[00:00:00] Speaker 02: I appreciate it. [00:00:01] Speaker ?: Thank you. [00:00:01] Speaker 01: Thank you, Judge Wallach. [00:00:02] Speaker 01: May it please the court, John O'Quinn, on behalf of the appellant. [00:00:06] Speaker 01: This is a classic case of obviousness under KSR. [00:00:10] Speaker 01: Malancrot overreached to claim all oxymorphone compositions that meet the FDA mandated standard, no matter how they are made, even when made with well-known prior techniques. [00:00:23] Speaker 01: And this isn't a patent on Malancrot's particular process. [00:00:26] Speaker 01: It has another patent that claims its process. [00:00:30] Speaker 01: This is just a patent on the composition itself. [00:00:33] Speaker 01: And with respect to that, I respectfully submit that the key facts are undisputed. [00:00:38] Speaker 01: The issue before the court is what conclusion to draw from that. [00:00:42] Speaker 02: Mr. O'Quinn, you argue that the FDA in its mandate identified the problem, which is that oxymorphone infuriating, and put forth a solution, reducing concentrations to 10 parts per million or lower for ABUK. [00:00:59] Speaker 02: And that this provided a person of skill motivation to combine the prior art. [00:01:05] Speaker 02: How does an unspecified mandate to purify oxymorphone motivate a person of skill to combine the prior art in this case? [00:01:14] Speaker 02: Doesn't the FDA simply motivate a person to solve the general problem? [00:01:19] Speaker 01: So I agree, Judge Wallach, that what you have is akin to the Norgan case, quoting KSR, where what you have is a known problem, [00:01:28] Speaker 01: for which there was an obvious solution. [00:01:31] Speaker 01: And what this case, I think, looks a lot like is this court's decision in Distar, which was a pre-KSR case, but nonetheless recognized that there's an inherent motivation that comes from the prior art when you have a technology-independent problem. [00:01:48] Speaker 02: So the FDA's notification is irrelevant then? [00:01:52] Speaker 01: Well, I think the FDA's notification [00:01:55] Speaker 01: is a motivation as to why a person of ordinary skill in the art would want to have low ABUK oxymorphone. [00:02:03] Speaker 01: And oftentimes when you're fighting about what was the motivation, that's what you're fighting about, which is why would anyone even think to do this? [00:02:12] Speaker 00: Just for a second, I mean, if the prior combination is Weiss in view of Chapman, how does that general statement from the FDA, which I agree is strong evidence of something, [00:02:25] Speaker 00: How does that show specifically that one of our nearest gun the art would have been motivated to modify Weiss in view of Chapman? [00:02:32] Speaker 01: Yeah, I don't think we're not arguing that the FDA provided a specific Motive reference or motivation to combine specific prior art references what the FDA did was provide a motivation to use the prior art to solve the problem and You're saying well there was an obvious solution here. [00:02:53] Speaker 04: That's the question in the case and [00:02:55] Speaker 04: Sure, and I think... The big debate is whether or not Weiss and Chapman, in the eyes of one of ordinary skill in the arts, says, aha! [00:03:03] Speaker 04: It's obvious. [00:03:04] Speaker 01: I think that's right, Judge Klobuchar. [00:03:05] Speaker 02: Is oxycodone the same thing as oxymorphone? [00:03:08] Speaker 01: No, there's a slight difference between oxy... In terms of the chemical structure, there's a slight difference. [00:03:14] Speaker 01: Oxycodone has a methoxy group attached to it, whereas oxymorphone has a hydroxy group attached to it. [00:03:20] Speaker 01: Now, oxycodone is in fact a precursor to oxymorphone, [00:03:24] Speaker 01: And they are closely related. [00:03:25] Speaker 01: Indeed, this patent itself is predominantly, if you read the specification, a patent about purifying or reducing ABUKs in oxycodone. [00:03:35] Speaker 00: But we can't rely on that as evidence, right? [00:03:37] Speaker 00: I mean, that would be hindsight, right, to look at the specification. [00:03:43] Speaker 00: in that way. [00:03:44] Speaker 00: Use the specification to say, oh, this invention uses the same process, so therefore it must work. [00:03:50] Speaker 01: We can't do that. [00:03:52] Speaker 01: No, not at all, Judge Stolman. [00:03:53] Speaker 01: That wasn't my point. [00:03:54] Speaker 01: My point was, to the extent that there's a suggestion that there's some vast difference between oxycodone and oxymorphone, I think that is belied by the prior art, like Weiss itself. [00:04:06] Speaker 01: And I was just making the point that, indeed, in terms of the processes [00:04:10] Speaker 01: that the, the patentee came up with here, their own process applies to both as well. [00:04:16] Speaker 01: But my point is not that you look at the fact that there's work for oxycodone in any way as being dispositive. [00:04:23] Speaker 01: But coming back to the question that you asked, Judge Clevenger, I think in some sense that the issue about the FDA, about the FDA notice is a little bit of a red herring because at the end of the day, there's no dispute that that is what motivated [00:04:38] Speaker 01: a person of ordinary skill in the art to want to solve the problem. [00:04:41] Speaker 01: There's no dispute that the prior art taught... What else does it tell us? [00:04:47] Speaker 04: What else does the FDA mandate tell us for purposes of deciding this case? [00:04:51] Speaker 01: Sure. [00:04:51] Speaker 01: I think it tells you a couple of things. [00:04:53] Speaker 04: One is... I mean, it'd be like if there were a market demand for something and everybody said, well, gee whiz, I'd love it if an iPhone could do this or that. [00:05:00] Speaker 01: Well, I think that hits back to KSR. [00:05:03] Speaker 01: I mean, KSR teaches that [00:05:05] Speaker 04: What is it you want the FDA mandate to do? [00:05:10] Speaker 04: You want it to combine Weiss and Chapman? [00:05:13] Speaker 04: What do you want to happen? [00:05:16] Speaker 01: I think in many cases, the dispute is why would a person... You're not answering my question. [00:05:21] Speaker 04: I mean, I couldn't understand in the briefing what it was that once I decided that the FDA mandate meant what you thought it meant, what difference did it make to the case? [00:05:31] Speaker 01: Well, Judge Clevenger, I think it does a couple of things. [00:05:34] Speaker 01: One, the fact that the FDA issued this mandate and the fact that that is what everyone responded to in the industry and responded within a couple of years is highly relevant to the issue of simultaneous invention. [00:05:49] Speaker 01: Really? [00:05:49] Speaker 02: That it took them a couple of years to do it when it was so obvious? [00:05:52] Speaker 01: Well, Judge Wallach, you look at what the time was in the context of this is a drug that had been around for 100 years, had been approved by the FDA for 60 years. [00:06:06] Speaker 01: The FDA issues a mandate, and everyone responds to it in a couple of years' time. [00:06:14] Speaker 01: It's very similar to the facts in Georgia. [00:06:15] Speaker 04: Well, there's a large market for this stuff, right? [00:06:19] Speaker 04: And the FDA was saying what you're now selling isn't going to be on the market anymore. [00:06:23] Speaker 04: Well, and I think that the... So, I mean, that's what urges folks to leap forward. [00:06:29] Speaker 04: Let me put it this way. [00:06:30] Speaker 04: I still don't understand. [00:06:31] Speaker 04: I mean, your brief made a whole mountain out of the district court ignoring the FDA mandate or failing to treat it properly. [00:06:42] Speaker 04: I still don't understand what it is you want me to do with it. [00:06:44] Speaker 01: Well, I think at the end of the day, the significance of the FDA mandate for this particular case is this. [00:06:52] Speaker 01: In many cases, [00:06:53] Speaker 01: The idea, where the idea comes from is itself evidence that the invention is not obvious. [00:07:01] Speaker 04: The fact that somebody wouldn't have thought... Right, but you're talking about it in terms of making you to combine the references. [00:07:07] Speaker 04: And then I'm saying we'll combine... I couldn't understand it because it looked to me like the district court had Chapman in one hand and Weiss in the other. [00:07:16] Speaker 04: and is looking at both at the same time, trying to figure out whether either one or in combination get the trick done. [00:07:23] Speaker 04: Sure. [00:07:23] Speaker 04: Right? [00:07:24] Speaker 04: So that's combining references as far as I can tell. [00:07:27] Speaker 04: So what else would the FDA mandate have been doing? [00:07:31] Speaker 04: So I'm trying my best to pay careful attention to your brief and figure out what you're telling me. [00:07:37] Speaker 04: And I keep coming up with nothing. [00:07:40] Speaker 01: Well, respectfully, Judge Cleminger, I don't think there's anything that I'm going to say today that's going to add any significance to the FDA mandate. [00:07:48] Speaker 01: Let's move past that. [00:07:49] Speaker 00: Can I ask you a question, though? [00:07:50] Speaker 00: OK. [00:07:51] Speaker 01: Sure, Judge. [00:07:52] Speaker 00: Let's say I agree with you that the FDA mandate is prior to 1-2-F, and I agree that it should be relevant to the obviousness determination in some way. [00:08:01] Speaker 01: Sure. [00:08:02] Speaker 00: How do I get around the fact that I think that Judge Andrews, while he used some strong language at some parts and said it's not relevant [00:08:09] Speaker 00: And he later addressed it, at least with respect to reasonable expectation of success at page JA30. [00:08:18] Speaker 00: Right. [00:08:18] Speaker 00: I mean, how do you get around that fact-finding there, where he says that the FDA mandate wouldn't have provided a person born in U.S. [00:08:27] Speaker 00: again in the art with a reasonable expectation of success? [00:08:30] Speaker 00: Isn't that a fact-finding? [00:08:32] Speaker 01: Well, Judge Stoll, I think that the question of whether or not the FDA mandate [00:08:39] Speaker 01: would by itself, which is all he addresses at JA 30, whether that would provide a reasonable expectation of success is not the proper question for him to be asking in this case. [00:08:50] Speaker 01: The question is, would the prior art, which of course would include Weiss and Chapman, would that provide a person of ordinary skill in the art a reasonable expectation of success? [00:09:01] Speaker 01: And respectfully, he never answers that question. [00:09:04] Speaker 01: He never addresses Weiss or Chapman in the issue of reasonable expectation of success. [00:09:09] Speaker 01: In fact, the only thing he ultimately says about them is that they did not provide a, quote, definitive solution. [00:09:16] Speaker 01: That's in Appendix 24. [00:09:18] Speaker 01: And that's the only place that he talks about them. [00:09:20] Speaker 00: I understand you have that separate argument. [00:09:23] Speaker 00: Sure. [00:09:23] Speaker 00: OK. [00:09:24] Speaker 00: And I understand that. [00:09:25] Speaker 00: But I was trying to understand, with respect to your argument specifically about the FDA mandate, [00:09:32] Speaker 00: I understand your points about there's some positions taken with respect to whether it's relevant, whether it's prior art. [00:09:40] Speaker 00: But then, regardless, the judge seems to at least consider the FDA mandate. [00:09:46] Speaker 00: How do I deal with that? [00:09:47] Speaker 01: Sure. [00:09:48] Speaker 01: I don't think that there's anything inconsistent with the way that he considered the FDA mandate. [00:09:54] Speaker 01: And ultimately, our argument that what the FDA mandate does [00:09:59] Speaker 01: is provide a strong reason for a person to want to solve the problem of purifying oxymorphone. [00:10:06] Speaker 01: And that then leads you to the question of, okay, what with the tools that the person with the ordinary skill in the art had available to them, what would they have been able to do, and what would they have reasonably expected? [00:10:17] Speaker 00: And we know we... Was the FDA mandate like your primary reference? [00:10:20] Speaker 00: And then you'd modify or use voice? [00:10:23] Speaker 00: I mean, I'm just trying to [00:10:24] Speaker 00: Go back to the point that Judge Clavinger was making in trying to really understand what in your view it adds to the mix. [00:10:32] Speaker 01: What I think it adds to the mix is it is the market motivation that KSR talks about. [00:10:37] Speaker 01: KSR talks about when deciding questions of obviousness, the question isn't just do you find something together in the prior art and it says please combine X with Y or think about combining X with Y and maybe you'll get some good result. [00:10:49] Speaker 01: KSR threw all that out and said no, you can look [00:10:52] Speaker 01: to market conditions and other demands in deciding what to do with prior art. [00:10:57] Speaker 04: And so what the FDA mandates... Whether or not to combine prior art. [00:11:01] Speaker 04: Sure. [00:11:01] Speaker 04: And what... So, but I mean, why didn't... In what respect did the district court fail to combine prior art in this case? [00:11:10] Speaker 04: Fail to combine it? [00:11:13] Speaker 01: I don't know that the district court at the end of the day failed to combine... Well, then what's your argument? [00:11:18] Speaker 01: My argument is that... [00:11:21] Speaker 01: On the FDA? [00:11:23] Speaker 01: Well, my argument with respect to the FDA issue is that the district court didn't look at this case through the lens of KSR. [00:11:29] Speaker 01: It treated the FDA mandate as being irrelevant. [00:11:35] Speaker 02: It says that... But if the court had, given the findings that the court made, wouldn't the mandate cut against you? [00:11:46] Speaker 02: The strong motivation to combine, right? [00:11:49] Speaker 02: And you say, [00:11:51] Speaker 02: Well, a person of skill in the art would know instantly that it's obvious to take that action, right? [00:11:58] Speaker 02: Given that strong mandate, why didn't they? [00:12:01] Speaker 02: They did judge Waller. [00:12:04] Speaker 02: Oh, I don't think that's true. [00:12:06] Speaker 01: The issue with respect to catalyzing. [00:12:08] Speaker 02: Not based on findings in the court and the evidence before us from your opposing counsel. [00:12:13] Speaker 02: They themselves did multiple experiments involving both those references and others. [00:12:20] Speaker 01: There's a lot there, and it's kind of the crux of what I had hoped to talk about today. [00:12:24] Speaker 01: I know you're well in there. [00:12:27] Speaker 01: Let me say a few words about that. [00:12:29] Speaker 01: Because number one, when you look at the district court's opinion, the only place he addresses catalytic hydrogenation. [00:12:35] Speaker 01: And catalytic hydrogenation, we submitted, and you can see at appendix 2026, a quote from the inventor of, and it's within a brief, but it's a quote from the inventor of the dung patent. [00:12:46] Speaker 01: And the dung patent, which was involved in the interference with their patent, [00:12:50] Speaker 01: uses catalytic hydrogenation, using the same catalyst as involved in Weiss, and involved in Chapman, and very similar conditions in terms of temperature, pressure, and so forth, and achieves the result. [00:13:04] Speaker 00: So just to make sure I understand your argument, I'm sorry to interrupt you. [00:13:10] Speaker 00: But are you saying Deng, which was post the invention? [00:13:14] Speaker 00: Yes. [00:13:15] Speaker 01: It's not prior. [00:13:16] Speaker 00: You're saying that that shows that Weiss would have worked? [00:13:18] Speaker 01: Yes, it does. [00:13:20] Speaker 01: It absolutely does. [00:13:22] Speaker 01: And indeed, that's exactly what Dr. Gogol testified to at a number of places in the record, appendix 3038 to 3039 and 3042. [00:13:37] Speaker 01: That was subject to factual dispute, though, right? [00:13:42] Speaker 01: Well, it's not a dispute that the district court resolved. [00:13:45] Speaker 01: And that's a key point here. [00:13:47] Speaker 01: The issue is this. [00:13:48] Speaker 01: They don't claim a process. [00:13:50] Speaker 01: They claim the low ABUK oxymorphone no matter how made. [00:13:55] Speaker 01: And our argument is that it would have been obvious to a person of ordinary skill in the art that you could make low ABUK using, among other things, catalytic hydrogenation. [00:14:04] Speaker 01: The district court doesn't ever address the testimony from the co-inventor of the dung patent. [00:14:10] Speaker 01: It predicts 2026. [00:14:12] Speaker 02: Just be aware when that red light goes on, I'm going to make it stop. [00:14:17] Speaker 01: Yeah. [00:14:18] Speaker 01: Well, the last thing that I want to say then is we also have an issue of anticipation. [00:14:23] Speaker 01: The district court here rewrote the claims to say what Malancroc wished that they had said instead of what they actually claimed. [00:14:29] Speaker 01: And I'd point you specifically to claim four, which is itself the chemical structure formula. [00:14:37] Speaker 01: for the 14-hydroxymorphanone. [00:14:41] Speaker 01: And they want to say that even though they went to the trouble of actually laying out the chemical structure formula for 14-hydroxymorphanone freebase, and it's undisputed that's what it was, that that actually should be read as being 14-hydroxymorphanone hydrochloride. [00:14:55] Speaker 01: That's inconsistent with this court's precedence, and at a minimum this court should reverse the finding, reverse the claim instruction, and with it falls anticipation. [00:15:05] Speaker 00: I want to ask you a quick yes or no question. [00:15:07] Speaker 00: I'll do my best. [00:15:10] Speaker 00: In the court's opinion, it suggests that you argued that there should be no reasonable expectation of success requirement. [00:15:18] Speaker 00: Is that correct? [00:15:20] Speaker 01: I think there were some arguments below about whether or not that stands alone as a separate independent requirement, and that's not an issue that we're pursuing on appeal. [00:15:28] Speaker 02: Thank you. [00:15:30] Speaker 02: I'm going to give you a couple of minutes. [00:15:31] Speaker 01: Thank you, Judge Wallach. [00:15:44] Speaker 03: May it please the court. [00:15:46] Speaker 03: We had a trial in this case, the district court. [00:15:49] Speaker 03: We had experts who appeared. [00:15:50] Speaker 03: We had a theory that was proposed, which was that hydrogenation was somehow in the air, and the FDA mandate would have caused everyone to simply make low-A buck oxen or phone. [00:16:02] Speaker 03: The district court made very strong credibility findings with respect to the experts. [00:16:08] Speaker 03: He found that their position was not credible. [00:16:10] Speaker 03: Their burden was clearly convincing evidence. [00:16:14] Speaker 03: The FDA mandate is exactly what the judge said it was. [00:16:18] Speaker 03: It was a motivation to get to work. [00:16:20] Speaker 03: What's interesting about the case is the evidence, as Your Honor pointed out, showed that when a handful of companies who were capable of working with opioids did get to work, they had enormous problems in making low-abock oxymorphone. [00:16:32] Speaker 03: Malinkrott did several dozen experiments using double hydrogenation. [00:16:39] Speaker 03: They hired catalyst experts. [00:16:42] Speaker 03: They tried the most modern catalysts. [00:16:44] Speaker 03: They hired someone who was called a hydrogenation expert. [00:16:46] Speaker 02: Let me be clear about this, because this is where I read the record. [00:16:49] Speaker 02: Those were seriatim. [00:16:51] Speaker 02: Correct. [00:16:52] Speaker 03: Those were seriatim. [00:16:54] Speaker 03: What they actually did is they started a research plan where they said, we have no idea whether this is going to work. [00:17:00] Speaker 03: Even the testing methodology for determining at that low level what the concentrations are was new. [00:17:09] Speaker 03: So they tried bisulfite, which is what [00:17:12] Speaker 03: They eventually ended up patenting. [00:17:14] Speaker 03: They tried hydrogenation many times, failed. [00:17:17] Speaker 03: They tried chromatography. [00:17:18] Speaker 03: They tried another technique. [00:17:20] Speaker 00: Do you maintain the position that the FDA mandate is not relevant at all to motivation, and it's not prior art? [00:17:29] Speaker 00: No. [00:17:29] Speaker 03: I look at it this way. [00:17:33] Speaker 03: The judge clearly considered it, and he considered it for what it was worth, the motivation for people to get to work. [00:17:38] Speaker 03: The 102F point is kind of an interesting one. [00:17:41] Speaker 03: How does 102F relate to 103? [00:17:43] Speaker 03: What's prior art? [00:17:45] Speaker 03: I mean, if we filed a patent application today, I suppose yesterday's Washington Post would be a prior publication and it would count. [00:17:54] Speaker 03: It would really be prior art. [00:17:55] Speaker 02: Would it be fair to call it a motivation to act? [00:17:57] Speaker 03: Yes, it would. [00:17:58] Speaker 03: Motivation to act and motivation to get to work. [00:18:01] Speaker 00: But it's still relevant. [00:18:02] Speaker 00: It's relevant. [00:18:02] Speaker 00: Something could be prior art and not have any relevance at all to the invention claimed. [00:18:08] Speaker 00: But it's still prior art, right? [00:18:10] Speaker 03: Right. [00:18:10] Speaker 03: And I think what the judge was reacting to is that really prior art, if it doesn't add anything. [00:18:15] Speaker 00: But that's not how the law works, is it? [00:18:17] Speaker 03: It isn't. [00:18:17] Speaker 03: No. [00:18:18] Speaker 03: It certainly has to be considered in the obviousness analysis, just like, as you pointed out, a market demand. [00:18:24] Speaker 03: That's what this really was. [00:18:25] Speaker 03: It was a market demand. [00:18:26] Speaker 03: We wouldn't ordinarily, as lawyers who work in the patent area, say if there was a strong market demand that that demand was prior art. [00:18:34] Speaker 03: It's considered in the obvious misanalysis. [00:18:36] Speaker 03: That's really a matter of semantics. [00:18:39] Speaker 03: And the district judge, as you pointed out, did consider the FDA mandate. [00:18:43] Speaker 03: He just didn't think it was enough to get them over the hurdle. [00:18:46] Speaker 00: Can I ask you another question? [00:18:47] Speaker 00: This is on the reasonable expectation of success standard. [00:18:50] Speaker 00: And I just want to ask you about one sentence. [00:18:52] Speaker 00: And maybe you can explain what you think it means. [00:18:56] Speaker 00: So it's on page JA26. [00:18:58] Speaker 00: And it's the third line. [00:19:03] Speaker 00: And it starts, there is no evidence that anyone ever combined these methods prior to the invention date. [00:19:10] Speaker 00: And Dr. Gockel himself never did any experiments to show they work, semicolon. [00:19:14] Speaker 00: He merely opined that a person of ordinary scale would have thought to try it and would have expected it to work. [00:19:20] Speaker 00: Now, this is my question. [00:19:21] Speaker 00: Why isn't it enough that he opined that he would have expected it to work? [00:19:26] Speaker 00: Why does it have to be that Dr. Gockel did experiments or that there's required that there's evidence [00:19:32] Speaker 00: that anyone ever actually combined these methods. [00:19:34] Speaker 00: That would be anticipation, I would think. [00:19:38] Speaker 03: Well, I think what the judge was saying was recounting what Dr. Goffel's testimony was. [00:19:46] Speaker 03: In Dr. Goffel's view, this, that, or the other thing would have happened. [00:19:50] Speaker 03: There would have been an expectation of success. [00:19:53] Speaker 03: Dr. Davies testified in an imposing way, and the judge made credibility findings against them. [00:19:59] Speaker 03: It's closely related to a fact which, in this case, makes this case almost unique. [00:20:05] Speaker 03: In an obviousness case, the law says you look at the prior art, look at the differences between the prior art and the claimed invention, then we apply the analysis. [00:20:14] Speaker 03: But there's an underlying assumption, which is that when you make the combination, that you actually will result in the claimed invention. [00:20:20] Speaker 03: It's an enablement in Ray Kumar. [00:20:23] Speaker 03: The combination has to be able to make the invention. [00:20:26] Speaker 03: There was no evidence in this case [00:20:28] Speaker 03: that if you took Chapman, modified it in some fashion, that you would result in low ABUCC oxymorphone. [00:20:35] Speaker 03: None. [00:20:36] Speaker 03: Council pointed to dung. [00:20:37] Speaker 03: The evidence in the case was that dung started with orypovine, a unique starting material. [00:20:43] Speaker 03: All other opioid synthesis starts with thebane, because that's what you get when you first process poppy straw. [00:20:49] Speaker 03: That was a different process. [00:20:51] Speaker 03: The problem they have with the case is they never identified a reaction path that would have led to low ABUCC oxymorphone. [00:20:58] Speaker 03: So there was nothing for the court to look at and say, oh, that reaction path differs from Chapman in this fashion, and it would have been obvious to make that modification. [00:21:08] Speaker 03: They didn't do that. [00:21:09] Speaker 03: Now, we asked Dr. Gockel at this trial. [00:21:11] Speaker 00: Just to make sure I understand what you're saying, you're saying this sentence is really going to whether the combination as a whole enables one of the ordinary scale in the art to reach the claim, which is as opposed to the question of, [00:21:26] Speaker 00: What reasonable expectation of success? [00:21:28] Speaker 03: I think it goes, I think he's saying Dr. Gopal said there was an expectation of success, but we don't even know whether this thing would have made Loebak oxymorphone. [00:21:38] Speaker 03: Normally in an obviousness case, you have, say in an electrical case, you've got a circuit and all the components are known and somebody says, well, nobody knew how to put them all together. [00:21:48] Speaker 03: And the question is, was it obvious to put them together in the way that the inventor did? [00:21:52] Speaker 03: But you almost never have any doubt about [00:21:54] Speaker 03: if you put the things together that are claimed to be the prior art, whether you'd result in the claim. [00:22:00] Speaker 03: Here, you don't know what would have been Chapman by itself does not make oxymorphone, low A buck, it makes oxycodone. [00:22:07] Speaker 03: Their argument was, well, you'd modify Chapman, but how? [00:22:11] Speaker 00: We don't know. [00:22:12] Speaker 00: Well, what about, I mean, you know, there's also some common sense thought that when the FDA says, we want you to make this with an A buck of a certain parts per million, that there's some sort of common sense thought that [00:22:24] Speaker 00: They expect it to be able to work. [00:22:27] Speaker 03: It still has to work. [00:22:28] Speaker 00: I understand I'm not the fact finder. [00:22:30] Speaker 00: I just want to press you on this. [00:22:31] Speaker 03: Sir, I understand. [00:22:34] Speaker 03: We've got to have regular order here when we have obviousness cases. [00:22:39] Speaker 03: You've got to point to the things that are in the prior art. [00:22:43] Speaker 03: You've got to prove that those things, when combined, would reach the claimed invention. [00:22:47] Speaker 04: Well, whether there's a reasonable expectation [00:22:50] Speaker 03: The first... I don't think so. [00:22:52] Speaker 03: I think the first thing, the predicate to even get to the starting gate is to show a combination that would actually make the invention. [00:22:59] Speaker 04: If not... Well, then what's the reasonable expectation of success about? [00:23:03] Speaker 04: Success is making the invention. [00:23:05] Speaker 03: Right. [00:23:05] Speaker 03: The reasonable expectation would be that... [00:23:08] Speaker 03: Now, you can have a situation where you have, in my circuiting... Well, just stop. [00:23:11] Speaker 04: I mean, what's, in your view, the reasonable expectation of success has no purpose? [00:23:17] Speaker 03: No, no. [00:23:17] Speaker 03: It has a major purpose. [00:23:18] Speaker 03: It's just that you don't get there unless you, unless the combination would, at the end of the day, make the invention. [00:23:24] Speaker 04: Oh, you mean if it would have been obvious to make the invention... Now, we have a deeper problem. [00:23:29] Speaker 04: ...when you don't care whether there was a reasonable expectation of success? [00:23:32] Speaker 03: We have a deeper problem that if Chapman doesn't make, if Chapman can't be modified to make low A-buck oxymorphone, [00:23:39] Speaker 03: then they don't have an obviousness. [00:23:40] Speaker 00: How does that not subsume the reasonable expectation, the way you're looking at it, in terms of enablement? [00:23:45] Speaker 00: It subsumes. [00:23:46] Speaker 00: How does it not subsume the reasonable expectation of success requirement? [00:23:50] Speaker 00: It can subsume. [00:23:50] Speaker 03: First, you have to show the combination would work. [00:23:53] Speaker 03: And then the question is, would it have been reasonable for people to make the combination? [00:23:56] Speaker 03: Would it have been obvious to put the combination together? [00:23:59] Speaker 04: Why would it have been unreasonable to do it once you know it worked? [00:24:03] Speaker 04: I mean, that's my problem with your argument. [00:24:05] Speaker 03: No, no, Your Honor. [00:24:06] Speaker 03: You often have cases where there are multiple pieces of things from different areas and the inventor says... And one ordinary skill in the art would be motivated to put them together. [00:24:15] Speaker 04: And Hosanna, when they put them together, they got at the level the FDA wanted you to. [00:24:20] Speaker 03: That's right. [00:24:21] Speaker 04: But the problem... And if that's the case, then what on earth does the reasonable expectation of success have to do with the obvious? [00:24:29] Speaker 02: I'll give you an example. [00:24:30] Speaker 02: Let me interject. [00:24:31] Speaker 02: I think this is where you're going. [00:24:33] Speaker 02: You're saying... [00:24:35] Speaker 02: Step one, is there any possibility of success? [00:24:39] Speaker 03: Yes. [00:24:39] Speaker 02: Yes. [00:24:40] Speaker 02: Because if there's no possibility of success, there can't be any reasonable. [00:24:43] Speaker 03: That's another way to put it. [00:24:44] Speaker 03: For example, if you took example four from Chapman. [00:24:47] Speaker 04: OK, so apply that to our case. [00:24:49] Speaker 04: And you say there's Chapman, there's Weiss, there are a number of different ways to fiddle with this molecule. [00:24:54] Speaker 03: But we don't know whether. [00:24:55] Speaker 04: And one of ordinary skill in the art would say, well, there's a possibility. [00:25:00] Speaker 04: Because you can use these tools. [00:25:01] Speaker 04: That gets you by where the presiding judge is. [00:25:04] Speaker 04: Well, nobody's arguing about whether that particular problem was met in this case. [00:25:09] Speaker 04: Of course it was. [00:25:10] Speaker 04: The question then is you've got your expert says, well, if you take Weiss or Chapman or any other models and you tinker with them and you tinker with them, the problem is you can't, there is no reasonable expectation you're going to get to the goal line. [00:25:24] Speaker 03: That's correct. [00:25:25] Speaker 04: Because the molecule keeps changing. [00:25:27] Speaker 04: It makes the stuff you don't want. [00:25:29] Speaker 04: And then when you get rid of that, it makes some more stuff you didn't want. [00:25:32] Speaker 03: Yes, Your Honor. [00:25:32] Speaker 03: That's exactly right. [00:25:33] Speaker 04: And the other side simply said, as you would expect it to say, said, well, would there be a reasonable expectation of success if you tinkered? [00:25:39] Speaker 04: Of course there would be. [00:25:42] Speaker 03: Right. [00:25:42] Speaker 04: And of course... And so there's a fact finding on that motivation issue. [00:25:46] Speaker 04: Yes, Your Honor. [00:25:46] Speaker 04: And the question in our case is, was the judge clearly erroneous? [00:25:50] Speaker 04: Yes or no? [00:25:50] Speaker 03: That's exactly right, Your Honor. [00:25:52] Speaker 04: And my only point was that this is a- Don't say it just to appease me. [00:25:56] Speaker 03: No, no, it's correct, Your Honor. [00:25:57] Speaker 04: We've been going around in lots of circles, you know what I mean? [00:26:01] Speaker 03: Well, the bottom line is this is, in some ways, this is a very straightforward case. [00:26:05] Speaker 03: The district judge made fact, and that's how I started. [00:26:07] Speaker 03: The district judge made factual findings. [00:26:09] Speaker 03: He made credibility findings. [00:26:10] Speaker 03: It's an obviousness case. [00:26:11] Speaker 03: My only point was this is an unusual obviousness case because they didn't even show that the thing they claimed rendered the claims obvious could actually have enabled and made the claim. [00:26:20] Speaker 02: Is 14-hydroxymorphone referred to anywhere in the claims or broader specification as a hydrochloride? [00:26:34] Speaker 03: The claims refer to, they just have the word 14-hydroxymorphenol, just like they just have the word oxymorphone. [00:26:46] Speaker 02: And what the evidence has been... Is it well known [00:26:49] Speaker 02: Does the record show that it's well known that 14-hydroxymorphanone in an oxymorphanone salt would also be a salt? [00:27:00] Speaker 03: Yes, Your Honor, and both experts agreed to that, that it could not exist in the freebase form. [00:27:05] Speaker 03: This was a fascinating argument because neither Tevin nor their experts in the first trial occurred to them. [00:27:10] Speaker 03: It certainly didn't occur to the Patent Office that this was the construction of the claims, or the Patent Office would never have allowed it. [00:27:16] Speaker 03: The district court made factual findings that people often use the word oxymorphone or ABOT without adding salt, just like they don't add freebase every time they say oxymorphone, and that the only way to construe the claims was the way he construed them. [00:27:30] Speaker 03: Here he did it based on underlying factual evidence, which is entitled to deference under TEBA. [00:27:36] Speaker 03: But I want to make one final point, which is that this is a trial which actually should never have happened, because we should have been granted summary judgment on collateral estoppel against TEBA. [00:27:46] Speaker 03: We had a case against Teba. [00:27:49] Speaker 03: They lost. [00:27:50] Speaker 03: The product is exactly the same product as is at issue in this case. [00:27:56] Speaker 03: Yet the district judge had us go through the trial a second time. [00:28:01] Speaker 03: Now, that would be harmless error if you defer. [00:28:05] Speaker 03: But it does create an issue of potential problematic application in the future that if a generic can lose a case, [00:28:15] Speaker 03: set up a subsidiary. [00:28:16] Speaker 03: I understand they bought the subsidiary here, but analytically, there's not much difference between setting up a new subsidiary that's totally under your control and filing another ANDA on the same product. [00:28:26] Speaker 03: The distinction here is not that Teva owned the stock of activists. [00:28:30] Speaker 03: That's not sufficient. [00:28:32] Speaker 03: But the evidence that we obtained after the trial was that Teva controlled the communications with the FDA. [00:28:38] Speaker 03: And most importantly, Teva was making the launch decision on the activist ANDA. [00:28:44] Speaker 04: So you got this information after the trial. [00:28:46] Speaker 03: That's right. [00:28:46] Speaker 04: So it's not in the record. [00:28:47] Speaker 03: No, no, it's in the record. [00:28:49] Speaker 03: The merger took place in the run-up to trial. [00:28:53] Speaker 03: We asked the court to grant summary judgment on collateral estoppel. [00:28:56] Speaker 03: He said, no, we'll go through the trial. [00:28:59] Speaker 03: We got some discovery. [00:29:00] Speaker 03: We filed summary judgment on that point after the trial. [00:29:03] Speaker 03: It merged into the record. [00:29:04] Speaker 03: Now granted, the reason for collateral estoppel is judicial economy, and here we've had the trial. [00:29:12] Speaker 04: There's not much economy to be had, but... Well, also, can we here, as a matter of fact, decide exactly what the relationship between Teva and activists is? [00:29:22] Speaker 03: It's in the record. [00:29:23] Speaker 03: It's in the record. [00:29:24] Speaker 03: Those facts are in the record, and they're cited in our brief. [00:29:26] Speaker 04: Well, weren't they adjudicated? [00:29:28] Speaker 03: It was adjudicated that it didn't matter. [00:29:32] Speaker 04: Wait, did the other side have a chance to cross-examine what you were putting in? [00:29:36] Speaker 04: Yes. [00:29:37] Speaker 04: Was there a record, a cross-examination record made on the facts, the control facts? [00:29:41] Speaker 03: Yes, there were depositions taken of Teva witnesses and activist witnesses that they defended, and then we submitted that evidence. [00:29:47] Speaker 04: And that hasn't been, but there was no fact-finding by the district court. [00:29:51] Speaker 03: What the district court said was... The district court said I'll have to go to that issue. [00:29:54] Speaker 03: What the district court said is it didn't matter because that wasn't sufficient privity. [00:29:57] Speaker 03: He ruled as a matter of law that because the activists [00:30:00] Speaker 03: Activists had been acquired is by way of an acquisition that it didn't yeah, what's that? [00:30:04] Speaker 04: Maybe a legal error, but what I'm trying to guess what the factual underpinnings are I don't think the factual underpinnings are in dispute. [00:30:10] Speaker 04: I believe it's a pure legal error Thank you Thank you Well as is Teva in front of us in the [00:30:29] Speaker 01: Well, Teva was joined into this case. [00:30:31] Speaker 04: I know. [00:30:31] Speaker 01: Are you represent them? [00:30:32] Speaker 01: Are they in front of us? [00:30:33] Speaker 01: You represent activists. [00:30:35] Speaker 01: I represent activists. [00:30:36] Speaker 04: Teva was also named as a defendant in this particular... On the other side, you told me that you're actually representing Teva. [00:30:42] Speaker 01: Teva controls your client. [00:30:45] Speaker 01: Teva owns activists. [00:30:47] Speaker 01: Activists is a separate legal entity. [00:30:49] Speaker 04: The district court heard the evidence... Well, in fact, you heard what he said. [00:30:51] Speaker 04: I mean, my view was that the district court might have gotten a little bit wrong in how he chose to deal with [00:30:58] Speaker 04: with a collateral stubble issue, but I thought there were some underlying facts that might have to be ventilated. [00:31:04] Speaker 04: Do you concede that Tavis sufficiently controls activists? [00:31:11] Speaker 01: No. [00:31:11] Speaker 01: What I would say is that the district court heard their argument, saw the evidence that he is referring to. [00:31:17] Speaker 01: The district court exercised its discretion. [00:31:20] Speaker 01: The question is, is discretionary under Park Lane hosiery [00:31:23] Speaker 01: on whether or not you apply issue conclusion. [00:31:25] Speaker 04: I'm asking about fact finding. [00:31:26] Speaker 04: Did the district court make these fact findings? [00:31:29] Speaker 01: The district court has two pages of its opinion addressing this issue, and it rejects the notion that their facts are sufficient to establish privity. [00:31:38] Speaker 01: So I think the district court made factual conclusions to find that what they offered was not sufficient to establish privity. [00:31:44] Speaker 01: And I think that should be enough. [00:31:45] Speaker 01: In any event, it's tough. [00:31:47] Speaker 04: So you would say we could review that issue independently here? [00:31:50] Speaker 04: Well, I think you would have to... If we said the district court judge was wrong on the facts and that Teva controls out of us. [00:31:56] Speaker 01: I think you would have to review it deferentially because it is ultimately a question of abuse of discretion by the district court in the posture in which it arises because the application... We don't know which specific findings the district court made because it didn't say so in its opinion. [00:32:12] Speaker 01: I don't think his opinion goes through and parses in great specificity, but he does consider [00:32:17] Speaker 01: the facts that they have offered and rejects them. [00:32:21] Speaker 01: Judge, while I can see I'm essentially out of time, if you would grant me leave, I would like to respond to the arguments. [00:32:27] Speaker 01: I'll give you another minute. [00:32:28] Speaker 01: OK. [00:32:28] Speaker 01: So Dung did what they say that Gokul should have done. [00:32:32] Speaker 01: Again, that's appendix 3038 and 3042. [00:32:35] Speaker 01: And the question in this case is, did the district court do a proper analysis of reasonable expectation of success? [00:32:42] Speaker 01: He doesn't address it at all. [00:32:43] Speaker 01: The only place he addresses it, you identify a judge stole. [00:32:46] Speaker 01: He says not one word about what a person of ordinary skill in the art would expect from Chapman or from Weiss. [00:32:52] Speaker 01: And indeed, there is testimony from the inventor of Dung that the differences that you have are essentially the kinds of things that would come out of routine optimization. [00:33:01] Speaker 01: You can see appendix 3224 and 3041. [00:33:05] Speaker 01: There is no finding that there's no reasonable expectation of success vis-a-vis Chapman. [00:33:09] Speaker 01: The only finding [00:33:10] Speaker 01: was that there was no definitive solution. [00:33:12] Speaker 01: And if there had been a definitive solution, that would be anticipation. [00:33:15] Speaker 01: That's the wrong standard. [00:33:17] Speaker 04: Do you think that the court got confused? [00:33:22] Speaker 04: If any solution you keep pointing to, you said the district won't use those words? [00:33:26] Speaker 01: Yes. [00:33:27] Speaker 01: At what page? [00:33:27] Speaker 01: Appendix 24. [00:33:28] Speaker 01: It's the carryover sentence from 23 to 24. [00:33:32] Speaker 01: And Judge Stoll, I'm sorry, your question. [00:33:35] Speaker 00: I was just going to ask you, do you think that the idea that you have to have [00:33:39] Speaker 00: your combination enabled to claim and the idea of reasonable expectation of success. [00:33:46] Speaker 00: Do you think those got confused by the district? [00:33:49] Speaker 01: I think they may have been. [00:33:50] Speaker 01: I think there also is a flavor in the district court's opinion that smells a little bit as though he was thinking about this through the lens of inherent anticipation, which of course, you know, something must necessarily be present. [00:34:01] Speaker 01: I think that's right. [00:34:02] Speaker 01: And one last point, if Judge Wallach, you'll allow me, and that is this much was said about [00:34:08] Speaker 01: the idea that Malinckrodt did all kinds of experiments. [00:34:11] Speaker 01: But let's be clear, if you look at page 32 of their red brief, footnote seven, excuse me, footnote nine, they didn't do experiments with oxymorpha. [00:34:20] Speaker 01: The experiments they did were with oxycodone. [00:34:23] Speaker 01: And that's significant because in the oxycontin case, low ABUK oxycodone was held to be obvious [00:34:33] Speaker 01: And this court affirmed in the Purdue case. [00:34:36] Speaker 01: So all this stuff that he wants to tell you about, oh, we did this, and we did this, and it was hard, well, that goes to whether or not you can make low ABUK oxycodone, which was found to be obvious, and this court affirmed. [00:34:50] Speaker 01: And I would submit that the court here should therefore reverse. [00:34:53] Speaker 02: Thank you, Judge Bowman. [00:34:54] Speaker 02: Thank you, Mr. O'Quinn. [00:34:55] Speaker 02: To strive to seek, to find, and not to yield, Mr. O'Quinn. [00:34:59] Speaker 02: Thank you. [00:34:59] Speaker 02: Google that, and you'll know why I just said it.