[00:00:39] Speaker 03: Your honor, may I proceed? [00:00:41] Speaker 05: I think we're all ready. [00:00:42] Speaker 03: Thank you. [00:00:44] Speaker 03: Good morning. [00:00:44] Speaker 03: Bob Gunther for Genentech. [00:00:46] Speaker 03: The district court articulated two reasons for denying. [00:00:49] Speaker 06: Before you begin, could I ask a question before we start your clock running? [00:00:56] Speaker 06: There are a lot of confidentiality designations in the briefs. [00:01:06] Speaker 06: to the disposition of the case and perhaps too important to anything we may say today. [00:01:13] Speaker 06: Yes. [00:01:15] Speaker 06: One of them in particular has to do with the licenses. [00:01:19] Speaker 06: Yes, Your Honor. [00:01:19] Speaker 06: Various facts relating to the licenses, which would make it a little difficult if those confidentiality [00:01:26] Speaker 06: representations still obtained, it's going to be a little difficult to talk about that issue. [00:01:32] Speaker 06: So I would ask the parties, is that something which the passage of time has rendered no longer necessary to respect confidentiality or not? [00:01:41] Speaker 03: Your Honor, I think with respect to the licenses in particular, the answer to the question is yes, the passage of time has changed things. [00:01:48] Speaker 06: So we can talk about. [00:01:49] Speaker 03: We can talk, yes, and in particular, we can talk about what the terms of the licenses are, Your Honor. [00:01:56] Speaker 03: When license entry would be permitted, I think is now, for the most part, at least in terms of the first entrant, has become clear. [00:02:06] Speaker 06: OK, now there's one other issue, and this may be more appropriately addressed to Mr. Lampkin. [00:02:11] Speaker 06: On page 36 of the red brief, [00:02:14] Speaker 06: There are a number of designated confidentiality having to do with labels. [00:02:23] Speaker 06: Is that still an issue that we should not discuss? [00:02:32] Speaker 03: Your Honor, from our perspective, we think that that information, which, of course, is FDA, was back and forth with the FDA. [00:02:40] Speaker 03: We think that, again, that ought to be open. [00:02:42] Speaker 03: That ought to be subjects that we can discuss. [00:02:46] Speaker 03: We agree that it's central to the appeal on the delay issue. [00:02:50] Speaker 06: OK. [00:02:50] Speaker 06: Well, let's see if. [00:02:51] Speaker 03: Yes. [00:02:52] Speaker 01: Your Honor, it's okay with us. [00:02:54] Speaker 06: Okay, so those two are off the table. [00:02:56] Speaker 06: Can we start the clock back at 15? [00:03:01] Speaker 05: Thank you. [00:03:01] Speaker 05: Thank you very much, Your Honor. [00:03:02] Speaker 05: Can I just start off by asking what at this stage of the game kind of remedy are you seeking here? [00:03:08] Speaker 03: Your Honor, we continue to seek a preliminary injunction. [00:03:11] Speaker 03: We believe that this drug that is at issue in this case, Herceptin, which is in fact a cure for women who receive the drug. [00:03:22] Speaker 05: Well, you've got the licensees on the market, right? [00:03:25] Speaker 03: That's correct. [00:03:25] Speaker 05: There are others on the market. [00:03:27] Speaker 05: How many other? [00:03:28] Speaker 05: products are on the market. [00:03:30] Speaker 03: There are now two, in addition to Amgen and Genentech, there are two additional biosimilars that have come to the market. [00:03:38] Speaker 05: Do you think that makes your case about irreparable harm a little tougher at this stage of the game? [00:03:43] Speaker 03: Your Honor, I would argue, and I think we put in evidence to this effect from our economist Dr. Jenna, which is in the record, that in fact the entry of those [00:03:52] Speaker 03: other biosimilars and the two that have entered at this point are Mylan and Pfizer. [00:03:58] Speaker 03: That makes the irreparable injury even more difficult because at this point now we're trying to conjure a blood for a world where other folks have entered, licensed sentries occurred, and now we're trying to figure out [00:04:11] Speaker 03: at that point, remember, because they skipped, they jumped to the head of the line and decided to launch at risk. [00:04:17] Speaker 03: Now, the fact that we're trying to unwind all of that at this stage becomes even harder. [00:04:22] Speaker 06: But the unwinding in the sense that you mean, I think, would involve going back to July and figuring out what would have happened in that four-month period before the others entered the market. [00:04:36] Speaker 06: But that's not where we are right now. [00:04:37] Speaker 06: Where we are right now is there are already [00:04:41] Speaker 06: two other players in the market. [00:04:43] Speaker 06: So if you judge, if, for example, this case were to go back to Judge Conley and you were asked, as of now, [00:04:52] Speaker 06: What's the irreparable harm? [00:04:54] Speaker 06: Wouldn't that be a tougher call for you, a tougher lift? [00:04:57] Speaker 03: Your Honor, I don't think so. [00:04:59] Speaker 03: And the reason I say that is that even though there's certainly an important period here, which is between July and November, and that's happened. [00:05:07] Speaker 03: And that's happened. [00:05:08] Speaker 03: And I recognize that. [00:05:09] Speaker 03: But Your Honor, the impact of that launch that began in July and continues to this day [00:05:14] Speaker 03: is actually continues to have an impact with respect to the issue of whether or not we can actually set forth a compensable damage claim for all of our compensable damages. [00:05:28] Speaker 06: As I understand it, your position with respect to the injunction that you would seek is that you would not seek to enjoin patients who are currently on Amgen's product, but only patients who would [00:05:44] Speaker 06: Begin to use that after the injunction. [00:05:47] Speaker 03: That's correct is entered. [00:05:49] Speaker 06: That's correct And we're talking about there's a trial in this case is in April April 20th Yes, so we're talking about five or six weeks and only those patients who would become starting patients taking Amgen's drug between now and then [00:06:06] Speaker 06: That seems to me to be a pretty small window of, I wonder if that's significant enough for the disruption that will occur upon stopping [00:06:17] Speaker 06: the Amgen drug from being sold, and then if they win the case, starting it again six weeks hence. [00:06:23] Speaker 03: Right. [00:06:24] Speaker 03: And Your Honor, what I would say to that is they have, as of the end of this year, one of the things that they have projected is that they're going to get the largest market share with respect to this product. [00:06:34] Speaker 06: But the market share we're talking about is just the share of new patients between now and April 20th, right? [00:06:40] Speaker 03: Well, I think it's actually, I think in terms of looking at irreparable harm at this moment, Your Honor, I think that that's right, but that is huge. [00:06:47] Speaker 03: Remember, this is a huge drug, and with respect to the biosimilars, it's a huge market with respect to them as well. [00:06:54] Speaker 03: So even though we've made the concession that we're not going to ask people who have already started on the drug to come off, [00:07:00] Speaker 03: One of the perverse aspects of that, Your Honor, is that the more, remember, they decided to take self-help to infringe the patent and get the patents and go forward. [00:07:10] Speaker 03: And as they do that, they are actually increasing the amount of patients that have been started with this drug. [00:07:16] Speaker 03: And then to turn around and say that in that context, that we should somehow be put in a box with respect to irreparable harm seems perverse. [00:07:26] Speaker 03: And I would say in addition to that, [00:07:29] Speaker 03: We are, we're in a position where this. [00:07:33] Speaker 05: Can you explain to me the comment you just made? [00:07:35] Speaker 03: Sure. [00:07:35] Speaker 05: I don't understand what is perverse about the position. [00:07:38] Speaker 03: So if you think about it. [00:07:39] Speaker 03: Yes. [00:07:40] Speaker 05: You had an adjudication of the irreparable harm issue a while back. [00:07:44] Speaker 05: You appealed it to this court and it was rejected. [00:07:47] Speaker 05: Nothing about that is perverse. [00:07:49] Speaker 05: You may disagree with that, but that was the judgment at the time. [00:07:52] Speaker 03: And Your Honor, I'm not suggesting that the judgment on the Rule 8 motion was perverse or anything like that, despite the fact that we tried to get before you as quickly as we can. [00:08:01] Speaker 03: What I'm saying though, Your Honor, is that, and I apologize if I'm not being clear on this, is that as they continue to start patients, [00:08:10] Speaker 03: That becomes an additional argument for them that, in terms of balance of hardships, for example, that you ought to look at this in a different light. [00:08:18] Speaker 03: And what we're saying is that, again, if you think about this in terms of what they did, deciding to launch at risk with no non-infringement argument in the face of IPR decisions, that it upheld the validity of these patents. [00:08:32] Speaker 03: That to put us in a box where we then can't basically say that even though the trial is in April, that there is important time left on this very, very significant important drug. [00:08:45] Speaker 03: Every day counts in our estimation. [00:08:49] Speaker 02: Mr. Dunham. [00:08:49] Speaker 03: Yes, sir. [00:08:52] Speaker 02: Refresh me. [00:08:54] Speaker 02: Isn't a preliminary injunction an equitable analysis? [00:08:59] Speaker 02: Yes, sir. [00:09:00] Speaker ?: OK. [00:09:01] Speaker 02: And the court specifically found undue delay in seeking the preliminary injunctions. [00:09:09] Speaker 02: That sort of pops up when you're talking about every day being important. [00:09:14] Speaker 02: But it looks like what the court said was the delay was so significant that it occluded a determination of irreparable harm. [00:09:25] Speaker 02: And the way the court lays it out, it looks like an ambush on your part. [00:09:29] Speaker 03: On their part. [00:09:30] Speaker 03: On your part. [00:09:31] Speaker 03: Well, Your Honor, let me respond directly to that. [00:09:36] Speaker 03: What the court determined is that we were required, and this is the first time, but this court... 14 months, let me quote. [00:09:43] Speaker 02: Yeah. [00:09:43] Speaker 02: 14 months after receiving Amgen's BPCIA notice. [00:09:48] Speaker 02: Yes. [00:09:49] Speaker 02: Three months after receiving a fairly specific launch date. [00:09:52] Speaker 02: And almost one month after Amgen had FDA approval to launch its product. [00:09:57] Speaker 03: Let me deal with each one of those three periods. [00:10:00] Speaker 03: Sure. [00:10:00] Speaker 03: The first one is the notice of commercial marketing. [00:10:04] Speaker 03: That was in May of 2018. [00:10:06] Speaker 03: They weren't approved until 13 months later in June of 2019. [00:10:12] Speaker 03: What happened during that period? [00:10:14] Speaker 03: Ten days after they sent us a notice of commercial marketing, on May 25, 2018, [00:10:20] Speaker 03: They got a complete response letter from FDA. [00:10:24] Speaker 03: What did that mean? [00:10:25] Speaker 03: That meant that they would not be able to get approval for that drug until they responded to the complete response letter. [00:10:33] Speaker 03: It took them seven months to do that. [00:10:36] Speaker 03: They didn't do that until December 28, 2018. [00:10:39] Speaker 03: When they did it, when they responded, Your Honor, [00:10:43] Speaker 03: They went from a full label and said, we don't want that anymore. [00:10:48] Speaker 03: You're aware of that. [00:10:50] Speaker 03: And they didn't change back to the full label until March, after they made a determination commercially that they didn't think they would be able to successfully sell the product that way. [00:11:02] Speaker 03: So that takes us to March. [00:11:04] Speaker 03: Okay, now the second part, Your Honor, is the point in April that the district court identified where he said, okay, at this point, there was unredacted, certain things were unredacted, and now you knew they were thinking about potentially launching in July. [00:11:22] Speaker 03: And Your Honor, what is extraordinarily important there is that all of their witnesses, and we tried to depose everyone we could get our hands on, said in sworn testimony that while they were making sort of launch readiness plans, that there was no decision to actually launch the product. [00:11:41] Speaker 05: And in fact, after FDA approved... Are you suggesting that there's some notification requirement to you that they're actually going to launch? [00:11:49] Speaker 05: Your Honor, I think that in the... You were prepared, the record before the district court is clear, right, that they intended to be, at all times, they intended to be prepared to launch in July 2019. [00:11:59] Speaker 05: Are you typically notified by competitors of their intention to launch a particular day? [00:12:06] Speaker 03: I can tell you what happened in one of the other cases, Your Honor, in this very situation. [00:12:12] Speaker 03: And it's referred to in the district court, I think it's footnote six in the district court's opinion, [00:12:17] Speaker 03: There was another biosimilar, and I'm going to be careful here in terms of what I say in terms of confidentiality. [00:12:22] Speaker 03: Another biosimilar told us, they said, if a particular thing happens, we will launch on X date. [00:12:31] Speaker 03: And what we did once we were told that is we went to the district court judge and we said, they've told us this, we'd like to set up a procedure for a preliminary injunction motion. [00:12:40] Speaker 03: And we did that. [00:12:42] Speaker 05: That may be nice, but my question went to whether they're required to do that or they typically do that. [00:12:48] Speaker 05: I mean, that was very nice that you worked it out with that one particular company. [00:12:54] Speaker 03: I think, Your Honor, it's mixed. [00:12:56] Speaker 03: I think it's mixed. [00:12:57] Speaker 03: Sometimes people do tell, and this is an example that I'm giving you right here. [00:13:01] Speaker 03: Sometimes they don't. [00:13:02] Speaker 03: But whether they have a requirement, and I'm not saying that there's sort of a flat out requirement that they tell us. [00:13:09] Speaker 03: What I am saying is that in assessing the issue of delay and looking at whether harm is imminent, that it's extraordinarily important to focus on what they are telling us and what they are telling the court. [00:13:22] Speaker 03: And what they told us and what they told the court, even weeks after they had obtained FDA approval, was that they had made no determination to launch. [00:13:32] Speaker 03: And in fact, one of the statements of counsel was, and this is in June of 2019, it could be too long. [00:13:40] Speaker 05: So is it your view that if you had gone the week before or two weeks before to the district court, the district court would have said, no, no, no, no, we don't have any authority to be here because we don't have any specificity [00:13:50] Speaker 05: as to the date that they were indicated specifically that they're going to work? [00:13:54] Speaker 03: Your Honor, I think they would have. [00:13:56] Speaker 03: And the reason I say that is that they were making those statements to the district court in order to maintain privilege over opinions. [00:14:03] Speaker 03: And what they were saying is, hey, we don't have any. [00:14:06] Speaker 03: I'm sorry. [00:14:07] Speaker 03: They were making those arguments in order to say that they had not come up to a point in time at that point where they would have to produce opinions of counsel on the issue of willful infringement. [00:14:18] Speaker 03: And so they were arguing, they were affirmatively arguing to the district court as late as June, after FDA had approved their product, they were affirmatively saying, it is not right for you to determine whether or not we have to produce the opinions of counsel because we haven't made a decision to launch. [00:14:37] Speaker 03: And so in that context, our position is that, and again, [00:14:42] Speaker 03: It's when we're required to actually go. [00:14:46] Speaker 03: And what the district court said is, in this context, even though they're telling you they haven't made a decision, you're required to do it, even if you get to court, as we did, before they launched the product. [00:14:59] Speaker 03: And this court has never found delay in that circumstance. [00:15:03] Speaker 03: And if you think about it, it really doesn't make a lot of sense. [00:15:06] Speaker 03: And the reason I say that [00:15:08] Speaker 03: is that the whole point of looking at delay is that if you suffer the irreparable harm, if you allow the sales to start and you allow them to continue and the status quo changes, at that point if you just sort of wait around, well yeah, maybe that's a good indication that you don't think that the harm is irreparable. [00:15:29] Speaker 03: But we got in there before they launched. [00:15:32] Speaker 06: Let me ask you this question. [00:15:35] Speaker 06: Moving from the delay to another aspect of irreparable harm, the license. [00:15:40] Speaker 00: Yes, sir. [00:15:41] Speaker 06: Suppose that you had licensed on day one, let's say, July 1 or June 15 to these other entities. [00:15:51] Speaker 06: Do you think then that the argument for irreparable harm, your argument for irreparable harm, would be significantly weaker? [00:15:58] Speaker 03: I don't think so. [00:16:00] Speaker 06: Do you think it would be just as strong as it was with the delay, even though the argument you made in your brief is that that four-month period was really critical in assessing the irreparable harm? [00:16:12] Speaker 03: We certainly made that argument, Your Honor, but we also went further than that, and district court didn't deal with this and the other side didn't deal with this, but we also said that once those licensees launch, [00:16:23] Speaker 03: that it's even going to get harder. [00:16:25] Speaker 03: And we put in testimony from an expert that's in the record on that. [00:16:29] Speaker 03: And we also, the other thing that we did, Your Honor, and again, this is in the record, is that we pointed out, and this is from testimony from our witnesses as well as documentary evidence, that Amgen is a particularly dangerous competitor. [00:16:44] Speaker 06: So to cut to the chase, I don't want to use up all your time. [00:16:49] Speaker 06: Yes, sir. [00:16:50] Speaker 06: Are you saying that you would have been better off with respect to irreparable harm if you had licensed those other companies to begin distributing right away? [00:17:00] Speaker 06: No, I'm not I'm not going I'm not going that I'm not [00:17:06] Speaker 03: Well, to the extent that I was sort of suggesting to you that the case is stronger, that wasn't my intent. [00:17:12] Speaker 03: My intent, Your Honor, and again, if I'm not being clear, I really apologize. [00:17:17] Speaker 03: But my intent was to say that I don't think it detracts from the strength of our case in terms of remarkable heart. [00:17:25] Speaker 04: You're well into your rebuttals, so why don't you reserve some of that time? [00:17:29] Speaker 04: Thank you, Your Honor. [00:17:41] Speaker 01: May it please the court, Amgen's biosimilar, Kenjinti, has been prescribed to patients now for eight months. [00:17:47] Speaker 01: It's joined by two other biosimilars that Genentech chose to license. [00:17:51] Speaker 01: Both on the facts before the district court and they exist today, the district court did not commit an abuse of discretion in refusing to ban Kenjinti from the market. [00:17:59] Speaker 01: What is your view? [00:18:01] Speaker 05: Is it clear from our cases that whether you can, not whether you will, [00:18:08] Speaker 05: In terms of launch, I mean the issue here in terms of the timeliness of the district court. [00:18:13] Speaker 05: The other side seems to be saying, you seem to be saying you could have launched, you were prepared to launch, and therefore it was incumbent upon them to seek the PI early. [00:18:22] Speaker 01: Right, well the district court found that based on discovery, and this is beginning in April, the discovery quote made clear Amgen's plan to launch marketing for Congenity in July 2019. [00:18:33] Speaker 01: And it drew a reasonable inference based on the delay after delay as evidence mounted on evidence mounted that we were going to launch in July 2019. [00:18:39] Speaker 01: And it drew the inference that if you really are threatened with reputable harm, if the threat of reputable harm is credible, then you're actually going to come into court early before someone actually makes that final decision and pushes the button to launch. [00:18:52] Speaker 01: And the fact that there was a decision maker out there that had to make that final go, no-go decision, as the documents describe it, doesn't mean that you get to sit on your hands. [00:19:01] Speaker 01: When that button is pushed, that means you're going to be suffering. [00:19:07] Speaker 01: We'll deal with that equitable doctrine in some other case. [00:19:11] Speaker 01: So it wasn't just that Genentech received notice of our intent to market back in May of 2018. [00:19:16] Speaker 01: It was that they received unredacted documents. [00:19:18] Speaker 01: Documents with redactions removed that, as the Discord said, enabled Genentech to see that Amgen planned to launch Kanjinti in July 2019. [00:19:26] Speaker 01: Three months ahead of the launch, they didn't move for an injunction. [00:19:30] Speaker 01: In fact, at a hearing in May, they said, we're not currently asking for an injunction. [00:19:35] Speaker 01: Then the district court noted that. [00:19:37] Speaker 01: And the court noted that, yeah, Appendix 7, Note 6, exactly. [00:19:40] Speaker 01: And the district court found that from April to mid-June, five Amgen witnesses testified, giving a fairly specific launch date in July. [00:19:48] Speaker 01: And I could walk through them. [00:19:49] Speaker 01: Our plan is to launch sometime in July. [00:19:51] Speaker 01: That's Robert Jackson. [00:19:53] Speaker 01: Shane Hall, we're targeting being called to launch in July. [00:19:56] Speaker 01: Dale Skeeters, we're targeting July 13 or 14. [00:19:59] Speaker 01: We read it. [00:20:00] Speaker 01: One and one again and again, they were told. [00:20:03] Speaker 01: And yet, once again, did not move for the injunction. [00:20:07] Speaker 01: Thin Cangenti gets licensed in June. [00:20:10] Speaker 01: June 13th. [00:20:11] Speaker 01: Five days later, there's a hearing in district court on June 18th. [00:20:15] Speaker 01: They don't mention the possibility of an injunction. [00:20:17] Speaker 01: They don't move for an injunction. [00:20:18] Speaker 01: They don't say we're getting ready for an injunction. [00:20:20] Speaker 01: What date was that? [00:20:21] Speaker 01: That was June 18th. [00:20:22] Speaker 01: There was another hearing on June 18th. [00:20:24] Speaker 01: When you have those repeated failures to try and seek the relief, the district court is able to draw a factual inference. [00:20:32] Speaker 01: I think the First Circuit has called it having evidentiary significance. [00:20:36] Speaker 01: You can infer that it's just not a credible claim of reputable harm. [00:20:40] Speaker 01: And the district court committed no abuse of discretion. [00:20:42] Speaker 01: It didn't commit any clear error in making that determination. [00:20:46] Speaker 01: And the undue delay alone was capable of preventing them from showing irreparable harm. [00:20:52] Speaker 01: Now I know that council has mentioned that you know there is a response letter to the FDA in December. [00:20:57] Speaker 01: But that actually supported the district court's decision, because it's a well-known fact, and the district court says it in its opinion, that six months after you get the response letter, FDA is likely going to be granting that approval. [00:21:08] Speaker 01: And that meant that we were going to get approval in June. [00:21:10] Speaker 01: So this had all the spontaneity of a rocket launch. [00:21:13] Speaker 01: We knew that this was going to happen. [00:21:15] Speaker 01: The skinny label, we went back to the full label in March. [00:21:19] Speaker 01: No request for an injunction. [00:21:20] Speaker 01: We got approved with the full label in June. [00:21:23] Speaker 01: no request for an injunction. [00:21:25] Speaker 06: Well, but the approval. [00:21:27] Speaker 06: The way you articulated that, it sounded like you were saying that the approval was a done deal. [00:21:31] Speaker 06: There was no question. [00:21:32] Speaker 06: I mean, I suppose there is some question. [00:21:34] Speaker 01: No, you're supposed to get a decision within six months. [00:21:36] Speaker 01: A decision. [00:21:37] Speaker 01: And it was conceivable that the FDA might do the opposite. [00:21:43] Speaker 01: But it's well known to parties in this and to counsel as well that you can go into district court and you can get the injunction even before the FDA has issued the label. [00:21:51] Speaker 06: But the question is, are they to be held accountable for not having done so prior to the FDA's approval? [00:21:58] Speaker 06: It seems to me that your case, of course, becomes stronger as you get closer to the July date. [00:22:04] Speaker 06: But I don't know that you have a terribly compelling case for delay prior to the FDA approval. [00:22:10] Speaker 01: Well, Judge Bryson, this isn't a case of like latches or something like that where you have a legal rule. [00:22:14] Speaker 01: I understand. [00:22:14] Speaker 01: It's an inference from the conduct. [00:22:15] Speaker 06: It's a question of the reasonableness of their conduct. [00:22:18] Speaker 06: And it seems to me that for them to say, we'll see if the FDA approves this, they didn't approve it previously, we'll see if they do now, is not unreasonable. [00:22:27] Speaker 01: I think it is unreasonable when you have document after document saying that there's a July launch. [00:22:33] Speaker 01: We're planning for a July launch. [00:22:34] Speaker 01: If we get approval, we can't launch without approval. [00:22:36] Speaker 01: If you get approval. [00:22:37] Speaker 01: But when you get up on that, at least once the approval is there, you don't go to the next hearing, say nothing about an injunction. [00:22:45] Speaker 06: I'm focusing on the date of the approval. [00:22:48] Speaker 06: That may still be enough to lay. [00:22:50] Speaker 06: to support the district court's finding. [00:22:52] Speaker 06: But I'm wondering whether the delay goes back any farther than that. [00:22:56] Speaker 01: I think it does go further back, because you're entirely capable, in the way the BPCI is structured, you can go in and you're given discovery to find out things like the launch date. [00:23:06] Speaker 01: You're given an artificial act of infringement so you can get into court early. [00:23:10] Speaker 01: You're given notice of intent to commercially market. [00:23:13] Speaker 01: So even claims that haven't been selected for litigation can be the subject of a lawsuit. [00:23:20] Speaker 01: And the preliminary injunctions, right there in LAV, I think, where it says preliminary injunctor. [00:23:24] Speaker 01: So all those things are available to you from the moment somebody files their biosignal application. [00:23:32] Speaker 01: That's an artificial active infringement. [00:23:33] Speaker 01: When you're confronted with all of those opportunities, all of those vehicles, all those ways of finding out the launch and preventing it before someone pushes that final button, [00:23:42] Speaker 01: If you have all those things, it's simply not reasonable to let opportunity go by after opportunity go by. [00:23:48] Speaker 01: And even if it otherwise, it's all in the discretion of the district court. [00:23:51] Speaker 01: Whether I or someone else might think that this was an OK timing, the district court, who was with the parties at hearing after hearing after hearing and saw all this unfold, that district court exercised his discretion to say, based on these repeated delays and the 11th hour attempt to prevent it, which engineered the circumstances that the BPCI seeks to prevent, [00:24:12] Speaker 01: The district part was well within his discretion and certainly committed no factual error in finding that there was undue delay that weighed disposably against it. [00:24:19] Speaker 06: Could I have you turn to the licenses? [00:24:23] Speaker 01: I think I should do that now then. [00:24:25] Speaker 06: Okay. [00:24:27] Speaker 06: Assuming, let's assume that the licenses had been issued not with a delay period but for immediate launches for the licensed parties. [00:24:39] Speaker 06: What is your assessment of [00:24:41] Speaker 06: the impact of licenses on the question of irreparable harm. [00:24:49] Speaker 06: Your opposing counsel suggested in the briefs that this was the judge used to kind of per se rule. [00:24:57] Speaker 06: What do you think the right rule is that a judge should use in assessing the presence of licenses vis-a-vis irreparable? [00:25:04] Speaker 01: I think it's highly contextual, Judge Bryson. [00:25:06] Speaker 01: I think the district court here was very sensitive to that context, because the judge looked at the features of the licenses. [00:25:12] Speaker 01: He looked at who was licensed. [00:25:14] Speaker 01: Celterion, Mylan, Pfizer, and I would add Samsung, BioEpsys. [00:25:19] Speaker 01: So virtually every other competitor was now licensed. [00:25:23] Speaker 01: The district court looked at the financial terms. [00:25:25] Speaker 01: And that's sealed, maybe I shouldn't mention it, but the specific financial terms are mentioned in his opinion. [00:25:31] Speaker 01: And also looked at when entry would occur. [00:25:34] Speaker 01: And it was a short time away. [00:25:36] Speaker 01: And the district court was able to infer from that that, look, someone doesn't give up so much [00:25:42] Speaker 01: exclusivity. [00:25:42] Speaker 01: This gave up exclusivity at least two years before the patent expired. [00:25:46] Speaker 01: In return for so little, for so many people, if entry creates irreparable harm. [00:25:52] Speaker 01: Genentech had to know roughly how much harm it was going to suffer. [00:25:56] Speaker 01: And the harm wasn't irreparable because it was letting competitor after competitor after competitor into the market. [00:26:01] Speaker 01: That's a fair and reasonable inference for the district court to withdraw. [00:26:04] Speaker 01: And it is a clear error for the district court to have drawn that inference on these facts. [00:26:08] Speaker 01: And the district court's ruling, and it paid nine to the appendix, you look at right at the top, it says, under these facts. [00:26:14] Speaker 01: The district court looked at the specific facts of this case, the specific facts of these licenses, and drew a specific inference from them. [00:26:21] Speaker 06: What do you think would be the kind of facts where you had licenses, but the district court would be in error by finding that those licenses effectively [00:26:38] Speaker 06: produced irreparable harm. [00:26:40] Speaker 01: So I think they wouldn't result in irreparable harm. [00:26:45] Speaker 01: And I think that Samsung versus Apple identifies one. [00:26:48] Speaker 01: There was a license to IBM, but IBM was using [00:26:50] Speaker 01: an infringing product, but it wasn't a competitor. [00:26:52] Speaker 06: It wasn't the same. [00:26:53] Speaker 01: It wasn't a competitor in the market, was on the answers. [00:26:55] Speaker 01: And there was another party that was using it, but it specifically carved out certain things that would prevent it from being a competitor. [00:27:02] Speaker 01: Or it used it in a very different product. [00:27:04] Speaker 01: Or if they were de minimis. [00:27:05] Speaker 01: Pardon? [00:27:06] Speaker 01: Or if they were de minimis. [00:27:07] Speaker 01: Right, or if they were de minimis. [00:27:08] Speaker 01: But you know, Pfizer... [00:27:09] Speaker 01: You know, these are no slouches, Your Honor. [00:27:12] Speaker 01: These are serious competitors in the market. [00:27:14] Speaker 01: So under certain facts, you could license people, you could license even potentially competitors to the market. [00:27:19] Speaker 01: And the district court, on a careful analysis, could, under particular facts, find, no, you can still have irreparable harm from Amgen entering. [00:27:25] Speaker 01: But on these facts, the district court had before, and on the analysis the district court gave, who, when, what financial terms, [00:27:33] Speaker 01: That, the district court committed no clear error, and it certainly didn't abuse its discretion based on the licensing. [00:27:39] Speaker 05: So you want to turn to where maybe you wanted to start, which is where you started with your friend, which is what does it do to us to be here and not today in terms of the appropriate relief that would be available? [00:27:50] Speaker 01: Honestly, Judge, I'm a little bit at a disadvantage because I'm a Pelley, and I frankly don't fully understand the strategy of bringing me here today when we have trial one month away in April. [00:28:01] Speaker 06: Well, to be fair to them, they filed their brief in July. [00:28:04] Speaker 06: So at the time, they filed their brief and initiated the case. [00:28:07] Speaker 06: It's entirely fair. [00:28:09] Speaker 01: But at this point, I think the notion of sending this back to the district court for reputable harm analysis on the facts as they exist today, there's no way this case comes out differently. [00:28:18] Speaker 01: And so it seems to me that, effectively, the passage of time has, in some sense, mooted all this. [00:28:24] Speaker 01: Because now we have the competitors on the market. [00:28:26] Speaker 01: It's not a future entry. [00:28:27] Speaker 01: It's a current entry. [00:28:28] Speaker 01: Now we are in the market and we're actually, you know, patients are being treated with our drugs. [00:28:33] Speaker 01: So it seems to me that under the circumstances, it's really just not a good basis for reversing, even apart from the fact that the district court committed no clear error and that there was no abuse of discretion. [00:28:43] Speaker 01: And that's even without going to the public interest factor, which I'd like to turn to last. [00:28:48] Speaker 01: And that is that the district court really understood that the injunction sought here would address, would reach two of four indications, indications that were not argued, not alleged to infringe any valid patent. [00:29:02] Speaker 01: And the district court understood, look, that would be contrary to the patent bargain. [00:29:07] Speaker 01: Herceptin, there was a period of exclusivity for it, and they obtained that period of exclusivity on the composition of matter patent by disclosing Herceptin and making it capable of being used by others following the expiration of the patent. [00:29:26] Speaker 01: Genentech to turn around and then say, well, we're going to take two uses of the receptive that are not alleged to violate any other patent and to try and take them off the market. [00:29:35] Speaker 01: That simply went too far for the district court. [00:29:38] Speaker 01: It's contrary to the public interest to take a lower competitor that has an expired patent [00:29:43] Speaker 01: and then try with an injunction reach overbroad and basically preclude indications that are not even arguably impringing. [00:29:51] Speaker 06: Your opposing counsel argues that that problem could have been solved if you'd gone back to the skinny label, but mechanically [00:29:59] Speaker 06: I was left wondering what, if you had decided to do that, if you had decided in July, you know what, we're too worried about the possibility of infringement. [00:30:09] Speaker 06: Let's go back to the skinny label. [00:30:10] Speaker 06: What would you have had to do to implement the skinny label? [00:30:14] Speaker 06: Would you have had to go back to the FDA? [00:30:16] Speaker 01: So I think I should draw a distinction here. [00:30:18] Speaker 01: If we were worried about infringing, we wouldn't necessarily have to change the label. [00:30:22] Speaker 01: We might merely change the way we market it. [00:30:24] Speaker 01: But if we were subject to an injunction that said, and mind you, the problem here is they never asked for a skinny injunction that only prohibited the infringing uses. [00:30:32] Speaker 01: But if they asked for that injunction, and they were granted such an injunction, we would have to make a choice. [00:30:38] Speaker 01: Do we change the way we market it? [00:30:39] Speaker 01: Should we go back to the FDA and ask them to adjust the label so the label only has the truly clearly nobody claims that they're infringing uses? [00:30:48] Speaker 01: Those are the types of decisions we'd have to make. [00:30:50] Speaker 01: But ultimately, it was the burden of Genentech to go to the district court and ask for an injunction that only prohibits infringing activities and doesn't reach non infringing activities that are in the public domain. [00:31:03] Speaker 01: That was their burden. [00:31:03] Speaker 01: And they simply never before the district court said, I want a narrow injunction. [00:31:07] Speaker 01: They never said it in their opening brief. [00:31:08] Speaker 01: I don't even understand their reply to say, we want a narrow injunction that only reaches the allegedly accused uses and excludes the non-infringing. [00:31:17] Speaker 06: But you say that mechanically all you would have to do, if you came up prior to the injunction request having been filed, [00:31:24] Speaker 06: And you decided, you know what, we don't want to take the risk here. [00:31:27] Speaker 06: We'll just go with the skinny approach, the skinny label. [00:31:31] Speaker 06: You could do that just by changing your label without getting FDA approval? [00:31:36] Speaker 01: No, no, no. [00:31:36] Speaker 01: I think if we wanted to change the label and we thought it was necessary to change the label, we would have to go back to the FDA to change the label. [00:31:44] Speaker 06: But if you didn't change the label, presumably you'd still be exposed to an argument that, yeah, you may be saying in your marketing that this is only for the limited purposes, but your label allows it [00:31:53] Speaker 01: I suspect that there will be arguments along those lines that are raised and addressed by the jury at an upcoming trial in April, whether or not there is inducement and things like that. [00:32:04] Speaker 01: And I suspect that they will point to the label as an inducement. [00:32:06] Speaker 01: But that's all a matter of things for trial later on. [00:32:09] Speaker 01: I think right now the fact is when you're seeking an injunction, you have to ask for a properly tailored injunction. [00:32:16] Speaker 01: Genentech never sought an injunction that excluded clearly and admittedly non-infringing uses. [00:32:21] Speaker 01: The district court didn't abuse its discretion, saying, that simply goes too far. [00:32:25] Speaker 01: You can't take things that have been dedicated to the public domain away from your competitors when they're not accused infringing on any other patent. [00:32:32] Speaker 01: If there are no other questions, I'd be happy to take my seat. [00:32:36] Speaker 01: Thank you. [00:32:36] Speaker 01: For those reasons, we ask for the judgment be upfront. [00:32:42] Speaker 03: Your honors, maybe taking these in reverse order and talking about the public interest first. [00:32:47] Speaker 03: On that point, the label is what we would say in terms of inducement, the infringement. [00:32:53] Speaker 03: So unless they actually change the label, [00:32:57] Speaker 03: being out there with an 863 label but saying, well, we're really not marketing that, that would not do the job. [00:33:04] Speaker 03: And our point on the public interest is 75% of the uses, everyone agrees, are infringing uses. [00:33:11] Speaker 03: With respect to the delay point, and my friend talked about the issue of the June 18th hearing, I really think it's important to understand what was said by Amgen's counsel at that hearing. [00:33:25] Speaker 03: Remember, this is after FDA approval. [00:33:27] Speaker 03: It's about five days after FDA approved their product. [00:33:30] Speaker 03: And they said to the district court, if we were to launch in two months versus six months versus a year, Amgen would still need to make preparations to launch, to be prepared in a position to launch. [00:33:43] Speaker 03: They were affirmatively stating to the district court not only that a launch decision had not been made, but it might not be made for as long as a year. [00:33:53] Speaker 02: What page are you on? [00:33:54] Speaker 03: I am on Appendix 1277, page 30, lines 3 to 8. [00:34:06] Speaker 06: Well, yes, yes. [00:34:08] Speaker 06: Bob, we're looking for that. [00:34:09] Speaker 06: Let me just confirm that you did not ask for the narrow injunction, I take it, including only infringing uses. [00:34:17] Speaker 03: And the reason being, Your Honor, the reason. [00:34:18] Speaker 03: You did not or you did not? [00:34:19] Speaker 03: We did not. [00:34:20] Speaker 03: We did not. [00:34:21] Speaker 03: And the reason, Your Honor, the specific reason we did not, is that as long as their label had 863 on it, that's an infringing label. [00:34:29] Speaker 03: And so effectively, what we said. [00:34:31] Speaker 06: Now, of course, you could incorporate that in your request for an injunction. [00:34:35] Speaker 06: the uses nor the label. [00:34:38] Speaker 03: Well, fair enough. [00:34:40] Speaker 03: And I think the point, though, was that we never said, and of course they were thinking about from the period of December through March going with a skinny label, we never said they couldn't do that. [00:34:50] Speaker 03: And in fact, our position is that if they wanted to go back and get one, that's fine. [00:34:55] Speaker 03: But in the interim, we could supply the market. [00:34:57] Speaker 03: And so there was no reason for making a determination on the public interest with respect to that issue. [00:35:04] Speaker 03: Your Honor, with that, we would ask that the Court respectfully reverse or remand the decision. [00:35:13] Speaker 06: Thank you for your time. [00:35:13] Speaker 06: I'm sorry, I cut you off when you were about to respond to Judge Wallach's question. [00:35:18] Speaker 03: Well, Judge Wallach, I actually pointed you to that specific statement. [00:35:22] Speaker 03: Yeah, I'm not... I'm not selling you with that? [00:35:25] Speaker 02: You're not selling me with that because of where the Court's coming from in that questioning. [00:35:30] Speaker 02: And I don't look on that as a... [00:35:34] Speaker 03: representation of anything other than what we're talking about let me give you let me give you one more opinion yeah let me give you one more and it's it's in that same back and forth with the court and counsel and this is appendix 1276 at line at page 29 10 to 17 [00:35:52] Speaker 02: Yeah, that's where I started. [00:35:53] Speaker 02: OK, good, good. [00:35:54] Speaker 03: Because, Your Honor, look, here's what the Council. [00:35:57] Speaker 03: I don't think it helps you. [00:35:58] Speaker 03: It's opinion letters. [00:35:59] Speaker 04: It's about opinion letters. [00:36:01] Speaker 03: Well, it certainly is about opinion letters. [00:36:02] Speaker 03: But think about it in this context, Your Honor. [00:36:05] Speaker 03: If they were saying it wasn't right so that they could continue to protect their opinion letters, how can they turn around and say, well, but it was right in terms of us being able to make a determination that harm was imminent in terms of a preliminary injunction? [00:36:19] Speaker 03: And the point that I wanted to get to directly, Your Honor, because I want to try my best to see if I can sell you on this, is that if you look at what the council says is making a distinction at that point in the record between getting launch ready and whether they will ever launch before the expiration of these patents. [00:36:39] Speaker 03: They're getting it all ready. [00:36:40] Speaker 03: She's talking about Amgen. [00:36:41] Speaker 03: They're getting it all ready for an ultimate decision maker to decide, and what's the decision? [00:36:46] Speaker 03: whether or not we take that product and we launch it before the expiration of the patents. [00:36:53] Speaker 03: Now in that context, Your Honor, for us to be sitting there and told that even though FDA approval has occurred and even though we were in front of the district court within three weeks, three and a half weeks after FDA approval occurred, Your Honor, that we delayed [00:37:08] Speaker 03: The district court felt that it was jammed. [00:37:11] Speaker 03: I get that. [00:37:12] Speaker 03: He was very frustrated by the fact that he felt that he was jammed in this situation. [00:37:18] Speaker 03: But I would ask your honors to consider whose fault is that? [00:37:22] Speaker 03: Is that our fault or is that the fault of the people who were telling him, 36 witnesses that were telling us? [00:37:28] Speaker 02: A, I don't buy your argument. [00:37:32] Speaker 02: B, I think the district court's closer to the circumstances and knows who's jamming whom. [00:37:38] Speaker 02: And C, I think that what you're representing to this court is not squarely on, and I'm not saying you're making a misrepresentation, I'm just saying it's not squarely on where the district court is. [00:37:54] Speaker 03: I hear you, Your Honor. [00:37:55] Speaker 03: And the one thing I would say to you is it's one thing if the district court said, you know what, I'm looking at all this, including what you've pointed me to, and I don't buy it. [00:38:03] Speaker 03: He didn't say that. [00:38:04] Speaker 03: He never even dealt with these statements that I'm reading to you. [00:38:09] Speaker 03: And so what I'm saying is- He's aware of them. [00:38:11] Speaker 03: Well, Your Honor, he certainly should have been aware of them. [00:38:13] Speaker 06: But the fact that he didn't say anything about them, I think- This is done as a fire drill. [00:38:19] Speaker 06: And he wrote what I thought was given the time constraints and given the fact that he has to deal with the heaviest patent docket in the country right now, 250 patent cases per judge per year in Delaware. [00:38:35] Speaker 06: The fact that he was able to write as much as he wrote is remarkable, and to hold him accountable for not having written something on every point that you made seems to me to be asking a lot. [00:38:49] Speaker 03: Your Honor, let me respond to that, because I think Judge Connolly is a terrific judge. [00:38:54] Speaker 03: We've been in front of him for a couple of years now on this case. [00:38:58] Speaker 03: And so I am not suggesting that Judge Connolly is somehow sort of lacking in terms of ability or [00:39:05] Speaker 06: But you're suggesting he give us the ball on this issue. [00:39:08] Speaker 06: I'm suggesting that he wasn't required to swing at all the pitches. [00:39:12] Speaker 03: I agree with that, Your Honor. [00:39:13] Speaker 03: And look, here's what it comes down to at the end of the day. [00:39:16] Speaker 03: It comes down to whether or not, in view of these statements that I've read to you, I can convince the court that in that context, if there is any sort [00:39:28] Speaker 03: Blame is not even the right word. [00:39:30] Speaker 03: If you're going to put the risk on one of the parties, in view of those statements, I think it's fair to put the risk on them, not us. [00:39:39] Speaker 03: Now, you may disagree with me on that. [00:39:41] Speaker 03: And I think Judge Friedman, I don't think, you know, you may well disagree. [00:39:44] Speaker 02: No, I have Judge Friedman. [00:39:45] Speaker 02: Oh, I'm sorry, Judge Wallach. [00:39:46] Speaker 02: I apologize. [00:39:48] Speaker 02: I think we're going to bring this to a close. [00:39:49] Speaker 03: I thank you very much, and I appreciate you letting me go way over my time. [00:39:54] Speaker 03: Thank you, sir. [00:39:54] Speaker 02: Thank you for taking me back to law school and Robert Cole. [00:39:59] Speaker 02: The risk of non-persuasion. [00:40:01] Speaker 02: Thank you, sir. [00:40:03] Speaker 05: They thank both sides of cases submitted. [00:40:05] Speaker 05: The conclusion received. [00:40:06] Speaker 04: All rise. [00:40:08] Speaker 04: The honorable court is adjourned until tomorrow morning at 10 o'clock AM.