[00:00:00] Speaker 02: The sources we can get to case 2020, 2329, Moderna versus Butis. [00:00:27] Speaker 02: And you'll tell us, with respect to standing, how this case differs from the first one, however we rule on the first one. [00:00:37] Speaker 01: May it please the court? [00:00:38] Speaker 01: This case involves the 069 patent held by Arbutus, which was the subject of a separate IPR from the ones we just discussed. [00:00:48] Speaker 01: Again, this is an IPR that was infected with legal error. [00:00:52] Speaker 01: But based on the court's guidance, I'll begin with the standing issue. [00:00:56] Speaker 01: There are common issues with the appeal we just argued, but the circumstances were different at the time the 069 appeal was filed. [00:01:06] Speaker 01: Because at that time, the COVID vaccine was in development. [00:01:09] Speaker 01: Phase 1, phase 2 trials were underway. [00:01:12] Speaker 01: And before the appeal was filed, there actually had been a contract entered with the government to distribute the vaccine in the event it was approved. [00:01:21] Speaker 01: And since that time, of course, further development has occurred. [00:01:24] Speaker 04: So what's in the record? [00:01:27] Speaker 04: Obviously, because the BLA was filed after 2019. [00:01:31] Speaker 04: So what's in the record to support the prior development of this vaccine? [00:01:40] Speaker 01: There's substantial evidence in the Ryan declaration about activities that were going on before September of 2020. [00:01:48] Speaker 01: At that time, there was phase one, phase two trials. [00:01:53] Speaker 01: They had developed the target, they developed the vaccine, and they were in the process of seeking and obtaining emergency authorization, which did happen after the appeal was filed. [00:02:03] Speaker 01: But substantial activity toward that end. [00:02:06] Speaker 04: So you're saying they were seeking, they sought emergency authorization before 2019? [00:02:12] Speaker 01: No, I'm sorry. [00:02:12] Speaker 01: We're talking now about September of 2020. [00:02:14] Speaker 01: So this appeal, the 069 appeal was filed later in September of 2020. [00:02:19] Speaker 01: I'm sorry if I misunderstood your question. [00:02:20] Speaker 04: So it was already, they'd already sought the authorization even though they hadn't found the BLA? [00:02:26] Speaker 01: Correct. [00:02:26] Speaker 01: So the emergency authorization was sought first and that was obtained in December of 2020. [00:02:34] Speaker 01: Just to make sure I'm clear that the 069 appeal was filed [00:02:39] Speaker 01: later than the 435 that we just argued. [00:02:42] Speaker 01: It was filed in September of 2020. [00:02:45] Speaker 01: And at that time, there was extensive activity ongoing with respect to the COVID vaccine. [00:02:52] Speaker 01: By that time, Moderna had begun manufacturing the COVID vaccine for commercial sale. [00:02:57] Speaker 01: They had begun enrollment in phase three clinical trials. [00:03:00] Speaker 01: and phase one results had been published. [00:03:03] Speaker 01: They had entered into a supply agreement with the Department of Defense as of August of 2020. [00:03:07] Speaker 01: All that had occurred by September 30th of 2020 when this appeal was filed. [00:03:12] Speaker 01: So this is more than enough to establish the concrete injury. [00:03:17] Speaker 01: The DuPont case, which is relevant to both standing and the merits, addresses this issue. [00:03:22] Speaker 01: And in that case, the company had just begun operating a plant that could make a product that could possibly infringe, and that was deemed [00:03:30] Speaker 01: enough for standing. [00:03:31] Speaker 01: And here the activities with respect to the COVID vaccine were much further along. [00:03:36] Speaker 01: So it is differently situated from the 435 appeal in that sense. [00:03:41] Speaker 01: In the 435 appeal, these facts help support ongoing live controversy. [00:03:45] Speaker 01: But for this 069 appeal, they meet the standard of concrete injury, the risk of a possible infringement action. [00:03:54] Speaker 01: Again, we don't need to concede infringement. [00:03:56] Speaker 01: There doesn't need to be a specific threat of an infringement action. [00:03:59] Speaker 01: But there's extensive activity at the time the appeal was filed. [00:04:04] Speaker 04: That activity was protected, right? [00:04:07] Speaker 01: That activity was protected from immediate suit. [00:04:11] Speaker 01: But that's not the standard. [00:04:13] Speaker 01: And in fact, the Altair case, which we cited in our briefs, was a much more attenuated situation where standing was found. [00:04:19] Speaker 01: There, there was concurrent litigation about an NDA obligation that the parties had. [00:04:25] Speaker 01: But the court found that if that were resolved in favor of [00:04:29] Speaker 01: the developer, they would file an ANDA, which would then lead to inevitably an infringement case. [00:04:37] Speaker 01: So it doesn't have to be that someone can be sued on the very day the appeal was filed. [00:04:41] Speaker 01: There has to be a risk of possible infringement action. [00:04:44] Speaker 01: That can be based on both concrete current and potential future activity. [00:04:50] Speaker 03: What is the evidence for the concern of an infringement suit? [00:04:54] Speaker 01: The broad statements that we've cited in our briefs and attached to Mr. Ryan's declaration that Moderna, that Arbutus believes it covers the entire landscape of lipid nanoparticles. [00:05:06] Speaker 01: There are lipid nanoparticles in the COVID vaccine. [00:05:10] Speaker 01: That is enough. [00:05:10] Speaker 01: They've studiously avoided, as Mr. Ryan, as our brief says, they've studiously avoided an accusation of infringement. [00:05:18] Speaker 01: But that's not enough to avoid standing. [00:05:20] Speaker 01: The reality is they could bring a lawsuit. [00:05:22] Speaker 03: There's also no covenant not to sue, right? [00:05:24] Speaker 01: Exactly. [00:05:24] Speaker 01: Paragraph 11 of Mr. Ryan's declaration makes that clear. [00:05:27] Speaker 01: In the context of broad conversations about potential licensing of more rights than we already have in the sublicenses I referred to in the prior argument, they could sue us the day after this appeal is resolved. [00:05:41] Speaker 01: And that can't be what's intended by the jurisprudence on standing. [00:05:46] Speaker 01: There is concrete activity. [00:05:48] Speaker 01: both current and potential future activity related to the COVID vaccine that Arbutus could bring a lawsuit about. [00:05:55] Speaker 01: And they've never said they won't. [00:05:56] Speaker 04: They have not stipulated... Was there a request for covenant not to sue? [00:06:00] Speaker 01: It came up in the discussions and that is addressed at Mr. Ryan's paragraph 11. [00:06:05] Speaker 01: They have not stipulated to infringement. [00:06:07] Speaker 01: And again, in the Altair case, that was one of the factors the court considered in finding that standing was there. [00:06:16] Speaker 01: They have never retracted their broad statements about the patent rights here. [00:06:20] Speaker 01: And they have never indicated that they will not proceed with a case against Moderna. [00:06:25] Speaker 01: And the fact that they haven't made a specific threat is not enough to undermine standing here. [00:06:31] Speaker 01: There's extensive activity relating to the vaccine. [00:06:34] Speaker 01: And I should add that the licenses that we talked about with respect to the 435 patent are still in play and still could lead to future development and sub-licensing. [00:06:42] Speaker 01: But that's certainly less concrete than the ongoing COVID [00:06:46] Speaker 01: vaccine. [00:06:47] Speaker 02: Want to get to the merits? [00:06:48] Speaker 01: Yes. [00:06:49] Speaker 01: So this is a case where DuPont is squarely on point. [00:06:54] Speaker 01: That was an IPR where the board had found non-obviousness. [00:07:00] Speaker 01: And this court reversed, finding that they failed to apply the proper legal framework because they failed to shift the burden upon showing of an overlapping range. [00:07:10] Speaker 01: And that is exactly what happened. [00:07:12] Speaker 03: Why is this case different in that, well, first of all, the board said, [00:07:16] Speaker 03: The presumption doesn't apply because you have to make certain assumptions in order to be able to reach the claimed phospholipid range. [00:07:25] Speaker 03: You need to make certain assumptions about other amounts of other components and so that it wouldn't have been obvious to make that assumption. [00:07:33] Speaker 03: And secondly, there's two part question, where the board said even if the presumption applied, read below for all the reasons why it would be rebutted. [00:07:46] Speaker 01: So I'll take those questions one by one. [00:07:47] Speaker 01: In terms of the failure to apply the presumption, it's incorrect that assumptions need to be applied. [00:07:55] Speaker 01: There's four lipids. [00:07:56] Speaker 01: Four lipids are disclosed in the prior art, including both the cholesterol and phospholipid components. [00:08:02] Speaker 01: Almost all the examples in the prior art we're relying on have four lipids and have a phospholipid. [00:08:09] Speaker 01: The prior art discloses specific ranges in words, in those words, for three of those four [00:08:16] Speaker 01: components, cationic, non-cationic generally, and cholesterol. [00:08:21] Speaker 01: So we know, and it's undisputed, that the total four lipids have to add up to 100% concentration. [00:08:27] Speaker 04: You know what your friend on the other side is going to say, because he said it in the last appeal, which is these things all have to work together. [00:08:34] Speaker 04: And the failure to disclose some of the elements is itself sufficient to rebut your argument. [00:08:44] Speaker 01: So two responses to that. [00:08:46] Speaker 01: First of all, these are disclosed because Arbutus chose in these prior art patents to disclose lots of different ranges. [00:08:56] Speaker 01: Presumably, they did that for a reason so that they could, if they wanted to in that patent family, make different claims with different ranges that they had disclosed in their written description. [00:09:04] Speaker 01: Instead, they came and tried to claim those things in a subsequent patent [00:09:09] Speaker 01: with a later expiration date. [00:09:11] Speaker 01: And that's a simple attempt at patent life extension. [00:09:15] Speaker 01: They chose to give these multiple ranges, including the 60% cationic lipid range. [00:09:21] Speaker 01: And we're not applying assumptions, because all those ranges are disclosed. [00:09:26] Speaker 01: And if you have a disclosure of what the non-cationic amount is in total and what the cholesterol amount is in total, which is exactly the case here, [00:09:38] Speaker 01: It's basic math, and a person of ordinary skill understands how to come up with that range. [00:09:42] Speaker 01: We did that math in our briefs, but it's simply A plus B minus A equals B. And that is disclosed. [00:09:51] Speaker 01: It may not be written in the words a range of 3% to 15%. [00:09:57] Speaker 01: But it's disclosed because you simply have to do the subtraction. [00:10:01] Speaker 03: So do I understand you to be disagreeing with the board's statement that you had to assume that the skilled artisan would have selected a cationic lipid amount of 60%? [00:10:11] Speaker 01: That is a disclosure. [00:10:12] Speaker 01: So it's not assumption. [00:10:13] Speaker 01: They were the ones who chose to put the 60% number in their patent. [00:10:18] Speaker 04: That number is in the range. [00:10:21] Speaker 04: So you're saying we have to assume that they would pick the top of the range in every single case to do the math, to make the math work. [00:10:30] Speaker 01: The range is disclosed, and the entire disclosure is what needs to be considered for obviousness purposes. [00:10:37] Speaker 01: This is not an anticipation case. [00:10:39] Speaker 01: The priority needs to be looked at for everything it discloses. [00:10:43] Speaker 01: There's different ways one could [00:10:46] Speaker 01: mix and match these numbers, but all of the numbers are there. [00:10:50] Speaker 03: Are you talking about obviousness aside from the presumption from ranges, the range presumption? [00:10:58] Speaker 03: Are you saying the range presumption need not apply? [00:11:00] Speaker 03: I'm having a hard time following your argument because I understand what you're saying about how 60 is one thing that's disclosed, but you're trying to get a particular legal presumption to apply to your claims. [00:11:14] Speaker 03: And there are specific conditions that have to be met. [00:11:17] Speaker 03: And so you want to pick part of the range in order to make the other ranges work. [00:11:23] Speaker 03: Why does that make sense when we're talking about a presumption here? [00:11:27] Speaker 01: That's exactly what the law requires. [00:11:30] Speaker 01: The Enrique Peterson case establishes it. [00:11:31] Speaker 03: I don't think the law requires that you get to pick a particular amount for one ingredient in order to then meet the range, adding up to 100 for another ingredient. [00:11:40] Speaker 01: It establishes that a slight overlap [00:11:43] Speaker 01: in ranges, that's a direct quote, creates a presumption of obviousness. [00:11:48] Speaker 01: Here, they chose to disclose a number of different ranges. [00:11:51] Speaker 01: That was their choice, but we're entitled to rely on any one of them to show overlap. [00:11:56] Speaker 01: And there doesn't need to be verbatim words in their prior art patent saying a phospholipid range of X to Y. If a person of ordinary skill can understand [00:12:07] Speaker 01: how to get to those numbers based on everything else that is disclosed. [00:12:14] Speaker 03: Could you address my other question, which was the alternative? [00:12:17] Speaker 03: The board said, even if it applies, that they conclude that the phospholipid is not a result-effective variable. [00:12:26] Speaker 03: They had a lot of other fact findings, too. [00:12:29] Speaker 01: Yes. [00:12:30] Speaker 03: How do you respond to that? [00:12:31] Speaker 01: That was a further compounding of their initial error, because they purported to do the analysis in the [00:12:38] Speaker 01: alternative, but instead of putting the burden on Arbutus where it needed to be upon a presumption of obviousness, they faulted Moderna for failing to establish, A, that the amount of phospholipid was recognized as result effective, B, that there would have been motivation or routine optimization. [00:12:59] Speaker 01: And I can provide quotes from the opinion of the final written decision where they did that. [00:13:05] Speaker 01: the Appendix 25, this is the final written decision, they said the presumption is rebutted because we find nothing in the evidence indicating that the amount of phospholipid was recognized as result-effective. [00:13:18] Speaker 01: It should have been Arbutus's burden to prove not that it was result-effective, but it was not in the DuPont and applied materials. [00:13:25] Speaker 04: What do we make of the fact that they're optional in the formula? [00:13:29] Speaker 01: Optional does not mean that they cannot be considered part of the prior art. [00:13:33] Speaker 01: We cited cases to that effect. [00:13:34] Speaker 01: If they're disclosed, they're part of the prior art. [00:13:37] Speaker 01: And the problem from a legal framework standpoint is that once that overlapping range was established, even as plain overlap, the burden should have shifted to Arbutus to either prove as a matter of burden of production that the range was too broad somehow to apply this presumption, [00:13:56] Speaker 01: The board did not require them to do that. [00:13:58] Speaker 01: To prove that somehow there would have been no motivation to routinely optimize, the board put that burden on Moderna. [00:14:06] Speaker 01: And that was the wrong party to have the burden. [00:14:09] Speaker 01: And most importantly, on the result effective, they completely bollocksed up the framework. [00:14:14] Speaker 01: Because what the law says, what the cases say, including DuPont and applied materials, is [00:14:20] Speaker 01: Once that presumption is established, it's incumbent upon the patent owner to come forward and show that the variable was not result effective. [00:14:30] Speaker 01: The board instead found that Moderna failed to prove that it was result effective. [00:14:36] Speaker 01: And that's completely contrary to what the law requires. [00:14:40] Speaker 01: So their alternative analysis that Your Honor asked about was all based on applying the burden to Moderna when [00:14:49] Speaker 01: the presumption should have shifted that burden to Arbutus. [00:14:53] Speaker 02: Council, your time is almost up. [00:14:55] Speaker 02: We'll give you three minutes for rebuttal. [00:14:57] Speaker 02: Thank you. [00:14:59] Speaker 02: We'll hear from Mr. Burl. [00:15:15] Speaker 00: Thank you, Your Honor, and may it please the Court. [00:15:17] Speaker 00: I'll begin with standing and address any questions that the Court has. [00:15:22] Speaker 00: I would observe here that the threats on which Moderna relies here are entirely stale. [00:15:29] Speaker 00: They were made in 2016, 2017, before COVID even existed. [00:15:35] Speaker 00: The evidence that Moderna has put into the record [00:15:37] Speaker 00: indicates that since that time they have changed their technology and they say the patents are no longer relevant to what they're doing with respect to COVID. [00:15:45] Speaker 03: Many times in cases like this, the parties arrive and one of them will say, I'll give you a covenant not to sue. [00:15:51] Speaker 03: We do that right now. [00:15:53] Speaker 03: We haven't seen that here. [00:15:54] Speaker 03: I recognize it puts you in a really awkward position. [00:15:58] Speaker 03: but I think we do have to take into account that there isn't a covenant not to sue here. [00:16:03] Speaker 00: Well, understand this. [00:16:04] Speaker 00: The issue is what my client has done, what its actions are, not what its actions were not. [00:16:09] Speaker 00: And so the Prasko versus Medici case, as well as the AIDS global health case, both stand for the proposition that a [00:16:16] Speaker 00: refusal to grant a covenant not to sue is not enough to trigger jurisdiction. [00:16:22] Speaker 00: The statements are more stale than the stale statements that have defeated jurisdiction in other cases. [00:16:32] Speaker 00: For example, the Citizens Electronics case [00:16:34] Speaker 00: It was a situation where they had made real threats. [00:16:37] Speaker 00: They'd said, we're not going to tolerate infringement. [00:16:39] Speaker 00: We're going to file lawsuits against unauthorized users. [00:16:43] Speaker 00: And then six months passed since those statements were made. [00:16:46] Speaker 00: And the court said, even if those statements could have triggered jurisdiction when made, the passage of time, their six months, here many years, refuted. [00:16:56] Speaker 04: so broad that they said that all of their activity in this field would be covered by the patents that already existed? [00:17:03] Speaker 00: Well, I don't think they can be read that broadly, first of all. [00:17:06] Speaker 00: And second of all, they couldn't have predicted the future. [00:17:09] Speaker 00: Moderna, through Mr. Ryan, has advanced evidence in this record that says, we changed our process. [00:17:15] Speaker 00: And we have an old process for which the patents are relevant. [00:17:18] Speaker 00: And we have a new process for which the patents are not relevant. [00:17:21] Speaker 00: We heard that again today with respect to their RSV vaccine, and the latest information they provided here to the court was that their new RSV technology uses the same technology as their COVID vaccine, indicating, per Moderna's own evidence, that the patents are somehow not relevant. [00:17:37] Speaker 00: So they're stale because Moderna says that they're stale. [00:17:41] Speaker 00: The world has changed and they say it no longer applies. [00:17:44] Speaker 00: So the notion that they can rely on old statements and at the same time suggest that everything has changed and so old statements about old technology aren't pertinent anymore, that just doesn't hold together. [00:17:55] Speaker 00: They point to no evidence at all that we've made any threat with respect to the COVID vaccine, which is the only [00:18:02] Speaker 00: product on which they are relying for jurisdiction in this 069 case. [00:18:05] Speaker 00: We heard nothing again about the RSV vaccine. [00:18:09] Speaker 00: So as of the date of appeal, which is September 2020, they point to no activity that's not stale from my client. [00:18:16] Speaker 00: And a refusal to give a covenant not to sue under the law is never enough. [00:18:21] Speaker 00: And it's not enough here. [00:18:23] Speaker 00: With the court's permission, I'll be happy to turn to the merits of the appeal in the event that the court does not dismiss it. [00:18:30] Speaker 04: Can you focus on the burden shifting argument? [00:18:32] Speaker 00: Absolutely. [00:18:33] Speaker 00: Absolutely. [00:18:34] Speaker 00: So first, it is a requirement of every one of these cases that the prior art disclosed overlapping ranges. [00:18:42] Speaker 00: That's what DuPont says. [00:18:43] Speaker 00: That's what Peterson says. [00:18:44] Speaker 00: Even the other cases they cite like Ormeteau and Galderma, they all require an actual disclosure of all of the overlapping ranges in the claim. [00:18:52] Speaker 00: That's missing here. [00:18:53] Speaker 00: the board found as a factual matter that that's missing here that's modernist evidence relied on all sorts of assumptions which were rejected by the board including that the ranges address a four lipid system with these four components and only these four components it's not true that a non-cationic lipid must only be cholesterol and a phospholipid the prior art discloses sterol amines dodecyl amines stearates and numerous other [00:19:23] Speaker 00: non-cat-ionic lipids. [00:19:25] Speaker 00: So the notion that you can just sort of divide it in the way that they assert is number one, not true. [00:19:29] Speaker 00: Number two, rejected by the board in a finding that Moderna does not dispute. [00:19:33] Speaker 00: The board says it, 25 and 26. [00:19:36] Speaker 00: Moderna assumes that the entirety of the ranges disclosed apply to the four-lipid system. [00:19:43] Speaker 00: That was rejected. [00:19:44] Speaker 00: And without that assumption, this math doesn't hold together. [00:19:48] Speaker 00: I would further observe that what Moderna is doing is not suggesting that even a narrow overlap can be enough for a range. [00:19:55] Speaker 00: When they pluck out 60% for the cationic lipid for their calculation, and to be clear, every one of the calculations in their petition at 133 and 134 requires this assumption. [00:20:04] Speaker 04: It requires the 60%. [00:20:06] Speaker 04: But what if you're talking about obviousness as opposed to anticipation? [00:20:09] Speaker 04: Why wouldn't it have been obvious to pick the top of the range? [00:20:12] Speaker 00: Well, there was a lot of evidence that it wouldn't have been obvious, that higher amounts of phospholipids, of cationic lipids, would have been considered deleterious. [00:20:22] Speaker 04: But you look at the chart that even you produced, and it shows that the dip, the other side of the curve, occurs after 60%. [00:20:34] Speaker 00: Well, that's one chart. [00:20:36] Speaker 00: That's the Linn. [00:20:38] Speaker 00: reference that your honor speaking to, there was copious amounts of evidence in the prior art. [00:20:43] Speaker 00: The gout prior art reference, to take one example, simple to take another. [00:20:47] Speaker 00: The analysis provided at A3365, which explains that where you have high cationic lipids, especially without high conjugate lipids, it would have been expected to be toxic, unstable, and the person of ordinary skill never would have done that. [00:21:03] Speaker 00: that it's fine up until sixty percent on that and it helps up to sixty well I'm actually without actually says in the board close this from on that at page fifteen of its opinion is that it's more desirable to use less cat ionic lipid in fact the entire purpose of the last versus more is [00:21:21] Speaker 04: 60 and less versus over 60. [00:21:24] Speaker 00: Well, first of all, Ahmed's lipoplexes were very different than those. [00:21:28] Speaker 00: So the percentages that attend to a lipoplex that has only cationic lipid and phospholipid and nothing else is not pertinent to the four-lipid system, which the board found was far more complex, where all of these components interrelate to each other. [00:21:42] Speaker 00: And we presented an enormous amount of evidence. [00:21:45] Speaker 00: If you look at 1710 through 1714, [00:21:47] Speaker 00: seventeen forty seventeen forty over and over again explaining that high cationic lipid was a bad idea and the person or near school thought that's pocket what what is your definition of high that's what i'm trying to talk about anything toward the higher end of the range anything over fifty percent [00:22:03] Speaker 00: is what the evidence explained. [00:22:05] Speaker 00: And certainly anything close to 60 would have been a non-starter for the person of ordinary skill. [00:22:10] Speaker 00: And again, there's no, Judge Stoll's point that what you're trying to do here is not sort of show the claim as obvious through a normal rubric. [00:22:18] Speaker 00: Moderna is trying to apply a presumption that requires a disclosure of a phospholipid range. [00:22:23] Speaker 00: And there is no support in the law for picking and choosing by hindsight [00:22:28] Speaker 00: certain percentages from ranges and then constructing through some calculation a phospholipid range. [00:22:34] Speaker 00: The very prior art on which they rely, the 196 patent, says that the preferred range for cationic lipid stops at 45%. [00:22:41] Speaker 00: The same prior art reference says that the preferred amount of conjugated lipid is 4 to 15%. [00:22:48] Speaker 00: they ignore all that and they say let's choose another number. [00:22:51] Speaker 00: Why? [00:22:51] Speaker 00: Because four to fifteen percent is outside of our claim so they just choose another one by hindsight without explanation in a manner that's rejected by the board. [00:22:59] Speaker 00: There is no support in any of the cases to do this. [00:23:02] Speaker 00: The only cases they cite to support the proposition that they don't need an actual disclosure of a [00:23:08] Speaker 00: range of fossil lipids are Ornko, which had an explicit disclosure of a 14 to 21 day period in the prior art, and the claim was 2 to 20. [00:23:17] Speaker 00: And they also cite Galderma, where the Schrute prior art reference had an explicit range of .01 to 1%. [00:23:23] Speaker 00: There's no case that allows this calculation. [00:23:26] Speaker 00: And I would observe, they did this calculation between their briefs and their petition six different times. [00:23:32] Speaker 00: six different times in the two cases, and every time they came up with a different number. [00:23:37] Speaker 00: And I would submit that refutes the notion that the phospholipid range just sort of falls out of the sky to the POSA. [00:23:43] Speaker 00: One time they say 0 to 65, next time it's 0 to 28, next time it's 0 to 40, next time in the 435 it's 0 to 20, which by the way is not anything like what they're asserting here, which is 0 to 19.5 and 0 to 30. [00:23:56] Speaker 00: So it's not true that the phospholipid range would have just been apparent to the POSA. [00:24:02] Speaker 00: they sort of admit soda voce that it's not true by having six different calculations that create six different things and it's based on unsubstantiated assumptions that the board rejected as a factual matter and the notion that that's somehow not supported by substantial evidence is not true. [00:24:19] Speaker 00: I would also observe that the board found even if [00:24:22] Speaker 00: the phospholipid range had been disclosed, which of course it wasn't, and so the range law presumption could not be invoked. [00:24:28] Speaker 00: There were numerous factual findings that defeat a finding of obviousness under this court's range law jurisprudence, including the interaction between the various components. [00:24:37] Speaker 00: There's been some question about whether one does that before or after the invocation of the presumption. [00:24:44] Speaker 00: Let me be clear here because there's been a lot of confusion about that in the briefs and here today. [00:24:48] Speaker 00: We don't have the burden to prove anything, whether one invokes the presumption or not. [00:24:53] Speaker 00: The law is clear and Moderna agrees the burden of proof never shifts. [00:24:58] Speaker 00: It is always on the challenger, including in an IPR. [00:25:01] Speaker 00: The only burden we would have undertaken is a burden of production, not a burden of proof. [00:25:07] Speaker 00: And there's no question that in both this case and the 435 case, we met that burden of production. [00:25:12] Speaker 00: We came forward with an enormous amount of evidence showing non-routine optimization, showing interaction. [00:25:18] Speaker 00: that evidence is that the rations of other things that we're going to talk about some and i can list them all get if you'd like but they're all there in the site in our group all of which the board was entitled to rely on so whether the presumption was invoked and then that information was considered after we discharge our production [00:25:34] Speaker 00: or whether it was never invoked in the first place, and honestly I read this court's law to suggest that it never should be invoked in the first place, where there's not routine optimization given what this court said in Horizon and given what it said in Genetics Institute and what it said about Genetics Institute in footnote 15 of the DuPont case. [00:25:50] Speaker 00: where it suggests that the burden should not be invoked, where there are too many options and it would not be routine experimentation to get there. [00:25:56] Speaker 00: Either way, that's sort of angels dancing on the head of a pin because we had the evidence. [00:26:01] Speaker 00: The board looked at all the evidence. [00:26:03] Speaker 00: The law says if the ranges are very broad, that's pertinent under the court's range analysis. [00:26:08] Speaker 00: The board considered that. [00:26:09] Speaker 00: The law says if the ranges interact with each other in an unpredictable way, applied materials and other cases, that's pertinent. [00:26:16] Speaker 00: The board looked at that. [00:26:17] Speaker 00: Whether the experimentation is routine or non-obvious invention, under Peterson, under Genetics Institute, the board looked at that and considered that. [00:26:26] Speaker 00: And time after time after time in both decisions, [00:26:29] Speaker 00: The board sided with us as a factual matter. [00:26:32] Speaker 00: And what Moderna is doing, it's unable to refute those factual determinations. [00:26:37] Speaker 00: It doesn't challenge a single one of them. [00:26:39] Speaker 00: So what it does instead is suggest that none of those factual determinations matter. [00:26:45] Speaker 00: Somehow there's this talisman of cases about ranges that uproots route to branch. [00:26:52] Speaker 00: every fundamental tenant of this court's obviousness case law, from motivation to combine, to expectation of success, to routine experimentation, to interactive unpredictability. [00:27:03] Speaker 00: Those are the basic tenants from KSR in the 15 years since, as explained by this court. [00:27:08] Speaker 00: And the idea that you can just throw those out the window whenever you have an overlapping rage is not well taken, and it's inconsistent with the very cases like Peterson and DuPont that they cite. [00:27:17] Speaker 00: I'm sorry, Your Honor. [00:27:18] Speaker 00: I wasn't asking. [00:27:20] Speaker 00: OK. [00:27:20] Speaker 00: Looks like you were. [00:27:21] Speaker 04: Before you're done, I have one question that goes back to standing and you argue that the fact of estoppel is meaningless or pretty close to meaningless. [00:27:33] Speaker 04: We have said it's not enough, but it's not completely meaningless, right? [00:27:38] Speaker 00: you'd be the fact that you'd be a stock on the other side yeah i mean i think that jake x case or however you pronounce that case uh... suggest that it's certainly not enough and i think all of the jurisprudence would would say the same thing that's not something we have done but the the crucial issue understand this is what has the patent he'd gone has it made a threat [00:27:59] Speaker 00: And so the fact that there could be some effect of a stopple as a result of the decision, not enough. [00:28:05] Speaker 04: Is it your view that they would, in fact, be statutorily stopped in both of these cases? [00:28:12] Speaker 00: They would be statutorily stopped under section 315, but that doesn't mean that there's some imminent threat as of the time that they file the notice of appeal of a lawsuit. [00:28:22] Speaker 00: And they haven't shown that. [00:28:24] Speaker 00: And they actually cited to Mr. Ryan's declaration at paragraph 8 and said, oh, that shows that these patents have some relevance to their payment obligations. [00:28:35] Speaker 00: And I would invite the court to look closely at what he said there and in his earlier declaration at 57-45-46 where he said the 069 and 435 patents and other patents are relevant to our payment obligations. [00:28:51] Speaker 00: He never says that the 435 [00:28:53] Speaker 00: and 069 are themselves relevant. [00:28:58] Speaker 00: And he never says that it would remove an important obstacle so that the other 40 pages of patents would somehow not be relevant or would disappear. [00:29:06] Speaker 00: And I will read from Apple Qualcomm, where it said, Apple nowhere provides evidence that the validity of any single patent, including the 037 and 362 that were relevant there, would affect its ongoing royalty obligation. [00:29:19] Speaker 03: Can I ask you one other question, which is, I read claim seven. [00:29:24] Speaker 03: of the 435 is being very similar to claim one of the 069. [00:29:29] Speaker 03: Do you agree with that? [00:29:29] Speaker 00: I agree. [00:29:30] Speaker 00: I mean, it has the four lipids required. [00:29:32] Speaker 00: And there can be differences in terms of percentages. [00:29:34] Speaker 00: But as a fundamental matter, I agree with you, Your Honor. [00:29:40] Speaker 02: I think you've concluded. [00:29:41] Speaker 00: Thank you very much, Your Honor. [00:29:43] Speaker 02: Thank you, Mr. Berl. [00:29:44] Speaker 02: Ms. [00:29:45] Speaker 02: Wigmore has three minutes for a bottle. [00:29:52] Speaker 01: Thank you, Your Honor. [00:29:53] Speaker 01: Just starting briefly with standing. [00:29:55] Speaker 01: The word threat was used many different times in counsel's arguments. [00:29:59] Speaker 01: And I just want to make clear there's no requirement for a threat that has not been a lot, at least since metamune. [00:30:04] Speaker 01: What is required for standing is that the appellant be engaged in or will likely engage in activity that would give rise to a possible infringement suit. [00:30:13] Speaker 01: And that is precisely the case here. [00:30:16] Speaker 01: There doesn't need to be a threat. [00:30:18] Speaker 01: As to Judge Amali's question about estoppel, [00:30:21] Speaker 01: The court has recognized in phygenics and consumer watchdog that estoppel is not an injury in fact when the appellant is not engaged in any activity that would give rise to possible infringement suit. [00:30:34] Speaker 01: But here we are, and therefore estoppel is relevant to the question of standing. [00:30:40] Speaker 01: As to the merits, I want to address the argument about so-called six different calculations. [00:30:46] Speaker 01: We disagree with that. [00:30:47] Speaker 01: First of all, some of those calculations related to the 435 patent, and there are different [00:30:51] Speaker 01: prior art disclosures and ranges involving the two patents. [00:30:54] Speaker 01: So that's not a fair assessment. [00:30:56] Speaker 04: In terms of the calculation... Is it fair for him to say that you came up with different numbers for the same calculations? [00:31:02] Speaker 01: There are, in fact, different numbers because there is a breadth of disclosure in the prior art. [00:31:07] Speaker 01: The main distinction between some of the numbers we provided, we provided two approaches. [00:31:11] Speaker 01: One is if you just look at the non-cadionic range, which is in this case the phospholipid and the cholesterol. [00:31:18] Speaker 01: If you have the non-cadionic range disclosed, [00:31:21] Speaker 01: And then you have the cholesterol disclose. [00:31:23] Speaker 01: It's easy to do subtraction and figure out what the phospholipid would be. [00:31:27] Speaker 01: So that's one way of looking at it. [00:31:28] Speaker 01: Another way of looking at it is to look at all four ranges and to start with the 60% cationic, as we explained in our brief. [00:31:35] Speaker 01: And if you deduct the higher and lower end of the ranges disclosed for the other three components, you end up in the same place. [00:31:42] Speaker 01: So we're not giving different calculations. [00:31:44] Speaker 01: We're showing different ways to get there based on the disclosure and the prior art. [00:31:49] Speaker 01: I want to turn to the burden because this was the board's fundamental error. [00:31:56] Speaker 01: Council discussed various evidence in the record, and we're not denying there's evidence in the record on both sides, but the problem is that the board put the burden on Moderna in the first instance to prove motivation, to prove the interdependence of the variables is not an issue. [00:32:15] Speaker 01: They should not have done that. [00:32:17] Speaker 01: We're not saying the burden of proof shifted. [00:32:19] Speaker 01: The burden of production should have shifted, and here the board improperly faulted Moderna's expert, Dr. Janna, for not presenting any arguments for why the skilled artisan would have been motivated to optimize. [00:32:32] Speaker 01: That should not have been our burden. [00:32:34] Speaker 01: That should have been their burden of production to which we could respond. [00:32:38] Speaker 01: Similarly, with respect to interdependence of the variables, the board committed legal error by faulting Moderna for not taking into account interdependence of the claimed [00:32:48] Speaker 01: lipid components. [00:32:49] Speaker 01: The in-ray applied materials case makes clear. [00:32:53] Speaker 01: It's up to the patent owner after the presumption is established to show anything unpredictable or unexpected in the interaction of the variables. [00:33:01] Speaker 01: So the problem is not that there is no evidence in the record on either side. [00:33:05] Speaker 01: The problem is the lens through which the board viewed the evidence. [00:33:09] Speaker 01: And they consistently impose the burden on Moderna to disprove these factors that the case law clearly establishes fall upon the patent owner [00:33:18] Speaker 01: to establish once the overlapping range exists. [00:33:22] Speaker 01: And so DuPont is squarely on point here. [00:33:25] Speaker 01: The board here made the exact same mistakes that were made in that case. [00:33:28] Speaker 01: And given the breadth of disclosure and the number of ranges that are very specific in the prior art, there is an overlap. [00:33:36] Speaker 01: The burden should have shifted. [00:33:37] Speaker 01: And this case should, at the very least, be remanded so that the board can view it through the proper lens. [00:33:42] Speaker 02: Thank you, Ms. [00:33:43] Speaker 02: Wigmore. [00:33:44] Speaker 02: The case will be taken on a submission. [00:33:46] Speaker 01: Thank you. [00:33:46] Speaker 02: Thank you for both of your arguments.