[00:00:33] Speaker 03: Okay. [00:00:34] Speaker 03: The next argued case is number 18-2167, in Divior, Incorporated against Dr. Reddy's Laboratories, I say. [00:00:44] Speaker 03: Mr. Martin. [00:00:45] Speaker 00: Yep. [00:00:45] Speaker 00: Good morning, Your Honors. [00:00:46] Speaker 00: May it please the Court. [00:00:48] Speaker 00: The District Court abused its discretion in entering a preliminary injunction against Dr. Reddy's continued sale of suboxone film. [00:00:56] Speaker 00: I would like to focus on three points today. [00:00:58] Speaker 00: First, this entire lawsuit is claim precluded under this Court's recent decision in simple air. [00:01:03] Speaker 00: Second, even if plaintiffs could get past claim preclusion, they still are not likely to succeed on the merits due to either a specification disclaimer or a violation of Section 112 certain description requirement. [00:01:15] Speaker 00: And third, the injunction should be vacated as quickly as possible for the benefit of both Dr. Reddy's and the public who is looking for this generic version of Suboxone film. [00:01:26] Speaker 00: I would like to start with the claim preclusion issue. [00:01:29] Speaker 00: plaintiffs have identified what they say is only one distinction between the asserted claims of the 514 patent as to which we already have a final judgment of non-infringement in the asserted claims of the 305 patent, and that is this drying issue. [00:01:43] Speaker 00: Drying appears in two places in Claim 62 of the 514 patent. [00:01:48] Speaker 00: First, the claim, the [00:01:50] Speaker 00: the wet matrix, what the films of both the 305 and the 514 start out as, the flow of the matrix. [00:01:57] Speaker 02: Your problem is that it's not in the claim 26, right? [00:02:02] Speaker 02: Drying. [00:02:03] Speaker 00: It is not explicitly in claim 26. [00:02:05] Speaker 00: However, there's absolutely no dispute between the parties, and Judge Penelty also found this, that the final limitation in claim 26 and also claim one, which is the continuously cast film, is a film which has been dried. [00:02:18] Speaker 00: And this was not, [00:02:19] Speaker 00: This was not a random admission by the plaintiffs. [00:02:23] Speaker 00: They had to make this admission because the prior art shows that there were examples such as the Schmidt reference in which you had uniformity up until the drying step. [00:02:33] Speaker 00: To get past Schmidt for purposes of anticipation, and we did make an anticipation argument below, the plaintiffs conceded that the continuously cast film in that final limitation is a film which has been dried [00:02:47] Speaker 00: That is exactly the same thing as the matrix subsequent to casting and drying. [00:02:51] Speaker 02: And why did he grant a preliminary injunction which presumes infringement when they've been found not to have infringed under the earlier patent? [00:03:02] Speaker 00: That is the question we've been asking ourselves, too, Your Honor. [00:03:05] Speaker 00: Because in our view, there's absolutely no difference between the final cast film and claim 62 of the 514 patent, which is, again, the matrix subsequent to casting and drying. [00:03:15] Speaker 00: And the continuously cast film in Claim 26 and Claim 1 of the 305, which they repeatedly agreed, and we have the citations in our brief. [00:03:23] Speaker 00: I could walk through them again. [00:03:24] Speaker 00: They repeatedly stated as a film that has been dried. [00:03:29] Speaker 00: What we think happened was that Judge McNulty below was confused by what Judge Andrews did in the Delaware case and viewed Judge Andrews as finding, as having found specification lexicography. [00:03:43] Speaker 00: that the specification of the, the shared specification of the two patents defines the word dried a particular way. [00:03:49] Speaker 00: And so if you read Judge McNulty's decision, what you get a flavor of is that because the word dried was gone, he thought he had to read the claims of the 305 patent differently. [00:04:00] Speaker 00: But Judge Andrews in Delaware did not find that there had been specification lexicography. [00:04:05] Speaker 00: He found that there had been a specification disclaimer. [00:04:08] Speaker 00: statements that you could not, you cannot read the shared specification of these two patents without finding a disavowal could not be clearer. [00:04:18] Speaker 00: So we just, we just think Judge McNulty got that wrong. [00:04:20] Speaker 00: He also committed what we thought we think is an elementary error of black-letter patent law by finding we did not have a substantial anticipation defense, because in plaintiff's words, the final claimed film is a solid film, which plaintiff's counsel agreed below is a film which has been dried. [00:04:37] Speaker 00: He found that it has to have been dried. [00:04:38] Speaker 00: There's a drying limitation for purposes of anticipation. [00:04:42] Speaker 00: But then when it came to claim preclusion and infringement, he found that there was no language in the claims which imported a requirement of drying. [00:04:50] Speaker 00: You cannot obviously have different claim constructions for purposes of anticipation and infringement. [00:04:56] Speaker 00: So if the way plaintiffs got past anticipation is to say the final film is a film which has been dried, just like the final film in the 514 patent, [00:05:06] Speaker 00: that that had to also apply for purposes of our claim preclusion argument, as well as our argument that we are unlikely to infringe this patent, even if you get past claim preclusion. [00:05:17] Speaker 02: And the disclaimer is that there is no top drying? [00:05:21] Speaker 00: The disclaimer, Your Honor, is a disclaimer of, well, what Judge Andrews found is that there's a disclaimer of using solely conventional convection air drying from the top. [00:05:30] Speaker 00: Because what the specification says is if you use that type of drying, then it results in non-uniform films. [00:05:36] Speaker 00: And the claims of both the 305 and the 514 are to uniform films. [00:05:41] Speaker 00: And that was not, again, just a random statement in the specification throughout the specification. [00:05:46] Speaker 00: There are repeated statements by the applicants that if you use what they refer to as conventional drying, it results in non-uniform films. [00:05:53] Speaker 00: They explain why it results in non-uniform films. [00:05:56] Speaker 00: There are a couple of different factors at play, the formation of the skin on top, as well as some lifting up from the conveyor belt. [00:06:05] Speaker 00: that occurs, which results in non-uniformity. [00:06:07] Speaker 00: So they explain all that. [00:06:09] Speaker 00: They have an example. [00:06:10] Speaker 00: It's example CG in the specification, where they say that when they used, quote, conventional drying rather than the uniform drying method of the present invention, they failed to maintain drug content uniformity. [00:06:23] Speaker 00: And they distinguished prior art in the specification on the basis that it used conventional drying methods, again, rather than the methods of the present invention. [00:06:35] Speaker 00: column three, line seven to 27. [00:06:36] Speaker 04: So... I understand your argument that the claim through the continuously cast film limitation includes drying. [00:06:46] Speaker 04: But do you think that's even required? [00:06:48] Speaker 04: I mean, I look at some of our case law on specification disclaimer, including, for example, the Symed versus advanced calorie vascular case, where this court said, where the specification makes clear that the invention does not include a particular feature, [00:07:03] Speaker 04: That feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, without reference to the specification, might be considered broad enough to encompass the feature in question. [00:07:15] Speaker 04: So does it even matter? [00:07:17] Speaker 00: I think ultimately there needs to be some textual hook in the claim to which you can apply the disclaimer. [00:07:22] Speaker 00: Plaintiffs sometimes argue that we have identified no textual hook. [00:07:25] Speaker 00: We think there is a textual hook. [00:07:27] Speaker 00: That final, continuously cast film is a film which everyone has now agreed is a film which must have been dried. [00:07:34] Speaker 00: We think this case is actually just like the Mylan, the medicines company versus Mylan case from last year, in which you had, it's actually remarkably similar. [00:07:44] Speaker 00: There you had two patents. [00:07:46] Speaker 00: One patent required the use of efficient mixing explicitly. [00:07:50] Speaker 00: The other patent didn't, and that is the same specification. [00:07:53] Speaker 00: The other patent's claims did not require use of efficient mixing. [00:07:57] Speaker 00: But as your honor was just saying, this court went back and looked at the specification, saw that the specification described [00:08:03] Speaker 00: efficient mixing is the only way possible to obtain the claimed degree of drug purity in the claims. [00:08:12] Speaker 00: And so found that there was a disclaimer of using inefficient mixing methods, even though the language of the claim just read by itself was not specific to the use of efficient mixing. [00:08:22] Speaker 00: Here, both the 514 and the 305 patents require a drug content uniformity measurement that shows a lack of uniformity of no greater than 10%. [00:08:33] Speaker 00: When you look at the specification, it says that to have that degree of drug content uniformity after going through the drying process, you cannot use solely conventional convection air drying from the top. [00:08:44] Speaker 00: What we use. [00:08:45] Speaker 02: You said earlier that the public is waiting for a generic version of this product, which of course isn't a legal argument. [00:08:53] Speaker 02: But is there no generic for this product? [00:08:56] Speaker 00: Well, that does go to the equities, Your Honor. [00:08:58] Speaker 00: There is no generic version of this product on the market right now. [00:09:01] Speaker 00: There is a generic tablet. [00:09:03] Speaker 00: that's available on the market. [00:09:04] Speaker 00: And so Judge McNulty said, in essence, the lack of a generic film isn't a big deal because the active ingredient is still available in a tablet form. [00:09:13] Speaker 00: The undisputed evidence below, however, was that for many people, they're unable to use the tablet. [00:09:19] Speaker 00: You have to keep it under your tongue for about six minutes for it to dissolve. [00:09:24] Speaker 00: And many people can't do that. [00:09:25] Speaker 00: They don't like the taste, the evidence was. [00:09:28] Speaker 00: And so they swallow it too quickly. [00:09:29] Speaker 00: And if you swallow it too quickly, you don't get the right dosage, whereas the film only has to be under your tongue for a matter of seconds in order for the dosage to be delivered. [00:09:38] Speaker 00: And again, the undisputed evidence below was that allowing access to a generic film would not just reduce the cost, but would meaningfully increase access even to the underlying active ingredient for the many people who can't afford the brand, which isn't covered by many insurance companies because it's so expensive, including [00:09:57] Speaker 00: the evidence was the insurance, the BA insurance. [00:10:00] Speaker 03: I thought you said in your brief that one of the harms that you were likely to suffer was that the patentee was going to produce the generic version before your product hit the market. [00:10:13] Speaker 00: And that is certainly still a risk, Your Honor. [00:10:15] Speaker 00: Even if they don't release the authorized generic, however, and there's some evidence in the confidential versions of the briefs dealing with authorized generics and other potential [00:10:25] Speaker 00: market entrance. [00:10:27] Speaker 00: The head start we don't. [00:10:28] Speaker 03: So you will offer that argument without any support? [00:10:31] Speaker 00: Oh no, certainly not, Your Honor. [00:10:34] Speaker 00: The evidence in the record about the authorized generic and other potential market entrants appears in the confidential version of the appendix, for example, at pages 96, 78 to 79, Your Honor. [00:10:55] Speaker 00: I would say that Dr. Reddy's was the first company to defeat the plaintiffs in the Hatch-Waxman litigation. [00:11:03] Speaker 00: It was the first and also to receive FDA approval. [00:11:07] Speaker 00: And so we had, as of June, a significant first mover advantage. [00:11:10] Speaker 00: Right now, we believe we still have a significant first mover advantage if we can get onto the market. [00:11:16] Speaker 00: If, however, this injunction drags on, every day it drags on, the head start we got by getting, by defeating them in Hatch-Waxman and getting the FDA approval erodes further. [00:11:25] Speaker 00: And every day is a day in which the tens of thousands of people who can't use the tablets are left without access to the underlying active ingredients. [00:11:34] Speaker 00: And you don't have to take our word for it, the significance of the film over the tablets. [00:11:38] Speaker 00: You can actually look at plaintiff's brief and the copending appeal from the Delaware litigation. [00:11:44] Speaker 00: What they say in their brief in the Delaware litigation, and this is at, excuse me, this is at page eight in their brief in the Delaware case. [00:11:54] Speaker 00: They point out that the tablet, as opposed to the film, presents abuse risks. [00:11:58] Speaker 00: And these, these are, you know, are, are patients who are, have an opioid abuse disorder. [00:12:03] Speaker 00: They also say that many patients have difficulty with the tablets, which, as I explained earlier, need to be kept under the tongue for six minutes. [00:12:11] Speaker 00: And that patients who swallow a tablet before it's dissolved do not receive the proper dose. [00:12:14] Speaker 00: So in the Delaware case, plaintiffs themselves are touting the advantages of the film over the existing generic tablet. [00:12:21] Speaker 04: What are, which particular paper are you referring to in Delaware? [00:12:24] Speaker 00: So I'm referring to the plaintiff's opening brief in the, the co-pending Delaware. [00:12:29] Speaker 00: In the appeal. [00:12:30] Speaker 00: Appeal. [00:12:30] Speaker 04: Before this court. [00:12:31] Speaker 00: Right, which is case number 172587, Your Honor. [00:12:34] Speaker 00: So, so going back, sorry, Your Honor. [00:12:41] Speaker 03: Well, no, we're into your rebuttal time. [00:12:43] Speaker 03: You can use it or not as you wish. [00:12:46] Speaker 00: I'll, I'll wait, Your Honor. [00:12:47] Speaker 00: Thank you. [00:12:55] Speaker 03: Mr. Ellicott. [00:13:00] Speaker 01: Ellicott may please the Court. [00:13:01] Speaker 01: I have a few quick points I'd like to make. [00:13:06] Speaker 01: The claims of the 305 patent are different from those that were litigated in Delaware in the 514 patent. [00:13:12] Speaker 01: They don't contain the words dried and dry. [00:13:16] Speaker 01: Indeed, not only are they not there, they were deleted. [00:13:20] Speaker 01: And under the law of this Court, in Blackburn, [00:13:23] Speaker 01: in Laryngeal and other cases, that fact means that the person with ordinary skill in the art, reading the claims, reading the specification in the prosecution history, will understand that that is no longer part of the claims. [00:13:38] Speaker 02: Kennedy But the product being described in the patent, both patents, one's a continuation of the other. [00:13:47] Speaker 02: The specification is the same, right? [00:13:52] Speaker 01: I'm sorry. [00:13:53] Speaker 01: I mean, drying will necessarily take place to have a final film. [00:14:00] Speaker 01: The film has to be dried, otherwise there's nothing to put under the tongue. [00:14:04] Speaker 01: That doesn't mean that drying is claimed, and it doesn't mean that how drying is performed is in any way limited. [00:14:13] Speaker 01: The specification, when you look at what continuously cast film means, [00:14:18] Speaker 01: and how it's restricted is very clear and the judgment multi-found accordingly. [00:14:24] Speaker 01: For example, there's a portion of the specification which describes viscosity, and this is in column 5, as an entirely different approach to controlled drying, to achieve uniformity. [00:14:36] Speaker 01: It's described as an alternative. [00:14:38] Speaker 01: Once dried and drying are not part of the claim, then the issue of what happens in, happened in Delaware, [00:14:47] Speaker 01: is no longer important here. [00:14:48] Speaker 01: There's been a concession. [00:14:49] Speaker 01: There must be a textual hook. [00:14:52] Speaker 04: I'm sorry. [00:14:52] Speaker 04: How do you respond to this Court's decision in SIMED life systems versus advanced cardiovascular, where in the context of claim construction, this Court said that it doesn't matter. [00:15:05] Speaker 04: It said, where the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent. [00:15:14] Speaker 04: even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question. [00:15:23] Speaker 04: So even though the word drying is not in the claim, the argument being that based on cases like Symed, that specification disclaimer still is operative. [00:15:36] Speaker 01: Your Honor, in MBO and in Pacing, which is one of the cases that [00:15:41] Speaker 01: that DRL is relied on, it's very clear that you need a textual hook. [00:15:47] Speaker 04: That's why they're... I'm not limited to the cases they're relying on. [00:15:49] Speaker 01: I understand. [00:15:50] Speaker 04: I should be looking at all of this Court's precedent, and this is a case that this Court has decided. [00:15:55] Speaker 01: And you're pointing to two such precedents that, at a minimum, would go the other way and require a textual hook that's pacing an MBO. [00:16:04] Speaker 01: The other thing here, these are composition claims. [00:16:08] Speaker 01: And what [00:16:09] Speaker 01: What we understand DRL to be doing is trying to import a limitation about process into the claims. [00:16:17] Speaker 04: Are you familiar with the case I'm asking you about? [00:16:20] Speaker 01: You're asking me about SIMED. [00:16:21] Speaker 04: SIMED v. Advanced Cardiovascular, where the claim was directed to a particular dilatation catheter. [00:16:28] Speaker 04: So it also was directed to a device or product. [00:16:33] Speaker 01: And I don't know whether this was addressed in the opinion, but there's a bar. [00:16:38] Speaker 01: to simply reading and process claims from Baldwin and Vanguard. [00:16:44] Speaker 01: And I don't know whether Simon had addressed that. [00:16:46] Speaker 01: That was addressed in the Medicines case that DRL relies on. [00:16:51] Speaker 01: In the Medicines case, the key, and this is in a footnote in the opinion, is efficient mixing was allowed to be read into the composition claim because the batches limitation of which it formed a part had been defined [00:17:06] Speaker 01: in terms of a particular process. [00:17:09] Speaker 01: We don't have that here. [00:17:10] Speaker 01: And the Medicines case suggests in that footnote the decision would have been different otherwise under Vanguard and Baldwin. [00:17:19] Speaker 01: So we believe a textual hook is required. [00:17:22] Speaker 01: The textual hook identified was continuously cast film, it seems. [00:17:27] Speaker 01: Initially, there was an emphasis below that there need be no textual hook, that there is a freestanding disclaimer. [00:17:35] Speaker 01: There was no finding of a freestanding disclaimer. [00:17:38] Speaker 01: The decision below is rooted in the words dried and dry. [00:17:42] Speaker 01: But on continuously cast film, I think there's something very important that the court needs to understand. [00:17:48] Speaker 01: DRL admitted, this was in the Delaware proceeding, that its film was a cast film. [00:17:57] Speaker 01: And that's part of the record in this case. [00:18:00] Speaker 01: It's exhibit 32 to the Langer Declaration. [00:18:04] Speaker 01: That's a docket entry 71. [00:18:07] Speaker 01: It's also clear from Appendix 4040 from the trial opinion that there was an admission that DRL's film was a cast film. [00:18:18] Speaker 01: And in this case, when trying to argue that the claims were essentially the same, DRL said that a cast film means materially the same thing as a continuously cast film. [00:18:31] Speaker 01: That's at 356 in the oral argument. [00:18:34] Speaker 01: It's at 59.62, and it's in Dr. Amici's declaration at 59.22 to 23. [00:18:42] Speaker 01: So there's been an admission, essentially, that their film is a continuously cast film. [00:18:49] Speaker 01: That's crystal clear. [00:18:51] Speaker 01: We heard reference to, Your Honor, I don't know if I've answered your question fully. [00:18:57] Speaker 01: I was gonna move on to a different issue. [00:19:00] Speaker 04: Oh, no, you answered my question. [00:19:02] Speaker 04: I think your response is, I understand. [00:19:05] Speaker 04: Okay. [00:19:07] Speaker 01: Thank you. [00:19:11] Speaker 01: So I had pointed already to the important distinction between a composition and a method claim. [00:19:18] Speaker 01: There are various steps that would need to occur to make a cast film. [00:19:24] Speaker 01: For example, mixing. [00:19:26] Speaker 01: Yet there would be no reason to start adding mixing limitations to this claim. [00:19:31] Speaker 01: even if those are necessary or integral. [00:19:33] Speaker 01: That was the Mark and Imagi case, where there was a claim to a data, a tape spooling device, and there was no mention in the claim of a method for measuring tension. [00:19:51] Speaker 01: And the Court said that can't be read in, even though it's necessary to the operation of the invention. [00:19:59] Speaker 01: And the example given [00:20:01] Speaker 01: I think it's very helpful. [00:20:02] Speaker 01: A claim to an engine providing motive power to a car should not be construed to incorporate a limitation for an exhaust pipe, though an engine may not function without one. [00:20:15] Speaker 01: That's essentially what's going on here. [00:20:17] Speaker 01: They're saying, oh, since the claim, since the film [00:20:22] Speaker 01: must perforce be dried, we can take whatever the judge construed dried and drying to mean and put it in here, even though those words are not part of the claim. [00:20:34] Speaker 01: And then I had mentioned Baldwin and Vanguard. [00:20:38] Speaker 01: Baldwin, the courts said in that case, and this was a key, again, in the medicine's decision distinguishing Baldwin, courts must generally take care to avoid reading [00:20:51] Speaker 01: process limitations into an apparatus claim. [00:20:54] Speaker 01: And in Vanguard, a novel product that meets the criteria of patentability is not limited to the process by which it was made. [00:21:02] Speaker 04: Your Honor, I take it that you are making some of these very arguments in your appeal from Judge Andrews' decision in the Delaware case. [00:21:11] Speaker 01: Your Honor, the appeal which will be heard in the first quarter of this, this, this year [00:21:18] Speaker 01: We're arguing that there shouldn't be any disclaimer attaching to the words dried and drying. [00:21:25] Speaker 04: Are you arguing in that based on the same argument you're presenting here about how there shouldn't be this limitation, this kind of process, shouldn't be read into the claim? [00:21:34] Speaker 01: We're certainly arguing in that case, among other things, that process limitations should not be read into composition claims. [00:21:43] Speaker 01: But just because the judge in Delaware, we believe, erred [00:21:49] Speaker 01: in reading dried and drying as process limitations, that's a different issue from here. [00:21:55] Speaker 01: The same principle applies. [00:21:57] Speaker 01: We're certainly not precluded from pointing to Baldwin. [00:22:00] Speaker 04: I understand, but you're looking at a likelihood of success issue in a preliminary injunction, where some of the arguments, the legal arguments that you're making, are going to form the basis of the arguments you're making in your other appeal, where a district court has already ruled against you. [00:22:15] Speaker 04: Doesn't that kind of undermine your likelihood of success argument? [00:22:19] Speaker 01: Your Honor, there's a likelihood of success here that the court in Delaware, and this is at Appendix 2007, it addressed the whole issue of what had been decided in Delaware. [00:22:31] Speaker 01: And the, and Judge McNulty, the district court judge said, this is referring to the Delaware judge, he found that, and give you a disclaimed conventional convection air drying from the top. [00:22:45] Speaker 01: Judge McNulty was fully aware of what was determined in Delaware and determined based on these were the words in these claims, in claim one, claim 62, which don't have dried and drying. [00:22:59] Speaker 04: So the difference is whether the language continuously cast film requires drying or not. [00:23:07] Speaker 04: The other claim has drying. [00:23:08] Speaker 01: The other, the claims in the 514 patent had drawing in. [00:23:13] Speaker 01: When we received the, the ruling with which we did not agree, Equestive deleted those words from the claim, lest the person of ordinary skill and the art would be confused in any way. [00:23:25] Speaker 01: They're gone from the claims that are, that are asserted here. [00:23:29] Speaker 01: So we're in a different situation as far as likelihood of success on the merits is concerned. [00:23:35] Speaker 01: We've established the likelihood of success on the merits [00:23:38] Speaker 01: based on these claims without dry and drying with the judge fully aware of what had taken place. [00:23:42] Speaker 01: That formed the majority of the argument below. [00:23:45] Speaker 01: We believe as well that we're going to succeed in removing the disclaimer from dried and drying in the Delaware case. [00:23:55] Speaker 01: And now the Court, on an abuse of discretion standard, is weighing whether it should upset the apple cart, irreparably change the market, [00:24:08] Speaker 01: irreparably harming indivior and equestive, that is what would happen if there is no preliminary injunction, when in a few months' time, if there's no disclaimer, even when the words dried and drying are there, the claim preclusion, issue preclusion, and written description arguments go away. [00:24:31] Speaker 01: We've heard about other factors. [00:24:35] Speaker 01: There are four factors here. [00:24:37] Speaker 01: There isn't any [00:24:38] Speaker 01: any serious argument about any legal error or clear error. [00:24:44] Speaker 01: The court looked at the evidence on irreparable harm, and in this case, 99 percent of Indivior's U.S. [00:24:54] Speaker 01: revenue derives from Suboxone film. [00:24:59] Speaker 01: There will be a number of people whose jobs will be lost if DRL is permitted to resume its launch. [00:25:08] Speaker 01: And there are products that will help people treating who need help with other dependence addictions, treatments for cocaine addiction, alcohol addiction. [00:25:22] Speaker 01: All of that will be put on hold. [00:25:25] Speaker 01: We don't know whether it will resume or not. [00:25:28] Speaker 01: That's the stuff of irreparable harm. [00:25:30] Speaker 01: Now, DRO, my friend at DRO, will certainly disagree with what happened below, but that's not the stuff. [00:25:37] Speaker 01: of an abuse of discretion. [00:25:40] Speaker 01: On the court, we'll look below also at the competing public interest. [00:25:46] Speaker 01: We don't know what price DRL will, would price its product at exactly. [00:25:52] Speaker 01: That's not in the record. [00:25:54] Speaker 01: But it assures that it will be cheaper. [00:25:57] Speaker 01: But in this case, the Court found that Indivior would not be able to [00:26:04] Speaker 01: launch, develop other products they'd be delayed for on average two years. [00:26:10] Speaker 01: So while DRL may disagree with the district court below, that's not the stuff of clear error and it's not the stuff of an abuse of discretion. [00:26:26] Speaker 01: I'm reminded of, I don't remember the case, but Judge Friendly is often quoted on the standard for abuse of discretion. [00:26:34] Speaker 01: It's as if the reviewing court must have a sense that the district court had come close to losing its senses. [00:26:40] Speaker 01: We don't have such a thing here. [00:26:43] Speaker 01: There is no abuse of discretion. [00:26:46] Speaker 01: DRL didn't even come forward with claim constructions. [00:26:50] Speaker 02: I don't think losing his sentence is part of our case law. [00:26:54] Speaker 01: I'm sorry, Your Honor. [00:26:55] Speaker 02: I don't think losing his sentence is part of our case law precedent. [00:27:01] Speaker 01: decision of this Court about 20 years ago, but I couldn't cite chapter and verse. [00:27:08] Speaker 01: I didn't look into that. [00:27:12] Speaker 01: Here we have a preliminary record. [00:27:15] Speaker 01: The judge pointed to the preliminary nature of the record. [00:27:21] Speaker 01: The witnesses were not provided. [00:27:22] Speaker 01: The Court looked at the patent. [00:27:27] Speaker 01: Luke saw that the continuously cast film [00:27:30] Speaker 01: can be made in many, many ways that the claim, presumably you saw that the claim also is a composition claim, not a process claim, and refused to allow DRL to import that limitation here. [00:27:46] Speaker 01: There is no reason now why that should happen through the reviewing court. [00:27:51] Speaker 01: We pointed to the case, the Rico decision, which held that even under those circumstances, the issue of claim construction. [00:27:59] Speaker 01: is reviewed or can be reviewed under an abusive discretion standard. [00:28:05] Speaker 01: Again, the market would be irretrievably changed, indivior and acquestive, irreparably harmed, and all of this would be for naught. [00:28:19] Speaker 01: Not only if we win at the end of the case, as we expect to do, but if this Court [00:28:25] Speaker 01: decides that there was no disclaimer in the first case when it hears arguments in just a few months' time. [00:28:33] Speaker 01: Unless the Court has questions. [00:28:38] Speaker 03: Thank you, Your Honor. [00:28:48] Speaker 00: There was a lot of discussion just now about what the standard is of review. [00:28:54] Speaker 00: An abuse of discretion is always committed when a district court makes an error of law. [00:28:58] Speaker 00: The application of claim preclusion is a question of law. [00:29:00] Speaker 00: The application of issue preclusion based on Judge Andrew's decision is a question of law. [00:29:05] Speaker 00: Claim construction is a question of law. [00:29:07] Speaker 00: These are all legal issues that we think Judge McNulty committed error with respect to. [00:29:13] Speaker 00: Plaintiffs' Council argued that the word dried was deleted. [00:29:16] Speaker 00: The word dried was not deleted. [00:29:17] Speaker 00: This is not a case like MBO where some claims said that there had to be [00:29:22] Speaker 00: an immediate retraction of a needle and other claims left out the word immediate. [00:29:26] Speaker 00: Here the word dried was replaced with different phrases. [00:29:30] Speaker 00: The final limitation of the claim in the 514, which referred to measuring uniformity in the matrix subsequent to casting and drying, was replaced with a phrase measuring uniformity in the continuously cast film. [00:29:44] Speaker 00: Plaintiffs repeatedly argued below in response to our anticipation argument that when that uniformity is measured in the continuously cast film, [00:29:52] Speaker 00: It's after drying that the continuously cast film is exactly the same thing as a matrix subsequent to casting and drying. [00:29:59] Speaker 00: And the language here could not be clearer. [00:30:01] Speaker 00: Page 379 in the appendix, for example. [00:30:04] Speaker 00: The fact of the matter is the claim is to the final film, and that film has been dried. [00:30:09] Speaker 00: Page 327, the final film of the 305 patent claims is dried. [00:30:14] Speaker 00: They repeatedly argued below that this just, that the film's in the 305, just like the film's in the 514. [00:30:21] Speaker 00: despite starting out as a flowable matrix, wind up as a dried film. [00:30:25] Speaker 00: Drying is an element of these claims. [00:30:28] Speaker 00: There was a suggestion that a person of skill in the art would not read these claims as requiring drying. [00:30:34] Speaker 00: Here's what their expert actually said. [00:30:35] Speaker 00: This is page 10,099 in the appendix. [00:30:38] Speaker 00: A person of ordinary skill in the art reading the claims of the 305 patent would understand that drying occurs. [00:30:44] Speaker 00: So you go from a wet matrix, you wind up with a final dried film. [00:30:48] Speaker 00: That's when you measure uniformity. [00:30:49] Speaker 00: It is exactly the same thing in the 514 and the 305. [00:30:53] Speaker 00: This is a, this really should be a textbook case for, for claim preclusion under simple error. [00:30:59] Speaker 00: Because plaintiffs have identified no other differences between the, the two claimed films. [00:31:04] Speaker 00: plaintiffs council argued that we're trying to read a process limitation into a, what is a composition claim. [00:31:10] Speaker 00: That is not the case. [00:31:12] Speaker 00: These claims are limited to films which are cast films. [00:31:15] Speaker 00: The specification explains that there are various methods of making a film. [00:31:18] Speaker 00: You can have cast films, you can have extruded films, you can have cast films that are cast into sheets, you can have cast films that are cast into individual wells. [00:31:27] Speaker 00: These films must be films which are created through a continuous casting method, a particular process. [00:31:32] Speaker 00: In fact, plaintiffs distinguish the prior art during prosecution on the basis of the process used to make these claimed films. [00:31:41] Speaker 00: If you look at [00:31:43] Speaker 00: For example, page 4357 in the appendix, the patent prosecutor, this is the very last office action for the 305 patent, distinguished prior art which cast into wells rather than into a particular sheet. [00:31:56] Speaker 00: They were distinguishing the prior art based on the process. [00:31:59] Speaker 00: If you look at Dr. Langer, their expert's declaration below, he again distinguished the prior art on the basis of the process. [00:32:06] Speaker 00: This is at page 1316 in the appendix. [00:32:08] Speaker 00: So the requirement that a particular process be used is right in the claim, and they relied upon that to get these patents issued. [00:32:16] Speaker 00: They relied upon it to address potential anticipation and obviousness arguments below. [00:32:21] Speaker 00: This case in that way is just like Medicines Co. [00:32:24] Speaker 00: Here, there's a requirement of a cast film. [00:32:27] Speaker 00: In Medicines Co., there was a requirement that the film be created through a compounding process. [00:32:32] Speaker 00: And what this court said in rejecting an argument that there was an improper effort to read a process limitation [00:32:38] Speaker 00: into the claims, it said, and this is at page 1304 of the Medicines Co. [00:32:42] Speaker 00: versus Milan decision, our decision does not impermissibly add a process limitation to a product claim that does not require a process because the specifications definition of batches by itself imports a compounding process, injects a compounding process as a limitation. [00:32:59] Speaker 00: Here we don't have to go to the specification to see that a certain process is required to make this composition. [00:33:04] Speaker 00: It's in the claim itself. [00:33:05] Speaker 00: It has to be made with a casting process. [00:33:08] Speaker 00: On the question of why the court should address these issues now and not just wait, which I think was suggested, plaintiffs actually opposed our motion to expedite this appeal and argued to the motions panel that there was no reason to hear this case quickly, just wait for the 514 case. [00:33:25] Speaker 00: Obviously, the motions panel rejected that suggestion because this was set down for an expedited appeal. [00:33:30] Speaker 00: We have no idea when the 514 case will be argued. [00:33:33] Speaker 00: We have no idea when that case will be decided. [00:33:35] Speaker 00: What we do know is that in the meantime, there are many people who are not getting treatment they need from a generic version of the film. [00:33:40] Speaker 00: And that DRL's opportunity to enjoy its first mover advantage, which it gained by winning the Hatch-Waxman litigation in Delaware and getting FDA approval, is eroding every day. [00:33:50] Speaker 00: If plaintiffs thought they had a good argument on the 514 case, what they could have done is go to Judge Andrews and sought an injunction pending the appeal. [00:34:00] Speaker 00: They then could have come to this court on the 514 case and sought an injunction pending appeal. [00:34:05] Speaker 00: They didn't do that. [00:34:06] Speaker 00: Instead, they took this 305 patent, which is not patentably distinct from the 514 case, and sought emergency relief from a different district court judge without all of Judge Andrew's familiarity with the underlying technology and the claim construction gained through a Markman hearing and a full week-long trial, and got him to enter a TRO and an injunction on an emergency basis. [00:34:27] Speaker 00: And now we're fighting that injunction. [00:34:29] Speaker 00: That never should have happened under simple layer. [00:34:32] Speaker 00: done this through the 514 if they thought they had a good case. [00:34:34] Speaker 00: And the fact they didn't, I believe, is telling on the preliminary injunction standard, where they're required to show a likelihood of success in the merits. [00:34:42] Speaker 00: Are there no further questions? [00:34:44] Speaker 03: Thank you, Your Honor. [00:34:45] Speaker 03: Thank you. [00:34:45] Speaker 03: Thank you both. [00:34:46] Speaker 03: The case is taken under submission. [00:34:48] Speaker 03: That concludes the article of the cases for this morning's trial. [00:34:53] Speaker 01: All rise. [00:34:58] Speaker 01: The Honorable Court is adjourned from day to day.