[00:00:00] Speaker 02: on to the important business of the day, 23-7402, Sid Nexus versus Inovia. [00:00:09] Speaker 02: Mr. Is it Rosato? [00:00:12] Speaker 02: Rosato, please proceed. [00:00:14] Speaker 00: Thank you, and good morning, and may it please the court. [00:00:18] Speaker 00: This case is an appeal from an IPR before the PTAB. [00:00:22] Speaker 00: And in this case, the board's own fact findings here demonstrate that this case is [00:00:27] Speaker 00: essentially a failed inherency case. [00:00:30] Speaker 00: It is not a case where the petitioner in an IPR satisfied their burden of proof as they're required to do. [00:00:36] Speaker 00: The issue that we're focusing on appeal here centers around the buffer limitation of the claims. [00:00:43] Speaker 02: Well, are you starting with whether there's substantial evidence for the board's finding, or are you starting with your other argument, which I thought was that the board placed a burden on the wrong party? [00:00:54] Speaker 02: Which of those two are you starting with? [00:00:57] Speaker 00: I think they both go together. [00:01:01] Speaker 00: There is an assertion here in the petition, and the petition theory was that this ACORN reference disclosed this buffering limitation. [00:01:09] Speaker 00: The board's fact findings did not affirmatively find that it's there. [00:01:14] Speaker 00: What the board found was it's possible, looking at a list of ingredients, it's possible that this ingredient was buffering. [00:01:21] Speaker 00: It's possible that it wasn't buffering. [00:01:23] Speaker 00: And then the board shifted to look at patent owners' arguments and reject them. [00:01:29] Speaker 00: So it was an unsubstantiated charge that this limitation was in the art. [00:01:35] Speaker 00: is a failed inherency case as the board's fact findings and a shift. [00:01:41] Speaker 02: One of your arguments, as I understand them, is that the board placed the burden on the wrong party. [00:01:48] Speaker 02: Is that correct? [00:01:49] Speaker 00: I think they did do that. [00:01:50] Speaker 02: Show me in the opinion the place that you think most crisply demonstrates that. [00:01:56] Speaker 00: Sure. [00:01:59] Speaker 00: I would go to [00:02:02] Speaker 00: I would say the board has two parts of its analysis. [00:02:06] Speaker 00: First, it finds a premier possibility. [00:02:08] Speaker 00: Then at A44, that's where the board turns to addressing essentially whether patent owner proved the negative. [00:02:18] Speaker 00: The key issue was whether ACORN disclosed a buffer. [00:02:23] Speaker 00: And from A41, A42, they're talking about how it's possible. [00:02:27] Speaker 00: It depends on the parameters. [00:02:29] Speaker 00: There may be a buffer. [00:02:30] Speaker 00: And then at A44, [00:02:32] Speaker 00: the board then turns to the next part of its analysis, which is asking whether patent owner proved that there was no buffer. [00:02:41] Speaker 00: And the rest of the analysis really focuses on rejecting Dr. Lasker's opinion, that was patent owner's expert, that he didn't think it was there. [00:02:52] Speaker 00: So with those two components, even if the board [00:02:56] Speaker 00: even if we were to accept the board's finding that Dr. Lasker and Patent Owner failed to prove the negative, it still doesn't answer the question of whether the Patent Owner, excuse me, the petitioner in this case, satisfied their burden of proof as they're required to do. [00:03:11] Speaker 00: And we would say if we turn to the first part of that, the mere possibilities, [00:03:18] Speaker 00: that the board's fact findings there demonstrate that there was no inherent disclosure. [00:03:24] Speaker 00: There was no disclosure of this limitation. [00:03:27] Speaker 03: So Acorn discloses the same two phosphate salts that are recited in your claim seven. [00:03:35] Speaker 03: Right you have a claim seven that recites these two phosphate salts as being buffering agents and an Acorn discloses those very two phosphate salts, and then they had an expert that said These particular phosphate salts are standard buffering agents so I guess what I'm trying to figure out is I [00:03:59] Speaker 03: why isn't that an affirmative case being made, especially when we look at your claim seven. [00:04:05] Speaker 03: Well, your claim one says a buffering agent to provide a pH from 4.8 to 6.4. [00:04:12] Speaker 03: And then you have a dependent claim saying the buffering agents are these two phosphate salts. [00:04:18] Speaker 03: Those two phosphate salts must necessarily buffer in that claim range. [00:04:24] Speaker 03: And then if the prior art discloses those same agents, [00:04:29] Speaker 03: then why isn't that a prima facie case? [00:04:33] Speaker 00: I'm glad you brought that up because the board does seize on that. [00:04:37] Speaker 00: It actually supports our argument rather than somehow exposing some inconsistency. [00:04:44] Speaker 00: that supports every not only what we were arguing before the board but what the board itself found and that you know that starts at a 41 the board's talking about the concept of a buffer as not being a static thing right it depends it entirely depends on the parameters of the solution and you can have a situation where phosphates are present they're not buffering and under a different set of circumstances they are buffering when we get to claim seven [00:05:11] Speaker 00: Again, the ultimate issue is whether ACORN discloses a buffer. [00:05:17] Speaker 00: ACORN has its own pH range, this USP compliance, it asserts it's in compliance with the USP quality standards. [00:05:26] Speaker 00: That pH range is listed in ACORN as pH 3.5 to 6. [00:05:31] Speaker 00: and they confirm that they're in compliance with that. [00:05:34] Speaker 00: That is inconsistent with using a phosphate as a buffer. [00:05:39] Speaker 00: That's not true of the claims in the patent, which also lists a pH that extends well above that. [00:05:47] Speaker 00: that same range from ACORN. [00:05:50] Speaker 00: So you can certainly have a narrowing dependent claim in a patent that focuses on a pH that is not present in the prior art. [00:05:58] Speaker 00: So there's no inconsistency there. [00:06:00] Speaker 00: In fact, if there's any inconsistency, I would say the board's conclusion they're drawing from that is inconsistent with everything they're saying at A41 about how whether an ingredient [00:06:14] Speaker 00: is buffering completely depends on the parameters of the solution as well as their definition of a buffer that they adopted A14, which imparts a functional requirement that the buffer act to maintain pH. [00:06:30] Speaker 00: That's how it's defined. [00:06:32] Speaker 03: And we know from- I got a little lost in all of that. [00:06:35] Speaker 03: And in fact, if anything, this starts to sound a lot like a substantial evidence question. [00:06:41] Speaker 03: We know that these phosphate salts are standard buffering agents. [00:06:46] Speaker 03: And I don't think you're disputing that. [00:06:49] Speaker 03: In fact, you can't be disputing that because your claim seven says that. [00:06:55] Speaker 03: we have evidence in the record that shows that these phosphate salts can be used to prepare a buffer having a pH below 6.0, somewhere at 5.4, which is within your claimed range. [00:07:12] Speaker 03: And if we have a disclosed overlapping range with the claimed range, then that's good enough for meeting the claimed range limitations. [00:07:22] Speaker 03: So again, [00:07:25] Speaker 03: I don't quite follow why, based on the evidence and the record, you may have evidence on your side that favors your point of view. [00:07:33] Speaker 03: But if the board has other record evidence that it could rely on, to the contrary, I don't know what we can do to help you, given our limited review of fact findings. [00:07:48] Speaker 00: I would say we can accept the board's fact findings, but I would draw one critical caveat in what you said, and that is can be. [00:07:57] Speaker 00: And that is the operative word. [00:07:59] Speaker 00: Phosphates can be a buffer, or they cannot be. [00:08:03] Speaker 00: And that's a key distinction here. [00:08:06] Speaker 00: Again, the board explains this at A41. [00:08:09] Speaker 00: They say buffer is not a static concept. [00:08:13] Speaker 00: It totally depends on the parameters of the solution. [00:08:16] Speaker 00: So you can have phosphates in a solution, as the patent explains, that are put there not as buffers, but as tonicity adjusting agents. [00:08:26] Speaker 00: for other reasons. [00:08:27] Speaker 00: They're non-buffer reasons people use phosphates. [00:08:30] Speaker 00: When we're looking at the acorn reference, we have no idea what the parameters of the solution are. [00:08:35] Speaker 00: They've never been shown. [00:08:37] Speaker 00: Still to this day, nobody knows it, nor does the board. [00:08:40] Speaker 00: All the board says is, you need to know the parameters to conclude some ingredients of buffer. [00:08:44] Speaker 00: We don't know them. [00:08:45] Speaker 01: And their findings that you highlight are... Can you identify for me in the board's decision where you take issue? [00:08:55] Speaker 01: with the board's finding kind of this could-be language or this possibility language. [00:09:00] Speaker 01: Can you point me to a specific record page and make that language that you're taking issue of? [00:09:04] Speaker 00: Absolutely, Your Honor. [00:09:04] Speaker 00: That type of conditional language is littered throughout the board's decision. [00:09:07] Speaker 00: We see the A41 where they're talking about the concept of a buffer being malleable. [00:09:13] Speaker 00: It's not static. [00:09:15] Speaker 00: That buffering capacity may exist. [00:09:17] Speaker 00: It may not. [00:09:18] Speaker 00: They're explaining that it depends on the parameters of the solution. [00:09:22] Speaker 00: At A42, they're saying phosphates may be a buffer. [00:09:25] Speaker 00: It's all conditional language. [00:09:27] Speaker 00: And we agree with that. [00:09:30] Speaker 00: Whether an ingredient is functioning as a buffer totally depends on the parameters of the solution. [00:09:36] Speaker 00: And in this case, they've never been identified. [00:09:39] Speaker 00: No one knows what they are. [00:09:41] Speaker 00: under those facts. [00:09:43] Speaker 00: The buffer pH is a result effective variable, right? [00:09:47] Speaker 00: Well, we're talking about pH. [00:09:48] Speaker 00: That's a different issue, right? [00:09:49] Speaker 00: So pH is different and that's, you know, that was another thing I wanted to come, thank you for bringing that up. [00:09:56] Speaker 00: There's another thing I wanted to address in your comments, your honor, is pH is a completely different issue. [00:10:02] Speaker 00: The argument here in the IPR was, this is a very important point of this case, is their whole argument was this simplicity argument. [00:10:14] Speaker 00: Their argument was this is a very simple case because you can simply take the acorn solution, which they claim was VFDA approved ophthalmic solution for atropine, and the only modification needed to make was adjust the drug concentration. [00:10:29] Speaker 00: That's it. [00:10:29] Speaker 00: It's already buffered. [00:10:31] Speaker 00: So it's already buffered and this USP compliance range satisfies the pH. [00:10:39] Speaker 00: So you've got the buffer, you've got the pH. [00:10:42] Speaker 00: They've never shown that a buffer exists. [00:10:45] Speaker 00: The pH we're not arguing about on appeal here. [00:10:50] Speaker 00: It did materialize differently as an issue, but there's a USP compliance range, we're not arguing about pH, [00:10:57] Speaker 00: this appeal comes down to whether a buffer is present. [00:11:01] Speaker 00: And as the board explains at A41, you don't know that until you know the parameters of the solution, which have never been identified. [00:11:08] Speaker 00: So at the end of the day, what the board's findings indicate is a mere possibility that a buffer exists, not that one necessarily exists under the well-established standard for inherent disclosure. [00:11:21] Speaker 00: were left with mere possibilities, and the board explains precisely that that's the case. [00:11:26] Speaker 00: And then they turn to criticizing patent owner for not proving that no buffer exists. [00:11:33] Speaker 01: So, Council, I went to those pages you pointed me to, up in this page 41 and 42, and I'm not seeing the precise name language that you identified. [00:11:42] Speaker 01: Can you just give me maybe the line or the paragraph that you're taking issue with here? [00:11:48] Speaker 00: So this whole paragraph in A41 is talking about the concept of a buffer being malleable and not static. [00:11:59] Speaker 00: At the end of that paragraph, they conclude, the evidence of record indicates that the pKa for a buffer is not static, but depends on the parameters of the solution. [00:12:10] Speaker 00: Above that, they talk about, a couple lines down, they're talking about some buffering capacity may exist. [00:12:18] Speaker 00: At the top of A42, buffering range for these buffers may be as low. [00:12:26] Speaker 00: A43, in the last full paragraph, in the middle of the paragraph, they talk about the evidence just discussed to be able to buffer. [00:12:38] Speaker 00: This is all conditional language, and we agree with that. [00:12:42] Speaker 00: Whether something is buffering completely depends on the parameters. [00:12:46] Speaker 00: It's not a fixed thing. [00:12:48] Speaker 00: And that is precisely our point. [00:12:50] Speaker 00: Where we take contention is what the board did with those findings. [00:12:55] Speaker 00: Rather than saying, okay, under the standards of inherency, a moving party must show that an element is necessarily present. [00:13:04] Speaker 00: Mere possibilities aren't good enough. [00:13:07] Speaker 00: And what they're explaining throughout this decision is whether or not the phosphates are acting as a buffer is a mere possibility. [00:13:15] Speaker 00: It's not necessarily present. [00:13:17] Speaker 00: They never say it's necessarily present. [00:13:19] Speaker 00: They find a mere possibility, and then they turn over to patent owners who are meant to knock that down. [00:13:26] Speaker 00: But we don't see... OK, I think you should save some time for rebuttal. [00:13:31] Speaker 00: Thank you, Your Honor, for reminding me. [00:13:33] Speaker 01: Can I ask one last question before you do that? [00:13:35] Speaker 01: Of course. [00:13:35] Speaker 01: It's a housekeeping question, right? [00:13:37] Speaker 01: So there are three patents of issue here on appeal. [00:13:40] Speaker 01: Are there any issues unique to one patent versus another patent? [00:13:44] Speaker 00: Not in the sense that the board's decision was essentially a cut and paste on the buffer issue. [00:13:52] Speaker 00: The 787 patent has more narrow and specific language about the buffer being dialed in to control pH at a stated pH range. [00:14:02] Speaker 00: So there's difference in the language. [00:14:04] Speaker 00: 787 is, I would say, a more narrow claim. [00:14:07] Speaker 00: But the board's reasoning is literally a copy paste. [00:14:12] Speaker 01: The board's review is the same across the three panels, right? [00:14:15] Speaker 00: That's correct. [00:14:15] Speaker 00: On this issue. [00:14:17] Speaker 00: Yes. [00:14:17] Speaker 00: Thank you. [00:14:18] Speaker 00: Thank you. [00:14:18] Speaker 02: I want to hear from opposing counsel. [00:14:24] Speaker 02: How do I say your name? [00:14:25] Speaker 02: Is it Wintner? [00:14:26] Speaker 04: Wintner. [00:14:26] Speaker 02: Mr. Wintner, please proceed. [00:14:28] Speaker 04: Good morning, and may it please the court. [00:14:29] Speaker 04: My name is Tom Wintner on behalf of the Appellee Inovia, Inc. [00:14:34] Speaker 04: This isn't a failed inherency case. [00:14:36] Speaker 04: This is actually a relatively straightforward obviousness case. [00:14:40] Speaker 04: And as indicated by the patent owner in their gray brief, there really are two issues. [00:14:46] Speaker 04: They're both factual issues. [00:14:48] Speaker 04: The one issue is what would a person of ordinary skill in the art understand that acorn reference to have disclosed. [00:14:55] Speaker 04: The second issue [00:14:56] Speaker 04: is a motivation question. [00:14:58] Speaker 04: Was there sufficient motivation that was shown by the petitioner in all three of these cases? [00:15:04] Speaker 04: Those are all factual questions. [00:15:05] Speaker 04: Those are all reviewed for substantial evidence by this court. [00:15:10] Speaker 04: They were all resolved in great detail by the board in the three final written decisions. [00:15:19] Speaker 04: Let me just turn to the extent there's a question about what the board was doing in its final written decision. [00:15:28] Speaker 04: It looked at this precise issue as a factual matter. [00:15:31] Speaker 04: And this is at Appendix 43. [00:15:35] Speaker 04: saying, with this record evidence in mind, we turn to what APOSA would glean from reviewing ACORN. [00:15:42] Speaker 04: That is the factual question. [00:15:44] Speaker 04: That is a quintessential question, a fact, how APOSA would understand what the reference suggests, what it teaches, what it discloses. [00:15:53] Speaker 04: They provide analysis following that. [00:15:55] Speaker 04: They provide factual findings for three or four pages. [00:15:57] Speaker 02: Well, I think the problem is they then say, Dr. Byrd testified this. [00:16:00] Speaker 02: That's a factual statement. [00:16:01] Speaker 02: He testified to it. [00:16:03] Speaker 02: credit Dr. Byrne's testimony and say, we agree with Dr. Byrne. [00:16:09] Speaker 02: He has convinced us. [00:16:12] Speaker 04: Good question. [00:16:12] Speaker 04: I'd say that the best way to see that is, if you go to their ultimate conclusion, which is what the other guy refers to, this is page 44, appendix 44, top of appendix 44. [00:16:25] Speaker 04: This is the alleged negative finding. [00:16:28] Speaker 04: We do not agree with Dr. Lasker's criticism that Acorn does not disclose [00:16:33] Speaker 04: buffers. [00:16:34] Speaker 04: So the converse of that is that we agree that Acorn does disclose buffers. [00:16:38] Speaker 04: Now, where's the record evidence of that? [00:16:40] Speaker 02: If you look to Dr... No, I'm not sure that's right. [00:16:46] Speaker 02: We do not agree with Dr. Lasker's criticism that Acorn does not disclose buffers. [00:16:53] Speaker 02: That could be we don't agree with the reasons Lasker is giving, but not necessarily we don't agree about what is or is not disclosed. [00:17:03] Speaker 04: Well, I would just say if you take a look at the portions of Dr. Lasker's declaration that they're citing, and this is now at appendix 9690. [00:17:16] Speaker 04: This is the section of Dr. Lasker's [00:17:18] Speaker 04: declaration where he says, the title of it is, Exhibit 1004 does not disclose a buffering agent to provide a pH from about 4.8 to about 6.4. [00:17:30] Speaker 04: And in this, he then says, I've been asked to evaluate Dr. Byrne's opinion that Exhibit 1004 discloses a buffer. [00:17:40] Speaker 04: to provide a pH from about 4.8 to 6.4. [00:17:43] Speaker 04: For example, Dr. Byrne repeatedly asserts, incorrectly, that's Dr. Laster's opinion, that exhibit 1004 discloses dibasic sodium phosphate and monobasic sodium phosphate as a buffering agent, quote, [00:17:58] Speaker 04: in the FDA-approved ACORN 1% atropine sulfon eye drops to maintain a pH of 3.5 to 6.0. [00:18:06] Speaker 02: And where do you see that the board adopted Dr. Lasker's or rejected? [00:18:13] Speaker 02: Where do you see the board's finding is what I'm trying to figure out. [00:18:16] Speaker 02: Where's the finding? [00:18:17] Speaker 04: Well, I think it's implicit in their finding. [00:18:21] Speaker 04: But this is the whole setup. [00:18:23] Speaker 04: The setup is that [00:18:28] Speaker 04: is the finding, if you take a look at appendix 43, Dr. Byrne testifies that acorn discloses standard buffering agents, including dibasic sodium phosphate, and so on. [00:18:42] Speaker 04: That had been shown in the evidence just discussed. [00:18:46] Speaker 04: to be able to buffer ACORN's formulation, at least in the upper part of the cited pH range. [00:18:51] Speaker 04: And then the rebuttal to that from Dr. Lasker is there is no way that is possible. [00:18:56] Speaker 04: It is impossible for a person of ordinary skill in New York to read the ACORN reference as disclosing a buffer. [00:19:04] Speaker 04: That's what Dr. Burns said. [00:19:05] Speaker 04: I don't believe it. [00:19:06] Speaker 04: And the reason I don't believe it is because of this pH rule in Waterman. [00:19:11] Speaker 04: And that was completely discredited by the board by no less than five references and by claim seven of the 787 patent itself. [00:19:19] Speaker 04: So that's where the evidence is. [00:19:22] Speaker 04: There's even additional evidence with respect to buffering that exists in the Condritza reference itself, which is another one of the grounds. [00:19:30] Speaker 04: This is at appendix 18. [00:19:35] Speaker 04: And where does the board reference this? [00:19:44] Speaker 04: This is appendix 18 in the final written decision. [00:19:48] Speaker 04: This is a direct quote from, I think, the second page of the Condritza reference, which is a very old chemistry paper. [00:19:57] Speaker 04: Quote, this is now the last sentence in the first paragraph about eight lines down. [00:20:04] Speaker 04: Quote, the preservation of aqueous atropine solutions by buffering at pH 4 to 5 has been recommended. [00:20:10] Speaker 04: So the notion that [00:20:12] Speaker 04: you couldn't have a buffer in connection with an atropine solution, and in particular with an atropine ophthalmic solution. [00:20:20] Speaker 04: That's the Remington Formulator's Bible. [00:20:23] Speaker 04: It just doesn't add up. [00:20:27] Speaker 01: Council, following up on Chief Judge Moore's question, are you relying on the bottom of page 43 partially to see where you think the board would summarize the impriming and maybe potentially pregnant Dr. Burns testimony? [00:20:42] Speaker 04: uh... [00:20:43] Speaker 04: Yes, I think if you look at the bottom of 43, there's the one sentence that I read that says what Dr. Byrne testifies. [00:20:54] Speaker 04: So that's an example of them crediting Dr. Byrne and his testimony from two paragraphs of his expert declaration. [00:21:01] Speaker 04: And then they go on to say that they disagree with Dr. Lasker. [00:21:06] Speaker 04: This is, to me, a classic weighing of the evidence as between experts. [00:21:11] Speaker 04: It shouldn't be overturned on substantial review. [00:21:13] Speaker 04: If there are no further questions, does the board want to hear anything about the motivation question? [00:21:24] Speaker 04: Or if not, I feel. [00:21:30] Speaker 02: So Board Judge Chen, do you want to hear anything? [00:21:32] Speaker 02: Do you need to hear anything? [00:21:35] Speaker 02: No. [00:21:35] Speaker 02: OK. [00:21:35] Speaker 02: No, I think we're good. [00:21:36] Speaker 02: Thanks. [00:21:37] Speaker 04: All right. [00:21:38] Speaker 04: Thank you, Your Honor. [00:21:53] Speaker 00: Thank you. [00:21:58] Speaker 00: I have a minute. [00:21:59] Speaker 00: Yes. [00:21:59] Speaker 00: Yeah, okay. [00:22:00] Speaker 00: I'll be brief So one thing I want to respond to and also make sure is clear is [00:22:07] Speaker 00: It's really important, obviously, in an IPR petition to understand the argument that was made, and the argument was very much centered in the IPR petition about this alleged simplicity, that there are no modifications that need to be made to this existing FDA product other than changing the drug concentration. [00:22:23] Speaker 00: That's important for a couple reasons. [00:22:27] Speaker 00: One is this idea, looking at the board's findings, we point, council pointed to the portion where the board is talking about what they glean from the reference. [00:22:36] Speaker 00: So if an element is so clearly disclosed in a reference, why is the board spending pages and pages and pages trying to figure out what they can glean from a reference? [00:22:47] Speaker 00: There is no affirmative findings based on Dr. Byrne other than possibilities. [00:22:54] Speaker 00: And in terms of the chondritzer, no argument was made to modify acorn in view of chondritzer. [00:23:00] Speaker 00: It's a 1950s reference where this is a drug used by the military for nerve gas treatment. [00:23:08] Speaker 00: Those aren't ophthalmic solutions. [00:23:11] Speaker 00: And it's not an accurate characterization. [00:23:14] Speaker 00: But it's an argument never made. [00:23:16] Speaker 00: Any questions? [00:23:17] Speaker 00: Otherwise, I'll... Okay. [00:23:19] Speaker 02: Thanks both counsel. [00:23:20] Speaker 02: We'll take this case under submission.