[00:00:00] Speaker 01: 017-1499 Allergan sales versus Sandoz. [00:00:33] Speaker 03: Mr. Quinn please proceed. [00:01:02] Speaker 00: Thank you, Judge Moore, and may it please the court, John O'Quinn, on behalf of Sandoz. [00:01:06] Speaker 00: Under the district court's ruling, only the 425 patent stands in the way of generic competition. [00:01:11] Speaker 00: So I'd like to focus my opening argument on that patent and why it is both not infringed and should be found invalid. [00:01:20] Speaker 00: And that patent has not previously been subject to litigation, so there are no collateral issues that relate to it. [00:01:25] Speaker 00: Instead, the questions presented with respect to the 425 patent [00:01:29] Speaker 00: or simply whether the district court was correct to find that a claim specifically requiring 0.5% timmalol-free base can be literally infringed when timmalol-free base is not used as an ingredient and 0.5% timmalol-free base does not even form in the resulting solution. [00:01:48] Speaker 00: And whether it has to end validity, claiming the observed results from administering an obvious composition dosed in an obvious manner can save the claim from being found obvious. [00:01:59] Speaker 00: The answer to both should be no. [00:02:01] Speaker 00: Now, non-infringement respectfully begins and ends with the plain language of the claim term, which requires 0.5% by weight timolol-free base. [00:02:12] Speaker 00: And the history surrounding this patent and the entire family of patents forecloses the argument that when the claim specifically says 0.5% timolol-free base, that that includes a different chemical compound, namely timolol-malleate. [00:02:28] Speaker 00: The patent team knew how to claim or to refer to Temulal more broadly or more generically. [00:02:33] Speaker 00: And it did so in five other patents, including the 149 and 976 that are before the court, as well as the 258, the 409, and the 890, which were previously asserted but dismissed prior to trial. [00:02:46] Speaker 00: And in fact, the 258 patent draws, I think, very specific distinctions between Temulal Freebase and Temulal Mallee. [00:02:54] Speaker 00: They're directly relevant to the issue of [00:02:57] Speaker 00: Infringement, the 258 patent gives specific examples where 0.5% timolol free base is used instead of timolol maleate. [00:03:06] Speaker 00: And the 258, that's an appendix 2378. [00:03:08] Speaker 00: And the 258 patent specifically says this distinction results in a superior product. [00:03:15] Speaker 00: At 2375, it says that compositions having a combination of the free base and the gramanidine partrate are more stable than the combination of timolol maleate [00:03:27] Speaker 00: and Brahmanidine tar trade. [00:03:28] Speaker 00: So you have a specific distinction in the related family of patents between Timlall-Malley and Timlall-Freebase. [00:03:35] Speaker 00: And that makes this case look very much like the district court decision in V versus Lupin, which this court affirmed. [00:03:43] Speaker 00: In that case, the court recognized and drew specific distinctions where you have claims that identify base versus salt and where you have differences in the handling properties. [00:03:57] Speaker 00: And all of those are present here. [00:04:01] Speaker 00: And for these reasons, the Judge Court simply erred as a matter of law in concluding that there was infringement, because there is no Temulal free base that is used in ingredient or that forms in solution. [00:04:15] Speaker 00: And there's nothing in the documents that are ultimately inconsistent with that. [00:04:22] Speaker 00: And in particular, to the extent the court's got questions about some of the documents, I'd point you to the exchange with Allergan's expert at trial at 2708 to 2709. [00:04:33] Speaker 00: And it specifically explains what it means when people refer to the 0.68 timmalol malleate corresponding to 0.5 timmalol or 0.5 timmalol free base. [00:04:48] Speaker 00: In that exchange, their expert agreed that all that's happening here is the mathematics of adding up the weight of the atoms and allocating them either to the acid or the base, and that this is a, quote, mathematical exercise. [00:05:02] Speaker 00: But with the ingredients still going in, their expert was specifically asked, it's still timolal malate salt, correct? [00:05:09] Speaker 00: And the answer was yes, and that's a 2709. [00:05:11] Speaker 00: So for these reasons, [00:05:14] Speaker 00: I think that the district court's decision of non-infringement simply is not sustainable. [00:05:19] Speaker 00: Similarly, the decision on the 425 patent with respect to obviousness should also be reversed because this is exactly presenting what this court said in Santeros for, excuse me, 649F3 at 1354, you cannot do. [00:05:36] Speaker 00: You have an obvious formulation [00:05:38] Speaker 00: And it cannot become non-obvious. [00:05:40] Speaker 04: Can I ask you this? [00:05:41] Speaker 04: There are a lot of claims here, and I get a little confused. [00:05:44] Speaker 04: But the actual product from your competitor has, I mean, we're talking about the two main ingredients. [00:05:53] Speaker 04: It is the 0.2% of the, I can't say this, where Bromina didn't tartrate in that form. [00:06:01] Speaker 04: Correct. [00:06:01] Speaker 04: And then the 0.68% of the total malate. [00:06:05] Speaker 04: Is there not a claim that includes both of those terms together? [00:06:09] Speaker 04: Is that the problem here? [00:06:10] Speaker 04: Because some of the claims have one of them, some of them have the other. [00:06:13] Speaker 04: Is this just a claiming problem? [00:06:15] Speaker 04: Because everybody knows what the composition is. [00:06:18] Speaker 04: The composition was found, I believe, invalid by us last time around. [00:06:22] Speaker 00: That's exactly right. [00:06:23] Speaker 00: The composition was in the force 6-3 patent wasn't validated. [00:06:30] Speaker 04: But we found valid a certain method claim, and the district court found valid a certain method claim here. [00:06:35] Speaker 04: But now you're saying even if those method claims are valid, and I know you have arguments as to why they're not, there's not a single method claim that includes the brimadine tartrate and the temelol maliet in the same amounts that are in the product together. [00:06:49] Speaker 00: That's exactly right, Judge. [00:06:51] Speaker 00: There is fundamentally a claiming problem here. [00:06:54] Speaker 00: And Allergan has gone out and continued to get new patent after new patent. [00:06:58] Speaker 00: And in fact, they have now gotten patents [00:07:00] Speaker 00: that I've specifically referred to. [00:07:02] Speaker 04: So I thought that was what this was getting at, but I'm a little troubled by that because the bigger, the other claims we have here, nobody, I mean, the specification, I mean, pretty much when it's talking about the product that's, that is the pharmaceutical one on sale is talking about the combination we're talking about, right? [00:07:21] Speaker 04: There's no real dispute that the specification discloses the, the, the tartrate and the malate forms in the right amount. [00:07:29] Speaker 04: So there's larger claim language that then just refers to, how do you say that again? [00:07:36] Speaker 04: Brahmanidine. [00:07:37] Speaker 04: Brahmanidine and timolol without specifying whether it's the free base or the salt forms. [00:07:46] Speaker 04: It just seemed to me really problematic that even though they've said those words, [00:07:52] Speaker 04: and the specification that talks about them in the right amounts, that that shouldn't be the right claim construction of those terms. [00:07:58] Speaker 04: There's no real dispute about what the product here is. [00:08:00] Speaker 04: And your ANDA is the same thing, because it has to be. [00:08:03] Speaker 04: Sure. [00:08:04] Speaker 00: Our ANDA is tracking the NDA. [00:08:05] Speaker 00: But of course, whether or not the NDA drug is covered by the claims is a separate question. [00:08:11] Speaker 00: And respectfully, that was exactly the issue that was before this court when it affirmed the district court in the Veave case. [00:08:18] Speaker 00: That was exactly the argument that was made. [00:08:22] Speaker 00: And ultimately, the court concluded that there you had a claim that required a specific chemical and that that was the free base and that that wasn't what was being used. [00:08:32] Speaker 00: What was being used in it was what was disclosed in the patent and in the NDA was the salt. [00:08:36] Speaker 04: I get that. [00:08:37] Speaker 04: But in the other claims, and I know this is their cross appeal, but I think they're all kind of mashed up together in a certain sense, they don't specifically call out the free base or the salt. [00:08:46] Speaker 04: Why isn't the proper claim construction of those broader terms [00:08:50] Speaker 04: the one that corresponds to the specification for the common agreement. [00:08:55] Speaker 00: Sure. [00:08:56] Speaker 00: And just to be clear, I mean, so I think that this all, what you're asking goes to the claim one of the 976 and claim four of the 149. [00:09:05] Speaker 00: Because those, as you say, they refer to Temulal and to Brahman and Dean. [00:09:09] Speaker 00: They don't refer to a specific salt or a specific base. [00:09:13] Speaker 04: Let me add to this to make it really clear. [00:09:15] Speaker 04: If they had asked for and gotten [00:09:18] Speaker 04: a claim construction that says in either of those claims, the brimonidine means 0.2% of the salt. [00:09:27] Speaker 04: And the temelol means 0.68% of the salt reduced to 0.5% temelol. [00:09:36] Speaker 04: If those were the claim constructions, would you infringe these method claims, assuming they're valid and everything? [00:09:42] Speaker 04: Because your product has 0.2% of the tartrate version [00:09:46] Speaker 04: and 0.8% of the sol that reduces to five. [00:09:51] Speaker 04: Sure. [00:09:51] Speaker 00: So I think that if bromonadine was interpreted as being bromonadine tartrate, that element would be met. [00:10:00] Speaker 00: The problem that you then run into is it doesn't just say any amount of temelol or temelol malia, it says 0.5%. [00:10:08] Speaker 00: And so if that was interpreted as 0.5% temelol free base, as opposed to just temelol, [00:10:14] Speaker 00: then we'd have the same non-infringement argument that we have with respect to the 425 patent. [00:10:19] Speaker 00: And I don't think that you could reasonably construe 0.5 temelol to mean 0.68 temelol maliate. [00:10:29] Speaker 00: And indeed, the very distinction between maliate and free base is what's discussed in the 258 patent. [00:10:35] Speaker 04: Even though that's what's in the product. [00:10:37] Speaker 00: Even though that's what is ultimately in the NDA product. [00:10:42] Speaker 04: It would have had to say in the claims, [00:10:44] Speaker 04: 0.68 Temulal-Maliet. [00:10:47] Speaker 00: Correct. [00:10:47] Speaker 00: And they have pursued patents that use now 0.68 Temulal-Maliet as well. [00:10:54] Speaker 00: And to the point that you're asking about, and again, just to be clear, the district court found that the 149 and the 976 patents were not infringed. [00:11:05] Speaker 00: And they're not infringed because he adopted, I think, a very reasonable claim construction [00:11:12] Speaker 00: that treated these terms... Okay, I don't think I agree with that statement. [00:11:17] Speaker 01: I don't see how it could be reasonable to say they can either be all salts or they can be base only. [00:11:25] Speaker 01: I don't see how that would give the world notice as to what's being claimed. [00:11:28] Speaker 01: I don't think that claim construction is reasonable, doesn't hurt you. [00:11:32] Speaker 01: So make sure you're listening to my question because it's not a hostile question. [00:11:37] Speaker 01: I just don't see how you could defend that claim construction as clearly correct. [00:11:42] Speaker 00: Let me come out a slightly different way, Judge Moore, and I don't want to eat too much into my rebuttal time, but I think the point he's making in Appendix 1539, and this is the only point that I'm meant to make, is that he says there's no reason to treat Temelol term and the Brahmanidine term differently and say... Yes, but I'm just wondering how a patentee can get both out of this claim. [00:12:04] Speaker 01: How in the world do you get the salt form at 0.2 and 0.5 and the base only form at 0.2 and 0.5 out of this claim language? [00:12:13] Speaker 01: And that's what his construction really amounts to. [00:12:15] Speaker 00: Well, I think what is ultimately being driven at there... That's like saying, I'm going to weigh you naked, I'm going to weigh you with your clothes. [00:12:22] Speaker 01: And if in either case you weigh 165 pounds, you infringe. [00:12:26] Speaker 00: I don't actually think that's what [00:12:28] Speaker 00: he meant. [00:12:29] Speaker 00: And it's certainly not how it was applied at trial. [00:12:33] Speaker 00: And I think the main point that he's... Okay. [00:12:36] Speaker 01: 0.5 milliliters of vodka in a screwdriver, 0.5 milliliters of orange juice in vodka in a screwdriver. [00:12:43] Speaker 00: I understand the question. [00:12:46] Speaker 00: And the only point that I'm getting at is I think that his construction... I'm now hungry for something salty and would also like a cocktail at the same time. [00:12:55] Speaker 00: I don't think I can top that, Judge Moore. [00:12:58] Speaker 01: Sit down and we'll save your rebuttal time. [00:13:06] Speaker ?: All right. [00:13:07] Speaker 03: Thank you. [00:13:08] Speaker 03: May it please the court in the practice of patent law and drive all of us to drink your honor. [00:13:14] Speaker 03: I want to start with the 425 patent and get us back to the evidence. [00:13:17] Speaker 03: I mean, the case law is that the ANDA, we have lots of cases from this court that the ANDA governs the infringement inquiry. [00:13:24] Speaker 03: And the assignment of error that's being asked for here on the 425 patent would ask the court to basically say that an ANDA that says the composition has 0.2% remodeling tartrate and 0.5% tin wall base, which is what the claims require, does not have that. [00:13:45] Speaker 03: We're talking about assays that were run and submitted to the FDA. [00:13:48] Speaker 03: And you can tell it's not a shorthand, because sometimes we [00:13:53] Speaker 03: We saw on the record, sometimes people are using these terms as shorthand. [00:13:56] Speaker 04: But the ANDA doesn't say the ingredient is Temmeloff rebase. [00:14:01] Speaker 04: It says the ingredient is 0.68% of the malliate that reduces to 0.5%. [00:14:07] Speaker 03: Well, the question for the construction judge, actually, it talks about the initial ingredient. [00:14:14] Speaker 03: We're talking about the thing that's on the table, the powder. [00:14:17] Speaker 03: I think I would agree with you, Your Honor. [00:14:21] Speaker 03: The question is what the composition by those of skill in the art contains. [00:14:26] Speaker 03: That's what the claim requires, a composition of 0.2% vermonity and 0.5% Timbalall free base. [00:14:35] Speaker 01: You stood up and said the ANDA says 0.5% Timbalall free base, but it doesn't, right? [00:14:42] Speaker 03: Well, that would beg to differ, and we would point to the [00:14:46] Speaker 03: testing that was submitted as part of the quality overall summary from the... Wait, can you show us the chart? [00:14:52] Speaker 04: There's the chart. [00:14:53] Speaker 03: What page is that on? [00:14:54] Speaker 03: The chart is at 4236. [00:14:56] Speaker 03: That's where it talks about the 6.83 malolates equivalent to the 5-milligram Timbalaw base. [00:15:04] Speaker 01: I'm sorry, what page was that? [00:15:05] Speaker 03: I believe I have it as 4236. [00:15:08] Speaker 03: And I think that's the chart that you're referring to. [00:15:15] Speaker 03: Yeah, this was in a brief. [00:15:16] Speaker 03: Right, right. [00:15:17] Speaker 03: But then also, and so the question is whether the composition can be, actually has, right, the 0.5 milligram Timbalall base. [00:15:29] Speaker 03: And they actually test that composition as part of their ANDA. [00:15:34] Speaker 03: And this is also in the briefs, Your Honor. [00:15:36] Speaker 03: And if you go, and it's a big appendix. [00:15:41] Speaker 03: I believe, I want to say, it's a big appendix. [00:15:45] Speaker 05: Is this the same chart that's in the brief? [00:15:55] Speaker 04: The side-by-side? [00:15:56] Speaker 02: Is it in your brief or is it in their brief? [00:16:06] Speaker 02: It's in our brief, Your Honor. [00:16:17] Speaker 03: It is. [00:16:18] Speaker 03: On page 13. [00:16:19] Speaker 01: And what is this chart from? [00:16:21] Speaker 03: This is from the ANDA. [00:16:22] Speaker 03: It's talking about the ingredients, as you just indicated. [00:16:27] Speaker 03: And it talks about the, if you will, it says, ingredient, timmalol malate, 0.5% as timmalol base. [00:16:37] Speaker 03: And that's what is in the composition. [00:16:39] Speaker 03: That's what is described as in the composition, which we are measuring against the claims. [00:16:45] Speaker 03: And I was referring to your honors, too. [00:16:47] Speaker 04: This is incredibly confusing, this chart, because on the ingredient list, it says timolol malate. [00:16:54] Speaker 04: And it has a footnote 1 that says 6.83 milligrams timolol malate is equivalent to 5. [00:17:02] Speaker 04: So that, if I'm reading that, says you're putting in 6.83 milligrams of the malate. [00:17:08] Speaker 04: Right. [00:17:08] Speaker 03: You're putting in 6. [00:17:09] Speaker 03: That's correct, but at the same time, you're putting in 6. [00:17:12] Speaker 01: But one of the things I feel like you're really [00:17:15] Speaker 01: somehow glossing right over, it is my understanding, and I can profess to understand very little in this case, but it is my understanding that timolol base is not the same thing as timolol free base. [00:17:28] Speaker 03: No, that is not correct. [00:17:29] Speaker 03: The timolol base and timolol free base as present in the timolol malate are the same thing. [00:17:34] Speaker 03: There was no argument that there was a distinction between timolol base as [00:17:39] Speaker 03: as formed between the Timelalp as the part of the Timelalp. [00:17:42] Speaker 01: I even remember an expert admitting that he didn't know how much free base was in something. [00:17:48] Speaker 03: Again, the ANDA assay shows that it's 0.5% Timelalp base. [00:17:53] Speaker 03: And I'm referring to appendix 4241. [00:17:56] Speaker 03: And this is where Dr. Sando's experts admitted that this was what was in solution in the actual product. [00:18:07] Speaker 03: And that is [00:18:08] Speaker 03: a test where they assay the actual composition. [00:18:12] Speaker 03: And that's what the claim requires, what's in the composition. [00:18:15] Speaker 03: And they come out with remodeling tartrate at 0.201 to 0.204% in the various bottles that they tested. [00:18:23] Speaker 03: They tested a 5-milliliter bottle and a larger bottle. [00:18:27] Speaker 03: And then they assayed Timilal base at 0.505 and 0.507. [00:18:33] Speaker 03: That is what they tested and told the FDA was in there. [00:18:38] Speaker 03: composition as the composition is going to be sold in the bottle. [00:18:43] Speaker 03: That is what is in the bottle, and they did that in the stability test as well, which is found at Appendix 4313. [00:18:49] Speaker 03: And the 30B6 witness for Sandoz also admitted that at his deposition. [00:18:55] Speaker 03: That's what he said at Appendix 2633. [00:18:57] Speaker 03: So the question of what the powder is, I think, is sort of [00:19:06] Speaker 03: It's putting the focus in the wrong place. [00:19:09] Speaker 03: The question is, what do persons of skill in the art, infringement is governed by that standard, believe to be or understand to be in the composition? [00:19:18] Speaker 01: OK, so why don't you turn to Appendix Page 2713. [00:19:21] Speaker 03: Hang on one moment. [00:19:26] Speaker 01: It's volume two. [00:19:39] Speaker 01: Twenty-seven thirteen line nine. [00:19:42] Speaker 01: Okay, have you done anything to determine how much would be in the free base form? [00:19:48] Speaker 01: I have not performed a personal experiment. [00:19:51] Speaker 01: Okay, and some of it might be floating around in there as... A timolal cation, right? [00:19:57] Speaker 03: In theory. [00:19:58] Speaker 03: In fact, maybe a lot of it would be in that form. [00:20:00] Speaker 03: Is that fair? [00:20:01] Speaker 03: I can't agree with that. [00:20:03] Speaker 03: And the answer though, your honor, to that is Sandoz did the tests. [00:20:08] Speaker 03: The expert [00:20:09] Speaker 03: Allergan, in the case law, the infringement inquiry is answered by the ANDA. [00:20:13] Speaker 03: Allergan is not required to do a test of what's in there to somehow confirm what Sandoz says in its ANDA. [00:20:22] Speaker 01: Where is there proof that free base and base is exactly the same thing? [00:20:26] Speaker 01: Because I understood one of them to be a charged version and the other one not to be. [00:20:30] Speaker 01: I don't get this chemistry stuff perfectly, so I could be wrong. [00:20:33] Speaker 01: But I also saw your expert on 2787 saying something similarly. [00:20:39] Speaker 01: about a difference between Timalol Freebase. [00:20:42] Speaker 01: And so I've tried to dive into this record, so I'm just trying to understand whether I should read that and whether it's proper, technically, to read that and of the way you suggest. [00:20:54] Speaker 01: If it said Timalol Freebase, game over. [00:20:57] Speaker 03: But it doesn't. [00:20:57] Speaker 03: So you can see in the patent, the term freebase is used in connection with the base component. [00:21:03] Speaker 03: So you're talking about the base component [00:21:05] Speaker 03: of the timolal malleate versus the freebase, if you will, as somehow distinct. [00:21:11] Speaker 03: In the depiction, excuse me, in the chart listing Combigand, in example, I think it's example two of the specification, example one, it talks about the 0.68 timolal malleate, and it says equivalent to 0.5 timolal freebase. [00:21:29] Speaker 03: That is the same as the base the experts were talking about at trial, the timolal base, the timolal freebase, [00:21:35] Speaker 03: is a reference to the base component of the salt. [00:21:39] Speaker 03: And the assay, as I described, in the end, it talks about the Timbalong base. [00:21:44] Speaker 01: Didn't what he say is it would be, quote, equivalent to? [00:21:48] Speaker 03: The patent says equivalent to Timbalong freebase. [00:21:52] Speaker 03: So you were asking, Your Honor, your question was the base and the freebase something different. [00:21:57] Speaker 03: That's what I was trying to answer, not the equivalent issue. [00:22:00] Speaker 03: It was talking about, and the patent treats the two as the same. [00:22:04] Speaker 03: I do want to address just the cross appeal. [00:22:12] Speaker 04: Can I just? [00:22:12] Speaker 04: Sure. [00:22:13] Speaker 04: I'm still a little skeptical on this 425. [00:22:15] Speaker 04: I mean, I understand. [00:22:17] Speaker 04: They have the same composition as you do. [00:22:20] Speaker 04: Yes, they do. [00:22:21] Speaker 04: But the claim terms are all over this place. [00:22:23] Speaker 04: And I don't understand why you don't have a claim term that exactly matches up the ingredients that you're using. [00:22:34] Speaker 03: I think we thought we did, and we think we do. [00:22:37] Speaker 04: And that goes to... Let me ask you this, and I don't know the answer to this, which is why I'm asking. [00:22:43] Speaker 04: I don't even know if there's anything on the record. [00:22:44] Speaker 04: Is it possible that if you start with putting in 0.5% free base of Timalol into making this composition, you don't end up in the same place? [00:22:56] Speaker 04: I.e., does the choice to use the salt form that's [00:23:02] Speaker 04: larger than the 0.5% have a difference than just using the Temelof Freebase. [00:23:08] Speaker 03: And I think the concentration of the Freebase in the product would be identical. [00:23:15] Speaker 03: I think that is what the record reflects. [00:23:20] Speaker 03: So the difference when you put the salt form is you have some portion of the salt is in solution. [00:23:25] Speaker 04: So if that's the case, why are you using the salt instead of the Freebase? [00:23:30] Speaker 03: that is the salt that's available, that's commercially available, that has been traditionally used. [00:23:34] Speaker 03: And then why didn't you say use the salt? [00:23:38] Speaker 04: I'm not trying to be quite here. [00:23:39] Speaker 04: I mean, the arguments on both sides of these seem to be kind of hyper-technical and obviously trying to find infringement or not infringement. [00:23:47] Speaker 04: But if I'm reading the plain language of this claim, you've used Temelol, Temelol, Freebase, all these different terms. [00:23:56] Speaker 04: differently throughout, but yet you want us to construe it the same way. [00:24:01] Speaker 04: And I have to, I'm sorry, I'm full of us during, but I have to take some significance to the fact that you chose to use the word timolol freebase here, and maybe in other places you only use the word timolol. [00:24:15] Speaker 04: Did you ever use the word timolol, is it malleate? [00:24:19] Speaker 04: I get, yeah, malleate. [00:24:20] Speaker 04: Did you ever use the phrase Timbalong malleate in any of these claims? [00:24:25] Speaker 03: I believe there are some claims that were disclaimed that used the term Timbalong malleate. [00:24:28] Speaker 03: And then they asked for 0.68%? [00:24:30] Speaker 03: No, they were 0.5. [00:24:33] Speaker 04: Which wouldn't reduce to 0.5% Timbalong. [00:24:35] Speaker 03: That's right. [00:24:36] Speaker 03: That would not be infringed. [00:24:37] Speaker 03: And so you asked why. [00:24:40] Speaker 03: And there's a historical reason here. [00:24:42] Speaker 03: That's what's going on here. [00:24:44] Speaker 03: You asked why did they get a 0.2 to 0.5 [00:24:47] Speaker 03: claim because that's how the product is labeled. [00:24:50] Speaker 03: When you pull the ANDA label, when you pull the CombiGAN label, it talks about two milligrams per kilogram. [00:24:56] Speaker 04: So the other claim you were talking about that you said it was disclaimed that you use 0.5% of the malate wouldn't cover your product. [00:25:04] Speaker 03: That's correct. [00:25:06] Speaker 03: That was disclaimed. [00:25:07] Speaker 03: But you asked why. [00:25:10] Speaker 03: This is not a case on a fresh playing field. [00:25:15] Speaker 03: These products [00:25:17] Speaker 03: were in existence before, and these numbers and terms were in existence before. [00:25:22] Speaker 03: And 0.5 strength, Timilal has always been the way persons of skill in the art have referred to the product with the 6.8 or the 0.68 milligrams. [00:25:34] Speaker 04: I get that, but I'm not sure how that helps you. [00:25:36] Speaker 04: I don't want to meet a dead horse, but you didn't use the word Timilal here with the understanding that the 0.5 is referring to this specific amount. [00:25:45] Speaker 04: Instead, you went ahead in this one and used the word [00:25:47] Speaker 04: Temulal Freebase. [00:25:48] Speaker 03: Right. [00:25:48] Speaker 03: And that was to get at the claim construction issue. [00:25:53] Speaker 04: But if you're really getting at the claim construction problem, why didn't you say, because this is what your product actually uses, 0.68 Temulal Malliott? [00:26:02] Speaker 03: Because we had an admission that the product had 0.5 Temulal Freebase, and an admission it had 0.25%, excuse me, 0.2% for monitoring tar trade. [00:26:12] Speaker 03: And that was why. [00:26:14] Speaker 03: And we have NANDA documents that say that, Your Honor. [00:26:17] Speaker 03: that test it in that way. [00:26:20] Speaker 03: I wanted to save a minute or so for any rebuttal on the cross-appeal points and simply raise the issue of issue preclusion and the prior litigation with respect to the other patents, if in fact the court reaches those other patents. [00:26:41] Speaker 03: And the obviousness is the exact same arguments were raised before [00:26:45] Speaker 03: that were litigated here again. [00:26:48] Speaker 03: And with that, I will save the remainder of my time for you. [00:27:04] Speaker 00: OK. [00:27:04] Speaker 00: Thank you again, Your Honors. [00:27:06] Speaker 00: I want to come to the assay documents that he was referring to. [00:27:09] Speaker 00: And you can see this discussed at appendix 2888 [00:27:13] Speaker 00: testimony from our expert was very clear that the assay doesn't say anything about the form of the Temelol that is in the bottle. [00:27:23] Speaker 00: It's essentially the same mathematical, hypothetical exercise to come up with the number that they rely heavily on when they point to the assay documents. [00:27:34] Speaker 00: And this comes back to the point that Temelol [00:27:37] Speaker 00: free base is not what forms in solution. [00:27:40] Speaker 00: And this is discussed extensively at 2787 to 2788. [00:27:44] Speaker 00: And what you get is the cation. [00:27:47] Speaker 00: It's the positively charged ion. [00:27:49] Speaker 00: It's not the free base. [00:27:51] Speaker 00: And that testimony was undisputed. [00:27:53] Speaker 00: There was no dispute that you're not going to get that amount of free base in solution. [00:27:58] Speaker 00: In fact, the testimony was it's just this mathematical exercise. [00:28:02] Speaker 00: That's at 2709. [00:28:03] Speaker 00: And they're expert, and this comes to some of the language that Judge Moore was asking about. [00:28:07] Speaker 04: Why does the chart describe it as base, then? [00:28:10] Speaker 04: So I think that Judge Hughes called the chart. [00:28:11] Speaker 04: And both of you describe it as timelock base. [00:28:15] Speaker 00: And so to be clear, of course, our ANDA, as is required by statute, is copying their NDA. [00:28:21] Speaker 00: So to the extent that there's question or confusion about what they meant, it's about what they meant. [00:28:27] Speaker 00: At the end of the day, I think all that they are saying is that, [00:28:32] Speaker 00: is that 0.68 timolol amalate is going to give you the same amount of cation as 0.5 timolol free base might give you, hypothetically, if you subtracted away the acid amount and you did this hypothetical numerical exercise. [00:28:51] Speaker 00: But in fact, what you don't have is free base as a starting point. [00:28:56] Speaker 00: And you asked the question, Judge Hughes, does the form you start with matter? [00:29:01] Speaker 00: And if you look at 2375 and 2378, that's the related 258 patent. [00:29:08] Speaker 00: And the answer is yes, it matters. [00:29:10] Speaker 00: And they have claim four of that patent that specifically refers to Timbalaw Mallier. [00:29:15] Speaker 00: And then finally, their expert didn't test anything in solution. [00:29:19] Speaker 00: The court has our arguments on obviousness. [00:29:21] Speaker 00: But again, I would submit this case is just like Santeros. [00:29:26] Speaker 00: And with respect to the arguments about issue preclusion and claim preclusion, just so that there's no mistake, they never asserted that there was claim preclusion or issue preclusion on the issue of infringement of the 149 patent, or for that matter, the 976 patent. [00:29:44] Speaker 00: And with respect to the invalidity arguments, [00:29:48] Speaker 00: Whatever you think regarding the 149, certainly the 425 patent has never been litigated before this court. [00:29:56] Speaker 00: They don't argue that any kind of issue, preclusion, or claim preclusion should apply there. [00:30:00] Speaker 00: If the panel has further questions, I'm happy to try to answer those, but I see my time is otherwise expired. [00:30:06] Speaker 01: Okay, thank you, Mr. O'Quinn. [00:30:08] Speaker 01: You saved rebuttal time, but it has to be limited to the cross appeal, and he didn't touch your cross appeal. [00:30:14] Speaker 01: Okay? [00:30:14] Speaker 01: So that concludes our case for today. [00:30:17] Speaker 01: Thank both counsel. [00:30:18] Speaker 01: Case is taken under submission.