[00:00:00] Speaker 04: Mr. McBride, please proceed. [00:00:02] Speaker 02: Thank you, Your Honor. [00:00:04] Speaker 02: I deserve three minutes for rebuttal. [00:00:14] Speaker 02: May it please the Court, the patent trial on the appeal board made a legal error in applying the incorrect standard for inherent anticipation in its ruling on the 779 patent. [00:00:26] Speaker 02: It replaced the legal standard of inevitability [00:00:30] Speaker 02: with a standard of reasonableness. [00:00:32] Speaker 00: And can you point us to where you draw that conclusion from? [00:00:36] Speaker 02: Yes, Your Honor. [00:00:37] Speaker 02: If you look at the final written decision at around page 35, which is Appendix 35, that is the key section where, even though they've invoked the correct language up front, they then begin their analysis of the standard. [00:00:52] Speaker 00: But what about, I mean, well, they not only invoke the correct standard up front, but do they invoke the correct standard elsewhere in the opinion? [00:01:00] Speaker 02: Yes, Your Honor, they use the correct words in their conclusions. [00:01:03] Speaker 00: Yeah, and then on page 41, where it's a little similarity between what was said in 35, but it says, [00:01:12] Speaker 00: the CS2 was produced under all conditions utilized and that crystallization in all cases leads to. [00:01:21] Speaker 00: So there's a lot you would agree that there's a lot in the opinion that invokes the correct standard, the correct analysis. [00:01:29] Speaker 00: You rely on the one sentence from 35 [00:01:34] Speaker 00: It seems to say something other than that. [00:01:37] Speaker 02: It's the analysis that starts on 35 and goes through on to 36 into that section on their response to our argument that Dr. Bohofsky and ESI needed to actually show that if you vary the conditions, you would in fact get the same result to get informed CS2. [00:01:57] Speaker 02: Where is that on 36? [00:02:01] Speaker 02: It carries through, this sentence on 35 says, we're not of the view that inherency requires a showing that Example G inevitably produces form CS2 under all its conditions. [00:02:12] Speaker 02: They then go through their analysis of that and on 36 they talk about that it was appropriate for Dr. Bohofsky to pick out one or more exemplary points within the more general descriptions or ranges of parameters set forth in Example G. [00:02:25] Speaker 00: So do you disagree with that? [00:02:27] Speaker 00: I mean, they conclude that his experiments were probative of inherency in this proceeding because it was appropriate for him to pick up one or more exemplary points. [00:02:37] Speaker 00: You say that's wrong, that's error? [00:02:39] Speaker 02: We're not disputing that Dr. Bohofsky conducted a single experiment replicating Example G. That is probative, but it is not sufficient, Your Honor, for inherency, we would say. [00:02:49] Speaker 01: Okay, and how many different samples [00:02:53] Speaker 02: It's a very fact-dependent inquiry, Your Honor. [00:02:56] Speaker 02: I mean, when you take something like Example G, which has ranges for different temperatures, it has choices to be made at different conditions. [00:03:04] Speaker 02: I mean, the hallmark of the strict standard of inherency and showing of inevitability is you have to do replications, you have to do variations. [00:03:12] Speaker 01: But you don't necessarily have to do a test at every single point. [00:03:17] Speaker 01: Correct, Your Honor. [00:03:18] Speaker 02: And that's one of the places that the panel went wrong. [00:03:20] Speaker 01: And then the question is, well, all right, if you don't have to do it for every single point, then what's appropriate? [00:03:26] Speaker 01: And isn't the answer, it depends on the facts and circumstances as to [00:03:33] Speaker 01: how a person of literary skill in the art would consider reasonable. [00:03:38] Speaker 02: Yes, your honor. [00:03:39] Speaker 01: But that is the choice. [00:03:40] Speaker 01: And isn't that exactly what the board did? [00:03:42] Speaker 02: We would say they did not, your honor. [00:03:43] Speaker 02: I mean, we would say that they, in fact, said, starting on 35, that they were applying the incorrect standard. [00:03:49] Speaker 02: And if you apply the correct standard and you say, is that one experiment for something like Example G enough, that is not substantial evidence. [00:03:58] Speaker 01: They weren't setting a new standard. [00:04:00] Speaker 01: They were just commenting on the [00:04:02] Speaker 01: the types of proof necessary. [00:04:04] Speaker 01: They recited what the proper standard is several times in the opinion. [00:04:09] Speaker 02: They did recite the standard, but Your Honor, we would say that given that the way that they have articulated their rebuttal to our claim that you have to actually show variation in order to show inherency, that shows that they're not applying the correct standard. [00:04:24] Speaker 04: Okay, so for me, I looked at this case and [00:04:28] Speaker 04: At first, I was a little troubled, because what I would say, the prima facie case the board lays out has just two tests that were performed. [00:04:35] Speaker 04: And those two tests resulted in the CS2. [00:04:41] Speaker 04: But two tests doesn't seem like enough to prove always, as opposed to possible or probable. [00:04:47] Speaker 04: And so I was a little concerned by that. [00:04:49] Speaker 04: But then you all introduced a test that went the other way. [00:04:51] Speaker 04: And I feel that there was substantial evidence [00:04:54] Speaker 04: that the board articulated why your test was not performed under the right set of conditions and was suffering all these flaws and differences, and that when they redid that test, it again produced the crystal form and everything. [00:05:08] Speaker 04: And so I guess the question I have is, is there reason to think that two tests in this space isn't enough? [00:05:16] Speaker 04: And I think I agree with you. [00:05:19] Speaker 04: It's very fact dependent. [00:05:20] Speaker 04: But I don't know how many tests [00:05:23] Speaker 04: you need to prove, and I certainly don't think you have to prove one at every point in the entire range. [00:05:28] Speaker 04: I don't think that that could possibly be necessary to establish anticipation. [00:05:33] Speaker 04: So what's the magic number? [00:05:34] Speaker 04: I mean, maybe two isn't enough, but what is enough? [00:05:38] Speaker 04: You can't be right that the entire universe of parameters has to be tested for them to establish inherency. [00:05:44] Speaker 04: That can't be right. [00:05:46] Speaker 04: So where do we go? [00:05:48] Speaker 02: We're not saying you have to actually test the entire range of parameters. [00:05:52] Speaker 02: That is correct. [00:05:52] Speaker 02: You have to perform sufficient tests to show that under all possible parameters you would inevitably get it. [00:05:59] Speaker 02: The answer to your question is, again, it's very fact dependent, and I think you've zeroed in on exactly the problem here. [00:06:04] Speaker 02: We would actually say they only have one test for each of the two procedures, and they are two separate procedures, and that cannot be enough. [00:06:11] Speaker 00: You say one test because, as the Chief pointed out, we shouldn't be counting the tests that they gave in reply to your testing? [00:06:20] Speaker 02: Correct, Your Honor. [00:06:21] Speaker 00: But what if we disagree with that, so we put all the tests into the bucket? [00:06:26] Speaker 02: Well, in that case, Your Honor, they would have tripled their evidence by putting in, you know, two additional tests that we simply could not rebut. [00:06:33] Speaker 04: And yes, Your Honor, at that point we would be in... But you say you couldn't rebut. [00:06:35] Speaker 04: I mean, I don't... I think that what is fair is you performed a test under conditions [00:06:43] Speaker 04: I mean, you started with orange. [00:06:45] Speaker 04: You didn't even start with the right color. [00:06:47] Speaker 04: I mean, your test was really flawed. [00:06:50] Speaker 04: And so what they did is replicate it under the correct conditions and show that you do get the crystal. [00:06:56] Speaker 04: I don't see how that evidence should be excluded. [00:06:59] Speaker 04: It is directly rebutting your evidence. [00:07:02] Speaker 04: And yes, it is further confirming their prior evidence. [00:07:06] Speaker 04: I don't see what the problem is with that. [00:07:08] Speaker 02: Well, Your Honor, we're not disputing the findings with respect to our experiments by Dr. Rogers. [00:07:14] Speaker 02: And in doing so, we are taking off the table the reply experiments, which were a rebuttal to what he did. [00:07:20] Speaker 02: And I would say that if you now bring them in as support for the prima facie case, you're rewarding... You can't take them off the table. [00:07:27] Speaker 04: You're the one that introduced a crappy set of experiments. [00:07:30] Speaker 04: Then they showed what was wrong with them, and it further reaffirmed their prior finding [00:07:34] Speaker 04: That's on you. [00:07:36] Speaker 04: You're the one that introduced these flawed experiments and opened the door for them to introduce this other evidence. [00:07:41] Speaker 04: And now you're saying, okay, well, we withdraw our flawed experiments, so please don't look at the other evidence. [00:07:46] Speaker 04: That's not that way. [00:07:48] Speaker 02: Yes, Your Honor, and since we are saying that, we're saying we're taking our experiments off the table by not challenging the factual findings against them. [00:07:55] Speaker 02: And in doing so, those reply experiments... Let's say we disagree with you on that. [00:08:01] Speaker 00: So let's take it off the table. [00:08:02] Speaker 00: The statement that you rely on, and it seems to be that this is the heart of your argument, do you think that the standard requires that the petitioner show that the entire universe of parameters with respect to within example G produce blah, blah, blah? [00:08:23] Speaker 02: They need to produce sufficient evidence to show it's more likely than not that's the case, but they do not need to do actual experiments at every possible point. [00:08:34] Speaker 00: So I'm not exactly clear. [00:08:36] Speaker 00: It requires a showing that. [00:08:38] Speaker 00: So how do we do a showing that the entire universe of parameters produces this? [00:08:44] Speaker 02: You have to do sufficient tests that, for example, you have temperature ranges. [00:08:48] Speaker 02: You'd need to do more than one test. [00:08:50] Speaker 02: You need to test that range, perhaps the top and the bottom, depending on the width of the range. [00:08:55] Speaker 02: If you have other examples for heating or cooling to a particular point, you're going to need to do more than one test that shows at the edges and perhaps in the middle of those ranges. [00:09:08] Speaker 00: So your assumption is that heating or whatever may affect the results. [00:09:13] Speaker 00: So those experiments that you came up with on rebuttal worked to establish that, right? [00:09:20] Speaker 00: That they show a different result. [00:09:21] Speaker 02: I mean, the experiments that we're not bringing into the appeal were designed to try and rebut Dr. Bohofsky's work, yes. [00:09:30] Speaker 01: Is there anything in this record to suggest that testing at different parameters would produce a different result? [00:09:38] Speaker 02: There's no evidence in the record following example G or alternate example G that shows varying the parameters would or would not affect it. [00:09:48] Speaker 01: And am I correct? [00:09:50] Speaker 01: I think the board commented that the evidence that they examined suggested that it wouldn't make a difference. [00:10:00] Speaker 01: Changing the parameters wouldn't make a difference. [00:10:03] Speaker 02: Yes, Your Honor, and this is what we consider to be their flipping of the burden on us, which is that they then said that there was no evidence put in the record that other forms existed. [00:10:12] Speaker 02: And in doing so, they discounted the evidence showing that an amorphous form existed, which we think was also incorrect and shows not substantial evidence. [00:10:21] Speaker 01: So you're referring to the brief statement in the specification referencing an amorphous form? [00:10:27] Speaker 02: Yeah, it's three places in the specification, Your Honor, yes. [00:10:30] Speaker 01: But it also showed that that was unstable and would, I mean I don't want to read anything into this, but it seemed to suggest that it was unstable and would revert to a crystalline form. [00:10:45] Speaker 02: It did make statements about its stability, but as is known in the artamorphous forms, very often aren't the most stable of forms. [00:10:52] Speaker 02: That is correct. [00:10:54] Speaker 02: But, Your Honor, I think this goes to the point, which is when you look to see what the correct standard is of inevitability, we have the single experiment replicating the example G, nothing else. [00:11:05] Speaker 02: which, again, fails the standard on its own. [00:11:07] Speaker 02: But added to that, we have this evidence, discounted by the board, that there does exist an amorphous form. [00:11:14] Speaker 04: Can I ask why we are here? [00:11:16] Speaker 04: And what I mean by that is, suppose that you prevail on inherency, so the anticipation claim is gone. [00:11:26] Speaker 04: There was still obviousness here. [00:11:27] Speaker 04: And they found obviousness of claims seven and eight. [00:11:34] Speaker 04: I don't see how you would have any chance of prevailing against this exact same set of facts on the obviousness inquiry. [00:11:45] Speaker 04: So why are you here? [00:11:47] Speaker 04: Why is your client here? [00:11:49] Speaker 04: You're not going to win on obviousness. [00:11:51] Speaker 04: So whether you win on inherency right now or not, you're going to lose ultimately. [00:11:57] Speaker 04: And so why? [00:11:57] Speaker 04: Why are we here? [00:11:59] Speaker 02: Well, I would say, Your Honor, that the argument on obviousness hinged entirely on the inherency argument. [00:12:03] Speaker 02: It was not separately and distinctly put forward. [00:12:06] Speaker 02: And therefore, if inherency falls, anticipation and obviousness both fall. [00:12:10] Speaker 04: How in the world does obviousness fall? [00:12:13] Speaker 02: It falls because the argument was entirely predicated on the idea that you inherently get this form CS2. [00:12:20] Speaker 02: There was no separate argument other than that inherency aspect. [00:12:24] Speaker 04: OK, but if perhaps they didn't prove that it happens [00:12:27] Speaker 04: every single time. [00:12:29] Speaker 04: They proved that in every instance in this case it happened. [00:12:33] Speaker 04: So why would their obviousness argument be thrown out? [00:12:36] Speaker 04: They have evidence. [00:12:38] Speaker 04: I don't understand. [00:12:39] Speaker 02: And I do see that in my rebuttal time, Your Honor. [00:12:41] Speaker 02: But very quickly, I would simply say that this is perhaps a formalistic aspect of the way in which their obviousness argument was presented. [00:12:50] Speaker 02: It was not presented in any way other than the inevitability of the inherency argument. [00:12:54] Speaker 02: And I don't believe there was any disagreement that obviousness fell [00:12:58] Speaker 02: Rosen fell on inherency as well. [00:13:01] Speaker 02: And since I'm into my... Okay, that's okay. [00:13:02] Speaker 04: I'll ask them that question when I call. [00:13:04] Speaker 02: Thank you, Your Honor. [00:13:04] Speaker 02: We ask that you reverse the board. [00:13:21] Speaker 03: Good morning, Your Honors. [00:13:22] Speaker 03: May it please the Court? [00:13:23] Speaker 03: This is not a polymorph case. [00:13:25] Speaker 03: This is a nature [00:13:26] Speaker 03: driving the formation. [00:13:28] Speaker 04: Can you stop, not with your canned argument, but rather where we ended up, and just tell me, what about this obviousness question? [00:13:35] Speaker 04: Because he is saying that the way it was pled, and I 100% appreciate that whenever you have IPRs, you as the petitioner are limited to the four corners of what you actually petition for. [00:13:47] Speaker 04: So was your obviousness hinged entirely on adopting the inherency concept? [00:13:53] Speaker 03: Your Honor, our obviousness depended [00:13:55] Speaker 03: a lot on adopting the inherency concept. [00:13:57] Speaker 03: And we feel that the inherency concept was very strong. [00:14:00] Speaker 03: There is nowhere in the record that it was shown that there is any other form. [00:14:03] Speaker 00: You speak up a lot. [00:14:04] Speaker 00: I'm sorry. [00:14:05] Speaker 00: Pardon me? [00:14:05] Speaker 00: You speak up a lot. [00:14:06] Speaker 00: Sure. [00:14:06] Speaker 03: There is nowhere in the record that it was shown that there is any other form of lumbar accent other than personal form two. [00:14:14] Speaker 03: It is inherent in the formation of this act. [00:14:16] Speaker 04: Well, see, there's nowhere in the record it was shown that it isn't there. [00:14:20] Speaker 04: That is putting the burden on him. [00:14:21] Speaker 04: That's exactly not the way that it should be approached. [00:14:25] Speaker 04: It should be approached of, have you established? [00:14:28] Speaker 04: It always happens, that it is the natural result of, and always happens. [00:14:32] Speaker 04: So the fact that nowhere in the record was it established that it doesn't always happen, that is wrong. [00:14:39] Speaker 04: Let me tell you, if that's what you need to prove to win, you lose. [00:14:42] Speaker 04: Because that's not the law. [00:14:44] Speaker 03: Sarah, let me address your question. [00:14:46] Speaker 03: According to all the evidence in the record, CS2 is the only crystal form of limborexin, and there are no other polymorphs. [00:14:52] Speaker 03: There is no credible evidence of record that the amorphous form or any other solid form of limborexin actually exists. [00:15:00] Speaker 03: And as the board acknowledged, and that's at appendix 36, the inventors of the 779 patent did allude in the background section, the patent to having created this amorphous form by allegedly performing a different method, not Monets, [00:15:14] Speaker 03: in another ASI prior art patent, which was a completely different procedure, different reagents, different crystallization process, and it did not show that an amorphous form was actually obtained. [00:15:28] Speaker 03: Notably, the expert Dr. Rogers, who is crystal pharma's expert at Deposition, testified that he had seen no evidence of amorphous data that was referenced in the patent either. [00:15:38] Speaker 03: And there's no experimental mental evidence of record. [00:15:42] Speaker 04: The problem that I'm having with this case is that the initial prima facie case included only two tests. [00:15:52] Speaker 04: That's it. [00:15:54] Speaker 04: So for me, what I'm used to seeing in these inherency cases is some scientific analysis that shows [00:16:02] Speaker 04: And whenever you put the baking soda in with the vinegar, you have a volcano. [00:16:07] Speaker 04: Some scientific evidence, somebody walks me through why, when you do this to this, it's always going to result in that. [00:16:15] Speaker 04: And we don't have anything like that here. [00:16:17] Speaker 04: All we have is, well, we did two experiments, exactly two, one on each of the two things, and both of them turned out this way. [00:16:25] Speaker 04: So therefore, it's inherent. [00:16:26] Speaker 04: And I'm thinking, was it just Tuesday, and you got lucky? [00:16:30] Speaker 04: It's not their burden to prove it never happens. [00:16:32] Speaker 04: It's your burden to prove it always happens. [00:16:35] Speaker 04: And how does two experiments get you to always? [00:16:39] Speaker 03: So Your Honor, I would posit that there is substantial evidence in the record, far beyond two. [00:16:44] Speaker 03: There are two experiments. [00:16:45] Speaker 03: They were submitted in a size petition. [00:16:47] Speaker 03: They were conducted by Dr. Biowski. [00:16:49] Speaker 03: He followed two different processes within Monath. [00:16:52] Speaker 03: And he got crystal form two. [00:16:54] Speaker 03: and that the board explained this in this decision at Appendix 29. [00:16:58] Speaker 03: That's just two experiments. [00:16:59] Speaker 03: Right. [00:16:59] Speaker 03: The board went on to cite three internal batches, ASA's Lumbarexin, that were made using variations on the MONITS process in connection with innovative new drug product, Davigo, that ASA was selling. [00:17:11] Speaker 03: That's in Appendix 37. [00:17:13] Speaker 03: And the board explained its reliance on that evidence there. [00:17:16] Speaker 03: Well, explain that to me. [00:17:17] Speaker 04: What is its reliance on that evidence? [00:17:18] Speaker 04: I didn't see that. [00:17:19] Speaker 04: It's prima facie case. [00:17:20] Speaker 04: I saw that later in the opinion in response to one of their arguments or something. [00:17:24] Speaker 04: But when I say prima facie case, they've got exactly one paragraph. [00:17:28] Speaker 04: And they seem to hinge their conclusion of inherently entirely on the two tests, and they don't cite anything else other than the two tests, until they're then, I would say, rebutting the patentees argument. [00:17:40] Speaker 04: And that's my only concern is, did they flip the burden here? [00:17:43] Speaker 04: Because I don't think two tests standing alone are enough. [00:17:47] Speaker 04: And when I see them concluding their inherency, I see them relying on nothing but the two tests. [00:17:53] Speaker 04: And so then I see them rebutting and, OK, so you all proved it because you showed two tests. [00:17:58] Speaker 04: And I don't see them relying on all that other stuff. [00:18:00] Speaker 04: So help me. [00:18:01] Speaker 04: Where's the one paragraph that I'm worried about? [00:18:04] Speaker 04: Is it 29, I think? [00:18:06] Speaker 04: No. [00:18:06] Speaker 04: What page? [00:18:07] Speaker 03: so I would like to back you to Appendix 37 in the written decision. [00:18:11] Speaker 04: But 29, right, is where I'm talking about. [00:18:15] Speaker 04: Go to page 29 first. [00:18:16] Speaker 03: Okay. [00:18:17] Speaker 04: So if we go to 29... We are persuaded by and credit the testing evidence submitted with Dr. Bohofsky's and Dr. Mayo's initial declarations in support of the petition which shows that Form CS2 will naturally and inevitably result if a procedure follows the procedures of Example G. But it's clear that [00:18:36] Speaker 04: Everyone agrees. [00:18:37] Speaker 04: There's no dispute that only two tests were performed here. [00:18:43] Speaker 04: Just two. [00:18:44] Speaker 03: So, Anna, let me point you to Appendix 37, the final written decision, where the board goes through other evidence that it considers probative. [00:18:51] Speaker 03: And I would say that there is definitely support in the record that other probative evidence can be properly considered in finding inherencies. [00:19:00] Speaker 03: For example, in the Smith-Klein-Beacham case, Federal Circuit 2010. [00:19:03] Speaker 04: No, no, you stop. [00:19:05] Speaker 04: You said Smith-Klein-Beacham is not saved on page 37. [00:19:07] Speaker 04: You said go to page 37. [00:19:09] Speaker 04: So I'm now on page 37. [00:19:11] Speaker 04: What is it in particular you want to show me that constitutes something more than the board's simple reliance entirely on two tests to establish inherency? [00:19:22] Speaker 03: Sure. [00:19:22] Speaker 03: So let's start the top of page 37, where we're talking about Bergen's own Chinese patent application. [00:19:28] Speaker 03: Then the board states, in particular, as noted by Petitioner, patent owner's own Chinese patent application discusses 20 different embodiments, precipitating E2006. [00:19:37] Speaker 03: And that's the internal ASI code for Lumbarexin, using multiple different methods, all of which resulted in crystal form II. [00:19:45] Speaker 03: Then it goes on to talk about XRPD analysis of internal ASI batches. [00:19:49] Speaker 03: Then the board states, [00:19:50] Speaker 03: Likewise, we've considered the evidence in showing that XRPD analysis of Petitioner's own internally manufactured lots of limber accent from as early as 2010 showed the same characteristic peaks as the claimed form CS2. [00:20:03] Speaker 03: PattenOwer does not dispute that these other manufacturing processes from both PattenOwer and Petitioner also produced the claimed form CS2. [00:20:11] Speaker 03: Then if you look at the bottom of the page, there is a third line up from the bottom as evidence in this proceeding. [00:20:18] Speaker 03: goes on, as evidenced in this proceeding, Petitioner did submit its new drug application a day ago, in which it represented that there is only one crystal form of Lemporexin, no other polymorph. [00:20:28] Speaker 03: There is no evidence that this representation to the FDA made before the petition in this case was even filed was false or misleading. [00:20:36] Speaker 03: So we would posit that, while that is not the two experiments Dr. Biafsky conducted, the board definitely considered that, weighed this evidence appropriately, and found it probative [00:20:46] Speaker 03: and properly applying the standard for inherent anticipation here. [00:20:51] Speaker 04: So you did two experiments and you think that it's okay for the board to rely on your representation to the FDA that this is the only thing that will happen? [00:21:03] Speaker 04: I mean, I'm just, you know, it feels a little bit biased, like maybe that isn't. [00:21:08] Speaker 04: I'm used to seeing scientific literature. [00:21:10] Speaker 04: I'm used to seeing something that feels more objective in these inherency cases. [00:21:15] Speaker 04: And I just don't see that here, and that's what's bothering me. [00:21:17] Speaker 04: I'm not saying this maybe isn't substantial evidence, but boy is it weak. [00:21:23] Speaker 03: Well, to address your point on the statement that ASM made to the FDA, that statement was scientifically supported. [00:21:29] Speaker 03: And in the submission of new drug applications that contain crystal forms, the applicant must conduct extensive polymorph screening. [00:21:37] Speaker 03: This was backed by scientific evidence. [00:21:39] Speaker 04: And this was given to the board. [00:21:41] Speaker 03: The polymark screening? [00:21:42] Speaker 04: No, the FDA application in which the statement was made. [00:21:46] Speaker 04: So that it could see the board had in front of it how you're saying the application itself contained this explanation, this scientific explanation. [00:21:57] Speaker 04: The only thing the board quoted is this sentence, right, which it feels conclusory. [00:22:01] Speaker 04: But you're telling me the board did in fact have in front of it, as part of the evidence it was considering in this case, that FDA application, which included not just the sentence, [00:22:09] Speaker 03: but the scientific explanation. [00:22:24] Speaker 03: that the processes used there, which were consistent with MONIT, with a few variations, that also showed that those consistent processes made Crystal Form II. [00:22:34] Speaker 04: But let me ask you this, because I'm struggling with this part. [00:22:38] Speaker 04: So a few variations. [00:22:39] Speaker 04: I appreciate your candor. [00:22:41] Speaker 04: It is so important that litigants be candid. [00:22:44] Speaker 04: And I really am going to commend you on not overstating your case. [00:22:49] Speaker 04: because you're actually doing a really nice job, and it gives you immense credibility, quite frankly. [00:22:55] Speaker 04: So good for you. [00:22:56] Speaker 04: But these variabilities are part of what I just don't understand. [00:22:59] Speaker 04: On page 37, which you pointed me to, it's when it talks about the XRDP analysis, I think that [00:23:12] Speaker 04: Doesn't the board want to explain that these processes are different from example G and therefore maybe aren't necessary? [00:23:22] Speaker 04: It's not like these are right on point. [00:23:24] Speaker 04: They're maybe analogous. [00:23:25] Speaker 04: They're maybe close, but they're not the same. [00:23:28] Speaker 04: So it's not like this evidence is further evidence that when you do the exact procedure in example G, you will always get this thing. [00:23:38] Speaker 03: Well, Your Honor, I think why the board gave this evidence the way it did is because it really shows that all paths here lead to crystal form two. [00:23:45] Speaker 03: And that goes to Bergen's arguments kind of picking apart what Dr. Biazzi did, saying, well, you only chose certain data points within these ranges. [00:23:54] Speaker 03: Our argument would be [00:23:55] Speaker 03: Look, you could do monits. [00:23:57] Speaker 03: You could do variations on monits. [00:23:58] Speaker 03: You could do completely different procedures, like crystal formidate in its Chinese patent application. [00:24:04] Speaker 03: And you would still get crystal form II. [00:24:06] Speaker 03: There is no other form of limber exome that exists, period. [00:24:10] Speaker 03: So all paths lead to crystal form II. [00:24:13] Speaker 03: And I think that's why the board found that evidence probative. [00:24:16] Speaker 04: Is there any reason to think that variation was? [00:24:21] Speaker 04: So what you've shown is, OK, we tested it twice. [00:24:25] Speaker 04: using exactly the two different example G things and we got the crystal CS2. [00:24:31] Speaker 04: And then here's these other things that have happened where it was slight variations and it all resulted in CS2 crystallization as well. [00:24:40] Speaker 04: Is there any evidence at all that has ever been introduced in this case about [00:24:45] Speaker 04: varying parameters and you know whether or not that has any impact or are you saying that this evidence on thirty seven thirty eight kind of goes exactly to that point that there was in fact evidence of record that even though you are varying some of the parameters you're still getting CS2 you know is that [00:25:04] Speaker 04: What are your thoughts on that? [00:25:06] Speaker 03: So your honor, I'll answer that in two parts. [00:25:08] Speaker 03: So I think the evidence of Berger does show, even if you vary these parameters, even if you do completely different processes, like Bergen did in this Chinese priority application, you still get crystal form two. [00:25:17] Speaker 03: And I would also like now to mention the reply experiments that the board credits on appendix 24, where Dr. Biafsky did do additional variations within Monix. [00:25:27] Speaker 03: And of course, that was in response to the failed experiments of Bergen's own experts. [00:25:31] Speaker 03: Dr. Biafsky repeated those experiments. [00:25:34] Speaker 03: He used the right beginning material. [00:25:35] Speaker 03: It was off-white. [00:25:36] Speaker 03: It wasn't orange. [00:25:37] Speaker 03: He did two experiments tracking what Dr. Rogers did, and then he did two additional experiments to kind of address what might have been flaws in Dr. Rogers' methodology. [00:25:47] Speaker 03: For example, Dr. Rogers used a lot of filter material. [00:25:50] Speaker 03: It might have captured all the limbo exits. [00:25:51] Speaker 03: So in the end, there wasn't much left to solidify. [00:25:54] Speaker 03: So it was so additional. [00:25:56] Speaker 04: So you all believe you asserted, and even though [00:26:01] Speaker 04: maybe I think the record is a little sparse, you established that all roads lead to CS2 and crystallization. [00:26:08] Speaker 04: And then they said, no, it doesn't. [00:26:09] Speaker 04: And then you're like, really? [00:26:10] Speaker 04: It doesn't? [00:26:11] Speaker 04: Let us do five different experiments and vary a bunch of things, and all roads led to crystallization. [00:26:16] Speaker 04: That's correct. [00:26:18] Speaker 04: And so now they would like to discount your rebuttal evidence entirely because they say, OK, we withdraw our claim that ours didn't. [00:26:24] Speaker 04: But I mean, I just don't think it works that way. [00:26:26] Speaker 04: I don't think your rebuttal evidence could exist to fulfill [00:26:30] Speaker 04: your initial burden. [00:26:33] Speaker 04: But I think it could certainly further bolster your burden in response to their arguments about varying parameters or insufficient numbers or that kind of thing. [00:26:42] Speaker 03: Yes. [00:26:43] Speaker 03: I agree. [00:26:43] Speaker 03: We're not relying on that to make out the prima facie case. [00:26:46] Speaker 03: But we do see this as additional bolstering evidence, probative evidence, supplemental evidence that all paths lead to crystal form two. [00:26:52] Speaker 04: Did the board rely on the rebuttal evidence in a way that suggests it was sort of part of the date [00:26:59] Speaker 04: because that period I read you made it seem to me like they were just looking at these two experiments, full stop. [00:27:04] Speaker 04: And so I didn't really sense that they used the rebuttal evidence as what I would say is to meet your prima facie case. [00:27:11] Speaker 03: Yeah, that's correct. [00:27:13] Speaker 03: They actually expressly stated they were not relying on the rebuttal evidence as part of the prima facie case. [00:27:17] Speaker 03: If you look at appendix 40, footnote 12, [00:27:24] Speaker 03: I think that's a very important statement there, where the board states our overall conclusion would not change even if we were to disregard the additional experimental evidence submitted with Petitioner's Reply. [00:27:35] Speaker 03: So to your point, Your Honor, they did view that as additional probative evidence, supplemental evidence, that kind of addressed that concern that Bergen was waiving about just two experiments. [00:27:45] Speaker 03: We would posit there are far more than two in this record that gives substantial evidence to support the board's findings. [00:27:55] Speaker 04: I think you're good. [00:27:55] Speaker 04: Thank you very much, counsel. [00:27:57] Speaker 04: Why don't we give Mr. McBride his medal time. [00:28:00] Speaker 04: Thank you very much. [00:28:05] Speaker 02: But first, Your Honor, on the obviousness point, I just want to point to appendix page 41, where at ground two, which was the main obviousness point, the board said, we do not address the merits of this ground in view of our conclusion that claims 1-4 anticipated. [00:28:21] Speaker 02: So I would argue, as I said before, that the obviousness point rises and falls entirely on the basis of whether or not you find inherent anticipation. [00:28:31] Speaker 02: I would also point out, Your Honor, that at the end of the day where we are, under the correct legal standard, there simply is insufficient evidence to satisfy their burden of proof. [00:28:43] Speaker 02: This idea that all roads lead to form CS2 is simply a misnomer. [00:28:49] Speaker 02: I mean, first of all, we know that they don't all lead to CS2 because we have the evidence that there is an amorphous form. [00:28:55] Speaker 04: No. [00:28:55] Speaker 04: See, that's just not right. [00:28:56] Speaker 04: This is a substantial evidence standard of review. [00:29:00] Speaker 04: What you just said was 100% true when you were before the board. [00:29:03] Speaker 04: But before us, you can't just point to contrary evidence and say that overcomes the substantial evidence in the case. [00:29:12] Speaker 04: You have to prove to me there isn't substantial evidence. [00:29:15] Speaker 04: Not that there existed some evidence that would have supported a different outcome. [00:29:19] Speaker 02: Your Honor, on the idea that there is not substantial evidence, I would say that it rises and falls on whether or not you consider that single experiment replicating example G to be enough. [00:29:29] Speaker 02: We would say it does not, especially in light of the other evidence showing that in fact there is an amorphous form. [00:29:35] Speaker 02: specifically to this point that came up at the end, this idea that the REPLY experiments as well as the internal batches are somehow showing variations on the MONETS example G, is that if you look at [00:29:51] Speaker 02: Appendix 36, which is starting that section, they are describing these as, in fact, widely varying methods of precipitating Lemborexan. [00:30:01] Speaker 04: So these are not informative of what is happening with Example G. But that was in response to your argument that where they quoted at the top, the entire universe of parameters must be tested. [00:30:13] Speaker 04: So, I mean, I think that at a minimum, their response is to your argument. [00:30:21] Speaker 02: It is in response to our argument, but your honor, but this idea that this is a road leading to form CS2 according to example G or alternate example G is simply wrong. [00:30:30] Speaker 02: These are roads, different roads. [00:30:32] Speaker 02: They're not the roads we are looking for here. [00:30:35] Speaker 02: Example G and alternate example G are the roads to be traveled. [00:30:38] Speaker 02: And on those roads, there is only that single experiment. [00:30:41] Speaker 02: And that's what we think we're going to use. [00:30:42] Speaker 04: So what are the entire universe of parameters that you argued had to be tested? [00:30:46] Speaker 04: Tell me what those parameters are. [00:30:48] Speaker 02: In Example G and Alternate Example G, there are temperature ranges in the coupling reaction. [00:30:54] Speaker 02: Reaction has to be monitored to completion for at least 20 to 24 hours. [00:30:58] Speaker 02: Alternate Example G also has additional reagents being added when the reaction doesn't go to completion, a reactant called HATU, a reactant called fluoropyridine. [00:31:11] Speaker 02: The concentration in the extraction has to be [00:31:13] Speaker 02: done under reduced pressure to a minimum stirable volume. [00:31:16] Speaker 02: That is a general term that can be varied. [00:31:19] Speaker 02: There's no specific parameter there. [00:31:20] Speaker 02: And the isolation itself requires heating in no more than 50 degrees to achieve a clear solution, along with the n-heptane being added slowly with agitation. [00:31:29] Speaker 02: These are all critical process parameters that would be varied by personal skill in order to show inherency. [00:31:34] Speaker 02: And I say I'm over my time, Your Honor, so I apologize. [00:31:36] Speaker 02: But we ask that you reverse the board. [00:31:37] Speaker 04: Thank you very much. [00:31:38] Speaker 04: I thank both counsels. [00:31:39] Speaker 04: The argument was helpful. [00:31:40] Speaker 04: This case is taken under submission.