[00:00:16] Speaker 00: and in session. [00:00:17] Speaker 00: God save the United States and its honorable courts. [00:00:21] Speaker 00: Please be seated. [00:00:27] Speaker 02: Our first case for argument today is 22-1706 Algenesis versus Cloudbreak. [00:00:38] Speaker 02: Is it Mr. Mazurk? [00:00:40] Speaker 02: Am I saying it right? [00:00:41] Speaker 02: Yes, Your Honor. [00:00:41] Speaker 02: Okay, great. [00:00:44] Speaker 02: Please proceed. [00:00:45] Speaker 01: Thank you, Your Honor. [00:00:46] Speaker 01: May it please the Court. [00:00:47] Speaker 01: My name is Don Mazurk, I represent All Genesis. [00:00:49] Speaker 01: It's a particular honor to be here as the Court writes the circuit, so to speak, and with being at law school and presenting the argument today at the law school. [00:00:57] Speaker 01: So it's a pleasure to be here. [00:00:59] Speaker 01: Thank you for letting us be a part of this. [00:01:02] Speaker 01: While Genesis respectfully submits, suggests that this Court has Article III jurisdiction to review the Board's finding [00:01:09] Speaker 01: that it could raise the issue of secondary or unexpected results as a secondary consideration of non-obviousness in the IPR and whether substantial evidence or really any evidence at all supports that finding. [00:01:24] Speaker 01: We also suggest that the board's finding regarding priority that the claims four and five were adequately described [00:01:33] Speaker 01: in the 063 provisional can be reconciled with this court's precedent in Biogen, et cetera. [00:01:42] Speaker 01: If Your Honors have any questions, I'd like to address your questions. [00:01:44] Speaker 04: I was curious, what do you think is your best argument for why you have Article III standing? [00:01:51] Speaker 01: Well, Your Honor, I think it's a pretty clear case that we have standing. [00:01:56] Speaker 01: We are practicing the method that is claimed. [00:02:00] Speaker 01: So there is a huge risk that if we proceed, we will face an infringement suit. [00:02:08] Speaker 04: So that's your concrete injury? [00:02:11] Speaker 01: Yes. [00:02:14] Speaker 02: I'm sorry, where is the evidence? [00:02:16] Speaker 02: Is it Mr. Chang? [00:02:17] Speaker 02: Is that the evidence? [00:02:19] Speaker 02: that you are practicing the claim invention? [00:02:22] Speaker 02: Is it a Mr. Chang declaration? [00:02:24] Speaker 01: Well, yes, Your Honor. [00:02:25] Speaker 01: It's the Chang declaration. [00:02:27] Speaker 01: It's our application that's part of the record of the patent that we've submitted for priority. [00:02:35] Speaker 02: But a patent doesn't mean you're practicing the invention, right? [00:02:38] Speaker 02: I mean, a patent is that you're applying for a patent on an invention. [00:02:40] Speaker 02: It doesn't mean you're actually actively infringing. [00:02:43] Speaker 01: No, but it describes what we're doing. [00:02:46] Speaker 01: and we have the citation to the... But where's the proof that you're doing that? [00:02:50] Speaker 02: The patent isn't proof that you're doing something. [00:02:53] Speaker 01: Correct. [00:02:53] Speaker 01: No, the proof is Mr. Chang's declaration where he states that we are using... I think you have to look at the concrete injury in connection with the limitations of the patent at issue. [00:03:09] Speaker 04: Sure, the apprehension of suits. [00:03:11] Speaker 04: So in his declaration, [00:03:13] Speaker 04: He refers to some phase two testing that occurred in 2020. [00:03:22] Speaker 04: The question is, one thing I'm concerned about, is I don't see concrete plans after 2021 in his declaration. [00:03:31] Speaker 04: I just see that he says, you know, he refers to that earlier testing that occurred, and you need to show that concrete plans to continue to use the method. [00:03:40] Speaker 04: But there's nothing since the Phase 2 clause that is referenced on page 8, 5140, paragraph 6. [00:03:48] Speaker 01: Well, he's describing that this is an ongoing research project that we have. [00:03:52] Speaker 01: There's a paragraph 26 where we talk about how much money we're spending. [00:03:59] Speaker 01: Spending money is activity. [00:04:02] Speaker 01: And we describe how much we've already spent on this project, how much we intend to continue to spend, [00:04:07] Speaker 01: continuing with this project. [00:04:08] Speaker 01: It's not been suspended. [00:04:09] Speaker 03: Is the permanent product AG 86893, is that the right thing that I should be looking at? [00:04:17] Speaker 03: I'm just trying to make sure I'm also level setting with you. [00:04:21] Speaker 03: Is that ready for market? [00:04:22] Speaker 03: Let me just ask you that question. [00:04:24] Speaker 01: Well, no, we have a lot of work to do before it's ready for market. [00:04:27] Speaker 01: But I think that's kind of the plaintiff's position or the patent owner's position. [00:04:32] Speaker 01: is that we have to spend these tens of millions of dollars before we have Article 3 standing. [00:04:38] Speaker 01: In the Lujan case, the Supreme Court said, no, we don't have to vet the company in order to prove Article 3 standing. [00:04:45] Speaker 04: In your brief, you say that you're working on, I think, phase three testing, but there's nothing in the declaration about that. [00:04:54] Speaker 04: Instead, he only refers to this testing, which I looked up, the clinical trials identifier, NCT, et cetera, et cetera. [00:05:00] Speaker 04: That refers to a phase two trial. [00:05:02] Speaker 04: Again, that occurred in 2020. [00:05:05] Speaker 04: But I don't see anything in his declaration that talks about concrete plans after that phase two trial. [00:05:13] Speaker 01: Well, I think the notion that we're spending some number, some amount of money on this project shows that we're going forward. [00:05:23] Speaker 02: The declaration doesn't actually say that. [00:05:25] Speaker 02: The declaration says if we were to bring a product to market, this is how much it would cost to do so. [00:05:31] Speaker 02: It doesn't actually say that you are in fact spending that money. [00:05:34] Speaker 02: It says, if we do it, quote, it will likely cost, and I won't use the number, even though you just mistakenly did, because it's confidential, but it says that's what it would cost if you did do it. [00:05:44] Speaker 02: Not that you are doing it, not that you're currently spending that money, but if you were going to bring it to market, that's what it would cost you to do it. [00:05:51] Speaker 01: Well, I mean, he says we're in an active project. [00:05:54] Speaker 01: This has not been suspended. [00:05:55] Speaker 04: Where? [00:05:56] Speaker 04: Where? [00:06:02] Speaker 01: Paragraph five. [00:06:03] Speaker 01: We have been and are continuing to develop formulations of an intendant for ocular use, such as the treatment of Tagerium, including through research and clinical trials. [00:06:15] Speaker 01: This is unrebutted. [00:06:16] Speaker 01: It's not like one of these other cases where the parties have acknowledged or admitted that they've suspended the PROD program. [00:06:22] Speaker 01: We have not. [00:06:23] Speaker 01: We are continuing. [00:06:24] Speaker 01: I mean, the idea is that if we have a patent issue that's popped up in the course of this thing, in the course of this project, [00:06:32] Speaker 01: And we're looking at, this patent is a huge deterrent in terms of us proceeding through this project. [00:06:42] Speaker 01: So like on any given day, is there any activity going on? [00:06:45] Speaker 01: We have these products that are under stability. [00:06:47] Speaker 01: They're there. [00:06:47] Speaker 01: All the things that are required to get FDA approval are ongoing. [00:06:51] Speaker 03: Has there been any threat by Clausework to sue Paul Genesis? [00:06:56] Speaker 01: Well, I think it's obvious that given what we are doing, [00:07:01] Speaker 01: that we are testing the tentative, using the tentative to treat Tagerion, that we are running into the buzzsaw of the 820 patent. [00:07:14] Speaker 01: We engaged in discussions that are outlined in the chain declaration to license the technology that would allow us to use it and to reach some kind of agreement. [00:07:27] Speaker 01: But why would we want to do anything with a patent that is invalid? [00:07:32] Speaker 01: And that's one of the other issues that would support standing, licensing an invalid patent, whether or not you should do that. [00:07:38] Speaker 01: And the third part is we have this other patent application that is pending that the collateral or the preclusive effects of this decision will bear on [00:07:52] Speaker 01: the scope of PAN protection that we are allowed to get. [00:07:55] Speaker 02: No, it would not. [00:07:56] Speaker 02: You will have an opportunity to appeal. [00:07:59] Speaker 02: There's no preclusive effect. [00:08:00] Speaker 02: There's no collateral estoppel here. [00:08:01] Speaker 02: You will absolutely, in that other patent application of your own, if an examiner or the board should come to a conclusion like this case about priority, you'll have the ability to appeal that. [00:08:14] Speaker 02: Well, Your Honor, I... That's not a lateral stop or a political effect. [00:08:17] Speaker 02: The Board doesn't even have to follow what was done here. [00:08:20] Speaker 02: They don't even have to, and we sure as heck don't, so you can appeal it in that circumstance. [00:08:25] Speaker 02: You don't lose a right to challenge that. [00:08:26] Speaker 01: But it's certainly going to have a practical effect on what the Patent Office will do, that there was a Board finding and that there would be a review. [00:08:34] Speaker 02: Oh my goodness, that Patent Office, are you kidding? [00:08:35] Speaker 02: How many times do we see them do the exact opposite in two cases? [00:08:38] Speaker 01: Oh, Your Honor, I still believe it would [00:08:41] Speaker 01: bear on their decision making process in a way that would be adverse to the interests of our client. [00:08:47] Speaker 02: But the fact that somebody somewhere decided something that may have an adverse interest on your client doesn't mean in this situation you therefore have standing. [00:08:58] Speaker 01: Well, Your Honor, I think we've explained that in terms of what the findings will be will have a bearing on what people do with the decision that's being from the court right now. [00:09:10] Speaker 01: And that is all is required for Article III standing. [00:09:14] Speaker 01: It's not a, it is a minimum. [00:09:17] Speaker 02: I do not agree. [00:09:18] Speaker 02: What case do you have that says that all is required for Article III standing? [00:09:22] Speaker 02: is that something that's going on will have some bearing on you. [00:09:25] Speaker 02: That's what you just said. [00:09:26] Speaker 01: Something I apologize. [00:09:29] Speaker 01: I'm just saying that the standard is the base of the minimum Article 3 standard which requires a concrete plan for future activity that creates a substantial risk of future infringement. [00:09:40] Speaker 01: We have demonstrated that there are concrete plans [00:09:43] Speaker 01: to continue with this development program, and that creates a substantial risk of future infringement. [00:09:51] Speaker 01: The way that this, everything we do, they argue that we don't have a formulation yet, but the patent doesn't apply to a formulation. [00:09:57] Speaker 01: It applies to using just a therapeutically effective amount of Nintendo. [00:10:03] Speaker 03: What does it say now? [00:10:04] Speaker 03: Is it in phase three trials? [00:10:05] Speaker 03: Just tell me where it stands right now. [00:10:09] Speaker 01: The next step will be the commencement of the phase three trial. [00:10:13] Speaker 03: So they have not commenced, is that what you're telling me? [00:10:15] Speaker 01: The phase three trial has not commenced at this time. [00:10:18] Speaker 01: It is the preparations for it have been going on, all the work has been going on, and the stability testing, the stability testing of the product, all those things that are reported to you. [00:10:27] Speaker 04: Where about these things you're referring to right now, stability testing, all of that, where is that in the record? [00:10:33] Speaker 04: for us to rely on besides what you're saying as you're standing here right now. [00:10:37] Speaker 01: Well, Your Honor, if that detail is something that you don't think is implicit in the continuing effort that is in Paragraph 5. [00:10:48] Speaker 04: You know what, in Paragraph 5, you have been continuing, and you say Algenesis and Library both have been and are continuing to develop formulations of mid-10th of it. [00:11:00] Speaker 04: But it's not very specific. [00:11:02] Speaker 04: I mean, I think you need to have pretty specific factual allegations in order to show concrete plans. [00:11:09] Speaker 04: And your argument today goes beyond what the evidence says. [00:11:12] Speaker 01: Well, Your Honor, we'd be happy to submit a supplemental declaration if additional details are necessary to support the jurisdiction of the Court. [00:11:18] Speaker 01: We believe that because of the clinical trials and information provided in those documents with the representation that this project is continuing. [00:11:27] Speaker 04: Clinical trials that we refer to are in the past. [00:11:30] Speaker 04: They're from 2020. [00:11:32] Speaker 04: They don't show continuing development. [00:11:36] Speaker 01: Well, they show that when you say you're going to do this, everyone knows what the process is for the clinical development of a project. [00:11:43] Speaker 01: You do phase one, you do clinicals, and then you do the next set of clinicals. [00:11:47] Speaker 03: Sometimes people stop. [00:11:48] Speaker 01: But we have not stopped, and we've described that. [00:11:52] Speaker 04: There's no evidence in the record that we've stopped. [00:12:02] Speaker 04: that that earlier patent application, if it has priority, could be something that could impact the scope of your continuation applications. [00:12:12] Speaker 04: But I don't necessarily see where you spelled that out as explicitly as you could have in your blue brief or gray brief. [00:12:19] Speaker 01: Well, I think we do in response to the, in our reply brief, in the last section of our reply brief, where they talk, they try to call it collateral and say that [00:12:27] Speaker 01: the collateral efforts. [00:12:29] Speaker 01: But the collateral references there, it's on the last page of our reply brief, beginning on page 12 of our reply brief, where they describe our efforts as being collateral. [00:12:44] Speaker 01: And we say, no, we're not talking about the kind of collateral, about the patentee or the challenger being barred from raising the same grounds in a future [00:12:57] Speaker 01: case for infringement. [00:12:59] Speaker 01: But what do you say you're talking about? [00:13:01] Speaker 01: We talk about our Algenesis TCT in page 13 on top of the page. [00:13:12] Speaker 01: So we're referencing, we say it injures Algenesis by impairing Algenesis' own patent rights. [00:13:20] Speaker 02: But that's so non-specific. [00:13:22] Speaker 02: Do you understand? [00:13:23] Speaker 02: That doesn't tell me anything. [00:13:24] Speaker 02: You haven't identified a specific patent, a claim. [00:13:27] Speaker 02: You haven't identified anything with specificity that would be effective. [00:13:31] Speaker 01: But Your Honor, I don't need to. [00:13:32] Speaker 01: Claim five is so specific. [00:13:34] Speaker 01: And what we're doing is so specific. [00:13:36] Speaker 02: It's like, how much more specific can we get besides referring to... Well, that's not in the record is the problem. [00:13:41] Speaker 02: I understand what your argument is, and your argument is very good. [00:13:44] Speaker 02: But you don't have the evidence to back it up. [00:13:47] Speaker 01: Well, Your Honor, respectfully, I disagree that we do. [00:13:49] Speaker 01: It's like, because it's not that how much evidence do we need to put in to establish in an unreputted fashion that we're using, that we're using nintendonib in a therapeutically effective mount to treat tegerium. [00:14:04] Speaker 01: I mean, that's it. [00:14:05] Speaker 01: That's all that's required. [00:14:06] Speaker 01: And that is in the record. [00:14:08] Speaker 01: This is not a complicated patent where you have all these little pieces and claim elements that have to be shown for. [00:14:16] Speaker 04: It's the concrete plan's part of the standing test that I have concern about, that I think the panel has concerns about. [00:14:24] Speaker 04: And so it's not whether you're practicing the claim. [00:14:28] Speaker 04: Whether what you're practicing, if you're in fact practicing it, meets the claim's invention. [00:14:35] Speaker 04: It's more a question of have you demonstrated [00:14:39] Speaker 04: because it is your burden, the statement of concrete plans. [00:14:43] Speaker 04: And there's just a little bit of lack of specificity, and that's the big concern that we are having. [00:14:50] Speaker 01: I think, Your Honor, just, I think, I think it is that we have enough information in the declaration with the amount of effort to show that this project is moving forward. [00:15:02] Speaker 01: It is not stopped. [00:15:04] Speaker 01: It's got a beginning, a middle, and an end. [00:15:06] Speaker 01: And I think that we don't have to demonstrate that there's any specific forward movement. [00:15:14] Speaker 01: We have to demonstrate that there is forward movement in the project. [00:15:17] Speaker 01: And I think the record is clear that there is. [00:15:19] Speaker 02: OK, why don't we use all your time in rebuttal time. [00:15:22] Speaker 02: I'll restore some of your rebuttal time, for sure. [00:15:24] Speaker 02: But let's move on and hear from our president now. [00:15:30] Speaker 02: Is it missed? [00:15:30] Speaker 02: Good morning, Your Honors. [00:15:36] Speaker 00: May it please the Court, Matika Fiorella, on behalf of the Appellee Cloudbreak Pharmaceuticals. [00:15:41] Speaker 00: Your Honor, this Court should dismiss the appeal because Algenesis simply has not demonstrated that it has Article III standing to maintain the appeal. [00:15:49] Speaker 00: Now, as we've heard, there is no dispute that Algenesis does not have a product [00:15:54] Speaker 00: that is ready for market that can be infringing our patent. [00:15:58] Speaker 00: So what do they need to show? [00:15:59] Speaker 00: They need to show, as this court has already said, concrete plans of future infringement, and that that future infringement or the concrete plans will give rise to a substantial risk of future infringement by us. [00:16:13] Speaker 00: And they simply haven't put in the evidence on those fronts. [00:16:16] Speaker 00: I'm happy to walk through them. [00:16:18] Speaker 00: I did hear that I think some of the same concerns Your Honors have raised are the ones that we have. [00:16:22] Speaker 00: So I'm going to mostly respond [00:16:24] Speaker 00: to some points that we heard. [00:16:26] Speaker 00: So first, on this continuing research and investment, they have pointed to, all I heard was paragraph five and paragraph six on appendix five 140. [00:16:37] Speaker 00: Neither are specific. [00:16:39] Speaker 00: Neither demonstrate any facts, any even allegations of next steps. [00:16:45] Speaker 00: They just say they're continuing development. [00:16:47] Speaker 00: And we're supposed to kind of guess what that means. [00:16:50] Speaker 04: So paragraph six refers to phase two [00:16:53] Speaker 04: clinical trial. [00:16:54] Speaker 04: So why is it guessing? [00:16:58] Speaker 04: Their view is when they say they're continuing to develop, they say that they've already completed phase two. [00:17:04] Speaker 04: Shouldn't we infer from that that they're going to engage in phase three? [00:17:10] Speaker 00: No, Your Honor, I don't think we should infer that from [00:17:12] Speaker 00: the one statement about the clinical trials and for a few reasons. [00:17:15] Speaker 00: First, the phase two clinical trial was a small study that was conducted over four years ago now. [00:17:21] Speaker 00: It was completed over four years ago now. [00:17:23] Speaker 00: The results were posted over three years ago. [00:17:25] Speaker 00: There is not one specific next step that they've identified going from that phase two trial anywhere further. [00:17:32] Speaker 00: They try to say now and in their brief that there's some phase three development in the work, but that's never in the record. [00:17:39] Speaker 00: There's no evidence of that. [00:17:40] Speaker 00: Mr. Chang doesn't even refer to a phase three study. [00:17:43] Speaker 00: And one thing I'd like to point out, Your Honors, about the phase two studies in particular is the results of those studies. [00:17:52] Speaker 00: So Mr. Chang says nothing about whether or not the phase two results were actually positive to the point where Algenesis is really continuing to develop this project. [00:18:02] Speaker 00: Now in the gray brief, we hear Algenesis come back and say, no, the results were positive and they show a potential for this drug to be useful in the treatment of the disease. [00:18:13] Speaker 00: I want to pause there for a second because I do think it's a little misleading the way that's characterized. [00:18:18] Speaker 00: If you look at the actual quote that they cite and you look at the publication from where that quote is, [00:18:24] Speaker 00: That publication is not about the Phase 2 trials. [00:18:28] Speaker 00: That publication, if you click on that link and go to it, it is about a study that ended before the Phase 2 trials and was done in rabbits. [00:18:35] Speaker 04: Are you referring to, I'm sorry I'm interrupting, are you referring to the Phase 2 trial that's referring to paragraph 6 now or are you referring to the publication that's cited in the grade brief? [00:18:46] Speaker 00: I'm referring to the publication that's cited in the grade brief that's at grade brief 7. [00:18:50] Speaker 00: So what we have before us is no evidence from malgenesis that the phase two study results were even promising to the point where they want to continue developing this drug. [00:19:02] Speaker 00: And then if you actually look at the clinical study results, which we went to, [00:19:06] Speaker 00: They didn't have statistical significance for any of their clinical endpoints. [00:19:09] Speaker 04: Where would I see those? [00:19:10] Speaker 04: Is that what I would look at if I saw the NCT, you know, that number there? [00:19:15] Speaker 00: Yes, Your Honor. [00:19:16] Speaker 00: If you go to the clinical trials gov website and you plug that in, you can actually read the protocol and the results and they didn't achieve statistical. [00:19:25] Speaker 00: I believe so. [00:19:27] Speaker 00: I mean, it's a public record, and you'll be able to... They presented it in their great brief. [00:19:32] Speaker 00: You can go to that website. [00:19:34] Speaker 00: But that's even further than what we need to prove, right? [00:19:36] Speaker 00: We don't have a burden here. [00:19:37] Speaker 00: They needed to prove that they have standing. [00:19:40] Speaker 00: All they did was identify the space to trial. [00:19:42] Speaker 00: What about their other grounds for standing, where they say, well, [00:19:45] Speaker 04: You know, this is a situation where I believe I remember there was your client's application, provisional application was filed, then their PCT was filed like two weeks later, and then you had your patent application filed two weeks after that. [00:20:03] Speaker 04: And so your argument is that they can somehow show that your US patent application can't rely on the earlier date of their provisional application. [00:20:14] Speaker 04: that you then would be the first to invent, right? [00:20:17] Speaker 04: You'd be the first to file, excuse me, not the first to invent. [00:20:20] Speaker 00: Yes, Your Honor, with respect to these specific claims, yes, we would be. [00:20:24] Speaker 04: I think that's what they argue. [00:20:25] Speaker 04: Well, I don't think they argue it as expressly as they should have. [00:20:28] Speaker 00: I agree. [00:20:29] Speaker 00: I think that's the import of what they were arguing. [00:20:31] Speaker 00: But that does not confer independent standing jurisdiction at all. [00:20:35] Speaker 00: So our best medical case that we cite we think is on point for this proposition. [00:20:39] Speaker 00: First, this is a very hypothetical situation that maybe they're going to come up in a different situation. [00:20:45] Speaker 00: and have an examiner or someone else point to this board's priority decision and say, because of that, now all of a sudden, you can't get claims that you want. [00:20:55] Speaker 00: That hasn't happened, and they haven't alleged that that is going to happen. [00:20:58] Speaker 00: In fact, we don't know if they're even really going to be continuing pursuing. [00:21:02] Speaker 00: They do have continuation applications, don't they? [00:21:05] Speaker 00: They do, but they haven't shown that there's any direct risk to any of those based on this. [00:21:10] Speaker 00: But I think the other point. [00:21:11] Speaker 04: So the problem might be lack of specificity. [00:21:13] Speaker 00: Yes, and I think that lack of specificity is the problem throughout the chain declaration and a lot of what we've heard today at argument as well, which is, you know, at most they've said, we're in the works for phase three, for example. [00:21:26] Speaker 00: One, that's not in the record, but even if it was, what does that mean? [00:21:29] Speaker 00: They're saying that there's some amount of money they might spend later, but we don't have, like, for example, after a phase two trial, you would expect maybe some discussions with FDA. [00:21:38] Speaker 00: How that trial went. [00:21:39] Speaker 00: Do we need to fix anything? [00:21:41] Speaker 03: What about the substantial risk of infringement piece of it? [00:21:45] Speaker 03: And I know you guys have some confidentiality concerns, so talk to the level. [00:21:48] Speaker 03: You can speak to that aspect as well. [00:21:50] Speaker 00: Certainly, Your Honor. [00:21:51] Speaker 00: So this is not a case like some of the others, grid energy solutions, for example, where there has been any previous threat of suit. [00:21:58] Speaker 00: Cloudbreak has never threatened to sue Algenesis on this patent or any other patent. [00:22:02] Speaker 00: So what they need to prove or what they need to show is something that's [00:22:06] Speaker 00: going to come in the future, even though nothing has signaled it in the past. [00:22:09] Speaker 00: And they talk about two things, competitor standing and the negotiations. [00:22:14] Speaker 00: I think we deal with competitor standing in our briefs, happy to answer questions on that, but since my colleague on the other side talked about the discussions, I'll focus there. [00:22:23] Speaker 00: Again, it's a lack of specificity. [00:22:25] Speaker 00: What we have in the declaration is Mr. Chang saying that Algenesis, Mr. Chang, reached out to us and said, hey, in the context of this IPR, maybe since we're both looking at the same product, why don't we talk about our proposals and see if we can come to some agreement? [00:22:41] Speaker 00: And then it was Algenesis who said to Cloudbreak, by the way, we are going forward trying to invalidate your patent. [00:22:48] Speaker 03: And we're going to protect ourselves. [00:22:50] Speaker 03: So part of your problem is that it's Algenesis doing these reach-outs as opposed to all the way around. [00:22:53] Speaker 03: Is that part of your argument? [00:22:54] Speaker 00: Exactly. [00:22:54] Speaker 00: So I mean, they have to show that we are going to see what they're doing. [00:22:58] Speaker 00: Eventually, potentially, if they have a product that we could actually accuse of infringement, we are going to sue them. [00:23:04] Speaker 00: But all the evidence they presented is just that they are trying to prevent us from getting our patents and progressing with our investment. [00:23:16] Speaker 00: So, Your Honor, on the investment point, I just have a few more comments there. [00:23:20] Speaker 00: Again, lack of specificity as to what they're actually spending the money on. [00:23:24] Speaker 00: And if you look at paragraph 26 in particular of the Chang Declaration, the amount of money that they've spent compared to what they say they're going to spend is quite small. [00:23:34] Speaker 00: It's only about 15%. [00:23:36] Speaker 00: So that also signals there's a lot more work to do. [00:23:38] Speaker 00: And that's fine. [00:23:39] Speaker 00: You can have a lot more work to do. [00:23:41] Speaker 00: difficult things to actually get approved at the end of the day, but the point is they haven't actually identified what those next steps are that they might be spending the money on. [00:23:52] Speaker 02: I'm just making sure I have nothing else to say. [00:23:58] Speaker 04: Is there something you think they could have said to prove standing with respect to their pending patent applications? [00:24:08] Speaker 00: No, Your Honor, I don't. [00:24:09] Speaker 00: Because ultimately, even under best medical, say they were able to show that there was some medical involved. [00:24:15] Speaker 04: Totally different facts, right? [00:24:16] Speaker 00: It does. [00:24:17] Speaker 00: I think the general import from that case, though, is that they don't have standing here, so it would be non-appealable judgment so they can fight any fight that they need to fight and get it up to appeal should there be a situation later on. [00:24:30] Speaker 00: where there's an impairment of their patent rights. [00:24:34] Speaker 04: But right now they don't have any. [00:24:46] Speaker 00: I'm not sure that I would say it's necessarily the case that they would be the first to invent. [00:24:52] Speaker 00: Perhaps there's [00:24:53] Speaker 00: I should say first to file. [00:24:56] Speaker 04: I'm sorry. [00:24:57] Speaker 04: First to file. [00:24:57] Speaker 04: We don't have any appearances anymore. [00:24:59] Speaker 00: Right. [00:25:00] Speaker 00: You know, I would still say that that's not, well, one, again, those facts I don't think are specific before us. [00:25:06] Speaker 00: But two, even in that situation, that's not an independent basis to confer standing because if that is a injury right now, they haven't shown that there is going to be any effects of that injury. [00:25:16] Speaker 00: So it's a hypothetical situation that we're talking about. [00:25:20] Speaker 04: So maybe if they had shown that they have continuation to application pending, that they are going to broaden those claims, they're going to seek broader claims if they could clear the path that they would do that, then that's something that could have shown that they have standing. [00:25:35] Speaker 00: I agree, Your Honor. [00:25:36] Speaker 00: If they had more specific facts like that, then perhaps we'd be having a slightly different decision. [00:25:41] Speaker 00: But we don't. [00:25:42] Speaker 00: Thank you, Your Honor. [00:25:43] Speaker 02: Thank you, Counsel. [00:25:46] Speaker 02: Mr. Freeman at the Provincial Court. [00:25:53] Speaker 01: Your Honor, I just wanted to point you also to another paragraph of the Chang Declaration, paragraph 25, where he states, all Genesis has not abandoned its development of an intended and is continuing to devote resources to the development of this project, but reasonably expects that Cloudbreak will seek to enforce its patent against any product brought to market. [00:26:13] Speaker 01: It's on appendix page 5144. [00:26:15] Speaker 01: That's unrebutted in the record that we're continuing [00:26:21] Speaker 01: It's like, sure, there are other cases where... I don't think anybody thought that anyway. [00:26:26] Speaker 04: It's gotta be your personal allegations as to what you're doing. [00:26:31] Speaker 04: My concern, I just want to make sure you address my concerns, okay? [00:26:39] Speaker 04: I'm having a problem seeing how this is concrete, because it doesn't give me, looking at our case law and the level of specificity required under our case law, why is this enough to show that we've got concrete findings? [00:26:52] Speaker 04: It's not, you know... Well, I agree. [00:26:57] Speaker 01: I think that under the facts of this case, okay, and that the claims of the patent are so specific to something, the use of this compound to treat tigerein, [00:27:10] Speaker 01: It's established that we're going to run into this buzzsaw of the patent if we proceed with this project. [00:27:18] Speaker 03: What about your opposing counsel's point that all the reach-outs were kind of in the direction of Al Genesis reaching out to Cloudbreak as opposed to the other direction? [00:27:26] Speaker 03: Well, they call back. [00:27:28] Speaker 01: They signed an agreement. [00:27:32] Speaker 01: Not only did they do that, they entered an agreement with us to govern the discussions. [00:27:43] Speaker 03: I just want to make sure I have the facts right. [00:27:46] Speaker 03: You initiated the discussions as opposed to the other way around. [00:27:49] Speaker 01: Yes, I believe we initiated the communication because we see the obvious import of the situation here. [00:27:57] Speaker 01: It's like we're running into the buzzsaw of this particular problem. [00:28:03] Speaker 01: We just need some injury. [00:28:05] Speaker 01: A lot of people go into the Supreme Court under Article 3 and some pretty tiny injuries. [00:28:10] Speaker 01: We're in the context where we're used to some really huge injuries because of drug developments and whatnot, but any injury, no matter how small, is significant enough to create Article 3 standing as long as it's real and it's there. [00:28:23] Speaker 01: There's no question that this patent, this invalidity issue, presents a huge [00:28:28] Speaker 01: obstacle to this case and the risk of infringement if we proceed is real. [00:28:34] Speaker 01: And you know I think according to what the patent owners proposed or suggesting is that we have to spend the rest of this money in order to get there and they're not even sure they'd admit that that would get us there and in Lujan the Supreme Court said [00:28:50] Speaker 01: The rule that a plaintiff must vet the farm or risk damages before seeking a declaration of its actively contested legal rights finds no support in Article 3. [00:29:02] Speaker 01: So I think for the purposes of establishing Article 3 jurisdiction, we have provided the court with sufficient information in this particular set of facts, this particular patent, to justify hearing our appeal of the Board's decision. [00:29:17] Speaker 01: which is another right that Congress gave us to appeal the board's decision, provided we have Article III standing. [00:29:23] Speaker 02: Okay, we thank both counsel. [00:29:25] Speaker 02: This case is taken under submission. [00:29:26] Speaker 01: Thank you, Your Honor.