[00:00:00] Speaker 01: This is Eagle Pharmaceuticals versus Slaback Pharma, LLC, case number 191924. [00:00:07] Speaker 01: It's an appeal from a dismissal under Rule 12C in a judgment from the District of Delaware. [00:01:02] Speaker 01: OK, Mr. Brown, you want four minutes for rebuttal? [00:01:05] Speaker 04: That's correct, Your Honor. [00:01:08] Speaker 01: OK. [00:01:08] Speaker 01: OK, you may begin. [00:01:10] Speaker 01: Well, let me ask a question first. [00:01:13] Speaker 01: You go ahead. [00:01:16] Speaker 01: There's lots of stuff you don't want us to say in open court, which seems a little crazy since it's laid out. [00:01:25] Speaker 01: There are only so many things that could constitute the alternative solvents, and they're laid out on the face of the patent. [00:01:31] Speaker 01: which is a public document. [00:01:34] Speaker 01: So is it really necessary for us to use things that will trip our tongues, like Slayback's secondary solvent or something? [00:01:45] Speaker 04: None of those are our issue, Your Honor. [00:01:47] Speaker 04: These are all Slayback's issue. [00:01:49] Speaker 04: So I'll let Slayback counsel answer. [00:01:50] Speaker 02: Your Honor, I'm really pleased to know that we're OK with you using the actual word. [00:01:54] Speaker 02: OK, great. [00:01:56] Speaker 01: Because we were all saying, how are we going to avoid saying this? [00:02:00] Speaker 01: Because we've been saying it to our law clerks for weeks as we talk about this. [00:02:04] Speaker 01: OK. [00:02:05] Speaker 01: Was that what you were going to say? [00:02:06] Speaker 01: Yes. [00:02:09] Speaker 01: Great minds think alike. [00:02:10] Speaker 01: OK, go ahead. [00:02:11] Speaker 04: May it please the court, I want to delve into the central error in the district court decision here. [00:02:17] Speaker 04: And the district court concluded that when the specification in this patent [00:02:22] Speaker 04: described something as a pharmaceutical acceptable fluid or solvent for one purpose, that that component is disclosed as a pharmaceutical acceptable fluid for every purpose within the patent. [00:02:36] Speaker 04: And I want to focus in particular on three concrete examples that we would submit refute that interpretation of this patent specification. [00:02:46] Speaker 04: First is example one. [00:02:48] Speaker 04: Within example one, ethanol is tested [00:02:52] Speaker 04: both with a stabilizing amount of a chloride salt and without. [00:02:57] Speaker 04: And without, it is described as it says it would not be suitable. [00:03:02] Speaker 01: Is there anything, I mean, is there anything that in the record that shows that it would not be suitable in the claimed formulation? [00:03:13] Speaker 04: No. [00:03:14] Speaker 04: With respect to the claim category, there is no, the specification is entirely silent on the use of ethanol within the claimed formulation. [00:03:22] Speaker 04: Okay, so you your argument is the well it's ethanol is better with the salt formulation But I don't see anything that says that in any other formulation you couldn't use it well There actually is because in example one and that's that's what I'm getting to in example one where they test it without the stabilizing amount of chloride salts that they say it's not suitable [00:03:44] Speaker 04: If you skip to example two, they test DMSO, also a pharmaceutically acceptable fluid. [00:03:51] Speaker 04: They test it without a stabilizing amount of chloride salt. [00:03:54] Speaker 04: Also without an antioxidant, it's tested as a single solvent. [00:04:00] Speaker 04: It does work. [00:04:01] Speaker 04: And so you would conclude on the face of that, example one versus example two. [00:04:05] Speaker 03: DMSO is its own embodiment in this specification. [00:04:07] Speaker 03: Absolutely. [00:04:08] Speaker 03: I mean, the DMSO separately disclosed embodiment doesn't talk about using some pharmaceutical acceptable fluid in addition to the DMSO. [00:04:20] Speaker 04: No, DMSO is the pharmaceutical acceptable fluid. [00:04:23] Speaker 03: So you wouldn't be wondering about whether to combine DMSO with any other solvent, whether it's ethanol or something else. [00:04:33] Speaker 04: Correct. [00:04:33] Speaker 04: But the way the district court here transported ethanol from its textual disclosure in what I'll call the category B formulations in the specification to the category A formulations is he latched onto the term, pharmaceutical acceptable fluid. [00:04:50] Speaker 04: which he labeled the solvent limitation. [00:04:52] Speaker 04: And he said, since it's disclosed as a pharmaceutically acceptable fluid, that means it's disclosed as an alternative to PG in the category A formulations. [00:05:02] Speaker 04: But if that were true, then you could take ethanol and transport it, because it's also a pharmaceutically acceptable fluid, as is DMSO. [00:05:11] Speaker 04: You could transport it to the category 3 formulations, but the patent tells you you can't. [00:05:16] Speaker 03: And what the specification... I'm getting lost when you talk about Formulation A, Formulation B, Category 3. [00:05:24] Speaker 03: Can you just use antioxidant, chloride salt, DMSO? [00:05:29] Speaker 04: Correct. [00:05:30] Speaker 04: So when the patent specification tells you in its discussion of the chloride salt embodiments that ethanol by itself, benzyl alcohol by themselves without the chloride salt present, [00:05:45] Speaker 04: They are not suitable for the invention. [00:05:48] Speaker 04: DMSO, without a chloride salt present, without an antioxidant present, is suitable. [00:05:57] Speaker 04: It works. [00:05:58] Speaker 04: And so you can't conclude by the label, pharmaceutical acceptable fluid, that something is an alternative if it's described in one category, the chloride salt category. [00:06:09] Speaker 04: You can't conclude just because of the label, pharmaceutical acceptable fluid. [00:06:14] Speaker 04: That label does not translate into a disclosure for all purposes where you see the word pharmaceutical acceptable fluid. [00:06:21] Speaker 01: There's some mental gymnastics that seems you're going to have to jump through because [00:06:27] Speaker 01: I mean, we know it works, right? [00:06:30] Speaker 01: It ultimately worked. [00:06:31] Speaker 01: Yes. [00:06:32] Speaker 01: And you concede that there's nothing in the patent itself that says it definitely won't work. [00:06:40] Speaker 01: Correct. [00:06:41] Speaker 01: Right? [00:06:42] Speaker 01: And then you're going to try to say under DOE that it's just a simple substitution. [00:06:49] Speaker 01: So if it's such a simple substitution and we know it worked, why isn't the district court [00:06:57] Speaker 01: correct that you ultimately disclosed all the pieces and parts? [00:07:01] Speaker 04: I think the requisite case there is the Sandisk case. [00:07:05] Speaker 04: So under the Sandisk case, the court very clearly said that the issue and the requirement is actual disclosure. [00:07:15] Speaker 04: It's not enough that a skilled artisan could read it and determine that it could or couldn't be used. [00:07:22] Speaker 04: The requirement is actual disclosure as an alternative. [00:07:25] Speaker 04: It's not required that there be some magical language or specific language. [00:07:28] Speaker 04: But the issue is, does a skilled artisan reading this find that something disclosed is disclosed as an alternative to the claim limitation at issue in the claimed invention? [00:07:41] Speaker 04: And so I think Sandus. [00:07:44] Speaker 04: clearly answers that issue. [00:07:47] Speaker 04: And I would point out that all of these claims have a stability limitation. [00:07:53] Speaker 04: And so the idea that there's this interchangeable solvent limitation. [00:07:56] Speaker 00: So why would someone skilled in the art not find and disclose that ethanol is an alternative to the other solvents? [00:08:07] Speaker 04: So what I think is particularly telling on that part, there are two things. [00:08:13] Speaker 04: First of all, [00:08:14] Speaker 04: on column four, line 45 to 46 of the patent at appendix page 45. [00:08:23] Speaker 04: That's where the first discussion of the chloride salt embodiment is. [00:08:27] Speaker 04: And there it specifically states that preferred pharmaceutically acceptable fluids include PG, PEG, and ethanol. [00:08:34] Speaker 04: What line are you at? [00:08:36] Speaker 04: Lines 45 to 46. [00:08:39] Speaker 04: And it says PG, PEG, and ethanol are preferred [00:08:44] Speaker 04: in this embodiment of the invention. [00:08:46] Speaker 04: So it textually limits that disclosure to that particular embodiment of the invention that it's disclosing. [00:08:52] Speaker 04: So you have to jump from that to say, well, that really means in all embodiments of the invention. [00:08:58] Speaker 04: The second textual limitation that I would point to, Your Honors, is at columns five and six. [00:09:04] Speaker 04: And in our reply brief, in the gray brief at page 12, we repeat this section, it appears, three times. [00:09:13] Speaker 04: And all three time, the specification describes the pharmaceutically acceptable fluid as, quote, containing one of the following. [00:09:22] Speaker 04: And A, this is where my A, B, and C was coming from, Your Honor. [00:09:26] Speaker 04: A is PEG, PG, or mixtures thereof, and a stabilizing amount of an antioxidant. [00:09:33] Speaker 04: B, one or more of PG, ethanol, PEG, glycopherol, and benzyl alcohol. [00:09:40] Speaker 04: a stabilizing amount of chloride salt, or DMSO. [00:09:44] Speaker 04: And the language here is important. [00:09:46] Speaker 04: The introductory language doesn't say one or more. [00:09:50] Speaker 04: It doesn't have the open-ended language that you've seen in the cases where this court has found dedication disclosure, where something is for the purposes of this invention. [00:09:58] Speaker 04: It says it includes one of the following. [00:10:02] Speaker 04: It uses one or more within the text of the category B, the stabilizing salt formulations. [00:10:09] Speaker 03: Let me ask you a hypothetical. [00:10:11] Speaker 04: Yeah. [00:10:11] Speaker 03: What if the patent is directed to jackets? [00:10:16] Speaker 03: And then the disclosure says, I have my first embodiment for a jacket, and it requires a fastener. [00:10:24] Speaker 03: And the fastener can be a zipper, or it can be buttons. [00:10:29] Speaker 03: I've got another jacket though, embodiment number two, completely different embodiment. [00:10:35] Speaker 03: It also has a fastener, and the fastener can be any one of a zipper, buttons, or Velcro. [00:10:44] Speaker 03: Are you saying that because of the way I separated out those two embodiments and [00:10:50] Speaker 03: and used coded language about this is for purposes of this embodiment and this is for purposes of that embodiment, one of skill and the jacket art wouldn't understand the disclosure as equating Velcro and zippers and buttons as being interchangeable and alternatives for each other? [00:11:10] Speaker 04: That's exactly the question, Your Honor. [00:11:12] Speaker 04: If one of skill would understand that as disclosing that as an alternative to Velcro, then yes. [00:11:17] Speaker 03: Well, I guess my point is [00:11:19] Speaker 03: You know, I'm listening to you, and you're saying, well, you know, embodiment one says for purposes of this embodiment, and embodiment two for purposes of that embodiment. [00:11:27] Speaker 03: But I'm not sure if that phrase is good enough to really drive a wedge between ethanol and PG as alternative solvents, at least in the context here, when there's really nothing in the patent specification that indicates any kind of chemical sensitivity [00:11:48] Speaker 03: with respect to the solvents you might use with an antioxidant as opposed to solvents that you might use for a chloride salt. [00:11:56] Speaker 03: And then at the same time, I didn't see you try to amend your complaint to include any such allegations of how one of skill reading this reference would recognize at the time of this invention there was some great sensitivity with antioxidants that you wouldn't want to use ethanol [00:12:18] Speaker 03: Maybe ever as a solvent in combination with an antioxidant. [00:12:23] Speaker 04: So we were never given the opportunity to amend our complaint. [00:12:25] Speaker 04: Did you try? [00:12:27] Speaker 04: Well, the motion to dismiss was granted. [00:12:29] Speaker 04: That ends the matter and makes it right for appeal. [00:12:31] Speaker 03: But when the motion to dismiss was filed, did you ask to amend the complaint? [00:12:35] Speaker 04: We did not. [00:12:36] Speaker 04: We believed we plausibly pled infringement under the Doctor of Equivalence, and especially under this court's decision in NALCO. [00:12:43] Speaker 04: And we think this patent is replete with the fact that the formulations are sensitive to the solvents present. [00:12:51] Speaker 03: That's why I was starting with the example one where... And I guess for me, getting back to Judge O'Malley's earlier question, it would maybe be difficult for you to try to amend your complaint to say that [00:13:04] Speaker 03: one reading this reference would understand there's some kind of special chemical sensitivity of using an ethanol with an antioxidant because after all that's the very basis of your doctrine of equivalence claim that it would be totally insubstantial to replace PG with ethanol. [00:13:25] Speaker 04: So that's the case in every dedication disclosure argument. [00:13:29] Speaker 04: You're saying something that [00:13:31] Speaker 04: works was not disclosed in your specification. [00:13:35] Speaker 04: We think as a factual matter, we believe that we can show under this court's factual requirements for equivalence. [00:13:42] Speaker 04: We think we can show equivalence at the district court. [00:13:47] Speaker 01: But at best, you're arguing that the specification says that certain combinations [00:13:57] Speaker 01: work better than other combinations. [00:14:00] Speaker 01: But you conceded earlier that there's nothing in the spec that says they won't work if the combinations are jumbled in a different way. [00:14:10] Speaker 04: Except the fact that the DMSO category will not work with ethanol, with benzyl alcohol, or with PEG. [00:14:19] Speaker 04: So three of the components are tested without a stable up, without the antioxidant, and without the [00:14:26] Speaker 04: chloride salt, and they were found unsuitable. [00:14:28] Speaker 04: DMSO was not. [00:14:30] Speaker 04: And so that does tell you there is a sensitivity. [00:14:32] Speaker 04: And the declaration we submitted at the district court clearly laid out that different mechanisms would be understood to be at work in the category A formulation. [00:14:42] Speaker 04: The chloride salts would be addressing hydrolysis, whereas the presence of it. [00:14:45] Speaker 01: There was nothing in that declaration, again, that said it wouldn't work. [00:14:50] Speaker 01: It just said you'd kind of like to use chloride salt with ethanol because of the [00:14:57] Speaker 01: water properties. [00:14:58] Speaker 01: But it doesn't say, but that's the only option. [00:15:02] Speaker 04: Correct. [00:15:03] Speaker 04: But the Sandisk case makes very clear, Your Honor, we don't have to show it wouldn't work. [00:15:08] Speaker 04: It could be very clear to a skilled artisan that it would work if we don't actually disclose it as an alternative. [00:15:14] Speaker 04: That's the standard. [00:15:16] Speaker 00: Your argument, you don't disclose it as an alternative because it's disclosed in a different embodiment. [00:15:23] Speaker 04: In a different embodiment. [00:15:24] Speaker 00: But that's not our law, is it? [00:15:26] Speaker 00: I mean, that's not what we say in Johnson. [00:15:29] Speaker 04: Well, so in Johnson, there was a global statement that there was a substrate. [00:15:35] Speaker 04: And there was a global statement that it was preferred to be aluminum. [00:15:37] Speaker 04: It could also be steel. [00:15:38] Speaker 04: That applied globally. [00:15:40] Speaker 04: Here we have a difference. [00:15:41] Speaker 04: The disclosure of ethanol is specific to the chloride salt formulation, textually, in every instance. [00:15:48] Speaker 04: And what I think is very important here is in examples three through eight, [00:15:55] Speaker 04: I counted 10 different concrete formulations that use PEG, PG, and a stabilizing amount of an antioxidant. [00:16:04] Speaker 04: Those are what I believe this court's precedent means by a completed embodiment that isn't required under Johnson & Johnson overruling the YBM Magnex case. [00:16:13] Speaker 04: But here, if we had said globally anywhere, ethanol can be used as a pharmaceutically acceptable fluid in this invention, then we would fall within Johnson and Johnson. [00:16:26] Speaker 04: We didn't. [00:16:26] Speaker 04: We textually limited it to this particular category that a skilled artist would understand is functioning by a particular... What about my jacket's hypothetical? [00:16:35] Speaker 03: I mean, to me, I would look at that and say, yeah, this disclosure equates or renders interchangeable Velcro zippers and buttons. [00:16:48] Speaker 04: But I think the mechanical context here versus a claim that has a particularized stability limitation, which was the point of this patent. [00:16:57] Speaker 04: And they tested certain things and they found you got the stability. [00:17:01] Speaker 04: They tested certain things and said you didn't get the stability. [00:17:04] Speaker 04: And other things they didn't test it, they were silent on. [00:17:06] Speaker 04: And so here we're addressing something they were silent on. [00:17:10] Speaker 04: And that, we think, is right down the middle of what is fair under Johnson & Johnston, particularly as it resolved the Graver Tank issue. [00:17:19] Speaker 04: And fair under this court's precedent is what the Doctor of Equivalence is made for. [00:17:25] Speaker 01: We've got a time. [00:17:26] Speaker 01: I'll restore two minutes for rebuttal. [00:17:32] Speaker 01: Good morning, Your Honors. [00:17:38] Speaker 02: I want to pick up with some of the points that Your Honors raised with the appellant. [00:17:44] Speaker 02: I think the problem with the position that they're taking here is that on the one hand, they say, and they concede in their brief, that the dedication disclosure doctrine applies to disclosures of claim limitations. [00:17:56] Speaker 02: You don't need a whole embodiment. [00:17:58] Speaker 02: And I agree, that's the law. [00:18:00] Speaker 02: On the other hand, they take the position that because the patent never says you can use this list of acceptable solvents for the pharmaceutically acceptable fluid in conjunction with an antioxidant, that therefore it's not disclosed. [00:18:15] Speaker 02: And I think that there's a fundamental inconsistency between that. [00:18:18] Speaker 02: Because effectively, if you follow the logic of their position, they're basically saying you have to disclose the entire embodiment consisting of bendamustine and ethanol in conjunction with an antioxidant. [00:18:30] Speaker 02: And I think that that is not the law. [00:18:33] Speaker 02: And certainly, the district court found that it was not the law. [00:18:35] Speaker 01: Part of my problem, and admittedly, I'm a process freak, but to do this on a 12C, even I kept saying, I just wish I had a little more. [00:18:47] Speaker 01: I wish I had a little more information. [00:18:49] Speaker 01: Even the declaration that the district court wouldn't consider would have been something that I wish we could weigh in the balance. [00:19:00] Speaker 01: Or could I have had some prosecution history discussion of any of this? [00:19:06] Speaker 01: The problem is the district court really jumped quickly to this. [00:19:12] Speaker 01: Why shouldn't we say this is just not something you should do on a 12C? [00:19:17] Speaker 02: Because, Your Honor, there's plenty of precedent for deciding issues like dedication disclosure and prosecution history estoppel in a 12B context. [00:19:26] Speaker 02: I mean, there are a number of courts, many courts, the cases are cited in our brief that have done that. [00:19:30] Speaker 02: I don't disagree that it would probably benefit you to have additional evidence in the record. [00:19:36] Speaker 02: But the fact of the matter is the district court found that he had sufficient context to decide the issue, because he had the prosecution history in front of him, and he had the relevant portions of the NDA in front of him, as well as the patents and their disclosure. [00:19:50] Speaker 02: And in this case, it didn't really require rocket science, because the patent states on its face that acceptable solvents for this pharmaceutical [00:20:00] Speaker 02: Pharmaceutically acceptable fluid which is a common element of all of the embodiments, but they're also an expert opinion available to the court You if you're referring to dr. Amici's declaration The district court did not consider dr. Amici's declaration because if it had it before well among other things because the eagle the appellant told the court that it would be improper to consider expert testimony at the [00:20:25] Speaker 02: the 12C stage of proceedings. [00:20:27] Speaker 01: So the court took them at their word. [00:20:29] Speaker 01: Right. [00:20:29] Speaker 01: That's what I don't understand. [00:20:31] Speaker 01: Why not just convert it into a motion for summary judgment and say, I'll consider expert testimony? [00:20:37] Speaker 02: Well, Your Honor, the court certainly could have done that, but I don't believe it was required. [00:20:40] Speaker 02: And even if it had considered Dr. Imigi's declaration, Dr. Imigi doesn't address the critical issue, which is, is there any reason why a person of ordinary skill and regard would think that ethanol would not work with an antioxidant? [00:20:53] Speaker 00: Did Eagle argue that this should be converted into a summary judgment decision or proceeding? [00:21:00] Speaker 02: I'm sorry, I missed the first part of your question. [00:21:01] Speaker 00: Did Eagle argue that they should convert the 12b6 proceeding into a summary judgment? [00:21:08] Speaker 02: Not that I recall, Your Honor, but I don't have perfect recollection. [00:21:12] Speaker 02: But my recollection is that the argument was that there were fact questions which precluded a ruling under 12C. [00:21:20] Speaker 02: The basis for that was the Imigi Declaration. [00:21:23] Speaker 02: But at the same time, they said it's not proper to consider expert testimony in the context of a 12C motion. [00:21:28] Speaker 02: And again, the Imigi Declaration doesn't really address [00:21:31] Speaker 02: the question of whether within the limitation of pharmaceutically acceptable fluid, which was the issue before the district court, whether there was anything in the patent that would suggest to a person of ordinary skill that ethanol wouldn't work with an antioxidant. [00:21:46] Speaker 02: And there's a couple of things in the patent that I think are worth noting. [00:21:52] Speaker 02: For one thing, if you look at [00:21:56] Speaker 02: If you look at the purpose, I mean, the pharmaceutical-acceptable fluid is defined in the patent. [00:22:00] Speaker 02: It's basically defined as something that is safe for human use. [00:22:06] Speaker 02: But the patent also talks about the function of the pharmaceutical-acceptable fluid. [00:22:14] Speaker 02: And the only thing that it says about that is that it's a solvent for bendamustine. [00:22:19] Speaker 02: And if you look at the examples, they talk about, in all of the examples, dissolving bendamustine in the pharmaceutical-acceptable fluid. [00:22:26] Speaker 02: So if ethanol dissolves bendymostene in one embodiment, it doesn't really require expert testimony to say, well, it's going to dissolve bendymostene in all of the embodiments, because that's what it's doing. [00:22:36] Speaker 01: Is it your position that this solvent limitation, as you've described it, the judge described it, applies to all embodiments? [00:22:45] Speaker 02: I believe that the courts decided that there's only one embodiment of the patent, so he didn't address that issue per se. [00:22:53] Speaker 02: But what he said was the patent discloses a list of alternatives for the pharmaceutical acceptable fluid. [00:22:58] Speaker 02: And one of those alternatives was ethanol, which is what is used in our product. [00:23:02] Speaker 02: What do we do about the DMSO? [00:23:04] Speaker 02: Well, the DMSO, I think, is a little bit of a red herring because the DMSO doesn't require an antioxidant or chloride salts to work. [00:23:13] Speaker 02: But there's nothing in the patent to indicate that it wouldn't work in the presence of an antioxidant or chloride salts. [00:23:18] Speaker 02: There's also, if you look at the examples three and four, which are the antioxidant examples, it says, the language of the patent says, so this I'm reading from column, this is column eight of the 831 patent, which is appendix 38. [00:23:46] Speaker 02: But it says as shown in table four Ben de mustine when dissolved in a pharmaceutical acceptable fluid such as a combination of polyethylene glycol and polypropylene glycol And it goes on but the language I want to focus on is the such as I mean clearly inventors envision the possibility that other solvents would be used with antioxidants and that The other solvents that are disclosed as being suitable for this invention are those listed in [00:24:16] Speaker 02: You know that we've talked about which include ethanol as well as PEG PG. [00:24:22] Speaker 00: I think furanol and Butyl alcohol or isobutyl alcohol, so What is your view as to the applicability of Johnson in this case you heard your opponent say? [00:24:34] Speaker 00: Distinguish it, but what do you say to that? [00:24:36] Speaker 02: I don't I think Johnson is directly on point I mean Johnson makes it very clear that you don't have to have You know column one from column a one from column B one from column C all disclosed together [00:24:46] Speaker 02: in order for there to be a dedication disclosure. [00:24:48] Speaker 02: It's sufficient if there is a disclosure of alternatives to any limitation of the claim, so long as a person of ordinary skill and the art would recognize that this is an alternative to that limitation. [00:25:00] Speaker 02: In this case, the patent says, almost in hot verba, these are alternative solvents for use in the pharmaceutically acceptable fluid. [00:25:08] Speaker 02: The only argument that EGLE makes is that because those statements are made [00:25:14] Speaker 02: in the context of the embodiments that include chloride salt, that therefore they wouldn't apply to the other, you know, the posts that wouldn't understand them to apply to the other embodiments that are discussed in the patents, including the antioxidant embodiment. [00:25:26] Speaker 02: And again, there's nothing in the patents to indicate that ethanol would not be suitable in those embodiments. [00:25:32] Speaker 02: It's true that the inventors didn't test that, but there's nothing in the patent to indicate that it wouldn't work. [00:25:37] Speaker 02: And as I mentioned, there is language in the patents in examples three and four that pretty clearly suggests that the inventors envisioned that other solvents would work. [00:25:48] Speaker 02: I mean, the other thing to bear in mind here is that we are talking about the minor component of the pharmaceutical acceptable fluid as it's laid out in the claims. [00:25:57] Speaker 02: The claims have a limitation. [00:25:59] Speaker 02: I think PEG has to be roughly 90% of the solvent, and the remaining 5% to 10% [00:26:07] Speaker 02: in the claim is PG. [00:26:08] Speaker 02: So we're talking about substituting ethanol for PG as the minor component of the pharmaceutical acceptable fluid. [00:26:16] Speaker 02: And so the question the judge decided is whether or not the specification made clear to a person of ordinary skill in the art that ethanol could be used as an alternative to PG. [00:26:28] Speaker 02: And that's exactly what the patent says. [00:26:30] Speaker 02: I think in answer to your question, Judge O'Malley, that's why the judge didn't feel he needed expert testimony. [00:26:35] Speaker 02: And again, the expert testimony that they put in really wouldn't have helped him because what it talks about, the two points I want to make, what it talks about is the mechanism of action for the chloride ions. [00:26:47] Speaker 02: It doesn't discuss the mechanism of action for an antioxidant. [00:26:50] Speaker 02: And again, these are completely different elements. [00:26:52] Speaker 02: So it's not talking about what is the mechanism of action for the pharmaceutically acceptable fluid. [00:26:57] Speaker 02: It's talking about how do the chloride salts prevent degradation. [00:27:00] Speaker 02: And with respect to antioxidants, all it says is a person of ordinary skill would recognize that antioxidants don't have a chlorine ion. [00:27:07] Speaker 02: So there may be a different mechanism. [00:27:09] Speaker 02: It doesn't even definitively say that the mechanism is different or what that would be. [00:27:14] Speaker 02: But even the point here, though, is- How it might relate to ethanol. [00:27:18] Speaker 02: It doesn't. [00:27:19] Speaker 02: What I'm saying is that the declaration that they put in really doesn't relate to the issue in the case, which is whether or not a person of ordinary skill in the art would recognize ethanol as an alternative to PG [00:27:30] Speaker 02: in the claim, which requires the antioxidant. [00:27:33] Speaker 01: I mean, recognizing that the trial judge is not one of ordinary skill in the art, I mean, we have to accept the proposition that what he's saying is that anybody would recognize this. [00:27:45] Speaker 02: I think he's saying that the plain English words in the patent make it clear that these are disclosed as alternative fluids for use in the pharmaceutically acceptable fluid [00:27:58] Speaker 02: limitation. [00:28:00] Speaker 02: And I don't think he felt that he needed expert testimony, and I don't think he did need it. [00:28:04] Speaker 02: I think this is a situation that, in my mind, is very similar to the Indivior case that this court decided. [00:28:10] Speaker 02: In Indivior, the issue was, I think the claim limitation was for a saccharide, and the saccharide to prevent hydrolysis. [00:28:19] Speaker 02: The claim required a saccharide. [00:28:23] Speaker 02: Maybe I'm getting myself mixed up here, but the claim required [00:28:27] Speaker 02: I'm sorry, I am getting myself mixed up. [00:28:30] Speaker 02: Indivior was a film-forming agent. [00:28:33] Speaker 02: And the claim required a specific film-forming agent. [00:28:36] Speaker 02: The specification disclosed that something else was also usable as a film-forming agent. [00:28:42] Speaker 02: And the argument was made that because the claim also required another element that had to be present in the form of mixed molecular weight, I think it was polyethylene oxides, [00:28:53] Speaker 02: And the patent never said, well, you can use this other film-forming agent with a mixture of high and low molecular weight PEOs, that therefore there's no dedication disclosure. [00:29:02] Speaker 02: And this court found that there was dedication disclosure. [00:29:06] Speaker 02: It's the same kind of argument that they're making here. [00:29:09] Speaker 02: They're saying, well, it's only disclosed in reference to the embodiments with chloride salts. [00:29:13] Speaker 02: It's not disclosed in reference to the embodiment with antioxidant. [00:29:17] Speaker 02: Therefore, it doesn't count. [00:29:18] Speaker 02: And I think if you look at the endevior opinion, that of all the cases that are discussed in both parties brief, I think, is most factually apposite to this situation. [00:29:30] Speaker 02: Your Honor, I just want to say very briefly a couple words. [00:29:34] Speaker 02: They have a couple of other arguments in their brief. [00:29:37] Speaker 02: And one of them, as we argue in our brief, we think they waived because they didn't raise it below. [00:29:43] Speaker 02: That's the argument that says that the disclosure of ethanol is too generic. [00:29:47] Speaker 02: to place a person of ordinary skill on notice that the particular absolute ethanol in our product was dedicated to the public. [00:29:58] Speaker 02: We do not believe this argument was raised below. [00:30:00] Speaker 02: I would invite you to look at the references to their brief below where they say they raised the issue. [00:30:06] Speaker 02: I don't think they did. [00:30:07] Speaker 02: In any event, on the merits, I think it's almost silly to argue that the disclosure of ethanol, which is a specific chemical moiety that [00:30:16] Speaker 02: probably any high school chemistry student could draw is a generic disclosure. [00:30:22] Speaker 02: And if you look at the cases that have found dedication disclosure, I don't see any argument that ethanol is generic here on the merits. [00:30:36] Speaker 02: And lastly, Your Honor, [00:30:40] Speaker 02: I just want to address briefly their argument that there were undecided fact questions below that precluded or that should have precluded the judge from granting the motion to dismiss. [00:30:52] Speaker 02: I've mentioned some of the things that I think make it clear that there were no disputed factual issues with respect to the actual deciding factor in this case, which is whether or not there was disclosure of an alternative for the pharmaceutically acceptable fluid limitation. [00:31:10] Speaker 02: A couple of other things that I would mention. [00:31:13] Speaker 02: At various points in their brief, they talk about how these work in different ways, is one of the ways they say it, by different mechanisms, fundamentally differ from the formulations. [00:31:21] Speaker 02: There is no evidence of that. [00:31:23] Speaker 02: There is no evidence in the specification to indicate that these embodiments are, that there's any preference for one embodiment versus the other. [00:31:31] Speaker 02: There's no instruction on when you would pick one versus the other. [00:31:34] Speaker 02: There's nothing to indicate. [00:31:35] Speaker 02: that there's really anything different. [00:31:37] Speaker 02: They're all means of getting to the same end, which is a storage-stable Ben-de-Mustin solution. [00:31:43] Speaker 02: So there's certainly nothing in the specification that would place anybody on notice that there's any distinction between these embodiments other than that they are different embodiments, which is true in most patents. [00:32:00] Speaker 02: The other thing. [00:32:02] Speaker 02: I want to note is, and I think Judge O'Malley, you alluded to this, that there's, I think, a fundamental inconsistency between arguing that our product is equivalent to their product. [00:32:12] Speaker 02: And the only difference, again, is this pharmaceutically acceptable fluid limitation. [00:32:16] Speaker 02: There's, I think, an inconsistency in saying, on the one hand, it's insubstantially different, and on the other hand, saying, as they say in the brief, that there are fundamental differences here that preclude application of the dedication disclosure argument. [00:32:29] Speaker 02: really two sides of the same coin. [00:32:31] Speaker 02: It was the mental gymnastics that I referred to, but we have to deal with one issue at a time. [00:32:36] Speaker 02: Understood. [00:32:37] Speaker 03: If your side loses on the dedication disclosure doctrine argument, are you in trouble on doctrine of equivalence then? [00:32:44] Speaker 02: I don't think so. [00:32:46] Speaker 03: Well, how would you explain that? [00:32:48] Speaker 02: As to why one would not be equivalent to the other? [00:32:51] Speaker 03: I think when you get just you know dedication disclosure ruling is Completely contingent on the view that one reading this patent would believe oh these things are interchangeable. [00:33:01] Speaker 02: They're no big deal That's what the patent well your honor has a point and it's it might not be a helpful fact, but I Truthfully we've not I don't think there's been any Discussion there's no discussion in the patent about [00:33:16] Speaker 02: How this this the pharmaceutical how the pharmaceutical acceptable is a mouthful to say I apologize how the pharmaceutical acceptable fluids Work or what role they play other than dissolving bend a mustang what the patent says is it may but not necessarily You know be used to dissolve the bend of mustang as to what other functions if any there are I don't at this moment know but I agree with you that there that it cuts two ways and [00:33:45] Speaker 02: So while I wouldn't concede at this point that it would create problems for us, it would certainly be something that would have to be addressed. [00:33:54] Speaker 01: Thank you. [00:33:55] Speaker 01: Your time's up. [00:33:57] Speaker 02: Thank you. [00:33:57] Speaker 04: I have just a couple things. [00:34:04] Speaker 04: I'd like to pick up quickly on one of the last things that the Slaybacks Council said, which is there's no evidence in the specification [00:34:12] Speaker 04: supporting our contention that there are different mechanisms of action. [00:34:16] Speaker 04: The reason for that is we have no record. [00:34:19] Speaker 04: This specification is directed to a person of ordinary skill in the art, which is presumably pharmaceutical formulation, which deals with stabilizing complex pharmaceutical agents. [00:34:30] Speaker 04: And we put in a lot of factual evidence into this specification that shows certain things work, certain things didn't work. [00:34:39] Speaker 04: Another thing counsel said, which she said, which I don't believe there's support in the record for, that the function of ethanol in this is to dissolve the Bindemustene. [00:34:49] Speaker 04: This is not a patent about dissolving Bindemustene. [00:34:51] Speaker 04: The claims all require stable formulations. [00:34:54] Speaker 04: This was a problem that had plagued the art for a long time. [00:34:56] Speaker 04: Bindemustene is an old drug. [00:34:57] Speaker 04: It was always sold as a powder. [00:34:59] Speaker 04: This was the first liquid formulation that was able to come to the market. [00:35:04] Speaker 04: And so we solved the problem and we laid out very carefully things that worked, things that didn't work, and we presented it to a skilled artisan. [00:35:13] Speaker 04: I'd like to focus on two particular things. [00:35:15] Speaker 04: Just the mere fact that one embodiment, one category of invention says stabilizing amount of a chloride salt. [00:35:22] Speaker 04: I doubt if anybody sitting at this table knows what the mechanism of degradation of indomastene is and how that affects it. [00:35:31] Speaker 04: The center embodiment says stabilizing amount of an antioxidant. [00:35:34] Speaker 04: That, I guess, relates to oxidation. [00:35:36] Speaker 04: We don't have any testimony about that either. [00:35:39] Speaker 04: And so would a skilled artisan think those are the same thing? [00:35:43] Speaker 04: I can tell you they wouldn't, but we don't have a record to support that. [00:35:45] Speaker 04: I think that's the central basis for this court's now co-decision, which is this is replete with factual issues. [00:35:53] Speaker 04: And on page 43 of our opening brief, I just wanted to point out, we lay out several Federal Circuit cases addressing dedication disclosure that were all dealing with much later stages of the case, not the 12C stage, which we would contend is inappropriate. [00:36:10] Speaker 04: And my final... [00:36:15] Speaker 04: Two final things. [00:36:18] Speaker 04: On the issue of the Amiji Declaration, our contention in submitting that to the district court was the court could deny the motion for 12C and let the case proceed into discovery in a normal course. [00:36:30] Speaker 04: without considering expert evidence. [00:36:32] Speaker 04: But we should not lose and be denied our day in court. [00:36:35] Speaker 04: We haven't even had oral argument. [00:36:36] Speaker 04: We have had no proceedings attendant to us having a fair chance to prove our case here. [00:36:43] Speaker 00: Why didn't you ask the court to take this into a summary judgment proceeding? [00:36:47] Speaker 00: If you want factual evidence to be considered. [00:36:50] Speaker 04: I believe under the rule, under rule 12, it's automatic. [00:36:54] Speaker 04: In other words, if we submit the factual evidence and we say you should deny the 12C motion, it doesn't need to be converted into a summary judgment motion to deny it. [00:37:04] Speaker 04: If the court thinks it's necessary, then the court needs to convert it to a summary judgment motion and needs to allow all parties to be appropriately heard for summary judgment purposes. [00:37:16] Speaker 04: Um, but the one last thing I want to make sure I don't miss is we did ask in our briefing for leave to amend if the court, um, um, you know, if the court were inclined to believe that, that, that, uh, amendment was appropriate. [00:37:28] Speaker 01: So I want to make sure we don't wait. [00:37:32] Speaker 04: Um, if it's just a pleading issue to plead that the specification discloses certain facts that would not lead a skilled artisan to conclude that ethanol was [00:37:42] Speaker 01: Disclose as an alternative for the claimed for the claim formulation, but that what the judge said is that that even giving all fair inferences Looking at the patent itself [00:37:54] Speaker 01: It was clear that there was disclosure. [00:37:57] Speaker 04: Correct. [00:37:58] Speaker 04: And we don't think that that is supportable at all, that given all fair inferences to our case and how a skilled artisan would read this patent, that you could not conclude with the appropriate expert testimony in front of you, that a skilled artisan reading column A would think one thing was at work and seeing a reference to a stabilizing amount of antioxidant would think a different thing was at work and would not know. [00:38:20] Speaker 04: Aren't you asking for another bite at the apple [00:38:23] Speaker 04: We're asking for our first bite of the apple this is really the this is why the 12c standard is so high if there's any reasonable inferences that can go our way or entitled to have our due process rights of discovery of Going through the normal district court proceedings. [00:38:40] Speaker 04: We want to present expert testimony. [00:38:42] Speaker 04: We think we can compellingly show that [00:38:43] Speaker 04: Not only that this is not disclosed as an alternative. [00:38:48] Speaker 04: We think we can show this is an insubstantial difference. [00:38:50] Speaker 04: They copied every last detail of our product, of our most detailed formulation. [00:38:57] Speaker 04: Council referenced the 90% peg, a minor amount of PG. [00:39:01] Speaker 04: That's some of the narrowest claims that are at play here. [00:39:05] Speaker 04: And the issue is swapping out ethanol in that context. [00:39:09] Speaker 04: versus PG, an insubstantial difference, when you don't have anything disclosed in here, where you have a majority PEG, a minority PG. [00:39:18] Speaker 04: and any suggestion that ethanol is an alternative. [00:39:22] Speaker 04: We don't have to show there's a teaching away in our specification. [00:39:26] Speaker 04: We just have to show it's silent. [00:39:28] Speaker 04: Silence is enough under SanDisk. [00:39:30] Speaker 04: We don't have to show it wouldn't even be enabled under SanDisk. [00:39:33] Speaker 04: We just have to show, for the claimed invention, with the stability limitations, with the ratios, with all of that detail, that it isn't actually disclosed as an alternative for that purpose. [00:39:45] Speaker 04: We need to wrap up. [00:39:46] Speaker 04: Thank you, Your Honor.