[00:00:00] Speaker 03: And let me add, I mean that not in the context of this casement, but in the context of all the cases. [00:00:50] Speaker 01: Good morning, Your Honor. [00:01:08] Speaker 00: Ed Haug for Shire, the appellant here. [00:01:12] Speaker 00: We ask for this panel to engage in claim construction and review [00:01:17] Speaker 00: two instances of claim construction by the district court here, one with respect to matrix and the other with respect to lipophilic, both of these words appearing in claim one in the phrase inner lipophilic matrix. [00:01:35] Speaker 01: The parties stipulated to the definition of those claim terms. [00:01:38] Speaker 01: So your argument is that what, the district court changed that definition when he applied it in an infringement context? [00:01:45] Speaker 00: Correct. [00:01:45] Speaker 00: And he did it at the [00:01:47] Speaker 00: insistence really of the defendant here, Zydus, at trial. [00:01:52] Speaker 00: Both parties here agreed early on that matrix was a macroscopically homogeneous structure in all its volume. [00:02:01] Speaker 00: And similarly, lipophilic was poor affinity for aqueous fluids. [00:02:06] Speaker 00: And when we had a Markman hearing in this case, which we did, those terms were not disputed. [00:02:11] Speaker 00: They were accepted by the court based on the party's agreement. [00:02:14] Speaker 03: The district court identified three independent [00:02:16] Speaker 03: grounds for finding non-infringement. [00:02:20] Speaker 03: Would you agree with us that if we affirm the district court on any of those three grounds, you lose? [00:02:31] Speaker 00: Yes. [00:02:31] Speaker 00: I think if you affirm the district court on any of those three grounds, correct. [00:02:34] Speaker 00: I think that the first two grounds are, one is on matrix and whether or not the claim construction by the district court was correct or not. [00:02:43] Speaker 00: That's number one. [00:02:44] Speaker 00: were to agree with that claim construction, then findings, in fact, were made by the court. [00:02:49] Speaker 00: If the second one would be lipophilic, the court went beyond what the parties agreed to, which was poor affinity for aqueous fluids. [00:02:57] Speaker 00: It went on and added limitations that were required to meet that claim element. [00:03:03] Speaker 00: And so we, of course, believe that that was a legal error and should be corrected. [00:03:07] Speaker 00: Just to follow up. [00:03:09] Speaker 01: I'm sorry. [00:03:10] Speaker 01: I'm sorry to interrupt, but just to follow up on Judge Wallach's question, we're still left with a third alternative conclusion with respect to the melting point that doesn't involve the questions of law that you're trying to present to us, right? [00:03:22] Speaker 00: It does not involve questions of law as to claim construction. [00:03:25] Speaker 00: It does involve a question of law as to the misapplication of a doctrine of equivalence as to that element of the melting point. [00:03:32] Speaker 00: In other words, what the district court did here [00:03:35] Speaker 00: is the district court did not do a proper doctrine of equivalence analysis. [00:03:40] Speaker 00: It did not compare the accused product with the claim element where the court found no literal infringement. [00:03:48] Speaker 00: And the reason for that is because the court compared below 90 degree melting point, which is the claim language, with the finding of 125 degree melting point for a different ingredient or excipient. [00:04:05] Speaker 00: In other words, the 125 degrees is with respect to an anhydrous form of magnesium stearate. [00:04:13] Speaker 00: That is not the zytus product at issue here. [00:04:17] Speaker 00: The zytus product, by agreement of zytus, is an hydrated form of magnesium stearate. [00:04:22] Speaker 00: So the proper doctrine of equivalence analysis should have been comparing the claim [00:04:28] Speaker 00: with the Zytus product which is in the hydrated magnesium stearate or contains a hydrated magnesium stearate excipient and determining whether or not... Answer me that house keeping question. [00:04:42] Speaker 03: In the red brief at 29, Zytus says, Shire truncates and inaccurately represents the evidence presented to the district court, referring to your reproduction of certain images. [00:04:54] Speaker 03: And I've got both rates in front of me. [00:04:58] Speaker 03: They clearly are different. [00:05:00] Speaker 03: Explain to me why you selected to reproduce these versions of the images. [00:05:05] Speaker 00: Well, I think those are the ones we thought were most relevant to the points that we were making as to the meaning of the terms, the matrix, and the structures that we were talking about in the brief. [00:05:17] Speaker 00: Certainly, well, that's the answer we thought to be most relevant. [00:05:23] Speaker 00: And again, Your Honor, if I may, [00:05:25] Speaker 00: The problem here has also been matrix. [00:05:28] Speaker 00: While the parties agreed to the construction until trial, it's a macroscopically homogeneous structure in all its volumes. [00:05:35] Speaker 00: That language comes right out of the specification. [00:05:37] Speaker 00: In other words, that term is defined in patent specification. [00:05:41] Speaker 00: What's now happened in this trial is Zydus said, well, structure requires certain limitations. [00:05:47] Speaker 00: You have to connect. [00:05:49] Speaker 00: There has to be a physical connection between the various different molecules. [00:05:54] Speaker 00: That's not in the claim term. [00:05:56] Speaker 00: Structure isn't even in the claim. [00:05:58] Speaker 00: That's nowhere appears in the claim. [00:06:00] Speaker 01: Yeah, but the agreed upon claim construction included structure, right? [00:06:03] Speaker 01: And that appeared in our earlier opinions, too. [00:06:06] Speaker 01: So that wasn't just made up by the district court. [00:06:09] Speaker 00: No, no. [00:06:09] Speaker 00: The word clearly appears in the specification itself. [00:06:12] Speaker 00: It says a matrix is a macroscopically homogeneous structure in all its volume. [00:06:16] Speaker 00: The dispute, however, trial became what is meant by a structure. [00:06:21] Speaker 00: And the district court accepted [00:06:23] Speaker 00: the trial testimony of Zydus's expert saying that that requires a connection between the molecules, and that therefore, if there is no connection, there can be no structure. [00:06:36] Speaker 00: That was extrinsic evidence. [00:06:38] Speaker 03: Let me turn you to lipophila, because you agree with all three. [00:06:41] Speaker 03: You have to win on all three. [00:06:43] Speaker 03: Yes, sir. [00:06:44] Speaker 03: So in the blue brief at 28, you argued the district court, quote, did not apply appropriate weight to the evidence of lipophilicity. [00:06:54] Speaker 03: We can't independently reweigh the evidence on appeal. [00:07:00] Speaker 03: And you don't identify specific errors in the district court's discussion of the party's evidence. [00:07:05] Speaker 03: I'm looking at 27 to 32. [00:07:08] Speaker 03: If we disagree with the argument that the district court improperly imported limitations into the agreed upon construction of Lipopillic, aren't you just inviting us to reweigh the evidence? [00:07:23] Speaker 00: No, Your Honor. [00:07:25] Speaker 00: Our position clearly is that there was a mistake in error of law in the construction of lipophilic by the district court. [00:07:32] Speaker 00: Once that error was made, you cannot do a proper infringement analysis, which is why we think that would require proper construction of lipophilic and that a review is necessary. [00:07:46] Speaker 03: So as to that, you argued that district court imported additional limitations [00:07:53] Speaker 03: citing one sentence in which the district court was describing, quote, multiple infirmities of your expert's experiment. [00:08:02] Speaker 03: The district court considered and rejected your argument that the granules must be lipophilic because they include magnesium stearate, which imparts lipophilic properties into the granules by virtue of their own lipophilicity. [00:08:19] Speaker 03: The district court, in fact, found [00:08:20] Speaker 03: The granules themselves were hydrophilic in nature. [00:08:25] Speaker 03: These findings don't depend upon any limitations other than the agreed upon construction of lipophilic as poor affinity towards aqueous solutions. [00:08:35] Speaker 00: I respectfully disagree that that's the case. [00:08:38] Speaker 00: Those findings go to the additional limitations that were added to the claim term lipophilic, namely that it has to have a lower affinity than the outer hydrophilic matrix, for example. [00:08:50] Speaker 00: That is nowhere to be found in this patent. [00:08:52] Speaker 00: That language isn't there. [00:08:53] Speaker 00: It's not in the prosecution history. [00:08:54] Speaker 00: It's nowhere. [00:08:55] Speaker 00: And in addition, the district court said that it had to have below average affinity. [00:09:00] Speaker 00: Well, we don't know what that means because that's not a defined term. [00:09:03] Speaker 00: That's not in the patent anywhere. [00:09:05] Speaker 00: So what the court did is it set up the obstacles that had to be overcome to show infringement and did so by an improper claim construction, by adding these limitations, these additional limitations to what the parties had agreed to. [00:09:20] Speaker 00: The parties agreed to it has a poor affinity for aqueous fluids. [00:09:25] Speaker 00: And the district court actually found, in its opinion, that the testing by Dr. Hoyg in this case did show that the- Did he test Zydus's product? [00:09:37] Speaker 00: He tested a simulation of the product. [00:09:39] Speaker 00: He did not actually test the product. [00:09:41] Speaker 00: We're talking getting inside granules and all. [00:09:45] Speaker 00: So he tested and compared. [00:09:47] Speaker 00: the affinity for aqueous fluids between pure misalamine, which is about 90% of this entire formulation. [00:09:56] Speaker 00: He compared pure misalamine with the affinity for aqueous fluids in a compact that has misalamine plus magnesium stearate plus colloidal silicon dioxide, which is what is in the zytus product. [00:10:10] Speaker 03: I don't think there's any doubt about that. [00:10:11] Speaker 03: In prior development, the Watson [00:10:14] Speaker 03: We previously determined that the inner lipophilic matrix must be, quote, separate if not distinct from the outer hydrophilic matrix. [00:10:25] Speaker 03: When your proposed interpretation, which would permit the inner lipophilic matrix to have a similar affinity to the outer hydrophilic matrix, run afoul of our requirements that they be separate if not distinct. [00:10:41] Speaker 00: The prior Watson decision found that they had to be separate. [00:10:45] Speaker 00: And in fact, we agreed with that. [00:10:47] Speaker 00: What it didn't find is that they had to be distinct, depending upon how you define distinct, because distinct is not a word that appears in the patent either. [00:10:55] Speaker 00: And so the Watson court found that they had to be separate. [00:11:00] Speaker 00: They are separate here. [00:11:01] Speaker 00: Clearly, we believe they're separate. [00:11:04] Speaker 00: And the inner lipophilic matrix, which consists of the magnesium stearate in this case, [00:11:10] Speaker 00: is clearly lipophilic. [00:11:13] Speaker 00: And we believe the evidence that was presented to the court through Dr. Hoyt's testing, if using the correct claim construction, which was agreed to by the parties, does show that. [00:11:23] Speaker 00: The outer hydrophilic matrix is different. [00:11:26] Speaker 00: It has hydrophilic excipients in it. [00:11:29] Speaker 00: And the affinity for fluids is very different. [00:11:31] Speaker 00: It has an affinity for fluids. [00:11:34] Speaker 00: And so it's almost the opposite. [00:11:36] Speaker 00: If you're following, I think that was clear. [00:11:41] Speaker 00: And back up, we do need to win on three grounds. [00:11:44] Speaker 00: And I think that there were three legal errors made here, two on claim construction. [00:11:48] Speaker 00: This court, respectfully, I submit, should engage in the proper claim construction of matrix and lipophilic, because it's now been put in dispute by the parties. [00:12:00] Speaker 00: It was not in dispute before we got the trial. [00:12:03] Speaker 00: It became a disputed trial. [00:12:05] Speaker 00: The district court relied on Zydus's expert testimony [00:12:10] Speaker 00: together with a reference to the file history, and came up with the claim construction at 41, which is appendix 42, actually. [00:12:24] Speaker 00: I conclude that a collection of unconnected molecules distributed throughout another substance does not a matrix make. [00:12:34] Speaker 00: I credit the conclusion of Zydus's infringement expert, Dr. Umesh Bannachar. [00:12:38] Speaker 00: that in the context of the 720 patent, the term structure means something more than the arrangement of disconnected particles dispersed throughout a granule. [00:12:48] Speaker 00: So one, the court is clearly basing this claim construction on the testimony he heard at trial, which was contrary to other testimony he heard from Shire's expert, but he accepted this testimony. [00:13:02] Speaker 00: And this is clearly claim construction. [00:13:05] Speaker 00: There is nowhere in a patent where you're going to find unconnected or connected particles. [00:13:10] Speaker 00: None of this is there. [00:13:11] Speaker 00: This was an interpretation by their expert. [00:13:13] Speaker 03: Touch on melting point. [00:13:17] Speaker 00: On melting point. [00:13:17] Speaker 03: Because it seems to me that you're doing the same thing with melting point. [00:13:22] Speaker 03: It relates to what the district court did. [00:13:24] Speaker 00: On melting point one, we are taking the position that it was clearly erroneous on the factual findings. [00:13:33] Speaker 03: Well, you're saying he relied on the other side more than he relied on us. [00:13:37] Speaker 00: But he relied on the other side based on the wrong test. [00:13:40] Speaker 00: It was a hot, you know, he invested on DSC, which he also said was the differential scanning calorimetry, which was the right test to use to determine melting point. [00:13:50] Speaker 00: He then pointed to HSM, which was used by zytus, and that's how he got to this 125 degree melting point. [00:13:58] Speaker 00: And he found that [00:13:59] Speaker 00: that Shire didn't carry its burden in showing that the melting point of the Zytus product was below 90. [00:14:07] Speaker 00: But there's nothing in this record that says the melting point of Zytus' product is 125, because they don't have that product. [00:14:13] Speaker 00: They don't use an anhydrous product. [00:14:15] Speaker 00: And so the question really is, whatever Zytus' product is, is that equivalent to below 90 degrees? [00:14:22] Speaker 00: And when you look at the district court's opinion, [00:14:26] Speaker 00: It really looks to the doctrine of vitiations and says, if the claim says below 90 and if I'm looking at 125, it's game over because it's too big a gap, too close to the doctrine of equivalence. [00:14:38] Speaker 00: And you think that's legal error? [00:14:40] Speaker 00: I think it's legal error because the 125 is irrelevant. [00:14:43] Speaker 00: That's not their product. [00:14:44] Speaker 01: But then it becomes a factual question. [00:14:47] Speaker 00: Then it becomes substantive, whether there's [00:14:50] Speaker 00: Your Honor is absolutely right. [00:14:51] Speaker 00: It is a factual question. [00:14:52] Speaker 00: But that factual question was never determined by the district court. [00:14:54] Speaker 00: In other words, the district court didn't engage in that fact-finding, did not look at the Zydus product versus the claim. [00:15:02] Speaker 00: And there was expert testimony showing function way result. [00:15:07] Speaker 00: He didn't even touch on that. [00:15:09] Speaker 00: He just said, I don't have to do it because of this initiation doctrine. [00:15:12] Speaker 00: It's too far a gap. [00:15:14] Speaker 00: OK. [00:15:14] Speaker 00: Why don't we keep your rebuttal on here from the other side. [00:15:17] Speaker 01: Thank you, Your Honor. [00:15:27] Speaker 02: I think it's still good morning. [00:15:28] Speaker 02: Good morning. [00:15:28] Speaker 02: May it please the court. [00:15:29] Speaker 02: I'd like to first address the melting point limitation on the two aspects. [00:15:34] Speaker 02: One is the findings of fact. [00:15:36] Speaker 02: Mr. Howe said that Judge Jordan relied on the wrong test. [00:15:40] Speaker 02: I believe that he's referring to the hot stage microscopy test, which is zytus introduced into evidence, which was uncontested. [00:15:47] Speaker 02: Shire didn't present any evidence whatsoever on hot stage, did not rebut zytus's evidence. [00:15:52] Speaker 02: They don't even dispute that the evidence is correct. [00:15:55] Speaker 02: And what Judge Jordan did is Judge Jordan used the hot stage to weigh the evidence of a different test, DSC, which everybody admits is a proper test to a judge in the melting point of magnesium stearate. [00:16:08] Speaker 02: And although Shire faults Judge Jordan for actually looking at hot stage in conjunction with DSC, Shire actually submitted it into evidence and its expert relied on several scientific references when in fact experts in other fields of melting point relied on DSC. [00:16:25] Speaker 02: And I can refer you to appendix 10239, 10240, and 10253. [00:16:33] Speaker 02: What Judge Jordan did is he looked at hot stage, along with DSC, along with scientific references. [00:16:39] Speaker 02: It was a morass of scientific, highly technical evidence that went in through multiple experts, maybe a half a dozen or so, stretching over hours, if not days, of testimony. [00:16:50] Speaker 02: And he weighed the credibility of that evidence, and he made a factual determination [00:16:55] Speaker 02: that Shire failed to prove a melting point below 90 degrees C. Judge Wallach, as you pointed out, what Shire wants this court to do is look at this evidence all again and put its thumb on the scale and decide it should be weighed differently. [00:17:08] Speaker 02: And that's not an appropriate exercise for this court audit. [00:17:11] Speaker 03: I didn't say anything about thumbs. [00:17:12] Speaker 02: OK. [00:17:13] Speaker 02: Finger. [00:17:14] Speaker 02: How's that? [00:17:15] Speaker 02: On the scales of evidence. [00:17:17] Speaker 02: And this court made clear in previous cases, and I'll talk about the biotech case, which is 267, [00:17:23] Speaker 02: Fed 1325 at 1330 through 31, even when there's a reasonable range of scientific opinions. [00:17:31] Speaker 02: Let's even give Scheir had a reasonable theory. [00:17:34] Speaker 02: Their theory, by the way, is you can see the melt, but it's there. [00:17:37] Speaker 02: It's hidden in the data. [00:17:38] Speaker 02: They can see there's no physical evidence of the melt. [00:17:41] Speaker 02: It's hidden somewhere in this data. [00:17:43] Speaker 02: But even if Judge Dorn were to credit that theory, if there's a reasonable range of differences on scientific opinion, the resolution of that difference based on the weight and credibility evidence [00:17:53] Speaker 02: is the providence of the trial effect. [00:17:55] Speaker 02: There is simply no clear error in the melting point determination that Judge Jordan made. [00:18:01] Speaker 02: Now, shifting to the DOE, Shire's meshing things together because they don't want to go through the element by element analysis that the doctrine of equivalence requires and that Judge Jordan went through during the trial. [00:18:17] Speaker 02: Judge Jordan recognized the DOE is done on an element by element basis. [00:18:22] Speaker 02: And that's what he did. [00:18:23] Speaker 02: Now, when we talk about the melting point limitation, there's a Mark Khrush group. [00:18:28] Speaker 02: I think, Chief Judge Prost, you were involved in a prior case involving the Mark Khrush group in this case. [00:18:33] Speaker 02: Judge Dorn recognized that the Mark Khrush group creates two limitations. [00:18:38] Speaker 02: And this is in paragraph 49 of his findings of fact. [00:18:41] Speaker 02: And I don't hear Shire disputing that. [00:18:45] Speaker 02: It creates two limitations. [00:18:46] Speaker 02: One restricts the type of compound. [00:18:49] Speaker 02: And the second limits the melting point. [00:18:52] Speaker 02: All the evidence that Shire has ever offered on DOE talks about the first limitation, the type. [00:18:58] Speaker 02: For example, it's a long chain fatty acid. [00:19:01] Speaker 02: Judge Jordan gave them that. [00:19:03] Speaker 02: Judge Jordan actually filed in favor of Shire on the type of compound. [00:19:06] Speaker 02: So you've got to put that to the side. [00:19:09] Speaker 02: The second question is, on doctrine of covalence, is what's the melting point? [00:19:14] Speaker 02: And for melting point, that falls into the numeric range cases that both sides have cited to this court. [00:19:21] Speaker 02: In the numeric range cases where a claim requires, for literal infringement, a numeric value to fall into a range. [00:19:28] Speaker 02: To show DOE, this court has ruled, you have to show that the accused number that's outside the range is actually equivalent to a number within the range. [00:19:38] Speaker 02: Both sides have cited cases to that effect. [00:19:42] Speaker 02: So for purposes of the melting point, separate element of this claim, it was incumbent upon Shire [00:19:49] Speaker 02: to show a melting point outside the below 90 degree range that was somehow and substantially different or satisfied the function way result test to a melting point below 90 degree C. They never even made an effort to do that. [00:20:04] Speaker 02: There's no evidence in the record at all that wasn't presented to Judge Jordan. [00:20:08] Speaker 02: And it's not presented to you now. [00:20:10] Speaker 02: Judge Jordan could have stopped there. [00:20:13] Speaker 02: But instead, he said, OK. [00:20:15] Speaker 02: In the numeric range cases, I'm supposed to look for a number outside the literal infringement range to compare it to a numeric value inside the literal infringement range. [00:20:25] Speaker 02: The only number out there was 125 degrees C. Because what Shire did is Shire went all in on literal infringement. [00:20:33] Speaker 02: They went all in. [00:20:34] Speaker 02: They tried to prove 82.5. [00:20:36] Speaker 02: Judge Jordan found, and there's nowhere a fact, that there's no literal infringement because they failed to prove 82.5 was the correct number. [00:20:45] Speaker 02: After that, it was not the left. [00:20:47] Speaker 02: So when Judge Jordan did say, let's give him the benefit of the doubt, let's try to find a number outside the range and see whether it's insubstantially different from a number inside the range. [00:20:59] Speaker 02: Well, the only other number that left was the number that we put into evidence, which was 125 degrees C. That's why Judge Jordan looked at that number. [00:21:07] Speaker 02: That was the only option that was given to him. [00:21:09] Speaker 02: In fact, it wasn't even given to him. [00:21:11] Speaker 02: He searched the record to find it. [00:21:13] Speaker 02: And what Judge Jordan did said, well, wait a second. [00:21:16] Speaker 02: There is no evidence that 125 degrees C is insubstantially different to a numeric value below 90 degrees C. Therefore, there can't be infringement. [00:21:25] Speaker 02: It can't that be vitiation, which is, vitiation goes back to this court's precedent. [00:21:31] Speaker 02: And I'll cite the Deere and Company case 703, Fed 1349 and 1356, which is, vitiation derives from the requirement [00:21:41] Speaker 02: that the doctrine of equivalence must be applied to the claims on an element by element basis so that every claimed element of the invention or its equivalent is present in the accused product. [00:21:52] Speaker 02: That's exactly what Judge Jordan was doing. [00:21:54] Speaker 02: He was looking for the below 90 degrees C element to make sure it wasn't read out of the claim. [00:21:58] Speaker 02: So his reference to vitiation is absolutely appropriate. [00:22:02] Speaker 02: His analysis of DOE was appropriate as well. [00:22:04] Speaker 01: Why don't you turn to your friend's argument with respect to the first two issues, the other two alternatives that the court made committed legal error by revising the claim? [00:22:14] Speaker 02: We'll switch the lipophilic now. [00:22:17] Speaker 02: Judge Wallach, as you pointed out, the place where Shire argues that Judge Jordan actually imported limitations into lipophilic isn't bad. [00:22:27] Speaker 02: It is actually a litany of finding of facts that Judge Jordan made to rule that Shire failed to carry its burden of proof of lipophilicity. [00:22:38] Speaker 02: But one thing before we get to that, Chief Judge Prost, is I'm a little confused as to where we're going on this whole lipophilic argument, because as we briefed in Shire Doesn't Dispute, what happened in trials, they had two theories going here. [00:22:51] Speaker 02: They had one, the matrix is the granule. [00:22:54] Speaker 02: and one, the matrix is this dispersion, which I'll get to a second on the structure. [00:22:58] Speaker 02: So they had these two competing theories, and Judge Dorn called them out on that. [00:23:03] Speaker 02: What he found was, and we'll get to it in a second, that this dispersion isn't a structure. [00:23:07] Speaker 02: But he said, okay, I'll give them that, assuming, let's go to a granule now. [00:23:11] Speaker 02: So you tack to the granule, I'll look at whether your granule is a structure. [00:23:16] Speaker 02: All the lipophilicity evidence that they put in went to whether the granule [00:23:20] Speaker 02: was a structure, the lipophilicity of the alleged granule, not the alleged matrix, the dispersion, which we'll talk to in a second. [00:23:27] Speaker 02: So in many ways, I'm not sure what the purpose of this is, because now I understand Shire's all in on their distribution as a matrix theory. [00:23:36] Speaker 02: So we'll go into this in detail, but it seems to be a bit irrelevant, because if you look at the evidence, it all goes to the granule. [00:23:43] Speaker 02: And back to the findings of fact on lipophilicity and Mr. Howard's arguments on that. [00:23:52] Speaker 02: Judge Jordan applied the agreed construction and found, as a matter of fact, a number of things that aren't contesting. [00:24:00] Speaker 02: Number one, he found that Dr. Hoyt disavowed his test. [00:24:04] Speaker 02: He no longer stood by it. [00:24:05] Speaker 02: And this is to your question, Judge Wellett. [00:24:08] Speaker 02: He disavowed that his test is representative of a test on the design of the product. [00:24:12] Speaker 02: That's at appendix 22 to 23. [00:24:15] Speaker 03: But he did say that Dr. Hoyt's test demonstrated [00:24:20] Speaker 03: that Zydus' product exhibits some resistance to the penetration of water relative to mesalamine. [00:24:30] Speaker 02: He did, but he put a little gloss on that. [00:24:33] Speaker 02: What he said is he found that the mixture of mesalamine, colloidal silicon dioxide, and magnesium stearate opposes some resistance or has some resistance to water. [00:24:43] Speaker 02: It's important for two reasons. [00:24:45] Speaker 02: One is colloidal silicon dioxide is outside the Marcoosh brook. [00:24:49] Speaker 02: That's a hydrophilic substance. [00:24:50] Speaker 02: And I know that issue is in front of this court now. [00:24:52] Speaker 02: So if colloidal silicon dioxide is part of that mixture that opposes resistance to water, they fall outside the consisting of language and violate the Mark Kusch group. [00:25:02] Speaker 02: We brief that issue as an alternative issue on this appeal. [00:25:05] Speaker 02: You don't need to reach that because I agree there's three other bases to do it. [00:25:08] Speaker 02: But if that's the finding that's important, I think we're going to have to grapple with that too. [00:25:13] Speaker 02: The second thing that Judge Doran found, although it has some resistance to water, [00:25:18] Speaker 02: that's not enough to show poor affinity. [00:25:20] Speaker 02: I mean, leaving aside the, all the other deficiencies in the test. [00:25:24] Speaker 02: And I think that makes sense here and why you can't have some resistance as the standard, because the patent teaches that both matrices oppose penetration of water. [00:25:33] Speaker 02: We have those citations in the record. [00:25:36] Speaker 02: So if you're looking to oppose some resistance to water or give some resistance, I don't know how you can decide what's a lipophilic matrix and a hydrophilic matrix, because both of those have those standards. [00:25:47] Speaker 02: Really, [00:25:48] Speaker 02: When Shire is trying to put that language back into the agreed construction, they're trying to expand it. [00:25:53] Speaker 02: They're trying to equate poor affinity with some resistance when that was never the issue. [00:25:58] Speaker 02: It was accepted that it was poor affinity. [00:26:00] Speaker 02: And trying to expand it not only is beyond the claim construction, it also would just, again, it doesn't make sense in the context of the patent. [00:26:09] Speaker 02: Some of the other things that Judge Jordan ruled on lipophilic [00:26:13] Speaker 02: Your time's brief. [00:26:15] Speaker 03: Can you hit structure? [00:26:17] Speaker 02: I can certainly hit structure, Your Honor. [00:26:19] Speaker 03: Okay. [00:26:19] Speaker 03: Can you identify any intrinsic support that the court cited for its finding that the matrices have a structure that is, quote, something more than an arrangement of disconnected particles first through the granule? [00:26:34] Speaker 02: We don't think that the court engaged in claim construction exercise. [00:26:38] Speaker 02: In fact, you can read Shire's briefs. [00:26:40] Speaker 02: And they don't say exactly what it is that the court construed the claim to be. [00:26:45] Speaker 02: In fact, in a footnote to the provision that Mr. Haug cites, Judge Jordan expressly says, I'm not making a decision on this. [00:26:52] Speaker 02: The judge didn't need to, because if you read the opinion, he found it's devoid of any structure. [00:26:57] Speaker 02: On multiple occasions, he says, there is no structure whatsoever. [00:27:01] Speaker 02: Because the theory is 0.33%, one third of a percent of this mixture [00:27:07] Speaker 02: form some sort of structure, because it's dispersed within it, as Judge Jordan said. [00:27:11] Speaker 02: It's strewn throughout the granule. [00:27:13] Speaker 02: So he didn't need to go as far as to make a construction. [00:27:17] Speaker 02: And by the way, no one ever asked him to. [00:27:20] Speaker 02: There was a debate at trial, certainly, on how to prove structure. [00:27:25] Speaker 02: When Mr. Haug suggests that we invited the judge to do that, that's not fair, and that's not true. [00:27:31] Speaker 02: What our expert did is he went through illustrations and technical references that were actually in the intrinsic record. [00:27:38] Speaker 02: The patentees submitted technical references to the patent office to show characteristics, that's how they describe it in the prosecution history, of a matrix system. [00:27:48] Speaker 02: So what our expert did is he walked through those illustrations to show to Judge Jordan, this is what a person of ordinary skill in the art, and we can get beyond that. [00:27:57] Speaker 02: This is just what references, technical references, would show what looks like a matrix in a pharmaceutical. [00:28:03] Speaker 03: Discuss your, I'm looking at page 29 of your red brief. [00:28:08] Speaker 03: And I raised this with Mr. Powell. [00:28:14] Speaker 02: Yeah, there were some games playing there. [00:28:18] Speaker 02: At the time, this dealt with one of the arguments that Shire has raised in the past that just because it's only 0.33% doesn't mean it can't be a structure, because there can be a low volume of that. [00:28:32] Speaker 02: And again, Judge Jordan did not just rely on the volume. [00:28:35] Speaker 02: He relied on any lack of structure at all. [00:28:38] Speaker 02: But what Shire tried to do is Shire, frankly, cut and pasted some of these exhibits to try to create the illusion that the technical references in the prosecution history actually showed very little lipophilic matrix formers. [00:28:51] Speaker 02: In fact, the vast amount of it was active. [00:28:54] Speaker 02: But when you go back and take a look at the references as we cut and paste them in the brief, it actually shows quite the difference. [00:29:00] Speaker 02: It shows that it's much more dense in terms of the matrix formers. [00:29:04] Speaker 02: And they also took out words that are inconsistent [00:29:07] Speaker 02: with how our expert viewed in the illustrations and the evidence of a matrix structure in particular. [00:29:14] Speaker 02: And so we thought, again, that sort of evidence, Judge, of them trying to reach so far to try to find an argument in basis of the structure point where they had to frankly misrepresent the evidence that Judge Dorn was presenting. [00:29:28] Speaker 02: But Judge Dorn wasn't required to. [00:29:31] Speaker 02: He didn't need to make a claim construction. [00:29:34] Speaker 02: Most importantly, he was never asked to. [00:29:36] Speaker 02: In fact, now, as I understand it, Shire's not even asking for a remand. [00:29:40] Speaker 02: Shire's asking this court to engage in a derivative claim construction of a non-claim term that no one ever asked the court to do. [00:29:49] Speaker 02: I'm not aware of any precedent where this court has done that. [00:29:52] Speaker 02: Shire certainly hasn't cited any. [00:29:54] Speaker 02: The one case they cited when this court reviewed a derivative claim construction is because it was presented to the district court. [00:30:00] Speaker 02: The district court made a ruling, and that was then presented to this court for review. [00:30:05] Speaker 02: I will end now as I'm out of time. [00:30:08] Speaker 02: But as you pointed out at the beginning, Judge Jordan found three independent bases for infringement. [00:30:14] Speaker 02: He made a very detailed opinion, findings of fact on Melting Point, 20 pages of findings of fact, where he weighed all the evidence very thorough. [00:30:21] Speaker 02: There is simply no clear error, and there's no legal error as well. [00:30:25] Speaker 02: Thank you. [00:30:38] Speaker 00: On structure. [00:30:40] Speaker 00: On structure, the court did engage in claim construction. [00:30:43] Speaker 00: You can see it in the opinion. [00:30:45] Speaker 00: He required there to be a connection of molecules and then found that the Zydus product didn't have that. [00:30:52] Speaker 00: That is a negative limitation that the court put into that claim term. [00:30:56] Speaker 00: That is a construction. [00:30:58] Speaker 00: I don't think it's the right construction, but that was a construction the court made. [00:31:02] Speaker 00: And once that construction was made, [00:31:04] Speaker 00: then there's a finding of no infringement, because it follows. [00:31:07] Speaker 00: He said the zytus product is not connected. [00:31:09] Speaker 00: So what we have taken in our appeal brief here, we say the correct claim construction is there is no limitation to the word structure requiring such a physical connection. [00:31:19] Speaker 00: And there is evidence in the record that shows the zytus product is an arrangement of molecules, in this case, magnesium stearate. [00:31:28] Speaker 00: I believe the court should construe the word matrix, because it is in dispute by the parties. [00:31:34] Speaker 00: and the macroscopically homogeneous structure in all its volume. [00:31:38] Speaker 00: The structure is the matrix. [00:31:40] Speaker 00: The structure is not the volume. [00:31:43] Speaker 00: And there's been confusion in this case, and others, but there's been confusion in this case, maybe, as to is the matrix the volume or not. [00:31:52] Speaker 00: It can't be. [00:31:52] Speaker 00: The matrix is the structure. [00:31:54] Speaker 00: The structure is not the volume. [00:31:56] Speaker 00: And therefore, with that correct claim construction, [00:32:01] Speaker 00: The interlipophilic matrix is not the inner region of the granule. [00:32:05] Speaker 00: It is the magnesium stearate, which is a collection of molecules of magnesium stearate that then exhibit lipophilicity. [00:32:13] Speaker 00: That, we believe, is the correct claim construction of matrix. [00:32:17] Speaker 00: As to lipophilic, again, the parties did agree to poor affinity for aqueous fluids. [00:32:25] Speaker 00: The court, as Judge Wallach pointed out, very aptly, [00:32:29] Speaker 00: Paragraph 46 in appendix 23, he said, I do credit it to a limited extent. [00:32:34] Speaker 00: He's talking about the testing that was done by Dr. Hoyt. [00:32:37] Speaker 00: I find that his test and testimony demonstrated that the addition of magnesium stearate and CSD to misalamine results in some resistance to the penetration of water. [00:32:47] Speaker 00: Some resistance to the penetration of water is all you need to satisfy the claim limitation, to satisfy what the patent says, poor affinity to aqueous fluids, what that is. [00:32:59] Speaker 00: And it comes right out of the patent itself, column one, I think lines 17 to 21 or thereabouts. [00:33:05] Speaker 00: My last. [00:33:05] Speaker 00: Yes, you want to have one last sentence. [00:33:07] Speaker 00: One last sentence is doctrine of equivalence. [00:33:09] Speaker 00: Again, the 125 is not the Zydus product. [00:33:13] Speaker 00: And that is not the correct comparison. [00:33:15] Speaker 00: You can't compare below 90 with 125. [00:33:18] Speaker 00: You have to compare below 90 with the Zydus product. [00:33:21] Speaker 00: That was done by the expert. [00:33:22] Speaker 00: The expert, Fashari, did the function way result test, gave testimony to that. [00:33:28] Speaker 00: import, but it wasn't considered by the court. [00:33:30] Speaker 01: Thank you. [00:33:30] Speaker 01: We thank both sides. [00:33:31] Speaker 01: The case is submitted. [00:33:32] Speaker 01: That concludes our proceedings for this morning.