[00:00:00] Speaker 03: The first case this morning is Sun Pharmaceutical versus Insight Corporation. [00:00:04] Speaker 03: Mr. J, when you're ready. [00:00:06] Speaker 03: Have you done something different with your time? [00:00:09] Speaker 00: I have not, Your Honor. [00:00:10] Speaker 00: I think the clock should be 15. [00:00:12] Speaker 03: The clock says, OK. [00:00:13] Speaker 00: Yeah. [00:00:14] Speaker 00: You reserved four minutes, right? [00:00:15] Speaker 00: That's correct. [00:00:16] Speaker 00: OK. [00:00:16] Speaker 00: Thanks. [00:00:17] Speaker 00: When you're ready. [00:00:18] Speaker 00: Thank you very much. [00:00:18] Speaker 00: Good morning, Your Honors. [00:00:19] Speaker 00: I may please the court. [00:00:20] Speaker 00: William J. for the appellant, formerly Concert, now part of the Sun. [00:00:24] Speaker 00: The board took a series of shortcuts in this case. [00:00:27] Speaker 00: And those shortcuts resulted in legal errors. [00:00:29] Speaker 00: And those legal errors infected how it treated motivation, how it treated reasonable expectation of success, and how it resolved the objective indicia. [00:00:38] Speaker 00: The board shortcuts let it disregard two important categories of evidence. [00:00:43] Speaker 00: One, about the uncertainty of how deuteration affects a drug's performance in the body. [00:00:49] Speaker 00: And the second is the objective evidence about the efficacy of Concert's deuterated product to treat AA. [00:00:55] Speaker 00: The board made no findings on either of those key points, and that is why we've asked the court to reverse. [00:01:01] Speaker 00: Insight tries to fill the gaps by citing its own evidence below. [00:01:05] Speaker 00: But of course, the board didn't resolve the factual disputes on these points. [00:01:09] Speaker 02: Are you saying the board didn't even make any findings on the predictability of deuteration and whether it would lead to success? [00:01:16] Speaker 00: We are basically saying that, Your Honor. [00:01:18] Speaker 00: And I think that the best place is to look for that. [00:01:22] Speaker 00: I think the top of page 31 in the board's [00:01:26] Speaker 00: decision that where the board says that for reasonable expectation in particular it's really just it's saying that you could make the deuterated compound and then in the alternative that these compounds may display superior ADME properties that's as far as it goes [00:01:47] Speaker 00: It doesn't say that there's a reasonable expectation that deuterated drugs with a litinib would display the properties that the board had identified as the motivation to make deuterated drugs with a litinib. [00:01:57] Speaker 00: May display is not a reasonable expectation of success, but that's as far as the board goes. [00:02:02] Speaker 02: What YAs may display not at least some reasonable probability of success? [00:02:08] Speaker 02: Can you point to any cases that say that would not be sufficient? [00:02:10] Speaker 00: Well, so a couple of cases about the definition of reasonable expectation, and then I would like to illustrate the context in the board's decision. [00:02:19] Speaker 00: But as far as the cases, I mean, [00:02:21] Speaker 00: This court said in Sanofi versus Watson that reasonable expectation basically means a scientifically reasonable likelihood. [00:02:28] Speaker 00: And in OSI, that hope is not enough. [00:02:32] Speaker 00: And I think that all the board is saying here is that there's a potential. [00:02:37] Speaker 00: It does not evaluate the reasonableness of that potential with respect to deuterated ruptualitinib. [00:02:42] Speaker 03: And I think that- I'm a little confused about what you're arguing, because the claim [00:02:47] Speaker 03: have specific pharmacokinetic limitations in them, right? [00:02:56] Speaker 03: It's just the compound claim. [00:02:57] Speaker 00: There are compound claims, but that has been true in each of these court's compound cases where it has assessed reasonable expectation [00:03:04] Speaker 00: with regard to whether the compound would be expected to display the properties that motivate you to make it. [00:03:10] Speaker 00: In other words, if there's a motivation to pursue a desirable property, then you wouldn't make the compound unless there is a reasonable expectation that you'd succeed. [00:03:18] Speaker 00: And I could rattle off a whole bunch of cases that involve compound claims. [00:03:23] Speaker 00: Don't claim the activity Takeda, Sanofi, Pfizer, UCB, Procter & Gamble. [00:03:27] Speaker 00: All of them compound claims. [00:03:29] Speaker 00: And all of them look at, for example, whether it would be a successful compound. [00:03:34] Speaker 00: That's exactly what the board did not do here in the reasonable expectation. [00:03:37] Speaker 00: All it looked at was, could you physically carry out the process of making the deuterated compound? [00:03:43] Speaker 00: And that is not sufficient when the motivation is to pursue the desirable ADME properties. [00:03:50] Speaker 00: That's what the board identifies the motivation as, but it never closes the loop and says that a skilled artisan would reasonably expect to succeed in achieving those desirable ADME properties in the body. [00:04:02] Speaker 00: I think that the unpredictability of deuteration is set out in the prior art. [00:04:08] Speaker 00: It's set out in the declarations. [00:04:12] Speaker 00: did not referee that dispute. [00:04:14] Speaker 00: I understand that that insight says in its brief that it thinks it was clear that deuterated ruxolitinib would display these properties, that a skill artisan would be able to foresee that. [00:04:25] Speaker 00: But you'll see in the brief that there are no citations to the board's findings on that. [00:04:29] Speaker 03: Isn't this a matter of degree? [00:04:33] Speaker 03: I mean, almost all chemistry is unpredictable in some sense. [00:04:38] Speaker 03: But that's not alone enough to render things [00:04:42] Speaker 03: non-obvious if there's at least some degree of certainty, isn't that right? [00:04:47] Speaker 00: Some degree of certainty, I think that's the important part of your question. [00:04:49] Speaker 03: Why doesn't the concert backgrounder give that teaching and also the motivation in that [00:04:58] Speaker 03: here's this, I mean, I think it's the business plan, right? [00:05:00] Speaker 03: We're going to take previously known compounds and deuterate them. [00:05:05] Speaker 03: And some of them might work, some of them might not, but here's how you try it. [00:05:09] Speaker 03: And then you have the additional shilling reference, which teaches you specifically which hotspots to look at on this particular compound. [00:05:17] Speaker 03: Why isn't that enough to at least give you a path to how to make this compound? [00:05:24] Speaker 03: And then the concert, I'm sorry, backgrounder. [00:05:28] Speaker 03: tells you why that's desirable. [00:05:30] Speaker 03: Isn't that substantial evidence for motivation to combine? [00:05:37] Speaker 00: Your question was just about motivation to combine. [00:05:40] Speaker 03: Well, I'm sorry. [00:05:41] Speaker 03: And if you're talking about expectation of success, why doesn't the concert backgrounder excel [00:05:49] Speaker 03: tell you that in some cases it's going to work and in some cases it's not. [00:05:54] Speaker 03: But when you put all this elements together, this is not, nobody has thought of deuteration before. [00:06:00] Speaker 03: That's well known, right? [00:06:02] Speaker 00: Well, deuteration as a scientific concept is known, but there was no approved deuterated pharmaceutical approved for use in the human body at this time. [00:06:10] Speaker 00: So there's still much uncertainty about how these drugs would perform in the body. [00:06:15] Speaker 00: And so on the backgrounder, I mean, [00:06:18] Speaker 00: Statement at page 1740 of the appendix right in the background or that says that how they perform cannot be predicted a priori It's an important caveat in the background or that the board doesn't take adequate account of and on the previous page You see what right at the bottom where the board is talked Oh, sorry where the background or is talking about the potential the potential to achieve this these desirable properties, you know as speaking broadly across the category of deuterated products and [00:06:42] Speaker 00: Potential is what the board quotes twice, but it never follows through in establishing whether you would expect deuterated ruxolitinib. [00:06:52] Speaker 00: Now about the hotspots. [00:06:53] Speaker 00: It's true that there is the publication identifying [00:06:59] Speaker 00: hotspots for ruxolitinib. [00:07:02] Speaker 00: But that's the point of concert's evidence that just knowing the hotspots doesn't tell you how this is going to perform in the body, precisely because when you deuterate a compound, it may actually shift the location of the drug's metabolism in the body. [00:07:17] Speaker 00: That is something that the board did not address at all. [00:07:20] Speaker 00: It didn't. [00:07:21] Speaker 03: I guess what I'm struggling with here is this seems a pretty, it seems like everything that's neat [00:07:28] Speaker 03: needed to know to make this drug is after the partner art and the only question is whether somebody would have expected it to succeed in demonstrating beneficial characteristics but that's never going to be known until you just actually do the process and then test it right so under your theory even if we have a known compound [00:07:52] Speaker 03: We have a really well-known, easily done, and if you disagree with these facts, just assume it's a hypothetical, a really well-known method in the prior art to how to perform the deuteration and a specific reference telling you where you do the deuteration. [00:08:11] Speaker 03: It doesn't even have to be for this compound. [00:08:13] Speaker 03: It's for any compound. [00:08:15] Speaker 03: Is your position that unless you know with some degree of certainty that it's going to [00:08:20] Speaker 03: have increased beneficial results, even if everything else is obvious, it's still unexpected results. [00:08:28] Speaker 00: So more is known today than was known in 2012 about generation. [00:08:32] Speaker 00: So that's part of my answer. [00:08:34] Speaker 00: And I think I'd call the court's attention in particular to the points about 95, 65 from our expert about how little was known from in vivo testing. [00:08:45] Speaker 00: In other words, there were examples of in vitro testing. [00:08:48] Speaker 03: OK, I get that. [00:08:49] Speaker 03: But what I'm struggling with, and I'm trying to find the dividing line, is whether you're making a legal [00:08:54] Speaker 03: argument or a factual argument, because I think you have an uphill battle if it's a factual argument. [00:08:59] Speaker 03: But it seems to me you're making the legal position that, you know, just knowing the process, the compound, and where on the compound to target is never enough as a matter of law. [00:09:12] Speaker 00: Is that the argument you're making? [00:09:13] Speaker 00: No, I'm not saying that that's never enough as a matter of law. [00:09:16] Speaker 00: What I'm saying as a matter of law in this case is that the board just looked at whether you could make the compound. [00:09:22] Speaker 00: That's it. [00:09:23] Speaker 00: In other words, it never looked at whether you would reasonably expect it to display these properties in the body. [00:09:28] Speaker 00: So I think that it would vary from case to case about whether the patent challenger could show a reasonable expectation of success. [00:09:35] Speaker 00: We're not asking for some legal rule about deuteration. [00:09:38] Speaker 00: What we are asking for is for the court to say that it requires more than just you could deuterate the compound, and the compound as a class would display the potential for desirable effects in the human body. [00:09:49] Speaker 03: But again, that's getting back to what I'm struggling with, is before you actually do it, you're not going to know whether it works or not. [00:09:57] Speaker 00: And reasonable expectations of success doesn't require absolute certainty. [00:10:00] Speaker 00: We're not challenged. [00:10:01] Speaker 03: So what would that evidence look like, that in every single case, before you make it, you're not going to know whether it works or not? [00:10:10] Speaker 03: Where's the line between that as an accepted fact and what's enough to show that it's expected results instead of unexpected results. [00:10:19] Speaker 00: Well I'm not sure what the evidence would show today with priority date in 2023 but at the time of the priority here not much. [00:10:27] Speaker 00: Not that much was known. [00:10:29] Speaker 00: I think more would have to be known about how a particular class of drugs would perform in vivo, as to which there was no evidence. [00:10:37] Speaker 00: And in particular, some of the examples that Insight itself cited as examples of well-characterized products that had hot spots, [00:10:46] Speaker 00: We put in evidence before the board that once you test those products in vivo, they have unpredictable effects and sometimes actually go in the other direction from what you'd expect. [00:10:57] Speaker 00: We're not asking the court to refereed that here, but we are asking you to tell the board that it should have refereed that because the board did not do so. [00:11:03] Speaker 02: Can we come back to what has to be shown for reasonable expectation of success? [00:11:08] Speaker 02: You rattled off a list of cases. [00:11:10] Speaker 02: Your friend has talked about intelligent biosystems. [00:11:13] Speaker 02: They say we made a distinction there between motivation, where you can look at what the beneficial properties were, and reasonable expectation of success, which they say is limited to just what's claimed. [00:11:24] Speaker 02: Why is there a reading of intelligent biosystems wrong? [00:11:27] Speaker 00: So two things about intelligent biosystems. [00:11:29] Speaker 00: One is just the factual point that it's a method claim. [00:11:31] Speaker 00: It doesn't deal with the question of, [00:11:33] Speaker 00: how to deal with compounds in this lead compound context, which is what the court's looking at, and what the cases that I've rattled off are actually dealing with compound claims. [00:11:42] Speaker 00: But even if you took intelligent biosystems as sort of resetting the scoreboard and setting out the controlling analysis, what's important to note is that intelligent biosystems in that case said, okay, reasonable expectation is set, but [00:11:57] Speaker 00: In that case, we're going to look in the motivation bucket at this same category of stuff. [00:12:04] Speaker 00: Then that expectation will be central to motivation. [00:12:08] Speaker 00: Central is the word from the case. [00:12:10] Speaker 00: So it is less important to us which bucket you put the unpredictability of deuteration in. [00:12:16] Speaker 00: We think that the best way to read ticada and similar compound cases is that it belongs in reasonable expectation. [00:12:21] Speaker 00: But I think even if you looked at intelligent biosystems, it has to be resolved somewhere. [00:12:25] Speaker 00: whether you would expect the desirable properties on the priority date. [00:12:31] Speaker 00: Because if you don't, maybe you could make the product, but this court in reasonable expectation cases has always said it's a matter of would, not a matter of could. [00:12:38] Speaker 00: And the board here only answered the question of could. [00:12:41] Speaker 00: Can I just say one thing about Longfellow Need and then try to save my remaining rebuttal time? [00:12:45] Speaker 00: And that really is just that long felt need, none of this court's pharmaceutical cases, all of which say that the right way to look at long felt need is on the priority date. [00:12:56] Speaker 00: None of them has ever required that the product have achieved FDA approval on the priority date. [00:13:01] Speaker 00: That's never happened. [00:13:01] Speaker 00: And this court has regularly sustained showings of long felt need when there's something like a 15-year gap, as in Procter & Gamble, between when the patent application is filed and when the product actually comes on the market. [00:13:12] Speaker 00: So in this case, the board did not referee whether there was a long felt need. [00:13:18] Speaker 00: It just said, as a legal matter, we're not going to look at it because this is mere potential. [00:13:22] Speaker 00: Well, potential is exactly what this court has looked at, like, for example, the FDA fast track designation, which is exactly what this court cited in the ADAPT versus TEVA case as an indication. [00:13:31] Speaker 00: We have that too. [00:13:32] Speaker 00: The board should have looked at that. [00:13:34] Speaker 00: Unless the court has further questions, I'd like to say bye for now. [00:13:36] Speaker 00: Thank you. [00:13:37] Speaker 01: Thank you very much. [00:13:38] Speaker 01: Mr. Feldstein. [00:13:39] Speaker 01: Please, the court. [00:13:40] Speaker 01: Mark Feldstein on behalf of Appellee Insight. [00:13:42] Speaker 01: The case really is very much a factual case based on the court's findings. [00:13:48] Speaker 01: And in terms of structural obviousness, it's hard to imagine a case that's closer than this to obviousness. [00:13:55] Speaker 01: And essentially, as you're asking Judge Hughes, [00:14:00] Speaker 01: We have everything short of anticipation here. [00:14:02] Speaker 01: There are three kind of key points in terms of what the district, what the board found and what patent owners in fact conceded. [00:14:11] Speaker 01: Patent owners conceded that there's an expectation that Deuteronomy and Brux-Lytnib would [00:14:16] Speaker 01: retain the important properties of selectivity and potency. [00:14:21] Speaker 01: They substantially ignore the motivation to create a new compound based on the expectation of similarity, but that's in this court's decision in Ventus, which Pat Nohner actually recognizes. [00:14:34] Speaker 04: And the board's finding... How do you respond to Mr. Jay's argument that there was no [00:14:40] Speaker 04: Fact findings of the board with respect to the reasonable expectation of success in terms of pharmacokinetics [00:14:49] Speaker 01: So I think the board was right to say that reasonable expectation of success is the claimed subject matter. [00:14:57] Speaker 01: They went on to say that they further find, this is appendix 32, by a preponderance of the evidence that a skilled artisan would have had a reasonable expectation that synthesized Rux litinum analogs may display superior properties based on combined teachings of shilling and concert background, as explained in our discussion of motivation to combine. [00:15:19] Speaker 01: Is that enough over showing that it may display those properties? [00:15:23] Speaker 01: It's more than enough reasonable expectation of success because the expectation of success as per intelligent biosystems is that of the claimed subject matter and even if it were a requirement to have an expectation of success for what the motivation is in terms of it is enough because potential motivation is enough that's recognized in the Belden case [00:15:47] Speaker 01: You can't require absolute predictability. [00:15:50] Speaker 01: That's the Pfizer case that a patent owner essentially doesn't respond to. [00:15:54] Speaker 01: So yes, an expectation of potential improvement is enough for an expectation of success or expectation of success. [00:16:04] Speaker 01: to incorporate the motivating properties. [00:16:08] Speaker 04: When I was reading the board's opinion, at one point I thought to myself that the board really confused the two prongs, the motivation and the reasonable expectation of success. [00:16:24] Speaker 04: But what's your comment on that? [00:16:28] Speaker 01: I think this patent owner that Tried to confuse the issue about motivation expectation success and the board did its best to respond It said directly that you disagree with patent owner that expectation of success requires any properties and in terms of motivation it found that [00:16:45] Speaker 01: specific reason why a person of ordinary skill would deuterate ruxolitinib. [00:16:50] Speaker 01: They would deuterate it to obtain a compound with similar properties, potency and selectivity. [00:16:56] Speaker 01: They found a second reason to deuterate ruxolitinib to have the potential to improve its pharmacokinetics. [00:17:03] Speaker 01: They found specific reasons, specific motivation to do it at specific hot spots based on the teachings of Schilling and the background are combined. [00:17:11] Speaker 01: So to the extent there was confusion between motivation and expectation, I think the board did lay it out plainly in its expectation of success argument that in the first instance, expectation of success as intelligent file systems is the claimed invention. [00:17:29] Speaker 01: It's met here. [00:17:29] Speaker 01: There was no dispute about [00:17:32] Speaker 01: being able to synthesize and prepare the compound and then the board went on to say even if you incorporate motivation we find the expectation for potential improvement as well. [00:17:44] Speaker 02: Mr. Jay distinguishes intelligent biosystems as being a method case. [00:17:49] Speaker 02: What do you say to that distinction? [00:17:51] Speaker 02: And do you cite cases with new compounds where we've made the dividing line between reasonable expectation of success and motivation that you want us to agree to here? [00:18:02] Speaker 01: Sure, I don't think there can be a separate law for the scope of reasonable expectation of success for any patent. [00:18:13] Speaker 01: That intelligent biosystem has to speak to patent law as a whole. [00:18:17] Speaker 01: It can't be a special rule for expectation of success for [00:18:22] Speaker 01: chemical compounds. [00:18:23] Speaker 01: I think Intelligent Biosystems' explanation that sometimes motivation, or sometimes the motivating factor and the expectation bleeds into an overlap with the motivation to make the modification. [00:18:36] Speaker 01: And I think if you read Takeda, for example, in that light, the question that's being addressed, the fact finding from the district court is whether or not there was a motivation to modify the prior compound. [00:18:50] Speaker 01: they find that there was no motivation because you wouldn't have been had any reason to do it. [00:18:55] Speaker 01: You wouldn't have expected lower toxicity. [00:18:58] Speaker 01: And so I think while some of the reasonable expectations, excuse me, while some of the lead compound cases do use the words reasonable expectation success in each one that I've looked at is in the context of is there motivation and [00:19:12] Speaker 01: a finding on motivation, we agree or disagree there was a motivation. [00:19:16] Speaker 01: And so I don't see any cases that say separately an expectation of success for claim properties. [00:19:25] Speaker 01: There's the Sanofi case on bisphosphonates where they do address expectation of success, but there it seems, my reading of the case is it seems that there may have been no expectation of success to actually be able to make the bisphosphonate there. [00:19:41] Speaker 01: So I don't see any inconsistency between the statement of law as set forth in intelligent biosystems and the lead compound cases like Takeda or Aventis that work through whether or not there's a reason to make the modification. [00:20:01] Speaker 01: Here there was a reason to make the modification and that reason wasn't hypothetical or artificial. [00:20:08] Speaker 01: That reason was exactly what [00:20:11] Speaker 01: backgrounder caught you, deuterated the hotspots, and Schilling telling you exactly where that is for deuterated ruxolitinib, and then a whole host of chemistry telling you that for this type of molecule, with this type of metabolism and this type of oxidative metabolism, you should actually expect reduced metabolism in a kinetic isotope effect. [00:20:35] Speaker 02: I have some concern about the secondary considerations. [00:20:38] Speaker 02: You make the argument about [00:20:40] Speaker 02: whether the one compound is commensurate with the scope of the claims. [00:20:46] Speaker 02: That didn't appear to be an issue that was resolved by the board. [00:20:49] Speaker 02: Is it right that the board didn't resolve it? [00:20:51] Speaker 02: And if so, is that an issue we can decide in the first instance? [00:20:55] Speaker 01: Here you can decide it your honor because there's no disputed facts on whether or not the claims cover multiple compounds. [00:21:03] Speaker 01: There's no disputed facts on that some of the claims don't even cover. [00:21:07] Speaker 02: Sure but the compound that got all the attention it could be representative of the full scope of the claims. [00:21:14] Speaker 02: How do we know that it is or isn't. [00:21:15] Speaker 01: there's no evidence below, and there was no argument below that is representative of any other compound. [00:21:22] Speaker 01: In fact, what Padmore argues is that the metabolism is unpredictable on a compound-by-compound basis. [00:21:28] Speaker 01: And so they cite Victronix in their reply to say that this court can't decide things where there's [00:21:36] Speaker 01: substantial evidence in dispute and need for weighing. [00:21:39] Speaker 01: There's no substantial evidence in dispute or need of weighing to know that the CTP 543 is not even in the scope of some claims and is not co-extensive with the scope of any claim. [00:21:52] Speaker 02: I think they're further arguing that in your petition you only put maybe three compounds at issue and therefore they were entitled to respond at that level and not worry about the full scope of their claims. [00:22:03] Speaker 02: What's wrong with that argument? [00:22:05] Speaker 01: I think it's just wrong as a matter of law. [00:22:08] Speaker 01: I find it a surprising argument. [00:22:10] Speaker 01: We can show obviousness by showing that any subject matter within the scope of the claim is obvious. [00:22:15] Speaker 01: To show that a claim is non-obvious based on secretary of considerations, you have to, the burden is on the patent owner to establish nexus and commence certain scope. [00:22:24] Speaker 01: And so they have to establish that the full scope of [00:22:28] Speaker 01: of the claim is not obvious based on objective indicia. [00:22:33] Speaker 01: We can show obviousness based on any one point within the claim. [00:22:37] Speaker 01: I'll just mention on the long-felt need. [00:22:39] Speaker 01: I think that that was raised in Sun's opening remarks and focus of their brief that they continuously characterize what the patent office did as requiring FDA approval [00:22:54] Speaker 01: It's pretty quick to read that that's not stated anywhere in the board's findings on why they found an absence of Sun having established that it met a long-felt need. [00:23:09] Speaker 01: They said it was premature. [00:23:10] Speaker 01: There were admissions from counsel at the oral argument. [00:23:15] Speaker 03: This part troubles me a little bit because even though it doesn't seem like they went [00:23:20] Speaker 03: all the way and saying you have to get FDA approval. [00:23:23] Speaker 03: It does seem to suggest that they required something more than potential to treat the product. [00:23:31] Speaker 03: But potential to treat the condition, the potential to treat the condition is not good enough to satisfy a long felt need. [00:23:42] Speaker 03: I mean, it seems like that prong would almost never be satisfied in a pharmaceutical case because you would be patenting it before [00:23:50] Speaker 03: you know whether it's really going to work necessarily. [00:23:53] Speaker 01: Well, I mean, that's another way of saying I think that it's obvious when you're trying to patent it. [00:23:58] Speaker 01: And it is obvious when you're trying to patent it. [00:24:00] Speaker 01: And if later in time you can develop objective indicia that are not potential but actually showing that you met a long-belt need, good for the patent there. [00:24:09] Speaker 01: But you can't get a patent today on what speculative objective indicia you might develop later. [00:24:15] Speaker 01: And if you don't have that objective issue, if you don't have having met a long felt need, you can't rely on it. [00:24:20] Speaker 03: What if you come in, and again, this is hypothetical because I'm sure this is not necessarily the record in the case, that you patent this new deuterated compound and you've done enough work somehow, either initial trials or just because you've done this in other kind of areas with other kind of drugs, [00:24:39] Speaker 03: You say, well, this is probably going to work. [00:24:41] Speaker 03: And here's our evidence for why this is probably going to work. [00:24:44] Speaker 03: Would that be enough to satisfy long felt need? [00:24:49] Speaker 01: I don't know. [00:24:49] Speaker 01: I mean, I'd have to think about what the specific facts are. [00:24:52] Speaker 01: Here, it's notable that the patent doesn't ever anywhere address the long felt need for a treatment for alopecia areata. [00:24:59] Speaker 01: It doesn't teach using the compound for alopecia areata. [00:25:03] Speaker 01: It doesn't show any efficacy in alopecia areata. [00:25:05] Speaker 03: Are there other claims in this patent or patent family that deal with a specific treatment for alopecia? [00:25:10] Speaker 01: There's a later patent file that four years later that patent owner mentions that there's a separate PGR that's currently on appeal where later they claim the use of the drug for alopecia areata but it's not here. [00:25:23] Speaker 01: It's not this case. [00:25:24] Speaker 03: And what happened in that case. [00:25:26] Speaker 03: Sorry. [00:25:27] Speaker 03: What happened in that case. [00:25:28] Speaker 01: There, unfortunately, before you again on this will be the appellant. [00:25:35] Speaker 01: Those claims are valid. [00:25:38] Speaker 01: There the court found that the board found that you would be motivated to use this drug, but that we hadn't shown that you'd be motivated to use only this drug or preferably this drug, which we think is wrong under Novartis. [00:25:55] Speaker 02: Is that, does that happen to be the case that cited at page two of the gray brief, your other litigation with them? [00:26:00] Speaker 01: It is. [00:26:00] Speaker 01: It is the TGR. [00:26:02] Speaker 02: And they, of course, bring it to our attention. [00:26:05] Speaker 02: I think evidently the board said something there about deuteration of compounds was not predictable. [00:26:11] Speaker 02: Should we make anything of that in this other case that you all have? [00:26:15] Speaker 01: I don't think that it, I don't think it was proper to cite that here as evidence in this case. [00:26:21] Speaker 01: So I don't think that it pertains, but you know, to the extent you consider it, the board found, I mean there, [00:26:29] Speaker 01: The 149 patent, the patent that's subject of this case, is the prior art in that case. [00:26:33] Speaker 01: And the CTP 543 compound 111 in this patent is fully disclosed. [00:26:39] Speaker 01: And the question is whether you would use it to treat alopecia areata or not. [00:26:44] Speaker 01: And so it's a separate question in whether the compound is obvious based on the backgrounder and shilling and prior art. [00:26:55] Speaker 01: Thank you. [00:26:56] Speaker 01: So in terms of long-felt need, back a little bit to what you're asking Judge Hughes, the problem that, or the context here, is that there were prior treatments for alopecia areata. [00:27:10] Speaker 01: So ruxolitinib itself was taught for alopecia areata. [00:27:14] Speaker 01: And what [00:27:15] Speaker 01: Concert below Sun below tried to argue was they need to argue that there was some long-felt need that hadn't already been met by Roxalytinib and so the way they framed it over and over again was oh there's a need for FDA approval and that carries through the briefs it carries through into in the amicus brief that there was a need for an FDA approved drug and that the problem for Sun here is that there's no way they can define a [00:27:43] Speaker 01: a long-felt need that they met that ruxolitinib doesn't already met. [00:27:48] Speaker 01: If you define it as a potential utility in alopecia rata, ruxolitinib was already taught for that, as was topocitinib, another JAK inhibitor. [00:27:57] Speaker 01: And so the potential that they show isn't enough, especially where there wasn't need for a potential. [00:28:05] Speaker 01: That was already taught by ruxolitinib. [00:28:07] Speaker 01: They continuously framed it as something higher [00:28:10] Speaker 01: And what the board found is that they didn't establish the potential, anything about potential. [00:28:17] Speaker 01: OK, thank you. [00:28:17] Speaker 01: Thank you. [00:28:18] Speaker 01: Lee. [00:28:19] Speaker 00: Just a couple of points on reasonable expectation and a couple on secondary considerations just to run through the cases on Whether Takeda and Procter & Gamble which is I think what my friend meant to say are talking about reasonable expectation or motivation and again, I don't think that the [00:28:42] Speaker 00: As long as someone answers the question in one of the two buckets, I don't think it matters, but analytically, Takeda says, no reasonable expectation that piaglitazone would possess the desirable property. [00:28:51] Speaker 00: Procter & Gamble, in a paragraph at 996, headed, reasonable expectation of success. [00:28:55] Speaker 00: No reasonable expectation in 1985 that resedrinate would be a successful compound. [00:28:59] Speaker 00: And those are compound cases, and those are not claimed properties. [00:29:03] Speaker 00: But the court is nonetheless looking at whether the desirable property would be expected to be found. [00:29:10] Speaker 03: Why do you think we said that? [00:29:11] Speaker 03: It seems odd to me that you have to show that it would work for something that's not in the claims when all the claim is to the compound. [00:29:20] Speaker 03: Why shouldn't you just show somebody could reasonably, based upon the prior art, make the compounds? [00:29:25] Speaker 03: I know we're bound, but I'm just curious. [00:29:26] Speaker 00: Yeah, but I think it's all about would versus could. [00:29:28] Speaker 00: It's a hundred percent about would versus could there are lots of things that a skilled artisan could do if with the With the synthetic chemistry at their disposal, but why wouldn't that come under? [00:29:38] Speaker 03: Motivation rather than expectation of success, right? [00:29:41] Speaker 00: So I agree that if motive if motivation you could look at it in motivation and say well I would like a compound that displayed these properties [00:29:50] Speaker 00: Would I expect this compound to be such a compound? [00:29:55] Speaker 00: That's one way of looking at it. [00:29:56] Speaker 00: Another is to say, here's a compound with the potential. [00:30:00] Speaker 00: Shall I make it? [00:30:01] Speaker 00: Well, you're going to ask whether you would reasonably expect to succeed. [00:30:04] Speaker 00: Again, not certainty. [00:30:05] Speaker 00: But at some point in one of the two buckets, you're going to look at whether this is not just a thing that you could do, but whether you would reasonably expect it to have the desired properties. [00:30:14] Speaker 00: And that is the finding that the board never made in this case. [00:30:16] Speaker 04: But what is it that you have to have a reasonable expectation of success? [00:30:22] Speaker 04: Is it the synthesis of the compound or the synthesis of a compound that performs and provides the [00:30:33] Speaker 00: Properties that you're looking for right you'd have to we think the right way to look at it is that it you would expect it to have At least one of the desired properties that is motivating you to pursue the new compound right and that that's The only thing that's motivating you is just the idea of making the compound [00:30:54] Speaker 00: So I think in this court's similarity cases, it is still said that there still has to be a reason or a motivation to pursue the things that are similar. [00:31:03] Speaker 00: In other words, you don't just go out. [00:31:05] Speaker 03: But this is a little bit about what we were talking about when you were out the first time, is I'm still a little confused about what that needs to be. [00:31:11] Speaker 03: Because if you have this teaching from the concert, here's the way you do it, and it could have [00:31:20] Speaker 03: benefits. [00:31:21] Speaker 03: Why isn't that enough to say, well, here's this compound, let's try to do to rate it because it might work. [00:31:28] Speaker 03: Isn't that, you know, in itself, it says sometimes it'll work and sometimes it's not. [00:31:32] Speaker 03: Isn't that enough for both motivation and [00:31:35] Speaker 00: reasonable expectation of success it doesn't have to be it will work it's we know this works and it's beneficial in some cases it doesn't have to be certain but that's not enough precisely because I mean and I think in 2012 as our expert explained at 95 65 95 73 74 and those are the best passages to look at [00:31:57] Speaker 00: that the points that you built into your question, Judge Hughes, those were not enough to make you conclude that a deuterated compound would work in the human body. [00:32:07] Speaker 00: There was very little in vivo evidence and no approved deuterated compounds at that time. [00:32:12] Speaker 00: No deuterated drugs had ever been approved at that time. [00:32:15] Speaker 00: And of course, also at that time, can I just do a little bit on long felt meat? [00:32:21] Speaker 00: I appreciate that very much. [00:32:22] Speaker 00: And so the commensurateness point was not resolved below. [00:32:26] Speaker 00: And one important thing to point out about that, Judge Stark, is that the board cited the fact that it wasn't resolving the commensurate [00:32:34] Speaker 00: question for why it was not looking at our substitute claim motion. [00:32:39] Speaker 00: It said, well, we don't need to address that because we have resolved the secondary considerations on a completely different ground, i.e., the Galderma percentage point that we agreed. [00:32:55] Speaker 00: for this court to then affirm that on some alternative ground when the board didn't reach our motion to amend because it was going off on this other ground. [00:33:05] Speaker 00: I think that would not be good use of the court's discretion. [00:33:09] Speaker 00: But ultimately, there is a factual dispute on this point. [00:33:12] Speaker 00: And if you send it back, the board would have the opportunity to look at that. [00:33:15] Speaker 00: And one of the things the board would have the opportunity to look at, if the record were reopened, [00:33:19] Speaker 00: This is a final written decision from four years ago, and a lot has happened with this product since then. [00:33:25] Speaker 00: We'd have the opportunity to supplement the record with our phase three data, with the breakthrough designation from FDA. [00:33:30] Speaker 00: I think we have your argument. [00:33:31] Speaker 00: Thank you, Your Honor, very much. [00:33:33] Speaker 00: Thank you. [00:33:34] Speaker 00: The case is submitted.