[00:00:00] Speaker 02: Mr. Jay, good morning. [00:00:27] Speaker 03: Good morning. [00:00:28] Speaker 03: May it please the court, William J. for the Glenmark Appellants. [00:00:31] Speaker 03: Mayors sought to extend the life of its azelaic acid franchise by getting a patent on a formulation that encompassed only a very specific combination of excipients. [00:00:40] Speaker 03: It could not have patented azelaic acid. [00:00:42] Speaker 03: It could not even have patented an azelaic acid hydrogel, because the art knew those. [00:00:46] Speaker 03: So it told the world that its innovation was this very specific combination of excipients. [00:00:52] Speaker 03: Glenmark set out to make a different combination, one that did not meet the claims, did not literally infringe. [00:00:58] Speaker 03: And the district court nonetheless held that Glenmark's different formulation infringes by equivalence. [00:01:05] Speaker 03: And it used reasoning that gave Bayer a much broader range of equivalence than it has a right to. [00:01:12] Speaker 02: Can I ask you just one threshold question, which is a process question? [00:01:14] Speaker 02: There's documents marked that deal with the and, [00:01:18] Speaker 02: of your client, there are documents in the joint appendix that are marked confidential. [00:01:24] Speaker 02: But it appears to me, at least, when we're talking about what representations were made by your client before the FDA, the district court actually referred to some of those in her opinion, which I think is public information. [00:01:36] Speaker 02: So is it clear? [00:01:37] Speaker 02: For purposes of our discussion here, can we talk about that or not? [00:01:41] Speaker 03: I believe that we can talk about what the district court talked about here in open court. [00:01:44] Speaker 02: That's correct. [00:01:45] Speaker 02: Sorry to interrupt. [00:01:47] Speaker 03: Thank you. [00:01:48] Speaker 03: I should note that the end of it is still pending. [00:01:51] Speaker 03: The district court's reasoning rested on three... But the representations haven't changed, right? [00:01:57] Speaker 03: No. [00:01:58] Speaker 03: The district court's holding rest on three separate legal errors. [00:02:01] Speaker 03: One about the function wave result test. [00:02:04] Speaker 03: The district court allowed Bayer to benefit from a theory of what function lecithin and triglycerides perform. [00:02:12] Speaker 01: The patent doesn't actually ever tell you, certainly not expressly, at most, a tiny inference, but what the actual function of lecithin and triglycerides are in this composition. [00:02:24] Speaker 01: The patent is just radio silent on it. [00:02:27] Speaker 03: We think that there is a suggestion, as Your Honor alluded to in column two, we think that the prosecution history actually sheds more [00:02:33] Speaker 03: light on that, suggesting that it is exactly what Bayer would later tell the FDA it is, that lecithin is an emulsifier and triglycerides are an emollient. [00:02:41] Speaker 01: But it can be both an emulsifier and a skin penetrator. [00:02:44] Speaker 01: It's entirely possible. [00:02:45] Speaker 01: It can serve both. [00:02:47] Speaker 03: It can serve both in the abstract. [00:02:49] Speaker 01: And the proper question is... And most of this patent, to the extent that they talk about the advantages of this particular formulation, it's almost exclusively about the surprising [00:03:00] Speaker 03: Advances of the skin penetration up to three to five times more over Skinner in their product that their last iteration Yes, your honor, but the district court correctly concluded that you can't get from the patent specifically example two Which is what Bayer's expert tried to read to get penetration enhancer to connect it up to lecithin and triglycerides and [00:03:22] Speaker 03: You can't get that out of the patent. [00:03:24] Speaker 03: The district court was exactly right about that. [00:03:28] Speaker 00: Why does that matter? [00:03:29] Speaker 00: Do we really have doctrine in the doctrine of coalesce that says the patent has to disclose the function? [00:03:40] Speaker 00: And in particular, if it doesn't do so at all or not very clearly, [00:03:45] Speaker 00: Extrinsic evidence can't do that, including, most importantly, what the chief was referring to before your own end of time. [00:03:53] Speaker 03: Well, let me take that in two steps, if I may, because I think the answer to your question is yes, but you don't need to agree with me in order to rule for our client in this case. [00:04:02] Speaker 03: Precisely, because I think that, and let's get back to my colloquy with Judge Moore, I think that there's more here that this patent actually teaches. [00:04:09] Speaker 03: Not only does it not say anything about function, it suggests that the function is something else. [00:04:15] Speaker 03: And the court's cases clearly do say that when the patent and the intrinsic record disclose one function, you can't make up another function. [00:04:23] Speaker 01: OK, so where is your best evidence in the patent that LESAPIN functions as an emulsifier? [00:04:27] Speaker 03: I think it would be in column two, line 56. [00:04:31] Speaker 01: Yes, it's a nano emulsion point Okay, but but really all this says is that at less than 1% less than you're not gonna see nano emulsion and that that's an advantage I must be honest. [00:04:47] Speaker 01: I'm I'm dying to know I actually now know what nano emulsion is But why do you not want it? [00:04:56] Speaker 03: Why would the art not want a nano emulsion? [00:05:00] Speaker 01: Yeah, because it's listed as an advantage. [00:05:02] Speaker 01: At the concentration of 1%, it's an advantage not to have nano emulsions. [00:05:06] Speaker 01: Why is that? [00:05:07] Speaker 03: I think if you look at the district court's opinion on claim construction, you'll see the dispute between the parties was about, and this came up also in the dispute about what the prior art shows, where does a nano emulsion stop and where does the hydrogel begin? [00:05:20] Speaker 03: That, I think, is the key. [00:05:23] Speaker 03: the key relevance of that. [00:05:24] Speaker 01: Is it because if you have nano emulsion, then you're telling me you don't have hydrogel? [00:05:29] Speaker 01: Because that can't be right, because they're claiming a hydrogel at where you have one and a half and three percent of lecithin, but then they're admitting that only when you go below one percent do you have no nano emulsion. [00:05:42] Speaker 03: I think that gets to a dispute between the parties, and I think that the court doesn't need to resolve here, but that [00:05:48] Speaker 03: to kind of step back a second and answer, I think, the question that Your Honor was getting at. [00:05:54] Speaker 03: Where do we get out of the intrinsic record the function that this is performing? [00:05:59] Speaker 03: So there are two places. [00:06:00] Speaker 03: One is the fact that more or less than more likely to be an emulsion. [00:06:05] Speaker 03: The second is, if you look in the prosecution history, the [00:06:08] Speaker 01: But wait, the timeout, but it actually encourages you to use, as a preferred, the most preferred embodying it, less, less-a-than, and have no nanoemulsion. [00:06:16] Speaker 03: Right, less, less-a-than, no nanoemulsion, more, more, more less-a-than, and a nanoemulsion, a nanoemulsion that suggests an emulsifier. [00:06:27] Speaker 01: But, but if there's no nanoemulsion, it's not an emulsifier, right? [00:06:31] Speaker 03: If there's, no, that's not right, your Honor, because of the way this is, I understand the question. [00:06:37] Speaker 03: The, this, this was, [00:06:39] Speaker 03: extensively debated in the district court as well. [00:06:42] Speaker 03: But even if the formulation winds up as a hydrogel, that doesn't mean that there was no role for an emulsifier in preparing this product. [00:06:50] Speaker 03: in the course of the formulation, it may end up as an emulsifier. [00:06:53] Speaker 01: OK, but you're suggesting that all of it stop. [00:06:55] Speaker 01: You're suggesting that all these things were disputed. [00:06:57] Speaker 01: These sound like the sticky, wickedest little mess of fact findings I can imagine. [00:07:02] Speaker 01: They found against you. [00:07:03] Speaker 01: You're up against a deferential standard of review. [00:07:06] Speaker 01: And if you're telling me that to some extent, whether I say lessethin functions as an emulsifier turns on whether I am willing to overturn a fact finding below about whether or not when you have no nano emulsion, it's not functioning as an emulsifier, [00:07:18] Speaker 01: You lose. [00:07:19] Speaker 03: Respectfully, no, Your Honor, no on the standard of review and no on what the district court held. [00:07:23] Speaker 03: This is a question of law because the district court misallocated the burden and the district court never made a finding. [00:07:30] Speaker 01: Misallocated what? [00:07:31] Speaker 01: We're talking about what the function is, function way result. [00:07:35] Speaker 03: Correct, Your Honor. [00:07:35] Speaker 03: And while function way result is a factual question, the district court made its factual findings [00:07:39] Speaker 03: pursue it to a misallocation of the burden. [00:07:41] Speaker 03: If you look at pages 32 and 33, you will see that the district court held ultimately that it could not rule out the possibility [00:07:52] Speaker 03: that lecithin might function as a penetration enhancer in this formulation. [00:07:56] Speaker 03: That is not the same thing as finding that it does. [00:07:59] Speaker 03: But it was, in fact, plaintiff's burden to prove that it does. [00:08:02] Speaker 01: That's one thing. [00:08:03] Speaker 01: No, it found that it does. [00:08:04] Speaker 01: It didn't just find it. [00:08:05] Speaker 01: It does have that sentence, which is really unfortunate because it's poorly worded. [00:08:08] Speaker 01: But the rest of what I read in that opinion seemed to support the idea that they found it to be proven. [00:08:17] Speaker 03: I respectfully disagree, Your Honor. [00:08:19] Speaker 03: What page? [00:08:19] Speaker 03: A32 and A33. [00:08:23] Speaker 03: Begin the last full sentence on a 32 nonetheless although plaintiffs position lacks scientific rigor The court discerns nothing in the record that indicates that less of than entry glycerides cannot act as penetration enhancers And this comes out again first full paragraph on the next page first sentence of [00:08:42] Speaker 03: does not exclude the possibility that they function as such in the claimed composition. [00:08:47] Speaker 02: Yeah, but then they go on on A33, plaintiffs provided testimony from both sides' witnesses to support the common sense proposition. [00:08:54] Speaker 03: That A, given excipient may perform more than one function. [00:08:57] Speaker 03: It logically follows. [00:08:59] Speaker 03: That listing them does not mean that the excipients cannot also act as penetration enhancers. [00:09:06] Speaker 03: I've looked for a positive statement finding against us and I do not see one. [00:09:09] Speaker 01: But then it went on to say the court is also swayed by defendants, your repeated statements in your ANDA, that this thing does in fact function as a skin penetration cancer. [00:09:19] Speaker 01: Yes, that is the closest thing to a boom, Your Honor, but respectfully that's not... Well, it's a really big boom and this is a deferential standard of review. [00:09:26] Speaker 01: The court has made a finding regarding what the function is. [00:09:31] Speaker 01: He didn't say it might be. [00:09:32] Speaker 01: This is what he found it was. [00:09:33] Speaker 01: And then he went on to apply the doctoral equivalence to that. [00:09:36] Speaker 01: And your own statements seem like the smoking gun that really doomed you. [00:09:40] Speaker 03: Well, respectfully, Your Honor, this is statements in our ANDA about our generic product. [00:09:45] Speaker 01: No, these are not statements in your ANDA about your generic product. [00:09:47] Speaker 01: These are statements in your ANDA about what excipients not used in your product do, and that yours do the same thing as those. [00:09:55] Speaker 03: It's sorry, I was saying this is an end about our generic product. [00:10:00] Speaker 03: You're right. [00:10:01] Speaker 01: These statements are not just about the exhibits used in your product. [00:10:04] Speaker 01: They are about what you understand the exhibits, and you have to. [00:10:08] Speaker 01: You have to say you do the same thing, or you can't get the ANDA. [00:10:11] Speaker 01: And so you've identified exactly what you believe less than triglyceride do. [00:10:16] Speaker 01: Well, let me ask you. [00:10:17] Speaker 01: Oh, my goodness sakes, did you make a misrepresentation? [00:10:20] Speaker 01: Is this perjury before the FDA? [00:10:21] Speaker 03: Absolutely not, Your Honor. [00:10:23] Speaker 03: Respectfully, Your Honor is not correct that they have to do the exact same thing where you can't get approval. [00:10:28] Speaker 03: You have to show that the foreign militia. [00:10:29] Speaker 01: But you said they did. [00:10:30] Speaker 01: But you said they did. [00:10:31] Speaker 01: You said they did the exact same thing. [00:10:34] Speaker 01: In the context of this. [00:10:36] Speaker 01: They have an NDA for this formulation. [00:10:39] Speaker 01: You said their lecithin, their triglyceride, functions as skin enhancers. [00:10:44] Speaker 01: So does our excipient isopropyl myristate. [00:10:49] Speaker 03: We were wrong, Your Honor. [00:10:50] Speaker 03: That apparently is not what they saw their function as. [00:10:54] Speaker 01: It doesn't matter what they see their function as. [00:10:57] Speaker 01: That's irrelevant. [00:10:58] Speaker 01: The question is, what is the function? [00:11:00] Speaker 01: And the district court made a finding. [00:11:02] Speaker 03: No, Your Honor. [00:11:03] Speaker 03: I think, Your Honor, that's an excellent way of pointing it. [00:11:05] Speaker 03: The question is, what is the function? [00:11:08] Speaker 03: And if we thought, incorrectly, that the function was x, that does not make the function y. So do you think that your representations to the FDA were incorrect? [00:11:17] Speaker 01: We think that and then have you corrected them because it's really important when you file documents in a federal court that you later discern our federal agency and you later find That you have made really important factually erroneous statements. [00:11:29] Speaker 01: Have you corrected them with the FDA your honor? [00:11:31] Speaker 03: We've told the FDA that our proper our formulation contain told them that these things don't function as skin penetrators the FDA knows that your honor because the the Bayer NDA clearly tells the FDA exactly what function is [00:11:44] Speaker 01: And you came in and told them the opposite. [00:11:46] Speaker 01: When you make a misstatement of fact to a federal agency, you are obligated to correct it if you later discover your statement is a misstatement of fact. [00:11:53] Speaker 01: So if you're standing here telling me it's a misstatement, I'm asking you a yes or no question. [00:11:57] Speaker 01: Have you notified the FDA of your inaccurate representation to them? [00:12:01] Speaker 03: I believe we are in regular contact. [00:12:03] Speaker 01: Yes or no. [00:12:04] Speaker 03: I don't know the answer to this specific question you're asking, Your Honor, because I do not believe that we have failed to carry out any duty [00:12:13] Speaker 03: Ultimately, this goes to the legal question whether a statement in our ANDA can give to the other side's product a function that it does not have, that they did not think that it has. [00:12:25] Speaker 00: The role that that statement played in this litigation was as one piece of evidence in a pool of various kinds of evidence [00:12:35] Speaker 00: This one had a particularly great weight, and it might well have been proven to be incorrect and overcome by other evidence. [00:12:45] Speaker 00: But the other evidence is kind of iffy in what it says. [00:12:50] Speaker 00: So this ends up being pretty powerful. [00:12:52] Speaker 03: Well, I think, Your Honor, that if this evidence is not legally relevant, and if there is no other evidence, or if it's iffy or ambiguous or equipoise, then we win. [00:13:03] Speaker 00: It can't be not legally relevant. [00:13:05] Speaker 03: I think it is not legally relevant whether we concluded that this probably was a penetration enhancer based on the fact that we prepared a generic formulation using isopropyl meristate, which is a penetration enhancer, and we got a bioequivalent result. [00:13:26] Speaker 03: That was the surmise that we drew, but it's important to note that lecithin and triglycerides, not known to the art as penetration enhancers, [00:13:34] Speaker 03: And the fact that we made this guess to the FDA does not change the fact that the patent itself. [00:13:41] Speaker 02: I'm sorry, I didn't hear it. [00:13:43] Speaker 02: The fact that we made this guess? [00:13:45] Speaker 02: to the FDA? [00:13:46] Speaker 02: Is that the word you used? [00:13:48] Speaker 03: Yes, that was the best understanding that we could come to about what function this is performing in the brand product. [00:13:58] Speaker 03: After we filed Aranda, after the other side had seen Aranda, that's when the other side for the first time identified its function as [00:14:10] Speaker 03: Penetration enhancement, something not reflected. [00:14:12] Speaker 01: You're almost out of time altogether. [00:14:14] Speaker 01: With the indulgence of my colleagues, I'd like to ask you to, nonetheless, spend a few minutes and address your practicing the prior arguments. [00:14:20] Speaker 01: Would you add to that? [00:14:21] Speaker 03: Sure. [00:14:21] Speaker 03: Yeah, I think that the district court's legal error on ensnarement is key, because the district court applied the wrong hypothetical claim. [00:14:29] Speaker 03: The district court gave, to use the word this court's cases have used, coverage, extremely broad coverage to this very specific term, lecithin and triglycerides become any penetration enhancers. [00:14:39] Speaker 03: Yet the district court didn't apply a hypothetical claim that reflects that extremely broad coverage. [00:14:44] Speaker 03: The correct hypothetical claim wouldn't smear that. [00:14:48] Speaker 00: In what way did the district court give extremely broad coverage? [00:14:54] Speaker 00: All it did was to make a finding that your particular thing was an equivalent, and in the course of that said, as to the function, [00:15:05] Speaker 00: There's enough evidence, and I find, that it performs this function. [00:15:08] Speaker 00: It didn't say that all penetration enhancers are now within the scope. [00:15:13] Speaker 03: On the contrary, Your Honor, if you look at the discussion of way, we had contested whether the formulations could be said, even if they could perform the same function, whether they could be said to do so in the same way. [00:15:25] Speaker 03: The district court said that it was not going to get into, this is page 838, it was not going to get into particular sub-mechanisms. [00:15:32] Speaker 03: So in other words, it discounted our evidence about way by saying it wasn't going to get into the sub mechanisms question. [00:15:40] Speaker 03: But then it didn't apply a hypothetical claim that reflected the breadth of the equivalence theory without consideration of sub mechanisms that it was applying. [00:15:50] Speaker 03: And that was the legal error. [00:15:53] Speaker 01: Well, it said it's not going to get into the sub mechanisms. [00:15:57] Speaker 01: because the parties both accept that both of these excipients cause disruption of stratum corneum lipids. [00:16:05] Speaker 01: I don't have the first clue what any of that is. [00:16:08] Speaker 01: But she then says, and that's sufficient to enhance penetration. [00:16:11] Speaker 03: And a hypothetical claim directed to that would ensnare the prior art. [00:16:15] Speaker 03: But the district court did not examine that question, Your Honor. [00:16:17] Speaker 01: This has nothing to do with what the hypothetical claim should be directed to. [00:16:20] Speaker 01: This has to do with the way in which two particular excipients both operate. [00:16:25] Speaker 03: If I may answer the question, Your Honor, the scope of the equivalence theory absolutely has everything to do with the breadth of the hypothetical claim. [00:16:32] Speaker 03: The breadth of the hypothetical claim, the coverage of the hypothetical claim, should reflect the range of equivalence that the plaintiffs are seeking. [00:16:39] Speaker 03: It does not reflect [00:16:40] Speaker 01: No, they're only seeking an equivalent, as far as I can tell, to isopropyl meristate. [00:16:46] Speaker 01: The arguments they're making may well extend, as you point out, to other excipients, but they're not asking for coverage of any of those other excipients. [00:16:54] Speaker 01: They're only asking, and by the way, it's not a claim extension. [00:16:57] Speaker 01: The doctrinal equivalence doesn't extend the claim scope. [00:16:59] Speaker 01: The claim scope is the claim scope. [00:17:00] Speaker 01: The doctrinal equivalence allows for interchangeable elements to fall within that claim scope. [00:17:05] Speaker 01: So in any event, [00:17:07] Speaker 01: They're saying isopropyl meristate. [00:17:10] Speaker 01: Unless I'm mistaken, I mean, I don't remember them saying all skin penetration enhancers are going to be now within our claims. [00:17:16] Speaker 03: To quote the court's decision in Wilson Sporting Goods, there is no principal difference between isopropyl meristate and the other penetration enhancers. [00:17:23] Speaker 01: Wilson Sporting Goods in the golf ball case has a quote about isopropyl meristate? [00:17:27] Speaker 03: Your Honor, the courts in Wilson Sporting Goods explains how we're supposed to do hypothetical claim analysis. [00:17:34] Speaker 03: And in Wilson Sporting Goods, it says there is no [00:17:37] Speaker 03: The claim said zero dimples on the golf ball can intersect a great circle. [00:17:42] Speaker 03: And the theory was that 60 dimples on the golf ball intersecting a great circle was equivalent. [00:17:52] Speaker 03: And so this court said the hypothetical claim isn't zero or 60. [00:17:57] Speaker 03: It's zero to 60. [00:17:59] Speaker 03: It encompasses the entire range, the coverage of the equivalence theory. [00:18:02] Speaker 03: And there is no principal difference between any point in that range on their theory. [00:18:06] Speaker 03: If they want to make a broad theory of equivalence, they are stuck with a broad hypothetical claim to ensure that their equivalence theory doesn't ensnare the prior art. [00:18:14] Speaker 03: This hypothetical claim, the correct hypothetical claim, does ensnare the prior art, which knew an azelaic as a hydrogel with a penetration enhancer. [00:18:25] Speaker 02: Thank you. [00:18:26] Speaker 02: Will we store two minutes of rebuttal? [00:18:28] Speaker 02: Thank you. [00:18:31] Speaker 04: Good morning. [00:18:33] Speaker 04: Judge Moore, I think I can answer the question about the FDA correspondence, because they are under a court order to update us. [00:18:40] Speaker 04: And as recently as Wednesday, there's been no representation to the FDA that any representation they made to the FDA is wrong. [00:18:48] Speaker 04: Now, at trial, we had a five-day trial. [00:18:50] Speaker 04: One of the witnesses was the director of regulatory, Mr. Mafia. [00:18:54] Speaker 04: And he testified specifically that... His name is Mafia? [00:18:59] Speaker 01: Very good. [00:19:00] Speaker 01: Keep going. [00:19:01] Speaker 04: M-A-F-F-I-A is the spelling. [00:19:04] Speaker 01: Maybe I'm mispronouncing it. [00:19:05] Speaker 01: You have Dr. Wiener and Mr. Mafia. [00:19:08] Speaker 01: Those are your witnesses. [00:19:09] Speaker 01: Just pointing out the obvious. [00:19:10] Speaker 01: Go ahead. [00:19:12] Speaker 04: OK. [00:19:13] Speaker 04: Anyway, he gave sworn testimony that all of the statements made to the FDA were accurate, including, and he was specifically asked about this, the statements concerning the penetration enhancing. [00:19:25] Speaker 04: So that's the state in the FDA. [00:19:27] Speaker 04: And of course, the district court relied upon that. [00:19:29] Speaker 04: I think there was a mountain of evidence to support the function finding. [00:19:34] Speaker 04: There was the evidence. [00:19:35] Speaker 01: But there's nothing in the patent that ties lecithin and skin penetration. [00:19:40] Speaker 01: Nothing in the patent that ties it together. [00:19:42] Speaker 04: Well, there's no explicit statement. [00:19:44] Speaker 04: But I think, Judge, as you pointed out, that whole patent is about penetration enhancement. [00:19:48] Speaker 04: The inventor gave testimony which indicated that [00:19:54] Speaker 04: Those, the lecithin and the triglyceride were their penetration enhancing qualities. [00:19:59] Speaker 04: And that example, too. [00:20:00] Speaker 01: Is that the doctor I referred to? [00:20:02] Speaker 01: No, no, no. [00:20:03] Speaker 01: This is Dr. Franca. [00:20:04] Speaker 01: OK, because I was going to say, because I remember the court saying that she rejected Dr. Weiner's testimony because it didn't even appear to know triglycerides were present in something or whatever. [00:20:13] Speaker 04: Well, that's true. [00:20:14] Speaker 04: Look, we said this in our brief, and I believe it was a very well-reasoned opinion. [00:20:19] Speaker 04: We disagreed with that particular finding. [00:20:23] Speaker 04: But it almost doesn't matter because the evidence was so strong in favor of the function. [00:20:29] Speaker 04: If you look at their own admissions and also the district court's way findings, I think are particularly appropriate here because they almost dictate, they have conceded the way prong and they've conceded result. [00:20:42] Speaker 04: And so if you look at the way analysis- [00:20:45] Speaker 01: On appeal. [00:20:45] Speaker 01: Right, yeah. [00:20:46] Speaker 01: They disputed it before Judge Robbins. [00:20:48] Speaker 04: They did, but not on appeal. [00:20:49] Speaker 04: And so their conceding way, and what the district court found there is that there was a very well-reasoned analysis there that the isopropyl meristate, the lecithin and the triglyceride, all act in the same way in the skin. [00:21:04] Speaker 04: They disrupt the lipids of the stratum corneum letter. [00:21:06] Speaker 04: And so they all function in the same way. [00:21:08] Speaker 04: And that dictates the function result, because what else could they be doing? [00:21:14] Speaker 04: There was other evidence, there was publication evidence, and so forth. [00:21:17] Speaker 04: So there was a lot of evidence to support that finding. [00:21:20] Speaker 01: But what about his argument, which we only got to near the end, about the fact that for purposes of practicing the prior art, the same [00:21:33] Speaker 01: arguments you make about function-way result that otherwise define what you're claiming to be equivalence of your claim elements ought to apply. [00:21:43] Speaker 01: You can't have it both ways. [00:21:45] Speaker 01: You can't say everything that acts as a skin penetrator is going to be an interchangeable equivalent with lecithin and triglycerides, and then say, oh, but for practicing the prior art purposes, we're just going to [00:21:56] Speaker 01: You know, we're just going to kind of carve this one out and look at it and say, OK, isopropyl mirror state's not in the prior art. [00:22:02] Speaker 01: So we can have less of an triglycerides and isopropyl mirror state without sort of focusing on the function way and result analysis, which is all about skin penetration. [00:22:13] Speaker 04: Well, I mean, we do not claim that all penetration enhancers fall within the scope of those claims. [00:22:20] Speaker 04: They have admitted that there's some hundred or more known penetration enhancers. [00:22:25] Speaker 04: We don't claim all of them. [00:22:26] Speaker 04: There's a mechanism of action. [00:22:29] Speaker 04: I think that what the district court found is you just can't mix and match these things. [00:22:33] Speaker 04: It's very formula dependent, or very formulation dependent. [00:22:37] Speaker 04: And- Can I ask you specifically about that? [00:22:40] Speaker 00: Yes. [00:22:40] Speaker 00: Was your evidence on the way component that all penetration enhancers work in substantially the same way, or that some subclass of which the accused product is a part [00:22:56] Speaker 00: work in the same way? [00:22:57] Speaker 04: No, our evidence was not that they all work in the same way. [00:23:00] Speaker 04: And in fact, the Gaskill reference that they rely upon on the ensnarement uses a compound called DMSO. [00:23:07] Speaker 04: We made the point, and the district court found this, that that's just fundamentally different than the three penetration enhancers at issue here, which focus on the lipid. [00:23:18] Speaker 04: They disrupt the lipids of the skin, not the proteins. [00:23:22] Speaker 04: And DMSO also has an impact on the protein. [00:23:24] Speaker 04: They're in different classes that district court found that these penetration enhancers are in different classes based on their chemistry and based on the impact they have in the skin. [00:23:34] Speaker 04: And so no, the evidence was very specific as to this type of class. [00:23:39] Speaker 02: Is it your view that it's a matter of law, the hypothetical claim can only be broadened just enough to cover the accused product? [00:23:48] Speaker 04: Yes. [00:23:49] Speaker 02: And what's the support for that? [00:23:52] Speaker 02: Just enough and no more? [00:23:54] Speaker 04: well then to cover the accused product well i i i think our reading wilson's sporting goods for example and pew uh... spine is that you need to you need to cover it it wouldn't be fair in my view to extend it beyond what you're trying to cover on equivalents now a range gate you two separate things whether you need to cover it and whether you can extend it beyond coverage of the accused product [00:24:18] Speaker 02: So are you reading the cases to say, no, it can't be broadened any more than just enough to cover the accused product because they're different things? [00:24:27] Speaker 04: Yes, Your Honor, that's the way we read the cases. [00:24:30] Speaker 04: And nor do I think it would be fair to extend beyond what we're asking for. [00:24:34] Speaker 01: It doesn't. [00:24:38] Speaker 01: And that doesn't preclude you, though, for asking for more, right? [00:24:41] Speaker 01: You can come back for seconds in another case. [00:24:43] Speaker 01: Isopropyl meristate in this instance, and maybe if I could think of a name of any other chemical or ever new one, I might throw it out now, but I don't. [00:24:51] Speaker 01: That's all I've got for you. [00:24:52] Speaker 01: So maybe there's some, you just said there's hundreds of possible ones. [00:24:55] Speaker 01: So next case, you could go after a different one, right? [00:24:57] Speaker 01: So how are they to know in formulating, I mean, you know, it's not a terrible thing for the market to have competition, and so how are they to know [00:25:05] Speaker 01: what excipients are in fact fair game going forward because the whole point of patents is notice. [00:25:11] Speaker 01: So now that we've all kind of gotten down to the idea that there are possibly a hundred excipients that could function as skin penetrators and you're saying some of them might not fall within these claims because they operate in a different way. [00:25:23] Speaker 01: How do they go ahead and figure out how to compete? [00:25:27] Speaker 04: Well, I think first of all we have a record in the case, right? [00:25:29] Speaker 04: We've taken certain positions but I think that [00:25:31] Speaker 04: we'd analyze another case the same way we analyze this one. [00:25:35] Speaker 04: We take a look at that particular chemical, see what the way was, and determine whether it functioned in the same way. [00:25:42] Speaker 04: I think it's pretty clear that we have taken a position that DMSO, for example, doesn't function in the same way. [00:25:49] Speaker 01: So if they had another excipient, not isopropyl meristate, that functioned in the same way, but was present in the prior art, [00:25:59] Speaker 01: you wouldn't go after that one because it's present in the prior art, right? [00:26:04] Speaker 04: Well, I wouldn't say that, Judge Moore. [00:26:07] Speaker 04: I think that it would depend, right? [00:26:09] Speaker 04: The doctrine of equivalence is a function, weight, result analysis. [00:26:14] Speaker 04: You'd have to have the same result. [00:26:16] Speaker 04: All of these things are in the prior art somewhere, right? [00:26:18] Speaker 04: And so it's just a matter of putting them together. [00:26:20] Speaker 01: But the point of the exception is it's after you've already established function, weight, or result, right? [00:26:27] Speaker 01: I mean, you don't get to [00:26:30] Speaker 01: practicing the prior art unless you've already established a prima facie case of infringement under DOE. [00:26:35] Speaker 01: It's an exception to DOE. [00:26:37] Speaker 01: So you have another excipient, another random excipient. [00:26:41] Speaker 01: Same formulation, but rather instead of isopropyl mirror state, they choose a different excipient. [00:26:46] Speaker 01: And if it operates in the same function, way, and result, but is nonetheless present in the prior art, are you going after it or are you not going after it for infringement? [00:26:55] Speaker 04: I'm not sure I can answer that question, because it's a hypothetical. [00:26:59] Speaker 04: It would depend on what the function way results show. [00:27:02] Speaker 01: But occasionally, you have to answer judges' hypotheticals. [00:27:04] Speaker 01: But I don't know how to answer a hypothetical. [00:27:06] Speaker 01: You don't have to answer a hypothetical. [00:27:08] Speaker 01: No, no, no, no. [00:27:08] Speaker 04: I'm not saying I don't have to. [00:27:10] Speaker 04: That's not what I'm saying. [00:27:11] Speaker 04: All I'm saying is I don't know how to answer a hypothetical without facts. [00:27:15] Speaker 01: And so if you gave... I thought I gave a couple of those. [00:27:18] Speaker 01: There's another excipient that is identical in function, way, and result to lecithin and triglycerides, exactly the same way isopropylmerostate is. [00:27:29] Speaker 01: And that other excipient happens to be present in the prior art. [00:27:34] Speaker 04: All right. [00:27:35] Speaker 04: So if there's another excipient, under the hypothetical claim, it still would not [00:27:44] Speaker 01: It still would not anticipate or render obvious because gas go was not gas go the reference they use was not a hydrogel Okay, so if it's so you're saying it would well, but if I get news for you if there's prior art It's a hydrogel and it's azelaic acid and it's an excipient. [00:28:03] Speaker 01: You're friggin invalid I mean, you know, that's the end of that forget about practicing the prior art So where is that line because practicing the prior art means something right? [00:28:13] Speaker 01: There is some [00:28:14] Speaker 01: universe of things, which are encompassed by it, like that golf ball and Wilson's sporting goods. [00:28:18] Speaker 01: So what, I mean, I guess what I'm trying to figure out is really what I'm trying to get at with all of this is how broad should the hypothetical claim be drafted? [00:28:30] Speaker 01: Cause if you're going to go after every single skin penetrator, just like isopropyl mere state, then we ought to probably be thinking about that, right? [00:28:40] Speaker 01: When we're drafting that hypothetical claim, if your argument is, [00:28:43] Speaker 01: Every single skin penetration enhancer that functions in this way, every single one of them is within the scope of what we ought to be able to sue for infringement for DOE purposes. [00:28:56] Speaker 01: And that is, to some extent, the nature of your argument of function way of result. [00:29:02] Speaker 01: Then why is that not, as your colleague on the other side says, exactly the way we ought to be thinking when we're drafting the hypothetical claim? [00:29:11] Speaker 04: Well, my answer to that would be, we're not going after everyone. [00:29:16] Speaker 01: In this particular case, that's why I was trying to figure out where else it's going. [00:29:19] Speaker 04: But even in future cases, Judge Moore, the reason I commented before that way is because it depends on a particular recipient. [00:29:28] Speaker 04: If it functions in the same way, that would be consideration number one. [00:29:32] Speaker 04: If it gives the same result, that would be consideration number two. [00:29:35] Speaker 04: And so before you decided to bring another case, you'd have to look at both the way and the result. [00:29:41] Speaker 04: Does it give the same unexpected properties that the claimed formulation gives? [00:29:47] Speaker 04: And I think you'd have to look at that whole thing before you decide to give a case. [00:29:50] Speaker 04: But I can say unequivocally, nobody would have an intention of bringing a case on every penetration enhancer that people know about. [00:29:58] Speaker 04: That just wouldn't happen. [00:30:02] Speaker 01: No, but I'm just trying to figure out how to craft the hypothetical claim. [00:30:06] Speaker 01: Suppose isopropyl mirror state. [00:30:10] Speaker 01: has a brother. [00:30:11] Speaker 01: I don't even know what we'll call him, but he's got a brother. [00:30:14] Speaker 01: They're identical. [00:30:15] Speaker 01: Everybody knows these two are actually interchangeable. [00:30:19] Speaker 01: And suppose the brother of isopropyl meristate is disclosed in the prior art, such that if you were trying to assert your claims against a composition with not isopropyl meristate, but rather with its brother, that it would fall within the practicing the prior art issue. [00:30:37] Speaker 01: That would absolutely thwart you from doing so. [00:30:40] Speaker 01: Do you understand my hypothetical this time? [00:30:42] Speaker 01: Yes. [00:30:42] Speaker 01: So then, why should you be able to claim isoperable mirror state if it's exactly like this other one? [00:30:50] Speaker 01: I mean, in function, way, and result, they're identical. [00:30:55] Speaker 01: Why should you be able to go after, under the doctrine of equivalence, why aren't we considering whether or not isoperable mirror state is more like what's in the prior art when we're drafting that hypothetical claim? [00:31:07] Speaker 04: Well, it may be that if something's very, very similar to isopropyl myristate and we get the same result, that that would be a case that we would bring. [00:31:14] Speaker 04: But I don't know that anything like that exists. [00:31:16] Speaker 04: And I think we're dealing in a lot of hypotheticals or speculation that may not exist. [00:31:22] Speaker 04: And I understand, Judge Moore, your question, you want to know. [00:31:24] Speaker 01: Well, the problem is we've got to come up with a hypothetical claim. [00:31:26] Speaker 01: And so I'm in a universe where I actually have to come up with a hypothetical claim. [00:31:29] Speaker 04: Well, what I would suggest is that for the purposes of this case, we leave the hypothetical claims the district court concluded. [00:31:35] Speaker 04: And if there's another case, then the court deals with that particular case. [00:31:38] Speaker 01: And do you think, then, that this is just different than ranges? [00:31:40] Speaker 01: So let me ask you. [00:31:41] Speaker 01: Suppose that your claim covers 0% to 15% less than, and you want to go after someone under the doctrine of equivalence who's outside that range, and he's at 18%. [00:31:55] Speaker 01: Suppose the prior art discloses 16 and 17. [00:31:57] Speaker 01: Do you think it would be proper for your hypothetical claim, should it have to be, you'd have to fight the hypothetical claim from 0 to 18, or could you fight 0 to 15 and 18, with a hole in the middle for 16 and 17? [00:32:09] Speaker 04: No, no, no. [00:32:09] Speaker 04: On a range, I agree. [00:32:11] Speaker 04: If there's a range, and there were range cases that they cited, there was one range case, 5 to 25, and then the equivalent was 29.3. [00:32:19] Speaker 04: I agree in a range case, you go straight through to the range. [00:32:21] Speaker 04: But this is different because we have particular species that we're dealing with. [00:32:26] Speaker 04: But range cases, I think, are distinguishable. [00:32:29] Speaker 04: But I agree with you on how you'd analyze that. [00:32:36] Speaker 04: Thank you. [00:32:42] Speaker 03: Thank you, Your Honor. [00:32:44] Speaker 03: I want to emphasize that it's the other side's burden, the plaintiff's burden, [00:32:49] Speaker 03: to prove that the correct hypothetical link does not ensnare the prior art. [00:32:54] Speaker 03: And my friend said that the district court made a finding that DMSO, which is in the prior art, is different. [00:33:01] Speaker 03: It works differently than isoperable mirror state. [00:33:04] Speaker 03: Respectfully, there is no such finding. [00:33:06] Speaker 03: If you look at page A44 to A45, that's where the district court discusses DMSO. [00:33:11] Speaker 03: And what it's discussing is whether you would swap [00:33:14] Speaker 03: Isopropyl mirrors, whether you'd swap lecithin and triglycerides for DMSO. [00:33:18] Speaker 03: And the court says no, at least in part because lecithin and triglycerides were not known penetration enhancers. [00:33:23] Speaker 03: However, if you look at two things, 3197 of the appendix is the testimony of our expert that they're in the same class of chemical penetration enhancers. [00:33:32] Speaker 03: And 55-79-80 is a paper named Barry, which refers to DMSO having an effect on the stratum corneum lipids. [00:33:44] Speaker 03: Ultimately, we don't have to prove this. [00:33:45] Speaker 03: The other side had to prove that a correct hypothetical claim would not ensnare the prior art. [00:33:50] Speaker 03: And I think that the colloquy with Judge Moore is really quite revealing. [00:33:53] Speaker 03: And it illustrates the problem that my friend's view of hypothetical claims would have for [00:33:58] Speaker 03: generic, trying conscientiously to design around this very specific patented formulation that apparently, according to my friend, even a penetration enhancer that is in the prior art would not be safe if it was equivalent to the very specific excipients that they're claiming in this formulation. [00:34:15] Speaker 00: Tell me if I'm understanding the way that the arguments are being presented to us. [00:34:25] Speaker 00: The district court said the appropriate hypothetical claim is just put in isopropyl erystrate. [00:34:32] Speaker 00: You say, no, the appropriate hypothetical claim is any penetration enhancer. [00:34:38] Speaker 00: That leaves out a potential significant middle. [00:34:42] Speaker 00: And you don't make any argument that if there is [00:34:47] Speaker 00: Narrow or theory of equivalence like amphiphilic water soluble That that would ensnare the priority. [00:34:59] Speaker 00: You just don't make an argument like that and their testimony and in particular their post trial brief is [00:35:05] Speaker 00: rather strongly emphasized, I think at pages 29 and 30 of their post-trial brief, those features that are shared by your isopropyl meristrate and the lecithin. [00:35:18] Speaker 00: They didn't say that anything that would be a penetration enhancer would do it. [00:35:24] Speaker 00: But you haven't made an argument about that being an insufficient hypothetical. [00:35:32] Speaker 03: We do think that anything like what they advanced would ensnare DMSO and would therefore be invalid. [00:35:42] Speaker 03: And the two appendix references that I just gave you, Your Honor, would do that. [00:35:46] Speaker 03: I mean, our submission is that the district court used the wrong hypothetical claim. [00:35:50] Speaker 00: So it never resolved anything. [00:35:51] Speaker 00: Their argument about amphiphilic combined with water insolubility would, I think, not ensnare DMSO. [00:35:59] Speaker 00: Because DMSO, I think, is [00:36:00] Speaker 00: isn't the testimony highly water-soluble? [00:36:03] Speaker 03: I believe that that's right. [00:36:04] Speaker 03: The DMSO is not itself amphiphilic, but I don't believe that that's the theory that they, in fact, advance. [00:36:14] Speaker 03: For their hypothetical claim, nor did the district court resolve it. [00:36:18] Speaker 03: I mean, I think that the best illustration of this is the hypothetical claim used in Ultratex, in which the court did not take, and I believe this was conceded, [00:36:30] Speaker 03: The claim said wax-coated and the alleged equivalent was polyethylene-coated, but the hypothetical claim said waterproof. [00:36:42] Speaker 03: And I think that illustrates exactly what we're getting at here. [00:36:46] Speaker 03: What is the equivalence theory? [00:36:47] Speaker 02: Thank you. [00:36:48] Speaker 02: We thank both sides. [00:36:48] Speaker 02: The case is submitted.