[00:00:02] Speaker 02: See, we have four arguing cases this morning. [00:00:08] Speaker 02: We're going to take a recess after the third case to adjust the panel. [00:00:15] Speaker 02: The first case is number 16-1619, Sopernos Pharmaceuticals versus Activis Mr. White. [00:00:26] Speaker 00: Thank you, Your Honor. [00:00:26] Speaker 00: May it please the Court? [00:00:28] Speaker 00: The issues in this case both [00:00:30] Speaker 00: on infringement and validity can be divided between two different claim terms, the first being homogeneous matrix, the second being agent that enhances the solubility of oxcarbazepine. [00:00:42] Speaker 00: And I'd like to address them in that order with respect to the claim terms. [00:00:48] Speaker 02: Let me tell you, I've looked at the patent and the prosecution history here. [00:00:53] Speaker 02: It seems to me that when this term homogeneous was introduced into the patent, [00:00:59] Speaker 02: that the applicant gave an explanation which said homogeneous means processed according to the examples of the patent, basically. [00:01:13] Speaker 02: I think that said 14809. [00:01:18] Speaker 02: So why isn't that the definition of homogeneous? [00:01:24] Speaker 02: That is, processed according to the examples of the patent. [00:01:27] Speaker 02: And I guess the two examples that [00:01:29] Speaker 02: describe the mixing process are examples one and four. [00:01:35] Speaker 02: And in fact, in the written description argument, he relies on those, particularly example four, as providing the written description support for homogeneous. [00:01:49] Speaker 02: So why isn't that the proper construction of homogeneous? [00:01:55] Speaker 00: Thank you, your honor. [00:01:56] Speaker 00: The statement was that support for the amendment can be found in the specification, and they pointed to two parts. [00:02:06] Speaker 00: They pointed one to the textual phrase, homogeneous matrix. [00:02:10] Speaker 02: Yeah, there's not much there. [00:02:11] Speaker 00: Correct. [00:02:12] Speaker 00: And then they said, and in the working examples. [00:02:15] Speaker 00: So I think there's a big difference, Your Honor, between saying I can find support for an amendment in something and saying, [00:02:24] Speaker 00: that the characteristics of an example then define the meaning for terms of claim construction. [00:02:33] Speaker 00: So I think if I was making that argument saying homogeneous matrix is limited to the result of example four, that's the only one that actually has all four ingredients. [00:02:48] Speaker 00: It is limited to that. [00:02:50] Speaker 02: Well, I'm not sure it's the ingredients. [00:02:53] Speaker 02: I think it's because the patent contemplates different ingredients. [00:03:00] Speaker 02: It's more of the mixing process, which is described both in one and four. [00:03:04] Speaker 00: Although the claim requires elements, specific elements, and example one doesn't have all of them. [00:03:10] Speaker 00: But let's put that aside if we could, Your Honor. [00:03:12] Speaker 00: If I was arguing the homogeneous matrix was limited to the [00:03:18] Speaker 00: product made by that process, then I would be accused, and I think probably rightly, of trying to limit the claim to the working example, or trying to import limitations from the specification into the claim. [00:03:35] Speaker 00: And there's a big difference, Your Honor, I respectfully submit, between having an express definition in the terms of either lexicography, [00:03:46] Speaker 00: or as used herein, this term means that, on the one hand, which will clearly control claim construction. [00:03:56] Speaker 00: And on the other hand, having the standard statement that says support for the amendment can be found at this paragraph. [00:04:03] Speaker 00: And I would continue. [00:04:06] Speaker 02: That's really the problem is there really isn't anything in the specification other than the [00:04:15] Speaker 02: one appearance of the word homogeneous that tells you what it means. [00:04:20] Speaker 02: And the only part of the prosecution history that tells us what it means is that reference which I cited to you, which refers to the example. [00:04:30] Speaker 00: But again, I don't think that controls for purposes of claim construction. [00:04:34] Speaker 00: I think, Your Honor, that the limitation, not in terms of a claim limitation, but the limited amount of information that's in the specification, [00:04:44] Speaker 00: with respect to homogeneous matrix contributes both to the problems that we pointed out with lack of written description and indefiniteness but if i could take the infringement first the district court's claim construction on its face she seems to rely on [00:05:01] Speaker 02: the process is showing infringement to a large extent. [00:05:05] Speaker 00: Yes, the district court. [00:05:07] Speaker 02: Yeah, the district court. [00:05:08] Speaker 02: And regarding the other things, that is, the FDA standard and the chemical analysis is merely, quote, confirming what she found as a result of the process, right? [00:05:19] Speaker 00: Yes, and we address why that's wrong. [00:05:21] Speaker 00: But if we look at the district court's verbal claim construction at the Markman phase, right, we thought we won this. [00:05:28] Speaker 00: This was basically what we argued for. [00:05:30] Speaker 00: And the district court at the Markman phase said, a matrix in which the ingredients or constituents are uniformly dispersed. [00:05:39] Speaker 00: And Her Honor specifically rejected the arguments by Supernus to say, substantially uniform, or to say, in a given volume. [00:05:51] Speaker 02: So. [00:05:52] Speaker 02: You're now saying the claim construction, you've got us indefinite. [00:05:55] Speaker 02: that you proposed. [00:05:56] Speaker 00: No, I don't think it is. [00:05:59] Speaker 00: And the claim construction on its face is not indefinite, but it is pretty narrow. [00:06:08] Speaker 00: So uniform doesn't mean mostly uniform, substantially uniform, largely uniform. [00:06:15] Speaker 00: It doesn't mean that only the active pharmaceutical ingredient needs to be uniform. [00:06:20] Speaker 00: It doesn't mean that only part of the formulation needs to be uniform. [00:06:24] Speaker 00: It is a narrow term that was construed. [00:06:30] Speaker 00: It was the patentee's choice to use homogeneous matrix during the prosecution. [00:06:37] Speaker 00: And it is now stuck with that. [00:06:41] Speaker 00: Now, it could have challenged the claim construction on appeal. [00:06:43] Speaker 01: Would you have claimed construction mostly relying on extrinsic evidence for that understanding of what homogeneous matrix means? [00:06:53] Speaker 01: And so it's like the plain and ordinary meaning to one of ordinary ages in New York? [00:06:57] Speaker 00: Largely, yes, Your Honor. [00:06:58] Speaker 00: I mean, dictionary definitions, both regular definitions and technical definitions. [00:07:03] Speaker 00: Because as Judge Dyke pointed out, there isn't a specific definition in the specification. [00:07:09] Speaker 00: And each of the words are common enough English words in science and in pharmaceuticals. [00:07:16] Speaker 00: Homogeneous, although I think there's a typo when it says homogenous. [00:07:20] Speaker 00: homogeneous is a common enough English word matrix is a common enough English word in the pharmaceutical industry but there was no evidence or testimony that the phrase homogeneous matrix in quotes has a particular standardized meaning to one of ordinary skill in the art so the district court I think quite correctly looked at the extrinsic evidence and said uniformly dispersed and [00:07:49] Speaker 00: It's strange to say that the district court didn't follow its own claim construction. [00:07:55] Speaker 00: But that is, in fact, we respectfully submit. [00:08:02] Speaker 00: What happened here? [00:08:04] Speaker 00: And how didn't it follow its claim construction? [00:08:06] Speaker 00: Because the district court rejected qualifiers around uniform, substantially uniform, which was proposed. [00:08:14] Speaker 00: It did uniform. [00:08:16] Speaker 02: But what does that mean? [00:08:17] Speaker 00: Uniform means unvarying throughout. [00:08:20] Speaker 00: It's a narrow term. [00:08:22] Speaker 02: But I don't understand. [00:08:23] Speaker 02: I mean, that sounds awfully subjective, is that one person might say this is uniform. [00:08:31] Speaker 02: Another person might say it's not. [00:08:33] Speaker 02: It's not a very helpful definition, it seems to me, as opposed to looking to the examples in the patent for the process. [00:08:42] Speaker 00: Well, Your Honor, so either it's very narrow. [00:08:46] Speaker 00: and we don't infringe, or if it's really as unhelpful as the question posed, it's indefinite. [00:08:54] Speaker 00: And looking at the process, Your Honor, I don't think it's right. [00:08:57] Speaker 00: First of all, I don't think it's a claim construction issue when somebody says, I rely on this for support. [00:09:01] Speaker 00: But let's consider a claim wherein the applicant had said a matrix wherein the uniformity of the [00:09:17] Speaker 00: ingredients is in accordance with the result of example one or example four. [00:09:24] Speaker 00: Because that's really where this is going. [00:09:28] Speaker 00: And I don't think that that amendment would remotely have been accepted. [00:09:33] Speaker 00: It would not have been found by the examiner to have been supported. [00:09:36] Speaker 00: It would not have been found to be definite. [00:09:39] Speaker 03: Why wouldn't it have been supported by an example? [00:09:43] Speaker 03: Right. [00:09:43] Speaker 03: Because they're taking issue with your [00:09:46] Speaker 03: statement that it wouldn't have been supported. [00:09:48] Speaker 00: Yes, Judge. [00:09:49] Speaker 00: So I would not have an issue with a picture claim that is directed to a specific example. [00:09:57] Speaker 03: You went close to that in your recitation of what the claim would have looked like. [00:10:03] Speaker 00: Well, not really, Your Honor, because [00:10:07] Speaker 00: The picture claim that specifies what the ingredients are and the quantitative formulation, et cetera, is very different. [00:10:14] Speaker 00: Here, we have a particular characteristic of the formulation, which is not identified at all in the specification. [00:10:23] Speaker 00: So there's this phrase homogeneous matrix, which talks about something else. [00:10:27] Speaker 00: There's nothing in the description of the working examples that calls out or identifies as their characteristic [00:10:37] Speaker 00: uniformity, a certain level, et cetera. [00:10:41] Speaker 00: And so now we have a situation that's very analogous to the Purdue V-Folding case that we talked about in our brief, where the applicant takes a characteristic, an arguable characteristic. [00:10:54] Speaker 00: In that case, it was a clear characteristic. [00:10:57] Speaker 02: But in Purdue, the examples had different characteristics. [00:11:00] Speaker 02: I'm sorry, Your Honor. [00:11:01] Speaker 02: In Purdue, the examples had different characteristics. [00:11:05] Speaker 02: That was the problem. [00:11:06] Speaker 02: Here, the only two examples which talk about the mixing are one and four, and it's the same. [00:11:13] Speaker 02: Other than perhaps the difference in the ingredients, which it would seem is not a characteristic of the mixing method. [00:11:21] Speaker 00: Sorry, Your Honor, to have stepped over you for a moment. [00:11:25] Speaker 00: That was part of the problem. [00:11:27] Speaker 00: Nobody usually apologizes for that. [00:11:29] Speaker 00: It's probably the first time anybody's apologized. [00:11:32] Speaker 00: That was part of the problem in Purdue, Your Honor, but it was not the only problem. [00:11:36] Speaker 00: See, there's not a problem with claiming less than what's in your specification. [00:11:40] Speaker 00: So the fact that some examples have a characteristic and some don't, [00:11:45] Speaker 00: does not cause a problem if I have a narrowing amendment to claim some of them. [00:11:48] Speaker 00: The problem in Purdue really, which is what's analogous to this, is that C max over C24 ratio was never identified in the specification as mattering to anything. [00:12:01] Speaker 00: It wasn't characterized. [00:12:03] Speaker 00: It wasn't discussed. [00:12:04] Speaker 00: There was nothing in there. [00:12:06] Speaker 00: That's the situation here. [00:12:08] Speaker 00: With respect to the working examples, there's a nice discussion of what the ingredients are. [00:12:13] Speaker 00: But there's no discussion of the characteristic of them in terms of uniformity. [00:12:20] Speaker 03: Can we look at the infringement and the invalidity issues independently of one another, or are they inextricably tied? [00:12:26] Speaker 03: For example, if we conclude that there was sufficient evidence here for the district court to have concluded that there's infringement, we reach that conclusion. [00:12:36] Speaker 03: Doesn't that tell us that the claims are not indefinite? [00:12:39] Speaker 00: No, Your Honor. [00:12:40] Speaker 00: Why not? [00:12:43] Speaker 00: I do, Your Honor. [00:12:45] Speaker 00: I do, Your Honor. [00:12:46] Speaker 00: I certainly do. [00:12:47] Speaker 00: It can be the case that a claim that is legally indefinite in an enormous part of the middle may have something clearly on one side that's infringed, that's within the claim, and clearly something on the other side that's outside of the claim. [00:13:07] Speaker 00: But is that the situation? [00:13:11] Speaker 03: Doesn't that hypothetical describe a different situation than we have here? [00:13:15] Speaker 00: I don't think it does, Your Honor, and I'm sorry, I was answering the question in the abstract. [00:13:19] Speaker 03: Judges looking at the manufacturing methodologies and whatnot and saying, well, they followed this protocol, and that protocol is going to result in the requisite amount of homogeneity, whatever it is. [00:13:32] Speaker 03: than one ordinary skill in the art, knowing how to perform those tasks, doesn't that person know that the claim is not indefinite? [00:13:43] Speaker 00: No, Your Honor, because again, there's not a description of the stand. [00:13:48] Speaker 00: I didn't explain myself very well on that. [00:13:51] Speaker 00: Again, the fact that I can follow something in the specification and infringe the claim does not mean necessarily [00:14:00] Speaker 00: that the boundaries of that claim are clear. [00:14:02] Speaker 00: The fact that I can pick out examples. [00:14:04] Speaker 03: Yeah, but necessarily is the key word there, because you created a hypothetical when you've got edges. [00:14:10] Speaker 03: You can say, well, it's infringed over here, but not infringed over there, and therefore. [00:14:14] Speaker 03: But I'm not convinced that it isn't sort of a syllogism here. [00:14:18] Speaker 03: If we sustain infringement, then it's not indefinite. [00:14:21] Speaker 00: I think, Your Honor, if you look at the particular, and I point the court to the Bougei testimony, Dr. Bougei's testimony about infringement [00:14:29] Speaker 00: his ramen images. [00:14:31] Speaker 00: And again, with respect to the district court, I think it really got it wrong when it said that they were not very important, that the manufacturing process is what was important. [00:14:40] Speaker 00: We look at his testimony [00:14:41] Speaker 00: It's clear there's no standard, there's no content, there's no objectivity. [00:14:45] Speaker 00: It is no better than I know it when I see it situation. [00:14:50] Speaker 02: So if the patent had said by homogeneous we mean mixing according to example four, that wouldn't have been indefinite, right? [00:15:00] Speaker 00: It would be a very different case. [00:15:03] Speaker 00: So the case then would have been, the short answer is I don't know, Your Honor, but it would have been a very different case. [00:15:09] Speaker 03: Close to a very clean, close to a picture clean. [00:15:11] Speaker 00: Well, we then would have looked at, for example, what are the conditions in example four? [00:15:17] Speaker 00: There's nothing there about how long things were screened, how they were milled, what the particle size was, how they were mixed. [00:15:25] Speaker 00: And Dr. Hopfenberg testified without contradiction that those things are all very important if you're trying to characterize the uniformity of a resulting product [00:15:37] Speaker 00: by its manufacturing process. [00:15:39] Speaker 00: So we would have had to have looked at that, and that would have been a very different case that we would have tried. [00:15:45] Speaker 00: It would have been a very different infringement case also that we would have tried, as well as a very different indefiniteness case. [00:15:54] Speaker 02: The homogeneity is not what was used to distinguish the prior hierarchy, right? [00:16:01] Speaker 00: was made specifically to distinguish the prior art. [00:16:04] Speaker 02: No, but I guess I'm not being clear. [00:16:07] Speaker 02: In terms of the obviousness analysis, there's no contention that homogeneity in some form or other distinguishes the prior art. [00:16:18] Speaker 00: I'm sorry, Your Honor, I'm not following. [00:16:20] Speaker 02: I think that the amendment that was made... In terms of the obviousness analysis, there's no claim that there's novelty in the homogeneity requirement. [00:16:29] Speaker 00: Well, no, that was specifically done to distinguish the prior art, and I think the applicant may have, and my own view probably perhaps did, pick a much more restrictive amendment there to get over the prior art perhaps than they had to. [00:16:44] Speaker 00: And we talked about the possibility that maybe they could have tried a negative limitation. [00:16:49] Speaker 00: Some examiners like negative limitations, some view them with a lot of suspicion when it comes to written description, but for better or worse, [00:16:57] Speaker 00: They chose to go with a very narrow term, and they got an allowance based on that. [00:17:03] Speaker 00: And now they're stuck with it, and to say, well, I didn't have to go that narrow is an incorrect analysis. [00:17:10] Speaker 00: Or to say, I'm going to look at that claim, and I'm going to construe it not on its face and not on its terms, but I'm going to give the patentee the full breadth that he could have gotten if he had made a [00:17:26] Speaker 00: less of an amendment. [00:17:28] Speaker 00: So I don't think that really answers the question either from claim construction or [00:17:33] Speaker 01: Why isn't it a fact question? [00:17:35] Speaker 01: So the court says it means uniformly dispersed. [00:17:39] Speaker 01: And then you have experts who argue over whether the accused product is uniformly dispersed. [00:17:45] Speaker 01: Why isn't it a fact issue? [00:17:46] Speaker 01: It's a second part of the infringement stuff. [00:17:48] Speaker 00: Yes, Your Honor. [00:17:51] Speaker 00: And in many cases, determining where claim construction ends and fact question begins can be tough. [00:17:58] Speaker 00: I don't think that this is one of them. [00:18:01] Speaker 00: because we have the benefit of the district court's analysis. [00:18:06] Speaker 00: This is not a black box jury verdict. [00:18:09] Speaker 00: But what's clear is not that people are disagreeing over the characteristics of the product, which is I say your Raman images are wrong and these Raman images control. [00:18:21] Speaker 00: That's not what's being disputed here. [00:18:23] Speaker 00: What's being disputed here is the meaning of uniform. [00:18:26] Speaker 00: wasn't it what's being disputed whether those ramen ramen images show uniformity or not but again and and yes your honor but what what controls that question is what does uniformity mean so I think again we're right back to the claim construction issue here so I do view it as an issue of claim construction but even if the court's construction correct your honor but even if it's viewed as a fact question [00:18:52] Speaker 00: You know, that does not put it beyond review. [00:18:55] Speaker 00: Obviously, clear error is a deferential standard, but this court reverses on facts, on jury verdicts even, which is an even more deferential standard. [00:19:04] Speaker 00: In the U.S. [00:19:05] Speaker 00: gypsum case says, you know, a definite and firm conviction that it was error. [00:19:10] Speaker 00: It's not an unreviewable standard, and we think looking at the Rahman images, we think the court actually, even if you apply [00:19:16] Speaker 00: The most favorable construction that you can come up with in favor of the plaintiff and trying to get to affirmance, I think there's still clear error on that. [00:19:26] Speaker 01: Right. [00:19:26] Speaker 01: So we'd have to find clear error with the reliance on the Raman images, the FDA, and also the reliance on the fact that the same mixing process was used. [00:19:36] Speaker 00: It sounds like a lot, Your Honor, but it really isn't. [00:19:38] Speaker 00: When you look at what the FDA is, there's no testimony. [00:19:42] Speaker 00: There's nothing in the, I'm sorry, no testimony. [00:19:44] Speaker 00: There's nothing in the intrinsic evidence here about FDA standards. [00:19:48] Speaker 00: Not anywhere. [00:19:48] Speaker 00: There's nothing that says that example one and example four meet FDA standards. [00:19:53] Speaker 00: There's absolutely nothing in there. [00:19:55] Speaker 00: And so what we have here, I think, is one of these gotcha situations where supernus pours through the record and finds words that match up. [00:20:05] Speaker 00: I find the word uniform. [00:20:06] Speaker 00: I find the word homogeneous, gotcha. [00:20:08] Speaker 00: It's like saying, well, your bioequivalents are therefore you must infringe. [00:20:12] Speaker 00: It's just not right. [00:20:13] Speaker 00: I've run way over, Your Honors. [00:20:15] Speaker 02: Okay, we'll restore your rebuttal time for three minutes. [00:20:18] Speaker 02: Thank you, Your Honors. [00:20:23] Speaker 02: Mr. Gluff. [00:20:35] Speaker 05: Good morning, Your Honors, and may it please the Court [00:20:38] Speaker 05: I think I'd like to pick up where the last discussion left off. [00:20:41] Speaker 05: And I think I could shed some light on this question that the panel and activists as counsel are struggling with, which what does uniform mean? [00:20:51] Speaker 05: And I think the best way to do this is chronologically. [00:20:54] Speaker 05: So let's start with the prosecution history. [00:20:57] Speaker 05: During prosecution, the claims at issue were a formulation having four categories of ingredients, A, B, C, and D. [00:21:08] Speaker 05: The examiner identified prior art, a prior art reference, a specific reference, and rejected the claims over a formulation that had A, B, and C inside the tablet and then a coding of element 1D. [00:21:27] Speaker 05: Superness comes back. [00:21:28] Speaker 05: That's not our invention, your honor. [00:21:30] Speaker 05: Our invention is a matrix, a homogeneous matrix comprising A, B, C, and D. [00:21:38] Speaker 05: This concept of homogeneous matrix is a term of art. [00:21:44] Speaker 05: All persons of ordinary skill in the art understand what a matrix tablet is, what a homogeneous matrix tablet is. [00:21:50] Speaker 05: The court made that finding, in her opinion, at appendix 51 and 52. [00:21:54] Speaker 02: I'm not sure that's true. [00:21:56] Speaker 02: I mean, homogeneous matrix is a pretty unclear term unless you tie it to something. [00:22:03] Speaker 02: Now, it may be that [00:22:05] Speaker 02: What you did in the prosecution was to tie it to the examples in the patent, of which one and four talk about the mixing. [00:22:15] Speaker 02: But standing alone, uniform doesn't seem to have a very precise definition in the art. [00:22:26] Speaker 02: It's not necessarily fatal, but it's a problem. [00:22:30] Speaker 05: With all due respect, Your Honor, there was [00:22:32] Speaker 05: ample testimony during trial from multiple experts and fact witnesses that the concept, the system of a homogeneous matrix tablet is well known in the art. [00:22:42] Speaker 02: I would direct the court... Well, sure. [00:22:43] Speaker 02: I mean, there's no question about that. [00:22:45] Speaker 02: The question is, what does it mean? [00:22:47] Speaker 02: How does someone who's accused of infringing look at it and say, I can know with some certainty whether I'm infringing or not infringing. [00:22:57] Speaker 02: And there has to be some standard. [00:22:59] Speaker 02: I mean, you have these [00:23:00] Speaker 02: ramen images or the specs here, and people take different views as to whether image A or image B shows uniformity. [00:23:11] Speaker 02: It doesn't give a lot of guidance if that's the only term that you have. [00:23:17] Speaker 02: Whereas if you look to example four, as you did during the prosecution, [00:23:24] Speaker 02: And as the district court did in finding infringement, you have a standard which is more comprehensive. [00:23:31] Speaker 05: I think example four is important to that analysis. [00:23:34] Speaker 05: But this is why, again, starting, this is why I started with the prosecution history. [00:23:39] Speaker 03: The boundary. [00:23:40] Speaker 03: What's the analysis without example four? [00:23:43] Speaker 03: That's what you keep talking about, this sort of hovering omnipresence. [00:23:47] Speaker 03: Right. [00:23:47] Speaker 03: Everyone knows what it means. [00:23:50] Speaker 03: The presiding judge is saying to you, well, what does it mean? [00:23:53] Speaker 03: He's offered example six. [00:23:56] Speaker 03: Absent example four, what's it mean? [00:24:00] Speaker 03: What do you look to? [00:24:01] Speaker 05: Let me answer that question directly. [00:24:04] Speaker 05: It's a binary analysis. [00:24:05] Speaker 05: You're either homogeneous or you're not homogeneous. [00:24:08] Speaker 05: If you're not homogeneous, you have one of the ingredients, A, B, C, or D, dispersed in a discrete area, like a coding. [00:24:18] Speaker 05: Or you can envision what we call bilayer tablets, where you have A and B on one side, C and D on another. [00:24:23] Speaker 05: Or you could have like an onion, a layer of A, a layer of B, a layer of C. This is what persons of skill in the art understand to be [00:24:31] Speaker 05: on one side of that binary equation. [00:24:33] Speaker 05: You mean that it's not a coding? [00:24:35] Speaker 05: Not a coding, not a layer, not a discrete core, not a discrete section. [00:24:40] Speaker 05: You didn't argue for that construction before the district court, did you? [00:24:44] Speaker 05: No, that's precisely what the district court found during Markman proceedings and, in her opinion, at appendix 51 and appendix 52. [00:24:54] Speaker 05: Quote, the constituents are not localized in one discrete area, but rather are found throughout the tablet surface. [00:25:01] Speaker 05: Appendix 52, this is again the opinion, homogeneity in this context is measured by a lack of localization in a discrete part of the tablet. [00:25:11] Speaker 05: So again, the binary analysis is are you mixed together or are you dispersed in a localized structure? [00:25:19] Speaker 03: What do you mean by mixed together? [00:25:22] Speaker 03: Inside the boundary of the pill, it's all just in there, not that it's in there in any particular way, shape, or form. [00:25:28] Speaker 05: Mixed together is not mixed like we would mix cake batter on a countertop. [00:25:34] Speaker 05: This is industrial processes that for almost a century have been well used now. [00:25:39] Speaker 02: You're saying no matter how little it's mixed within the tablet, as long as it's within the tablet instead of in a layer, it's homogeneous. [00:25:48] Speaker 02: A very good question, Your Honor. [00:25:49] Speaker 01: One side of the tablet versus another side of the tablet. [00:25:52] Speaker 01: You said bilayer, something about A, B, yellow. [00:25:55] Speaker 05: So bilayer is where you have [00:25:58] Speaker 05: For instance, ingredients A and B in one half of the tablet, and ingredients C and D on the other half. [00:26:02] Speaker 03: Discreetly separate. [00:26:03] Speaker 03: Discreet sections of the tablet, yes. [00:26:05] Speaker 03: Perhaps messed up. [00:26:06] Speaker 05: Right. [00:26:06] Speaker 05: But to get back to Judge Dyke's inquiry, which I think is an important one, because I heard during the activist's argument that the patent in suit says nothing about FDA uniformity testing. [00:26:19] Speaker 05: No, no. [00:26:20] Speaker 05: But stick with my last question. [00:26:21] Speaker 02: Right. [00:26:21] Speaker 05: And your question was, can you do [00:26:23] Speaker 02: A minimal amount of mixing. [00:26:25] Speaker 02: Are you saying that it's homogeneous as long as it's not in a separate layer? [00:26:29] Speaker 02: I am saying that as long as there's some mixing in the center of the tablet, it's homogeneous. [00:26:37] Speaker 05: I would agree with that entirely, except for the concept of some mixing. [00:26:40] Speaker 05: The mixing, the degree of mixing, is you have to read this specification and example four through the lens of a person of ordinary skill in the art. [00:26:48] Speaker 05: Now, you, Judge Dye, correctly identified examples one and four, which show [00:26:53] Speaker 05: manufacturing processes that, according to the applicant and the patent office, necessarily result in homogeneous matrices. [00:27:01] Speaker 02: Why? [00:27:01] Speaker 02: So are you agreeing that the mixing process described in example four is the definition of what is required for homogeneity? [00:27:10] Speaker 05: What I am agreeing to is that if you mix A, B, C, and D according to the process in example four, you will necessarily get a homogeneous matrix, but there are other ways to mix that persons of skill in the art know. [00:27:22] Speaker 02: Other? [00:27:23] Speaker 02: Yes, go ahead. [00:27:24] Speaker 02: That's not what you told the examiner. [00:27:26] Speaker 02: You said that, in describing to him what homogeneous means, you said look at the examples. [00:27:34] Speaker 02: Right. [00:27:34] Speaker 02: And the examples are... So why aren't the examples definitional in that respect? [00:27:39] Speaker 05: Because the examples disclose, in 1 and 4, processes called wet granulation. [00:27:44] Speaker 05: It's a standard process for mixing A, B, C, and D. Right? [00:27:49] Speaker 05: Now, every time you [00:27:51] Speaker 05: conduct that properly. [00:27:52] Speaker 02: How does it hurt you if the examples are definitional? [00:27:55] Speaker 02: Why are you fighting this? [00:27:56] Speaker 05: Oh, it doesn't hurt us. [00:27:58] Speaker 05: I'm just trying to make sure that for validity purposes, for validity purposes, that the court understands that you have example four as a perfectly valid way to assess infringement. [00:28:09] Speaker 05: In fact, it's what the district court did, and she was successful. [00:28:12] Speaker 02: Fine, yeah, I understand that. [00:28:13] Speaker 02: But I thought you were disagreeing in saying, [00:28:16] Speaker 02: that that's not definitional in terms of what homogeneous is and that we want to say that anything that's not in the layer in the tablet is homogeneous. [00:28:27] Speaker 05: Well, to the extent example four says mix for three minutes, then add this ingredient and mix for another four minutes at this RPMs, my point only was, and maybe we were talking past each other, my point only was that it's not limited to those precise specifications, but the concept of example four, which is wet granulation, [00:28:45] Speaker 05: which is a mixing, blending, chopping, milling, sieving. [00:28:48] Speaker 05: High shear. [00:28:49] Speaker 05: High shear. [00:28:50] Speaker 05: These are standard mixing processes. [00:28:52] Speaker 05: And all I was saying, Your Honor, was that example four will necessarily mix these ingredients such that they are comprising a homogeneous matrix. [00:29:00] Speaker 03: What would be the written description support for any other form of homogeneous matrix other than what Judge Dyck has been referring to? [00:29:06] Speaker 05: So written description support can be found in examples one and four, which we've already discussed. [00:29:13] Speaker 05: Example four ends with the production of tablets, and these tablets are tested in the lab. [00:29:20] Speaker 05: Those tablets are then taken into example five, where they're administered to canines, and then example seven, where they're administered to humans. [00:29:28] Speaker 05: Now, viewing this disclosure through the lens of a person of ordinary skill in the art who would know that 21 CFR 211 absolutely requires, in every instance of pharmaceutical manufacturing, that a tablet be [00:29:43] Speaker 05: that pass FDA uniformity testing, blend and content uniformity testing, before being administered to a canine or to a human, that is an implicit disclosure of the fact that these tablets were in the possession of supernets. [00:29:57] Speaker 05: They actually made them according to the process. [00:29:59] Speaker 05: That was example four. [00:30:01] Speaker 05: And then they administer them. [00:30:02] Speaker 03: I understand that, but the reason why I asked the question was that you and the presiding judge were having a discussion about whether or not this homogeneous matrix [00:30:12] Speaker 03: is actually defined by examples one and four, which I'm suggesting he thought might be. [00:30:17] Speaker 03: And you were saying, well, yes, you agree with that. [00:30:19] Speaker 03: But no, you could also achieve homogeneous matrix some other way. [00:30:24] Speaker 03: Correct. [00:30:24] Speaker 03: Over here. [00:30:25] Speaker 03: And with the over here part, I was saying, where's the written, where's the WD support for some other way of establishing homogeneous matrix other than one and four? [00:30:35] Speaker 05: There are other disclosures in the patent that explain that. [00:30:40] Speaker 05: the claimed formulations can be made by any one of a number of other processes, like slugging and other types of dry mixing and dry granulation. [00:30:52] Speaker 05: This is a wet granulation. [00:30:54] Speaker 01: Is that expressly provided in the patent, or is that something that you would maintain one of ordinary skill and the art would understand from reading the specification and being familiar with the technology? [00:31:03] Speaker 05: I would direct the court to column seven of the 898 patent at around [00:31:11] Speaker 05: line 43, drug polymers and other excipients are typically... Which column? [00:31:18] Speaker 05: 898... 898 patent column 7, line 43. [00:31:24] Speaker 03: Okay, and other methods of borrowing such as slugging... [00:31:39] Speaker 02: Well, but that's not tied to homogeneity. [00:31:42] Speaker 02: And your problem is, in looking to these other things, is that during the prosecution, the one thing that you identified as support was the examples in the specification. [00:31:54] Speaker 02: I mean, other than the one word, homogeneous, in what used to be paragraph 34 of the application. [00:32:00] Speaker 03: And I don't understand why you want a broader meeting. [00:32:02] Speaker 03: But for purposes of this particular case, if you stand on example one and four, you prevail both ways on improvement and on, but you want to be able to go after somebody's bill later on that's done some way other than one and four. [00:32:14] Speaker 05: No, I think we're all saying the same thing. [00:32:16] Speaker 05: Maybe I'm confusing the issue. [00:32:19] Speaker 05: What I want the panel to understand is that example four is a very specific process with very specific [00:32:27] Speaker 05: steps and ingredients added at certain times. [00:32:29] Speaker 01: And you don't think your claim should be limited to that specific time? [00:32:32] Speaker 05: No. [00:32:32] Speaker 05: And in fact, example one and example four have slight variations. [00:32:37] Speaker 05: So that in and of itself shows you that there are variations that persons of skill and the art would understand. [00:32:42] Speaker 02: I think what you said in the prosecution was not about what the ingredients were in examples one and four, but the mixing methodology. [00:32:51] Speaker 05: That's absolutely correct. [00:32:52] Speaker 05: But to have the claimed formulation, you would have to have A, B, C, and D mixed according to that process. [00:32:58] Speaker 01: Do you think that in the prosecution history, you said that the term homogenous matrix should be understood in light of the methods that are disclosed in the patent? [00:33:08] Speaker 05: Yes. [00:33:09] Speaker 05: It was unequivocal. [00:33:10] Speaker 05: There was an express statement that the homogenous matrix support what we're talking about here [00:33:19] Speaker 05: is necessarily results from examples one and four. [00:33:21] Speaker 01: I understand you're saying that that's the written description support, but are you interpreting the claim that way? [00:33:26] Speaker 01: Is that how you're telling the PTO to understand the meaning of the word homogenous matrix? [00:33:31] Speaker 05: Yes, the PTO was hung up on the concept that maybe having something in the coding could still be part of the matrix. [00:33:40] Speaker 05: So that explanation was added, and the amendment and the corresponding explanation was added so that [00:33:48] Speaker 05: it was understood that everything was mixed together in the core. [00:33:51] Speaker 05: And they pointed to example four to show, look, we've actually made the type of tablet where you mix everything in the core, and that's a way to mix it. [00:33:59] Speaker 05: There's expert testimony that the district court credited that says persons of skill in the art understand this dichotomy between localized dispersion and uniform dispersion. [00:34:12] Speaker 05: And uniform dispersion is made by these techniques that mix the ingredients [00:34:16] Speaker 05: Whereas these localized dispersions result from coating a tablet or making a layered tablet or a bilayer tablet or a core surrounded by some of the other ingredients. [00:34:25] Speaker 05: So that's really the dichotomy here. [00:34:27] Speaker 05: And for this case, to address Judge Clevenger's earlier [00:34:33] Speaker 05: question. [00:34:34] Speaker 05: For this case, clearly the manufacturing process in example four tracks what activist does to produce its accused product, and that was the benchmark of the judge's opinion. [00:34:45] Speaker 05: And then she found confirmatory evidence, layers of confirmatory evidence, all fact findings, all the result of weighing competing expert testimony and fact testimony. [00:34:55] Speaker 05: And she found that this FDA uniformity testing [00:35:00] Speaker 05: while not necessary in and of itself, confirms that the process that activists used mixes A, B, C, and D sufficiently, just like example four mixes A, B, C, and D sufficiently to result in a homogeneous matrix tablet. [00:35:14] Speaker 05: She also relied on chemical imaging. [00:35:16] Speaker 05: She dealt with chemical imaging in 15 plus pages. [00:35:19] Speaker 05: But she only found that it was confirming. [00:35:21] Speaker 05: Correct, but the idea that she just brushed it aside is incorrect. [00:35:24] Speaker 05: 15 pages of her opinion are dedicated to analyzing the competing expert's interpretation of the chemical imaging. [00:35:30] Speaker 02: But who shares if the definition is example four? [00:35:35] Speaker 05: If the definition is example four, you stop at the manufacturing process. [00:35:39] Speaker 05: Judge Bum was diligent in that she layered her infringement decision with three distinct layers of evidence and weighed each party's evidence [00:35:49] Speaker 05: in those three distinct layers to show that not only is the manufacturing process that tracks example 4 can end the discussion, but the second uniformity testing and chemical imaging supports her decision. [00:36:06] Speaker 03: Okay? [00:36:07] Speaker 03: Icing on the cake. [00:36:09] Speaker 05: Precisely, Your Honor. [00:36:12] Speaker 02: Okay. [00:36:13] Speaker 05: Unless Your Honors have any other questions, I rely on my briefing for the other issues. [00:36:16] Speaker 02: Okay, thank you, Mr. Love. [00:36:18] Speaker 02: Mr. Weiss, you have two minutes. [00:36:21] Speaker 04: Thank you, your honor. [00:36:38] Speaker 00: Mr. Giovi said something right at the end in response, I think it was to your question, Judge Dyke, to the effect that if example four is definitional, you don't even get to the images. [00:36:49] Speaker 00: And that, to me, is an absolutely remarkable proposition in a composition of matter claim and not a method of making claim. [00:36:57] Speaker 00: So let's consider what would have to be the case if example four was definitional. [00:37:02] Speaker 00: We would have a claim that says the same degree of uniformity as example four, because it's a composition of matter claim, not a method of manufacture claim. [00:37:13] Speaker 00: So we would have that. [00:37:14] Speaker 00: And then the way you would have to prove infringement of that [00:37:18] Speaker 00: is not saying you use the same manufacturing process, because this isn't a process claim. [00:37:25] Speaker 00: It would be, here I ran example four, this is the result in terms of uniformity, and this is the result of your process, your product, because you have to compare product to product. [00:37:42] Speaker 00: And saying in that circumstance that we can disregard the images, [00:37:46] Speaker 00: is a really striking proposition for... Is it too late for you to make that argument? [00:37:52] Speaker 03: No, it's not. [00:37:54] Speaker 03: I'm hearing that argument for the first time. [00:37:56] Speaker 03: And it's in response to what your adversaries have been arguing. [00:37:59] Speaker 03: It just seemed to me like they're blindsided here a little bit. [00:38:03] Speaker 00: This theme is... I don't mean to be... This is all over in our briefs, Your Honor. [00:38:09] Speaker 00: Yeah. [00:38:10] Speaker 01: Did anyone argue that the claims were limited to example four below? [00:38:14] Speaker 00: No. [00:38:16] Speaker 00: OK. [00:38:16] Speaker 00: And we have also, I think that would be also a paradigm of indefiniteness. [00:38:23] Speaker 00: I have a claim to composition of matter. [00:38:27] Speaker 00: It's a structural limitation. [00:38:29] Speaker 00: Even if you say the degree that's required is the degree that's achieved in example four. [00:38:37] Speaker 00: it's still a structural limitation. [00:38:39] Speaker 00: So I have a structural limitation where infringement can be proven by a manufacturing process and cannot be disproven by the actual structure of the product. [00:38:48] Speaker 00: That, to me, is a remarkable proposition. [00:38:52] Speaker 00: But I want to also point to something in the record that bears on this. [00:38:59] Speaker 00: Table four, actually it's table five, are the only examples we have [00:39:06] Speaker 00: of embodiments that are within the scope of the claims in terms of having all four elements. [00:39:11] Speaker 00: Put aside uniformity. [00:39:13] Speaker 00: Ingredients. [00:39:13] Speaker 00: I'm sorry, Your Honor. [00:39:14] Speaker 00: Right ingredients. [00:39:15] Speaker 00: Correct. [00:39:16] Speaker 00: And they all have 5% SLS. [00:39:20] Speaker 00: In fact, the only formulations that are ever referred to as within the scope of the claims have 5% SLS. [00:39:29] Speaker 00: And there was unrebutted testimony from Dr. Muzio. [00:39:32] Speaker 00: This is in the record and appendix [00:39:35] Speaker 00: 1, 2, 8, 4, 3, lines 14 to 23, where he talks about why the activist manufacturing process doesn't lead to a homogeneous matrix. [00:39:48] Speaker 00: And he says, quote, Supertis is conducting its granulation using a large amount of sodium lauryl sulfate, SLS. [00:39:55] Speaker 00: SLS is universally used by formulators everywhere to [00:39:58] Speaker 00: promote uniform homogeneous graduation. [00:40:01] Speaker 00: And you don't have the SLS? [00:40:03] Speaker 00: Correct, Your Honor. [00:40:04] Speaker 02: So even if we look... Mr. Weiss, I think we're about out of time. [00:40:07] Speaker 02: We're way too long down. [00:40:08] Speaker 02: Thank you for indulging us. [00:40:09] Speaker 02: Thank you. [00:40:10] Speaker 02: Thank both counsels. [00:40:11] Speaker 02: The case is submitted.