[00:00:00] Speaker 03: The final case this morning is number 21-12-62, Sanofi Avantis versus Mylan and Mr. Banks again. [00:00:11] Speaker 03: You've already had a fair amount of arguing about written descriptions, so it's not necessary to repeat what we've gone through so far. [00:00:19] Speaker 00: Okay. [00:00:19] Speaker 00: Appreciate that, Your Honor. [00:00:21] Speaker 00: So this morning, this is the appeal from the District Court infringement decision. [00:00:26] Speaker 00: I'll focus on the infringement issues. [00:00:27] Speaker 00: happy to address the written description issues as well as they arise. [00:00:30] Speaker 00: To the extent the court has questions, the records are different, and there are some differences. [00:00:35] Speaker 00: But starting with the infringement issues, I think it's clear to understand, and this is what the district court itself said, that the case for infringement doesn't turn on any disputed facts. [00:00:45] Speaker 00: It's about how the facts apply to the infringement arguments. [00:00:50] Speaker 00: And here, the district court misconstrued the claim language by adding limitations in each case [00:00:55] Speaker 00: that just simply aren't there in the claim language. [00:00:57] Speaker 00: And I'd like to start with claim 21 and the limitation that the sleeve is releaseably connected to the dose indicator. [00:01:06] Speaker 00: There's no dispute that in the Vistra, when a user presses the button to engage, to inject a dose, the Vistra setback, which is its sleeve, is connected to the dose set knob, which is indicator. [00:01:20] Speaker 00: And then when the user releases her finger from the button, the connection between the two components is released. [00:01:26] Speaker 00: That's enough to demonstrate that the components are releasably connected. [00:01:30] Speaker 00: They are releasably connected during those administrations. [00:01:34] Speaker 01: This has confused me, and I remain confused. [00:01:39] Speaker 01: So put aside for one minute that this is just a 271E2 case, right? [00:01:47] Speaker 01: Correct. [00:01:48] Speaker 01: OK. [00:01:48] Speaker 01: Put aside from that. [00:01:49] Speaker 01: In the ordinary 271A, B, C case, you would first of all religiously avoid, if you were noticing that there was a problem here, language about products infringing. [00:02:04] Speaker 01: Products don't infringe under 271A, B, and C. Actions by defendants infringe. [00:02:10] Speaker 01: And you would ask, well, when Sanofi makes this thing, [00:02:15] Speaker 01: Is it making something where the things are connected to answer? [00:02:20] Speaker 01: No. [00:02:21] Speaker 01: Maybe in testing, it would be using it where, yeah, the other side. [00:02:30] Speaker 01: And you would ask, is the selling a form of contributory infringement? [00:02:34] Speaker 01: Because there's only one use. [00:02:36] Speaker 01: Every single one of these things that's used at all is going to, at some point, be a device covered by the thing and the [00:02:45] Speaker 01: patient will be using it. [00:02:49] Speaker 01: I don't see any discussion of that sort of analysis, which 271A, B, and C provide for in the papers here, and I want help understanding whether that kind of analysis has any bearing on a 271E2 analysis. [00:03:09] Speaker 00: Right. [00:03:09] Speaker 00: So I think there, I think your honors identify sort of two separate issues. [00:03:12] Speaker 00: And I think the easier one is to look at the E2 situation because the act of infringement here is submitting an application where the use of the commercial use of the device would infringe. [00:03:23] Speaker 01: And so that's, there's no question that that's, is that, is that the language of E2? [00:03:27] Speaker 00: I don't have the E2 in front of me, but it's something to that effect, which is it's an act of infringement to submit an application. [00:03:34] Speaker 00: for the commercial use of the drug product where the drug product would infringe the patent. [00:03:40] Speaker 00: I can pull up a language on that. [00:03:42] Speaker 01: The use of which is claimed in a patent. [00:03:44] Speaker 00: Correct. [00:03:45] Speaker 01: Well, I'm sorry. [00:03:47] Speaker 01: The use is not claimed. [00:03:49] Speaker 01: This is a product claim. [00:03:50] Speaker 00: I think it's the tag along of the, I don't have it in front of me, but it's E of A, B, C, E of the E, and then you have what follows after the parentheticals where I think, I believe it says, [00:04:00] Speaker 00: for the commercial use of the product, um, will infringe. [00:04:06] Speaker 00: And, and, and, and the point being there's no dispute that when the pen is used, it infringes. [00:04:12] Speaker 01: And then to the, to the, I agree with what you say. [00:04:16] Speaker 01: How things occur is undisputed. [00:04:19] Speaker 01: The question is entirely the legal characterization of that. [00:04:24] Speaker 01: And that's why, if you've got something to say about 271 E2, [00:04:27] Speaker 01: That, to me, is where the action is. [00:04:29] Speaker 00: Correct. [00:04:31] Speaker 00: That's what makes it even cleaner. [00:04:33] Speaker 00: But even putting that aside, to answer your question about ABC, the cases are clear that a device that infringes part of the time still infringes. [00:04:42] Speaker 00: Vices don't infringe. [00:04:45] Speaker 00: Vices don't infringe. [00:04:47] Speaker 00: A device encompassing components that read on the claim language [00:04:54] Speaker 00: will infringe. [00:04:56] Speaker 00: And beyond that, you have to look at the nature of the infringing product. [00:05:02] Speaker 00: And the nature here of the product is that it's going to be used to inject medication. [00:05:08] Speaker 00: It's not going to sit in its packaging at a store as a district court found. [00:05:15] Speaker 00: The nature of the product is that it's going to be used to inject medication. [00:05:18] Speaker 00: And when the product is so used, [00:05:21] Speaker 00: the components will be connected. [00:05:24] Speaker 00: Otherwise, if an infringer could avoid infringement simply by packaging their product differently, that certainly can't be correct. [00:05:37] Speaker 00: If they could avoid infringement by packaging them in one configuration versus another, [00:05:42] Speaker 00: when it's clear that for the product to be used, it will infringe, that would be an untenable result. [00:05:52] Speaker 00: I think it's telling that to make the case for infringement work here, both the district court and Mylan have to read, releasably connected to mean connected in their resting or default state. [00:06:03] Speaker 00: And that's simply not what the plain language of connected means. [00:06:06] Speaker 00: Connected implies that they are joined, but doesn't set a limitation on [00:06:11] Speaker 00: when those things are connected or disconnected. [00:06:14] Speaker 00: And it's clear that they are both connected at the time of injection. [00:06:19] Speaker 00: And that's enough to meet the claim limitation. [00:06:24] Speaker 00: If I could move on to the next limitation, Your Honor, this is a part of claim 21 as well. [00:06:30] Speaker 00: It requires a piston rod holder that is configured to prevent rotation of the piston rod during dose setting. [00:06:38] Speaker 00: The undisputed facts resolve this matter too. [00:06:41] Speaker 00: There's no dispute that a key connection. [00:06:44] Speaker 01: I just want to return to this one. [00:06:46] Speaker 01: So the language I think you were referring to is at the end of E2, before you get to three, and it will say, if the purpose of the submission is to obtain approval under the act to engage in the commercial manufacturing use or sale of blah, blah, blah. [00:07:02] Speaker 01: The only one, as far as I can tell, who's ever using a device that meets the claim requirements is the patient. [00:07:10] Speaker 01: I wouldn't call that a commercial use, would you? [00:07:12] Speaker 00: Well, I think it's the patient, but also Mylan and testing and seeking even approval for the drug. [00:07:17] Speaker 01: You ever say anything about testing? [00:07:19] Speaker 01: I don't remember this ever coming up. [00:07:21] Speaker 00: If you look at the NDA itself, and I think if you look at... No, but in the district court, I don't remember any mention. [00:07:28] Speaker 01: I don't know all of your papers. [00:07:30] Speaker 00: Sure. [00:07:31] Speaker 01: Or in your briefing here. [00:07:33] Speaker 01: any reference to Mylan or whatever, whoever the company is that makes this thing for Mylan, testing as part of the analysis. [00:07:41] Speaker 00: It's evident from, we refer to the NDA, I think, as demonstrating how the product will be used. [00:07:47] Speaker 00: And part of that, if you look at NDA appendix 220, sorry, 22120 and following, there's a long description of the approval process, including testing. [00:07:57] Speaker 00: So it's certainly part of the record. [00:08:00] Speaker 00: But more to the point, the nature of this product is not something that's going to sit on the shelves. [00:08:08] Speaker 01: Right, but the ones who are transforming it into a device that meets the requirement are not doing it commercially. [00:08:15] Speaker 00: I would direct your honor to the fantasy sports case, for example, right? [00:08:18] Speaker 00: which is a case where it didn't infringe literally the claim until a user is a computer game. [00:08:26] Speaker 00: It didn't infringe until the user started playing the game. [00:08:30] Speaker 00: So it was still an act of infringement to sell the product, even though it didn't literally infringe until the user pressed on, for example. [00:08:39] Speaker 03: Was that contributory or induced infringement? [00:08:42] Speaker 00: I don't believe it was contributory or induced infringement, Your Honor. [00:08:46] Speaker 00: That's my understanding of the case. [00:08:48] Speaker 00: And so, if I can turn back to the Piston-Ronfolder limitation, there's no dispute that there is [00:08:58] Speaker 00: key connection in the Vistra that exists at all times between its tower core, which is its piston rod holder, and its plunger rod, which is the piston rod. [00:09:09] Speaker 00: The two can never rotate. [00:09:10] Speaker 00: The piston rod can never rotate. [00:09:13] Speaker 00: It's snapped together. [00:09:15] Speaker 00: The district court recognized this in its findings directed the court to Appendix 71. [00:09:20] Speaker 00: It specifically found that the tower core has a capacity to prevent the plunger rod from rotating. [00:09:25] Speaker 00: In finding non-infringement, the distant court again added an additional limitation here. [00:09:31] Speaker 00: And this is what we'd characterize as a causation requirement, that the rotation that's prevented be caused by the dose setting operation. [00:09:38] Speaker 00: That language is not present. [00:09:40] Speaker 00: And if you look at the 43 of the board's decision, I think it's a clear example of how the board reached this conclusion. [00:09:48] Speaker 00: It found that the tower core does not prevent the transmission of rotational force during dose setting. [00:09:54] Speaker 00: But again, that's not the claim language. [00:09:56] Speaker 00: The claim language is, does it prevent rotation during the setting full stop? [00:10:00] Speaker 00: The key connection does this. [00:10:02] Speaker 00: It prevents rotation at all times. [00:10:05] Speaker 00: And again, this record added to the claim language by requiring that causation element. [00:10:10] Speaker 00: The district court did find that a separate component, the setback, was configured to prevent rotation during this setting because it interrupted the rotational flow. [00:10:20] Speaker 00: Again, even if that were so, it doesn't change the outcome. [00:10:24] Speaker 00: There's nothing in the claim language that limits the rotation to only one [00:10:29] Speaker 00: only one component as preventing rotation. [00:10:32] Speaker 00: The undisputed fact remains that there's never a rotation of the plunger rod at any time because they're keyed together and so therefore it emits the client language. [00:10:44] Speaker 00: I think that district court compounded its error even further with a factual one, finding that gravity didn't exert rotational forces [00:10:53] Speaker 00: And again, here, the only evidence in the record is that it does, putting aside physics. [00:10:58] Speaker 00: You have an experiment on the one hand that Dr. Reinholz did that demonstrated when the key connection was removed, there was rotation. [00:11:05] Speaker 00: And you even have the expert on the other side admitting that the gravitational forces, he used the gravitational forces to produce rotation. [00:11:18] Speaker 00: So there's no dispute that [00:11:21] Speaker 00: without the tower core and the key connection, there would be rotation. [00:11:26] Speaker 00: So that's what satisfies that claim limitation as well. [00:11:32] Speaker 00: Just quickly, if I can turn to the written description issues here, I think the affirmative case that we argued is substantially similar to what we went through this morning. [00:11:45] Speaker 00: I would say that the district court here [00:11:47] Speaker 00: went wrong by analyzing the case under an enablement standard. [00:11:52] Speaker 00: It asked whether the design choices necessary to make or use an ejector pen would be numerous and complicated. [00:12:00] Speaker 00: That's an enablement standard. [00:12:03] Speaker 00: And separately, the court found that the claim was enabled in findings that Mylan doesn't challenge on appeal. [00:12:10] Speaker 00: And it's error in this regard, I think, affected. [00:12:12] Speaker 03: Why isn't it relevant to written description that it's difficult to implement the alternative and that in terms of someone envisioning that invention being in the possession of the inventors, that the difficulty of implementing it is relevant? [00:12:33] Speaker 00: I think it's important to look at the reasons why the court said it was difficult. [00:12:37] Speaker 00: It said it was complicated. [00:12:39] Speaker 00: And the reason it said it is because a person would have to figure out what type of plastic to use, how long to make the stinger, and so forth. [00:12:47] Speaker 00: These are sort of manufacturing details, none of which was disclosed [00:12:51] Speaker 00: with respect to the embodiment that they agree was adequately disclosed in the patent. [00:12:56] Speaker 00: So it sort of demanded more than what was necessary to show written description, more than what this court's cases have said is necessary to show written description. [00:13:04] Speaker 00: And by the way, it found that those things actually weren't all that unduly complicated because it found that the claim was properly enabled. [00:13:10] Speaker 00: So looking at it through that lens led the court down a path of errors in concluding that the written description test wasn't met here. [00:13:20] Speaker 00: I think it's important to look at the record as it relates to the actual testimony, as to the actual language of the disclosure, which is, again, the key of the written description analysis is what does the disclosure say? [00:13:31] Speaker 00: And as to that, you had the court finding that the description in the patent was even broader than what Dr. Slocum said it was. [00:13:42] Speaker 00: It was on page 53 of the opinion. [00:13:44] Speaker 00: And then Mr. Linsing, who is the expert on the other side, didn't address the disclosure language at all, except for one conclusory sentence in which he said it wasn't described. [00:13:53] Speaker 00: So look on the record, which is what is important here. [00:13:57] Speaker 00: And on the record, as it relates to what the actual disclosures are, [00:14:00] Speaker 00: Here, I think the case was overwhelming that the disclosure was satisfied. [00:14:05] Speaker 00: I see I've got a few minutes left for my rebuttal time. [00:14:10] Speaker 00: I'm happy to address. [00:14:10] Speaker 00: We have less than two minutes, but we'll give you two minutes. [00:14:13] Speaker 00: Thank you, Your Honor. [00:14:16] Speaker 03: Mr. Karsten. [00:14:19] Speaker 02: I had to look at my watch. [00:14:20] Speaker 02: It still is good morning. [00:14:21] Speaker 02: So good morning and may it please the court. [00:14:24] Speaker 02: This is the appeal on the district court decision. [00:14:27] Speaker 02: Judge Chesler heard three, four days of testimony. [00:14:30] Speaker 02: Uh, had hours with these witnesses, uh, poured over the record and issued his decision finding written description violation here as well as four different bases of non-infringement, two of which independently would also dispatch of the entirety of this appeal. [00:14:50] Speaker 02: So the court has before it three separate grounds upon which it could affirm Judge Chesler's decision, the written description, written description decision. [00:14:59] Speaker 02: the releasably connected or the configured to prevent rotation during dose setting. [00:15:05] Speaker 02: Your Honor seemed most interested in the infringement aspects when you were asking questions of my learned colleague. [00:15:12] Speaker 02: I'm happy to jump there. [00:15:14] Speaker 02: I would simply note that there is really no evidence that Judge Chessler was confused on the written description part about the enablement standard. [00:15:22] Speaker 02: We know that from the decision itself. [00:15:26] Speaker 02: Judge Chessler had before him [00:15:27] Speaker 02: enablement as well as written description and found oppositely between the two. [00:15:32] Speaker 02: And we disagree with his decision in connection with the enablement, but had he simply misapplied and applied the enablement standard for written description, he would have had the same result for both, and that's not what happened below. [00:15:48] Speaker 02: With respect to the infringement, [00:15:51] Speaker 02: you know, Sanofi is stuck with their claim language, and they chose the words, releasably, connected. [00:15:58] Speaker 02: They didn't choose connectable, which they very well might have. [00:16:02] Speaker 02: That would have, of course, raised written description and enablement issues in and of itself. [00:16:08] Speaker 01: But Mylan's device... Can you just help me on what, and I may be the only one on what I've spent a fair bit of time with your friend on the other side with, [00:16:22] Speaker 01: I keep asking myself the question, what statutory provision are we dealing with here? [00:16:31] Speaker 01: I think we're dealing with 271E2. [00:16:33] Speaker 01: The facts seem to be undisputed. [00:16:39] Speaker 01: As sold, the claim elements are not met in your product. [00:16:44] Speaker 01: As used, let's assume for current purposes, every single time, they are met. [00:16:52] Speaker 01: It seems to me there's no factual question here about infringement. [00:16:56] Speaker 01: There's a question about the governing legal standards. [00:16:59] Speaker 01: And yet, I don't see any discussion of 271E2, except I think your brief says, by the way, this is a 271E2 case. [00:17:08] Speaker 01: And then you're on to talking about other things. [00:17:13] Speaker 01: So help me understand how to think about these undisputed facts under the statutory regime here for so-called infringement. [00:17:23] Speaker 02: Well, you're absolutely right, Your Honor. [00:17:28] Speaker 02: I did pull up the language of 271E2, which shall be inactive infringement, to submit an application under, and I'm omitting words, 505B2. [00:17:40] Speaker 02: of such for a drug claimed or the use of which is claimed in a patent and neither the drug, which is the insulin larging drug product. [00:17:50] Speaker 01: So why are we under 272 E2 at all? [00:17:53] Speaker 02: That's a very good question, your honor. [00:17:55] Speaker 01: However, I thought your brief refers to some other statute that says something like this goes, I didn't follow it. [00:18:01] Speaker 02: Well, it's a good question under 271E2. [00:18:04] Speaker 02: There were some claims under 271A, B, and C that were raised by Sanofi below. [00:18:11] Speaker 02: There was a motion to dismiss them, which I believe was never ruled upon. [00:18:14] Speaker 02: So it's possible that 271A, B, and C are still in play and live in the record below. [00:18:19] Speaker 02: I'd need to look to check and see if that's the case. [00:18:23] Speaker 02: Having said that though, there was no commercial sale. [00:18:25] Speaker 02: This is a Hatch-Waxman case. [00:18:27] Speaker 02: I'm sorry? [00:18:29] Speaker 02: Commercial use. [00:18:30] Speaker 02: Right. [00:18:31] Speaker 02: So there was no commercial sale. [00:18:33] Speaker 02: Oh, I'm sorry. [00:18:33] Speaker 02: There was no commercial. [00:18:34] Speaker 02: Well, there was no commercial sale as of the time that the case was being litigated. [00:18:39] Speaker 03: No, no, but the statute depends on the objective. [00:18:43] Speaker 03: Right. [00:18:43] Speaker 03: Fair enough. [00:18:45] Speaker 03: I mean, you really think that commercial use as referenced in E2 is avoided because it's a consumer using it, as opposed to it's being sold for a use that would infringe? [00:18:59] Speaker 02: Well, Your Honor, I don't think it infringes while the consumer uses it. [00:19:04] Speaker 02: And so we went to a different question. [00:19:06] Speaker 03: But the question we were dealing with is whether [00:19:11] Speaker 03: The commercial use language of the statute reaches a situation in which a manufacturer is selling a device which, when used by the consumer, would infringe, and whether that constitutes sale for commercial use. [00:19:27] Speaker 03: It just seems to me a little unlikely that the statute wasn't designed to include a situation that I just described. [00:19:37] Speaker 02: Well, it certainly sets forth an artificial act of infringement such that the court is able to look to how the drug product would be used. [00:19:49] Speaker 02: And that's often the case where you have a method of use claim, for example, as well in the case. [00:19:53] Speaker 02: It so happens that the claims that went to trial here [00:19:58] Speaker 02: are simply device claims and odd device claims in the sense that you don't typically see medical device claims in connection with a Hatch-Waxman case. [00:20:10] Speaker 02: It's typically the drug product. [00:20:12] Speaker 02: Now, Sanofi has taken the view here that it is somehow authorized to list these patents which deal with the [00:20:28] Speaker 02: I'm going to call it the packaging, although it is the device that administers the drug product, but it is not the drug product itself under the Patent Act. [00:20:39] Speaker 02: or any defendant that's faced with such a circumstance has an option to go ahead and try to file for delisting or make a claim for delisting of such claims. [00:20:50] Speaker 02: But remember, the purpose of the Hatch-Waxman Act is to try to get patent clarity. [00:20:55] Speaker 02: So that way you're not in a situation where you clear the patent thicket and then you launch your product and you're suddenly facing additional patent litigation under A, B, and C. [00:21:08] Speaker 02: And so in this instance, Mylan opted not to try to delist the claims to get that patent clarity and certainty under 271E. [00:21:18] Speaker 02: But remind you, I also understand that Sanofi did have 271A, B, and C claims here, which we moved to dismiss and the court never ruled on, is my recollection. [00:21:29] Speaker 02: And so I think that Sanofi was trying to say 271E under Hatch Waxman, [00:21:35] Speaker 02: And then as it came time for commercial launch, we could transfer over to A, B and C, or if there were commercial launch. [00:21:43] Speaker 01: But a 271C or actually A, B and C all are pretty plausible here. [00:21:55] Speaker 01: C in particular. [00:21:57] Speaker 01: If you make and sell a product, which as far as I can tell from the record, [00:22:04] Speaker 01: with arguments, meets every claim limitation in every single use by the consumer. [00:22:13] Speaker 01: How is that not a 271C? [00:22:14] Speaker 01: And yet I don't see any reference to 271C below. [00:22:17] Speaker 02: Well, that's a failure of proof of stability. [00:22:19] Speaker 01: Obviously there are knowledge requirements and stuff. [00:22:22] Speaker 01: I'm not sure how hard that would be here. [00:22:24] Speaker 02: Sanofi could have made this into a 271C. [00:22:27] Speaker 01: You just said that there were 271C claims in the case. [00:22:30] Speaker 02: At trial, they could have offered evidence to substantiate and support that. [00:22:34] Speaker 02: They chose not to, and this is a failure of proof on Sanofi's end. [00:22:38] Speaker 02: So I disagree with the hypothetical or the conclusion [00:22:42] Speaker 02: that at some point this product that the Vistra pen will infringe each and every element. [00:22:48] Speaker 02: I don't think that's the case at all. [00:22:50] Speaker 02: But assuming if it were. [00:22:51] Speaker 01: But the only basis on which the district court said no infringement is that as sold, there's an element that's not met. [00:22:59] Speaker 02: Well, the court applied a claim construction. [00:23:02] Speaker 01: He didn't doubt that when the button is pushed down and the thing is injected at the [00:23:09] Speaker 01: that at that point, that element is met. [00:23:12] Speaker 01: I didn't understand that to be in dispute, is it? [00:23:15] Speaker 02: Well, the claim construction was the device at rest is disconnected. [00:23:20] Speaker 02: It is the opposite of what is claimed and disclosed. [00:23:24] Speaker 02: And I don't think the court made a finding at all about the infringement during use or whether it would infringe during use. [00:23:32] Speaker 02: In fact, the claim construction [00:23:34] Speaker 02: which required an analysis of the pen at rest, because of the past pen's releasably connected language and not connectable language, made the determination or the infringement scope about the product as it sits. [00:23:50] Speaker 02: And I think that's ably supported by the record here and the claim language that Sanofi voluntarily elected to pursue. [00:23:57] Speaker 02: When Sanofi wanted to talk about how the pen is operating during dose setting, [00:24:04] Speaker 02: dialing up, dialing down, they did so. [00:24:07] Speaker 02: When Sanofi and that claim wanted to talk about what the device does during dose administration, during injection, they did so. [00:24:15] Speaker 02: Here, there's a claim limitation that doesn't talk about dose setting, it doesn't talk about dose administration, it simply says, releasably connected in the past tense. [00:24:25] Speaker 02: And that's a finding of no infringement under that claim. [00:24:29] Speaker 02: And that non-infringement under the claim does not change simply because or during the use of the claim. [00:24:37] Speaker 02: And maybe that's why we didn't see so much of an analysis under B or C. [00:24:43] Speaker 02: uh... also be a failure proof of sanofi they should have been there post-trial brief said hey judge we have a that we have a b or c issue we have an inducement or contributory infringement and here's the evidentiary records to support they didn't do that or a claim for test or a quality for testing that you're quibbling around on whether it falls within the the the experimental use exception if that testing is designed [00:25:08] Speaker 02: to give rise to an FDA submission, right? [00:25:11] Speaker 02: So I think it's more the B and C than the A necessarily, right? [00:25:15] Speaker 02: Because there's nobody saying that myelin is running around injecting patients with this pen. [00:25:20] Speaker 02: It's the patients themselves or their caregivers who presumably would be injecting them. [00:25:26] Speaker 02: And that was on Sanofi to do. [00:25:28] Speaker 02: It's their burden of proof, and they failed to do it. [00:25:31] Speaker 02: So, and secondly, even if we get past the releasably connected, even if you all think, okay, you know, Judge Chesler, very smart guy, but he happened to get this one wrong, you have the second, which is the, you know, configured to prevent rotation during dose setting. [00:25:52] Speaker 02: The judge heard all of the evidence on this. [00:25:56] Speaker 02: He watched and heard from the experts and made credibility determinations about the cut up and incorrectly rebuilt pen that omitted elements. [00:26:11] Speaker 02: And that was the foundational testimony that Sanofi relied upon in order to convince the judge that there was [00:26:19] Speaker 02: infringement under that claim limitation. [00:26:22] Speaker 02: That's not a claim construction issue. [00:26:24] Speaker 02: That was their attempt to meet the claim language that everyone understood to be plain and ordinary meaning. [00:26:31] Speaker 02: And they failed under Judge Chessler's, based upon Judge Chessler's credibility determinations and weighing of the evidence. [00:26:39] Speaker 02: And that's entitled to deference here, with respect. [00:26:42] Speaker 02: But there's no suggestion that Judge Chessler, well, [00:26:48] Speaker 02: That is an attempt, as we've seen repeatedly throughout the morning today, of Sanofi to take a factual finding that it disagrees with and try to dress it up into a legal framework of violation clothing. [00:27:05] Speaker 02: It is the classic throw the Pleistocene against the wall and hope that a noodle sticks. [00:27:11] Speaker 02: But there are significant factual findings here that ably support Judge Chesler's finding on that second basis, which itself is an independent basis for non-infringement. [00:27:24] Speaker 02: I understand the releasably connected language, but that is language of Sanofi's choice. [00:27:32] Speaker 02: They chose to go past tense. [00:27:35] Speaker 02: They chose to describe the invention based on the specification in the way that they did. [00:27:40] Speaker 02: Judge Chessler considered that intrinsic evidence. [00:27:46] Speaker 02: He heard from the witnesses. [00:27:48] Speaker 02: He reached his claim construction determination. [00:27:51] Speaker 02: And I believe the claim construction determination based upon the claim language alone and then in view of the specification is exactly how the claim ought to be read. [00:28:02] Speaker 02: So I disagree, Judge Taranto, with the predicate of the assessment, and that is that during administration, the pen will be in an infringing configuration. [00:28:13] Speaker 02: Under Judge Chesler's construction, which I believe to be correct, I don't think that's the accurate analysis, because the pen at rest under the construction [00:28:23] Speaker 02: pardon me must be disconnected uh... must be connected under the construction and violence and indisputably is disconnected at rest and it will always be so i have forty five seconds on the clock but uh... i'm happy to feel that he forty two second questions at the panel may have okay i think we're done thank you your honor and again thank you again this morning [00:28:52] Speaker 03: Mr. Banks, two minutes. [00:28:55] Speaker 00: Just quickly, Your Honor, on the E2 point, and the idea that we have a failure of proof. [00:29:01] Speaker 00: The reason this was an E2 case is that there wasn't an authorized sale of the product yet. [00:29:05] Speaker 00: So that's why there aren't claims that were live at trial as it relates to ABNC. [00:29:14] Speaker 00: I think on the language there, again, I think the court's claim construction was that [00:29:20] Speaker 00: connected meant connected at arresting state. [00:29:22] Speaker 00: And that simply is just not in the claim language. [00:29:25] Speaker 00: The claim language just says, releasably connected. [00:29:27] Speaker 00: And I don't think there's any factual dispute that the pieces are connected when the pen is used as it's intended to be. [00:29:35] Speaker 00: And so that resolves that issue. [00:29:38] Speaker 00: On the piston rod configured to prevent rotation, counsel referred to the factual findings there with respect to the experiment that our expert did. [00:29:49] Speaker 00: the district court, again, just got this backwards. [00:29:51] Speaker 00: If you look at appendix page 40, the court identifies the pertinent question as, were it not for the tower court keys connection if the plunder wall would rotate during dose setting. [00:30:04] Speaker 00: And that's exactly what the experiment showed. [00:30:08] Speaker 00: He then criticizes it because no one contends that the key connection gets removed during the operation of PEN. [00:30:16] Speaker 00: But of course, that's the entire point. [00:30:17] Speaker 00: In an operating PEN, [00:30:19] Speaker 00: there is the key connection. [00:30:20] Speaker 00: And our experts show that when the key connection is gone, it's missing. [00:30:24] Speaker 00: And there's nothing, it rotates. [00:30:26] Speaker 00: And there's nothing in the district court's opinion that shows that that's wrong. [00:30:29] Speaker 00: He just sort of mixed up his own test in that respect. [00:30:34] Speaker 00: Finally, I think just with respect to the overall nature of these appeals, I think that the point I want to emphasize is that there were four specific claims that were infringed [00:30:49] Speaker 00: in this case. [00:30:50] Speaker 00: And district court said that based on the plain language of, based on the testimony and the evidence here, there's no dispute as a matter of the facts. [00:30:58] Speaker 00: This really is about how the law applies to the facts here. [00:31:02] Speaker 00: And it's not at all a suggestion that we're trying to transform factual disputes into legal ones based on the district court's sort of own understanding of the district court's own factual findings here. [00:31:14] Speaker 00: the language of the claims demonstrates that the VISTA infringes the pen. [00:31:19] Speaker 03: Thank you, Mr. Banks. [00:31:20] Speaker 03: Thank you, Mr. Arston. [00:31:22] Speaker 03: The case is submitted. [00:31:23] Speaker 03: That concludes our session for this morning.