[00:00:00] Speaker 03: A lot of things this morning are legal pharmaceuticals versus playback pharma and Apotex 2023-1110. [00:00:08] Speaker 03: Mr. Gar. [00:00:16] Speaker 00: Thank you, Judge Laurie. [00:00:16] Speaker 00: I may have pleased the court. [00:00:18] Speaker 00: For two independent reasons, the district court's decision to any judgment for defendants should be reversed. [00:00:24] Speaker 00: First, the district court's decision rests on the construction of the ready-to-use limitation [00:00:30] Speaker 00: that, as the defendant's own experts admitted, excludes all of the preferred embodiments in the patent and all then-a-must-gain products generally, rendering the patent utterly inoperable. [00:00:45] Speaker 00: Whether viewed through the lens of claim construction or clear error, that result is untenable. [00:00:51] Speaker 00: Second, the district court erroneous decision. [00:00:55] Speaker 05: Until we get to this appeal, you stipulated to this claim construction, right? [00:00:59] Speaker 00: Your honor, we stipulated to a construction that ready to use minimal, if any, effort or preparation, which is the one that the patent examiner adopted. [00:01:08] Speaker 00: And obviously, the patent examiner didn't adopt it, a construction that rendered the patent meaningless. [00:01:13] Speaker 00: And so what happened was, and this was made clear by the district court's pretrial rulings in this Flaherty case and on the motion and limiting here, is the district court's understanding of that term shifted radically, so that after one day of trial on infringement, [00:01:28] Speaker 00: It adopted this construction that shifted from the level of effort to the level of risk inherent and been a Muslim product generally. [00:01:38] Speaker 05: And that's what you're saying is the clean construction error, the shifting from error to risk. [00:01:44] Speaker 05: Exactly, Your Honor. [00:01:46] Speaker 00: And I think that the linear technology case sort of illustrates that problem where [00:01:50] Speaker 05: the understanding of the term shift in a manner that excludes... Well, you can call it a shift and I think somewhere maybe you use the term that they conflated effort and risk. [00:02:02] Speaker 05: But it found that the risk involved meant that a person needed to be extremely precise, which in turn required more than minimal effort. [00:02:12] Speaker 05: How is that problematic under the construction? [00:02:14] Speaker 05: How is that reconstruing the claim? [00:02:16] Speaker 00: So it's problematic because it excludes all venomous steam products. [00:02:21] Speaker 00: No liquid venomous steam product qualifies as ready to use. [00:02:25] Speaker 00: The patent is inoperable. [00:02:27] Speaker 00: It's problematic because it shifts the district court's own district. [00:02:30] Speaker 01: Are you saying it renders a patent indefinite? [00:02:33] Speaker 00: inoperable. [00:02:34] Speaker 00: It covers nothing, Your Honor. [00:02:36] Speaker 00: There's no liquid venom mustine product that is ready to use under that understanding, and the defendant's own expert admitted that. [00:02:44] Speaker 01: I'm sorry. [00:02:45] Speaker 01: The claims would cover nothing, or they would cover everything? [00:02:49] Speaker 01: Nothing. [00:02:51] Speaker 05: Is there a problem with the minimal effort required? [00:02:56] Speaker 00: Right, because this should... [00:02:59] Speaker 00: I'm sorry, because the shift from effort to risk. [00:03:02] Speaker 00: And if you look at the question of further dilution, Your Honor, which is the district court prior to the trial in this case, in the Solarity case involving the same patent, the same limitation, recognized that ready to use did not exclude further dilution. [00:03:19] Speaker 00: Yet, under the district court's decision in this case, and this is on page 13 of the appendix, it held that each step, including a dilution step, [00:03:29] Speaker 00: required more than minimal effort because of the inherent risks and therefore rendered a product not ready to use. [00:03:35] Speaker 00: That's completely incompatible. [00:03:37] Speaker 00: You can't square that shift. [00:03:40] Speaker 00: Similarly, in its motion and limiting ruling in which it denied the defendant's efforts to say, our experts can't testify about a comparison between using the liophilized [00:03:52] Speaker 00: powdered Benamostene that had to be reconstituted in cumbersome process and using the concentrated liquid Benamostene that the district court agreed with us. [00:04:02] Speaker 00: That comparison, and he allowed that because he recognized that a person of skill of the art would want to know the comparison in determining what was minimal. [00:04:13] Speaker 00: But all of that is irrelevant under the district court's construction in its decision, and that's clear on page [00:04:19] Speaker 00: 14 of the appendix where he said that the problem with Dr. Sewell's testimony was all he talked about the gist of it was a comparison, but that's not the relevant question. [00:04:28] Speaker 00: That's what he said. [00:04:29] Speaker 05: So again, that shows the shift. [00:04:34] Speaker 05: isn't this case correctly looked at. [00:04:38] Speaker 05: It was left to the damages to the experts to testify. [00:04:41] Speaker 05: And that's really a huge basis for it. [00:04:44] Speaker 05: And it seems to me that the experts as well as the district court really did apply the stipulated claim construction. [00:04:51] Speaker 05: So if we're there, [00:04:53] Speaker 05: Isn't he well within his authority to credit one expert versus the other? [00:04:58] Speaker 05: And he gave plenty of reasons in his opinion why he was credit. [00:05:02] Speaker 05: He didn't just say, I believe him and not him. [00:05:04] Speaker 05: He gave plenty of reasons why he thought Dr. Grant was more probative than the other expert. [00:05:11] Speaker 05: Why doesn't the case begin and end with that? [00:05:13] Speaker 00: because your honor, he found both experts credible. [00:05:15] Speaker 00: He even found our expert credible and that's when... But the problem is that our expert talked about the level of effort and said that the effort in dispensing liquid bundle mustang was minimal and trivial. [00:05:29] Speaker 00: Their expert came in and said, [00:05:31] Speaker 00: Wait a second, this is an inherently dangerous product. [00:05:35] Speaker 00: Every step you take, even looking at the vial, and that's clear on page 12 of the appendix, looking at this wrench, every single step is more than minimal because of the inherent risk in this product. [00:05:47] Speaker 00: And that is what creates the problem. [00:05:49] Speaker 00: That's a completely different way of looking at it. [00:05:51] Speaker 00: It means that the patent examiner was wrong in adopting this construction and improving this patent. [00:05:58] Speaker 00: under this understanding of the patent and the ready-to-use limitation, no Ben and Mustang product qualifies. [00:06:04] Speaker 05: But going back to the experts, though, I mean, our review is minimal in terms of reviewing his assessment of the credibility and accountability of the experts, right? [00:06:18] Speaker 05: And one of the things he lied on heavily, I think, was that the expert on the other side had done these injections hundreds of times. [00:06:26] Speaker 05: And so what he said carried more meaning than the expert on the other side who had never done these injections and came from the UK, which doesn't even allow this drop, right? [00:06:35] Speaker 00: So first of all, our expert was, that's right, Your Honor, he said that our expert was qualified. [00:06:40] Speaker 00: There was no dispute that he was qualified. [00:06:43] Speaker 00: But the crux of this came down to Dr. Grant, their expert's answer to this question. [00:06:47] Speaker 00: This is on page five. [00:06:50] Speaker 00: 53-79, the appendix, why aren't the steps minimal or trivial? [00:06:55] Speaker 00: And what he said is, quote, there's nothing minimal or trivial about compounding a highly toxic chemotherapy drug. [00:07:02] Speaker 00: And that's the reasons that the district court gives on page 13 of the appendix, paragraph 39, where he finds [00:07:08] Speaker 00: that these are minimal because these are these are not minimal because of the current risk in liquid venomous products and so therefore each step and he's referring back to the steps on page 12 of the appendix including just removing the vials cap. [00:07:23] Speaker 00: Renders is not ready to use. [00:07:25] Speaker 00: That makes no sense. [00:07:27] Speaker 00: It means the patent is utterly inoperable. [00:07:29] Speaker 00: It means that the patent examiner who applied the same construction, which is based on medical dictionary definition, was wrong to approve this. [00:07:37] Speaker 00: It overlooks that we're looking at this from the standpoint of the person of skill in the art, which is someone who works [00:07:43] Speaker 00: in this sphere, who works in a clean room, who works in a glove box, who knows the inherent dangers. [00:07:48] Speaker 00: And the question for that person, is this liquid been a mustang product that all I have to do is add it to lutein and then it's ready to dispense, ready to use compared to the prior fullized powdered version that had to be reconstituted in a 15 to 30 minute process that was inconvenient, which was the whole reason for the patent. [00:08:07] Speaker 00: And it's really this completely different way of looking at it. [00:08:10] Speaker 00: that caused the district court to reach this conclusion, and it's evident in the district court's decision on page 13. [00:08:18] Speaker 00: And that doesn't come down to an issue of credibility. [00:08:22] Speaker 00: It comes down to a question of how you're looking at this claim limitation. [00:08:26] Speaker 00: And we went through a world in which it was minimal effort, in which the district court recognized that a dilution step did not render a product not ready to use in its celerity ruling, and in which in order to determine what was minimal, you would look at a comparison to the world in which you used the powdered version that you had to reconstitute. [00:08:45] Speaker 00: And we shifted entirely to a decision in which all that mattered was the inherent risk in the liquid Benamostene product generally, in which a dilution step alone rendered a product not ready to use, and in which a comparison to the prior world of the powdered Benamostene was irrelevant. [00:09:04] Speaker 00: And those are night and day. [00:09:06] Speaker 00: And whether you look at that as a conclaimed construction issue, which is, I think, analogous. [00:09:10] Speaker 01: Did you raise an objection to Apley's, the experts' testimony? [00:09:15] Speaker 00: We didn't, Your Honor, and what happened was we had these pre-trial rulings. [00:09:20] Speaker 00: I mean, look, the defendants themselves described their products to the FTA as ready to use. [00:09:25] Speaker 00: The patent examiner clearly thought there were liquid benefit mustang products that were ready to use when we approved this patent. [00:09:31] Speaker 00: The district court's pre-trial rulings recognized that as well, that a diluting step didn't render it not ready to use and that you would compare it. [00:09:39] Speaker 00: It was comparative inquiry. [00:09:40] Speaker 00: It was only at trial. [00:09:43] Speaker 00: at the close of the first day of trial that the district court adopted this radically different way of looking at it, we objected immediately to that and here we are. [00:09:53] Speaker 00: And I think that the linear technologies case is an analogous case. [00:09:58] Speaker 00: There the court had a limitation which was monitoring the current and the commission adopted [00:10:05] Speaker 00: an understanding of that that excluded, improperly narrowed it so that it didn't cover measuring voltage, and the court said that that was wrong. [00:10:13] Speaker 00: Even though the courts didn't say it was reconstruing the term, that was the effect. [00:10:18] Speaker 00: It changed the scope and meaning of it and improperly narrowed it. [00:10:22] Speaker 00: Here, the district court didn't only narrow the meaning of ready to use, it rendered it [00:10:29] Speaker 00: irrelevant. [00:10:30] Speaker 00: It rendered all liquid venom mustang compositions not ready to use. [00:10:34] Speaker 01: At what point did you object to any of the evidence regarding that there was a minimal effort issue? [00:10:44] Speaker 00: We didn't object, Your Honor. [00:10:46] Speaker 00: They were entitled to put in the evidence that they wanted to put in. [00:10:50] Speaker 01: But if it's getting away from claim construction and it's contrary to claim construction, then shouldn't you object at that point? [00:10:57] Speaker 00: So they had their expert, they put on an expert, and during that expert's testimony, he testified about the inherent risks in local venom in his mustang products. [00:11:06] Speaker 00: It wasn't until the district court adopted that and said that was the reason that this was not minimal, that a comparison was irrelevant, and that a dilution step alone would render it not ready to use, contrary to his prior 180 degree different ruling before trial on that, that it became apparent that he had completely [00:11:27] Speaker 00: taking the ground from underneath the meaning of ready to use that the parties had stipulated to do. [00:11:31] Speaker 01: I'm just concerned that you may be facing a waiver issue here. [00:11:38] Speaker 00: With respect, Your Honor, I don't think there's any waiver at all. [00:11:41] Speaker 00: And again, think about the world as we understood it. [00:11:44] Speaker 00: The defendants themselves had described their products, which are generic products, to the FDA as ready to use. [00:11:50] Speaker 00: The patent examiner [00:11:51] Speaker 00: recognized that liquid, bent, and must-be products could be ready to use and approve the patent. [00:11:56] Speaker 00: The district court itself, prior to trial, recognized that a dilutant step did not render something not ready to use. [00:12:04] Speaker 05: You've said twice about what the FDA did. [00:12:06] Speaker 05: Yes. [00:12:07] Speaker 05: But you had the chance at trial, did you not? [00:12:09] Speaker 05: I mean, the question at trial was, when the FDA uses the term ready to use, is that synonymous with the stipulated construction? [00:12:18] Speaker 05: And I think the district court even tried to do a side for why don't you bring me in the FDA so that they can give us the answer we need as to what the relevance is of what you're making today. [00:12:29] Speaker 05: And you didn't do that. [00:12:31] Speaker 00: So I think that imposed an improper burden on us, Your Honor. [00:12:35] Speaker 00: In this case, in the power of pharmaceutical versus eagles case, dealt with the same situation. [00:12:39] Speaker 00: And there, the court said that [00:12:41] Speaker 00: that the defendant's own statements to the FDA recognizing that a claim limitation were met because of the way they characterized their product were just positive controlling on the infringement inquiry. [00:12:51] Speaker 00: But even more than that, Your Honor, in the intended case, the court recognized that FDA statements by a manufacturer show the ordinary meaning of the term. [00:13:01] Speaker 00: So at a bare minimum, the fact that the defendants described their products as ready to use is consistent with the ordinary meaning of the term. [00:13:09] Speaker 00: We didn't have to [00:13:10] Speaker 00: come in and prove how the FDA understood that. [00:13:12] Speaker 00: That was really irrelevant. [00:13:14] Speaker 05: What matters is... Well, doesn't it matter if the FDA construed it the way the stipulated construction construed it? [00:13:21] Speaker 05: Don't you think that matters? [00:13:22] Speaker 05: Not on this. [00:13:23] Speaker 05: Not on this. [00:13:24] Speaker 05: If the FDA says no, our view of ready to use is not consistent with what the stipulating construction of that term is. [00:13:31] Speaker 00: So I suppose if there were a regulation or something like that, Your Honor, there was nothing. [00:13:34] Speaker 00: They were silenced here. [00:13:36] Speaker 00: And so what matters is the way the defendants used it, because if this court recognized an intent is that. [00:13:41] Speaker 05: It matters what the term. [00:13:42] Speaker 05: I mean, everybody from the get-go of prosecution, somebody figured they needed to define what ready to use meant in this particular context. [00:13:51] Speaker 05: And that's the stipulated construction that both parties agree to. [00:13:55] Speaker 05: You're saying that we absolutely have to assume that that's precisely the definition that the FDA uses when they use that term in this context? [00:14:03] Speaker 00: So I think the question is a claim construction question of what's the ordinary meaning of the term. [00:14:08] Speaker 00: And the fact that the defendants themselves characterize their products as ready to use is reflective of the ordinary meaning, which is what this court said in attendance. [00:14:16] Speaker 00: The district court prior to trial recognized that this was the ordinary meaning of ready to use. [00:14:21] Speaker 00: when he refused to agree that a dilution step in itself would render it not ready to use. [00:14:27] Speaker 00: And that was on page 14652. [00:14:29] Speaker 03: So this is... Council, your total time is just nearly up. [00:14:35] Speaker 03: We'll give you two minutes for butter. [00:14:37] Speaker 03: Thank you. [00:14:37] Speaker 03: That's my first minute. [00:14:40] Speaker 03: Thank you very much. [00:14:41] Speaker 03: Thank you, Mr. Wollingberg. [00:14:48] Speaker 02: Good morning and may it please the court. [00:14:50] Speaker 02: Eric Rehlinger on behalf of the Apotex defendants. [00:14:53] Speaker 02: EGLE got the trial it wanted under the claim construction that it repeatedly asked for and it lost. [00:14:59] Speaker 02: The district court determined as fact that the defendant's Benda Mustang products cannot be dispensed with minimal effort or preparation due to the great care that has to be taken in preparing these cytotoxic products for administration. [00:15:12] Speaker 02: That holding is reviewed plainly for clear error. [00:15:15] Speaker 05: Well, let me ask you. [00:15:16] Speaker 05: I mean, one of the points that Mr. Garvey had to do with this, I guess it's appendix 13 or whatever, it seemed like the trump card here and what we rated it all is it didn't really matter what the steps were. [00:15:27] Speaker 05: It was the fact we're dealing with a toxic drug and we're dealing with fragile cancer patients. [00:15:34] Speaker 05: So given those two factors, outside of anything else we're doing here is going to require more than minimal effort because of those circumstances. [00:15:44] Speaker 05: Is that the right way to look at this and to analyze this? [00:15:48] Speaker 02: Well, I think we have to analyze it within the context of the stipulated definition, which is to ask whether or not these products can be dispensed with minimal effort or preparation. [00:15:57] Speaker 02: And I think it's key to focus on the preparation. [00:15:59] Speaker 05: Well, what if anybody stipulated that as we weren't dealing with cancer patients, and we were dealing with the less toxic drug, but we're dealing with the exact same steps, [00:16:11] Speaker 05: it would have required minimal effort. [00:16:13] Speaker 05: So those are the two variables in this context which take it out of that. [00:16:18] Speaker 05: Are you comfortable with that? [00:16:20] Speaker 05: Yeah, I'm assuming you don't want to defend that. [00:16:24] Speaker 02: Well, I think at that point you are dealing with a very different case. [00:16:27] Speaker 02: I'm not sure I'm prepared to concede that even going through the 13 steps themselves, even if you're not doing it in a glove box and wearing a protective suit, which is what the facts were here, is minimal effort. [00:16:37] Speaker 02: But certainly within the context of these drugs and the definition that EGLE stipulated to repeatedly, I think the district court was well within its [00:16:48] Speaker 02: well within its authority to look at the preparation that went into the dispensing process and say, yeah, that's not minimal. [00:16:55] Speaker 02: I have an expert up here who says he's dispensed the shrug hundreds of times, and it takes anywhere from 15 to 30 minutes. [00:17:02] Speaker 05: No, but I'm asking you, if there's anything improper, if I construe the district court as having said that everything about this that made it non-minimal had to do with the toxicity of the drug and the fragility of the patient. [00:17:18] Speaker 02: I don't think I would understand the district court's holding that way, Your Honor. [00:17:21] Speaker 02: I think that was certainly a big part of it. [00:17:25] Speaker 05: But the... Well, is there anything wrong with that being a big part of it? [00:17:30] Speaker 02: No. [00:17:31] Speaker 02: Okay. [00:17:32] Speaker 02: No, no. [00:17:32] Speaker 02: It's minimal effort or preparation. [00:17:34] Speaker 05: Because we're talking about this drug. [00:17:35] Speaker 05: That's what this case is about. [00:17:37] Speaker 02: It is... The holding is specifically about this drug, the evidence that was presented at this trial, and applying it to the definition that we all stipulated to. [00:17:47] Speaker 02: And Judge Raina, I want to pick up on a line of questioning that you were asking about, you know, whether or not there should have been an objection. [00:17:54] Speaker 02: I think it's really important to point out that there were no surprises when we went in to try it. [00:17:59] Speaker 02: We were going in to have a battle of the experts to apply the stipulated definition. [00:18:04] Speaker 02: We had already gone through expert discovery, so we knew what these experts intended to say and how the parties intended to frame that testimony. [00:18:12] Speaker 05: And when we went in, I mean, Mr. Garvin referred to, you know, the one-day trial [00:18:17] Speaker 05: really quickly, but that was pre-set, right? [00:18:20] Speaker 05: The timing of this was all pre-set, right? [00:18:23] Speaker 02: I believe so, yes. [00:18:24] Speaker 02: It was supposed to be one day on infringement and one day on invalidity. [00:18:27] Speaker 02: And Judge Connolly said that after he had heard the infringement evidence, he was convinced there was no infringement, so there's no need to go into invalidity. [00:18:33] Speaker 05: But that was the time frame that was pre-established, just the one day infringement. [00:18:40] Speaker 01: Correct. [00:18:40] Speaker 01: So suppose that I have a concern about whether the court engaged in new clamp construction [00:18:47] Speaker 01: as opposed to fact-finding analysis that informs the stipulated claim. [00:18:55] Speaker 01: What would you say to that? [00:18:57] Speaker 02: So my response would be to point you to this court's case in Versata, the upshot of which is that when there is an effective, when you have a stipulated construction to a term, everything after that becomes application. [00:19:11] Speaker 02: And in so far as there is a litigant who after the fact wants to add a negative limitation, which is effectively what my friend is asking you to do, that's a fact issue. [00:19:20] Speaker 02: Everything after that becomes fact. [00:19:22] Speaker 02: It's application. [00:19:23] Speaker 02: And I think Versata's particularly informative because there the question was whether or not source code could be viewed as computer information, which was the key limitation, the key definition in that pattern. [00:19:34] Speaker 02: And I think there's a very highly [00:19:36] Speaker 02: There's a very clear analogy here. [00:19:38] Speaker 02: We're talking about the effort, excuse me, the risk to the provider and to the patient in preparing these drugs and whether or not that is, whether that is probative of the effort and the preparation that go into the dispensing process. [00:19:53] Speaker 02: That's an application question and that's a fact question in light of the stipulation. [00:19:58] Speaker 02: If EGLE thought that that testimony was going to stray beyond the bounds of the stipulated construction, they were obligated to raise their hands. [00:20:07] Speaker 02: and say something, but they did the opposite. [00:20:10] Speaker 02: During the motion-eliminate proceedings, they argued vigorously, quote, the die is cast on claim construction. [00:20:17] Speaker 02: In their view, all that was left to do was to go to trial, let the experts duke it out, and for Judge Connolly to make his fact-finding. [00:20:25] Speaker 05: What about the actual use of the camera? [00:20:27] Speaker 02: Sure, so let's go there. [00:20:30] Speaker 02: I think what EGLE is doing is they are taking a very basic legal proposition and stretching it to the point, well past its breaking point, to attack findings of fact. [00:20:42] Speaker 02: The upshot of their argument is that they're upset that Judge Connolly did not credit a couple of snippets out of a pre-India firing that used the words, ready to use, as a legally binding admission. [00:20:55] Speaker 02: Judge Conley was not required to do that. [00:20:57] Speaker 02: My friend cannot cite you to any proposition of law that requires that. [00:21:00] Speaker 02: What the law requires is to consider the totality of the FDA evidence and weigh it just like any other piece of evidence. [00:21:08] Speaker 02: And when you look at the totality here, I think it's important to point out that the labels, the proposed labels do not say ready to use. [00:21:16] Speaker 02: Apotex specifically said, and they later filing, our product is not ready to use. [00:21:23] Speaker 02: We explicitly disavowed it. [00:21:25] Speaker 02: and then if you look at the totality of the references throughout the record, both of the defendants are separate. [00:21:31] Speaker 01: Are you saying that statements made to the FDA have no bearing? [00:21:36] Speaker 01: Not at all. [00:21:37] Speaker 01: Not at all. [00:21:37] Speaker 01: They do have bearing, but they don't have [00:21:39] Speaker 02: legally, unless it rises to some level of unambiguity that we do not have here, you consider the whole body of the FDA statement. [00:21:50] Speaker 05: But didn't Judge Collier also kind of encourage them to all bring in somebody else? [00:21:54] Speaker 05: I think he would have been persuaded if the FDA came in and said ready to use means and gives the definition of the stipulated construction right? [00:22:03] Speaker 05: Sure, I think that is... I thought, maybe I'm misremembering, but I thought that was part of his [00:22:08] Speaker 02: No, that absolutely is a key part of his ruling. [00:22:12] Speaker 02: I think it's, I think it's finding number 36 of his opinion. [00:22:15] Speaker 02: And I think the reason that he framed it in that way is because he was responding to Eagle's argument where they are trying to put legally dispositive weight on the one or two references. [00:22:25] Speaker 05: What about your friend's argument that this patent under this construction patent covers nothing? [00:22:30] Speaker 02: So I have two responses to that. [00:22:32] Speaker 02: Number one, when we're talking about what was held in this case, the only thing that was held here was that these particular products at issue didn't require more than minimal effort and preparation. [00:22:44] Speaker 02: Whether or not that translates into something broader is for another day and another set of litigants. [00:22:50] Speaker 02: In terms of just practical reality of does it render the patent inoperable, my response to that is EGLE chose its definition. [00:22:59] Speaker 02: And during patent prosecution, they had the opportunity to use different claim language. [00:23:04] Speaker 02: The examiner explicitly offered them ready for further dilution. [00:23:08] Speaker 02: And they said, no. [00:23:10] Speaker 02: We want ready to use. [00:23:12] Speaker 02: And in order to get over an indefiniteness objection by the examiner, they accepted this definition that was found on an online dictionary. [00:23:19] Speaker 02: So insofar as that may render the patent inoperable, that is their own doing. [00:23:25] Speaker 02: And the fact that there was an allowance in this case [00:23:27] Speaker 02: is not just positive because, I mean, the PTO allows patents that are inoperable or invalid all the time. [00:23:35] Speaker 02: I mean, if that weren't the case, we wouldn't have much to do in this court. [00:23:40] Speaker 03: And validity is not an issue. [00:23:42] Speaker 02: No, it's not. [00:23:43] Speaker 02: My only point is that my friend seemed to suggest that the fact that there was an allowance in this case militates against construing the patent or understanding the patent in a way that might render it nonoperable. [00:23:54] Speaker 02: And my point is that is not accurate. [00:23:58] Speaker 02: So the last point I'd like to make in my very brief remaining time is to address this notion about the requiring the comparison of liquid to lyophilized bendimostene. [00:24:13] Speaker 02: And my only point for you there is that we're asking whether these products can be dispensed with minimal effort and preparation. [00:24:20] Speaker 02: Both sides agreed what dispensing is generally, and that is the process of taking what the manufacturer gives you [00:24:27] Speaker 02: doing all of the steps in order to get it ready to administer for the patient. [00:24:32] Speaker 02: So when you're talking about Vendamocene, that includes the reconstitution of a lyophilized product and the dilution of a liquid concentrate product. [00:24:40] Speaker 02: Judge Connolly considered all of the party's evidence on this front. [00:24:44] Speaker 02: He specifically considered Dr. Sewell's comparison and found it unpersuasive. [00:24:48] Speaker 02: That's finding number 32, appendix H14. [00:24:51] Speaker 02: With that, I see my time has expired. [00:24:53] Speaker 02: Unless you have any further questions, I'm prepared to see the podium. [00:24:56] Speaker 03: Thank you, counsel. [00:24:57] Speaker 04: I don't want to repeat much of what you heard. [00:25:12] Speaker 04: In the case here, the legal question and the factual question are very much intertwined. [00:25:18] Speaker 04: So what I would like to address is the argument that even if there was no new claim construction and the judge applied the stipulated construction, that he nonetheless got it wrong on the facts, that his decision was somehow clearly erroneous or not supported by the evidence. [00:25:38] Speaker 04: You know, as you've heard, there were two experts in this case, Dr. Sewell and Dr. Brandt. [00:25:42] Speaker 04: One expert had done this many, many times. [00:25:44] Speaker 04: That was Dr. Brandt. [00:25:46] Speaker 04: The other expert had never done it. [00:25:48] Speaker 04: The court came into the case, heard the testimony, and concluded, for reasons that he made clear on the record, that Dr. Brant's testimony was more credible. [00:25:58] Speaker 04: He specifically noted the fact that Dr. Sewell had no prior experience with the drug, and he specifically commented on Dr. Brant's demeanor on the stand and characterized him [00:26:09] Speaker 04: as I think one of the best witnesses he had, most credible witnesses he had ever seen. [00:26:13] Speaker 04: So there was ample reason. [00:26:15] Speaker 05: Well, I think he was limiting it at least to the trials he had in the past year. [00:26:19] Speaker 04: Very much. [00:26:20] Speaker 04: That may be, Your Honor. [00:26:21] Speaker 04: But he nonetheless lauded Dr. Brand as a very credible witness. [00:26:25] Speaker 04: I mean, I think he described his testimony at one point as compelling. [00:26:28] Speaker 04: And the argument here is that the judge got it wrong because he conflated effort and risk. [00:26:34] Speaker 04: And I personally think that's a red herring. [00:26:36] Speaker 04: I mean, you can't, it's like if you drive, [00:26:39] Speaker 04: from Pittsburgh to Cleveland in a snowstorm and you drive the same route in a sunny day, it's the same route, it's the same road, the same car. [00:26:46] Speaker 04: But you're going to be a lot tighter after you drive in a snowstorm because you have to pay attention. [00:26:50] Speaker 04: You have to be careful. [00:26:51] Speaker 04: And it's the same issue here. [00:26:53] Speaker 04: Dr. Brandt testified about the dispensing process. [00:26:56] Speaker 04: There was no dispute what the steps were, but he testified that when you dispense this drug, each step has to be performed carefully, and it has to be double checked. [00:27:06] Speaker 04: And it requires a lot of focus. [00:27:08] Speaker 04: And focus and attention are our effort. [00:27:12] Speaker 04: I mean, they are the same thing. [00:27:14] Speaker 04: pay attention to something, can't carefully perform a series of acts without using effort. [00:27:21] Speaker 04: And the judge was persuaded by that testimony that more than minimal effort was required to dispense the drug. [00:27:27] Speaker 04: Dr. Brand testified, and I think this was mentioned, Dr. Brand testified that even though he's an experienced oncology pharmacist, it takes him 15 to 30 minutes to prepare a dose of this drug because this is a drug that has to be individually tailored for each patient that comes in. [00:27:43] Speaker 04: Like many cancer drugs, you have to identify the dose based on body surface area. [00:27:48] Speaker 04: You do a calculation. [00:27:50] Speaker 04: You find the amount of the drug that you need to inject into the bag to make that concentration, and then you carry out these other steps to make sure that the injection is going to be safe and effective. [00:28:02] Speaker 04: And part of the reason for that, and the judge noted this in his opinion, is that this is a drug with a very narrow therapeutic window. [00:28:09] Speaker 04: If you don't do it exactly right, you could harm the patient instead of giving the patient benefits. [00:28:14] Speaker 04: So for all those reasons, the judge, I think, was well within his rights to conclude that more than minimal effort on the factual presentation was required to dispense this drug. [00:28:26] Speaker 04: And I don't think there's really any merit to the notion he substituted toxicity or general problems with chemotherapy for the stipulated construction. [00:28:37] Speaker 04: the effort required as a function of the level of attention that is required to prepare this dose. [00:28:42] Speaker 04: And the judge found out, I think, in findings 24 and 29, and that was the testimony of trial. [00:28:48] Speaker 04: So, you know, the way that they approached this trial was to focus on, you know, very few steps and to focus essentially on the comparison between the lyophilized product and liquid concentrate product. [00:29:04] Speaker 04: And ultimately, it was a failure of proof on their part. [00:29:06] Speaker 04: This was the way they chose to present their case. [00:29:09] Speaker 04: There was, as noted, no objection to Dr. Brand's testimony about the risks inherent in the defencing process. [00:29:17] Speaker 04: This was all in his report. [00:29:18] Speaker 04: He was escorted as deposition. [00:29:20] Speaker 04: So there were no surprises here. [00:29:22] Speaker 04: There was no motion in limiting. [00:29:23] Speaker 04: There was no [00:29:24] Speaker 04: argument that this, you know, for example, with respect to the FDA. [00:29:28] Speaker 05: Well, there was a motion in Lemony, but you lost it. [00:29:30] Speaker 04: It was our motion in Lemony. [00:29:32] Speaker 04: They didn't make a motion. [00:29:33] Speaker 04: My point is that they did not move in Lemony or otherwise suggest that Dr. Brandt's testimony about what they call risk was inappropriate under the stipulated constructions. [00:29:43] Speaker 04: All came in, the judge weighed all the evidence, and he reached the conclusion that he reached. [00:29:48] Speaker 04: And I think, you know, as [00:29:51] Speaker 04: what you have here is a garden variety appeal in a case where there was a stipulated construction where the judge held the trial, heard two experts, and came up with, came to the conclusion that one expert was more credible than the other, and that was Dr. Grant. [00:30:06] Speaker 04: And so I don't, you know, I don't think the rest of this I think is somewhat bordering on metaphysical. [00:30:11] Speaker 04: I mean, this was a case where the judge heard the evidence, he made his decision, he rendered his opinion. [00:30:17] Speaker 04: So the only other thing I wanted to [00:30:20] Speaker 04: say anything about. [00:30:21] Speaker 04: There was, and this did not come up during the argument, but there was a suggestion in the briefs that the judge shouldn't have relied on Dr. Brand's testimony because allegedly it was inconsistent with some testimony that he gave about some other drugs not related to bendimustine that he characterized as being ready to use. [00:30:41] Speaker 04: I think the judge, and the primary drug was a drug called nulasta, which is a drug that comes in a pre-dose syringe. [00:30:48] Speaker 04: It's in a box. [00:30:49] Speaker 04: You take it out of the box, you attach the needle, and you're done. [00:30:52] Speaker 03: You're ready to go. [00:30:53] Speaker 03: Your time has expired. [00:30:55] Speaker 03: I think we have your point. [00:30:58] Speaker 03: Mr. Dahr has a couple of minutes for a bottle. [00:31:03] Speaker 00: Thank you, Your Honor. [00:31:05] Speaker 00: Thank you, Your Honor. [00:31:05] Speaker 00: With respect, I don't think there's anything guarding variety about this case. [00:31:09] Speaker 00: The claim covers a ready-to-use liquid venomous steam containing composition. [00:31:14] Speaker 00: That no longer exists under this decision. [00:31:18] Speaker 00: because everyone knew and everyone agrees that Benamostene is highly toxic. [00:31:22] Speaker 00: But under the district court's decision in this case, and this is made clear on page 13 of the appendix, the only thing that matters is that this is a highly toxic chemical. [00:31:31] Speaker 00: And as a result of that, each step, that's what the district court said, renders this not ready to use. [00:31:38] Speaker 00: That not only is inconsistent with the district court's prior ruling in the celerity case, it renders the patent inapplicable. [00:31:45] Speaker 00: And my friend tried to push back on that, but their own expert admitted that no Bega Musty product is ready to use under their understanding of this. [00:31:56] Speaker 00: And that was at page 5425 of the appendix. [00:32:00] Speaker 00: This court repeatedly says constructions that rule out preferred embodiments are highly disfavored. [00:32:06] Speaker 00: This case, the construction [00:32:08] Speaker 00: adopted after trial renders the patent inoperable. [00:32:12] Speaker 00: Now with respect to the statements, Your Honor, I would point you to this court's decision in Tendis where it said that the repeated statements to the FTA, that the limitation were met, show how one of skill and the art would understand the claimed defunct [00:32:29] Speaker 00: And that's on page 1362. [00:32:31] Speaker 00: And that's what defendants repeated characterization of their own generic products as ready to use did. [00:32:37] Speaker 00: It showed the ordinary understanding of that term, ready to use. [00:32:42] Speaker 00: And that was not one that ruled out liquid bundle musting as ever being ready to use. [00:32:47] Speaker 00: Now the snow storm example is actually a good one. [00:32:50] Speaker 00: Because the question in this case is not, is it hard to drive in the snow or is it hard to drive in Arizona during the day? [00:32:57] Speaker 00: The question is someone driving in the snow, and imagine that there's a set of tires that makes that easier and a set of tires that doesn't. [00:33:05] Speaker 00: The person with skill in the art knows how to drive in the snow, just as the person with skill in the art here knows [00:33:10] Speaker 00: all the dangers in using liquid venom mustang. [00:33:14] Speaker 00: But what made this product ready to use is it went from a cumbersome reconstitution process to a product that you just withdraw from a vial, put it in the dilution bag, mix it, inspect it, and it's ready to use. [00:33:26] Speaker 00: That, the district court's construction in this case, which renders the pot inoperable, is reconstituted in error of law and reconstituted in error of fact. [00:33:35] Speaker 00: We urge the court to vote. [00:33:38] Speaker 03: Thank you. [00:33:39] Speaker 03: Okay sir, thank you very much.