[00:00:39] Speaker 04: Council, just come on up to the podium. [00:00:49] Speaker 04: Come on up to the podium. [00:00:51] Speaker 04: Both of us? [00:00:51] Speaker 04: No, you. [00:00:54] Speaker 04: You're on. [00:00:55] Speaker 04: I just wanted to let you know you could stand there. [00:00:57] Speaker 04: Okay. [00:00:59] Speaker 03: You're good to go. [00:01:00] Speaker 03: Okay. [00:01:01] Speaker 03: May it please the court, Stephen Maddox for Appellant's Amnial Pharmaceuticals. [00:01:05] Speaker 04: And you're reserving five minutes. [00:01:07] Speaker 04: Yes, sir. [00:01:10] Speaker 03: What happened here is the district court applied the wrong legal standard for clearing convincing evidence of imparency. [00:01:18] Speaker 03: Instead of following this court's decisions in Smith-Kline v. Apotex v. Copley or in Ray and Meprisol. [00:01:25] Speaker 04: Is claim one illustrative or representative of the 993 patent? [00:01:31] Speaker 03: Yeah. [00:01:31] Speaker 03: The 993 patent asserted claims, basically a claim to form A [00:01:38] Speaker 03: as defined by characteristic peaks, given the number of values. [00:01:41] Speaker 03: Also, in other claims, as defined by an XRPG plot, saying figure one. [00:01:46] Speaker 03: The only claim that involves more than form A is claim 22, which is form A plus a pharmaceutically acceptable carrier. [00:01:53] Speaker 04: 22 through 25, or just 22? [00:01:56] Speaker 04: Just 22. [00:01:58] Speaker 02: Mr. Maddox, is there any debate in this case that [00:02:04] Speaker 02: Example three of the 406 application doesn't specify any of the drying conditions. [00:02:12] Speaker 03: It specifies a yield to which you dry, but other than that, that's correct. [00:02:17] Speaker 03: It doesn't have a time or a temperature. [00:02:19] Speaker 02: So those are open variables. [00:02:22] Speaker 02: For the person of ordinary skill to use. [00:02:25] Speaker 02: You're relying on the evidence that Nissan submitted earlier about two different data points, I guess. [00:02:33] Speaker 02: Two different drying conditions, yes. [00:02:38] Speaker 02: And even if we accept the fact that under those two different conditions, form A results [00:02:52] Speaker 02: That leaves open the question of what happens under other drying conditions. [00:02:57] Speaker 02: Well, actually what we're relying on is Nissan's conclusions of their scientists having done this. [00:03:04] Speaker 02: But it's your burden by clearing convincing evidence to show that necessarily Form A will result regardless of what the drying conditions might be. [00:03:16] Speaker 03: Well, it's our burden to show [00:03:19] Speaker 03: Your burden, your... That the natural result flowing from, that it discloses to the person of ordinary skill in the art, that the natural result flowing from it would produce Form A. Would necessarily produce Form A. And what we point to, you've jumped to the basis for Nissan's conclusion and assistance. [00:03:36] Speaker 03: What we point to is their own conclusion, of their own scientists, that Example 3 teaches, inevitably, directly, and unambiguously, the Form A. [00:03:46] Speaker 02: Yeah, but that's in a different proceeding with possible different emphasis. [00:03:54] Speaker 02: I've read that evidence. [00:03:56] Speaker 02: I'm not entirely persuaded that it's as significant or as specific as you argue. [00:04:08] Speaker 03: We were arguing it is what it is by its words and the EPO's finding of the same. [00:04:13] Speaker 03: When a patentee says, yeah, [00:04:17] Speaker 03: We've looked at this. [00:04:18] Speaker 03: We've done the replications. [00:04:19] Speaker 03: And we conclude that it teaches inevitably, directly, and ambiguously. [00:04:26] Speaker 03: What we suggest at the standard is that's at least a prima facie case. [00:04:32] Speaker 03: And you've got to come up with something that you can show that example three at least sometimes doesn't. [00:04:38] Speaker 03: And what we got in this case was there are circumstances we think. [00:04:42] Speaker 03: I'm not going to tell you what they are. [00:04:45] Speaker 03: I didn't test them out. [00:04:46] Speaker 03: You can't test me because I can't tell you what they are. [00:04:49] Speaker 03: And I relied on some testimony I heard in court on a reading of an exhibit that was excluded by the judge, that it's possible. [00:04:57] Speaker 03: And this amounts to you have to prove it's impossible under any set of circumstances to do something else. [00:05:04] Speaker 04: You have a tendency to over argue there. [00:05:06] Speaker 03: How so? [00:05:08] Speaker 04: Well, let me turn you to page 45 of the blue brief where you say, [00:05:13] Speaker 04: Dr. Byrne declared that he did not test his theory to convince the court because he had already convinced himself that he was right. [00:05:40] Speaker 04: to 2969 in the record. [00:05:43] Speaker 04: And when I go to that, he doesn't say that. [00:05:48] Speaker 04: He does say, because I was already convinced, I think is the exact language he uses. [00:05:55] Speaker 04: And if you go back through the prior three pages, he says what the problems were and why he didn't actually do that form of testing you wanted. [00:06:08] Speaker 04: But he didn't say, he did not test his theory to convince the court because he had already convinced himself that he was right, end quote. [00:06:18] Speaker 04: He didn't say that. [00:06:20] Speaker 03: He said, because I was already convinced. [00:06:21] Speaker 03: Right. [00:06:22] Speaker 03: And right above that. [00:06:23] Speaker 03: And so you misquoted him. [00:06:25] Speaker 03: I don't believe we quoted him. [00:06:33] Speaker 03: What page? [00:06:45] Speaker 03: He said, already convinced. [00:06:48] Speaker 03: We quoted already convinced that he was right, where he said, I was already convinced. [00:06:54] Speaker 03: You don't see the difference. [00:07:00] Speaker 03: And all that was in response to, did you do any tests or replications to prove your theory? [00:07:07] Speaker 03: To which he said, no. [00:07:09] Speaker 03: We said, why? [00:07:10] Speaker 03: And he said, because I was already convinced I was, well, I was already convinced. [00:07:16] Speaker 04: already convinced of his theory. [00:07:21] Speaker 04: Yeah. [00:07:23] Speaker 04: As I say, I think you have a tendency to over-speak yourself, especially when I look at the prior three pages. [00:07:29] Speaker 04: I really found that misleading. [00:07:33] Speaker 03: Actually, I'm sorry, Judge. [00:07:34] Speaker 03: Our point was there was no testing. [00:07:38] Speaker 03: There was no drying conditions given that someone could try and see if he was right [00:07:47] Speaker 03: There was no anything. [00:07:49] Speaker 03: There was an expert saying, you know, I think there are conditions under which, based on these documents having nothing to do with example three, that it could happen. [00:08:01] Speaker 03: And the district court said, well, since it's theoretically possible that it might, that means you can't have an inheritance. [00:08:13] Speaker 03: not the standard that this court applies. [00:08:15] Speaker 03: In fact, in Omeprazole and in public, when confronted with the patentees. [00:08:21] Speaker 03: I'm going to say something now. [00:08:24] Speaker 04: And when I'm quoting from him, and when I analyze that example, it can produce all kinds of forms, AEMP and some others that I have seen. [00:08:31] Speaker 04: And so I don't see how I can agree with you that now I look at it today with all the science that I've got, and so on, right through to where he says, [00:08:45] Speaker 04: When you say, I'm asking, I assume this is you asking. [00:08:48] Speaker 04: Yes. [00:08:49] Speaker 04: I'm asking you whether you actually attempted to replicate an example three and obtained something other than form A. And he says, no, because of all this prior stuff. [00:08:59] Speaker 03: Because he said so. [00:09:01] Speaker 03: The prior stuff is him saying, I looked at it, and I declared. [00:09:06] Speaker 03: There's not any empirical evidence at all. [00:09:10] Speaker 03: There's Nissan's empirical evidence, Nissan scientific conclusions, European patent offices, [00:09:15] Speaker 03: acceptance and determination not to be swayed by an argument without contrary evidence. [00:09:21] Speaker 03: 20 years have gone by. [00:09:22] Speaker 03: No one has ever done example A, example three, without producing form A. It's fantastical. [00:09:34] Speaker 03: With respect to the various documents [00:09:42] Speaker 03: humidity report about what happens when you have Form A and then subject it to extreme humidity. [00:09:48] Speaker 03: That has nothing to do with Example 3. [00:09:50] Speaker 03: Let's start with Form A, not even Form A made by Example 3. [00:09:54] Speaker 03: The claim isn't to Form A and then subject it to humidity. [00:09:59] Speaker 03: The claim is to getting Form A. The Indian patents. [00:10:03] Speaker 03: The district court suggested, well, the differences are slight and don't matter. [00:10:07] Speaker 03: What Dr. Brown himself said [00:10:10] Speaker 03: And he said this not only in cross, but on direct, when he was loaded up with the question, given all of these similarities. [00:10:17] Speaker 03: What can you say? [00:10:18] Speaker 03: And he says, when Nissan asked him, given the similarity between EP406 example 3 and these two Mylon applications, what is your understanding as to how one could obtain multiple polymorphic forms? [00:10:31] Speaker 03: Dr. Bernd, I don't have. [00:10:33] Speaker 03: I don't think people can explain the appearance of these forms. [00:10:36] Speaker 03: Personal skill just don't have an explanation. [00:10:39] Speaker 03: And later on, [00:10:40] Speaker 03: He said, well, not what we're saying. [00:10:42] Speaker 03: And this is at 3004, 6 through 9. [00:10:46] Speaker 03: That's correct. [00:10:46] Speaker 03: What we're saying is different forms can be produced by different procedures. [00:10:50] Speaker 03: That was when he was saying that form P could be attributable to the differences in the procedures. [00:10:54] Speaker 03: The district court became its own expert witness and went places that Dr. Byrne himself refused to go. [00:10:59] Speaker 04: You say on page 28 of the blue brief. [00:11:02] Speaker 04: OK. [00:11:05] Speaker 03: I'm sorry. [00:11:06] Speaker 03: I have offended him. [00:11:08] Speaker 03: Go ahead. [00:11:08] Speaker 04: that is later confirmed in Koah's closing statement. [00:11:12] Speaker 04: The testimony upon which Dr. Byrne relied for his correlation was a description and explanation of Sawai 14B by Sawai's expert in Sawai's action. [00:11:23] Speaker 04: Yes. [00:11:23] Speaker 04: You cite the 3109, which runs through 3111, and then it cuts off. [00:11:32] Speaker 04: It appears the court admitted that evidence subject to striking. [00:11:37] Speaker 04: Did the court strike that evidence? [00:11:41] Speaker 03: The court never made a ruling on whether it was striking the testimonial description of the exhibit, which it did strike. [00:11:48] Speaker 03: The court's ruling, excluding the exhibit from Dr. Burns' testimony, is at 29-11-5-8. [00:11:57] Speaker 03: So the court was here encoding arguments after the trials, several weeks after, and said, go on, subject to striking. [00:12:04] Speaker 03: And the court never made a ruling. [00:12:06] Speaker 03: So we never got any resolution on that. [00:12:11] Speaker 03: I'm going to reserve the rest of my time. [00:12:25] Speaker 01: Council. [00:12:25] Speaker 01: Please, the court. [00:12:25] Speaker 01: My name is Dave Conlon, and I represent ESA and COA, ESA and Chemical and COA in this proceeding. [00:12:33] Speaker 01: To answer the last question in a minute, [00:12:35] Speaker 01: There was never a motion to strike. [00:12:37] Speaker 01: And in fact, the court did not strike the exhibits. [00:12:43] Speaker 01: The court instructed Dr. Byrne that because he had not treated those in his expert report, he could not talk about those exhibits. [00:12:52] Speaker 01: The court did not tell the doctor that he couldn't comment [00:12:58] Speaker 01: what was happening in trial. [00:13:00] Speaker 01: And indeed, he sat through the whole trial to monitor that and see what the answers are. [00:13:09] Speaker 01: So the evidence that's put forth and that's recited by the court below is filled with evidence that's based on experimentation. [00:13:28] Speaker 01: And probably the best evidence that was before the court is objected to by my opponent at page 50 of his brief. [00:13:39] Speaker 01: He says, the district court further erred in relying on a section of Nissan's drug master file for the extraordinary influence that Nissan ensured the production of Form A instead of Form E or others. [00:13:54] Speaker 01: by making sure that the water content remained within an unspecified range controlled by applying unspecified drying conditions to Nissan's crystallization process. [00:14:07] Speaker 01: And there it goes on to say, the district court's willingness to assume the existence of empirical data from statements to the FDA is both improper and troublingly selective. [00:14:23] Speaker 01: Your Honor, as I direct you to volume three of the appendix, page number 15739, and this is actually one of the pages that's cited at that point in page 50 of the brief. [00:14:40] Speaker 01: And there under section 15739, and there under section 3.3.1, [00:14:53] Speaker 01: which is entitled Critical Steps and Critical Process Parameters. [00:15:00] Speaker 01: The penultimate paragraph of that text says, in pitavastatin calcium drying step, it had been confirmed that the drying temperature and water content are linked to a crystal form change and a 5-ketone, that's an impurity increase, in pitavastatin calcium. [00:15:24] Speaker 01: These were also evaluated as high criticality parameters. [00:15:30] Speaker 01: Below in that little chart, it says critical steps and critical process parameters. [00:15:37] Speaker 01: The critical step is the drying step. [00:15:40] Speaker 01: And the specific limitations are putting on the drying temperature of less than or 40 degrees C, less than or equal to. [00:15:47] Speaker 01: And specific limitations were put on the drying end point. [00:15:51] Speaker 01: But drying end point's water content [00:15:54] Speaker 01: a little meld between Japanese and English, of 10.0 to 12.0%. [00:16:03] Speaker 01: The answer is very clear. [00:16:05] Speaker 01: All of this evidence that Dr. Byrne reviewed, that the court exhaustively treated, indicates that the form of this polymorph can change depending upon what the drying conditions are. [00:16:24] Speaker 01: They're not specified in that example. [00:16:27] Speaker 01: And the two points that have been submitted clearly don't establish inherency. [00:16:36] Speaker 01: Now, one of the things that's missing here is there is absolutely no expert opinion rendered on inherency on behalf of the other side. [00:16:47] Speaker 01: The expert they had was found to be incompetent to reach that opinion. [00:16:53] Speaker 01: So we're here at the court today without an opinion to that point. [00:16:58] Speaker 01: All we're relying, all the other side is relying on is those two data points and what they can make of them. [00:17:04] Speaker 02: Is there anything in the record to suggest that there is what I would characterize as sort of normal drying conditions that would be recognized as the way to go? [00:17:20] Speaker 01: ranges and approaches. [00:17:23] Speaker 01: So for example, Dr. Sesler, who is their expert on processing, he pointed out that it's a very broad range. [00:17:33] Speaker 01: It could be air-dried. [00:17:34] Speaker 01: It could be oven-dried. [00:17:35] Speaker 01: It could be vacuum-dried. [00:17:37] Speaker 01: And in fact, both of those examples that were submitted to the European Patent Office, those were both vacuum-dried. [00:17:46] Speaker 01: There are a wide variety of ranges of things that could be done. [00:17:51] Speaker 02: I didn't see anything in the record to suggest that there was sort of a normal range that persons of skill in the art would be expected to use in every case, and that going outside that range would be highly unusual and ill-advised, for example. [00:18:10] Speaker 01: There is no such disclosure. [00:18:11] Speaker 02: Because at least if that was in the record, maybe the argument could be made that absent [00:18:16] Speaker 02: any evidence to the contrary, one could necessarily expect Form A to be formed under normal conditions. [00:18:24] Speaker 01: There is no such disclosure. [00:18:25] Speaker 01: And in fact, if you look at the example itself, it doesn't even say they were dry. [00:18:32] Speaker 01: That was the conclusion that the experts said that probably there was some drying going on, because you don't want it wet to the touch when you're doing a melting point or something like that. [00:18:43] Speaker 01: And they did give a melting point for it. [00:18:45] Speaker 01: But there's no real suggestion of any particular range of conditions which should be followed through on. [00:18:57] Speaker 01: My opponent insists that the district court ignored those statements to the European examiner. [00:19:03] Speaker 01: And I have to say that is clearly not correct. [00:19:06] Speaker 01: The court dealt with Amniel's contentions regarding those matters from paragraphs 90 through 155 of the opinion. [00:19:15] Speaker 01: And particularly in paragraphs 150 to 154, they dealt specifically with those examples. [00:19:25] Speaker 01: The information concerning the statements of Nissan's patent attorney to the European examiner was also presented at least three times to the US examiner before the patent was issued. [00:19:39] Speaker 01: Those statements and the one or two Nissan data replications [00:19:43] Speaker 01: had to be weighed against all of the other evidence in the case. [00:19:48] Speaker 04: Well, the court was careful in doing it. [00:19:49] Speaker 04: I mean, at 154 or so, he says, this is a close question, if there was evidence the other way, and so on. [00:19:58] Speaker 01: I think you're right on point. [00:20:00] Speaker 01: I don't even have to make that point. [00:20:02] Speaker 01: I think the other thing I wanted to mention is this treatment of Dr. Byrne. [00:20:06] Speaker 01: Dr. Byrne didn't come up with a theory. [00:20:10] Speaker 01: when he heard Soai's expert witness. [00:20:14] Speaker 01: His theory was the same from the very beginning of the case. [00:20:18] Speaker 01: His theory was the same in his reports, in his expert deposition, and in his testimony. [00:20:24] Speaker 01: This is nothing that was dreamt up by listening to Dr. I can't think of his name at the moment. [00:20:36] Speaker 01: I think, Your Honors, that [00:20:41] Speaker 01: With those thoughts, I think you have an understanding. [00:20:47] Speaker 01: You've obviously read the opinion and I think when you read the application itself and the example, one of the things you won't get is the statement on page 16 of the brief which said, [00:21:09] Speaker 01: that the 406 application was directed to the preparation of polymorphs of pitavastatin. [00:21:16] Speaker 01: When I heard that, when I read that, I said, what? [00:21:20] Speaker 01: And then a few rounds later down, it says, Amiel goes on to say, in example three, Nissan set forth a process by which to make a certain polymorph of pitavastatin. [00:21:31] Speaker ?: What? [00:21:32] Speaker 01: It's not the case. [00:21:33] Speaker 01: Suffice it to say that that's not the case. [00:21:36] Speaker 01: Amiel bears a full burden to prove that example three produces form A each and every time without fail by clear and convincing evidence. [00:21:48] Speaker 01: Yet the challenge is without support of expert opinion or inherency and is contrary to a mass of evidence that the court review. [00:21:59] Speaker 01: Are there any further questions? [00:22:01] Speaker 01: Thank you, counsel. [00:22:02] Speaker 01: Thank you. [00:22:12] Speaker 03: We should admit they applied the wrong standard, but if that's the right standard, then if a patentee is attacking a claim, and it's in their interest to say it's inherent, and they do replications, and they make their conclusions, and they give it to the patent office, and they say, this teaches inevitable production of that claim, and then they buy it, and then they can get an expert to say, well, maybe not. [00:22:36] Speaker 03: It is kind of as simple as that. [00:22:39] Speaker 00: Even if we agree with you on all of that, the problem for you is the standard of review, which is clear error. [00:22:49] Speaker 00: And even if you think they went out and purchased an expert opinion to say what they wanted to say, the district court accepted it. [00:22:58] Speaker 00: It's an abuse of discretion standard for us if we were to consider to exclude it. [00:23:02] Speaker 00: And that expert report supplies [00:23:04] Speaker 00: evidence for the district court's conclusion, and it renders it not clear air. [00:23:08] Speaker 00: What can we do about it? [00:23:09] Speaker 03: Well, a couple things about the expert opinion that they accepted their credit and the district court credited. [00:23:15] Speaker 04: Well, the district court didn't more than credit that expert opinion. [00:23:17] Speaker 04: The district court rejected your expert opinion. [00:23:20] Speaker 03: We did not offer an expert opinion as to what the disclosure teaches. [00:23:25] Speaker 03: We said Nissan says what the tool teaches. [00:23:29] Speaker 03: I guess at one point, do we say a company has got [00:23:33] Speaker 03: Surely it must mean something that Nissan scientists went there and replicated it and said, yeah, it teaches it inevitably, and then told the patent office when it was in their interest to do so. [00:23:45] Speaker 03: And then when they bought it and it was no longer in their interest to do so, they tried to flip and the patent office said, no, no, no, you are what you are. [00:23:53] Speaker 03: Science shouldn't change. [00:23:55] Speaker 00: Nissan science shouldn't change based on what adults do. [00:23:59] Speaker 00: the United States Patent Office and not a patent office. [00:24:02] Speaker 00: I understand your frustration. [00:24:03] Speaker 00: It does seem like they're being inconsistent here, but if they can get a patent granted and they can get a district court to make factual findings that are supported by an expert testimony, even if you think all of that is inconsistent with what they were doing in the European Patent Office, what can we do on a clear error standard review? [00:24:21] Speaker 00: If we're not going to throw out the expert's opinion, which we're not, and we're going to operate under a clear error standard, [00:24:29] Speaker 00: which we are, then doesn't that expert's testimony provide support for the district court's decision and make it not clear error? [00:24:37] Speaker 03: The expert's testimony, his evidence, is there may be some conditions, I won't tell you what, under which this won't produce formant. [00:24:46] Speaker 03: There's no doubt. [00:24:47] Speaker 03: That's what his evidence is. [00:24:49] Speaker 03: Now, is that, as a matter of substantive law, enough evidence when the patentee itself has said to the contrary? [00:24:56] Speaker 03: If you look at Omeprazole, in this court said, [00:24:59] Speaker 03: Listen, if you had any evidence to the contrary, it's the same situation. [00:25:02] Speaker 03: Patentee did replications, said what they said. [00:25:06] Speaker 03: They said, if you had any actual empirical evidence, this was the time to come forward, giving us an expert opinion where the expert didn't even find out what you had done before. [00:25:17] Speaker 03: And Dr. Burns said, I didn't take any effort to understand why Nissan said what they said. [00:25:23] Speaker 03: That's inherent. [00:25:26] Speaker 02: But it was your burden throughout to prove by clear and convincing evidence that under all reasonable drying conditions that it necessarily would result in Form A. And you didn't do that. [00:25:47] Speaker 02: So Dr. Byrne comes back and says, you know, these two points that they've provided, yes, Form A [00:25:56] Speaker 02: results. [00:25:57] Speaker 02: But drying conditions, crystal formation is complex, and drying conditions aren't specified. [00:26:06] Speaker 02: And the humidity and drying circumstances may have a result. [00:26:11] Speaker 02: It may be for me. [00:26:12] Speaker 02: It may be something else. [00:26:15] Speaker 02: So I think Dr. Byrne is simply pointing out where your evidence was deficient at the outset. [00:26:26] Speaker 03: So it was good enough for Nissan when it was in Nissan's interest, but not good enough when it was against Nissan's interest. [00:26:34] Speaker 02: What do you perceive the Nissan science? [00:26:36] Speaker 02: Well, of course, if you look at that argument in the European case, the witness was talking about a particular experiment and said that if you follow example three, it inevitably will form a [00:26:56] Speaker 02: But that was with respect to a specific set of circumstances. [00:27:03] Speaker 02: It wasn't as broad a sweeping statement as you're suggesting, because he didn't say under all circumstances for drying, it would produce form A. Well, at some level, I guess I'm saying I don't think you stated the standard correctly, because it shouldn't be [00:27:26] Speaker 03: that you have to demonstrate that it's impossible to produce something else. [00:27:30] Speaker 03: You should do what this court said you need to do. [00:27:33] Speaker 03: You said you don't need to prove it's impossible in Smith County. [00:27:36] Speaker 02: Yeah, I'm not suggesting that you have to show it's impossible. [00:27:40] Speaker 02: But you do have to show that it necessarily, under reasonable conditions, would result in that. [00:27:48] Speaker 03: So how many different driving conditions is going to be the answer? [00:27:52] Speaker 04: Well, if you're going to ask questions in the court, [00:27:54] Speaker 04: Your time's long past.