[00:00:00] Speaker 01: 136, Shire versus O'Neill Pharmaceuticals. [00:00:42] Speaker 00: Mr. Reed, please proceed. [00:00:48] Speaker 01: You're intending to use only eight minutes and reserve three for rebuttal, correct? [00:00:52] Speaker 04: That's right. [00:00:53] Speaker 01: Your clock says 11. [00:00:54] Speaker 01: So just be aware that it's not set for eight. [00:00:57] Speaker 01: So if you go over eight, you're using your rebuttal time. [00:01:00] Speaker 04: Thank you for the reminder. [00:01:03] Speaker 04: May it please the court? [00:01:04] Speaker 04: Good morning. [00:01:05] Speaker 04: Matthew Reed on behalf of all appellants, defendants below. [00:01:09] Speaker 04: We're here today because the district court [00:01:12] Speaker 04: improperly granted plaintiff's motion for summary judgment of no invalidity, despite numerous genuine issues of material fact. [00:01:22] Speaker 04: In its decision below, the district court committed significant errors, including two that I'll highlight. [00:01:28] Speaker 04: First, it failed to consider two key prior art references that are at the heart of defendant's invalidity case, and second, [00:01:38] Speaker 04: it failed to consider the evidence defendant submitted in the form of expert testimony. [00:01:43] Speaker 04: Absent these errors, summary judgment never would have been entered. [00:01:48] Speaker 04: Because of these errors, this court should vacate the district court judgment and remand the case for trial where it is appropriate to weigh evidence and decide factual issues. [00:02:00] Speaker 04: Of course, on summary judgment, the district court must view the evidence in the light most favorable to the non-moving party [00:02:08] Speaker 04: And here, the district court did not. [00:02:11] Speaker 04: The district court's opinion contains many examples of the errors it committed. [00:02:16] Speaker 04: First and foremost, it did not consider the Miller patent and the Abramich article. [00:02:22] Speaker 00: Can I just be clear about something? [00:02:24] Speaker 01: You say he didn't consider expert testimony. [00:02:27] Speaker 01: I thought not only he considered it, but I thought the opinion at least mentioned that he concluded it wasn't sufficient. [00:02:34] Speaker 01: So are you saying he didn't consider it, or he didn't do right by it? [00:02:38] Speaker 01: He didn't properly analyze it the way you'd like him to? [00:02:41] Speaker 01: Because there's a difference, obviously. [00:02:43] Speaker 01: Not considering it makes it seem like he was oblivious to it. [00:02:46] Speaker 01: And I thought his opinion actually expressly referenced it. [00:02:50] Speaker 01: Am I misremembering? [00:02:52] Speaker 04: In fact, he did both. [00:02:54] Speaker 04: And there are numerous instances of both. [00:02:56] Speaker 01: So he referenced something, but nonetheless, you think it's fair to represent he didn't consider it? [00:03:01] Speaker 04: Exactly. [00:03:02] Speaker 04: There are different issues and uncertain issues. [00:03:05] Speaker 04: He failed to consider it entirely. [00:03:07] Speaker 01: And on other issues. [00:03:08] Speaker 01: He failed to consider it or he failed to mention those issues? [00:03:11] Speaker 04: Well, he failed to certainly expressly reference it. [00:03:15] Speaker 04: And in so doing, failed to account for it in the opinion that he wrote. [00:03:21] Speaker 04: In granting summary judgment of no invalidity when defendants submitted expert testimony on a particular issue and it was not even mentioned in his opinion, [00:03:32] Speaker 04: that certainly suggests that there was sufficient evidence on which a trier of fact could have found in defendant's favor. [00:03:39] Speaker 04: And so summary judgment was not appropriate. [00:03:42] Speaker 01: So I just want you to be a little more precise. [00:03:45] Speaker 01: What it just sounded like you said to me was the district court's failure to mention something pretty much automatically means there was enough evidence that summary judgment should have been granted. [00:03:55] Speaker 01: I really feel like that's not the legal standard that we ever apply. [00:03:59] Speaker 04: Well, in fact, what the district court did at page 32 of the opinion is he said that the defendants did not quote, provide any reason why the skilled artisan would have selected lysine, close quote, where there is a conjugation between L lysine and D amphetamine. [00:04:19] Speaker 04: The district court said that the defendants did not provide any reason why a skilled artisan would choose lysine when in fact we did. [00:04:27] Speaker 04: We submitted both prior references, the two references that the district court did not mention, Miller and Abramich, and we submitted significant expert testimony describing why those particular references particularly teach the use of lysine. [00:04:45] Speaker 04: If I can explain in a little more detail, this conjugation between L-lysine and D-amphetamine results from an amino acid and the D-amphetamine [00:04:55] Speaker 04: and that is taught explicitly in the 168 reference that the court did consider and the district court did discuss in its opinion. [00:05:04] Speaker 04: But the Miller patent, which the court neither mentioned nor described. [00:05:13] Speaker 04: There was a footnote in which the district court referred in passing to two references. [00:05:17] Speaker 04: I think that if you trace the reference there that what the district court is referring to is the use of Miller and Stein [00:05:25] Speaker 04: to references regarding progress. [00:05:27] Speaker 01: So you just said he didn't even reference Miller anywhere, but now you're telling me, well, he did reference Miller in a footnote, correct? [00:05:32] Speaker 04: He referenced Miller in a footnote, but he did not reference it in the context of L-lysine, when he explicitly said that defendants didn't give a reason why L-lysine would be selected. [00:05:45] Speaker 04: In fact, L-lysine was one of the listed amino acids, both in the 168 reference and in the Miller reference. [00:05:53] Speaker 04: And then the Abramich reference [00:05:55] Speaker 04: explicitly talks about the use of lysine and in fact teaches that it is one of the best amino acids to use in this kind of conjugation when what you want to do is you want to find enzymatic cleavage in the body between the amino acid and the underlying compound where it's an aromatic ring. [00:06:16] Speaker 04: And that amide bond in between those two constituents is targeted specifically by lysine. [00:06:24] Speaker 04: One of ordinary skill in the art would recognize that the teachings of these three references in combination, the 168, Miller, and Abramich, are sufficient on which a trior fact could decide that these, that lysine is a preferred amino acid for the conjugation reaction. [00:06:43] Speaker 01: Even if you're right about what you're saying, wouldn't there have been an incredibly large number of salts that could be made? [00:06:49] Speaker 01: Just the examples given are [00:06:52] Speaker 01: 1496 possible faults and formula four just goes to 1496 possible faults. [00:07:01] Speaker 01: I feel like even if you are correct that that was a problem in the district court opinion, you then also have to get over the other hurdle of whether or not there are such an absurd number of possibilities to try that this one would have been the obvious one to select out. [00:07:19] Speaker 04: Certainly, there are these two pieces of the puzzle here. [00:07:23] Speaker 04: There's the conjugation between L-lysine and D-amphetamine, and then there's the second piece of creating the dimethylate salt. [00:07:30] Speaker 04: And at page 31 of the district court's opinion, the district court asks, why would a skilled artisan be motivated to modify Lisdexamphetamine, the conjugation, to make the dimethylate salt? [00:07:44] Speaker 04: Defendants submitted evidence from an expert with decades of experience in salt selection and salt preparation, Dr. Atwood. [00:07:52] Speaker 04: Dr. Atwood offered testimony about the 168 reference and the Miller reference and Baerge and Byley references, describing how one of ordinary skill in the art would read those references. [00:08:05] Speaker 04: And in particular, he testified that one reading, the 168 reference, [00:08:11] Speaker 04: would recognize the use of P toluene sulfonic acid to create a salt. [00:08:16] Speaker 04: It's explicitly taught in the 168 reference. [00:08:19] Speaker 04: In the Miller reference, it's explicitly taught to use methane sulfonic acid. [00:08:25] Speaker 04: So it would be a simple substitution of using methane sulfonic acid to create the dimethylate salt. [00:08:32] Speaker 04: There's no question that the methane sulfonic acid results in the dimethylate salt here. [00:08:38] Speaker 04: By the way, plaintiff's counsel agreed that the purpose [00:08:41] Speaker 04: in formulating the salt is for use in a pharmaceutical composition. [00:08:47] Speaker 04: At the oral argument before the district court on summary judgment, counsel for plaintiffs was questioned repeatedly about the purpose, and the intended purpose, as he admitted, was for use in a pharmaceutical composition. [00:09:01] Speaker 04: The 168 reference teaches the preparation of salts conjugated by way of acid addition salts. [00:09:12] Speaker 04: Certainly, the defendant submitted evidence about one of ordinary skill in the art, the level of skill in the art, and that was never determined by the district court. [00:09:24] Speaker 04: The district court should have recognized the first gram factor consists of evaluating the level of skill in the art, but he failed to make that determination. [00:09:35] Speaker 04: Unless the court has additional specific questions at this point, I'll reserve the remainder of my time for rebuttal. [00:09:40] Speaker 00: Okay. [00:09:41] Speaker 00: Thank you, Mr. Reed. [00:09:42] Speaker 00: Mr. Atrello. [00:09:52] Speaker 03: Thank you, Your Honors. [00:09:52] Speaker 03: May it please the court. [00:09:54] Speaker 03: Johnson-Matthee joins in the invalidity argument. [00:09:58] Speaker 01: Why isn't Forrest [00:09:59] Speaker 01: finding on us, whether I wanted to go a different route or not, why do I even have that option after Forest? [00:10:06] Speaker 03: I think you have that option because Forest doesn't address the question presented here. [00:10:11] Speaker 03: Forest was a narrow decision. [00:10:15] Speaker 03: It did not involve any liability questions. [00:10:18] Speaker 03: There was a stipulation of liability in that case. [00:10:21] Speaker 01: No, actually there wasn't. [00:10:22] Speaker 01: Did you pull the stipulation? [00:10:23] Speaker 01: I did pull the stipulation. [00:10:24] Speaker 01: I have it here in front of me as well, because I didn't understand how you argued that CIFLA had stipulated to infringement [00:10:32] Speaker 01: based on the language in Judge Laurie Forrest's opinion. [00:10:35] Speaker 01: So I thought, well, maybe you know something I don't. [00:10:38] Speaker 01: Stipulation doesn't. [00:10:39] Speaker 01: Did you look at both stipulations? [00:10:41] Speaker 03: Well, one of them said that CIPLA and IVEC stipulated that they are jointly liable for infringement. [00:10:47] Speaker 01: No. [00:10:47] Speaker 01: No, no, no, no. [00:10:48] Speaker 01: False. [00:10:48] Speaker 01: They said they would be jointly liable for any such infringement. [00:10:52] Speaker 01: Would be. [00:10:53] Speaker 01: And the predicate sentence before that is, if the product is sold commercially in the United States following approval, they would be liable. [00:11:01] Speaker 01: They simply never stipulated to any current liability of any kind. [00:11:06] Speaker 03: Correct, Your Honor. [00:11:07] Speaker 03: And that's really the point. [00:11:08] Speaker 03: And if the brief was misleading on that, I apologize. [00:11:11] Speaker 03: It was certainly not our intent. [00:11:14] Speaker 03: The court in Forrest did not decide any infringement issues. [00:11:18] Speaker 03: In fact, the court made a point of saying, and this is at page 1266 of the opinion, that the district court had, because of the stipulation, the district court had only had to decide the validity issues presented by the counterclaims. [00:11:30] Speaker 03: So there were no liability issues before the court. [00:11:34] Speaker 03: The issue in Forrest was whether the injunction entered pursuant to that stipulation could properly include CIPLA as well as IVACs. [00:11:42] Speaker 05: But wasn't the subject matter jurisdiction question with regard to CIPLA before the district court? [00:11:50] Speaker 05: Subject matter jurisdiction? [00:11:51] Speaker 05: In other words, the same issue that we're discussing here was presented in the district court [00:12:00] Speaker 05: in the Forest case, was it not? [00:12:04] Speaker 03: I don't believe so, Your Honor. [00:12:05] Speaker 03: I don't believe that CIPLA argued that it could not be liable for infringement because of the safe harbor, which is, of course, Johnson-Maffey's argument here. [00:12:16] Speaker 05: Well, it was an order issued by the district court in March of 2005 based on a motion, CIPLA's motion, to dismiss for lack of subject matter jurisdiction [00:12:30] Speaker 05: Sipla contends the court lacks jurisdiction because the Hatch-Waxman Act does not confer subject matter jurisdiction over the aiding and abetting of an ANDA file. [00:12:40] Speaker 03: Right. [00:12:41] Speaker 03: And I believe that Sipla's argument was the action was for infringement under 271E2, which is if you file an ANDA, you can be charged with infringement. [00:12:51] Speaker 03: And I believe Sipla's argument was that it could not be held liable for that kind of infringement, which [00:12:59] Speaker 03: We believe here, too, I don't believe that that technically is really a subject matter jurisdiction argument. [00:13:03] Speaker 03: That really goes to whether you committed the act of infringement. [00:13:08] Speaker 01: But the dissent expressly says that CIPLA argued E1 goes through it, and the majority addresses whether or not CIPLA qualifies under E1 and whether that would exempt them from being able to be found liable or the scope of the injunction. [00:13:24] Speaker 01: I don't understand how you can argue that that is a distinction between that case and this case. [00:13:29] Speaker 03: Here's the distinction, Your Honor. [00:13:32] Speaker 03: In Forrest, the question was the scope of the injunction. [00:13:38] Speaker 03: What the court did have to say about infringement is it said that nothing up to that point was infringement, including supplying the API and information concerning it for use in the ANTA. [00:13:49] Speaker 03: That's the point we're at here. [00:13:51] Speaker 03: We're only up to that point here. [00:13:54] Speaker 03: What the court with the injunction in Forrest had to do with the potential for future infringement. [00:14:01] Speaker 03: And I would submit that to the extent that you read Forrest to say that there can be present inducement liability for something that may happen in the future, it didn't survive limelight. [00:14:12] Speaker 03: Because limelight is very clear that to have inducement liability today, you have to have some underlying direct infringement today. [00:14:19] Speaker 01: Yeah, but no. [00:14:20] Speaker 01: Limelight didn't change the law, Mr. Trela. [00:14:22] Speaker 01: I don't even like that you're making this argument. [00:14:24] Speaker 01: Because Limelight didn't change the law when it comes to the requirement of direct infringement. [00:14:29] Speaker 01: That's been established since Arrow. [00:14:31] Speaker 01: All Judge Bryson said in Limelight from our court was that there's a difference between direct infringement on the one hand and liability for direct infringement of the other. [00:14:40] Speaker 01: And Limelight clarified, uh-uh, no, there isn't. [00:14:43] Speaker 01: So I don't see how that could have affected what Judge Lurie was doing in Forrest. [00:14:47] Speaker 03: Well, what I'm suggesting to you is I don't think Judge Lurie [00:14:53] Speaker 03: was deciding that there was inducement liability on the part of the API supplier in Forrest. [00:15:00] Speaker 01: CIPLA has therefore actively induced the acts of IVACs that will constitute direct infringement upon approval of the ANDA. [00:15:07] Speaker 03: Your Honor, the key word is the act that will constitute direct infringement. [00:15:12] Speaker 01: But he doesn't say CIPLA will actively induce. [00:15:14] Speaker 01: He says CIPLA has therefore actively induced. [00:15:17] Speaker 03: But you can't actively induce something that hasn't happened. [00:15:21] Speaker 03: That's what limelight holds. [00:15:22] Speaker 03: And I understand that that was the law before then. [00:15:25] Speaker 03: And maybe it wasn't argued that way in forest. [00:15:27] Speaker 03: But if you read forest that way, it did not survive limelight. [00:15:30] Speaker 01: I don't understand, though, what your decision is premised on. [00:15:35] Speaker 01: I mean, you're nuancing the statutes. [00:15:36] Speaker 01: And I don't know that I would conclude you're wrong in your statutory interpretation analysis for the existence of forest, which I feel quite bound by. [00:15:46] Speaker 01: But what I don't understand is the scenario you're presenting happens all the time in DJ jurisdiction. [00:15:52] Speaker 01: Someone is imminently going to cause a harm to someone else, and you can seek and obtain an injunction to prevent that imminent harm. [00:16:01] Speaker 01: Upon approval, JM admits it's perfectly happy and willing to supply the drugs that would then harm the patentee. [00:16:08] Speaker 01: So why don't we, don't worry about your time, why don't we have a similar scenario here? [00:16:14] Speaker 01: Why doesn't this fall right into that well-established and accepted pattern? [00:16:20] Speaker 03: If we had an imminent risk of harm, subject, obviously, as Your Honor knows, for DJ action, you have to have immediacy in reality, the met immune factors. [00:16:31] Speaker 03: There was no showing of that here. [00:16:33] Speaker 03: There was no claim of that here. [00:16:34] Speaker 03: The district court, in fact, found that the ultimate potential infringement was remote and contingent on [00:16:42] Speaker 03: FDA approval and the generic decision to enter the marketplace. [00:16:46] Speaker 01: Did he actually say remote? [00:16:48] Speaker 03: He did use the word remote. [00:16:49] Speaker 03: He said two remote events, FDA approval and the generic entry into the marketplace. [00:16:55] Speaker 03: I think it's Appendix 16. [00:16:57] Speaker 01: So you're saying there's not sufficient immediacy to justify enjoining a supplier that does stand ready and willing to induce infringement. [00:17:10] Speaker 01: even if they haven't done it yet, because it's not sufficiently immediate. [00:17:14] Speaker 01: And that's why we should break stride with the notion that DJ judgment does allow for these sorts of injunctions. [00:17:23] Speaker 03: In this context, I believe that's right, Your Honor. [00:17:25] Speaker 03: And when you think about it, it makes sense, because the whole reason that Congress created the 271E2 technical act of infringement was because it needed to create some sort of a present dispute, a case or controversy, that federal courts could adjudicate. [00:17:40] Speaker 03: Because merely the filing of the ANDA. [00:17:42] Speaker 03: It wanted to move it up. [00:17:44] Speaker 03: It wanted to move it up, right. [00:17:45] Speaker 03: Because before that point, without the statute, there would not be immediacy in reality. [00:17:49] Speaker 03: You wouldn't have the imminence that you need for DJ jurisdiction or for a preliminary injunction. [00:17:55] Speaker 03: And so what E2 does, it creates that cause of action. [00:17:59] Speaker 03: It creates the current dispute that a federal court has to have to decide a case. [00:18:05] Speaker 03: And the other thing I would point you to, Your Honor, is E4. [00:18:09] Speaker 03: which specifies the remedies for an E2 active infringement. [00:18:14] Speaker 03: The court in Glaxo said these are the only remedies for E2 infringement, and the statute itself actually says the same thing. [00:18:22] Speaker 03: And there's no suggestion in there [00:18:25] Speaker 03: that other than in that context, that you can get a preliminary injunction against anybody other than the ANDA filer itself. [00:18:33] Speaker 03: It talks about the infringer, defines the active infringer. [00:18:36] Speaker 01: No, it says infringers, and certainly, for example, if your client was in charge of inducement, i.e., encouraging someone to file an ANDA, which was an active infringement, then wouldn't you agree that if that were the facts, which are not necessarily these facts as argued, that that would allow for, I mean, E4 says infringers, [00:18:55] Speaker 01: And couldn't someone be an induced infringer if they're encouraging the filing of an ANDA? [00:18:59] Speaker 03: I don't think so for a couple of reasons. [00:19:01] Speaker 03: One is I don't think, I think when it says an active infringement under E2, and it talks about infringer, I think it's talking about the person who infringed under E2, not 271B. [00:19:11] Speaker 03: And the other point, Your Honor, is if you've induced the filing of an ANDA, it's within the safe harbor. [00:19:19] Speaker 03: virtually by definition, reasonably related to the development and submission of the ANDA. [00:19:24] Speaker 03: You can't induce the filing of an ANDA by doing something that's not reasonably related to the submission of an ANDA. [00:19:29] Speaker 03: And that circles back to the whole reason that we shouldn't be here. [00:19:33] Speaker 03: And the reason, I think, that Forrest, if you carefully read, I think, pardon me, confirms that because, as I mentioned, Judge Lurie and Forrest said there has been no infringement up to this point. [00:19:45] Speaker 03: And that is the point we're at. [00:19:47] Speaker 01: The supply of any- And then you went on to hold the supplier nonetheless subject to an injunction. [00:19:53] Speaker 01: What's the harm to your client? [00:19:54] Speaker 01: Why are we here? [00:19:55] Speaker 01: Well, the harm to our client- Can we get any monetary damages? [00:19:58] Speaker 01: And I went back and looked, and the district court struck out by pencil, it looks like, the portions of the injunction that would otherwise apply to your client. [00:20:05] Speaker 01: So I'm not sure what really even is at issue here. [00:20:09] Speaker 03: Well, there are a couple of things at issue, Your Honor. [00:20:11] Speaker 03: One is there is a judgment against us for inducement [00:20:14] Speaker 03: It says we have induced infringement. [00:20:17] Speaker 03: The only direct infringement that could have occurred thus far as the filing of the ANDA, that's the safe harbor. [00:20:22] Speaker 03: We should not be subject to an inducement judgment for safe harbor activity. [00:20:27] Speaker 03: The other thing, Your Honor, is there's a policy question here. [00:20:29] Speaker 01: The whole purpose of... So would you be happy if we said your client has not yet induced infringement? [00:20:35] Speaker 01: However, under Forrest, that doesn't mean a court isn't capable of subjecting them to an injunction forward-looking. [00:20:43] Speaker 03: I wouldn't be thrilled with that. [00:20:45] Speaker 03: It's better than what we've got, certainly. [00:20:48] Speaker 03: I think the correct answer, Your Honor, is to reverse the judgment of inducement, because for multiple reasons we cannot be liable for inducing infringement today. [00:21:01] Speaker 03: And then in the future, frankly, if the Andes are approved, [00:21:05] Speaker 03: And Johnson Matthew is supplying the API for that. [00:21:09] Speaker 03: The normal infringement process applies. [00:21:12] Speaker 03: All the regular remedies apply. [00:21:14] Speaker 01: And going back to your remoteness point, if we didn't have what seems like a determination of remoteness, how far away from the approval process are we? [00:21:23] Speaker 03: I don't know the answer to that, Your Honor. [00:21:26] Speaker 03: Because we're not an andafiler, and we haven't even seen the andas. [00:21:29] Speaker 01: Yes, but if you could arguably be [00:21:33] Speaker 01: held subject to an injunction if there was an immediacy notion to your threatened infringement, then it would certainly be relevant how far along in the process the approval was, right? [00:21:46] Speaker 03: Wouldn't it? [00:21:47] Speaker 03: I do agree with that, Your Honor. [00:21:48] Speaker 03: Obviously, the question of immediacy and imminent harm and all of that, it depends on how far away you are from the actual real infringement taking place. [00:21:57] Speaker 03: And I don't know the answer to that, because as I said, we're not the antifiler. [00:22:01] Speaker 03: We haven't even been allowed to see the antifilings. [00:22:03] Speaker 03: So we don't know where that process stands. [00:22:08] Speaker 00: Thank you. [00:22:09] Speaker 00: All right. [00:22:11] Speaker 01: Mr. Chen, we went over with Mr. Trela. [00:22:15] Speaker 01: So especially on the JM side of this, if you need extra time, you can have some. [00:22:24] Speaker 02: Good morning, Your Honors. [00:22:26] Speaker 02: May it please the Court, my name is Angus Chen of the law firm Fromer-Lawrence & Haug on behalf of Appellee Patentee Shire. [00:22:33] Speaker 02: Your Honor, first off, we agree that the District Court did consider all the references and the expert opinions as evidenced in footnote seven of the opinion, as well as the District Court's order expressly stating that he considered all of the arguments. [00:22:49] Speaker 02: There was lengthy submissions before the District Court, as well as an oral argument. [00:22:56] Speaker 02: In sum, there are no disputed facts where there's a failure of proof. [00:23:02] Speaker 02: And there are no inferences to be drawn where there's absent facts to avoid summary judgment as the case is here. [00:23:10] Speaker 02: There's a full record that the district court considered. [00:23:13] Speaker 05: What about Mr. Reed's argument that the district court didn't consider two references and all these experts? [00:23:20] Speaker 02: Right. [00:23:20] Speaker 02: So one of the references as the court recognized was considered in footnote seven. [00:23:26] Speaker 02: And as I said, the district court's order said that he considered all the references. [00:23:30] Speaker 02: And I don't believe there's any requirement that the district court expressly address in its opinion each of the references as long as they were considered. [00:23:39] Speaker 02: Defendant's argument is hindsight reconstruction. [00:23:43] Speaker 02: And that's true for all the 17 compound claims that are directed to the compound itself as well as physical characteristics and also the one method of treatment claim. [00:23:52] Speaker 02: We know that because they define the problem in terms of its solution, the claim compound. [00:23:57] Speaker 02: Now, defendants did not appeal the district court's finding of no invalidity based on anticipation. [00:24:03] Speaker 02: So there's no dispute that the Lisdex amphetamine dimethylates not disclosed in the prior article. [00:24:08] Speaker 02: So the reality is for obviousness, a person of ordinary skill at the time of the invention would have had to have asked six questions. [00:24:17] Speaker 02: But defendants haven't offered any evidence of a motivation for why a POSA would have even wanted to ask those six questions, let alone answer them. [00:24:26] Speaker 02: So for example, question number one, why pick up de-amphetamine in the first place? [00:24:31] Speaker 02: Because in spite of whatever side effects it may have, defendants repeatedly say in their briefs that it has long been known as safe and effective. [00:24:38] Speaker 02: So what's the problem with de-amphetamine? [00:24:40] Speaker 02: They don't answer that question. [00:24:42] Speaker 02: Question number two, why chemically modify de-amphetamine? [00:24:45] Speaker 02: What's the problem with changing its formulation? [00:24:48] Speaker 02: Again, no answer. [00:24:49] Speaker 02: Question number three, why make a prodrug of de-amphetamine? [00:24:53] Speaker 02: What's the problem with making a new derivative? [00:24:56] Speaker 02: or derivative compound. [00:24:58] Speaker 02: Again, they don't answer that question. [00:25:00] Speaker 02: Question number four, why pick L-lysine? [00:25:03] Speaker 02: What's the problem with other amino acids, other amino acid derivatives, other modified amino acids? [00:25:10] Speaker 02: They don't answer that question either. [00:25:12] Speaker 02: Question number five, if you even had Lisdex amphetamine, why even make a salt of it? [00:25:18] Speaker 02: What is the problem with the free base compound? [00:25:20] Speaker 02: Again, they don't point to any prior art or data or evidence to suggest that problem or motivation. [00:25:26] Speaker 02: Finally, question number six, why make a mutilate salt specifically? [00:25:30] Speaker 02: In other words, what are the problems with the other salts? [00:25:32] Speaker 02: What's the problem with a hydrochloride salt, with a phosphate salt, with a sulfate salt, and all the other types of salts that are the numerous possibilities that Your Honor pointed out. [00:25:43] Speaker 02: So it's important to identify the motivation because as we all recognize, motivation is the safeguard against hindsight bias, and they failed on all fronts here. [00:25:53] Speaker 02: Now, this case is just like the Ortho McNeil case where this court affirmed summary judgment of non-obviousness of a compound patent from the same district court judge, Judge Schessler. [00:26:04] Speaker 02: Why is that? [00:26:04] Speaker 02: Because the references in Ortho McNeil dealt with compounds that had properties far afield from each other. [00:26:10] Speaker 02: That's exactly the case here. [00:26:12] Speaker 02: The compounds have properties far afield from each other in the references and from the claimed compound. [00:26:18] Speaker 02: AU, defendants admit in their reply brief at page 13, doesn't even teach photographs. [00:26:23] Speaker 01: to move over to the JM argument? [00:26:26] Speaker 01: Yes, Your Honor. [00:26:26] Speaker 01: Can you tell me your thoughts on that? [00:26:29] Speaker 02: With respect to JM, we agree that Forrest is binding. [00:26:35] Speaker 02: Stari decisis strongly applies, especially in non-constitutional situations. [00:26:40] Speaker 02: And it's actually straightforward reading of this court's precedent in Allergan, as well as Glaxo, which was also a compound patent. [00:26:46] Speaker 01: Well, what about what I proposed to Mr. Trela? [00:26:48] Speaker 01: I don't see a holding [00:26:51] Speaker 01: of liability against Cifla and Forrest, rather just a perspective injunction. [00:26:59] Speaker 01: Why isn't that what ought to be permissible in this case? [00:27:04] Speaker 01: Well, we believe... The district court in this case held J.M. [00:27:08] Speaker 01: liable for induced infringement. [00:27:10] Speaker 01: Right. [00:27:10] Speaker 01: But they haven't actually yet induced infringement, correct? [00:27:14] Speaker 02: Well, the essence of Hatch-Waxman is based on future acts of infringement. [00:27:18] Speaker 02: That's the sort of quirkiness of the statute, right? [00:27:20] Speaker 02: So Section 271E creates a case of controversy that imparts jurisdiction under 1338A, and then the traditional patent infringement analysis is conducted under 271A, B, or C, right? [00:27:34] Speaker 02: And that's been held since Glaxo and Allergan. [00:27:37] Speaker 01: Yes, but E1 only allows for liability against an and a filer. [00:27:43] Speaker 01: So what Congress sought to do was move up the date. [00:27:47] Speaker 01: I mean, you know, we don't generally like the idea of Congress messing with cases or controversies and what typically would amount to a case or controversy, right? [00:27:55] Speaker 01: But in this case, they sought to do it, but as to a very precise and specific group of people and filers, as the statute says. [00:28:04] Speaker 01: So they really, what they did is they sort of moved up the date. [00:28:07] Speaker 01: And I understand the rationale for why, because [00:28:10] Speaker 01: If you don't move up the date and you have to wait to sue them until they actually sell, then the brand is going to lose so much. [00:28:18] Speaker 01: So I understand why they moved up the date as to the ANDA filers. [00:28:23] Speaker 01: But the language is quite precise, and it's the ANDA filers. [00:28:27] Speaker 02: I would submit that under the Glaxo case from 1997, Glaxo v. Nova Farm, it clearly stated that infringement in the Hash Waxman case is not established by the filing of the ANDA. [00:28:37] Speaker 02: it's based on the product to be sold or likely to be sold. [00:28:41] Speaker 02: And if you focus on that future product likely to be sold, there certainly can be liability for induced infringement in the Hatch-Waxman context. [00:28:49] Speaker 02: Your Honor is very correct that there is no harm to Johnson and Matthew or any API supplier. [00:28:54] Speaker 01: Well, let's just be clear. [00:28:55] Speaker 01: Absent 271E, you couldn't have brought this case against the endofilers, correct? [00:29:02] Speaker 02: Well, I don't think this is [00:29:03] Speaker 02: Yes, against the ANDA filers. [00:29:05] Speaker 02: But actually, I don't think the situation is any different than Johnson-Mathie, just a few months ago, while this briefing was going on, filed a declaratory judgment against Pfizer, seeking a judgment of no infringement, no liability, based on an ANDA that hasn't been approved yet. [00:29:21] Speaker 02: So in my mind, that's the same thing here. [00:29:22] Speaker 02: Johnson-Mathie can't hide, an API supplier can't hide behind the safe harbor when it infringes, and then when it thinks it doesn't infringe, file a DJ. [00:29:31] Speaker 02: And so they're fully aware of that. [00:29:33] Speaker 01: I don't see what that has to do at all with how I construe 271E. [00:29:39] Speaker 01: The actions that they may or may not have taken in some other case, not before me, not part of this record, not something I'm subject to decide. [00:29:47] Speaker 01: So tell me what part of 271E gives you the basis to sue them? [00:29:54] Speaker 02: Well, as I said under Glaxo, because the infringement analysis established by the product likely to be sold [00:30:00] Speaker 02: the future product, that's what's the basis for infringement. [00:30:03] Speaker 01: And so because under Glaxo- That's not the basis. [00:30:05] Speaker 01: That doesn't create a basis for infringement. [00:30:07] Speaker 01: There is no 271z that says future product creates. [00:30:13] Speaker 01: The basis is still to even under Glaxo, the basis is 271e liability. [00:30:18] Speaker 01: And Congress may have explained that the reason they're doing that is preventing future sales, but Congress chose to limit it. [00:30:24] Speaker 01: And Glaxo doesn't say, and therefore you can go after anybody that helps them in this process, right? [00:30:30] Speaker 01: CLAXO just explains the rationale for why E can be applied and result in liability for the actual filer. [00:30:39] Speaker 02: Yeah, so I would submit my response to that is if you look at the Allergan case, it says that 271B2 is not a jurisdictional statute in the strictest sense. [00:30:50] Speaker 01: It's not a jurisdictional statute, it's a liability statute. [00:30:54] Speaker 01: It establishes the standard under which liability would be. [00:30:58] Speaker 02: I'm sorry. [00:30:59] Speaker 02: And the liability is then established under 271A, B, or C. What says that? [00:31:06] Speaker 01: Allergan doesn't say that. [00:31:07] Speaker 01: I've got it right here. [00:31:08] Speaker 02: You show me where in Allergan it says that the liability that you're actually suing on is under A, B, or C. I think that's under Glaxo, where it says after jurisdictions confer the case where controversy is established under E2, the traditional infringement analysis is conducted under 271A, B, or C. Which one came first, Glaxo or Allergan? [00:31:28] Speaker 01: Okay, so Glaxo came first, and you're saying it treats E as jurisdictional, but then a minute ago you just told me Allergan says it's not jurisdictional, right? [00:31:40] Speaker 01: Kind of, isn't that what you just said? [00:31:42] Speaker 02: I'm saying that E2 opens the door to create jurisdiction under 1338A, and then infringement is established under A, B, or C. With respect to your question about harm and immediacy, [00:31:57] Speaker 02: Actually, in this case, there are already three A&DAs already tentatively approved. [00:32:02] Speaker 02: And so in my mind, there would be some immediacy with respect to harm. [00:32:07] Speaker 02: Lastly, I'd like to just say the Safe Harbor argument is a red herring in our mind. [00:32:11] Speaker 01: Three of the ANDAs that are subject to this lawsuit are already approved? [00:32:15] Speaker 02: Tentatively. [00:32:16] Speaker 01: And are those three? [00:32:17] Speaker 01: I don't remember from the record. [00:32:19] Speaker 01: Is every one of the ANDA filers going to use JAM as a source supplier? [00:32:22] Speaker 02: Yes, Your Honor. [00:32:24] Speaker 01: And my last- And Mr. Shelley, you're going to have to address that when you get back up. [00:32:28] Speaker 02: My last point is the safe harbor argument is irrelevant. [00:32:32] Speaker 02: It's sort of a red herring because of Hatch Waxman looking at future acts. [00:32:37] Speaker 02: So regardless of whether the safe harbor protects an API supplier, you're looking at the future liability, the future acts of infringement. [00:32:45] Speaker 02: So that's it, Your Honor. [00:32:45] Speaker 02: Thank you. [00:32:47] Speaker 02: Unless the court has further questions. [00:32:49] Speaker 00: Nothing further. [00:32:50] Speaker 00: Mr. Reed, some rebuttal time left. [00:32:55] Speaker 04: Thank you, Your Honor. [00:32:56] Speaker 04: Picking up where I left off, regarding the level of ordinary skill in the art, the Supreme Court in Graham listed that as the first consideration, and one that is an issue of fact. [00:33:06] Speaker 04: In this case, Judge Chesler did not determine the level of ordinary skill in the art. [00:33:10] Speaker 04: That compounds the errors that he then made from the rest of his opinion. [00:33:14] Speaker 01: Was there a dispute among the parties about what the level of skill in the art was? [00:33:17] Speaker 04: Absolutely, a very heated dispute. [00:33:19] Speaker 04: And that underscores how there was evidence on both sides. [00:33:23] Speaker 04: The defendant's experts offered opinions that the level of skill in the art include a high level of education and skill, certain number of years of experience, whereas the plaintiff's experts opined that the level of skill would be relatively low. [00:33:36] Speaker 04: That dispute was never resolved. [00:33:39] Speaker 04: It's a dispute of fact. [00:33:41] Speaker 01: And if- Well, he can't resolve disputes of fact on summary judgment, so I just have to assume he found or that that fact would be favorable to you. [00:33:49] Speaker 01: Does it change the outcome? [00:33:50] Speaker 04: I think it does, because one, with a high level of skill, [00:33:53] Speaker 04: somebody with the years of experience that our experts opined would be necessary to have that level of skill. [00:33:59] Speaker 01: Why would they choose the one salt that is the patented salt out of thousands of possible options? [00:34:04] Speaker 04: The testimony that Dr. Atwood submitted lists the reasons why, and he described first of all that the making of salts is very common, well understood, and has been done for years. [00:34:17] Speaker 01: Second, that the- So they're making a salt, but there's lots of different ones. [00:34:20] Speaker 01: Exactly. [00:34:21] Speaker 01: It doesn't say why this one. [00:34:22] Speaker 04: But he explained that the 168 reference teaches the use of P- toluene sulfonic acid to make a salt and that immediately coming to his mind and to the mind of one of skill in the art would be a simple substitution to use methane sulfonic acid. [00:34:39] Speaker 04: From there, the Miller reference explicitly teaches the use of methane sulfonic acid. [00:34:45] Speaker 04: It's one of only 10 acids listed in the Miller reference. [00:34:48] Speaker 04: From there, the Berge and the Bailey references highlight the very routine nature of using salts, and both of them list the mesylate salt as among the top 10 most commonly used salts. [00:35:02] Speaker 01: And finally, and this is significant, plaintiffs have not... Wait, Miller, I have that Miller discloses 200 possible salts. [00:35:08] Speaker 01: 20 amino acid choices and 10 different acid choices. [00:35:12] Speaker 01: That would be 10 times 20. [00:35:13] Speaker 01: That would be 200, as best as I can tell. [00:35:15] Speaker 04: So that would be the two pieces, right? [00:35:17] Speaker 04: There's the first piece of conjugating L lysine with deamphetamine, and then the second piece is the salt. [00:35:21] Speaker 04: And deamphetamine isn't even disclosed in Miller. [00:35:24] Speaker 01: Miller has metaraminol, which is within the scope of the... But deamphetamine is not disclosed, and then you've got 200 possible salts, right? [00:35:33] Speaker 04: So deamphetamine falls within the claim construction of the district court. [00:35:37] Speaker 04: Metaraminol, excuse me, metaraminol falls within the definition of amphetamine as construed by the district court. [00:35:45] Speaker 04: And among the amino acids, Miller's disclosure includes about 20. [00:35:51] Speaker 04: The 168 reference includes about 20. [00:35:54] Speaker 01: Well, Miller discloses 20 and then 10 acid choices. [00:35:58] Speaker 04: Right, so then the 10 acid choices are kind of the second piece here. [00:36:02] Speaker 04: Among those 10 acid choices, methane sulfonic acid is explicitly listed. [00:36:07] Speaker 04: So we have the understanding of a person of ordinary skill in the art looking at these references in combination and saying that it would be obvious to combine L-lysine, to choose L-lysine. [00:36:19] Speaker 05: And the plaintiff's- But you've got to make selections from all of these different pieces to put this together. [00:36:27] Speaker 05: The question is what would motivate anybody and what evidence is in this record would motivate anybody to make these specific [00:36:36] Speaker 05: selections out of all of these variables. [00:36:40] Speaker 04: The rationale here, as articulated by our experts, is that combining known elements using known methods to achieve predictable results. [00:36:50] Speaker 05: Well, that's fine if you've got a handful, but when you've got hundreds, that's a different story. [00:36:55] Speaker 04: The testimony of the experts disclosed that one of ordinary skill in the art would immediately hone in on only particular components to combine. [00:37:04] Speaker 04: And so when you've got the level of ordinary school in the arc undefined, when you've got the selection of L lysine explicitly addressed by a reference, a Bromwich reference that the district court never considered, never acknowledged, and then you've got the selection of the mesolate salt, which the plaintiffs have never claimed have any particular properties. [00:37:25] Speaker 04: There's no specific reason on this record to choose the mesolate salt over any other salt. [00:37:30] Speaker 04: In that respect, it's slightly different than the Pfizer Vapotex case. [00:37:33] Speaker 00: Thank you, Mr. Reed. [00:37:35] Speaker 04: Thank you, Your Honor. [00:37:36] Speaker 01: Mr. Trellis, one minute. [00:37:39] Speaker 03: I will try to talk fast, so I'll start before I get up there. [00:37:42] Speaker 03: Two quick points, Your Honor. [00:37:44] Speaker 03: First, and I will get to the ANDA point. [00:37:47] Speaker 03: The argument about Glaxo and Allergan and future infringement is just wrong. [00:37:51] Speaker 03: The analysis in an ANDA case is [00:37:55] Speaker 03: If the act of filing today, an act of infringement, and the way you analyze that is by looking to what will happen in the future. [00:38:01] Speaker 03: But the infringing act has occurred today. [00:38:03] Speaker 03: It's not a determination of future liability. [00:38:05] Speaker 01: But you do agree courts can issue injunctions even absent present infringement if it is otherwise. [00:38:11] Speaker 03: If it's imminent and irreparable harm and all of that, of course. [00:38:15] Speaker 03: And so that gets to your question, Your Honor. [00:38:18] Speaker 03: Obviously, there's a different state of facts now than there was when the district court decided this. [00:38:21] Speaker 03: I think the proper disposition [00:38:23] Speaker 03: is to reverse the judgment that Johnson and Matthew has induced infringement, because it hasn't. [00:38:28] Speaker 01: But we don't know what the date is that the approval occurred, right? [00:38:31] Speaker 01: It could have occurred the day after the district court opinion. [00:38:34] Speaker 01: I don't have this information in the record. [00:38:35] Speaker 01: Right. [00:38:37] Speaker 01: And also, it hasn't been that long. [00:38:38] Speaker 01: So it seems like probably the immediacy component was met at the time he decided it. [00:38:44] Speaker 03: Well, no, I don't think so, Your Honor. [00:38:46] Speaker 03: The judge did say that there are future remote events that all of this is contingent on. [00:38:53] Speaker 03: At the time, all we can do is look at the record as it existed at the time he made his decision. [00:38:58] Speaker 03: The time he made his decision, it was just wrong to say that Johnson-Matthew has induced direct infringement because of the safe harbor. [00:39:04] Speaker 03: It couldn't be the end of filing. [00:39:06] Speaker 03: Nothing else had happened. [00:39:07] Speaker 03: Now the facts have changed. [00:39:09] Speaker 03: I think the appropriate disposition is reverse that judgment, send it back to him. [00:39:13] Speaker 01: Well, but we have Forrest. [00:39:15] Speaker 01: It says you can enjoin a supplier. [00:39:18] Speaker 01: And I had my clerk look it up while we were talking. [00:39:20] Speaker 01: And the ANDA and Forrest was approved five years after Judge Forrest's decision. [00:39:25] Speaker 01: So certainly he didn't premise his decision on some notion of immediacy, despite the fact that I'm bringing that up. [00:39:31] Speaker 03: Right. [00:39:31] Speaker 03: Well, I understand that, Your Honor. [00:39:32] Speaker 03: But Forrest, we think, because of the fact [00:39:36] Speaker 03: that the infringement liability had been taken out of the case, that all the court was deciding was the scope of the injunction, assuming infringement liability, assuming inducement liability, assuming direct infringement. [00:39:48] Speaker 03: It's not what we have here. [00:39:50] Speaker 03: Now, if the approval of the ANDUS changes things, that's something for the district court to consider in the first instance. [00:39:57] Speaker 03: There is a judgment that says Johnson-Maffey has induced infringement is just wrong, even if Forrest is correct. [00:40:05] Speaker 03: And even if Forrest somehow addressed liability, that judgment is wrong because there is no direct infringement that Johnson-Mathie could have induced. [00:40:14] Speaker 03: If the court has no further questions, I appreciate all of the time you gave me. [00:40:18] Speaker 01: Thank you, Mr. Trellis. [00:40:19] Speaker 01: Thank you. [00:40:21] Speaker 01: This case is taken under submission.