[00:00:05] Speaker 02: And our third case is Amgen versus Apotex. [00:00:49] Speaker 02: Council prefer to go forward. [00:00:50] Speaker 02: Mr. McTighe. [00:00:57] Speaker 03: Yes, may it please the Court, Your Honor. [00:00:59] Speaker 03: My name is Kerry McTighe from the law firm of Cozen O'Connor. [00:01:02] Speaker 03: I'm here on behalf of Apotex Inc. [00:01:04] Speaker 03: and Corp. [00:01:08] Speaker 03: Your Honor, the BPCIA was a carefully crafted congressional statute. [00:01:13] Speaker 03: It created a framework with choices for both [00:01:17] Speaker 03: the RPS, in this case Amgen, as well as the biosimilar applicants, in this case Apotex. [00:01:24] Speaker 02: With these choices... In the gray brief, Apotex says Amgen does not need an additional 180 days to assess an act upon its patent rights because it has already sued Apotex on all the patents on its paragraph 13A list. [00:01:41] Speaker 02: There's nothing left to assess or to assert [00:01:45] Speaker 02: What purpose does the 188 provisions serve as you interpret it under the facts of this case? [00:01:51] Speaker 03: So under the facts of this case, Your Honor, the biosimilar applicant does not have to follow the notice of commercial marketing, but that choice has a repercussion. [00:02:02] Speaker 03: The L9 provisions, specifically L9A, prevents either party from filing a DJ action until that notice of commercial marketing exists. [00:02:15] Speaker 03: With L9B, however, should Apotex choose not to file that, then the right to a DJ action endures only to the RPS. [00:02:25] Speaker 03: So Apotex has to make a choice. [00:02:29] Speaker 03: With this second phase or second wave of litigation, does it want the certainty of filing the notice of commercial marketing and giving itself the right to sue before launching in the face of potential intellectual property rights that weren't part of the first wave of litigation? [00:02:45] Speaker 03: Again, it's a choice. [00:02:47] Speaker 03: But what the district court has done is said, in all cases, we are going to make the notice of commercial marketing mandatory, even when Appitex has provided the L2A exchange. [00:02:59] Speaker 03: Meaning that in that case, the RPS has had the application, has had the opportunity to sue, litigate, and bring an injunctive relief should Appitex give the notice of commercial marketing. [00:03:12] Speaker 03: But it also could bring injunctive relief [00:03:15] Speaker 03: on all of the patents listed in that initial phase, the L2, L3, 4, 5 phase. [00:03:21] Speaker 03: Now, we're not before this Court on any patent-based injunction. [00:03:25] Speaker 03: We're here on a notice provision. [00:03:27] Speaker 03: And so on that notice provision that we're talking about, what we look at is the statute itself, the plain meaning of the statute. [00:03:35] Speaker 03: Congress obviously created a statute with choices. [00:03:38] Speaker 03: One of those choices is for an applicant [00:03:42] Speaker 03: And this court came down in San Diego with the decision that because there's a specific remedy in L9C, the shall provision in L2 was not mandatory, because there was that specific remedy in L9C. [00:03:57] Speaker 03: And what the court did was apply maxims of statutory construction that exist in this case too, specifically the first one, to not render any provision of the statute superfluous. [00:04:08] Speaker 02: What incentive would [00:04:10] Speaker 02: an applicant have to participate in an information exchange if the 180-day provision is imposed no matter what? [00:04:20] Speaker 03: Well, that's a great question, Your Honor, because actually with Apotex's interpretation, if you choose to participate in the L2 exchange, you are not then bound that the L8A notice of commercial marketing provision is mandatory in all cases. [00:04:36] Speaker 03: You could see the example where there are no statutes left to litigate. [00:04:41] Speaker 03: And subsection L is about litigating the patents. [00:04:45] Speaker 03: So if you choose to go through the L2A process, which this court acknowledged is optional, but if you choose to do that, what you get is the benefit of potentially not using the notice of commercial marketing. [00:05:00] Speaker 03: But then again, a biosimilar applicant could use that. [00:05:04] Speaker 03: In fact, all the time in the Hatch-Waxman context, we see generic companies not launch at risk. [00:05:09] Speaker 03: because they want the certainty of those patents. [00:05:12] Speaker 03: Biosimilars, and you've seen it in the Meekie briefs, are very complex. [00:05:16] Speaker 03: Oftentimes, they deal with billions of dollars. [00:05:19] Speaker 03: It's very possible that, as Apotex did here, choose to follow the L2 exchange, and it's very possible that for that same reason, for that same certainty, they choose to follow the notice of commercial marketing. [00:05:34] Speaker 03: Why it was not mandatory in the Sandovi Amgen case by the majority was because of those maxims of statutory construction. [00:05:43] Speaker 03: If you were to say that the L2 exchange was mandatory in all circumstances, then it would render L9c superfluous. [00:05:52] Speaker 03: In that same regard, and the court quoted from the Supreme Court case in TRW, Inc., Andrews, it's a cardinal principle of statutory construction that a statute ought [00:06:04] Speaker 03: upon the whole to be so construed that if it can be prevented, no clause, sentence, or word shall be superfluous, void, or insignificant." [00:06:12] Speaker 03: The Amgen reading would say that the L9B provision, which specifically says if there's a violation of L8A, the commercial marketing provision, the remedy for that is a declaratory junction. [00:06:27] Speaker 03: And what they could do is bring a patent-based injunction on anything at that point. [00:06:31] Speaker 03: But we're not here on a patent-based injunction. [00:06:33] Speaker 03: Similarly, Your Honor, the second maximum statutory construction is that when Congress creates a new right. [00:06:40] Speaker 03: And clearly, the notice of commercial marketing is a new right. [00:06:43] Speaker 03: In most cases, the companies that are accused of infringement don't have to give a notice of commercial marketing 180 days in advance. [00:06:51] Speaker 03: Here in the BPCIA, Congress put that in there. [00:06:54] Speaker 03: But when Congress creates a new right in a statute and expressly provides a remedy for that violation, in this case, the right for a DJ, [00:07:02] Speaker 03: then the agreed party's relief should be limited to that statutory remedy. [00:07:07] Speaker 03: Go ahead. [00:07:08] Speaker 03: It's cited throughout the briefs, Your Honor, but it's Bruce Juice versus American King. [00:07:14] Speaker 01: I understand that in this case, there are no L7 patents, shorthand. [00:07:20] Speaker 01: No patents that are either newly issued or were not included in the L6 group of patents. [00:07:29] Speaker 01: Do you think that the analysis of L8A [00:07:33] Speaker 01: would be different with respect to cases in which there are L7 patents. [00:07:38] Speaker 03: No, Your Honor, because the L7 patents, there's a procedure in there for the RPS to bring those patents, if they so choose, into the litigation. [00:07:48] Speaker 03: But what L8A refers to is a notice of commercial marketing that you must give that notice of commercial marketing, but it has nothing to do with the L7 patents. [00:07:58] Speaker 03: The L7 patents are separate. [00:08:00] Speaker 01: I've solved various places in the briefs that [00:08:03] Speaker 01: some, including the AMICS briefs, that some significant weight seemed to be placed on the fact that this, in this case, in case cases like this, there isn't anything that needs to happen during the L8A period because of the fact that there are no L7 patents. [00:08:22] Speaker 01: And I wondered whether that has significance for the way we read L8A. [00:08:26] Speaker 03: Your Honor, the answer is no. [00:08:29] Speaker 03: Your Honor, one of the things, though, that's obviously before this Court is the decision in Amgen v. Sando. [00:08:36] Speaker 03: And Amgen argues that in that case, the Court has determined in all circumstances LA8 must be read, the shall must be read as must. [00:08:47] Speaker 03: But that provision, as the Court noted there, cannot be read in isolation, just like the Court did not read in isolation L2A. [00:08:57] Speaker 03: Apotex chose here to go through the L2A process. [00:09:01] Speaker 03: It provided the abbreviated BLA. [00:09:05] Speaker 03: And what does that do from a policy perspective? [00:09:07] Speaker 03: The court there was concerned that without providing the L2A provision and without providing a notice of commercial marketing, how would Amgen know what patents to actually bring a DJI action on? [00:09:18] Speaker 03: In fact, the court said the subsequent failure to provide notice of commercial marketing doesn't apply. [00:09:25] Speaker 03: the subsequent failure. [00:09:26] Speaker 03: And that's what actually the title talks about, subsequent failures. [00:09:30] Speaker 03: And in fact, the court makes mention of the fact there was a complete failure to provide any of the patent exchange stands. [00:09:36] Speaker 03: And it said, so in this case, as in here, we find that it's mandatory. [00:09:40] Speaker 03: But for the same reasons the court said under L2A, because there's a specific remedy created by Congress for a specific statutory right, we must honor that right. [00:09:53] Speaker 03: It's not just the concluding sentence of the Sandovi Amgen case that the majority wrote that is Appitex's basis for this. [00:10:03] Speaker 03: In fact, throughout the opinion, the court notes and goes on to state, with respect to paragraph LAA, we do not find any provision in the BPCIA that contemplates or specifies the consequence for noncompliance with the notice provision here. [00:10:19] Speaker 03: Here. [00:10:20] Speaker 03: But what do they say? [00:10:21] Speaker 03: They distinguish this. [00:10:23] Speaker 03: They say, because Sandoz did not provide the L2A information, Amgen was unable to compile that patent list. [00:10:31] Speaker 03: The judge acknowledges, however, while it is true that paragraph L9B specifies the consequence for a subsequent failure to comply with paragraph L8A after the applicant has complied with L2A, it does not apply in this case. [00:10:45] Speaker 03: Your Honors, that's not this case. [00:10:48] Speaker 03: It does apply in this case. [00:10:50] Speaker 03: Where Sandoz did not comply with L2A, [00:10:52] Speaker 03: they found it was mandatory. [00:10:54] Speaker 03: But they carved out a distinction. [00:10:56] Speaker 03: And that distinction is the same rationale that they used when they were looking at the L2A. [00:11:02] Speaker 03: So based on the statutes of maximum statutory construction language that we've just talked about, and based on Sandor V. Amgen's rationale, we asked this court to move for Apotex in this case and vacate the preliminary injunction. [00:11:21] Speaker 03: Going back to the initial question of the fact that there is an exclusivity period, the 180 days, the amicus briefs and epitax lay out something that I think is important to note. [00:11:35] Speaker 03: And the district court got this wrong. [00:11:38] Speaker 03: The district court cited to the fact that this would be a unique situation where you would have to give this notice of commercial marketing, and somehow it would end in a 12 and 1 half year exclusivity period. [00:11:49] Speaker 03: Your Honor, [00:11:50] Speaker 03: That's just not the case. [00:11:52] Speaker 03: Because Sandoz elected not to make the L2A information, this court held that paragraph L9B did not apply. [00:12:00] Speaker 03: However, the 180-day notice of commercial marketing provision, if that was mandatory in all cases, it would require that only after the effective date of FDA approval of any applicant's ABLA [00:12:15] Speaker 03: Would someone be able to give that notice of commercial marketing? [00:12:19] Speaker 01: Now, if I understand it correctly, the FDA is not authorized to make its approval effective until after the exclusive period. [00:12:32] Speaker 01: But is it also prohibited from actually making the decision with respect to approval well before the expiration of the 12-year period? [00:12:43] Speaker 03: Your Honor, we're under a new statutory regime. [00:12:45] Speaker 03: Obviously, the BPCIA and the court has acknowledged it's analogous to the Hatch-Waxman Act. [00:12:50] Speaker 03: But to answer your question, even if they gave tentative approval, the FDA guidance cited in the briefs, and I think the best link, the easiest one for me to point to, because it's at the end of the biosimilar counsel's brief on the last page, it cites to the link of the FDA guidance. [00:13:08] Speaker 03: And in essence, what it says is you cannot get FDA licensure [00:13:11] Speaker 03: until that 12-year exclusivity ends. [00:13:13] Speaker 01: So the triggering act, whether you call it licensure or approval or effectiveness, the triggering act, as far as the FDA is concerned, whether it's by statute or by practice in the FDA, is not going to happen until after the 12-year exclusivity period. [00:13:33] Speaker 01: Is that what you're saying? [00:13:34] Speaker 03: Correct. [00:13:34] Speaker 03: OK. [00:13:35] Speaker 03: And if we read it to mean that this provision applies in all cases, there wouldn't be a single ABLA [00:13:42] Speaker 03: And this one is a perfect example. [00:13:43] Speaker 03: There's only one patent at issue. [00:13:45] Speaker 03: The fact discovery is over. [00:13:47] Speaker 03: It closed on Friday. [00:13:48] Speaker 03: The court has scheduled the trial for July. [00:13:51] Speaker 03: It's very possible that there's no patent left at issue in this case. [00:13:55] Speaker 03: And yet, if we read it mandatory, even though we followed the disclosure provisions of L2 and they've had our application for more than a year, and nothing has prevented them from bringing an injunction on the current patent, the one patent remaining, or any new patents under L7, [00:14:11] Speaker 03: We're not here on that injunction. [00:14:17] Speaker 03: Thank you. [00:14:26] Speaker 00: Good morning. [00:14:28] Speaker 00: So I think I'd like to start with the language of the statute, which is section LA to A, which is unequivocal. [00:14:37] Speaker 00: and says that the biosimilar applicant, the K applicant, shall provide this notice. [00:14:43] Speaker 00: Same language that was used in L2? [00:14:46] Speaker 00: Same, but some important differences. [00:14:48] Speaker 01: I mean, it was equally unequivocal. [00:14:51] Speaker 01: Until the court decided. [00:14:55] Speaker 00: The language is unequivocal, but Your Honour, this court is being asked to rewrite L8A, to put in language [00:15:04] Speaker 00: that actually appears elsewhere in the statute. [00:15:07] Speaker 00: What I mean is there are places, for example L9C, that say if a subsection K applicant fails to provide the application and information required under paragraph 2, 2A, comma, then certain things. [00:15:24] Speaker 00: The apotech's position is that this court should rewrite section L8A so that it has that same language. [00:15:34] Speaker 00: the position that is being argued. [00:15:37] Speaker 00: The drafters of this statute knew how to write something that was contingent upon that fact when they wanted to, and they didn't put it in L8A. [00:15:45] Speaker 00: Now, Your Honor, I'd love to turn to why is there a different outcome with L8A versus L2A? [00:15:52] Speaker 00: And the answer is, as this Court held in the majority in the Sandoz case, there are other provisions, specifically Section 271E2C2, [00:16:04] Speaker 00: and section 271E4 that provide, that define the failure to give, to comply with L2A as an act of infringement. [00:16:16] Speaker 00: And then in 271E4 specify the exclusive consequence for that. [00:16:20] Speaker 00: You cannot reach the majority of decision in the Sandoz case without that statutory underpinning. [00:16:28] Speaker 00: So again, the drafters knew how to specify an exclusive remedy [00:16:33] Speaker 00: when they wanted to. [00:16:35] Speaker 00: And what the majority of this court found in the Sandoz case was that's exactly what they had done in L2 with respect to a failure to comply with L2. [00:16:44] Speaker 02: Let me throw the same question to you that I asked the opposing counsel. [00:16:48] Speaker 02: What purpose does the 180-day provision serve, as you interpreted under the facts of this case? [00:16:55] Speaker 00: It serves a vital purpose for the parties, the judicial system, and the public. [00:17:00] Speaker 00: And let me explain why. [00:17:02] Speaker 00: What it serves is exactly the purpose that the unanimous portion of this court's decision in Sandoz lays out. [00:17:10] Speaker 00: It provides a defined statutory period in which to resolve patent disputes before launch of the biosimilar. [00:17:18] Speaker 00: There seems to be an argument that is made by the amici of Apotex and perhaps by Apotex itself that [00:17:27] Speaker 00: This right exists only with respect to patents defined in AB. [00:17:32] Speaker 00: That is not so. [00:17:33] Speaker 00: This case is a perfect example. [00:17:35] Speaker 00: If you take away the notice provision, the 180-day block protected time in which to resolve patent disputes, what you do is you say to the patent holder, the reference product sponsor, you need to seek a preliminary injunction immediately when you file your lawsuit, because you have no idea when the BioSem was going to be launched. [00:17:57] Speaker 00: And your only alternative would be to wait, risk irreparable damage to the market, and when that irreparable damage begins, run into court and seek a TRO. [00:18:06] Speaker 00: What would have happened in this case, were there no 180-day notice provision, is that Amgen would have had no choice but to seek a preliminary injunction on the patents that it asserted, a proceeding that would have, we now know, been a complete and utter waste of time. [00:18:22] Speaker 00: Why do I say that? [00:18:23] Speaker 00: As Mr. McTighe mentioned, we have a trial date [00:18:25] Speaker 00: set for July. [00:18:28] Speaker 00: If Apotex got approval tomorrow and gave 180-day notice, we could have that trial, have a plenary decision on the merits, and then be in a position to move forward. [00:18:39] Speaker 00: It would never have been necessary to seek a preliminary injunction. [00:18:42] Speaker 00: Without the notice period, we would say, [00:18:44] Speaker 00: We have no idea when this product is coming on the market. [00:18:47] Speaker 00: We need to move for a preliminary injunction right now. [00:18:50] Speaker 00: And whichever party was unhappy with the outcome of that would doubtless have been in this court already saying you have to rule on a PI motion. [00:18:57] Speaker 01: Now, so that is a perfect... Even if you lost on the merits in the July trial, you would say that the 180 days has to continue to run? [00:19:07] Speaker 00: I think the reading of the statute is that's correct you're on. [00:19:10] Speaker 00: And I think that [00:19:11] Speaker 00: as the majority stated in Sandow's case, we have to take the statute as it's written. [00:19:16] Speaker 00: And what I would say here is the drafters of this statute knew that it was going to be almost inevitable, perhaps always inevitable, that there would be patent disputes in every biosimilar case. [00:19:31] Speaker 00: And they simply said, we're going to establish a bright line rule that there is certainty value in having a bright line 180 day period. [00:19:39] Speaker 00: And that's how the statute is constructed. [00:19:42] Speaker 00: And therefore, I think that that's absolutely right. [00:19:44] Speaker 00: And I think that what we see here is there's a misperception that figures, for example, in the briefs of Apotex is amici and many other places that talk about 12 years of exclusivity. [00:19:59] Speaker 00: 12 and a half. [00:20:01] Speaker 00: Well, what they say, it's an argument that assumes its own conclusion. [00:20:06] Speaker 00: It assumes that the biosimilar should have the right to come on the market at the end of year 12, and then says any interpretation of the statute that pushes that to 12 and a half must in fact be wrong. [00:20:17] Speaker 00: If we look at what the BPCIA says, and this is 262K7, it says the FDA cannot make the approval effective until 12 years after the approval of the reference product. [00:20:33] Speaker 00: We know, because this court held it unanimously in Sandoz, [00:20:37] Speaker 00: that the notice provision can only be effective notice under LAA can only be given after FDA approval. [00:20:44] Speaker 01: Ah, but that raises the question that I asked your opposing counsel, whether approval and effectiveness mean the same thing, or whether approval can predate the effective date. [00:20:56] Speaker 00: As Mr. McTighe said, I don't believe FDA has spoken on that, Your Honor. [00:21:00] Speaker 00: My response would be no. [00:21:02] Speaker 00: No, I forgot which way I asked the question. [00:21:06] Speaker 00: it's something that happens to me frequently, that the FDA cannot give an approval in less than 12 years from the date of approval. [00:21:19] Speaker 01: While the 12-year period is ending. [00:21:20] Speaker 00: That's correct. [00:21:21] Speaker 01: Even if they're ready to approve, they have to wait for even the approval, never mind the effectiveness. [00:21:27] Speaker 00: That is correct, Your Honor, as we read the statute. [00:21:30] Speaker 02: So let me ask you another policy question. [00:21:34] Speaker 02: Again, what I ask your opposing counsel, what incentive would an applicant have to participate in exchanging patent information if about 180 period is imposed no matter what? [00:21:47] Speaker 00: I'm not sure. [00:21:48] Speaker 00: Well, the incentive they may have is that exactly as Mr. McTuck said, that they wish to not launch at risk and incur potentially ruinous damages, and they wish to flush out whatever patents there are. [00:22:02] Speaker 00: This statutory regime, [00:22:03] Speaker 00: has been deliberately architected to allow the players, and particularly to allow the biosimilar, if it wishes, to move forward and say, well, I would like to have resolved the patent issues before I go on the market and potentially incur billions of dollars of liability. [00:22:22] Speaker 00: And so that, to me, your honor, is the incentive, that if they want to do that, then they have to go through that information exchange process, following the holding [00:22:33] Speaker 00: of the Sandoz case, so no one ever uses this against Amgen. [00:22:40] Speaker 00: Amgen does not agree with the holding as it pertains to L2A. [00:22:45] Speaker 00: But following that, they're not obliged to make the L2A disclosure. [00:22:52] Speaker 00: But if they don't make the L2A disclosure, it becomes effectively impossible to then clear out [00:22:58] Speaker 00: or to obtain certainty regarding patents, and they're taking a chance of saying, maybe I will be subject to that ruinous liability. [00:23:04] Speaker 00: And so the incentive, I think, is if the biosimilar wants not to take that risk, then it will make the disclosure. [00:23:13] Speaker 00: If it's willing to incur, at least in some level, that risk, it will not. [00:23:16] Speaker 00: But why do I say that we need 180 days for the benefit of the judicial system? [00:23:23] Speaker 00: First of all, we don't want a situation where, in every single biosimilar case, it begins with a probably needless preliminary injunction motion. [00:23:32] Speaker 00: We don't want a situation where these products come on the market and then are yanked off the market. [00:23:38] Speaker 00: As the Amgen Amicus, the biotechnology innovation organization, says in its brief, it is potentially harmful for people to have a situation where they switch back and forth between these products. [00:23:53] Speaker 00: They're not like generics. [00:23:54] Speaker 00: They're similar, not identical. [00:23:56] Speaker 00: And there is a public harm to having a situation where a biosimilar is launched on the market. [00:24:03] Speaker 00: The patent holder moves for a preliminary injunction. [00:24:05] Speaker 00: The thing is yanked off the market after a month or two, and then it comes back on. [00:24:08] Speaker 00: The 180 days is intended exactly as this court held, unanimously, in that part. [00:24:16] Speaker 00: And I'm talking about section 2BA of the Sandoz opinion. [00:24:19] Speaker 00: Its purpose is to prevent this type of chaos. [00:24:23] Speaker 00: It is to block protect a time in which patents, be they in the first phase of litigation or the second phase of litigation, can rationally be resolved. [00:24:33] Speaker 00: And I'd like to turn, if I may, to the argument of superfluousness, which seems to underpin the position of Apotex and its amici. [00:24:45] Speaker 00: And it is not true that L9B would be rendered superfluous by Amgen's interpretation. [00:24:52] Speaker 00: A few important points. [00:24:55] Speaker 00: First of all, L9B does not give the reference product sponsor any more rights than it would already have if there were compliance under L9A. [00:25:08] Speaker 00: L9A allows, if notice is given, the reference product sponsor to bring a declaratory judgment action on a certain set of patents. [00:25:17] Speaker 00: L9B allows the reference product sponsor, if notice is not given, [00:25:22] Speaker 00: to bring a declaratory judgment action on the same set of patents. [00:25:26] Speaker 00: So there's no expanded rights. [00:25:29] Speaker 00: The reference product sponsor is getting nothing through L9B in compensation for the lack of notice. [00:25:34] Speaker 00: Except protection from a declaratory judgment action by the other side, if that's worth anything. [00:25:41] Speaker 00: Fair point, absolutely fair. [00:25:42] Speaker 00: But what I would say here is that what the reference product sponsor wants is the ability to enforce its patents and wants the notice. [00:25:52] Speaker 00: We look at that and say, well, are there situations where both a reference product sponsor would both bring a declaratory judgment action that now committed by L9B and also seek to enforce a notice provision? [00:26:05] Speaker 00: Absolutely. [00:26:06] Speaker 00: What happens if the biosimilar launches? [00:26:09] Speaker 00: It's not actually shipped the product, but it's now going around to customers and saying, don't buy from Amgen, buy from Apotex. [00:26:16] Speaker 00: And Amgen knows that in a matter of weeks or so that there will be [00:26:22] Speaker 00: real live 271A infringement, even if it's not happening now. [00:26:26] Speaker 00: And it says, all right, I want to bring a declarative judgment action, but I equally want to go into court, which I'm now permitted to do under L9B. [00:26:33] Speaker 00: But I want to go into court and ask for the court to enforce my 180 day period. [00:26:38] Speaker 00: So give us 180 days, please district court, in order to sort this out, because I plan to move for a preliminary injunction on these patents that I can now enforce. [00:26:47] Speaker 00: And I think that preliminary injunction will extend well beyond the 180 days. [00:26:51] Speaker 00: But right now I want a status quo protecting 180 days to allow us to do that in an ordinary fashion. [00:26:56] Speaker 00: There's no redundancy at all between these. [00:26:58] Speaker 00: And the fundamental premise that underlies the argument by the appellant and its amici is just plain wrong in that regard. [00:27:07] Speaker 00: Now lastly, I wanted to touch on this, even if one accepts that L9B were a remedy, to get to the outcome [00:27:16] Speaker 00: that the amici, that the appellant wants to get to, one has to accept that it is an exclusive remedy. [00:27:23] Speaker 00: And that is manifestly not so. [00:27:26] Speaker 00: First of all, the remedy says it refers to the ability to bring a declaratory judgment action under 28 U.S.C. [00:27:35] Speaker 00: 2201, which in itself makes clear that that remedy is not exclusive. [00:27:41] Speaker 00: The language of 2201 says a court can rule [00:27:45] Speaker 00: on an action brought under the Declaratory Judgment Act whether or not further relief is or could be sought. [00:27:50] Speaker 00: So I've got baked into that something that says it's not exclusive. [00:27:55] Speaker 00: And then the broader point, I would say, is that the rationale, the language that drove the majority on the L2A issue in the Sandoz case is conspicuously absent here. [00:28:11] Speaker 00: So in the Sandoz case, the majority says, [00:28:14] Speaker 00: section two seventy one p two c two defines as an act of infringement submitting your by similar application and failing to provide the l two a information that's the act of infringement and then section two seventy one e forces the remedies that are listed here in all the only remedies that can be given for an act of infringement under section two seventy one p two c two and uh... [00:28:41] Speaker 00: Therefore, we've got an exclusive remedy provision baked into the BPCIA for that failure. [00:28:47] Speaker 00: There's absolutely no cognate to that for a putative failure under L9B. [00:28:53] Speaker 00: And so even if you were to consider it, if one were to consider it a remedy, it is in no way, shape, or form an exclusive remedy. [00:29:00] Speaker 00: And it doesn't, thereby, stand in the way of enforcement of the notice provision for the manifest benefit of the judicial system, the parties, and indeed the public. [00:29:11] Speaker 00: And if the court has more questions, I'm happy to do my best. [00:29:15] Speaker 02: No, I just have a comment, which is I suspect that given the competence and experience of counsel and the interest of entities like MGen, around a year, 11 and a half, somebody puts their finger up in the wind and begins drafting some sort of preliminary injunction [00:29:35] Speaker 02: motion just in case. [00:29:39] Speaker 00: Obviously these are huge products with lots of resources but equally that is true on the other side and as we have seen in the Hatch-Watzman context there are certainly situations in which those who wish to will flood the market. [00:29:53] Speaker 00: I'd refer to the court if the court is interested to the so-called Clavix case in 2006 involving Apotex in which in a period of several days it shipped out from that recollection serves a year's worth of product. [00:30:04] Speaker 00: out into the marketplace. [00:30:06] Speaker 00: And by the time a TRO was sought, it was too late. [00:30:10] Speaker 00: That was gone. [00:30:11] Speaker 00: And so, yes, that by all means. [00:30:13] Speaker 00: But this is true on both sides of the equation. [00:30:16] Speaker 00: And the whole purpose of the 180 days is to prevent a situation where we have to have a fire drill over and over again in every single biosimilar case. [00:30:24] Speaker 00: And if this court doesn't effectuate that, I fear that's where we're going to be. [00:30:29] Speaker 00: We're going to see preliminary injunction motions and TROs on every single patent and concomitant appeals to this [00:30:35] Speaker 01: Let me, if I could just very briefly return you to a point you made earlier, which I don't think I fully understood. [00:30:43] Speaker 01: You were saying there is a situation where the applicant, the by similar applicant, would actually have an incentive to make an L8A disclosure or notification. [00:31:00] Speaker 00: What would that be? [00:31:01] Speaker 00: Well, I think the incentive there may be [00:31:05] Speaker 00: If I'm the biosignor applicant and I'm about to launch into commerce a potentially infringing patent product. [00:31:12] Speaker 01: And you think there's a potential for having a huge liability and I want resolution. [00:31:17] Speaker 01: I would rather... Of course, they're free to get that resolution by means other than taking a chance in the dark, right? [00:31:24] Speaker 00: I mean, that's... Well, not necessarily. [00:31:27] Speaker 00: Remember, they're not free to bring that declaratory judgment action unless and until they give the 8A notice. [00:31:34] Speaker 00: That's what L9A says. [00:31:37] Speaker 00: Neither side can bring a declaratory judgment action on phase two patents unless and until the L8A notice is given. [00:31:46] Speaker 00: So if I'm the biosimilar and I say, I want to bring that declaratory judgment action, I want that certainty, of course I'm going to give the notice. [00:31:53] Speaker 00: But equally, there may be cases where I say, no, I'll take my chances. [00:31:57] Speaker 00: You know, it may cause catastrophic harm to the market, but I think there's a good deal of money to be made here, and I'll do that. [00:32:03] Speaker 00: And that is why we have the 180-day block-protected period, to say you can't do that. [00:32:09] Speaker 00: There has to be an opportunity. [00:32:12] Speaker 00: In the words of this court in Sandoz, a defined statutory window during which the court and the parties can fairly assess the parties' rights prior to the launch of the biosimilar product. [00:32:24] Speaker 00: Thank you, Count. [00:32:25] Speaker 00: Thank you. [00:32:31] Speaker 02: Mr. McTighe, we'll give you a couple of extra minutes if you need any. [00:32:33] Speaker 03: Thank you, Your Honor. [00:32:35] Speaker 02: I'll make that $3.50. [00:32:37] Speaker 03: Your Honor, Apotex isn't asking to rewrite L8A, as counsel said, any more than it is asking this court to rewrite L2A. [00:32:46] Speaker 03: What it is asking is this court to give context to the remedial provision that is there in L9B for a violation of the L8A commercial marketing provision. [00:32:59] Speaker 03: Counsel's pointed out [00:33:01] Speaker 03: in response to one of the court's questions that the L9 provisions, L9A prevents either party from actually filing a DJ on those subsequently listed patents. [00:33:16] Speaker 03: But by not giving the notice of commercial marketing, the BLA is making a choice that Congress intended. [00:33:24] Speaker 03: That choice is you don't get the right under L9B to bring a DJ action. [00:33:30] Speaker 03: In fact, under L9C, the RPS can bring a DJ action that way as well. [00:33:35] Speaker 03: So under any scenario, counsel's right, the RPS can bring a DJ action. [00:33:40] Speaker 03: But only one scenario where the ABLA chooses not to give the notice of commercial marketing, can it go for the certainty of the second set of patents. [00:33:52] Speaker 03: Now, what counsel is actually saying, and he noted that even if no patents are at issue, [00:33:59] Speaker 03: that this statutory-based relief, injunctive relief, that's extra statutory and not part of the scheme, should apply in all cases. [00:34:09] Speaker 03: In so doing, what counsel is saying is even though L is based, the title of L is patents. [00:34:16] Speaker 03: Where no patents are in dispute, the extra statutory remedy of a preliminary injunction should be available to it in all cases so it can have patent certainty. [00:34:28] Speaker 03: This court has said, the Supreme Court has said, in Whitman versus American Trucking Association, where Congress has held fundamental details of a regulatory scheme in vague terms or ancillary provisions, it does not, one might say, hide elephants in mouse holes. [00:34:46] Speaker 03: The elephant in the room here, Your Honor, is whether or not they can have 12 and 1 half years exclusivity. [00:34:52] Speaker 03: And they're trying to get that elephant through a mouse hole by saying, even though it's not listed [00:34:57] Speaker 03: as a specific remedy, we think it's OK for a court to take that extraordinary remedy for the potential to stop a biosimilar from launching into what isn't just for Amgen. [00:35:09] Speaker 03: It's a carefully balanced statute that allows the biosimilar applicant and patients around the country to actually benefit from the Affordable Care Act in competition. [00:35:19] Speaker 03: There are choices to be made, and there are consequences from those choices. [00:35:23] Speaker 03: Apotex chose, unlike Sandoz, to provide its information. [00:35:27] Speaker 03: to provide its BLA and its manufacturing information. [00:35:30] Speaker 03: Amgen is not prevented, as we sit here today, from bringing that injunction today. [00:35:34] Speaker 03: They pled in their complaint, both for preliminary and permanent injunctive relief. [00:35:41] Speaker 03: We are not here under L, the patent part, for the merits of their one remaining patent. [00:35:46] Speaker 03: And nothing prevents them from bringing new patents. [00:35:49] Speaker 03: And in fact, if they did, Apotex, like any other BLA, would have to make a decision whether or not [00:35:56] Speaker 03: to launch in the face of additional patents. [00:36:00] Speaker 03: It's the same thing that happens in the Hatch-Waxman context. [00:36:04] Speaker 03: There might be other patents out there. [00:36:06] Speaker 03: What the statute doesn't require is complete certainty. [00:36:09] Speaker 03: And although Amgen would like to say the Congress intended there to be complete certainty, and that's why the extra 180 days is there, there's actually an incentive, of course, for the applicant, the K applicant, [00:36:24] Speaker 03: to give that notice of commercial marketing. [00:36:27] Speaker 03: We've talked about it. [00:36:28] Speaker 01: But also... The incentive that Mr. Groomridge was talking about? [00:36:32] Speaker 01: The incentive to avoid the risk of large liability and the uncertainty? [00:36:37] Speaker 03: Sure. [00:36:37] Speaker 03: There's an assessment that every council, every company, must make if they must launch and the patents are not precluded from launching because of the next facility. [00:36:46] Speaker 03: But more importantly, when we look at the incentives and the way that Sandovi Engine came down with, [00:36:51] Speaker 03: by ruling the way that the plain language of the statute and saying, if you give the L2A notice, if you go down that pathway, if you make that choice, you're not bound by L8A as mandatory. [00:37:07] Speaker 03: So there's an incentive written into the statute for you to go down the patent exchange information phase at the outset. [00:37:17] Speaker 03: And that actually helps with patent certainty. [00:37:19] Speaker 03: Because you can go through that discovery process, which we've completed. [00:37:23] Speaker 03: You can put forth the patents that Congress intended to be litigated early. [00:37:27] Speaker 03: You can have the assessment for the... I'm finishing up, Your Honor. [00:37:32] Speaker 03: You can have that assessment for not only the Amgen's of the world, but the biosimilars who are trying to bring biosimilar competition under the Affordable Care Act. [00:37:46] Speaker 02: Thank you. [00:37:47] Speaker 02: Submitted and this court is adjourned. [00:37:49] Speaker 02: Thank you.