[00:00:00] Speaker 01: We'll hear argument next in number 20-1273, pharmaceutical ink versus Tospira ink, Mr. Maloro. [00:00:10] Speaker 03: Thank you, Your Honor. [00:00:12] Speaker 03: May it please the court, Thomas Maloro for the appellant Tospira. [00:00:17] Speaker 03: The judgment from the district court of infringement of the patents in suit should be reversed. [00:00:24] Speaker 03: And I'll address two errors from the district court's ruling in my argument. [00:00:29] Speaker 03: First, the court improperly found that the 9 milligrams per milliliter of sodium chloride in Haspera's and the product meets the claim limitation of about 6 to 8 milligrams per milliliter of a tonicity regulating agent. [00:00:48] Speaker 03: Second, the court improperly found that Haspera is likely to sell a product that contains the claimed amount [00:00:57] Speaker 03: of transition metal complexing agent, that is 0.01 to 0.4 milligrams per milliliter. [00:01:08] Speaker 03: Starting with the tenacity regulating agent errors, in applying the claim limitation to the accused product, the district court ignored evidence which establishes that nine milligrams per milliliter cannot be within the scope of the claim. [00:01:26] Speaker 03: The 991 prosecution history confirms from PARZONE statements that 8.5 milligrams per milliliter is outside the scope of the range of about six to eight milligrams per milliliter. [00:01:43] Speaker 03: That can be found at appendix page 3958. [00:01:47] Speaker 03: The application that was at issue there, the 991, has the same disclosure [00:01:54] Speaker 03: with regard to tenacity regulating agent as his presence in the Pattinson suit. [00:02:01] Speaker 03: And that disclosure can be found at page 3674 of the appendix. [00:02:06] Speaker 02: Mr. Melora, this is Judge Toronto. [00:02:10] Speaker 02: What you're relying on now, this application, sounds rather like a basis for a claim construction argument, not so much [00:02:24] Speaker 02: Like a basis for an argument that a factual determination under the unchallenged claim construction It can go only one way so Can you can you address that? [00:02:41] Speaker 03: Yes, thank you honor and and to be clear we are we are not making a claim construction argument here we are [00:02:48] Speaker 03: We are disputing the court's analysis under the second prong of the infringement test, which is the application of the claim to the accused product. [00:02:58] Speaker 03: The word about was construed, agreed by the parties to mean approximately and the court purported to attempt to apply that construction. [00:03:12] Speaker 03: In applying that construction, of course, all relevant evidence ought to be used by the court in determining whether nine meets the limitation of about six to eight. [00:03:24] Speaker 03: And so this evidence is evidence that's relevant to whether the claim can extend to nine, because of course, if the claim can't extend to 8.5, [00:03:36] Speaker 03: then it can't extend to nine. [00:03:40] Speaker 02: But to get to the point of clear error, you have to get beyond saying that this would be relevant, right? [00:03:47] Speaker 02: That you have to get to the point that allows this court to say that the bottom line finding a fact, the application of the construction to the evidence is clearly erroneous, taking into account perhaps [00:04:05] Speaker 02: what you've been relying on but also the expert testimony of PAR. [00:04:13] Speaker 03: The court did commit clear error in this circumstance because if the claim can't extend to 8.5 and doesn't extend to 8.5, it can't extend to 9. [00:04:28] Speaker 03: And the prior art which taught 8.5 was prior art which in fact [00:04:34] Speaker 03: is physiologically compatible, which was the basis for the district court's ruling. [00:04:41] Speaker 03: There was a range of so-called osmolality that was specifically identified in the appendix by PAR at 3958 for the prior art. [00:04:53] Speaker 03: And that range is essentially the same. [00:04:57] Speaker 03: It's very similar to the range that PAR's expert identified. [00:05:02] Speaker 03: as physiologically compatible for his infringement analysis. [00:05:06] Speaker 03: So it's clear error to find that a claim can cover a nine milligram per milliliter because it's physiologically compatible, but can't cover 8.5 milligrams per milliliter, which is physiologically compatible. [00:05:21] Speaker 03: That's clear error that the court made in that application of the claim to the accused product. [00:05:28] Speaker 01: Let's put aside for the moment the prosecution history argument which may be only a claim construction argument and talk about the cohesive decision and the question of how the court is supposed to address the claim limitation about. [00:05:48] Speaker 01: And if I understand correctly from the cohesive decision, you have to focus here on the upper limit which would be eight. [00:05:57] Speaker 01: and talk about what the purpose of the upper limit is as opposed to the broader question of what the purpose of the invention is or the claim limitation is. [00:06:08] Speaker 01: And in reading the record here, I don't really see that either expert address the question of why there is a limit here of eight. [00:06:20] Speaker 01: which would be the necessary inquiry to figure out whether something satisfies the about limitation in this context. [00:06:29] Speaker 01: Could you address that? [00:06:30] Speaker 01: I don't think either the patentees expert or your expert really addressed that question. [00:06:38] Speaker 03: The patentees, I don't think that either expert, your honor, addressed why was eight chosen as the upper limit [00:06:47] Speaker 03: in the claim. [00:06:48] Speaker 03: That upper limit was part of the originally filed claims. [00:06:55] Speaker 03: The specification discloses that there are narrower or broader numerical ranges that were considered to be part of the invention. [00:07:04] Speaker 03: And the PAR expert didn't choose to really talk about the numbers at all, just talked about the function of physiological compatibility. [00:07:14] Speaker 03: It was Dr. Pinal, who was Haspera's expert, who talked about the stylistic context of the word about in a numerical range in a formulation like this. [00:07:26] Speaker 01: He didn't address the number eight as the reason for the upper limit either, right? [00:07:35] Speaker 03: He did not discuss the reason why eight was chosen. [00:07:37] Speaker 03: That's correct, Your Honor. [00:07:39] Speaker 03: He discussed what the word about does to a numerical range. [00:07:43] Speaker 03: of about six to eight. [00:07:46] Speaker 03: And his testimony was that that is something which serves to distinguish, as you're looking at the claim, the numerical range that's written down in the claim versus other numbers that are not literally within six and eight. [00:08:01] Speaker 03: And how far does the word about go to one skilled in the art? [00:08:05] Speaker 03: Or how does one skilled in the art look at the word about in applying that to an accused product? [00:08:12] Speaker 01: And could we maybe, since we have limited time, unless one of my colleagues has further questions about this issue, I want to bring you to the second issue. [00:08:23] Speaker 01: And that is whether the ANDA is infringing. [00:08:28] Speaker 01: And let's assume that we reject your contention that the ANDA didn't set an upper limit. [00:08:42] Speaker 01: Is the fact that the ANDA didn't seem to set a lower limit, that is 0.01, relevant in determining whether the ANDA infringes? [00:08:56] Speaker 03: Meaning that the ANDA didn't set that there had to be a minimum amount of, say, 0.01? [00:09:02] Speaker 03: Was that your question? [00:09:04] Speaker 03: Correct. [00:09:06] Speaker 03: Yes, Your Honor. [00:09:08] Speaker 03: Because it doesn't have a specification, that is an identified range of metals, therefore the ANDA doesn't answer the infringement question. [00:09:22] Speaker 03: And the Glaxo standard of what is the product that Haspera is likely to sell is the standard the court should apply here. [00:09:32] Speaker 03: And the evidence was the only evidence [00:09:36] Speaker 03: of what Haspera is likely to sell was the exhibit batches that Dr. Gockel examined and did his calculations on. [00:09:46] Speaker 03: And the even under parse theory of the case, trying to translate from metals to transition metal complexing agents. [00:09:54] Speaker 01: Let me interrupt you because I think you're not quite understanding the question I'm asking. [00:09:59] Speaker 01: I understand what your theory is. [00:10:02] Speaker 01: But I'm asking you to assume that [00:10:07] Speaker 01: by referencing this industry standard, the ANDA does set an upper limit for this transitional metal complexing agent. [00:10:22] Speaker 01: But the industry standard, as I understand it, doesn't set a lower limit. [00:10:29] Speaker 01: And the patent here does set a lower limit of 0.01. [00:10:33] Speaker 01: And I'm asking you, [00:10:37] Speaker 01: Is the failure to set a lower limit significant for purposes of determining infringement? [00:10:45] Speaker 03: Thank you, Your Honor, for clarifying. [00:10:48] Speaker 03: Let me try again. [00:10:49] Speaker 03: The claim, which has a lower limit and an upper limit, is a claim to a transition metal complexing agent. [00:10:59] Speaker 03: It's a component in the product. [00:11:01] Speaker 03: It's not the metals itself. [00:11:04] Speaker 03: It's, in this case, PAR argues citric acid. [00:11:07] Speaker 03: And for purposes of appeal, we're not contesting that they're going to argue citric acid. [00:11:12] Speaker 03: It's the amount of citric acid. [00:11:15] Speaker 03: And so there is no lower limit or upper limit of citric acid in Haspera's product, which acts as transition metal complexing agent. [00:11:28] Speaker 00: Citric acid. [00:11:29] Speaker 00: This is Judge Stoll. [00:11:30] Speaker 00: I hear where you're going with this, but I didn't think you challenged the methodology that was used based on the 30% upper limit to determine the amount of chelating agent or citric acid. [00:11:44] Speaker 00: So are you challenging that method now? [00:11:49] Speaker 03: No, Your Honor. [00:11:50] Speaker 03: On appeal, we are not challenging that if there were an upper limit of metals, [00:11:55] Speaker 03: Dr. Tost's calculation got him to an amount of citric acid that is within the claim. [00:12:02] Speaker 03: It rather is the fact that there's no specification for the amount of citric acid that is in the product as a transition metal complexing agent that yields inevitably to the Glaxo standard that the court must examine what is the product that Haspera is likely to sell. [00:12:24] Speaker 03: It has not specified the amount of transition metal complexing agent in its product. [00:12:30] Speaker 03: And therefore, Dr. Gokul, who examined the actual batches, examined the product that Haspira is likely to sell. [00:12:39] Speaker 03: And Dr. Tost, who is the PAR expert, admitted that he saw no evidence that the actual Haspira product contained anywhere near the level of metals that would be required to support his calculations. [00:12:55] Speaker 03: So I'm into my rebuttal time. [00:12:57] Speaker 03: If there are further questions, I'm happy to entertain them. [00:13:00] Speaker 03: Otherwise, we'll reserve the remainder of my time for rebuttal. [00:13:04] Speaker 01: All right. [00:13:04] Speaker 01: We'll give you the three minutes for rebuttal unless my colleagues have further questions. [00:13:10] Speaker 02: Nothing now. [00:13:10] Speaker 01: Thank you. [00:13:12] Speaker 01: OK. [00:13:13] Speaker 01: Thank you. [00:13:14] Speaker 01: Mr. Brown? [00:13:17] Speaker 04: Good morning, Your Honors. [00:13:19] Speaker 01: May I please leave the court? [00:13:21] Speaker 01: Could you start out by addressing the question [00:13:26] Speaker 01: that I was asking about this first issue and the cohesive case. [00:13:33] Speaker 01: As I understand the cohesive case, that would require an examination of the purpose of the eight, the upper limitation of eight. [00:13:46] Speaker 01: And that, in fact, we have a record here in which neither expert nor the district court [00:13:53] Speaker 01: asked what the purpose of the eight limitation is and related that to the question of nine falling within the about range. [00:14:05] Speaker 01: Did your expert address the reason for the upper limit of eight? [00:14:12] Speaker 04: Thank you, Your Honor. [00:14:14] Speaker 04: Our expert, Dr. Elder, he addressed the purpose [00:14:23] Speaker 04: I want to answer this as accurately as possible. [00:14:25] Speaker 04: He explained that there were two purposes for the about range, which is, as you add other ingredients to the formulation, the osmolality is a function of everything you put in. [00:14:40] Speaker 01: That's not the question I'm asking. [00:14:42] Speaker 01: He did address the purpose of the about limitation. [00:14:45] Speaker 01: But as I understand the cohesive case, it requires that you address the purpose of the upper limit of 8. [00:14:53] Speaker 01: And I don't see that your expert addressed that question. [00:14:56] Speaker 01: Tell me why I'm wrong about that. [00:15:00] Speaker 04: I think that that's implicit in his discussion about the fact that you're adding it on top of the other ingredients to the formulation to result in a physiologically acceptable tonicity. [00:15:17] Speaker 04: There's another important factor in the cohesive analysis. [00:15:20] Speaker 04: There are two things the court considered. [00:15:22] Speaker 04: which was the purpose and the criticality. [00:15:25] Speaker 04: In other words, in cohesive, they compared the limitation about 30. [00:15:29] Speaker 04: And that was critical in getting past prior art discussed in the specification that was around 20. [00:15:37] Speaker 04: And they said, well, below 23 points something or other, you don't get the function. [00:15:42] Speaker 04: So it was critical. [00:15:43] Speaker 04: The district court addressed the criticality here and said the tenacity regulating agent is not critical. [00:15:49] Speaker 04: The district court sat through four days of trial on invalidity challenge by Haspera and heard the inventors talk about all they had to do to solve the long-standing decades-old problem of instability of liquid formulations of epinephrine. [00:16:06] Speaker 04: And they did it by balancing things that weren't the tenacity regulating agent. [00:16:10] Speaker 01: They heard Dr. Zhang. [00:16:12] Speaker 01: Getting off the point that I'm asking about, and that is the question of whether there is any testimony [00:16:18] Speaker 01: as to the purpose of the eight upper limit. [00:16:22] Speaker 01: And what I hear you saying is that there is no such testimony, but that somehow it's implicit in the testimony. [00:16:28] Speaker 01: Am I correct about that? [00:16:31] Speaker 04: I believe it is implicit in his testimony that we cited in our brief that it's intended to encompass two factors, the addition of additional ingredients and the fact that you can have different tenacity regulating agents with different molecular weights. [00:16:49] Speaker 04: And so I think that is the purpose for the upper limit and the specification itself provides the purpose for the element. [00:17:01] Speaker 04: And I think given that combined with the finding on lack of criticality, in fact says that there isn't something critical and that's exactly what ABOUT was intended to encompass in that [00:17:17] Speaker 04: If you look further into the cohesive, the analysis they provide is essentially identical to a doctrine of equivalence analysis. [00:17:24] Speaker 02: This is Judge Taranto. [00:17:26] Speaker 02: Can I ask what may be a different question, a variation of the question, or the same question, I'm not sure, that at least implicit, maybe even explicit, I don't know, in an explanation of what the six to eight is doing [00:17:44] Speaker 02: and just tell me if this understanding is wrong, which it may well be, is that if you have less than that, you know, the cells will implode and if you have more than the upper range, they'll explode or vice versa. [00:17:58] Speaker 02: Is there something like that that is going on in your expert's explanation of the function of six to eight so that [00:18:13] Speaker 02: almost maybe implicitly, he is saying why not to go above eight? [00:18:23] Speaker 04: Yes, Your Honor. [00:18:24] Speaker 04: And so he explained, and it was the vice versa, if you get too low of tonicity, your cells explode. [00:18:31] Speaker 04: If you get too high, they shrink. [00:18:34] Speaker 04: And when you put other ingredients in before you put in the tonicity regulating agent, those other ingredients increase the tonicity. [00:18:41] Speaker 04: So the more other ingredients you put in, [00:18:43] Speaker 04: then you're going to adjust your tenacity regulating agent accordingly. [00:18:47] Speaker 04: And so that is the purpose of the range is to provide a physiologically acceptable tenacity. [00:18:55] Speaker 04: And it's important here, I want to emphasize the court's finding on criticality, however, because that becomes very important. [00:19:03] Speaker 04: You don't want to penalize a patentee or allow or truncate about with respect to the least important limitations. [00:19:11] Speaker 04: And here there was an extensive record on the other limitations being critical and this one not being critical. [00:19:16] Speaker 01: That's not the question. [00:19:18] Speaker 01: That's not the question. [00:19:20] Speaker 01: The question is about the eight limitation, not about whether this particular overall claim limitation is important or unimportant. [00:19:30] Speaker 01: And so I don't see that there's any testimony about whether the eight limitation is critical or not critical in terms [00:19:39] Speaker 01: of the statistically regulating agent. [00:19:49] Speaker 04: Your Honor, I think with respect to the criticality testimony that was at trial, there was extensive evidence that went into that. [00:19:59] Speaker 04: And in particular, the submission of [00:20:06] Speaker 01: the waiver request by Haspera to the FDA focused on a comparison to our- But there's no testimony, can you show me any testimony in which the criticality or relevance of the eight limitation is discussed by your expert? [00:20:23] Speaker 01: I don't see it. [00:20:25] Speaker 01: Am I missing something? [00:20:27] Speaker 04: He talked about the entirety of the range. [00:20:30] Speaker 04: He talked about the entirety of the range in [00:20:35] Speaker 04: in his testimony, what the function of the about six to eight, the entirety of the numerical range. [00:20:41] Speaker 04: I do not interpret cohesive as requiring specific testimony regarding the specific end point. [00:20:53] Speaker 04: They focused on it because that's where the criticality lie and the transition went into the criticality of the element. [00:20:59] Speaker 04: Here, there's not a criticality of the end of the range. [00:21:03] Speaker 04: The Dr. Elder testified that as you go up, it's not like going off the deep end of a pool. [00:21:10] Speaker 04: It's a gradual change in tenacity until you get to a point where you're too high. [00:21:14] Speaker 04: And so he said it's a gradual effect and that the eight was, he didn't call out the number eight specifically, but that's because there's no criticality to that number. [00:21:27] Speaker 04: And his testimony clearly establishes that point and makes the district court's fact finding [00:21:32] Speaker 04: clearly supportable under the clear error standard. [00:21:36] Speaker 00: This is Judge Stoll. [00:21:38] Speaker 00: I think you mentioned, I think you said Dr. Elder's testimony, at least that's what I was looking at for this. [00:21:44] Speaker 00: Are you, just to make sure I understand exactly where you're pointing to, are you pointing to pages, around pages A157, 158, or where else are you pointing to for your reliance on the fact that he, or where you're saying that he discussed [00:22:01] Speaker 00: you know, the criticality of the range and saying that you could go outside of the scope of 6 to 8 in order and still not have imploding or exploding. [00:22:12] Speaker 04: So the citation I have as appendix pages, I think I have 155 to 161 and 214 and 215. [00:22:25] Speaker 04: Let me just check those quickly. [00:22:36] Speaker 04: The first citation I had of 155 to 161, that is direct examination. [00:22:52] Speaker 04: For example, on page 158, [00:22:58] Speaker 04: The question is, is there a specific cutoff number for isotonicity? [00:23:02] Speaker 04: Not specifically. [00:23:03] Speaker 04: I mean, the range cited in the literature is 225 to 350, but that doesn't mean that at 224 all the blood cells will begin bursting or shrinking above 350. [00:23:12] Speaker 04: It's a gradient that some of the cells will be more sensitive to than others, and also the time of exposure will play a role. [00:23:19] Speaker 04: So we use the range that's typically cited in these references [00:23:22] Speaker 04: and as the range we shoot for in developing isotonic formulations. [00:23:25] Speaker 04: And so the tonicity that he's citing there is a function of how much of the tonicity regulating agent you have added to the formulation. [00:23:37] Speaker 04: And so that is in his discussion of the purpose of the claimed range. [00:23:43] Speaker 04: And then similarly on 214 and 215, I believe that's in the cross-examination. [00:23:58] Speaker 04: and I don't see that as relevant. [00:24:02] Speaker 04: It's, again, talking about the function, though, and the criticality of the tenacity element and the purpose of it. [00:24:10] Speaker 02: Okay, thank you. [00:24:12] Speaker 02: This is just Toronto... Oh, I'm sorry. [00:24:14] Speaker 02: I was going to change the subject to the other issue that was raised by Mr. Moloro, if I could. [00:24:22] Speaker 02: So, as I understand the issue there, [00:24:28] Speaker 02: The ANDA let's say by assumption says we are not going to go above 30% of these particular kinds of metal impurities and so, but we can go up to 30% and if we can go up to 30% I think your expert said we can then quickly calculate how much of the citric acid will act as a chelating agent for those. [00:24:58] Speaker 02: And that puts you into the claimed range of the chelating agent. [00:25:03] Speaker 02: I understood that Mr. Meloro's response to that was that the Glaxo decision says, don't look at what the ANDA permits you to do, but what the product is likely to be. [00:25:21] Speaker 02: And the evidence is that what the product is likely to have [00:25:26] Speaker 02: is something very much below the 30%, which would then translate into too small amount of the citric acid as a chelating agent. [00:25:37] Speaker 02: If that understanding is right, maybe you can correct me in my understanding of what the argument is, but what is your response, including about the Glaxo standard? [00:25:49] Speaker 04: Certainly. [00:25:49] Speaker 04: I believe you have correctly, Your Honor, I believe you've correctly summarized Hussbeer's argument in the case. [00:25:57] Speaker 04: And here, we think that the court's subsequent Sunovion decision controls for several reasons. [00:26:05] Speaker 04: And Sunovion explained the Glaxo decision specifically. [00:26:10] Speaker 04: And in Sunovion, this court held as a matter of law that a defendant and a product specification that had a range of, I think, less than 0.6 [00:26:26] Speaker 04: infringed as a matter of law a claim requiring less than .25 of a particular thing and said that you did not get to come in and try to show a likelihood scenario when your ANDA request encompassed the claimed range. [00:26:51] Speaker 04: And that's precisely what we have here. [00:26:53] Speaker 04: And in fact, in this case, we argued. [00:26:55] Speaker 04: We tried to get the very samples that Haspira tested. [00:26:58] Speaker 04: Haspira came into court and explicitly argued, synovian is all you need to look at in this case. [00:27:05] Speaker 04: You do not need to look at the actual batches. [00:27:08] Speaker 04: You do not need testing from these batches. [00:27:10] Speaker 04: And the court made a fact finding. [00:27:14] Speaker 04: It's on appendix page 39. [00:27:15] Speaker 04: First of all, the court found that the metal content [00:27:20] Speaker 04: was variable and not subject to control? [00:27:22] Speaker 01: I think you're getting off point here. [00:27:24] Speaker 01: Forget about the testing. [00:27:26] Speaker 01: I think the question that Judge Toronto is asking, and the question that I have also, is are we under Sinovian here in terms of the ANDA itself? [00:27:38] Speaker 01: And Sinovian does seem to be different in the sense that the limitation is less than a certain amount, whereas this patent has a range between x and y. [00:27:50] Speaker 01: And even accepting your argument that industry standard translates into the upper range being permitted by the ANDA to be within the patented range, I don't see that there is anything in the ANDA which sets a lower range that would satisfy the lower range of the patent. [00:28:15] Speaker 01: Could you address that, please? [00:28:20] Speaker 04: The basis for Synovian, Your Honor, is simply if the ANDA range encompasses the claimed range. [00:28:27] Speaker 04: There's no importance given that I can see to the idea of an upper or lower. [00:28:34] Speaker 04: The ANDA in Synovian had a broad range, and the patent had a narrower subset of that. [00:28:40] Speaker 04: Here we have the same thing. [00:28:41] Speaker 04: The ANDA has a range of 0 to 30%. [00:28:46] Speaker 04: a range that overlaps with that. [00:28:52] Speaker 04: They are allowed, if they are approved, that is the holding of Synovian. [00:28:55] Speaker 04: If they are approved, they are allowed to sell a product that falls within the claim. [00:28:58] Speaker 04: That is infringement as a matter of law under Synovian. [00:29:00] Speaker 04: Thank you, Your Honors. [00:29:03] Speaker 01: Okay, any further questions? [00:29:06] Speaker 01: Okay, hearing none, let's go back to Mr. Malora who has three minutes for rebuttal. [00:29:14] Speaker 03: Thank you, your honor. [00:29:15] Speaker 03: Uh, starting with the Sanobian issue that the court was just asking about, uh, Sanobian endorses that where the ANDA does not reveal whether the product will infringe, Glaxo is the standard. [00:29:31] Speaker 03: And here the ANDA does not reveal whether Haspera's product will infringe. [00:29:38] Speaker 03: And as the court pointed out the range [00:29:41] Speaker 03: that's set in the patent claim for transition metal complexing agent, it's not found in the ANDA, nor even using metals as a proxy would one find that there is a revelation in the ANDA that the product will infringe. [00:30:01] Speaker 03: There's a lower and upper bound to the claim. [00:30:04] Speaker 03: And yet, all the ANDA says is that there were tests done that showed very low levels, and therefore, there's no need to test the product as it's released that commercial batches are made because these levels are so low that the product that House Bureau is likely to sell will not be subject to any drug product testing. [00:30:31] Speaker 03: So here, essentially, Sinovian says Glaxo is still good law. [00:30:36] Speaker 03: It's just that where the ANDA reveals that there will be infringement or non-infringement, then that will control. [00:30:46] Speaker 03: But we don't have that situation in this case. [00:30:49] Speaker 03: Just as an aside, the samples issue was really a red herring at best. [00:30:54] Speaker 03: The samples were being sought for something else, never sought for metals. [00:30:59] Speaker 03: the synovian argument that was at issue there had to do with other impurities, and there was never a request to test for metals because the tests had already been done and reported, and those were the tests that Dr. Gockel had used. [00:31:15] Speaker 03: As far as the... Mr. Maloro? [00:31:18] Speaker 00: Yes. [00:31:19] Speaker 00: I wanted to ask you a question. [00:31:21] Speaker 00: Am I able to look at your ANDA, and I see that there's that, you know, arguably a judge [00:31:29] Speaker 00: Dyke asked you earlier to assume the engine does set an upper limit of 30%. [00:31:33] Speaker 00: Is it fair for me to assume a lower limit of zero? [00:31:40] Speaker 03: There are metals in the Hespera product, and so I don't think it's fair to assume a lower level of zero. [00:31:49] Speaker 03: There were metals that were seen, there were metals that will always be in the product, [00:31:54] Speaker 03: And so there was no lower limit established for what they could go below. [00:31:59] Speaker 03: So I think factually, zero would not be an appropriate lower limit. [00:32:06] Speaker 00: And then the alternative is that if the upper limit is 30, then does there really have to be a range in the ANDA, or is it sufficient that the ANDA would allow some amount of range that falls within the claim, or even if it's single? [00:32:22] Speaker 03: We would, of course, dispute that 30 is an upper limit, but because there is nothing on the lower end than the Glaxo standard of what is hospital likely to sell should be the analysis in our view. [00:32:40] Speaker 01: Okay. [00:32:41] Speaker 01: Thank you. [00:32:42] Speaker 01: Okay. [00:32:42] Speaker 01: Any further questions? [00:32:44] Speaker 02: Nothing for me. [00:32:45] Speaker 02: Thank you. [00:32:47] Speaker 01: Okay. [00:32:47] Speaker 01: Thank you, Mr. Maloro. [00:32:48] Speaker 01: Thank you, Mr. Brown. [00:32:50] Speaker 01: The case is submitted.