[00:00:01] Speaker ?: Thank you. [00:00:37] Speaker 00: Next case is Roxanne Laboratories versus Canberra Pharmaceuticals and Invergen, 2014, 1803. [00:00:46] Speaker 00: Mr. Shuler. [00:00:49] Speaker 04: May it please the court. [00:01:04] Speaker 04: Ken Shuler on behalf of Roxanne Laboratories. [00:01:07] Speaker 04: We're here because the district court committed three fundamental errors in the course of denying Roxanne's motion for preliminary injunction relating to Imogen's ongoing sales of its near-identical version of Roxanne's patented calcium acetate capsule product. [00:01:24] Speaker 04: First, the district court erroneously concluded that Imogen had raised a substantial question on the merits. [00:01:30] Speaker 04: But that conclusion was predicated on an erroneous claim construction analysis. [00:01:35] Speaker 04: one that was error both methodologically and substantively. [00:01:40] Speaker 04: Methodologically, the district court ignored the fact that the term size 00 that we have here is one of a technical term that needs to be construed from the perspective of a person with ordinary skill in the art, not from the perspective of a layperson. [00:01:54] Speaker 04: When we start with the intrinsic evidence, there's no special definition of that term in either the patent or the file district. [00:02:02] Speaker 04: So we have to ascertain the ordinary meaning of that term to the skilled artisan. [00:02:07] Speaker 04: Not only did the district court ignore the fact that sign zero zero is a term of art, it effectively asked for affirmative proof from Roxanne that the patentee had used the term according to its ordinary meaning. [00:02:19] Speaker 04: But that stands plain construction on its head. [00:02:21] Speaker 01: In the art, is the size of a capsule defined or determined by its diameter [00:02:31] Speaker 01: or let's say it's size or it's feelability, it's the quantity that it can contain. [00:02:40] Speaker 04: They're interrelated concepts, but the evidence from Dr. Park was that in the human pharmaceutical context, size is something that refers to a common diameter. [00:02:51] Speaker 04: It's related to swaddleability, which is- Was there evidence, direct evidence of that? [00:02:55] Speaker 04: Yeah, let me walk you through the size. [00:02:58] Speaker 04: So Dr. Park, [00:03:01] Speaker 04: extensively detailed to a person with an ordinary skill in the field at the time. [00:03:05] Speaker 04: The phrase capital with this size 00 refers to all capsules designated as 00, including 00EL, because they share a common diameter. [00:03:14] Speaker 04: That's at 82475 to 78 at paragraphs 8 to 11. [00:03:19] Speaker 04: To get a little more technical, Your Honor, the evidence indicates that a person with an ordinary skill in the art would understand that dimension that relates to swallowability is the diameter. [00:03:31] Speaker 04: Again, 2475 at paragraph 9. [00:03:34] Speaker 00: Mr. Schuler, this is on denial of a preliminary injunction. [00:03:39] Speaker 00: The court didn't really construe the claim, as I understand it. [00:03:44] Speaker 00: And there's a very high standard of review on preliminary injunction denial. [00:03:49] Speaker 00: And so if we affirm, you go back and you try your case and what the claim means. [00:03:55] Speaker 00: Why isn't that the best course for us to follow, given the standard of review? [00:04:00] Speaker 04: Well, Your Honor, we think that this case is like ARIA diagnostics in which when a denial of preliminary injunction is based upon the predicate that the defendant has raised a substantial issue that goes to the merits, but when that is predicated on an erroneous preliminary claim instruction, that is an error of law that needs to be reversed and remanded. [00:04:21] Speaker 00: Well, did the court make an erroneous claim construction, or did the court say, number one, I'm not construing it, and number two, there hasn't been shown to be a likelihood of success? [00:04:33] Speaker 04: I think it was the former, Your Honor, and I think that that's actually part of the error. [00:04:38] Speaker 04: I think that even at a preliminary stage, the court has to discern the ordinary meaning of technical terms like size 00. [00:04:45] Speaker 03: But maybe the judge finally decided he needed more [00:04:51] Speaker 03: evidence needed to do an evidentiary hearing on that. [00:04:54] Speaker 03: I mean I guess the question is here you have something to point to but the other side also has something to point to. [00:05:03] Speaker 03: Like for example the Lightfoot article that was part of the prosecution history so technically is part of the intrinsic evidence. [00:05:12] Speaker 03: When you look at that Lightfoot article there's a table in there that makes it pretty clear that capsule size [00:05:20] Speaker 03: 00 is different from capsule size 00EL. [00:05:25] Speaker 03: Now I'm not sitting here saying that must be definitive and dispositive here, but it is evidence on the other side. [00:05:39] Speaker 03: And then there's another manual excerpt in the record that was submitted by the other side that shows again a differentiation between [00:05:49] Speaker 03: capsule size 00 and capsule size 00EL. [00:05:53] Speaker 03: So I could see from the district court's point of view why he was troubled in trying to understand what does this term mean to one of ordinary skill in the art when there's evidence pointing like this. [00:06:07] Speaker 03: So why is he going to grant a preliminary injunction? [00:06:12] Speaker 04: Well, let me talk about one methodological point and then I'll come to the light foot. [00:06:18] Speaker 04: reference, because I think that it actually goes the other way. [00:06:21] Speaker 04: But the methodological point is that the district court understood and acknowledged that Roxanne had proffered substantial evidence relating to the fact that a person with an ordinary skill in the art would construe the term in the manner we propose, but rejected and refused to consider that evidence on the ostensible basis that that's the wrong place to start claim construction. [00:06:42] Speaker 04: But as this court said in Phillips, [00:06:45] Speaker 04: The understanding of a person of ordinary skill in the art, the manner in which they understand a claim term, provides an objective baseline from which to begin claim construction. [00:06:55] Speaker 04: So our concern is that the district court did not even begin the analysis with the right frame of reference. [00:07:02] Speaker 04: That's the fundamental area. [00:07:03] Speaker 04: Because once you ground yourself in the science, in the specialized technical terms that issue, you understand that Lightfoot and all the other references point to a single ordinary meat [00:07:15] Speaker 01: And your fear is that the court is stuck with that understanding, that perception? [00:07:21] Speaker 04: Well, our fear is that the methodology was pretty clear. [00:07:24] Speaker 04: I mean, the court was making references to things like the claim language being in the context of pharmaceutically acceptable capital. [00:07:32] Speaker 04: The court said that that's just a tangent. [00:07:35] Speaker 04: But it's not a tangent. [00:07:36] Speaker 04: As Philip says, the manner in which a claim term is used in the context of the claim itself is often highly instructive. [00:07:42] Speaker 01: As Judge O'Rourke said, don't you now have the opportunity to go back and to show what one skill in the art would define as the differences in the capsules? [00:07:52] Speaker 04: And we certainly, you know, we'll attempt to do that. [00:07:54] Speaker 04: The question today is, given the clear errors, both methodologically and substantively, that the district court committed, we're entitled to more than that. [00:08:03] Speaker 04: We're entitled to a remand with instructions that they have not raised a substantial question on accountability. [00:08:09] Speaker 04: And should I come back to your question about Lightbook? [00:08:11] Speaker 04: So Lightfoot is not inconsistent with the Ordinary Meeting for a number of reasons. [00:08:15] Speaker 04: The first is Dr. Park considered it and explained that to a person with ordinary skill in the art, they would understand that there's only eight capsule sizes. [00:08:23] Speaker 04: There's a number of references that we offer that indicate that. [00:08:26] Speaker 04: And given that, that chart would show 12. [00:08:30] Speaker 04: But the person, including the treatise from Banker, say there's only eight. [00:08:34] Speaker 04: So that's the first point. [00:08:35] Speaker 04: The second point is [00:08:37] Speaker 04: they would know that those 0000EL capsule references are actually one size. [00:08:43] Speaker 04: They're versions of the same size. [00:08:46] Speaker 04: The third point is that Lightfoot was before the board. [00:08:49] Speaker 04: And as you recall, the board's decision indicates that there's only one larger capsule size that is outside the scope of the claims. [00:08:56] Speaker 04: The last line of their opinion says that size 000 is not within the ambit of the claims. [00:09:01] Speaker 03: Didn't your side argue something like, [00:09:06] Speaker 03: You know, with this amendment, it's clear that outside the scope of this claim is size 000 for example, period. [00:09:16] Speaker 03: Yes. [00:09:17] Speaker 03: There's a line in your prosecution that says it like that, right? [00:09:21] Speaker 03: Which potentially suggests that beyond size 000 there can be and is something else also excluded from the scope of the claim. [00:09:31] Speaker 04: What would that be? [00:09:32] Speaker 04: That would be A323. [00:09:33] Speaker 03: Right, but no, what would that other size be besides size 000? [00:09:40] Speaker 04: The sizes are depicted at A323 and those are veterinary sizes that start, I think, at size 7. [00:09:46] Speaker 04: And so the person with an ordinary skill in the art would understand they're making clear that this is for human oral administration, first of all, and it has to be acceptable for swallowing because it was, that was what Ms. [00:09:58] Speaker 04: Urazie said or Dr. Urazie said in her declaration. [00:10:01] Speaker 04: So the Durgin reference, which is before the court, indicates that triple zeros typically can't be swallowed by Hughes. [00:10:10] Speaker 00: Actually, the claim says more than just size zero zero. [00:10:14] Speaker 00: It says size zero zero or less, meaning toward minimization. [00:10:22] Speaker 00: So the court wasn't so clearly wrong in saying that the elongated version probably wouldn't be included. [00:10:30] Speaker 04: Probably wouldn't. [00:10:31] Speaker 04: wouldn't be included. [00:10:33] Speaker 04: Well, I think that that's just an assumption that, again, is not grounded in the perspective of the person of ordinary skill in the art. [00:10:39] Speaker 04: Dr. Park's declaration was unrebutted. [00:10:41] Speaker 04: He's the only person that spoke to what's the perspective of a person of ordinary skill in the art. [00:10:46] Speaker 04: And his opinions were well-grounded in the independent references. [00:10:49] Speaker 04: The Durgeon reference, for instance, Your Honor, says triple zeros are not typically swallowable, but those in the size zero-zero family are. [00:10:59] Speaker 04: The context in which the claim language appears, pharmaceutical acceptable capsules, said capsule that is size 00, is exactly the type of language that is of inclusion. [00:11:10] Speaker 04: For instance, if I were to say a shoe that is size 10, people would understand that it would include a size 10 wide. [00:11:18] Speaker 04: A size 10 e-shoe is one that is size 10. [00:11:22] Speaker 04: And that language was ignored by the district court. [00:11:25] Speaker 04: The context in which it appears [00:11:26] Speaker 04: pharmaceutical acceptable, meaning swallowable, and the extrinsic evidence indicating that size 00EL, the Health Caps USA reference says size 00EL capsules are a great swallowable alternative. [00:11:40] Speaker 00: If I can swallow a capsule that's long, that's that long. [00:11:46] Speaker 00: If it's elongated, it might be a different story. [00:11:50] Speaker 04: Actually, Your Honor, the Jones reference, which is at 2629, says that that's not true. [00:11:55] Speaker 04: It's an interesting phenomenon. [00:11:56] Speaker 04: We reorient the capsule in our tongue so that the length is not a problem. [00:12:00] Speaker 04: It's much the way we can slurp down spaghetti, for instance. [00:12:03] Speaker 04: The dimension that impacts swallowability is diameter, and that's what Dr. Park explained, and that's what the DIRJ, the... You seem to point to support your position. [00:12:13] Speaker 01: You point to different portions of specification, for example. [00:12:16] Speaker 01: When I look at that, I don't see that the [00:12:21] Speaker 01: specification directs itself to size and diameter, but rather in field capacity. [00:12:27] Speaker 01: It talks about doses and the amount of content that a particular field can take or capsule. [00:12:37] Speaker 01: Isn't that significant? [00:12:41] Speaker 04: The size of a capsule does have some relation to how much can be filled into it, but the [00:12:47] Speaker 04: As we indicated in our reply brief, one of our nurses from the ARC would do the math, would readily do the math and show that the experiment that Ms. [00:12:54] Speaker 04: or the Dr. Erezzi did, for instance, would not exclude a double zero EL because that would likewise not have resulted in the claim to fill them out. [00:13:03] Speaker 04: So you're right. [00:13:04] Speaker 04: The claim to fill them out, there's a portion of the claim says 667 milligrams on an anhydrous basis. [00:13:10] Speaker 04: Another part of the claim says, in a pharmaceutically acceptable capsule, said capsule, that is size 00. [00:13:17] Speaker 04: So we still have to determine what the ordinary meaning of 5-0-0, which is a technical term in this field, is to a person of ordinary skill. [00:13:24] Speaker 03: Do you have 8-21-01 with you right now? [00:13:27] Speaker 03: 21-01? [00:13:27] Speaker 03: 21-01. [00:13:34] Speaker 03: There's a table in the lower right-hand corner on that page. [00:13:40] Speaker 03: Yes. [00:13:41] Speaker 03: And completely consistent with the table in Lightfoot at 8-3-86, [00:13:47] Speaker 03: This table at A2101 shows for various capsule sizes. [00:13:53] Speaker 03: There's a capsule size 000, and then there's a capsule size 00EL, and then there's a capsule size 00, capsule size 00EL, capsule size 0. [00:14:05] Speaker 03: This table, this reference, seems to strongly suggest that there's a difference in understanding about capsule size 00 and capsule size 00EL. [00:14:18] Speaker 03: which is, I'm not one of ordinary skill in the art, but I can read a table just like I can read the Lightfoot table, which is what your client relied on in prosecution history. [00:14:31] Speaker 03: Now you have Dr. Park, I guess, saying both Lightfoot and this other manual is off the mark, but nevertheless, how can we ignore these tables? [00:14:45] Speaker 04: So, Your Honor, the key, I think, is that [00:14:48] Speaker 04: The banker reference A2539 and other references of A2597 and 2630 indicate that there are eight capsule sizes. [00:14:57] Speaker 04: If you read this table as if 00EL is a separate capsule size, there's 12. [00:15:03] Speaker 04: But everybody agrees there's eight. [00:15:05] Speaker 04: So that's the background. [00:15:06] Speaker 03: I don't know if everybody agrees with that because Lightfoot doesn't and A2101 doesn't either. [00:15:12] Speaker 03: Right above the table it says table one lists the capsule sizes on the market [00:15:17] Speaker 03: and their respective filling capacity. [00:15:19] Speaker 03: And then it shows a whole bunch of different capital sizes, including 00EL different from 00. [00:15:27] Speaker 04: When I say everyone, I guess what I'm saying is it was unrebutted that Dr. Park's testimony was that those of skill in the art know there are eight. [00:15:34] Speaker 04: That is grounded in several references, including Banker, which is a treatise. [00:15:39] Speaker 04: So that's the first point. [00:15:40] Speaker 04: The second point is [00:15:42] Speaker 04: that the vital products brochure, which is at page 27 of our opening brief, visually depicts 00 and 00EL being together. [00:15:50] Speaker 04: They're versions of the same capsule size. [00:15:53] Speaker 04: The Health Caps USA reference, which is at 2614, literally says, 00EL is an elongated version of size 00. [00:16:03] Speaker 04: So that evidence indicates to a person with skill in the art, the eight and the versions indicates that, and Dr. Park's unroboted testimony, that that's the way that [00:16:12] Speaker 04: one of ordinary skill in the art would understand this, that these are interrelated versions tells one of skill in the art that this really was clear error, both substantively and methodologically. [00:16:22] Speaker 00: Surely your time has just about expired, but we'll give you two minutes back for rebuttal if you need it. [00:16:29] Speaker 00: Mr. Silver. [00:16:30] Speaker 02: Thank you. [00:16:31] Speaker 02: May it please the court that my name is Robert Silver on behalf of Appellees with me, Sal Guerrero. [00:16:37] Speaker 02: Your Honor, I submit that [00:16:39] Speaker 02: Roxanne has not overcome an extremely heavy burden on reversing or denial of a preliminary injunction. [00:16:46] Speaker 02: You must overcome both factors. [00:16:49] Speaker 02: Roxanne says there were nine legal errors in a 14-page opinion, and I'm thankful Judge Chesler didn't write a longer opinion. [00:16:57] Speaker 02: I'm perplexed by their arguments about what they say Judge Chesler did with the intrinsic and extrinsic evidence. [00:17:04] Speaker 02: Page 11 of their brief, the court refused to consider Roxanne's intrinsic evidence. [00:17:09] Speaker 02: Page 17, the court failed to consider the extrinsic and intrinsic evidence. [00:17:14] Speaker 02: Page 20, the court dismissed Roxanne's ample extrinsic evidence. [00:17:19] Speaker 02: Page 25, the court summarily dismissed the extrinsic evidence. [00:17:24] Speaker 02: Their reply, the court ignored the extrinsic evidence altogether. [00:17:28] Speaker 02: But what Judge Chesler merely said is, Roxanne, you're starting in the wrong place. [00:17:34] Speaker 02: You're starting with extrinsic evidence, [00:17:37] Speaker 02: when you have to start with the intrinsic evidence. [00:17:40] Speaker 02: And the reason they started with it is because there's nothing in the intrinsic evidence that supports the position. [00:17:46] Speaker 01: Judge Chesler held as a fact that... You're referring to the claim construction process, correct? [00:17:52] Speaker 01: Correct. [00:17:53] Speaker 01: Was there claim construction in this instance? [00:17:56] Speaker 02: I believe there was, Your Honor, because what he said on page A5, footnote 3, he says he weighed the intrinsic and extrinsic evidence. [00:18:06] Speaker 02: And he said, again, the intrinsic carries greater weight, but the court notes what is absent from Roxanne's extrinsic evidence is an independent reference showing a usage of the term, quote unquote, size 00 to refer to a size 00 EL capsule. [00:18:23] Speaker 02: And he came to what I believe is a preliminary claim construction when you look at A12. [00:18:29] Speaker 02: And he says, he found that the claim term capsule that is size 00 means one specific capsule, namely a size 00 capsule and not a family of capsules that includes 00EL. [00:18:43] Speaker 02: And that is further elaborated upon in pages A6 through 7. [00:18:48] Speaker 02: Now, I believe that [00:18:52] Speaker 02: First of all, I dispute the fact that Dr. Park's testimony was unrebutted. [00:18:57] Speaker 02: We had our expert, Dr. Goldberg, give a very lengthy declaration. [00:19:04] Speaker 02: And on page 1484, paragraph 62 of his declaration, he said there was a substantial difference between 00EL than 00 because it had a 12% greater fill capacity than the 00. [00:19:22] Speaker 02: And he went on to elaborate a great length. [00:19:25] Speaker 02: And I want to explain to you why Dr. Park's testimony about diameter and swallowability being completely irrelevant. [00:19:32] Speaker 02: Now, Judge Chen cited to the Stegman reference, and you referred to A2101. [00:19:38] Speaker 02: But when you look at 2108 of that reference, and that's a 2002 article, it's not litigation-induced. [00:19:45] Speaker 02: It's prior art to the 032 patent. [00:19:48] Speaker 02: It says specifically, [00:19:49] Speaker 02: Swallowability depends upon size, shape, surface area, and structure. [00:19:57] Speaker 02: Roxanne says on page 20 here in three of their brief, length is irrelevant. [00:20:02] Speaker 02: That's what Dr. Park says. [00:20:04] Speaker 02: Now let's imagine imaginary capsule and take his argument to the absurd level. [00:20:10] Speaker 02: Make a capsule that's the diameter of Roxanne's capsule and make it six feet long. [00:20:18] Speaker 02: Under his theory that length doesn't matter, Roxanne's theory that doesn't matter, you could swallow that six foot length capsule because the only thing that matters is diameter. [00:20:27] Speaker 02: That's utterly absurd. [00:20:28] Speaker 02: Unless you're a sword swallower or a giraffe, you would not be able to swallow that. [00:20:34] Speaker 02: So to come out and say that just diameter matters is contrary to the extrinsic evidence and it shows. [00:20:42] Speaker 02: I mean, there was an admonition in the Phillips case. [00:20:45] Speaker 02: The specification is usually dispositive in claim construction and is the single best guide to the meaning of a disputed term. [00:20:52] Speaker 02: It is usually dispositive. [00:20:55] Speaker 02: Unsupported expert testimony should be discounted if at odds with the claim construction mandated by the intrinsic evidence. [00:21:04] Speaker 02: It's less reliable. [00:21:05] Speaker 02: It's biased. [00:21:06] Speaker 02: It's created for litigation. [00:21:08] Speaker 02: It's conclusory. [00:21:10] Speaker 02: Unsupported expert allegations are not useful to the court. [00:21:14] Speaker 02: And the bias is exacerbated if there is no cross-examination. [00:21:18] Speaker 02: Here, there was no cross-examination. [00:21:20] Speaker 02: We did give the counter-declaration of Dr. Goldberg, but there was no cross-examination at the preliminary injunction because there were no live witnesses. [00:21:29] Speaker 02: Now, I'd like to point out to you other reasons why I find Dr. Park's testimony incredible. [00:21:34] Speaker 02: In A2490, he talks about this exhibit, the FDA guidance on swallowability. [00:21:43] Speaker 02: Well, first of all, he makes it sound like it's FDA gospel. [00:21:47] Speaker 02: He doesn't tell the court. [00:21:48] Speaker 02: It's only a draft. [00:21:49] Speaker 02: If you look at the front page of that FDA guidance, it says draft for comments only. [00:21:54] Speaker 02: Secondly, it's from 2013. [00:21:57] Speaker 02: What does the 2013 article tell a person of ordinary skill in the art in 2005 about swallowability, which Judge Chesler found to be an unsubstantiated peripheral bulge tangent? [00:22:14] Speaker 02: We showed numerous usages where there were larger sizes than 00. [00:22:19] Speaker 02: They claim that you can only swallow a 00. [00:22:22] Speaker 02: Obviously, you can swallow 00EL. [00:22:26] Speaker 02: In the Goldberg Declaration, he showed a picture of a 000 nutraceutical. [00:22:33] Speaker 02: Dr. Park countered that when he said his counter to that was, well, that's a nutraceutical. [00:22:38] Speaker 02: That's not a pharmaceutical for human use. [00:22:40] Speaker 02: So what? [00:22:42] Speaker 02: If your esophagus is swallowing a triple zero capsule, it doesn't know what's inside of it. [00:22:47] Speaker 02: We also had in Exhibit 22, 23, and 24 of our declaration, which did not make it into the appendix, two commercial products in triple zero size on the market, Fiorinol and Keflites. [00:23:00] Speaker 03: What do you make of the table that Roxanne relies on in A2635? [00:23:06] Speaker 03: This comes from the Modern Pharmaceutics textbook? [00:23:11] Speaker 02: where this table... I'm sorry, what was the page again, Your Honor? [00:23:15] Speaker 02: Page 2635. [00:23:15] Speaker 03: This is a table that, again, I'm not one of skill in the arts, but the table makes it pretty clear. [00:23:26] Speaker 02: Is that the banker reference? [00:23:30] Speaker 02: Is it the banker reference? [00:23:31] Speaker 02: Yeah, I'm trying to determine who wrote this. [00:23:35] Speaker 03: I'm not sure. [00:23:36] Speaker 03: Oh, well, you know, Your Honor, what, again... Doesn't this one show that [00:23:41] Speaker 03: You know, EL and standard are subsets of a particular capsule size? [00:23:48] Speaker 02: I don't see that anywhere on 2635, Your Honor. [00:23:52] Speaker 02: It shows merely 000 and up through size 4. [00:23:57] Speaker 03: If you look at... I'm sorry, I'm looking at the top table. [00:24:00] Speaker 02: Of the top table, that shows, it just shows 0 through 4. [00:24:04] Speaker 03: That's right, and then you go all the way across the page. [00:24:08] Speaker 03: you'll see a column for volume of standard length, and then volume of elongated length. [00:24:15] Speaker 03: That tends to strongly suggest that, at least according to the authors of this textbook, they understand standard and elongated to be subsets of a particular capsule size. [00:24:28] Speaker 02: Well, it's contrary to the intrinsic evidence. [00:24:31] Speaker 02: As you noted, the Lightfoot reference merely separates it into... Well, this is not a litigation-induced textbook, right? [00:24:38] Speaker 03: No, it's not. [00:24:39] Speaker 03: So, you know, it's evidence of something that we have to understand and we have to try to reconcile it with everything else. [00:24:45] Speaker 02: But if you look at the record, Your Honor, there are nine different references and it merely shows that different manufacturers refer to capsule sizes in different manners. [00:24:54] Speaker 02: Now, they talk about the bank reference saying there's only eight sizes, but what he said is he left out the word eight traditional sizes. [00:25:02] Speaker 02: He then goes on to the next two sentences and describes why zero zero [00:25:06] Speaker 02: EL and Y0EL are different. [00:25:09] Speaker 02: And again, the lightfoot reference separates it not into eight, like Dr. Park says, it separates it into 12. [00:25:17] Speaker 02: And that was written by the head of GlaxoSmithKline, who was the head of research and design for 46 years, and it's part of the intrinsic record. [00:25:25] Speaker 02: And so just like different manufacturers of cars may refer to different models in a different way, the extrinsic evidence, this is the only piece of extrinsic evidence that supports the position because when you look at the other capsule brochures and books that were cited in the record, they distinguish between 00 and 0EL in a different fashion than this one. [00:25:50] Speaker 02: And I wanted to further elaborate on [00:25:53] Speaker 02: Dr. Park's testimony. [00:25:56] Speaker 02: Like I said, he said diameter is the only thing you determine with respect to swallowability at 2475. [00:26:03] Speaker 02: And again, Stegman at 2108 says you must consider all those other factors. [00:26:09] Speaker 02: Roxanne first came out at the district court and said there were a family of sizeless encapsules. [00:26:14] Speaker 02: And the Judge Chessler noted in the, his footnote in his opinion, is the metaphor family really [00:26:21] Speaker 02: applicable to capsules? [00:26:23] Speaker 02: He questioned it because I challenged the judge to find a single reference in the record. [00:26:28] Speaker 02: I did a Google search. [00:26:29] Speaker 02: I challenged the judge to do it. [00:26:31] Speaker 02: Roxanne did not at all produce a single document in this case that says capsules come in families. [00:26:40] Speaker 02: So now they've switched their argument to diameter because they can't have any proof of capsule family sizes. [00:26:47] Speaker 02: But that's where Dr. Park started. [00:26:49] Speaker 02: And Dr. Goldberg, again, at 1484 of the appendix, paragraph 62, said, in this field, and he has been in this field 50 or 60 years, there is no such thing as a family of capsule sizes. [00:27:03] Speaker 02: Also, Park said at A1173, paragraph 25, that 00 is the largest swallowable of most humans. [00:27:10] Speaker 02: Yet, in his textbook, A2238, he has a chart with 000 there saying it's suitable for human use. [00:27:18] Speaker 02: But yet when he's trying to impart patentability to the arbitrary selection of a size double zero capsule, I mean, double zero capsules has been around for 100 years. [00:27:28] Speaker 02: What's patentable about that? [00:27:30] Speaker 02: I mean, all they did was take a zero zero capsule, take 667 milligrams of calcium acetate, which was disclosed in the FOSLO reference, and use a 60 year old technique of dry roller compaction. [00:27:44] Speaker 02: I mean, that's their invention here. [00:27:46] Speaker 02: So I submit that Dr. Park's testimony is not consistent with the intrinsic evidence, and it shows why the judge discounted it greatly. [00:27:58] Speaker 02: Again, the court found that the addition of the size 00 to the original claim was a narrowing amendment. [00:28:06] Speaker 02: He said it was not peripheral, as Roxanne would argue, but that it was central. [00:28:11] Speaker 02: And let me just briefly touch on irreparable harm. [00:28:15] Speaker 02: There's not a single document in this case that shows that a sale that we made was a sale that we took from Roxanne. [00:28:23] Speaker 02: They have conclusory declarations of Tate and Peterman, and their only piece of evidence is an email from Rite Aid that says to them, and it's not even in the appendix, it says, there's somebody else new in the market. [00:28:37] Speaker 02: Do you want to rebid? [00:28:39] Speaker 02: There's no evidence that we took sales away. [00:28:44] Speaker 02: Financial expert we had, Renatovich, said that Sandoz competes much more with Roxanne. [00:28:51] Speaker 02: It's the largest, number two generic in the world. [00:28:54] Speaker 02: And if there was any price erosion, it occurred over the last five years when Sandoz entered the market in 2009. [00:29:02] Speaker 02: And I see I'm eating into my rebuttal time, so. [00:29:07] Speaker 00: You don't get rebuttal time. [00:29:08] Speaker 00: You or Pelly? [00:29:09] Speaker 00: Oh. [00:29:10] Speaker 00: You don't have a cross field, so you still have two minutes. [00:29:12] Speaker 02: OK, fine. [00:29:13] Speaker 02: Fine then, Your Honor. [00:29:16] Speaker 02: And I would caution the court to look at what those Tate and Peterman declarations state, because they're not consistent. [00:29:23] Speaker 02: When it's in their favor to try to explode damages through the roof, they come out and say that Peterman and Tate at A1041 say that Roxanne, like most generics, has a 90% profit margin. [00:29:39] Speaker 02: they don't define profit margin. [00:29:41] Speaker 02: Yet when they want to make Canberra look poor, they say, well, Canberra only has a 5% net profit margin. [00:29:48] Speaker 02: Well, net profit margin and profit margin are two different things, but they don't come out and define what profit margin is. [00:29:54] Speaker 02: So how can you say that they're 90%? [00:29:57] Speaker 02: I mean, profit margin can be net of rebates, net of returns, net of manufacturing costs. [00:30:03] Speaker 02: I mean, there's no definition there, and our experts said, [00:30:07] Speaker 02: At 1439, it was purely speculative. [00:30:10] Speaker 02: There was no evidence that the sales that we made had anything to do with our client. [00:30:22] Speaker 02: And he also cited an FTC study at A1430. [00:30:25] Speaker 02: And that said where you're beyond the 180-day exclusivity period, if there are less than five players in the marketplace, then [00:30:36] Speaker 02: the additional entrance such as Canberra and Imogen has essentially no effect. [00:30:43] Speaker 02: And Kate's declaration, paragraph 44, is purely speculative. [00:30:48] Speaker 02: He said, it will be difficult for Roxanne to regain its prior formulary state. [00:30:54] Speaker 02: That doesn't mean it's impossible. [00:30:55] Speaker 02: And in fact, our expert showed earlier when Sandoz was unable to supply [00:31:04] Speaker 02: product to the market, Roxanne was able to regain its price. [00:31:08] Speaker 02: So price erosion is reversible, and they are purely speculative in their financial declarations. [00:31:15] Speaker 02: Their declarations assume lost profits, price erosion, and trouble damages, which we submit upon the denial of preliminary injunction. [00:31:24] Speaker 02: I don't see how we're going to prove willful infringement, but we'll see what this court has to say about that. [00:31:31] Speaker 02: They've asked that this be vacated. [00:31:33] Speaker 02: and remanded and we submit that they would be impossible for them to prove price erosion in view of the fact that they're not additional players in the marketplace. [00:31:43] Speaker 02: Thank you, Ron. [00:31:44] Speaker 00: You now have exceeded your time. [00:31:46] Speaker 00: Thank you, Mr. Silver. [00:31:47] Speaker 00: Thank you. [00:31:49] Speaker 00: Mr. Schuler has a couple of minutes or a minute, two minutes. [00:31:54] Speaker 04: Very briefly, I think that the fundamental problem here is that they appear to dispute what the ordinary meeting is and that the district court never grappled with that issue. [00:32:05] Speaker 04: That's clear error. [00:32:06] Speaker 04: I mean, the district court has to grapple with the evidence, ascertain the ordinary meaning, and as the Supreme Court indicated, then discern whether the artisan would ascribe the meaning to that term in the context... Does the district court judge have to do a Markman hearing and a Markman order before granting or denying a preliminary injunction? [00:32:29] Speaker 04: I don't think that's reasonable. [00:32:30] Speaker 04: I think this court constantly said it has to be a preliminary analysis. [00:32:34] Speaker 04: Obviously, we're going to have greater evidence at the Markman hearing than we did at the preliminary injunction stage, but the methodology still has to be the same. [00:32:42] Speaker 04: We don't approach the preliminary claim construction differently than we would approach the Markman for Markman. [00:32:47] Speaker 04: The second point I make is he said the specification is usually dispositive. [00:32:51] Speaker 04: Here, the specification gives an embodiment involving size 00 capsules. [00:32:55] Speaker 04: But under their version of the ordinary meeting, we'd be limited to that embodiment. [00:32:59] Speaker 04: When the specification specifically says it's not limited to the preferred embodiment, and under this court's precedent, including ARIA Diagnostics and Med-RAD, it can't be limited. [00:33:10] Speaker 04: There'd be an error of law to have what the district court did, which is to limit us to one embodiment described in the specification. [00:33:16] Speaker 04: Lastly, the file history. [00:33:19] Speaker 04: The file history includes statements including at the A347 [00:33:23] Speaker 04: where the patentee referred to the size 00 capsules in the plural claimed. [00:33:30] Speaker 04: That's only consistent with Roxanne's proper construction. [00:33:33] Speaker 04: And the last point I'll leave you with is that there may be a difference, but at least our construction, our proposed construction harmonizes the various references. [00:33:41] Speaker 04: Their proposed construction cannot harmonize any of the ones that I've presented to you here today, nor that statement in the prosecution. [00:33:48] Speaker 00: Thank you. [00:33:49] Speaker 00: Mr. Schuler will take the case under advisement. [00:33:53] Speaker ?: All rise. [00:33:54] Speaker 00: The honorable fourth is adjourned from day to day.