[00:00:00] Speaker 04: Okay. [00:00:02] Speaker 04: The next argued case is number 21, 1926, Azerity Pharmaceuticals Incorporated Against Biopharma, Inc. [00:00:12] Speaker 04: Mr. Torson. [00:00:13] Speaker 01: Thank you, Your Honor. [00:00:14] Speaker 01: Good morning. [00:00:15] Speaker 01: May it please the court? [00:00:17] Speaker 01: Richard Tortson with Nick Alkowski here for Azerity Biopharma. [00:00:24] Speaker 01: This is an ANDA case. [00:00:25] Speaker 01: It involves... Can you speak up a little bit, please? [00:00:28] Speaker 01: I'm sorry. [00:00:28] Speaker 01: Yes, Your Honor. [00:00:29] Speaker 01: This is an ANDA case. [00:00:31] Speaker 01: Azzurri suit, biopharma, because it had an abbreviated new drug application, directed toward a liquid oral formulation for Nalapril. [00:00:46] Speaker 01: Azzurri has epinephinid, which is a branded product for this. [00:00:55] Speaker 01: We would like to start with the buffer, particularly the court's lady construction of buffer, because that's really fundamentally why we're here today. [00:01:08] Speaker 01: A court must avoid a surprising and prejudicial construction of a term laid in the proceeding. [00:01:15] Speaker 01: Neither party provided a construction for buffer. [00:01:18] Speaker 01: Both sides agreed that the plain and ordinary meaning applied. [00:01:22] Speaker 01: Yet the court surprised us already when it narrowed the meaning of buffer when it was doing its analysis. [00:01:30] Speaker 02: That's in connection with the issue of whether or not there's actual infringement? [00:01:36] Speaker 01: The only issue in this case is Dr. McQuaid. [00:01:38] Speaker 02: I didn't see that this issue popped up in connection with the analysis of the prosecution history of Staple issues. [00:01:45] Speaker 01: Well, you can't apply a term [00:01:49] Speaker 01: more narrowly than you construed it. [00:01:51] Speaker 01: So if you're applying a term narrowly, and in this case, saying there's no buffer, what's the weather? [00:01:57] Speaker 02: I just couldn't. [00:01:58] Speaker 02: The way I saw this issue coming up in the briefing wasn't with respect to the estoppel issues, but with respect to the question whether it was actual infringement of the product. [00:02:08] Speaker 02: And I wasn't understanding how it's pertinent to the main issues. [00:02:13] Speaker 02: And you've got several hurdles you have to overcome here. [00:02:17] Speaker 01: I absolutely agree with that, Your Honor. [00:02:19] Speaker 01: And in fact, that's why at the end of our opening brief, we actually point to the Sabella case that this court decided, I believe, last fall. [00:02:28] Speaker 01: The point here is even if you decide the case on a different issue, we're still faced with the issue that our friends are saying there's an estoppel and other fora. [00:02:39] Speaker 03: Can I ask you a different question? [00:02:42] Speaker 03: What is the legal issue? [00:02:43] Speaker 03: that your argument about the interpretation of buffer relates to, so that we can make sure it's not seeking an advisory opinion? [00:02:52] Speaker 03: Because that's what I hear Judge Clevenger asking you, but I still don't know what your answer is to that question. [00:02:57] Speaker 01: OK, it's not an advisory decision, because we actually have active controversy. [00:03:02] Speaker 01: In fact, if you look at page two of the red brief, they tell you that there's a pending case, or no longer pending case, a case that's been dismissed [00:03:11] Speaker 01: subject to what the court decides on this issue. [00:03:15] Speaker 01: So that's the problem. [00:03:17] Speaker 01: We were stuck with a belated construction. [00:03:21] Speaker 01: We haven't had a chance to address it. [00:03:23] Speaker 03: But what is the issue that it relates to on appeal in this case? [00:03:28] Speaker 03: Is it function way result? [00:03:30] Speaker 03: What is it? [00:03:31] Speaker 01: Right. [00:03:31] Speaker 01: It's whether the buffer is met by the function way result. [00:03:36] Speaker 01: OK. [00:03:37] Speaker 01: That's what I thought it was. [00:03:38] Speaker 01: That's all I was looking for. [00:03:39] Speaker 01: OK. [00:03:40] Speaker 01: I'm sorry. [00:03:42] Speaker 01: So in that sense, why don't we go ahead and jump to the analysis. [00:03:47] Speaker 01: First of all, the court imposed several additional requirements on what a buffer must be. [00:03:54] Speaker 01: And they did this solely relying on extrinsic evidence. [00:03:57] Speaker 01: There's nothing in the claims or in the specification that requires this. [00:04:04] Speaker 01: It required that the buffer have a specific pKa, and it also imposed two process limitations on a buffer. [00:04:12] Speaker 01: The specific pKa is that it has to be within one pH unit of the formulation. [00:04:21] Speaker 01: But there's nothing in the intrinsic evidence that requires it. [00:04:24] Speaker 01: And in fact, we know that that's inconsistent with the specification, because among other things, the specification identifies a phosphate buffer that's more than one [00:04:34] Speaker 01: unit away from the formula. [00:04:37] Speaker 03: Do you mind telling me the page that you're relying on specifically in the board's opinion for where you think it construed the claims? [00:04:45] Speaker 03: Because I kind of view that discussion as being a fact finding as opposed to a claim destruction. [00:04:53] Speaker 03: And just so you see where I'm at in thinking that it's a fact-finding, I want you to know up front that's what I'm thinking so you can respond to that. [00:05:00] Speaker 01: Okay, I'll point you to the court's decision at Joint Appendix 69 where it says, neither of these are within one pH of the claim formulation pH. [00:05:16] Speaker 01: That only makes sense if the [00:05:18] Speaker 01: judge was reading that as a requirement of the pH. [00:05:24] Speaker 01: So there is an implicit construction going on there because there's nothing in the term pH that by itself requires that. [00:05:32] Speaker 01: As I pointed out, that's actually inconsistent with at least one of the buffers in the intrinsic evidence. [00:05:40] Speaker 01: So that can't be right. [00:05:41] Speaker 01: That cannot be the plain and ordinary meaning of the term [00:05:46] Speaker 01: And it can't be the meaning of the term. [00:05:47] Speaker 02: I'm still missing why you're spending all this time in your oral argument on an issue that we may never even reach. [00:05:54] Speaker 02: Because if we agree that there is amendment-based estoppel or argument-based estoppel, we don't reach these issues. [00:06:03] Speaker 02: Right? [00:06:05] Speaker 01: Well, again, that puts us exactly where we don't reach them. [00:06:08] Speaker 02: If Judge Stark for the court was correct, that amendment-based estoppel applies here. [00:06:15] Speaker 02: or if not, that argument-based estoppel, then your doctrine of equivalence claim fails. [00:06:20] Speaker 02: And we never reach the question of whether there was actual infringement. [00:06:23] Speaker 01: Right. [00:06:23] Speaker 01: That's why Sebel is so informative. [00:06:25] Speaker 02: So you have two grounds. [00:06:26] Speaker 02: And then you've got the preservative limitation that you devote about two pages of your brief to. [00:06:34] Speaker 02: And if we agree with the district coroner on that one, then all this other arguments are irrelevant. [00:06:38] Speaker 01: I'm happy to jump to that part if Your Honor's wish, but just to directly answer the question you posed, once again, my friend is raising this as an estoppel in other courts. [00:06:52] Speaker 01: If the claim construction exists and is right, then they would be right. [00:06:58] Speaker 01: If it doesn't exist or it's not right, then there can't be an estoppel. [00:07:04] Speaker 01: So just basic fairness. [00:07:07] Speaker 01: requires that something happened to that, even if you decide the case on a different basis. [00:07:14] Speaker 02: And in fact, your brief didn't attempt to undermine the estoppel arguments, amendment-based or argument-based, on this claim construction grant. [00:07:26] Speaker 02: I was having that trouble with the connection, which we talked about. [00:07:30] Speaker 02: Do you want to spend a minute or two on the preservative limitations? [00:07:33] Speaker 01: Absolutely, Your Honor. [00:07:35] Speaker 01: Again, I do want the court to take into consideration Isabella, where very, very similar circumstances exist, except there they'd actually waive the infringement argument. [00:07:46] Speaker 01: Right. [00:07:46] Speaker 02: I mean, the whole question about buffer and whether the claim construction was wrong is irrelevant if we agree with the district court on the preservative limitation. [00:07:55] Speaker 01: except that you run into the equitable problem and it's a live equitable problem. [00:08:00] Speaker 02: No, no, but I mean if the preservative limitation is not met by equivalence, there can't be any infringement. [00:08:06] Speaker 01: OK, well, let's go to the preservative problem. [00:08:11] Speaker 01: So the court addressed that issue as a disclosure dedication doctrine. [00:08:17] Speaker 02: And the main argument was that the district court didn't understand the law, didn't understand the degree of specificity was required because they didn't decide the right case. [00:08:26] Speaker 01: No, that would oversimplify our position. [00:08:29] Speaker 01: Our position is actually that the case law requires that the intrinsic evidence, the specification itself, must disclose, identify the incompatibility with that. [00:08:40] Speaker 02: Well, there are other ones that are applying the wrong standard. [00:08:43] Speaker 02: Right, well... And then you come back and say the correct standard, you know, can be found in PSC computer. [00:08:51] Speaker 02: I think they're the ones that are... Judge Stark cited [00:08:55] Speaker 02: And Pfizer relies on PSC computer. [00:08:58] Speaker 02: Indeed, PSC computer has exactly the language that you're saying is correct. [00:09:03] Speaker 02: And Judge Stark incorporated that in his legal analysis. [00:09:07] Speaker 01: Now, I think you're relying on my friend's brief. [00:09:10] Speaker 01: Our position is Sandisk actually cites the right standard. [00:09:13] Speaker 01: And Sandisk says you can't have a generic disclosure, which is all we have here, right? [00:09:18] Speaker 01: We say parabens, and we list some examples of parabens. [00:09:22] Speaker 01: none of which are the preservative that they are claiming, or I'm sorry, using. [00:09:26] Speaker 03: Why isn't example C, some of the examples like in table C1 in appendix page 214 columns 33 and 34 of the patent, why aren't those specific enough? [00:09:40] Speaker 03: You say that there has to be specificity and I think I understand your argument to be that [00:09:46] Speaker 03: There is an disclosure of the mixture, but I see the mixture, for example, in table C1, sodium methylparaben, sodium propylparaben. [00:10:01] Speaker 03: Why isn't that sufficient? [00:10:03] Speaker 01: Well, sodium benzoate, I mean, there's a blank spot in there for your sodium benzoate. [00:10:10] Speaker 03: If you look for components C1 and C2, [00:10:14] Speaker 03: you'll see for C1 and C2 formulations, there is a blank for the sodium benzoate. [00:10:21] Speaker 03: There is no sodium benzoate in C1 and C2. [00:10:24] Speaker 03: Do you see it's a line 65 of columns 33? [00:10:30] Speaker 01: So the specification identifies the methylparaben and propylparaben [00:10:43] Speaker 01: as species, it doesn't identify them as a mixture except... Except for in this example I've pointed out? [00:10:55] Speaker 01: So the example does show these being used, but again, it doesn't specifically disclose using them as a mixture. [00:11:08] Speaker 01: It's not clear how they've been used or added. [00:11:16] Speaker 03: Why? [00:11:16] Speaker 03: I mean, you have to show that a finding to the contrary, which is the finding the district court made, is clearly erroneous. [00:11:25] Speaker 01: Okay. [00:11:25] Speaker 01: So once again, then, this would get us back to... And show it's a legal issue. [00:11:30] Speaker 01: You're right. [00:11:35] Speaker 01: Even if the court wants to decide the case on the basis of the dedication, even if the court wants to decide the case on this issue, once again, we get to the problem, what do you do with the lingering claim construction? [00:11:50] Speaker 01: And once again, this is what Sabella directly addressed. [00:11:52] Speaker 03: So you're really here because you want that claim construction corrected. [00:11:56] Speaker 01: Again, look at the facts in Sabella. [00:11:58] Speaker 01: In Sabella, the appellants had actually conceded the infringement argument. [00:12:04] Speaker 01: conceded it, which the court found created a standing problem. [00:12:09] Speaker 01: It's a problem it also faced. [00:12:10] Speaker 01: The reason it took the appeal at all is because it was being confronted with this estoppel argument. [00:12:17] Speaker 01: And the problem is if we never have a chance to address it, it's not fair to do that. [00:12:24] Speaker 01: So if this court is going to affirm on an alternative basis, which is the case, I'm sorry. [00:12:34] Speaker 01: We cite Jennings versus Stevens as one of the cases we cite for this. [00:12:40] Speaker 01: Can you speak up a little? [00:12:42] Speaker 01: I'm sorry. [00:12:43] Speaker 03: We just need you to speak up a little bit. [00:12:46] Speaker 03: With all the plexiglass we have in here. [00:12:50] Speaker 01: Yeah, I'm sorry. [00:12:52] Speaker 01: And I'm in an echo chamber, so it sounds loud to me. [00:12:55] Speaker 01: OK. [00:12:56] Speaker 01: We cite, among other cases, Jennings versus Stevens for the idea that when the court affirms on an alternate basis [00:13:03] Speaker 01: that changes what the estoppos are. [00:13:06] Speaker 01: So if this court says we're deciding only on the disclosure dedication doctrine, that would solve our problem for us as well. [00:13:16] Speaker 01: Again, fundamentally our concern in this case is that the buffer construction is wrong as a matter of fact, wrong as a matter of law, and yet this is the only forum we've been allowed to address that in. [00:13:31] Speaker 01: And I've seen I'm way into my rebuttal, so I'm going to... Well, thank you. [00:13:36] Speaker 02: I appreciate your clarification of the significance of the claim for structure condition until it lies outside of this case. [00:13:47] Speaker 04: OK. [00:13:47] Speaker 04: Thank you. [00:13:49] Speaker 04: Mr. Odom? [00:13:50] Speaker 00: May it please the court. [00:13:50] Speaker 00: May I remove my mask? [00:13:56] Speaker 00: May it please the court. [00:13:57] Speaker 00: Andy Odom on behalf of Defendant of Pelley, By and Pharma, Inc. [00:14:00] Speaker 00: uh... by far as a small generic drug company we don't see really file and uh... seeking approval to market chair versions of patented brand-name drugs not an app attacks were not at all out of my one uh... we did everything we could avoid infringement in this case including by eliminating from our formulation entirely a buffer [00:14:19] Speaker 00: All the asserted claims call for a specific type of buffer at a specific concentration. [00:14:23] Speaker 02: But how does your formulation control the pH if you don't have a buffer? [00:14:28] Speaker 00: So Your Honor, unfortunately, because the limited amount of time. [00:14:30] Speaker 02: I'm just curious, because the FDA seemed to think that wasn't a problem. [00:14:34] Speaker 00: So unfortunately, because of the limited amount of time we had a trial, our expert wasn't able to get into it in too much detail. [00:14:41] Speaker 00: But he does say at one point, and the district court did find this, that it was through judicious use of excipients. [00:14:49] Speaker 00: that we were able to formulate in an alkyl liquid that didn't fluctuate in pH too much. [00:14:55] Speaker 00: This is an active ingredient that is lebyl, acid lebyl. [00:15:00] Speaker 00: And through judicious use of excipients, we don't use a lot of, we don't use sodium, we don't use sodium benzoate for instance, which is very acidic, which would drop the pH. [00:15:11] Speaker 02: I don't want to use up your time, but it just struck me as like, wow, how did you get this job done? [00:15:16] Speaker 00: And in retrospect, we probably should have filed a patent application on this. [00:15:20] Speaker 00: My client's a very small, generic drug company, and we just wanted to bring a generic version to market. [00:15:25] Speaker 00: But that's essentially how we got around the buffer limitation here. [00:15:31] Speaker 00: We also used a preservative system, methylparaben and propylparaben. [00:15:35] Speaker 00: that is expressly described in the common specifications being used as being a suitable alternative to claim subagent benzoate, but was never claimed, which provided us with a factual and legal defense. [00:15:45] Speaker 00: But most importantly, we relied on claim amendments and express disclaimers as already made during prosecution that narrow the literal and equivalent scope of these claims. [00:15:55] Speaker 00: We did all this in hopes of avoiding protracted patent litigation. [00:16:00] Speaker 00: Unfortunately, we ended up being subjected to, for the next two and a half years, what we respectfully submit can only be described as objectively baseless litigation. [00:16:08] Speaker 00: The judgment of non-infringement should be affirmed. [00:16:12] Speaker 00: Starting with our legal defenses, which at least Judge Clevenger showed somewhat of an interest in, we believe amendment-based estoppel bars their claims here. [00:16:22] Speaker 00: It appears the fundamental dispute here is between the parties that, in Azzurri's position, [00:16:27] Speaker 00: somehow our product is outside of the scope of territory that was surrendered during prosecution. [00:16:33] Speaker 00: We respectfully submit that's an erroneous view that's based on an incredibly narrow view of amendment-based estoppel that's never been endorsed by this court or the Supreme Court. [00:16:43] Speaker 00: In a certain view, we could only enjoy amendment-based estoppel if [00:16:48] Speaker 00: We followed the claims and just omitted sodium citrate or used less than the required amount. [00:16:54] Speaker 00: If we made any other changes to the formulation, then we're outside of amendment-based estoppel protection. [00:17:00] Speaker 00: And that just, common sense-wise, that doesn't make sense. [00:17:03] Speaker 00: It's a view that's never been endorsed by this court. [00:17:06] Speaker 00: We not only omitted sodium citrate, we don't use citric acid, and we don't use sodium benzoate. [00:17:11] Speaker 00: So we designed even further around the claims. [00:17:13] Speaker 00: We should still be able to enjoy amendment-based estoppel protection. [00:17:17] Speaker 00: tangential relation. [00:17:21] Speaker 00: The reason why they added sodium citrate to the broader 603 application claims was to [00:17:30] Speaker 00: narrow the scope of the claims to cover the only liquids that they actually had unexpected results for. [00:17:37] Speaker 00: They were facing an obviousness projection. [00:17:39] Speaker 00: The only way they could overcome obviousness was by pointing to unexpected results or relying on unexpected results. [00:17:45] Speaker 00: Unfortunately, the only liquids for which they had unexpected results were the example E-liquids, which all require specific concentrations of citric acid, sodium citrate, and sodium benzoate. [00:17:57] Speaker 00: That was the reason they narrowed the scope of the claims. [00:18:00] Speaker 00: The alleged equivalent in our product, this alleged maleic acid sodium malate system, cannot be said to be tangential of that, because they had no unexpected results for our formulation. [00:18:14] Speaker 00: Argument-based estoppel dispute really centers on the four ingredient disclaimer they issued. [00:18:20] Speaker 00: In a Zurides view of argument-based estoppel, that can only be invoked if a patent applicant [00:18:25] Speaker 00: see something in the prior art, points to it and says, that's not us. [00:18:29] Speaker 00: They actually did that here during prosecutions. [00:18:32] Speaker 00: The second sentence of the disclaimer, they say, these additional excipients and the other formulations are not needed or contemplated in the claim to Nalepo liquid formulations, as none of them are needed or necessary to produce an oral liquid formulation of the present claims that is stable. [00:18:46] Speaker 00: And this idea that a disclaimer is not a disclaimer if it's disguised as a motivation or reasonable success argument finds no support in this court's case law. [00:19:00] Speaker 00: Disclosure, dedication. [00:19:02] Speaker 00: They take issue with the district court's failure to include the words specific in its articulation of the legal standard here. [00:19:09] Speaker 00: Last month, this court in ADAPT Pharma versus Teva Pharmaceuticals, that's 2022 Westlaw 402-133 at Star 10, [00:19:17] Speaker 00: This court made clear that Rule 52A does not require the district court to articulate a legal standard that it's following, only to find the facts specifically and state the conclusions of law separately. [00:19:31] Speaker 00: This already points to nothing in the district court's opinion or in the record showing that the district court departed from the requirement for specificity. [00:19:38] Speaker 03: uh... i just asked one question on this alleged claim construction issue it's your position that there is no claim construction that was made instead that was just the district courts fact-finding on and what the function was am i correct on that so i think it was a i think their argument is more geared towards whether or not has already proved there was a buffer to begin with before we even get to the equivalent stop [00:20:03] Speaker 00: Because the district court found, first of all, that they failed to prove the existence of a buffer on our product. [00:20:08] Speaker 03: Forget about whether... And went on and said, assuming that's not correct, I'm going to talk about function-wise result now and decide on that issue. [00:20:15] Speaker 00: But their claim... That's correct, Judge Stolt. [00:20:17] Speaker 00: But their claim construction argument was more directed to the former, whether or not there was even a buffer to begin with, rather than the equivalency issue. [00:20:26] Speaker 00: And there, [00:20:29] Speaker 00: Again, we respectfully submit they're just trying to secure de novo review on what would otherwise be a factual issue that's reviewed by clear error here. [00:20:38] Speaker 00: Both parties agreed that for Azurite to prove the existence of a buffer in our product, it needed to do two things. [00:20:44] Speaker 00: First of all, it needed to show there were appreciable quantities of weak acid and conjugate base in our product, not just a few free-floating species in our formulation. [00:20:53] Speaker 00: Appreciable quantities of weak acid and conjugate base. [00:20:56] Speaker 00: They admit that. [00:20:57] Speaker 00: That's a gray brief at eight. [00:20:59] Speaker 00: If appreciable quantities of both weak acid and conjugate base are present, the formulation contains a buffer. [00:21:04] Speaker 00: Second, the parties agreed that for Azerty to carry its burden of proving a buffer in our product, they needed to show that the strength of the weak acid, i.e. [00:21:13] Speaker 00: its pKa, must be within a certain range of the formulation pH. [00:21:16] Speaker 00: They disagreed about what that proper range was. [00:21:22] Speaker 00: Those were the two facts that they had to prove to show the existence of a buffer. [00:21:27] Speaker 00: Forget about whether or not it's equivalent or not. [00:21:29] Speaker 00: They failed on both points. [00:21:32] Speaker 00: With respect to appreciable quantities of weak acid and conjugate base in our product, the district were credited to our expert's testimony, who said, maleic acid may not be fully dissociating from enalapyril, and the sodium hydroxide added to the penultimate step of our formulation process may be reacting with other acidic components in our product, including enalapyril itself. [00:21:52] Speaker 00: the mixed bury, the parabens, and that there was just no evidence in the district court made this specific finding that an appreciable buffer is formed. [00:22:03] Speaker 00: That's appendix 41 to 42. [00:22:05] Speaker 00: So we respectfully submit this is a fact dispute. [00:22:10] Speaker 00: There's no error, let alone clear error here. [00:22:12] Speaker 00: The other thing informing the court's opinion on this is, and they really don't touch on this too much in their briefing, is the fact that their expert's credibility was undermined. [00:22:22] Speaker 00: and also that their expert was found less credible than our expert, who was a tried and true formulator, and who'd actually formulated oral solutions with the recipients we're dealing with here in this case. [00:22:33] Speaker 00: Even if they did prove there were appreciable quantities of maleic acid and sodium malate in our product, they failed to prove that it was a buffer, because both sides agreed that for a weak acid and conjugate base, [00:22:44] Speaker 00: to qualify as a buffer, it had to behave as a buffer. [00:22:47] Speaker 00: And the only way it could is if the PKA was within a certain range of the formulation pH. [00:22:53] Speaker 00: Our experts said plus or minus 1. [00:22:55] Speaker 00: Their experts said plus or minus 2. [00:22:57] Speaker 00: Our expert backed his opinion up with corroborating written documentation that corroborated his opinion. [00:23:04] Speaker 00: Their expert did not. [00:23:05] Speaker 00: Their expert was also found less qualified and his credibility undermined on this issue. [00:23:09] Speaker 00: So another classic fact dispute that went in our favor [00:23:12] Speaker 00: that they fail to establish error, let alone clear error. [00:23:16] Speaker 00: Even if the district court erred on its finding that they failed to prove the presence of a buffer in our product, judgment of non-infringement should still be affirmed because they failed to prove that it was equivalent. [00:23:27] Speaker 00: On function way result, I think their biggest complaint is that the district court relied on the citizen petition to determine the proper function of the buffer. [00:23:36] Speaker 00: We respectfully submit the specific function of the claimed buffer limitation, which goes beyond just buffer [00:23:42] Speaker 00: its buffer and the concentration elements, which we submit are really important. [00:23:48] Speaker 00: The spec never actually spells out what that function is. [00:23:51] Speaker 00: It does spell out the function of buffering agents. [00:23:53] Speaker 00: We agree on the meaning of buffer, but it never actually spells out the function of the claim buffer limitation itself, in this case a citrate buffer at specific concentrations. [00:24:02] Speaker 00: Therefore, it was appropriate for the district court to rely on the citizen petition to find out which spoke exactly to the purpose of that claim buffer, that citrate buffer. [00:24:12] Speaker 00: even if that was error, that the function way result findings can still be upheld on appeal because we argued that the primary function of the buffer was to maintain formulation pH beyond any pH maintenance provided by any acid dissociated from an alkyl. [00:24:27] Speaker 00: And we argued that because there is no written description here in the common specification of any an alkyl liquid where the only buffer [00:24:36] Speaker 00: is acid dissociated from an alkyl, let alone one that's stable for 12 months at refrigerated conditions. [00:24:43] Speaker 02: What about dedication and disclosure? [00:24:46] Speaker 00: So thank you, Your Honor. [00:24:47] Speaker 00: So on that, we respectfully submit that, again, the primary dispute between the parties is the level of specificity that's required here. [00:25:02] Speaker 00: We respectfully submit we've met that level of specificity. [00:25:05] Speaker 00: The specification discloses that methylparaben and propylparaben are suitable preservatives. [00:25:11] Speaker 02: What role does the 482 patent play in this analysis? [00:25:15] Speaker 00: Thank you, Your Honor. [00:25:17] Speaker 00: So the 482 patent is a continuation, a claims priority to these patents. [00:25:21] Speaker 00: And therefore, presumably, all the claims in that 482 patent must be adequately described and enabled in these priority patents in the common specification. [00:25:31] Speaker 00: And the claims of the 4A2 patent actually claim in alkyl liquids where the only required buffer is... The ridge on your product. [00:25:40] Speaker 00: Correct. [00:25:41] Speaker 00: That's correct. [00:25:42] Speaker 00: And so under this court's case law, they can't erase that distinction by now arguing equivalents with respect to the earlier patents. [00:25:51] Speaker 03: So even if there's a dedicated disclosure in this case, there is a continuation patent that has the express limitations [00:26:00] Speaker 03: that at least with respect to this particular patent are dedicated to the public for purposes of doctrine of equivalence. [00:26:06] Speaker 00: That is correct, Your Honor. [00:26:08] Speaker 00: That is correct, even though arguably, although we're not conceding that right now, but arguably maybe these later claims do read on our product if they're valid. [00:26:19] Speaker 00: That's correct. [00:26:21] Speaker 02: But the 482 patent also teaches a little bit about what a poson would have understood looking at the terrain, correct? [00:26:28] Speaker 00: Yeah, I think it's the same specification. [00:26:32] Speaker 00: So there's really no more teaching there. [00:26:35] Speaker 00: And that's an issue that we have with them in some... Right. [00:26:39] Speaker 02: I mean, the notion that nobody would combine these two substances. [00:26:42] Speaker 00: That's exactly right. [00:26:43] Speaker 02: Because those substances are clearly dedicated and disclosed, the combination. [00:26:47] Speaker 02: So there was testimony from your expert that one of the skill in the art would understand the patent itself recognizes that you can have mixtures. [00:26:55] Speaker 02: and as i understood your expert was to testify that one of the skill in there would understand you could take these two things and mix them. [00:27:02] Speaker 00: They were the most commonly known. [00:27:03] Speaker 02: And then the 482 is sort of the Paraceno cherry on top of the ice cream sundae, right? [00:27:10] Speaker 00: That's exactly right, Judge Clevenger. [00:27:12] Speaker 03: What about example C? [00:27:14] Speaker 03: I was asking your adversary about example C in particular, C1 and C2. [00:27:18] Speaker 00: Thank you, Judge Soule. [00:27:19] Speaker 03: Could you give us my reading of that? [00:27:21] Speaker 00: I think his argument there is [00:27:24] Speaker 00: He didn't articulate it here, but it's in his brief. [00:27:27] Speaker 00: His argument that we can't rely on C1 and C2, and I believe there's one other one that uses both methylparaben and propylparaben, it's A6. [00:27:37] Speaker 00: I believe his argument, at least in his briefing, I'm not sure what it is today, but in his brief it was, well, you can't rely on those because there's another preservative in there. [00:27:44] Speaker 03: Maybe not sodium benzoate. [00:27:47] Speaker 00: It's potassium sorbate, I believe it is. [00:27:50] Speaker 00: uh... essentially what he's what was there is arguing here is you can only have disclosure dedication if you have a disclosed but unclaimed embodiment as opposed to looking at it as a limitation by limitation exercise that's something that's what rejected johnson and johnson versus re services uh... [00:28:09] Speaker 00: Basically, in a sorority's world, we could only enjoy disclosure dedication protection if the specification disclosed and an alkyl liquid were the only preservatives used for methylparaben and propylparaben alone. [00:28:21] Speaker 00: And that finds no support in this court's case law. [00:28:25] Speaker 00: Just one other thing I'd like to point out on equivalence, if this court even gets that far. [00:28:32] Speaker 00: On remedies, their point that somehow this is unfair, it's a predicament of their own making. [00:28:37] Speaker 00: We tried to get out of this case early and be in an early deposit motion. [00:28:41] Speaker 00: We were denied in part because they argued we were so close to trial. [00:28:44] Speaker 00: Now we have a judgment that's based on multiple legal and factual grounds. [00:28:49] Speaker 00: This court is not required to reach every single ground if it's going to affirm on our legal defenses. [00:28:54] Speaker 00: Had our legal defense been resolved before trial, they wouldn't be in this predicament they're in right now. [00:29:03] Speaker 00: Thank you. [00:29:04] Speaker 00: Unless the court has any further questions. [00:29:06] Speaker 04: Any more questions? [00:29:07] Speaker 04: No, thank you. [00:29:09] Speaker 04: Thank you, Professor. [00:29:13] Speaker 04: Mr. Jorsen, you have your rebuttal. [00:29:15] Speaker 01: Thank you, Your Honor. [00:29:17] Speaker 01: Let's go directly back to the disclosure doctrine, disclosure dedication doctrine. [00:29:23] Speaker 01: Your Honor had asked about the table. [00:29:26] Speaker 01: Another difference that wasn't pointed out is that those are both sodium salts, which is not [00:29:31] Speaker 01: what they're using. [00:29:32] Speaker 01: Again, the point is that you're not supposed to bring an obviousness-like analysis and say, could somebody figure this out? [00:29:40] Speaker 01: It's not even written description. [00:29:42] Speaker 01: So is there an embodiment that shows methyl and propylparaben not in salt form? [00:29:50] Speaker 01: No. [00:29:51] Speaker 01: And so the fact that we have generic claims because we have lots of species disclosed doesn't change the fact that that particular combination was not dedicated. [00:30:00] Speaker 01: I'd like to quickly go through, if I could, some of the other issues. [00:30:04] Speaker 01: On amendment-based estoppel, their version of this would limit us to a single species that was amended in another patent, even though that combination of limitations already exists in one claim. [00:30:20] Speaker 01: Whether or not that's limiting [00:30:22] Speaker 01: The question is, is this patent is it limiting? [00:30:25] Speaker 01: And the answer has to be no. [00:30:27] Speaker 01: Just look at the claims. [00:30:28] Speaker 01: The claims here are much broader than that. [00:30:31] Speaker 01: Also, look at their four ingredient argument. [00:30:34] Speaker 01: A disavowal has to be clear. [00:30:37] Speaker 01: And yet, the examiner told us that we should actually eliminate one of those ingredients because it wasn't necessary for patentability. [00:30:44] Speaker 01: There can't be any clear evidence that there's no disavowal, but there certainly isn't clear evidence that there was. [00:30:51] Speaker 01: On function way result, there's really no debate about the function. [00:30:55] Speaker 01: The function is that it's got to act as a buffer. [00:30:59] Speaker 01: But we didn't agree to this one unit away limitation on it. [00:31:07] Speaker 01: If they'd wanted that, they should have asked for it in claim construction. [00:31:10] Speaker 01: They didn't. [00:31:10] Speaker 01: Instead, what they tried to do is force it in with only on the basis of extrinsic evidence. [00:31:16] Speaker 01: There's nothing in the intrinsic evidence that requires that. [00:31:20] Speaker 01: Our experts showed why even two units out, this would be OK. [00:31:24] Speaker 01: And he did it with the math of the Henderson-Hasselbalch equation, which is gold standard evidence in this area. [00:31:32] Speaker 01: And finally, the real question about whether the way is limited or whether we're trying to cover all buffers is the fact that the result's the same, right? [00:31:43] Speaker 01: At the end of the day, you have to have a buffer. [00:31:45] Speaker 01: Both sides have an acid-base buffer system, and you have to have a result that this is stable for one to two years at five degrees Celsius. [00:31:56] Speaker 01: There's no question that they've had that. [00:31:59] Speaker 01: So you have the same function, a buffer, you have it working in the same way, however you got there because of the [00:32:07] Speaker 01: The ions are agnostic to how they were created. [00:32:10] Speaker 01: You have an acid-based system. [00:32:12] Speaker 01: And in that acid-based system, you get the result of long-term stability, unless there are any questions. [00:32:19] Speaker 04: Anything else for counsel? [00:32:21] Speaker 04: No, thank you. [00:32:23] Speaker 04: Thank you, Your Honor. [00:32:24] Speaker 04: Thanks to both counsel. [00:32:26] Speaker 04: The case is taken under submission.