[00:00:02] Speaker 05: The first case for argument this morning is 18-1335, Cosmo Technology versus Activists. [00:00:10] Speaker 05: Mr. Kanai. [00:00:12] Speaker 05: Seeing you for the second time this week, I recall. [00:00:27] Speaker 01: May it please the court. [00:00:29] Speaker 01: The district court construed the term [00:00:31] Speaker 01: macroscopically homogeneous composition, to mean a composition of a uniform structure throughout as observed by the naked eye. [00:00:41] Speaker 01: Because it observed varying yellow flecks in the actavis pill and bumps and holes in the alveogen pill that were, quote, not evenly distributed, it found no homogeneity. [00:00:54] Speaker 01: The district court's conception of uniformity effectively an ordered arrangement of ingredients [00:01:00] Speaker 01: is inconsistent with first, the patent and prosecution history, second, testimony of skilled artisans on uniformity, and third, testimony that it was literally impossible to achieve. [00:01:15] Speaker 05: So your complaint is that he relied on his naked eye issue. [00:01:22] Speaker 05: at all or just he shouldn't have relied solely on this because some of his looking at it was clearly invited by statements. [00:01:30] Speaker 01: Absolutely. [00:01:31] Speaker 05: So what's your bottom line? [00:01:33] Speaker 01: I think the fundamental difference is that the visual appearance is relevant evidence, but he made it that the definitive standard in Appendix 26, what he said, even if you prove uniform dispersion, you still have to prove with the naked eye. [00:01:50] Speaker 01: We think that's incorrect. [00:01:51] Speaker 01: But I'd really like to focus initially on the uniformity structure. [00:01:57] Speaker 04: Can you just clarify for me, what do you think that the proper meaning is of this claim phrase? [00:02:06] Speaker 01: Well, what it means is at a scale observed by the naked eye. [00:02:11] Speaker 04: I'm sorry, what is supposed to be true at that scale? [00:02:16] Speaker 04: At a scale doesn't yet tell you [00:02:18] Speaker 04: what you're looking for. [00:02:19] Speaker 01: Well, it just distinguishes the type of analysis. [00:02:21] Speaker 01: It's microscopic versus macroscopic. [00:02:23] Speaker 01: And at the claim hearing, there was really no distinction. [00:02:26] Speaker 01: So you're not doing microscopy. [00:02:28] Speaker 04: Right. [00:02:29] Speaker 04: But what you just said doesn't say anything about the meaning of the word. [00:02:32] Speaker 04: Is it homogenous or homogeneous? [00:02:34] Speaker 04: I don't know. [00:02:34] Speaker 01: Right. [00:02:35] Speaker 01: Homogeneous is uniform structure throughout. [00:02:37] Speaker 01: I'd like to turn to that at pages. [00:02:39] Speaker 04: Uniform structure. [00:02:40] Speaker 04: Your view is it means uniform structure at a certain scale that the eye can see. [00:02:46] Speaker 01: Yes. [00:02:46] Speaker 01: That's right. [00:02:47] Speaker 01: So at pages seven to eight, which is, I think, a very good place to start on uniformity, the patent at column two, line 29, distinguishes prior art reservoir structures from the invention because, quote, they were, quote, not macroscopically homogeneous along all the symmetry axis of the final form. [00:03:14] Speaker 01: And in prosecution, [00:03:15] Speaker 01: And this is illustrated in the graphics at page eight of the blue brief. [00:03:20] Speaker 01: The patentee distinguished the uniform structure of the invention from a specific prior art reservoir structure. [00:03:30] Speaker 01: It did not distinguish prior art pills with visible specks and bumps. [00:03:35] Speaker 01: And indeed, in prosecuting the parent application at appendix 2146, the patentee said, [00:03:45] Speaker 01: If the components are, quote, dispersed, the resulting in a matrix structure, the resulting structure is, quote, uniform and homogeneous. [00:03:56] Speaker 01: So homogeneity requires no specific degree of dispersion. [00:04:03] Speaker 01: And the specification teaches what the patent understood by homogeneity. [00:04:12] Speaker 01: The examples in eight places discuss homogeneous mixtures. [00:04:18] Speaker 01: And I want to take the court to Appendix 100 and Example 1, because it includes the yellow excipient soy lecithin. [00:04:28] Speaker 01: And Example 1 states that the lecithin mixture is brought to homogenization. [00:04:37] Speaker 01: Then you heat the resulting granules until, quote, [00:04:41] Speaker 01: homogeneous dispersion, and then further mixing, quote, homogeneously dispersing the powders. [00:04:50] Speaker 01: So a person of skill in the art would not understand example one to require him to line up evenly all the multiple excipients and make sure there are no randomly appearing dots throughout the mixture in the blender. [00:05:05] Speaker 01: And then the patent further teaches for the tablet that compression [00:05:11] Speaker 01: And this is Appendix 100, Column 5, Line 5. [00:05:15] Speaker 01: Compression of a homogeneous mixture into a tablet, quote, yields a macroscopically homogeneous structure in all its volume, namely a matrix containing a dispersion of the lipophilic granules in the hydrophilic matrix. [00:05:33] Speaker 00: So this argument goes to the bland uniformity and the content uniformity test, correct? [00:05:38] Speaker 01: No, that's just evidence. [00:05:39] Speaker 01: This is just about the meaning, the standard of what uniformity means. [00:05:43] Speaker 00: So it means that... But there are tests that describe that. [00:05:49] Speaker 00: And one is blending and one is content uniformity. [00:05:52] Speaker 00: Exactly. [00:05:52] Speaker 00: That's right. [00:05:53] Speaker 00: And the court found that that was not enough. [00:05:55] Speaker 00: And you invited the court to basically eyeball the appeal and to determine whether it was uniform or not. [00:06:04] Speaker 01: Right. [00:06:04] Speaker 01: And that's one form of relevant evidence. [00:06:06] Speaker 01: But my point here [00:06:07] Speaker 01: is that homogeneity is satisfied by a dispersion, not perfect or even dispersion. [00:06:14] Speaker 01: And the skilled artisans so testified. [00:06:17] Speaker 01: Dr. Davis testified to this understanding at Appendix 265, line 14, saying, quote, if the material were all mixed well together, then it would be homogeneous when you look at it with the naked eye. [00:06:32] Speaker 01: And Dr. Katruvada, [00:06:34] Speaker 01: who is Octavius' product formulator and a skilled artisan, had a similar sense of uniformity. [00:06:41] Speaker 01: He testified in observing the broken tablets with his naked eye that, and this is appendix 279, line 22, that quote, I didn't see any pockets of excipients, and quote, it appeared to be uniform in color. [00:06:56] Speaker 01: And then on the next page, line 14, he testified that he did not observe [00:07:02] Speaker 01: Any non-uniform distribution in the broken tablet, quote, it all looked the same to me. [00:07:08] Speaker 01: And so skilled artisans like. [00:07:12] Speaker 04: But doesn't that, to the extent that you're talking about claim construction, doesn't the material that you were just quoting rather support what Chief Judge Stark did? [00:07:22] Speaker 04: That is, it's translating into evenness [00:07:29] Speaker 04: the appearance when looked at. [00:07:32] Speaker 01: No, but Dr. Katrigata looked at the pills and he said, not uniform. [00:07:37] Speaker 01: And he's a skilled artisan. [00:07:39] Speaker 01: Dr. Davis looked at the magnified photos. [00:07:41] Speaker 01: He said, I don't see a non-homogeneous distribution of yellow specks or beads and excipients. [00:07:52] Speaker 01: And this is consistent with the court's interpretation of uniformity in superness. [00:07:58] Speaker 01: If the patent doesn't [00:07:59] Speaker 01: specify a degree of uniformity and doesn't hear, then uniformity inherently means not localization. [00:08:06] Speaker 01: There just needs to be some degree of uniformity. [00:08:09] Speaker 01: And then where the district court went astray was that it relied on the testimony of Dr. Joshi, Alvagen's product developer, who was evidently at pains to distinguish its product from the claims. [00:08:22] Speaker 01: And he testified at appendix 292, line 22, [00:08:27] Speaker 01: that it is, quote, physically impossible to achieve a uniform mixture in a multi-particulate system. [00:08:35] Speaker 01: And the district court embraced this absolutist concept of uniformity, which is not the concept of the patent for the skilled artisans, at appendix 27, last paragraph, when it found, citing Dr. Joshi, that even though Alvagen, quote, achieves or targets achieving the best [00:08:56] Speaker 01: possible mixture of the beads with the powder and preventing segregation, it does not target a uniform composition. [00:09:07] Speaker 01: So this conception of an impossible uniformity that excludes the best possible mixtures that are tabulated without segregation is not the [00:09:20] Speaker 01: uniformity of the patent. [00:09:22] Speaker 01: The patent doesn't claim. [00:09:23] Speaker 04: Was the testimony that you were just describing, this is what Derek, one of the defendant's experts. [00:09:28] Speaker 01: One of his primary, the product form. [00:09:30] Speaker 01: Right. [00:09:31] Speaker 04: Was that testimony about impossibility at a sub human eye visible level? [00:09:40] Speaker 01: No. [00:09:40] Speaker 01: He just said that it's, he said that you can't, he even said you can't mix these macroscopic [00:09:50] Speaker 01: particles with the excipients because of their different sizes and so he was saying that's a standard characteristic of a multi-particulate system and the patent clearly covers multiple size particles. [00:10:05] Speaker 01: You see in column four to five how many particles they have and indeed this conception excludes the only bodesynite embodiment in the patent which is example two and that's on appendix 100. [00:10:20] Speaker 01: And example two says that you mix podestinide with other excipients to a homogeneous dispersion, and then you combine it to form granules of up to one millimeter in size. [00:10:35] Speaker 01: And then you mix those granules with more excipients to a homogeneous dispersion, and mix it again with more excipients and tablet it. [00:10:44] Speaker 01: If you were to bisect an example two pill, [00:10:49] Speaker 01: granules, which are more than twice the size of alvagen's beads, would appear visibly distinct and randomly distributed. [00:11:00] Speaker 01: Because as Dr. Joshi said, it's impossible to get ordered arrangement in a mixture. [00:11:04] Speaker 01: And so this conception of uniformity at page 43 of defendant's brief, where they say if you have visible particles against surrounding excipients, [00:11:18] Speaker 01: cannot be maintained as the standard of the patent. [00:11:22] Speaker 01: And again, their products have to be homogeneous because the product works by the excipients controlling the steady release of the active ingredient as the product travels through the colon. [00:11:38] Speaker 01: So you have to be dispersed to do that. [00:11:41] Speaker 01: And to deny macroscopic homogeneity is to deny the function of their products. [00:11:45] Speaker 01: I'd also like the last point on uniformity. [00:11:47] Speaker 01: The district court could not properly devalue Dr. Davis' testimony from the photographs. [00:11:55] Speaker 01: If you look at the color photographs at appendix 1579 to 1581, and particularly 1581 is Octavius, you can see the visible yellow specks. [00:12:07] Speaker 01: 1579 to 1580, you can see the bumps and holes. [00:12:12] Speaker 01: And so everything is visible there that the district court describes. [00:12:16] Speaker 01: So the district court couldn't just throw out this testimony based on theoretical deviation between a pill and a photograph. [00:12:23] Speaker 01: He had to find that what was apparent in the photographs that Dr. Davis saw did not reflect the essential structures that he saw in the actual pill. [00:12:32] Speaker 01: Otherwise, he can't just throw out the testimony of a skilled artist who said, I don't see non-homogeneous yellow specks and bumps. [00:12:42] Speaker 01: And furthermore, Dr. Katragada, we're only on Rule 52C after a plaintiff's case. [00:12:47] Speaker 01: There's no other evidence from the other side. [00:12:49] Speaker 01: Dr. Katragada's testimony is enough, but certainly with Dr. Davis' testimony. [00:12:55] Speaker 00: Look at Appendix 25 and footnote 7. [00:13:00] Speaker 00: And I like your explanation of that exchange between plaintiff's counsel and the court. [00:13:08] Speaker 01: Yes. [00:13:09] Speaker 01: So again, we've always said that it's relevant evidence. [00:13:12] Speaker 01: And it is relevant evidence in the limited circumstance. [00:13:15] Speaker 00: Why is it this dispositive? [00:13:16] Speaker 00: Doesn't this describe what a person skilled in the art would observe with the naked eye, and you invited the court to take a look at it, and that a lay person could also be able to discern the... What we said is, he said, if you saw a non-uniform distribution, but a non-uniform distribution, [00:13:37] Speaker 01: as i just pointed out is one where there's localization or segregation. [00:13:41] Speaker 01: If you see a big pocket of recipients like Dr. Katragada did not see, then he's saying, yes, you could infer that throughout the whole volume. [00:13:51] Speaker 01: And this is also why the naked eye test is not the proper test. [00:13:56] Speaker 00: You're not answering my question. [00:13:59] Speaker 00: Look at that footnote and explain that to me, because you invited the court and you made certain statements there. [00:14:05] Speaker 01: Yes, exactly. [00:14:07] Speaker 01: And I'll pull it up exactly. [00:14:09] Speaker 00: Those statements seem to be somewhat dispositive to me. [00:14:12] Speaker 00: The concern I have with your case is, I guess it's that old saying, whether you've been raised by your own petard. [00:14:20] Speaker 01: I don't think we have, Your Honor. [00:14:21] Speaker 01: But just on this, if you look at what he says, if the yellow, and it's, I'll just say, excipient, is indeed not distributed uniformly. [00:14:31] Speaker 01: So he said, that's a conditional, right? [00:14:34] Speaker 01: which I don't think is the case here, then it would be an excipient that's not uniformly distributed and therefore we'd have a non-macroscopically homogeneous composition. [00:14:45] Speaker 01: So if you were to look at a pill and you'd see a reservoir structure, layered structure, or a clearly segregated pocket of excipients, which is a defacto structure, then you don't have uniformity. [00:14:58] Speaker 01: That's all he's saying. [00:14:59] Speaker 01: He's not saying that [00:15:01] Speaker 01: any yellow flecks, any minute variation, because that's against the testimony, and it's against the patent, and it's practically impossible. [00:15:09] Speaker 01: But the other problem with the naked eye test, which is why it has to be a scale limitation, because that's of course what macroscopically means, the plane, is that a naked eye test cannot reliably determine homogeneity. [00:15:24] Speaker 01: It is only in the happenstance where you happen to have visible shapes or visible colors [00:15:31] Speaker 01: that it can possibly find non-homogeneity if, I see I'm actually out of time. [00:15:39] Speaker 01: You're completely done. [00:15:40] Speaker 05: We'll restore some time for that. [00:15:42] Speaker 05: All right, thank you. [00:15:46] Speaker 05: All right, split time. [00:15:48] Speaker 05: Mr. Jay, are you arguing different things? [00:15:52] Speaker 05: We are, Your Honor. [00:15:53] Speaker 02: Good morning. [00:15:54] Speaker 02: I represent activists. [00:15:55] Speaker 02: I'll be addressing the common issues and any issues relating to activists' products, specifically. [00:16:01] Speaker 02: And then I'll be followed by Mr. Morata, who represents Albigen. [00:16:03] Speaker 02: He'll address the Albigen product if there are questions specific to that. [00:16:07] Speaker 02: Of course, we'll answer whatever questions the court wants to put. [00:16:12] Speaker 02: So good morning. [00:16:13] Speaker 02: I'd like to begin with the district court's factual findings, because I think especially in light of the position that counsel took this morning, that this really is a case about the findings made by the district court and not a question about how to construe the claims. [00:16:29] Speaker 02: The district court found, as a matter of fact, reviewing all the evidence submitted in the top half of the case, that the activists and algin products do not infringe because they do not contain a uniform distribution [00:16:42] Speaker 02: of all the ingredients. [00:16:43] Speaker 02: They are not a uniform composition. [00:16:47] Speaker 02: And that's the construction that plaintiffs urged. [00:16:49] Speaker 02: That's the construction that the district court applied throughout the case. [00:16:54] Speaker 02: So I'd like, if I can, to begin. [00:16:56] Speaker 04: Can I ask you something that confused me a little bit? [00:16:58] Speaker 04: When the district court was making those findings and using the notion of uniformity, I guess I was thinking that might mean either of two different things. [00:17:11] Speaker 04: looks like single color, like single color paint. [00:17:15] Speaker 04: It might also mean you can see flecks, but the flecks are really quite evenly distributed across the surface that you're looking at. [00:17:25] Speaker 04: So like, you know, flecked paint, but any given narrow field of the [00:17:33] Speaker 04: of the surface looks pretty much like any other. [00:17:35] Speaker 04: Which of those two was the district court using? [00:17:38] Speaker 02: At page 25, the district court found, this is I think accompanying the footnote call for footnote seven, that there was a non-uniform distribution of the disuniformities. [00:17:48] Speaker 02: So even if you thought that evenly distributed flex would still be a uniform composition, the district court specifically found that in both products there was a non-uniform distribution of the disuniformities. [00:18:02] Speaker 02: yellow dots in the activist product and the bumps and holes in the Alvagen product. [00:18:07] Speaker 02: So that, I think, really is central to our submission that this is a clear error case about what the district court found rather than a dispute about what the meaning of uniformity is. [00:18:17] Speaker 02: Because even if you thought the meaning of uniformity encompassed a uniform distribution, a loaf of raisin bread in which the raisins are all perfectly spaced apart from one another, [00:18:30] Speaker 02: That's not what the district court found here. [00:18:33] Speaker 02: We wouldn't agree with that construction either. [00:18:35] Speaker 02: But the court doesn't even need to reach that to affirm the findings made by the district court. [00:18:39] Speaker 04: And I trust you think that Mr. Kinnaird's arguments are really directed to the stronger view of uniformity, that it has to be a single color in which you don't anywhere on the surface you're looking at. [00:18:53] Speaker 04: see variations. [00:18:54] Speaker 02: I do take Mr. Canary to be saying that there can be visible variations as long as there is, I think what he described as a uniform distribution or the other phrase that I heard him use was some degree of uniformity. [00:19:05] Speaker 02: But that's not how we read either the construction or the patent. [00:19:09] Speaker 02: That uniformity throughout is the [00:19:12] Speaker 02: or a uniform structure throughout is the construction that the district court applied. [00:19:17] Speaker 02: But in any event, I think that's really a theoretical debate in a case where the district court has made a finding that not only are there disuniformities, but the disuniformities are distributed unevenly. [00:19:28] Speaker 02: And that would be enough under, I think, even under some degree of uniformity construction. [00:19:34] Speaker 02: We also don't think that some degree of uniformity is an accurate representation of what it means to have a uniform structure throughout. [00:19:39] Speaker 02: I suppose if you zoom far enough out, everything is uniform to some degree. [00:19:44] Speaker 02: Here, I think we and the plaintiffs agree to this extent that the scale at which these uniformities are to be assessed isn't the macroscopic scale. [00:19:57] Speaker 02: A scale, visible with the naked eye, or at least something large enough to be seen with the naked eye. [00:20:02] Speaker 02: Mr. Keneard is right that, [00:20:04] Speaker 02: You can't establish homogeneity just by visual inspection of a single cross section, but you certainly can establish non-homogeneity. [00:20:13] Speaker 02: You can establish heterogeneity if you split open the tablets and you see disuniformity is large enough to be seen with the naked eye. [00:20:22] Speaker 04: And the counterpart point to that is that if you see non-homogeneity along a plane, [00:20:31] Speaker 04: then by definition, there is non-homogeneity in the three-dimensional homes that view also. [00:20:37] Speaker 02: That's exactly right. [00:20:38] Speaker 02: You could take a cross-section of a loaf of raisin bread and not see any raisins along the plain that you've chosen to bisect. [00:20:45] Speaker 02: But if you do see some raisins unevenly distributed, it follows that the raisins are unevenly distributed in the loaf of raisin bread. [00:20:51] Speaker 02: And I think that this basic point is stated in page 14 of the reply brief. [00:20:58] Speaker 02: in which the other side agrees that if you bisected a tablet and saw a reservoir in it, that that would be persuasive evidence that the tablet does not infringe, because they agree that something with a reservoir in it is not of a uniform structure throughout. [00:21:13] Speaker 02: It is not macroscopic. [00:21:14] Speaker 02: Now, they certainly added the limitation to get around some prior art that had to do with reservoirs, but they didn't add a limitation that said add not a reservoir. [00:21:23] Speaker 02: They added a limitation that said macroscopically homogeneous composition, and they proposed construing that as uniform structure throughout. [00:21:30] Speaker 02: That's certainly more definite than not a reservoir, but it's also more rigorous. [00:21:36] Speaker 02: So they sacrificed claim scope for definiteness. [00:21:40] Speaker 02: They wrote a specific limitation. [00:21:42] Speaker 02: And that's the reason that the tablets, in this case, don't infringe. [00:21:46] Speaker 04: And what do you say about Mr. Kinnair's point about example two showing, I forget whether it was one millimeter or two millimeter, structures which would certainly be visible to the naked eye, assuming a certain level of vision? [00:22:01] Speaker 02: It says size below one millimeter. [00:22:03] Speaker 02: That's right. [00:22:04] Speaker 02: Below. [00:22:05] Speaker 02: Yes, that's what it says. [00:22:05] Speaker 02: So it can be up to. [00:22:06] Speaker 02: Exactly. [00:22:07] Speaker 02: And that, of course, is the starting point of that process. [00:22:10] Speaker 02: So nothing in the example says that the finished product is homogeneous at any scale. [00:22:17] Speaker 02: The portions that Mr. Kinnair is talking about are early in the combination process. [00:22:22] Speaker 04: And do we not know enough about the process to know that the one millimeter [00:22:28] Speaker 02: Particles remain one millimeter or might be Diced up later The patent doesn't say that there's nothing in the record about that About that that the particles remain one millimeter as they go through this process and of course the final step is compression and You certainly can't infer that the particles remain exact at exactly the same size after compression and the colleague mr. Cunard statement that [00:22:55] Speaker 02: that the granules survive compression, none of that is in the patent. [00:23:01] Speaker 02: But in any event, example two is not the formulation that the defendants are using here. [00:23:07] Speaker 02: So even if a formulation that looks like example two results in a macroscopically homogeneous composition, which, again, the patent doesn't say, that doesn't mean that every formulation involving eudesinide is going to result in that. [00:23:21] Speaker 02: And I think that the clearest illustration of that is that one of the [00:23:25] Speaker 02: excipients in example two is stearic acid. [00:23:28] Speaker 02: And one of the other patents asserted against activists at trial had a stearic acid limitation. [00:23:34] Speaker 02: And the district court granted judgment on partial findings at mid-trial, which the plaintiffs have not appealed because activist doesn't have stearic acid in its formulation. [00:23:42] Speaker 02: So it's certainly possible to make a generic [00:23:48] Speaker 02: version of Euseris without using all of the same excipients and certainly without it necessarily being the same formulation that is described in example two. [00:23:58] Speaker 02: So I'd like to turn, if I can, to the pictures because I think that's a substantial portion of Mr. Kinnaird's submission. [00:24:04] Speaker 04: These are the 1579 and 80 ones that Mr. Kinnaird was discussing. [00:24:09] Speaker 02: Correct. [00:24:09] Speaker 02: There are three photos, two of the alvagen product, one of the activist product. [00:24:13] Speaker 02: And I really would just like to make a couple of key points about that. [00:24:17] Speaker 02: One, Dr. Davis admitted at page 257 that he could not verify that the photos depicted what you would see with the naked eye. [00:24:25] Speaker 02: And the district court, I think, started from that, that even if you thought that the photos don't depict any disuniformity, that that doesn't tell you that when you open a tablet and look at it, that there will be no disuniformity visible with the naked eye. [00:24:43] Speaker 02: The district court, of course, looked at actual tablets. [00:24:46] Speaker 02: And now the photographs themselves depict the tablets that the defense experts examined, discussed in their reports, and were prepared to testify about in the bottom half of the case. [00:24:56] Speaker 02: And they would have submitted the actual tablets themselves. [00:25:00] Speaker 02: So these certainly are photographs showing the tablets or tablets like the ones that the defense experts looked at. [00:25:08] Speaker 02: But it does not follow that even if Dr. Davis looked at them and said, [00:25:12] Speaker 02: I don't see any disuniformity that that's enough to establish that the product doesn't need to be infringed. [00:25:18] Speaker 02: And I think if you look at the second alvagen photograph at page 1580, you can see the district court's point about why the best evidence is a tablet and not a photograph of a tablet. [00:25:27] Speaker 02: Because you can see the washed out white areas and the shadows that result from the uneven lighting in that photo. [00:25:33] Speaker 02: That's exactly what the district court said, that factors like lighting [00:25:36] Speaker 02: are reasons why he doesn't think that the photographs are the best evidence. [00:25:39] Speaker 04: He could also refer to factors like scale. [00:25:42] Speaker 04: But the scale here is maybe double real-life size, and not very different. [00:25:49] Speaker 04: These pills are like one inch? [00:25:52] Speaker 02: That's a centimeter. [00:25:54] Speaker 02: That's a centimeter? [00:25:55] Speaker 02: So it's 0.9 centimeters. [00:25:56] Speaker 02: And the activist one, the one with the ruler in it. [00:25:58] Speaker 02: OK, so that's blown up maybe four times. [00:26:00] Speaker 02: The activist one's blown up four times. [00:26:02] Speaker 02: I'm not sure what the scale is on the other one. [00:26:06] Speaker 00: When the content uniformity and the blending uniformity tests that manufacturers use, doesn't that result in the microscopic homogeneous composition? [00:26:18] Speaker 02: It does not, Your Honor, because it doesn't test for that. [00:26:23] Speaker 02: And there's no reason to think. [00:26:24] Speaker 00: It doesn't test for it, but doesn't it result in that? [00:26:26] Speaker 02: No, there's no reason to think that it results in macroscopic homogeneity, because the FDA wants each pill [00:26:36] Speaker 02: to contain the same amount of active ingredient within a certain range of tolerance. [00:26:42] Speaker 02: Now, even that certain range of tolerance might well be enough to defeat macroscopic homogeneity. [00:26:47] Speaker 02: But again, the tests prescribed by the FDA are for testing this pill against that pill, or this portion of the blend against that portion of the blend. [00:26:58] Speaker 02: Those are dissolved in solution, and then the amount of active ingredient is measured. [00:27:03] Speaker 02: It doesn't tell you anything at all [00:27:05] Speaker 02: about how the excipients or the active are distributed within a particular tablet. [00:27:11] Speaker 02: So for example, we all know that a tablet with a reservoir in it would not infringe. [00:27:16] Speaker 02: That's conceded. [00:27:17] Speaker 02: The other side says that was the purpose of adding this limitation. [00:27:22] Speaker 02: But a tablet with a reservoir in it would come out exactly the same way from blend and content uniformity testing, because it would have the same amount of active ingredient in it. [00:27:31] Speaker 02: It just would have it arranged in a different way. [00:27:33] Speaker 02: So that doesn't tell you anything about the arrangement within a particular tablet, but the other side has chosen to claim the arrangement within the particular tablet core as the key limitation in this case. [00:27:42] Speaker 02: So we think that's the main reason why the district court did not clearly error in explaining the limitations of blend and content uniformity testing. [00:27:49] Speaker 02: And the other side, I think, has attempted to use documents from the alvegen and activists [00:27:58] Speaker 02: And as the district court said, it's really only one reference to homogeneity that's talking about the active ingredient and it's talking about the blend. [00:28:06] Speaker 02: So this is the portion from page four of activists and the executive summary, which is also what Dr. Davis relied on in saying, [00:28:15] Speaker 02: I can tell that because of blended content uniformity, there's actually uniformity of excipients. [00:28:19] Speaker 02: He's relying on a sentence that, if you look at it, is clearly talking only about the active ingredient, because the executive summary hasn't said one word about excipients until after that sentence is already. [00:28:28] Speaker 00: So look at footnote seven. [00:28:30] Speaker 00: Yes. [00:28:33] Speaker 00: Appendix 25. [00:28:34] Speaker 00: Is it your view that that exchange is dispositive in this case? [00:28:42] Speaker 02: I take Mr. Keneard at his word that he doesn't think that the council conceded that the yellow dots that the district court could see were lecithin. [00:28:53] Speaker 02: We don't think that any other conclusion is possible, but I'm not saying that council... Is there a concession there of infringement? [00:29:01] Speaker 02: I think that the concession is that if the lecithin is distributed in an uneven way throughout the tablet at a scale that is visible to the naked eye, [00:29:11] Speaker 02: that that would not infringe. [00:29:12] Speaker 02: And I think that the district court proceeded to find that he could see the yellow dots, that the yellow dots corresponded to lecithin in the activist product, and that therefore the activist product did not infringe. [00:29:23] Speaker 00: Why do you think that's not dispositive here? [00:29:26] Speaker 02: We think it's dispositive. [00:29:28] Speaker 02: We think that the concession about the construction, that an uneven distribution of lecithin would be enough to defeat infringement, combined with the finding the district court made, [00:29:40] Speaker 02: that is dispositive. [00:29:42] Speaker 02: And I do think that even though the other side did not say, and we can see that those yellow dots are less than, we also don't think that there's any other conclusion that the district court could reach here. [00:29:53] Speaker 02: And again, and I just want to, I see that I'm over my time, but just one sentence to sum up, which is that [00:30:00] Speaker 02: In order for them to reverse partial findings by the district court based on all of this record, they have to convince this court that the only finding the district court could have made on the record so far was a finding of infringement and not non-infringement. [00:30:14] Speaker 02: In other words, if the non-infringement finding was clearly erroneous based on all of the evidence, and in this case, somewhat unusually for mid-trial, some of the evidence submitted by the plaintiffs in the top half of the case wound up defeating the plaintiffs' theory. [00:30:29] Speaker 02: Thank you. [00:30:48] Speaker 03: May it please the court? [00:30:55] Speaker 03: Jason Morata for Alvagen. [00:30:58] Speaker 03: Under either a scale limitation or an actual visual observation standard, there is no competent evidence that Alvagen's product is of a uniform structure throughout. [00:31:09] Speaker 03: Judge Stark properly found that Alvagen does not even have a goal of having a uniform composition, because it has two separate structures in it. [00:31:17] Speaker 03: It has beads that are large and a separate powder structure. [00:31:23] Speaker 03: Now, Dr. Davis and even counsel here today admitted that these beads are observable and can be seen with the naked eye in the product. [00:31:32] Speaker 03: Now, the claim construction calls for a uniform structure throughout, and we believe that means that it's the same structure throughout. [00:31:38] Speaker 03: So, in AlphaGen's product where you can see tablets at a macroscopic scale in one part and powder structure through a separate [00:31:46] Speaker 03: macroscopic observable part. [00:31:48] Speaker 03: That's just not uniform. [00:31:49] Speaker 03: It's not the same. [00:31:50] Speaker 04: Can I ask you, did the district court make for your product the same finding made on page 25, appendix 25, at the sentence with footnote seven call that the court made about Mr. Jay's? [00:32:12] Speaker 03: He did not, Judge Stark did not expressly say that the holes and the bumps that he saw were the beads. [00:32:21] Speaker 03: But nevertheless, when counsel for plaintiffs was asked about that, counsel stated that he could conclude that those are the beads that are uniformly distributed according to that. [00:32:34] Speaker 04: Let me just see if I can make what's in my head a little bit clearer. [00:32:38] Speaker 04: So I asked Mr. Jay whether uniformity, the uniformity, or lack of uniformity, I'm sorry, that was found by the district court was you can't see any different colors anywhere. [00:32:52] Speaker 04: Or whether it was merely that even though you might see some different colors, those specs were really quite evenly distributed. [00:33:01] Speaker 04: And as to activists, the sentence with the footnote seven call appears, in fact, to say that the judge found that as well. [00:33:08] Speaker 04: so that any visible flecks were themselves not evenly distributed. [00:33:15] Speaker 04: Did the judge make the same finding for your product? [00:33:19] Speaker 03: Yes. [00:33:19] Speaker 03: The judge found that the holes and bumps were not evenly distributed throughout the bisected tablets, and that's at APPX 25. [00:33:28] Speaker 03: And so, again, he's found that he sees these bumps and these holes. [00:33:35] Speaker 03: They're not even in a perfect arrangement or evenly distributed. [00:33:38] Speaker 03: He says that they're not evenly distributed throughout the process. [00:33:41] Speaker 04: So two sentences later. [00:33:43] Speaker 03: Yes. [00:33:43] Speaker 03: OK, thanks. [00:33:47] Speaker 03: And in plaintiff's brief, reply brief at nine, they say, whether something is macroscopic is determined by its size. [00:33:53] Speaker 03: And really, that ends the input. [00:33:55] Speaker 03: We have here beads that are of a size that can be visually observed. [00:33:59] Speaker 03: And they're not uniformly distributed throughout. [00:34:02] Speaker 03: And they're not even uniform with a powder structure. [00:34:05] Speaker 03: Now, we think that the judge properly rejected plaintiff's remaining evidence. [00:34:10] Speaker 03: The blend and content uniformity, Dr. Davis admitted, this has nothing to do with the arrangement of drug and other excipients in the tablet. [00:34:19] Speaker 03: And in fact, with content uniformity, he said, it doesn't tell you how the beads are arranged in the finished product. [00:34:28] Speaker 03: The photographs also, we think that [00:34:30] Speaker 03: Here, they're good enough, certainly, to see the non-uniformities. [00:34:33] Speaker 03: And in fact, counsel told us he sees the holes and the beads. [00:34:38] Speaker 03: So that tells us that they're good enough to show the non-infringing structure. [00:34:43] Speaker 03: But in order to say that they show uniformity, they have to be at a level that can be seen at the naked eye, to show the same amount of detail. [00:34:51] Speaker 03: Because low resolution can hide the details that would otherwise be visible. [00:34:56] Speaker 03: And of course, we heard Dr. Davis admitted he couldn't draw that link. [00:35:01] Speaker 03: I see I'm out of time if there's no questions. [00:35:03] Speaker 03: Thank you. [00:35:04] Speaker 03: Thank you. [00:35:07] Speaker 01: Your Honor, I only have three very quick points. [00:35:11] Speaker 01: First, their construction absolutely excludes, example two, the preferred embodiment. [00:35:19] Speaker 01: And the reason is, so he speculates, so maybe compression will destroy these granules. [00:35:24] Speaker 01: These granules are the three excipients that are controlling the release. [00:35:29] Speaker 01: They can't be destroyed. [00:35:30] Speaker 01: And furthermore, all the testimony is the only thing compression does is to preserve the segregation in the blend. [00:35:37] Speaker 01: It doesn't destroy structures. [00:35:39] Speaker 01: That's not what you do with compression. [00:35:41] Speaker 01: And that's true in the patent when it says if you compress a homogeneous mixture, you yield a macroscopically homogeneous composition in all its volume. [00:35:50] Speaker 01: Second, I'd also like to just go right to the testimony or the council statements in 455. [00:35:56] Speaker 01: He never says, [00:35:58] Speaker 01: evenly distributed. [00:35:59] Speaker 01: That was a misstatement by my colleague. [00:36:01] Speaker 01: He just says, if they're not distributed uniformly, which is not the case, then it would be an excipient that's not uniformly distributed. [00:36:10] Speaker 01: We wouldn't have a non-macroscopically homogeneous composition. [00:36:14] Speaker 01: That's just a truism under the construction. [00:36:16] Speaker 01: And he says, we have lecithin that is uniformly distributed throughout the blend and throughout the tablet cores. [00:36:22] Speaker 01: So it begs the question of what is uniformity? [00:36:25] Speaker 01: And that's where the district court went awry. [00:36:27] Speaker 01: You heard nothing [00:36:28] Speaker 01: from them about how uniformity was understood in the patent, in the prosecution history, and in the art. [00:36:35] Speaker 01: It doesn't mean flecks of color. [00:36:38] Speaker 01: It refers to the uniform structure. [00:36:42] Speaker 01: There's some variation in flecks of color. [00:36:44] Speaker 01: And I think it is variation in color that he was relying on, not the fact that there was just a different color. [00:36:50] Speaker 01: He wants there to be an even arrangement. [00:36:52] Speaker 01: That's physically impossible to do in these multi-particle. [00:36:55] Speaker 01: How do you mix it in a huge thing to have [00:36:58] Speaker 01: a uniform arrangement. [00:37:01] Speaker 01: So that's the core issue in this case. [00:37:04] Speaker 01: And we say there's legal error both on uniformity and on homogeneity. [00:37:11] Speaker 01: And that led to clear error. [00:37:12] Speaker 01: And there must be at least a vacator and remand. [00:37:14] Speaker 05: Thank you. [00:37:15] Speaker 05: Thank you. [00:37:15] Speaker 05: We thank both sides of the cases submitted.