive heart failure. [01:00:08] Speaker 03: And the last point I'd like to make is that the council has argued that, well, that when the collagen was pieced together, and your honor pointed out, it doesn't matter if it's in there or it's in there, but this wasn't a piece together. [01:00:21] Speaker 03: If we look at the indication right at the end, it says, see clinical studies 14.1. [01:00:26] Speaker 03: So it's telling the physician, let's go to 14.1. [01:00:30] Speaker 03: So let's go to 14.1. [01:00:31] Speaker 03: Appendix five, two, three. [01:00:35] Speaker 03: It's talking again about the less ventricular dysfunction following myocardial infarction, and it's talking about the Capricorn study, and this is on the label. [01:00:44] Speaker 03: And the physician's been told, go look here, and the physician is told that if we look about halfway down, background treatment included ACE inhibitors or andiotensin receptor blockers. [01:00:58] Speaker 03: 97% of the patients were on that. [01:01:01] Speaker 03: And 34% were on diuretics. [01:01:04] Speaker 03: that is more than sufficient to show those limitations were met. [01:01:08] Speaker 03: And let's finally, does this encourage a physician to use carbidolol to reduce mortality caused by congestive heart failure? [01:01:18] Speaker 03: If we look at the results of that study, right there on 5523, the last line, nearly all deaths were cardiovascular, which were reduced by 25% by carbidolol. [01:01:32] Speaker 03: So clearly, a physician's not going to read this and say, hey, I think I'm going to give carbidolol to a patient suffering from congestive heart failure to reduce the chance they're going to get hit by a bus. [01:01:42] Speaker 03: they're going to give it to them to reduce the chance they're going to die from the congestive heart failure. [01:01:47] Speaker 03: And we know that because if we look at the next page, Appendix 5524, Figure 1 shows the survival analysis for the capricorn patients. [01:01:59] Speaker 03: Remember, these are all patients suffering from heart failure who are suffering from heart failure because their left ventricle has been damaged as a result of a heart attack. [01:02:07] Speaker 03: And here, right this six-month [01:02:09] Speaker 03: number, which, by the way, is another limitation of the claim that they'd be on a maintenance period for six months, right at the six-month number, the two lines begin to diverge between the carbidolol group and the placebo group. [01:02:22] Speaker 03: And you can see that the mortality rate for the carbidolol group is significantly lower than the mortality rate for the placebo group. [01:02:30] Speaker 03: And again, all of this was presented to the jury in Dr. McCullough's testimony. [01:02:35] Speaker 03: And with that, I would conclude my remarks. [01:02:37] Speaker 03: The court has other questions. [01:02:39] Speaker 04: Thank you very much. [01:02:40] Speaker 04: We thank both sides for this helpful argument. [01:02:43] Speaker 04: This concludes the proceeding for this morning. [01:02:46] Speaker 04: Thank you. [01:02:47] Speaker 01: Thank you.