[00:00:00] Speaker ?: Thanks for watching! [00:00:43] Speaker 03: Okay, the next argued case is number 16, 1731, Braintree Laboratories Incorporated against Breckenridge Pharmaceutical. [00:00:53] Speaker 01: Mr. Fleming. [00:00:54] Speaker 01: Good morning and may it please the court Mark Fleming on behalf of Braintree Laboratories. [00:00:58] Speaker 01: It's stipulated that a patient following Breckenridge's label will drink a solution that is 473 milliliters in volume and that induces purgation and then 10 to 12 hours later will do it again. [00:01:11] Speaker 01: That is two acts of infringement and it should have compelled the judgment for Braintree. [00:01:15] Speaker 01: The district court's contrary ruling depended on two errors. [00:01:18] Speaker 01: First, it rewrote the claims to add an extra limitation nowhere in the claims. [00:01:23] Speaker 01: Second, it incorrectly held that a Hatch-Waxman defendant may escape liability if in addition to inducing one act of infringement, it also induces a second act of infringement the next day. [00:01:33] Speaker 01: Both holdings were incorrect and both are inconsistent with this court's prior decision in the novel case [00:01:38] Speaker 01: where Judge Dyke articulated both propositions in dissent and recognized that the majority rejected them. [00:01:43] Speaker 03: Are you saying that they're separate acts or that together they're an act of infringement? [00:01:49] Speaker 01: Or does it make any difference in your argument? [00:01:51] Speaker 01: There are two acts of infringement. [00:01:53] Speaker 01: One, the evening before the colonoscopy when the patient makes the infringing composition 473 milliliters, which induces purgation. [00:02:02] Speaker 01: And then 10 to 12 hours later, the morning of the procedure, [00:02:04] Speaker 01: The patient makes another 473 milliliter composition, consumes it, and that induces a second prugation. [00:02:11] Speaker 01: Those are two acts of infringement. [00:02:13] Speaker 01: Together, they achieve the approved indication. [00:02:16] Speaker 01: In fact, they are the only way to achieve the approved indication while following the label. [00:02:20] Speaker 01: And that's why there's clearly infringement under this court's precedence. [00:02:23] Speaker 02: Now, limiting ourself, as we must in light of the earlier decision that was made, [00:02:30] Speaker 02: I understand your arguments about the 100 to 500 milliliter point and why you believe our earlier decision took that off the table. [00:02:41] Speaker 02: What I don't understand is your argument about Judge Dyck's Sue Esponte points about ANDAs and unapproved uses. [00:02:51] Speaker 02: No party argued to us in any portion of any brief this unapproved use argument. [00:02:58] Speaker 02: no party even argued it to the lower court, and then just didn't appeal it to us. [00:03:02] Speaker 02: This was sort of a product of a judge's imagination, and it appears in the dissent. [00:03:12] Speaker 02: We did not even speak to it in the majority. [00:03:14] Speaker 02: We never mentioned the words. [00:03:16] Speaker 02: Why would the majority be viewed as rejecting an argument, never having been made in a case, at any stage in the proceedings, on appeal, even at oral argument? [00:03:26] Speaker 02: Why would the majority [00:03:27] Speaker 02: sub silencio be viewed as rejecting such a different argument from anything that had been made before. [00:03:33] Speaker 02: I understand your 100 to 500 milliliter argument. [00:03:36] Speaker 02: I don't understand if you are claiming that the majority rejected the unapproved use notion, which is specific to Hatch-Waxman law and the 271e claims, how the majority opinion can be viewed as having rejected that. [00:03:51] Speaker 01: If I may, Judge Moore, correct one premise of the question, which is that this argument was not made by Novel in the district court. [00:03:57] Speaker 01: It was. [00:03:57] Speaker 01: And Judge Sheridan in the district of New Jersey rejected it. [00:04:00] Speaker 01: Your Honor is right that Novel did not brief it and that Judge Dyke... And it was never argued to us. [00:04:09] Speaker 02: And it was never argued to us. [00:04:10] Speaker 01: Our basis for this proposition, Judge Moore, is in cases like Zenith and many other cases, Clemens from the Supreme Court and several cases from other circuits. [00:04:20] Speaker 01: where there was a dissent in a prior case, even though the parties had not argued the case. [00:04:24] Speaker 01: In Zenith, it had been raised only by an amicus. [00:04:26] Speaker 01: And in other cases, it hadn't been raised by anybody. [00:04:29] Speaker 01: But the subsequent panel said the prior court implicitly rejected the argument raised by the dissent. [00:04:35] Speaker 01: We quote a number of these in our blue graph. [00:04:36] Speaker 02: Well, that argument may well have been much more intertwined with the arguments that were made than this one. [00:04:44] Speaker 02: This unapproved uses argument seems completely divergent from [00:04:50] Speaker 02: the arguments related to prugation, the one bottle theory, the number of ounces that are present, those arguments are all very much intertwined. [00:04:59] Speaker 02: And so I understand exactly how you are relying on them. [00:05:02] Speaker 02: In these other cases, I believe that the arguments were likewise in Zenith, for example, intertwined in a way that it was reasonable to assume the majority had implicitly subsilentia rejected it. [00:05:14] Speaker 02: I'll be honest with you, the unapproved uses idea, I was like, huh, I don't know what to make about that. [00:05:19] Speaker 02: And boy, I'm not going to touch it in the majority because it wasn't briefed by anybody. [00:05:22] Speaker 02: So there you go. [00:05:23] Speaker 02: There you have an insight into exactly what the heck went through my mind when I saw his dissent. [00:05:27] Speaker 01: Your honor, I'm not going to try to convince you of what you meant in a prior decision. [00:05:31] Speaker 01: And we do not need to do that in order to prevail on this issue because even if the novel opinion had never happened, [00:05:38] Speaker 01: the district judge in this case was still wrong to reach the conclusion that the court did. [00:05:42] Speaker 01: And I'm happy to turn to the Hatch-Waxman argument, if your honor wishes. [00:05:46] Speaker 01: I'm also happy to talk about the volume limitation. [00:05:48] Speaker 03: Well, when I read it, I thought it was clear what was meant. [00:05:53] Speaker 01: Well, just kidding. [00:05:56] Speaker 01: Don't go back. [00:05:57] Speaker 01: We think that that is an easy way to reverse the district court in this case. [00:06:01] Speaker 01: But even if that opinion had never been issued, the district judge was wrong to do what happened. [00:06:05] Speaker 02: Can I summarize your unapproved uses in a slightly different way than you said it and see if it's nonetheless something that you think is an accurate reflection of what you were arguing? [00:06:15] Speaker 02: I kind of understood you to say, although maybe not exactly quite this clearly, that this isn't an unapproved use. [00:06:21] Speaker 02: It's exactly the same use. [00:06:23] Speaker 02: They're colon cleansing via purgation. [00:06:25] Speaker 02: We're purgation. [00:06:26] Speaker 02: How can you say it's an unimproved use? [00:06:30] Speaker 02: It's exactly the use. [00:06:31] Speaker 02: This is different from cases where it's discovered that, I don't know, we have one past one where birth control pills can help premenopausal women with hormone imbalances. [00:06:43] Speaker 02: That's a totally different use. [00:06:46] Speaker 02: It bears no resemblance to the use for birth control. [00:06:49] Speaker 02: This is a case where the use is, this is from a factual matter. [00:06:53] Speaker 02: I can agree with every statement of law and Judge Dyke's opinion if I want to, dissent. [00:06:58] Speaker 02: But nonetheless, from a factual matter, conclude that they don't apply here. [00:07:02] Speaker 02: Is that one of the arguments you make? [00:07:04] Speaker 01: It is the argument we make, Judge Moore. [00:07:06] Speaker 01: And if it's not clearly stated in the briefs, let me adopt it now. [00:07:09] Speaker 01: That's absolutely right. [00:07:11] Speaker 02: No, I think it's the argument you make. [00:07:13] Speaker 01: It sure is the argument. [00:07:14] Speaker 01: Right. [00:07:14] Speaker 01: I thought it was. [00:07:15] Speaker 01: And the point is that the FDA has approved [00:07:20] Speaker 01: directing a patient to perform the patented method. [00:07:23] Speaker 01: It's just done it in a context where it happens twice, once on the first day and once on the second day. [00:07:29] Speaker 01: In its reply brief below, this is on 2201 of the appendix, Breckenridge admits, quote, purgation is the mechanism by which the approved indication of colon cleansing is achieved, close quote, very different from the cases that Breckenridge relies on where a patient following the label wouldn't have performed the claim method at all. [00:07:47] Speaker 02: And I actually thought when I read it that this case could be quite narrow because I like to be narrow and not overreach it, especially if I don't necessarily know if I understand all the boundaries, but they stipulated to these things. [00:08:01] Speaker 02: So this is not a case where I have to conclude and make any fact findings about whether purgation is the method or whether purgation occurs. [00:08:11] Speaker 02: after 473, because those are all factual stipulations, correct? [00:08:15] Speaker 01: Page 1780 of the appendix, paragraph 25, drinking one six ounce bottle of Cyprus's, which is Breckenridge's predecessor, proposed generic version of suprep, diluted with water to 16 ounces, will induce prugation from the colon of a patient under the construction of the term prugation adopted by the district court in the novel case. [00:08:34] Speaker 01: And the rest of the stipulation makes clear that what happens the next day is exactly the same thing. [00:08:39] Speaker 01: The only way that [00:08:41] Speaker 01: this court could affirm the judgment in this case would be to create a special new Hatch-Waxman specific rule, which is basically what Breckinridge is asking for and what the district judge did, which is to say that if you add a second instance of the infringement, other unclaimed matter, [00:08:57] Speaker 01: That somehow gets you out of infringement in a Hatch-Waxman context, when it clearly wouldn't in the traditional infringement analysis, where this court has been very clear that the adding of unclaimed matter doesn't excuse or absolve infringement, a fortiori, where the unclaimed matter is a separate instance of performing the claimed method. [00:09:16] Speaker 01: I mean, we think simply that what regrettably happened in the district court, who didn't hold any oral argument or markman proceeding in this case, simply misunderstood the role of the label. [00:09:27] Speaker 01: in a Hatch-Waxman case. [00:09:28] Speaker 01: This court has always used the label as a way to figure out what's going to be induced when the generic product is marketed. [00:09:35] Speaker 01: But there has never been a case that I know of, and Breckridge certainly doesn't cite one, that says that a patent can only be infringed if it covers every single thing in the label. [00:09:45] Speaker 01: All that matters, and this is this court's decision in AstraZeneca, is whether the method induces performance of the claimed method. [00:09:51] Speaker 01: And here it clearly does that by stipulation. [00:09:54] Speaker 01: If the court has no further questions on that, I'm happy to address any questions the court has on the volume limitation. [00:09:59] Speaker 01: I mean, we think that's quite easily resolved based on the plain language of the claims, the claim start. [00:10:05] Speaker 01: If you look at claim 15 with a composition for inducing purgation, and then it says the composition having a volume of 100 to 500 milliliters, they clearly refer to the same composition. [00:10:16] Speaker 01: There is no reason in grammar or common sense to think that the composition that has a volume between 100 to 500 [00:10:24] Speaker 01: is anything other than the composition that induces purgation. [00:10:27] Speaker 01: So we would submit that on both those rulings, the judgment should be reversed and the case remanded for direction of entry of judgment for brain treat. [00:10:35] Speaker 01: I respectfully reserve the matter. [00:10:36] Speaker 02: Wait, entry of judgment for brain treat, did you have a cross motion that is now, that is on appeal? [00:10:41] Speaker 02: I mean, this is summary judgment. [00:10:43] Speaker 01: It is, Your Honor. [00:10:44] Speaker 02: So usually summary judgment results in vacating and remanding. [00:10:47] Speaker 01: That's true, and we wouldn't have a problem with that, but because of the procedural nature of this case, Breckenridge has stipulated that this is the only non-infringement argument they have. [00:10:57] Speaker 01: That's on 296 of the appendix. [00:10:59] Speaker 02: It's one thing to stipulate, this is their only non-infringement argument, so they stipulate to infringement. [00:11:05] Speaker 01: They do. [00:11:05] Speaker 01: They say page 296 of the appendix, paragraph 3, the second sentence, if the court denies Cypress's motion, Cypress stipulates that its proposed generic version of Braintree's suprep described in the ANDA infringes claims 15, 18, 19, 20, 23. [00:11:20] Speaker 03: I understand. [00:11:21] Speaker 01: So there's nothing left to try. [00:11:22] Speaker 01: All that's left is judgment of infringement. [00:11:24] Speaker 03: Okay, well they'd really have to stipulate in a Hatch-Whatson Act. [00:11:28] Speaker 03: Would they not in any case? [00:11:30] Speaker 01: I think that's right, Your Honor, given that this is the only defense that they preserved. [00:11:34] Speaker 01: Everything else they agreed to be bound by the novel judgment, which is now conclusive and not appealed. [00:11:38] Speaker 03: OK. [00:11:39] Speaker 03: Let's hear from the other side. [00:11:40] Speaker 03: Thank you, Your Honor. [00:11:42] Speaker 03: You're right. [00:11:43] Speaker 03: They wouldn't satisfy Hatch-Waxman otherwise. [00:11:48] Speaker 03: No? [00:11:48] Speaker 03: Mr. Lieberman? [00:11:55] Speaker 00: Good afternoon, Your Honors. [00:11:56] Speaker 00: Judge Newman may please the court. [00:11:58] Speaker 00: I'd like to address first the issue of waiver and preclusion and whether this court's prior ruling precludes my client from advancing the arguments that it's advancing. [00:12:12] Speaker 00: I think there's no question, as Judge Moore's question to Mr. Sheridan pointed out, and there's an admission from Braintree on this point in their blue brief [00:12:24] Speaker 00: page 29, note 3, that novel had not raised in the prior proceeding, I call it the unapproved dosage issue, the FDA Hatch-Waxman issue. [00:12:38] Speaker 00: So I think there's no question that the prior court's decision didn't address that. [00:12:42] Speaker 00: As to the issue of the volume limitation, there are two places in the record where I believe they come very close to admitting that that argument was not made at all. [00:12:52] Speaker 00: The first one is at page A, [00:12:54] Speaker 00: 1029 of the record, which was a joint letter to the district court judge in connection with the request for permission to file the summary judgment motion. [00:13:05] Speaker 00: And here's what they said. [00:13:06] Speaker 00: Novel did not appeal the district court's rejection of that non-infringement argument, and what they were referring to was the volume limitation, and instead appealed the court's infringement finding on other grounds. [00:13:21] Speaker 00: They also said something very similar, although a little more nuanced. [00:13:25] Speaker 02: Yeah, but who cares what they said, right? [00:13:28] Speaker 02: I mean, they can say something wasn't waived or was waived or wasn't decided and it was decided. [00:13:33] Speaker 02: Doesn't it only matter whether we conclude the court decided it? [00:13:37] Speaker 00: Yes. [00:13:37] Speaker 02: Yes. [00:13:38] Speaker 02: Okay. [00:13:39] Speaker 00: But they have admitted that the issue, at page 30, note three of the brief, they admit that this issue was not raised as a separate argument. [00:13:47] Speaker 02: Yes, that's not the same as saying we didn't issue an opinion that resolves this issue. [00:13:55] Speaker 00: Well, I would submit that you can look through that opinion and you will see no discussion except in Judge Dyke's dissent. [00:14:02] Speaker 00: of the volume limitation argument. [00:14:04] Speaker 02: That's not true. [00:14:04] Speaker 02: We say at 1.473 milliliters, i.e. [00:14:08] Speaker 02: the one bottle theory, falls within the claimed volume. [00:14:12] Speaker 00: In the context of the purgation argument that is being made, our argument is completely different. [00:14:17] Speaker 02: Which is the only thing that the claim covers. [00:14:21] Speaker 02: The claim says a composition for inducing purgation from about 100 to 500 milliliters. [00:14:27] Speaker 02: I'll tell you, all of your arguments [00:14:29] Speaker 02: about what the specification, the example says, and how we're talking about total volume, and if there are multiple doses, they all add up together. [00:14:35] Speaker 02: I agree with everything you say. [00:14:37] Speaker 02: The difference is, A, most of those examples go to cleansing. [00:14:42] Speaker 02: And we've already determined, and this we are bound by, the purgation is not cleansing. [00:14:47] Speaker 02: It's something less than cleansing. [00:14:48] Speaker 02: It's the beginning of the process of cleansing the colon, but you don't have to achieve cleansing. [00:14:54] Speaker 02: And so here, what this claim covers, [00:14:57] Speaker 02: which differs from those examples, is it focuses on the amount of liquid you must consume to induce purgation, not to induce colon cleansing. [00:15:06] Speaker 00: With all due respect, Judge Moore, I believe that's not correct. [00:15:08] Speaker 02: How? [00:15:09] Speaker 00: Look at the claim. [00:15:10] Speaker 00: Look at the claim. [00:15:11] Speaker 00: I'm looking at the claim language, and I see independent claim limitations, each of which must be met. [00:15:17] Speaker 02: A composition for inducing purgation. [00:15:20] Speaker 02: And we've all decided the inducing purgation is a claim language. [00:15:23] Speaker 00: And we are not challenging that point. [00:15:25] Speaker 00: And we have never challenged that point. [00:15:27] Speaker 00: There is a separate independent limitation, which is a composition comprising from about 100 to about 500 milliliters. [00:15:35] Speaker 02: How is that separate? [00:15:37] Speaker 02: We've decided that inducing purgation is a claim limitation. [00:15:41] Speaker 00: But what has to be administered is from 100 to 500. [00:15:45] Speaker 00: Now, how do you determine whether [00:15:49] Speaker 00: One partial dose. [00:15:51] Speaker 02: You've admitted that you administer between 100 and 500 and then that amount induces purgation. [00:15:57] Speaker 00: We've admitted that that is a partial administration. [00:16:00] Speaker 02: For colon cleansing. [00:16:01] Speaker 02: No, you've admitted that's a partial administration for colon cleansing. [00:16:05] Speaker 02: What you also stipulated to is that that amount by itself induces purgation. [00:16:11] Speaker 00: No. [00:16:12] Speaker 02: You didn't stipulate to that? [00:16:13] Speaker 00: Because I'll find the page. [00:16:14] Speaker 00: Yeah, yeah. [00:16:15] Speaker 00: That statement we stipulated to, we have never made [00:16:18] Speaker 00: the purgation argument that was made by Novel. [00:16:21] Speaker 00: Our argument is very simple, it's very clean and elegant, and it's completely different. [00:16:27] Speaker 00: There is an independent limitation of 100 to 500 milliliters. [00:16:31] Speaker 00: How do you determine whether that limitation applies to a partial dose or to the full dose, the only dose approved by the FDA? [00:16:40] Speaker 00: And here's how. [00:16:42] Speaker 00: In the specification, in four different places, talking about [00:16:47] Speaker 00: the small volume prior art, which was administered in multiple doses, the large volume prior art, which was administered in multiple doses, the experimental solution, which was the only example that they gave, and the Phos fleet soda, which they compared against the experimental solution. [00:17:07] Speaker 00: In each and every instance, they are referring to the total volume of product administered, which tells you something about [00:17:17] Speaker 00: It doesn't necessarily dispose of the issue, but I believe the prosecution history does. [00:17:22] Speaker 00: It tells you something about what that 100 to 500 means. [00:17:26] Speaker 00: Now you look at the prosecution history. [00:17:28] Speaker 00: When the Braintree folks were trying to distinguish over the Nisho and the Giuliani reference, how did they do it? [00:17:38] Speaker 00: They said, unlike Giuliani, which has four leaders or two leaders, I don't remember which was which, [00:17:47] Speaker 00: a volume, we have 100 to 500. [00:17:50] Speaker 00: And they did the same thing for Niche as well. [00:17:54] Speaker 00: So they're saying when you're looking to see what 100 to 500 is, you look to the total volume of what's administered. [00:18:02] Speaker 00: Twice. [00:18:05] Speaker 00: I'll get to that issue right now. [00:18:08] Speaker 00: Actually, no. [00:18:11] Speaker 00: Yes, there are two partial administrations. [00:18:17] Speaker 00: But under the claim construction that the district court adopted... 50 to 250? [00:18:23] Speaker 00: 100 to 500, Your Honor. [00:18:26] Speaker 00: Under the proper claim construction, the 100 to 500 refers only to the total dosage that's administered. [00:18:38] Speaker 00: And I can explain why in this case... Let me ask you something. [00:18:42] Speaker 02: In all of those prior references, [00:18:44] Speaker 02: And when they talk about the total dose for colon cleansing, why is that relevant to what the total dose is necessary to induce purgation? [00:18:54] Speaker 02: Excuse me for one second. [00:18:56] Speaker 02: That's what this claim covers. [00:18:58] Speaker 02: The dose necessary to induce purgation. [00:19:02] Speaker 02: So why are prior art discussions of total volume necessary to achieve colon cleansing necessary, necessarily a disclaimer, [00:19:11] Speaker 02: about what volume is necessary to induce purgation. [00:19:14] Speaker 00: I believe the predicate to your question is incorrect, and I would direct you to page A, 1399 in the appendix. [00:19:22] Speaker 00: That's the Nicho site, and I'll give you a site for Giuliani in a second. [00:19:27] Speaker 00: Here is the statement that Braintree made. [00:19:29] Speaker 00: And understand that the claims at that time had the word purgation in them. [00:19:34] Speaker 00: This was during the re-exam. [00:19:36] Speaker 00: The claims had the language purgation. [00:19:38] Speaker 00: This is how they distinguished Nicho. [00:19:40] Speaker 00: nor does Niche disclose the use of about 100 to 500 milliliters, rather Niche discloses the use of two liters. [00:19:48] Speaker 00: They don't say it's different because of purgation versus cleansing. [00:19:52] Speaker 00: The claim language is purgation. [00:19:56] Speaker 00: They say Niche is different because of the difference in the volume. [00:20:00] Speaker 00: Similarly, at A1426, with respect to Giuliani, they said during the re-exam, with regard to the volume, [00:20:09] Speaker 00: Giuliani discloses four liters, not about 100 milliliters to about 500 milliliters. [00:20:16] Speaker 00: So when the claim term had the limitation, purgation in it, this is how they distinguished it. [00:20:23] Speaker 00: Now, Your Honor, Judge Moore wrote a decision a couple of years ago in a case called Youship. [00:20:33] Speaker 00: This was an argument for the first time in the reply brief that Braintree had submitted [00:20:38] Speaker 00: They said, well, we understand that there were certain statements made during the prosecution, but those statements weren't necessary for us to get over the references. [00:20:47] Speaker 00: They weren't necessary because the prior art solutions were isotonic solutions, and we are claiming hypertonic solutions. [00:20:56] Speaker 00: But in the Youship case and a whole line of cases that you cited, Judge Moore, it's very clear that [00:21:04] Speaker 00: If you make a disclaimer during the prosecution history, even if you were not required to do it, even if it wasn't necessary because it was another way to distinguish your invention, you are bound by it. [00:21:18] Speaker 00: So our view is, number one, plain language, plain construction, using the claim in the prosecution history. [00:21:25] Speaker 00: Number two, if you don't agree with that, there is an expressed disclaimer at the two pages I cited and the other coordinate sites regarding Nisho and Giuliani. [00:21:35] Speaker 02: I guess I don't see it as an express disclaimer because what I don't see is them saying that NISO discloses two liters for purgation. [00:21:46] Speaker 02: What I see is the only use of the word purgation in here, I mean, they talk about a lavage solution. [00:21:52] Speaker 02: They talk about preparing for colon cleansing. [00:21:54] Speaker 02: The only use of purgation is nothing in NISO specifically teaches this combination, a particular salts for purgation. [00:22:01] Speaker 02: That's the only time they mentioned the word purgation. [00:22:03] Speaker 02: So I don't know [00:22:05] Speaker 02: how, with clarity, how their statement relates to purgation versus cleansing, which has now, in the infinite wisdom of this court, been declared to be something different. [00:22:16] Speaker 02: I don't know if that decision is right in hindsight. [00:22:18] Speaker 02: I'll be honest with you. [00:22:19] Speaker 02: I kind of looked at it and thought, hmm, I don't remember that case as well as I now see it. [00:22:22] Speaker 02: But I'm bound by it. [00:22:24] Speaker 02: That much is 100% clear. [00:22:25] Speaker 00: Judge Moore, I think that you don't have to see those words in their statement in the prosecution history, because the only word in the claim [00:22:35] Speaker 00: was purgation at that time. [00:22:37] Speaker 00: There was no cleansing in the claims. [00:22:39] Speaker 00: It was purgation. [00:22:40] Speaker 00: They were distinguishing the prior art over the claim which had the purgation language. [00:22:44] Speaker 02: Yes, but I don't know what the prior art uses two liters for. [00:22:49] Speaker 02: Does it use two liters for colon cleansing? [00:22:51] Speaker 02: Does it use two liters for purgation? [00:22:53] Speaker 02: If what they're saying here is the prior art requires two liters to achieve purgation, our claim only requires 100 to 500 milliliters to achieve purgation. [00:23:02] Speaker 02: then that doesn't have at all the disclaimer that you want it to have. [00:23:06] Speaker 02: And I don't know the answer to those questions. [00:23:08] Speaker 00: So let me tie this back into the specification. [00:23:12] Speaker 00: Somebody looks at 100 to 500 and says, OK, I know what about 100 to about 500 means. [00:23:18] Speaker 00: To what do I apply that? [00:23:20] Speaker 00: That's the question. [00:23:21] Speaker 00: And Mr. Sheridan says you apply it to each partial dose, so we infringe twice. [00:23:28] Speaker 00: And I say, no, what that applies to [00:23:32] Speaker 00: is the total volume that has been administered. [00:23:34] Speaker 00: This is what Judge Dyck said. [00:23:35] Speaker 00: This is what the district court judge said. [00:23:37] Speaker 00: Why? [00:23:38] Speaker 00: If you look at the specification, whenever there is a discussion of either the prior art or the experimental solution, which was the only example given, or what the experimental solution is compared to, it talks about the total solution that is administered. [00:23:56] Speaker 02: I agree, but in the specification, it has all these columns. [00:24:00] Speaker 02: And by the way, it looks like a somewhat disgusting experiment. [00:24:03] Speaker 02: And I do not wish to be a part of it. [00:24:05] Speaker 02: Because it involves drinking copious amounts of liquid. [00:24:08] Speaker 02: And then here's my favorite part. [00:24:09] Speaker 02: They measure the input. [00:24:10] Speaker 02: And guess what? [00:24:11] Speaker 02: They measure the output. [00:24:12] Speaker 02: So you've got input measurements and output measurements. [00:24:16] Speaker 02: So you're consuming various amounts of liquid en route to what I hope and imagine is a completely clean colon. [00:24:24] Speaker 02: But the whole point [00:24:26] Speaker 02: And so it makes sense that they're talking about the total amounts of volume in the course of that experiment, but that's different from saying the total amount for percation. [00:24:35] Speaker 02: I mean, that's the difference. [00:24:36] Speaker 02: The claim here is narrower than what those experiments sought to measure. [00:24:40] Speaker 03: Let me just add, for those of you with children, sounds like a science fair project. [00:24:45] Speaker 02: Oh, no, it does not. [00:24:47] Speaker 00: Let me see if I can reorient... You stay away from my children. [00:24:51] Speaker 00: Let me see if I can reorient the fundamental axis of this case. [00:24:54] Speaker 00: We normally in Hatch-Waxman cases, you presume that the patent is going to cover the brand company's product. [00:25:02] Speaker 00: You start with that assumption. [00:25:03] Speaker 00: And if it doesn't, you wonder why. [00:25:06] Speaker 00: What's the argument? [00:25:07] Speaker 00: There's got to be some problem with that. [00:25:09] Speaker 00: But here, if we look at page 1882 of the appendix, we have the answer. [00:25:15] Speaker 00: And the answer is in a declaration from Cleveland, the sole inventor. [00:25:20] Speaker 00: And what he says is, [00:25:21] Speaker 00: Due to these two concerns, this is in paragraph 11 on page 1882, and the two concerns were the palatability of the solution and the salt staying in solution, could they get it to stay in solution, that arose during early drug development, we increased the volume of the solution relative to the experimental solutions. [00:25:42] Speaker 00: So during the process of getting approval, they increased the volume. [00:25:48] Speaker 00: Now what they did, this patent was directed to their product, I assume, [00:25:51] Speaker 00: as it existed at the time that they prosecuted the patent. [00:25:55] Speaker 00: They got the original patent in 2005. [00:25:57] Speaker 00: They got the re-exam certificate issued in 2009. [00:26:01] Speaker 00: Their NDA didn't get approved till 2010. [00:26:03] Speaker 00: What we learned from Cleveland in 1882 is what happened is they increased the volume of their product because it couldn't keep stuff in solution and it was unpalatable. [00:26:13] Speaker 00: Yeah. [00:26:13] Speaker 02: Is your product still pending approval? [00:26:16] Speaker 00: We have tentative approval, Your Honor. [00:26:17] Speaker 00: Final approval is on hold [00:26:22] Speaker 00: only because the FDA has not yet finally determined that there's been a waiver of the first filer exclusivity that Lupin, which purchased novel, has. [00:26:34] Speaker 00: So that's the only issue holding us from final approval. [00:26:39] Speaker 00: So how do we know, how can we confirm from the prosecution history that this is in fact what was going on? [00:26:46] Speaker 00: When they filed for a patent term extension, when they filed for a patent term extension, [00:26:52] Speaker 00: It was a mess. [00:26:53] Speaker 00: They made mistakes twice. [00:26:55] Speaker 00: But in both cases, the first time I fought for a patent term extension, and this is back when, before the re-exam certificate issued, the language 100 to 500 milliliters wasn't there. [00:27:06] Speaker 00: It said small volume. [00:27:09] Speaker 00: They said, we come within the scope of the claims because small volume encompasses 946 milliliters. [00:27:18] Speaker 00: But the purgation language was still in there. [00:27:21] Speaker 00: So they're saying our product is 946 milliliters, and it still comes within the scope of the claims. [00:27:31] Speaker 00: That's what they argued for patent term extension. [00:27:34] Speaker 00: So we have Nisho Giuliani patent term extension every time the volume is referred to with respect to the prior art, the experimental solution. [00:27:44] Speaker 00: It all refers to the total. [00:27:46] Speaker 02: That was all before we decided what purgation meant. [00:27:49] Speaker 00: But our argument has nothing to do with purgation. [00:27:52] Speaker 02: That's where we disagree. [00:27:54] Speaker 00: Well, I hope that Your Honor will not actually disagree on that point, because I would suggest the claim language, which has a comma in it, is saying claim element one, claim element two. [00:28:07] Speaker 00: Claim element one is purgation. [00:28:09] Speaker 00: Claim element two is whatever is accused has to be 100 to 500. [00:28:14] Speaker 00: So let me transition very quickly, if I may. [00:28:17] Speaker 00: to the FDA issue and tie it into this. [00:28:20] Speaker 00: The FDA has approved only one product. [00:28:23] Speaker 00: The one product is a 946 milliliter product. [00:28:27] Speaker 00: It happens to be administered twice, but it is a 946 milliliter product. [00:28:33] Speaker 00: We can't sell it for 73. [00:28:36] Speaker 00: We can't tell a patient to take only one bottle. [00:28:40] Speaker 00: There is no evidence in the record and there was no argument that was ever made by Braintree. [00:28:45] Speaker 00: that any patient has ever taken just one bottle, or that we've ever encouraged a patient to take one bottle, or that any patient would take one bottle, the instructions are clear, the approved use is clear, it is only a product that is 946 milliliters. [00:29:00] Speaker 00: If you agree with me that there is an independent limitation of 100 to 500, then because the only product that's approved is 946, we should prevail. [00:29:12] Speaker 03: But you've agreed to infringement [00:29:14] Speaker 03: Is that right? [00:29:15] Speaker 03: Otherwise, there'd be no Hatch-Watchmen action at all. [00:29:19] Speaker 00: No, we've disputed infringement. [00:29:21] Speaker 00: We filed a paragraph for certification, Your Honor, disputing that we infringe. [00:29:25] Speaker 00: This is the only non-infringement argument that we have made because, pursuant to Rule 1 of the Federal Rules of Civil Procedure, we opted for a speedy, what we hoped would be a speedy, inexpensive determination of this matter by taking what we believe to be a silver bullet, absolutely correct claim construction position. [00:29:41] Speaker 03: On the theory that it was administered [00:29:43] Speaker 03: That the 900, so our milliliters was not administered in one dose? [00:29:49] Speaker 00: No, no, no. [00:29:51] Speaker 00: It's administered, well, I don't know that we need to focus on what the word dose means, but there's only one product. [00:29:58] Speaker 03: No, I'm really trying to understand where in the Hatch-Waxman proceeding. [00:30:04] Speaker 03: So it was only, it was under paragraph four, solely for non-infringement, not for invalidity? [00:30:12] Speaker 00: I don't remember if we certified on invalidity, but we agreed before the district court to be bound by the validity determination in the prior novel case. [00:30:22] Speaker 00: So we are not asserting an invalidity argument and we are precluded from asserting an invalidity argument. [00:30:30] Speaker 03: 900 some milliliters so that, but I had the impression from the record that your client also was providing the two separate 500 milliliter doses. [00:30:42] Speaker 03: Of course. [00:30:42] Speaker 00: We are required to do that, Your Honor. [00:30:45] Speaker 00: We have to sell two bottles and we have to provide the same instructions that are in the NDA, which is take one of them the night before and take one of them the morning of the procedure. [00:30:56] Speaker 03: Yes, that's what I thought was the case, in which case why the emphasis [00:30:59] Speaker 03: on the nine hundred milliliters. [00:31:01] Speaker 00: Ah, because under the Bayer versus Alon decision, which this court decided in 2000 that had to do with, it was a composition claim and the claim was to micronize nifetafenine having a specific surface area of not greater than four square meters per gram. [00:31:18] Speaker 00: A less disgusting case than the subject matter. [00:31:22] Speaker 00: Here, the accused product [00:31:25] Speaker 00: was defined by an ANDA that said that the micronized nifetapine would have a specific surface area of 4.7 square meters per gram. [00:31:33] Speaker 00: The court said the product is defined by the specifications in the ANDA. [00:31:39] Speaker 00: The specifications in the ANDA said 4.7, therefore there couldn't be infringement. [00:31:44] Speaker 00: Our product here, we only sell one product, it's 946 milliliters. [00:31:48] Speaker 00: We believe that it is irrelevant that it is taken in two separate partial doses because [00:31:55] Speaker 00: Properly construed the 100 to 500 milliliter But you said that it's required that the two doses two partial doses are required that that's absolutely correct and we can but a patient we are not allowed to market our product or To otherwise do anything to induce a patient to take only one How about if they talk to it once? [00:32:20] Speaker 00: Well, that would be contrary to that. [00:32:22] Speaker 00: It would be contrary to the label [00:32:23] Speaker 00: The label says you must, you're required to, I guess the patient isn't required. [00:32:30] Speaker 00: The label says take one the night before, take one the next morning. [00:32:34] Speaker 00: But we can only market it that way. [00:32:36] Speaker 00: But again, the total volume is 946. [00:32:39] Speaker 00: We sell only one product. [00:32:40] Speaker 00: We can't sell one bottle. [00:32:42] Speaker 00: The FDA would never approve one bottle because you have to copy the label of the brand name company. [00:32:47] Speaker 00: So we're selling one product. [00:32:50] Speaker 00: The product is 946. [00:32:51] Speaker 00: If you decide that that limitation is an independent limitation, and you agree that the independent limitation covers the total volume that's administered, then we would succeed, I would submit, on both the claim construction argument and on the FDA argument under the Bayer versus Alam case. [00:33:11] Speaker 03: OK. [00:33:11] Speaker 03: Any more questions? [00:33:13] Speaker 03: Any more questions? [00:33:14] Speaker 03: Thank you very much. [00:33:16] Speaker 03: Thank you, Mr. Lieberman. [00:33:22] Speaker 03: Mr. Fleming? [00:33:23] Speaker 01: Thank you, Your Honor. [00:33:24] Speaker 01: If the court thinks it's unpleasant to read about the experiments, one thing that would have been more unpleasant was taking the prior art isotonic solutions, which required a patient to consume up to a gallon of fluid over the course of one to three hours. [00:33:39] Speaker 01: And what would have been even more unpleasant than that is going for the colonoscopy and having the doctor say, you know what, you must not have had the full gallon because I can't see well enough to do this procedure. [00:33:49] Speaker 01: Go back and do it again. [00:33:50] Speaker 01: That's really what the invention was here. [00:33:53] Speaker 01: Instead of the prior art isotonic solutions, SUPREP was specifically designed as a kit with two separate bottles, each bottle carefully engineered to have just the right balance of salts, just the right volume of liquid so that when diluted, it creates a hypertonic solution of just the right concentration so that a patient can safely experience a purgation, then go to bed and 10 to 12 hours later, [00:34:18] Speaker 01: do it again, have another prugation, and then the colon is clear and can be visualized. [00:34:23] Speaker 01: The patent reads on each bottle's separate composition and each bottle's separate administration as directed by the label. [00:34:32] Speaker 01: I would point out on the volume limitation what the court didn't hear from Mr. Lieberman. [00:34:35] Speaker 01: The court did not hear any effort to situate [00:34:38] Speaker 01: his additional limitation of the entire treatment period in the plain language of the claims. [00:34:45] Speaker 01: He can't do it. [00:34:45] Speaker 01: The district court couldn't do it. [00:34:47] Speaker 01: It's impossible. [00:34:47] Speaker 01: The only way to do it renders the claim incoherent because it means that the first mention of the composition, A composition for inducing purgation, is directed to the amount that induces purgation, 473 milliliters. [00:34:59] Speaker 01: Whereas the second time when it says the composition that has the volume between 100 to 500 clearly refers back to the antecedent A composition, [00:35:08] Speaker 01: For some reason, that then is going to be referring to the total amount needed to induce cleansing. [00:35:13] Speaker 01: It makes no sense. [00:35:14] Speaker 01: That's why Mr. Lieberman runs directly to the way that he reads the specification and the prosecution history, but nothing he said pointed to an express disavowal that meets this court's standards for lexicography or disavowal, which the court has repeatedly said are exacting. [00:35:31] Speaker 01: With respect to the Hatch-Waxman point, [00:35:33] Speaker 01: The infringement test in the Hatch-Waxman case is whether the label induces a user to perform every step of a patent claim. [00:35:41] Speaker 01: The district court and Mr. Lieberman get that analysis exactly backwards. [00:35:44] Speaker 01: They're asking you to look for whether there's a patent claim that covers every step of the label that has never been required. [00:35:51] Speaker 01: As long as the label induces performance of the claim method, there is infringement. [00:35:55] Speaker 01: The fact that there may be something else besides does not matter. [00:35:59] Speaker 01: afore she or he, when the something else besides is performing the claim method a second time. [00:36:04] Speaker 01: If the court has no further questions, we respectfully submit the judgment should be reversed. [00:36:10] Speaker 03: OK. [00:36:10] Speaker 03: Thank you. [00:36:11] Speaker 03: Thank you both. [00:36:12] Speaker 03: The case is taken under submission. [00:36:15] Speaker 03: That concludes this morning's arguments. [00:36:17] Speaker 00: All rise. [00:36:25] Speaker 01: The honorable court is adjourned until tomorrow morning at 10 o'clock AM.