[00:00:06] Speaker 03: The next case is Salix Pharmaceuticals and Dr. Falk Farmer versus Mylan, 2017-26-36, 2018-13-20. [00:00:15] Speaker 03: Ms. [00:00:20] Speaker 03: Bork again. [00:00:21] Speaker 03: This is non-infringement. [00:00:23] Speaker 03: The other was validity. [00:00:25] Speaker 02: Correct. [00:00:31] Speaker 02: May I please the court? [00:00:32] Speaker 02: The district court erred in construing the claim terms, two claim terms, granulated misalamine formulation, and the 85 to 90 percent of the misalamine reaches the terminal ellium and colon. [00:00:45] Speaker 02: This erroneous construction led the court to improperly find that Mylens and the product did not infringe the asserted claims of the 688 patent. [00:00:55] Speaker 02: I'd like to start with the granulated misalamine formulation issue first. [00:00:59] Speaker 02: With respect to the granulated misalamine formulation, [00:01:02] Speaker 02: the court adopted a construction that is contrary to the teachings of the intrinsic evidence. [00:01:10] Speaker 03: Well, granulated is all over the patent. [00:01:15] Speaker 02: It is in connection with granulated misalamine formulation. [00:01:20] Speaker 02: It is never used independent of the phrase granulated misalamine formulation or granulated misalamine. [00:01:29] Speaker 02: It is also [00:01:31] Speaker 02: used interchangeably with the term mesalamine granules. [00:01:36] Speaker 02: And I can point the court to figures one and two of the patent where they talk about it as mesalamine granules. [00:01:45] Speaker 02: And in the text where those figures are referred to, they talk about it as granulated mesalamine. [00:01:51] Speaker 02: It is used interchangeably. [00:01:53] Speaker 02: It is also used interchangeably with the term pellets. [00:01:58] Speaker 03: Is there no question that Mylan doesn't use [00:02:00] Speaker 03: a granulated formulation? [00:02:02] Speaker 02: There's no dispute that Mylan does not use a granulation process. [00:02:06] Speaker 02: That's correct, Your Honor. [00:02:09] Speaker 02: But it's also undisputed that granules, and their expert admitted this, granules do not require a granulation process. [00:02:18] Speaker 03: And so if these terms are used interchangeably, which- Where do granules come from if they're not through a granulation process? [00:02:26] Speaker 02: You can make them through, and this is, [00:02:29] Speaker 02: You can see this in the 620 patent, which is incorporated by reference. [00:02:33] Speaker 02: There are all sorts of conventional processes that they talk about, spheronization and other processes. [00:02:39] Speaker 02: I can't name them all off the top of my head. [00:02:41] Speaker 02: But if you go to the 620 patent, which is for controlled release pellet formulation, despite the fact that the examples are all granulation, it specifically states how important- That doesn't say granulation, does it? [00:02:55] Speaker 02: What? [00:02:55] Speaker 03: 620 patent? [00:02:57] Speaker 02: It does not. [00:02:58] Speaker 02: It's only in the examples. [00:02:59] Speaker 02: It's just the examples showing the method of manufacturing, the claimed novel controlled release pellet formulation, and the patent expressly states that the novel pellet formulation can be made by conventional processes. [00:03:15] Speaker 02: And that's in column four of the 620 patent. [00:03:18] Speaker 03: But it doesn't mention granulation, does it? [00:03:22] Speaker 02: Not in the claims. [00:03:23] Speaker 02: It's only in the examples it describes the granulation process. [00:03:26] Speaker 03: Where in the specification is there a granulation process? [00:03:30] Speaker 02: Let's be clear. [00:03:31] Speaker 02: Let's be clear. [00:03:32] Speaker 02: Let's talk about the 688 patent. [00:03:33] Speaker 02: It's the patent that issued here. [00:03:35] Speaker 02: 620. [00:03:36] Speaker 03: You're referring to 620. [00:03:38] Speaker 02: The 620 refers to the granulation process in the examples. [00:03:42] Speaker 03: Where? [00:03:55] Speaker 02: It doesn't use the term granulated, but the process that's described there is a granulation process. [00:04:02] Speaker 02: I don't dispute that. [00:04:04] Speaker 02: OK? [00:04:06] Speaker 02: So let's be clear, though. [00:04:10] Speaker 02: In the 688 patent, it says nothing about a granulation process. [00:04:14] Speaker 02: None of the examples are a granulation process because it's not surprising. [00:04:19] Speaker 02: It's a method of treatment patent. [00:04:21] Speaker 02: And so these are clinical studies. [00:04:23] Speaker 03: How about the 85 to 90 percent? [00:04:26] Speaker 03: Doesn't Mylan have 95 percent? [00:04:28] Speaker 02: They have 94 percent, correct? [00:04:31] Speaker 03: Beyond 90, well beyond 90. [00:04:33] Speaker 02: Well, it's our position that the 85 to 90 is a lowered limit of the release of the drug. [00:04:40] Speaker 02: It is not an express range with a floor and a ceiling. [00:04:44] Speaker 02: In fact, it would be contrary to the understanding of a person of ordinary skill in the art to put a ceiling on mesalamine delivery. [00:04:53] Speaker 02: was the consistent testimony of both of our experts, unrebutted. [00:04:58] Speaker 02: Then why did the patent drafter do it? [00:05:03] Speaker 02: It's an express range. [00:05:04] Speaker 02: We don't dispute that. [00:05:06] Speaker 02: There are no words of approximation. [00:05:08] Speaker 02: But it's a range for the lower limit because of the inherent variability, inter- and intra-individual variability. [00:05:17] Speaker 03: It doesn't even say about. [00:05:18] Speaker 02: It does not say about. [00:05:19] Speaker 02: In and of itself is a qualifying [00:05:23] Speaker 02: a qualifying term because it's a range. [00:05:27] Speaker 03: And elsewhere in the claim the words at least appear with respect to six months. [00:05:33] Speaker 03: So obviously they didn't intend that to appear with 85 to 90 percent. [00:05:39] Speaker 02: I'm not asking for, we're not asking for there to be qualifying language in the claim. [00:05:43] Speaker 02: We're saying the range itself is qualifying for the lower limit. [00:05:47] Speaker 02: It is a range. [00:05:48] Speaker 02: But it is not a range that you target for delivery. [00:05:52] Speaker 02: The testimony of record is that it would be impossible to target such a narrow range to have the delivery of the misalamine there. [00:06:06] Speaker 02: And that's evident from just the coefficient of variations in the tablets. [00:06:10] Speaker 03: If you look at Table 1 and Tables 3 and 4, it's... I'm not surprised that this claim has all sorts of limitations in it. [00:06:18] Speaker 03: Because there's column after column of prior art references. [00:06:24] Speaker 03: And so this is a very crowded art. [00:06:27] Speaker 03: They had to put a lot of stuff in these claims to get it allowed. [00:06:31] Speaker 02: That may be, but that doesn't change the fact of what we're arguing here, Your Honor. [00:06:36] Speaker 02: So let's turn to the 85% to 90%. [00:06:41] Speaker 02: I would go back to the fact that I said that the court erred with the construction of that term. [00:06:47] Speaker 02: The court dismissed the extrinsic evidence, relied on the claim language itself, and that was error because where she went off the rails a little bit was she had a fundamental misunderstanding of the objective of the invention in the Salome formulations in general because [00:07:09] Speaker 02: She did not, and the court says this in her opinion, and this is an appendix 61 to 62, that the claim method is of a decidedly different character than simply getting as much misalamine to the terminal ileum and colon as possible, and never suggests that the claim method's objective is to deliver as much misalamine to the terminal ileum and colon. [00:07:37] Speaker 02: And that fundamental misunderstanding derailed her and got her to, led her to an erroneous claim construction, led her to erroneously dismiss the substantial extrinsic evidence that was submitted where it was all consistent, all unrebutted that the objective of these mesalamine formulations, and this is also in the intrinsic evidence, a column [00:08:05] Speaker 02: 27 and column 9 the objective is to maximize the delivery to the colon and that there was significant testimony that said that you would never put a ceiling on delivery of misalamine that You would never have a floor in a ceiling and the other thing I would say is that the two references in the specification are [00:08:32] Speaker 02: that talk about the release profile. [00:08:36] Speaker 02: And this is at column nine, which talks about the release profile being 85 to 90%. [00:08:41] Speaker 02: And then in example four, it talks about approximately 80%. [00:08:49] Speaker 02: It would be inconsistent to put a ceiling on the delivery, given those two teachings in the intrinsic evidence. [00:09:02] Speaker 02: why you need to go to the extrinsic evidence, which is not inconsistent at all with the construction that we propose. [00:09:12] Speaker 03: Of course, if the claim had said very high, then you might look to the specification. [00:09:17] Speaker 03: But here it says very specific, as you can see, very specific range. [00:09:23] Speaker 03: And therefore, a number outside that range doesn't necessarily [00:09:28] Speaker 03: construe that is necessarily inconsistent with the precise range which is in the claims. [00:09:37] Speaker 02: It doesn't say very high and that's why they don't put an upper limit on it because if I put in very high I'd be right back here at the court and you would be asking me what does very high mean. [00:09:48] Speaker 03: Well let me look at the specification. [00:09:49] Speaker 02: This is true. [00:09:52] Speaker 02: This is true. [00:09:53] Speaker 02: So even if you [00:09:56] Speaker 02: were to construe it as an express range with a floor and a ceiling, which we believe is inconsistent with the understanding of how a person of ordinary skill in the art would view this, particularly in light of the objective, generalized objective of misalamine formulations of getting the maximum amount to the coal, right? [00:10:20] Speaker 02: Even if you construe it as a strict range, which we believe to be error, [00:10:27] Speaker 02: We still have an argument under the doctrine of equivalence that we set a lower limit of 85 to 90. [00:10:34] Speaker 02: And if you've got 85 to 90 there, you're going to maintain remission. [00:10:39] Speaker 02: So if you got 94% there, you're going to maintain remission. [00:10:46] Speaker 03: You don't think a number outside the range vitiates the claim limitation that gives a precise range? [00:10:53] Speaker 02: I do not for the reasons that are set forth in the Abbott v. Day case that we cite in our briefs. [00:10:59] Speaker 02: I believe that's the name of the case. [00:11:06] Speaker 02: Where it says expressly, this was a very similar situation where they had an express range and they had testimony, just like we have here, that it's not insubstantially different if you have [00:11:23] Speaker 02: more than that express range. [00:11:25] Speaker 02: And that's the evidence that we have here. [00:11:28] Speaker 02: If you're maintaining remission, you're maintaining remission. [00:11:31] Speaker 02: And if you get the vast majority there, which is what our expert Dr. Safdie says, you're going to maintain remission. [00:11:44] Speaker 02: I am getting close to my time. [00:11:46] Speaker 02: I think I'm going to save the rest of my time for my rebuttal. [00:11:49] Speaker 03: We will save it for you. [00:11:50] Speaker 03: Mr. Florence. [00:11:59] Speaker 01: Thank you, Your Honors. [00:12:01] Speaker 01: I would like to start with the Court's construction of the granulated misalamine formulation. [00:12:11] Speaker 01: The Court properly looked at the claim and noted that the word granulated in the claim itself modifies the term misalamine formulation, and that it also modifies the term misalamine, because what the claim actually says is that [00:12:25] Speaker 01: The purported invention is practiced by administering to the subject a granulated misalamine formulation comprising four capsules, each comprising of granulated misalamine. [00:12:36] Speaker 01: And as your honor pointed out, the word granulated is all over the specification. [00:12:40] Speaker 01: It's literally used hundreds of times, hundreds of times. [00:12:43] Speaker 03: Well, what about the reference to the 620 pattern, which talks about pellets? [00:12:51] Speaker 01: Sure, absolutely. [00:12:52] Speaker 01: We can talk about that. [00:12:55] Speaker 01: The 620 patent does talk about pellets, but the 620 patent is incorporated by reference in a section of the 6 at 8 patent entitled granulated mesalamine formulations. [00:13:06] Speaker 01: And then it says methods for making mesalamine formulations are contained in the following references. [00:13:17] Speaker 01: And it cites the 620 patent and two other references that essentially have the same disclosures because they're all continuations of one another. [00:13:25] Speaker 01: And so what the focus on at the trial was the 620 patent and what it showed. [00:13:30] Speaker 01: And Ms. [00:13:31] Speaker 01: Ork pointed out correctly that the 620 patent in and of itself does disclose pellets just in general. [00:13:39] Speaker 01: Specifically, it discloses pellet formulations where they have a matrix core, and then they're covered with an enteric coating as well. [00:13:47] Speaker 01: But what the court found was that granulated mesalamine formulation, that term in itself granulated, [00:13:55] Speaker 01: is a term of art in the pharmaceutical arts. [00:13:58] Speaker 01: What does granulated mean? [00:14:00] Speaker 01: When a person of ordinary skill in the art reads the 6-8 patent, which uses granulated hundreds of times versus the 6-20 patent that doesn't use it at all, what does it mean? [00:14:12] Speaker 01: Because the 6-8 patent doesn't provide anything beyond the incorporated 6-20 patent on ways to actually make granulated miscellany formulations. [00:14:22] Speaker 01: But what the 6-20 patent does show [00:14:24] Speaker 01: If you look at the working examples, those are the only actual examples that show how you make such a formulation. [00:14:30] Speaker 01: As Ms. [00:14:31] Speaker 01: Bork acknowledged and as both formulation experts, Dr. Auslander and Dr. Davies testified, those examples are made using wet granulation. [00:14:40] Speaker 01: Now Dr. Davies argued on behalf of the plaintiffs that he believes that because it was incorporated by reference that the 620 patent covers any pellet formulation. [00:14:54] Speaker 01: Well, but the court said, well, that may be true. [00:14:56] Speaker 01: But incorporating the 620 patent by reference and arguing that you get the benefit of every conventional way of making a pellet from that patent is belayed by the disclosure of the 688 patent itself, which literally hundreds of times doesn't refer solely to pellet formulations. [00:15:16] Speaker 01: It talks about granulated mesalamine formulations. [00:15:20] Speaker 03: And the reference to the 620 patent [00:15:24] Speaker 03: talks about misalamine formulations, not granulated misalamine formulations. [00:15:31] Speaker 01: That's correct. [00:15:32] Speaker 01: And as your honor pointed out, and as Ms. [00:15:34] Speaker 01: Bork acknowledged, the term granulated isn't even used in the 620 patent. [00:15:39] Speaker 01: That's true, but it is used hundreds of times in the 628 patent. [00:15:43] Speaker 01: And every time that it's used, it's to modify the granulated misalamine formulation or the misalamine itself. [00:15:52] Speaker 01: What the patent does, [00:15:53] Speaker 01: There are places where it doesn't talk about granulated misalamine formulations. [00:15:58] Speaker 01: But every time it mentions misalamine formulations by themselves is either to talk about other prior art formulations in general for misalamine or to compare a granulated misalamine formulation with a non-granulated misalamine formulation. [00:16:16] Speaker 01: Now, but something that's important that hasn't been touched on is the court looked at [00:16:22] Speaker 01: and weighed the credibility of all the experts that were opining on this issue. [00:16:26] Speaker 01: And Ms. [00:16:28] Speaker 01: Bork pointed out that there are places where the 688 patent uses the terms pellet and granule interchangeably with granulated mesalamine formulations. [00:16:43] Speaker 01: Would so to seem that that's what happens. [00:16:46] Speaker 01: But that was from the perspective of Dr. Softe, who isn't a formulator. [00:16:50] Speaker 01: He's a practicing physician. [00:16:52] Speaker 01: And the court noted that given that a posa is presumed to review the claimed terms in light of the specification when determining what granulated means, the plaintiff had not demonstrated that Dr. Safdie, although he was an accomplished gastrointestinal clinician, qualifies as a posa with regard to the pharmaceutical formulation at issue. [00:17:15] Speaker 01: So he saw it as just under [00:17:18] Speaker 01: a more layman view of what a physician sees when they see the word granulation, he testified, well, to me, it's just small particles, pellets, granules, any small particle. [00:17:30] Speaker 01: But the court gave him some credit for that, and she did give his opinion some weight by noting that the interchangeable nature of the word, such as granulated and granule and pellet, in his professional vocabulary, [00:17:44] Speaker 01: shed some light on the 6-8 patents oscillation between mesalamine granules and granulated mesalamine formulation. [00:17:51] Speaker 01: And that was at appendix at 51. [00:17:54] Speaker 01: But the court went on to say that, however, such interchangeability fails to clarify the specifications referenced to pellets of the granulated mesalamine formulation, which under Dr. Softie's flawed interpretation would redundantly read as granules of the granulated mesalamine formulation, which is akin to saying the 6-8 patents stating [00:18:14] Speaker 01: granules of the granules misalamine formulation. [00:18:18] Speaker 03: What about the 85 to 90 percent claim limitation when the patent also talks about an 80 percent formulation? [00:18:27] Speaker 01: Sure. [00:18:28] Speaker 01: When the patent does talk, there are two places in the patent specification that relate to percentages of a misalamine that's either available or delivered to the [00:18:44] Speaker 01: target area. [00:18:46] Speaker 01: And what the court said about those, looked at those two portions of the specification and found that although a post-it might understand the 85 to 90 percent limitation to represent a minimum threshold of the salamine delivery, the limitation is expressed as a closed range in claim one and at best an approximation in the specification. [00:19:07] Speaker 01: So if you look at the specification itself, example four is where the approximately 80 percent comes from. [00:19:14] Speaker 01: And that's in column 17. [00:19:20] Speaker 01: And essentially, it states that approximately 80% of an administered oral dose of mesalamine is estimated to be available in the colon, sigmoid, and rectum when dosed as mesalamine grins. [00:19:31] Speaker 01: So obviously, the patentee knew how to use words, varying terms, such as approximation, [00:19:41] Speaker 01: We already saw that they knew how to use the term at least because they use it as it relates to the timeframe for remission in claim one. [00:19:47] Speaker 01: But they didn't use those terms in the claim. [00:19:50] Speaker 01: That's not what they claimed. [00:19:51] Speaker 01: The claim doesn't say anything about approximately 85 to 90 percent. [00:19:57] Speaker 01: And it certainly doesn't say approximately 80 percent. [00:20:00] Speaker 01: It just flat out doesn't say that. [00:20:01] Speaker 01: But if you look at the other part of the specification that does mention the 85 to 90 percent, [00:20:08] Speaker 01: and this is in column 19, lines 50 through 54, it has identical language with the claim. [00:20:15] Speaker 01: It says the release profile and additional pharmacokinetic data show that the pellets of the granulated misalamine formulation have a relatively low rate and extent of systemic absorption, and that 85% to 90% of drug reaches the diseased area. [00:20:31] Speaker 01: So it uses the exact same closed range that's in the claim. [00:20:34] Speaker 03: And you say this was in column 19? [00:20:37] Speaker 01: Yes. [00:20:39] Speaker 01: Lines 50 to 54. [00:20:40] Speaker 03: All right. [00:20:43] Speaker 03: Thank you. [00:20:46] Speaker 01: And so the specification really just supports essentially the construction that the district court came up with. [00:20:52] Speaker 01: But really what's going on here is the plaintiffs want to use just extrinsic evidence to come in and trump what the extrinsic evidence to trump what the intrinsic evidence actually teaches. [00:21:07] Speaker 01: Yes, we agree that their experts all testified that a person of ordinary skill in the art outside of the patent wouldn't use an express range for delivery of the salary. [00:21:24] Speaker 03: Tell me again where in column 19 of the 688 patent at lines 50 to 54 is the range. [00:21:34] Speaker 03: I don't see that. [00:21:35] Speaker 00: I'm sorry, I may have pointed you to the wrong spot. [00:21:39] Speaker 03: I think you did. [00:21:40] Speaker 01: I'm sorry, it's column 9. [00:21:51] Speaker 01: It's column 9, Your Honor. [00:21:52] Speaker 01: My apologies. [00:21:53] Speaker 01: Column line, lines 50 to 54. [00:21:56] Speaker 03: I see it, yes. [00:21:59] Speaker 03: I apologize for that. [00:22:04] Speaker 01: No, I see. [00:22:04] Speaker 01: Considering the intrinsic evidence, what the district court found was that said the contentions of Dr. Softy, Dr. Golden, and Dr. Johnson must be rejected as inconsistent with the plain language of the limitation, as well as the disclosures and the specification. [00:22:20] Speaker 01: None of the post-cita testimony established that close ranges, such as the 85 to 90% limitation, are regularly used as lower limits in the relevant art, or that they have that special meaning. [00:22:31] Speaker 01: Rather, the testimony the court found was but an extension of the plaintiff's argument that the 85% to 90% limitation should be construed to mean at least 85% or 85% to 100% rather than the plain language of the claim itself. [00:22:46] Speaker 03: So you're saying if the specification has two conflicting numbers or sets of numbers and the patentee decided to claim one but not the other, [00:23:00] Speaker 03: That's what the claim means. [00:23:03] Speaker 01: Yeah, essentially, that's what they claim. [00:23:05] Speaker 01: In the specification, there are two disclosures regarding percentages. [00:23:09] Speaker 01: And they went with the 85% to 90% closed range. [00:23:13] Speaker 01: That's what they claimed. [00:23:15] Speaker 01: They definitely could have claimed something different, but they didn't do that. [00:23:19] Speaker 01: They didn't use the term at least. [00:23:21] Speaker 01: Obviously, they knew how to do that, because they used it with permission. [00:23:23] Speaker 03: In any event, my land doesn't have the 80%. [00:23:26] Speaker 03: It has, what, 95%? [00:23:27] Speaker 01: 94%? [00:23:30] Speaker 01: Mylan disputes that the evidence put forth by Dr. Golden, that that evidence that you can actually tell how much of the percentage of the drug actually reached the targeted area, because that data was based on an extrapolation of bioequivalent studies from Mylan's ANDA itself. [00:23:48] Speaker 01: And Dr. Golden admitted that the plasma profiles, the information of how much mesalamine was absorbed [00:24:00] Speaker 01: that it doesn't tell her, it doesn't tell you where in the GI tract it was actually absorbed. [00:24:07] Speaker 01: Instead, she was relying on the FDA's allowance for showing bioequivalence as a surrogate, that if you do get systemic absorption, it's assuming that it was absorbed in that area. [00:24:21] Speaker 01: But it's just a surrogate. [00:24:22] Speaker 01: She admitted that you can't tell that based on blood plasma concentrations alone. [00:24:28] Speaker 01: And so we dispute. [00:24:29] Speaker 01: that it actually shows that. [00:24:31] Speaker 01: And she certainly didn't look to see whether or not any individuals. [00:24:35] Speaker 03: So Mylan has an ANDA which matches the blood levels of the reference product, but has a different result in terms of the pattern infringement question. [00:24:57] Speaker 01: Yeah, it is a different result. [00:24:58] Speaker 01: But I wouldn't characterize it as it matching. [00:25:01] Speaker 01: We feel that we've shown bioequivalence, that it's bioequivalent. [00:25:06] Speaker 01: But showing bioequivalence, you get a little bit of leeway for the area under the curve. [00:25:09] Speaker 01: There's an 80% to 100% variation that you can have. [00:25:12] Speaker 01: It doesn't match it exactly. [00:25:15] Speaker 01: But our position is that those blood levels alone can't show that. [00:25:19] Speaker 01: But the court didn't really get the goal wrong either. [00:25:23] Speaker 01: When they're talking about what they point to in the specification for the goal of delivering as much misalamine to the colon as possible, that section's actually talking about all misalamine formulations, pre-existing formulations, this formulation. [00:25:37] Speaker 01: The patent itself states in column one that the goal of treatment in ulcerative colitis, this is at line 49, is to induce and maintain remission and improve quality of life. [00:25:49] Speaker 01: And that's what this claim's directed to. [00:25:51] Speaker 01: Sure, it might be true that more is better, [00:25:53] Speaker 01: And if you do get more to the target area, you might be able to improve the quality of life. [00:25:59] Speaker 01: You might be able to maintain remission better. [00:26:03] Speaker 01: But that's not the specific goal. [00:26:06] Speaker 03: Was there relevant prosecution, I guess, if there had been, we would have heard about it, relating to the 85% to 90% in the prosecution of the patent? [00:26:15] Speaker 01: Well, it was added to overcome the Salex press release. [00:26:20] Speaker 01: They say express release doesn't have any information in it regarding the percentages of misalamine that's delivered. [00:26:26] Speaker 01: And it was added, and in the prosecution it states it was added to show, let me make sure I get this right. [00:26:45] Speaker 01: It was added to show how the drug is distributed. [00:26:49] Speaker 01: that the drugs are distributed in this manner. [00:26:51] Speaker 01: But there's no explanation in the prosecution history that it's not a closed range either. [00:26:56] Speaker 01: And one last point I'd like to make. [00:26:58] Speaker 01: There is evidence in the record that the commercial embodiment of Prezo is, in fact, covered by the strict range. [00:27:09] Speaker 01: And this is of the appendix at 3856. [00:27:12] Speaker 01: This is the testimony of Dr. Johnson, who calculated the 85% to 90% [00:27:18] Speaker 01: in the patent itself. [00:27:19] Speaker 01: And he stated that the lowest level for a single patient was 86.6%. [00:27:24] Speaker 01: So I know they argued in their briefs that the commercial embodiment would be excluded if it's a closed range. [00:27:31] Speaker 01: It's not. [00:27:32] Speaker 01: There's evidence that certain patients do fall within it. [00:27:34] Speaker 01: You might have some variability that some fall without. [00:27:37] Speaker 01: But this isn't a situation where they've claimed something that they can't even practice. [00:27:42] Speaker 03: Thank you, counsel. [00:27:44] Speaker 03: Ms. [00:27:44] Speaker 03: Bourque has some rebuttal time. [00:28:02] Speaker 02: Let's just start with the granulated misalamine formulation first. [00:28:07] Speaker 02: There is an argument that has been made that for some reason the 6-8-8 patent is narrower than the 6-2-0 patent because when the 6-8-8 patent refers to the 6-2-0 patent and incorporates by reference, it just says misalamine formulations. [00:28:26] Speaker 02: That's not true. [00:28:29] Speaker 02: What is disclosed in the 6-2-0 patent are both granulated mesalamine formulations, these small controlled release pellets, as well as mesalamine formulations, non-granulated mesalamine formulations, which are the tablets, the prior art salapal tablets. [00:28:50] Speaker 02: It's also true for the 6-8-8 patent. [00:28:52] Speaker 02: When the 6-8-8 patent distinguishes granulated [00:28:56] Speaker 02: misalamine formulations from non-granulated misalamine formulations. [00:29:00] Speaker 02: If you look at those passages, they're talking about treatment failure, and the treatment failure was with the tablet acicol. [00:29:09] Speaker 02: And so they're distinguishing the non-granulated misalamine formulations from the granulated misalamine formulations in terms of the tablets versus the small pellets, beads, granules. [00:29:22] Speaker 02: Remember, this is a patent that's a clinical patent. [00:29:25] Speaker 02: It's directed to methods of treatment. [00:29:28] Speaker 02: And so the one complete error that the district court made was when it went to look at the extrinsic evidence in Dr. Safdie, and he was mentioned earlier, what the district court did in discounting Dr. Safdie's testimony and all the rest [00:29:51] Speaker 02: and discredited and given it little weight was because he didn't go look at Miland's and product and process. [00:30:00] Speaker 02: We all know from this court's precedent that's completely contrary to the claim construction process, which should be based on the intrinsic evidence, not on the accused product. [00:30:12] Speaker 02: And that infected her analysis of the two other experts, the formulators, where she [00:30:20] Speaker 02: credits Dr. Auslander over Dr. Davies because she says, well, Dr. Auslander said that you had to go look at myelin and a manufacturing process. [00:30:34] Speaker 02: We all know that's not what claim construction is about. [00:30:38] Speaker 02: Let's also put all of this into perspective. [00:30:41] Speaker 02: When we went to trial, neither of these terms were given a construction at Markman. [00:30:50] Speaker 02: The parties all agreed that it was plain and ordinary meaning for both of those terms. [00:30:54] Speaker 02: So that's how the testimony came in. [00:30:57] Speaker 02: These experts were not doing a quote unquote claim construction. [00:31:01] Speaker 02: The claim construction was done later by the district court in the post-trial opinion. [00:31:09] Speaker 02: And so for the 6.8 patent, what matters is not the manufacturing process. [00:31:17] Speaker 02: It's the distinction between the [00:31:19] Speaker 02: big monolithic tablets that have the problem with the dose dumping, that as opposed to the multi-particulate systems, the small pellets, beads, granules, terms used interchangeably throughout the specification, because it's written in terms of a clinician, or at least people looking at methods of treatment. [00:31:45] Speaker 02: And so that's what the distinction is. [00:31:49] Speaker 02: They're not looking at the manufacturing process. [00:31:52] Speaker 02: No clinician would ever look at the manufacturing process. [00:31:56] Speaker 02: A couple of things on the 85 to 90. [00:32:01] Speaker 03: Your time has concluded, but if you have a sentence or two, we'll listen. [00:32:08] Speaker 02: All I would say is that in terms of Dr. Golden's infringement analysis, that was never challenged in the district court. [00:32:15] Speaker 02: They should have filed a Dalbert motion in terms of reliability of the methods that she was used. [00:32:20] Speaker 02: That was never done, so that's been waived. [00:32:22] Speaker 02: And all I would say is that with the 85 to 90, when the intrinsic evidence is ambiguous as it was to the district court, you must resort to the extrinsic evidence to understand how a person of ordinary skill in the art understood that range. [00:32:43] Speaker 03: Thank you, Council. [00:32:44] Speaker 03: Thank you both. [00:32:45] Speaker 03: We'll take the case under review.