Oral Argument Legal Case Summary

Case Summary

**Case Summary: Mylan Pharmaceuticals, Inc. v. FDA, Docket Number 2591084** **Court:** United States District Court **Date:** [Insert specific date if known] **Docket Number:** 2591084 **Parties Involved:** - **Plaintiff:** Mylan Pharmaceuticals, Inc. - **Defendant:** U.S. Food and Drug Administration (FDA) **Background:** Mylan Pharmaceuticals, Inc. filed a lawsuit against the FDA concerning regulatory actions or decisions affecting one of its pharmaceutical products. Mylan, known for its generic drug manufacturing, challenged the FDA’s position or ruling which they believed adversely affected their ability to market or distribute their medication. **Key Issues:** The primary issues in this case revolved around: 1. **FDA's Regulatory Authority:** Whether the FDA acted within its legal authority or overstepped its boundaries in making decisions related to the approval or marketing of Mylan's drug. 2. **Impact on Market Competition:** How the FDA's actions impacted Mylan's ability to compete in the pharmaceutical market, particularly regarding pricing, availability, and market entry for its products. 3. **Procedural Concerns:** Any procedural irregularities in the FDA's decision-making process that may have violated Mylan’s rights under the Administrative Procedure Act or other governing legal frameworks. **Arguments:** - **Mylan Pharmaceuticals, Inc.:** Argued that the FDA’s decision was arbitrary and capricious, lacked sufficient evidence, and failed to adhere to established regulatory procedures. Mylan contended that this unfairly hindered its ability to provide affordable medication to consumers and stifled competition. - **FDA:** Defended its actions by asserting that they were in compliance with regulatory standards and necessary to ensure the safety and efficacy of drugs being marketed. The FDA likely argued that its decisions were grounded in scientific evidence and regulatory oversight. **Outcome:** [Insert outcome if known, such as whether the court ruled in favor of Mylan or the FDA, any injunctions issued, or remand for further proceedings.] **Significance:** This case highlights the ongoing tension between pharmaceutical companies and regulatory agencies regarding drug approval processes, market access, and competition. It underscores the challenges generic manufacturers face and the intricate balance between ensuring public health and fostering a competitive pharmaceutical marketplace. **Conclusion:** Mylan Pharmaceuticals, Inc. v. FDA is a critical case that reflects the complexities in pharmaceutical regulation and market dynamics. The court’s decision is expected to have implications for both the pharmaceutical industry and the FDA's regulatory practices moving forward. (Note: This summary is a general overview based on typical case elements. Specific facts or outcomes should be filled in as appropriate based on the available case documentation.)

Mylan Pharmaceuticals, Inc. v. FDA

Oral Audio Transcript(Beta version)

. What is that, they're followed? They didn't clear some bureaucratic obstacles. They lost to go, that's not their fault. It's them's the breaks, basically. No, that's different. That's different than saying they did something wrong. They didn't do anything wrong. They took a course of litigation that perhaps you wouldn't have taken. There was nothing irresponsible or illegal on ethical about that, wasn't it? That's correct, Your Honor. Somebody made a business decision to do it. And so they pursued it. Right. And then through the way the process worked, they could have won. Who knows? And once they cleared that thicket, they still might not get it as a exclusivity in that correct. No, if they had, first of all, they did get exclusivity as to that particular patent, right? You said something and I didn't quite, you about to finish it, you said you didn't get it as to the two that you did have it as to O-60. That's right. And that means you won't get it until O-60 expires. Is that right? No, no, it's the other way around, Your Honor. Well, the other two were 13. They put a lot of guess. Well, I see. In 13 they got it. Right, right, right. But the argument from the other side, at least in Teeva's perspective, or at least from Loopers, is that 13 is when the 180 day started. That's, well, not actually not even in 13 does the 180 start. It starts under their view, FDA is you in Tevavu, when they start commercial marketing. In other words, you flip to the other trigger because there's been no court decision trigger on the second patent, the reissued patent. The O-48 patent. But if I could get back to the point originally that the judge shed was raising, it is that, them's the brakes. The cases are clear. There are times where you get an exclusivity period and you can't use it. We cite the right. I mean, the thing that troubles me is, I can put it bluntly, is, you seem to be a little bit of a free rider because you have another company come in. And they file this paragraph for certification. And that involves a lot of expense on their part. And it involves, as well as expense, it involves a lot of risk. And they know that once they assert the invalidity of the patent, they're going to be sued. And so they're going to incur a large cost. They're going to incur a large risk. And then you come along in their wake and want shared exclusivity. And that's a little troubling. I mean, because even when the reissued patent comes down, they still have to file another paragraph for certification to update and maintain their eligibility. But if the whole purpose of, I think, I'm just reiterating what my good colleagues said, but if the whole purpose of Hatch Waxman is to encourage generics to get on the market so that people can buy a more, by drugs, a more reasonable price, it would seem to me that the purposes of the statute are furthered by giving some kind of respect in the form of a single exclusivity period to the company that actually did what the Hatch Waxman acted wanted them to do, which was to go and challenge those patents and get to the point where you have the incentive for these drugs to come on the market for consumers to get them at more reasonable prices. And what are we doing to that whole scheme if we undercut those incentives? That can't be in the public interest, is determined by Congress. It actually doesn't undercut the incentive. And if you'll permit me to explain why. First of all, let me address the point. We are not a free rider in the situation. Myelin and Watson actually carried the water in the challenge to the later patent in that patent proceeding. You were a free rider in this instance that you didn't file the initial paragraph for certification to the original patent. That's correct, Your Honor, but as to that patent, the courts have repeatedly recognized that basically what you're trying to do is to set up an incentive, as you mentioned, to get the generic companies to challenge a patent. Once that challenge has been made, the incentive is satisfied. Sometimes the incentive pays off. Sometimes companies do get the exclusivity period and going in, they never know whether they're gonna get the excessive. It's not satisfied if there's gonna be shared exclusivity after the point of a patentary issue. Well, I would disagree, Your Honor, because the incentive was there for the company that it would have the chance of getting exclusivity. That's not the having a chance, it's not the same as having a sure thing. If in the event of a patentary issue, you file another title paragraph for certification, which the original, the challenge or the original patent would need to do. But if the second stage, and I don't know how often reissue patents are issued, but if at this second stage, this company loses the challenger, the original patent, loses out because they're shared exclusivity. That's a whole lot of incentive for somebody to say, oh, well, let's sit back and wait for somebody else to take the risk, and then we'll come in and share the exclusivity in the event that there's some technical flaw in the pattern and the patent that requires a reissue. So two responses, if I might, Your Honor. The first is that the courts have recognized that there are times where because of the way that the statute operates, you can be the first filer, you can get exclusivity and you can't use it. We cite two cases where that happened, the Nostrum case and the high-tech pharmacal case

. The other thing is, believe me, if a generic company is ready to file, they will file as quickly as they can because they have a huge incentive. When nobody's gonna stand back and let somebody else be the first filer and let them carry that heavy lifting because if you have a chance of being the first, you have to file on that first day that the patent is listed. Let me ask you this, isn't it your position that Tiva got exactly what it was entitled to on the statute, 180 days of exclusivity? That expired in November, two times a year. Okay, sorry. The fact that they couldn't take advantage of it has nothing to do with the statute, is that correct? That's correct. And we talked about the policy and the intent of Congress, how do we get to what seems to be a good policy and it looks like what Congress intended. Well, what do you say about that? Well, I said what Congress intended is precisely what the statute says, that if you get a court decision trigger that is on a and a decision that relates to a patent that is the subject of the certification, and I'm quoting from the statute here, which was what happened here. Maybe it may be for some discussion that maybe the policy doesn't reflect what Congress intended, but do we apply intent, or do we apply the words of the statute? You apply the words of the statute, and if the words of the statute would lead to a situation that would be an absurd result or that would clearly conflict with the intent of the numbers. Is there any absurd result here in saying there's one period under that O68? Is there any absurdity in that? There is not whatsoever, you're on. Let me ask you this, is there an absurdity with the application of the statute? There is not an absurdity with the application. Might somebody think the way the statute works in the real world is odd or not good? Might that be the case? Oh, sure. Well, if you're the injured party, you're gonna think it worked in a nod way. But there's another little point here that's a little bit, I think only a Hatchwaxman lawyer would know this, but the 180-day period was intended to be a very firm deadline. If you can't market within 180 days, then your exclusivity period is glad. That helps other generics to produce. I'm so general for. And what can happen is, and this does happen with some frequency. Company A, let's say Tevin, in this case, gets a first-file or status. So they're entitled to exclusivity. For some reason, the patent company doesn't sue them. So there is no court decision trigger to start their exclusivity period. So the only thing that triggers their exclusivity period is either commercial marketing and sometimes they're blocked from commercial marketing because they don't have the right application in. Is that an answer to the argument? Is that an answer to the argument? Yeah, well, it is if we're talking about the incentive. Well, we're talking about a very complicated situation here. And I don't know, sometimes, I don't know all the implications of it. But how can this, I don't understand the plain language argument. I don't know, the statute doesn't say anything about a reissue patent. And it's completely silent on that point. And what we really have to go by is that word, the patent. And you say that there, well, that means there are two, there must be two patents here. But that isn't at all clear to me that we're not talking about a single patent. I can make the arguments that I'm sure you would make about orange book registration and a different patent number. And I'm familiar with all those arguments because you've set them forth in your brief as to why they would be two patents. But there seem to be an awful lot of arguments as to why there would be just one patent. Because when you're talking about reissuing something, you reissue what? The, you know, you reissue the original patent. Well, hold on a second, you reissue an original patent. It's not something different. And this reissued patent thing, it's a slight error correction process. You can't introduce any new material. The reissue patent expires on the very same day as the original patent's term claims in the original patent litigation continue even when the reissue patent is issued. So what I'm saying is there are, five reasons over here to regard them as two patents. And there are five reasons over here to regard them as a single patent. The statute doesn't say, the statute doesn't exactly, the statute never addresses reissued patents. I don't understand why this wouldn't be a case in which we might show a certain a bit of modesty and let the agencies interpretation stand because I'm not confident there's any kind of really plain language argument here, but there is an ambiguity. That's what agencies are for as they work through the whole situation in their adjudicative and regulatory capacities. And I just don't understand why the statute is something we might defer on because we really don't have an awful lot of knowledge about it. We'll get into it episodically to say this and that, oh, this seems better to us, but the FDA is going to be dealing with this day after day after day. And it, Chevron One is always a little risky when you are trying to overcome the agency expertise and experience and something and trying to counterman what the agencies on the ground have interpreted the statute to me. And so Chevron One is always a little risky unless you really, really sure you know what you're doing. Sometimes it's better to say less rather than more and leave it up to the agency to work through the wrinkles and see how it works out in practice. Judge Wilkinson, I'm over my time. I take a little bit of time to respond to that. You made a lot of points. Thank you. The first thing is if you look at the language in the statute and not only says the patent, it says the patent, which is the subject of the certification. And it sets up a very precise structure. A patent is filed. There is a certification that is made to the patent by the generic drug company. That gives the opportunity for this patent litigation. The patent litigation occurs if it results in a court decision that triggers that specific period. So it's more than just the patent. It's the patent which is the subject of these sort of issues

. I'm just going to perpetuate the ambiguity. Well, in your honor, if you look at what the FDA is saying, they are saying the patent, which is the subject of the certification, can be the patent which is not the subject of the certification. It has to be the reissue patent which was not the subject of the certification that led to this patent litigation. And that's just wrong. That contrabeens the statutory language. I'd also like you said there's five on this side. Why is it called a reissue patent, man? I mean, well, it is called a reissue patent because there are limitations on the term and it is the same invention. But that's true of any patent about any drug and there are periods where the FDA would concede and tevd it as well. If this was a new patent on the same drug, there could be in this pre-MMA context, there could be multiple periods of exclusivity. But if you look at this specific patent and you look at the use codes and you look at the claims that were made, it is a different patent. If you look at the form that was filed by Pfizer when they filed this patent, they said it was not the same patent. And if you look at the case, the Supreme Court case that we cite, the grant case, which was sort of the granddaddy of reissue patents, it refers to at least 13 times a reissue patent as being a new patent or a second patent. So it is a different patent and different patents have different periods of exclusivity that attach to them under the words of the statute. So they- Let me ask you this. If it's the same patent, which I think FDA would take that position, when does 180 days run? Well, they say it only- No, under the statute. I don't- When does it run? Well- Does the statute give you the same patent, to 180 day periods? Doesn't do that, does it? Well, the same patent, don't you get one? I'm sorry, if it's the same patent, what FDA is saying- No, I'm just asking you, let me ask you this. There, I know what the opposition is. Right. But I'm asking, where does that- Do you see in the authority for a second 180 day period taking one has been granted and it is run without marketing? Where's the any statutory authority for a second 180 day period? The courts have held that there is ambiguity in terms of whether- They're asking about ambiguity. I'm saying, where's that in the statute? Is it anywhere in the statute? Well, I'm trying to answer your question. But what courts have said is that when the term is used- the patent term is used in terms of the creation of a period of exclusivity, then that is an ambiguous term. An FDA has stepped in and said, there can be multiple periods of exclusivity. And the issue, they said, I asked you what you say about that. We have no argument that when there are multiple different patents, there can be multiple periods of exclusivity. One can get exhausted and one can- Then one can be acted upon. That's for different patents. That's for different patents, yes, you're right. And it's our contention. You missed it. No, you missed it, my question. I'm sorry, then. If in fact here, I just want- If FDA argues that the reissue is the same patent- It does. That's what they argue, I think. Yes. Where's the authority for their 180-day period to run? Because on that very same one patent, it ran for in 2008. That's correct, Your Honor. Is there any language in the statute? In the statute. I know what FDA's doing, and I know what someone to do. Gosh, it's kind of a big old mess. Let's just let them do it or let agencies do it. But don't they have to be authorized to do it? It has to be in the statutory language. It has to be authorized and it is not. And the statute says that the framework doesn't it? It does. And that framework in this case may be kind of sloppy and doesn't lead to the results some I won't. Is that correct? Only tell them. But you say that that is mandated by the statute. I do, and it's- And it- I'll read the answer any more for me. OK, great. Thank you. Well, thank you. I have a question. I want to go back to something you brought up early and dealing with the usage of security with hatch-waxman type folks. And that is when the brand company does not sue, that events occur then. And you mentioned the marketing aspect of it. And I think you were going somewhere else with that. I was. Thank you. You're on our appreciate the opportunity to answer that and complete that question. What will happen is the 180-day exclusivity period will never run because the commercial marketing has an occurred and the patent infringement case didn't occur. Other generic companies have the ability to file a declaratory judgment action to try to get the patent declared invalid to create the court decision that will then trigger the exclusivity period for the company that was the first filer. So there's a remedy in that situation. And that's why the- We also very quickly, and that is, we're got to potential Chevron deference

. Even if we assume ambiguity, does that necessarily mean that we must give difference if we determine that the issue here is really one of patent law and not within the expertise of the FDA? Thank you, Rhonda. It was one of the points I wrote down to mention, and I ran out of time. But that's exactly right. You're saying that now. Yeah, thank you. The patent patent, you all have a lot more experience in patent law than FDA does. They have refused to exercise a review of patents in terms of what the claims are, whether they're different, that kind of thing in the past. What they look at is they got a form that's filed, and in this case, the form said it's a different patent. So therefore, they should be following the statute and saying that- We get all this expertise in patent law. Well, FDA doesn't have- Well, FDA disclaims at least. Let me put it out. I don't do ourselves when we wrote a case, at least one of the circuits, did that affect? Right. You didn't have expert teeth in patent law. There was a lot of cases on that. So a lot of cases on that. Thank you, Your Honor. I get your honor. There was one, I'm sorry. We made a mistake on page nine of our brief. I'll address that in my report. I'll put it in my comment. Mr. Landman. Thank you. May please the court. My name is Chad Landman. I'm with Axon, Velotrop, and Hark Rider. We represent Watson, Laboratories, Inc. And I'm here to address the second issue before the court, which is whether FDA is failure to follow its patent by patent approach to exclusivity with respect to the reissue patent should be reversed by this court. And a couple of these questions were actually already asked and addressed, but I wanted to circle back on a couple of them. Judge Wilkinson brought up the good question about the incentives. And what did Congress intend and what did they intend to inset? Well, they intended to incentivize prompt patent challenges. And what FDA then did, and it was a result of that, way back decades ago, said we should have patent by patent process and approach. So that every time there's a new patent, we are going to give a new period of exclusivity. FDA established that. There's a discussion in the Aepatex case and other cases in our papers. But once FDA establishes that, they can't deviate from it, because that's arbitrary and capricious. Is there any disagreement that there should be a patent by patent approach, at least as the earlier law before the amendment? Any in a disagreement on that in here? With respect to the parties here? Well, I think there is disagreement from FDA where they're not applying the patent by patent approach. I don't know how to apply it. There's the way it exists. That it should be. That is OK. The applications are different thing. I'm sorry. Yes. I don't believe any parties are here saying there shouldn't be patent by patent, exclusivity. So once FDA resolved that ambiguity, it can't depart from it here, because that's arbitrary and capricious. That is a reason for reversals. Now, the reason they established that was to provide an incentive for prompt patent challenges. So if a later filer to another patent, files first and challenges quickly, it will clear that later patent. So with respect to the reissue patent, thinking about the reissue patent, what that means is you want to incentivize companies to quickly file those. Yeah, in an agency change, it's position, and then that's subject to differences. Not without any reason to explanation. And reason explanation doesn't just mean, and we cite some cases, the effect, the Burlington case, doesn't just mean that you said forth an explanation. You have to actually explain why this patent. You're arguing it is letting this court take it that there's an ambiguity. Do you think there's an ambiguity in that statute? In the section of the statute that establishes, which says holding the patent, which is the subject of the certification, the patent, which is the subject of the certification, is there any ambiguity as to that? Well, I don't believe there is in the statute to a section about the court decision, and the patent, it's a subject to the certification. No, I don't believe there is. Why is this called a reissue patent? If it was a different patent, I would recall it. We call it the new patent. That's a great question, Your Honor. So part of it, we'll seeped in patent law, but that you go through a reissue proceeding, so you submit your application back to the PTO

. And you would ask the question about the differences between the reissue and the original. So the reissue patent is just like a couple of other types of patents out there. There are patents called continuation patents. There are patents called divisional patents. They all stem from the original patent application. They all just like the reissue patent, get the same expiration date as the original patent. And just like a reissue patent, there's a prohibition against adding what's called new matter. There's no reissue patent without the original patent. Correct. And just like there can be, you'd be like constructing the second story of a house without the first story. Right. And it's the same as there can't be a divisional or a continuation patent without having the original patent application. Let me ask you this down the road. Who's going to be dealing with this whole matter on a day-to-day basis? Well, FDA and the pharmaceutical industry. All right. How's the FDA going to be dealing with it on a day-to-day basis? Reissues, you also asked this question, don't happen all the time, but to the extent that they happen, FDA will have to decide. Not nearly, and it's a due to couture and capacity or in its regulatory capacity or what. When it's deciding whether to grant new drug, or approvals of generic drug applications, correct? So is the, is the, is the FDA wholly devoid of any kind of patent experience that your, your, your colleagues suggest that they really know nothing? So as far as, as, as, as patents are concerned. Sure. And I smiled a little bit about the question. FDA has repeatedly said, and courts have repeatedly found that they have no patent expertise. They swear off having any patent expertise. And they, they are firm and courts have a firm that they have merely a ministerial role as it relates to patents. And I actually just one question. What's the point of the argument? I don't even know what you argued quite well. I mean, I heard you words, but how do you advance this argument at all? I'm sorry, Your Honor, so the point of the, it might be me, it might be me. I'm just going to give you 15 to 30 seconds. I appreciate that. The, the point of this argument is that we believe that all first paragraph four filers to the reissue patent and namely here that's our client Watson, Milen and Teva are entitled to a period of exclusivity on the reissue patent. Because FDA itself has been applying patent by patent experts. May I ask one question? Sure, ma'am. Is, is the reissue patent, I call that 48, is that the number? Correct. Is, has 48, has there been a determination made, a certification made as to 48? Correct, yes. Is that on appeal? I'm sorry, the patent challenge, yes. The patent decision, the certification decision. Yes. Is that on appeal to the federal circuit? Yes, there was a, what happens if the federal circuit reverses the finding by the district court? What happens then? Of invalidity? So that, that patent was found in valid. Who's that all the parties think? So many of the parties including our client have actually, including Teva, which is actually the reason we're here. I'm answering my question. I'm sorry, I was trying to get, I was trying to get at the practical realities as most of the companies have licenses that started a period to enter the market. Oh, you just walked that out, outside this framework. Correct. If in fact, Pfizer, Teva, if they worked arrangements with the all of you on how you're going to market it, is that correct? Why not this mood? Well, because don't you have authority to market it? No, because FDA only gives approvals based on it's looking at the regulation who has exclusivity. So even if Pfizer, which Pfizer has done granted licenses to parties to enter, that doesn't mean that FDA will actually approve the application. So under FDA's letter decisions. Because they protect the exclusivity? FDA will follow the exclusivity and under their letter decision. Wait a minute, wait a minute. You telling me that if a party gains exclusivity under the statute, there's no question about that. Doing that 180-day period, they can't license another four or five or eight companies to use their exclusivity period. So the branded company could in Teva itself could license its exclusivity period. You do that all the time. That's what's been here in the happen a lot now. Sometimes that... With the 100-day period. Yes. They all go out licensing of the companies. That does happen, Your Honor. Thank you. Right, thank you. Mr

. Chairman. Good afternoon, Your Honor's Arthur Chan for appellate, Lupin Pharmaceuticals Inc. You're still in that federal suit that Judge Shed was talking about, aren't you? They didn't settle with you. Lupin has not yet settled. I understand. If it reverses in the case and the Judge Shed's analysis then for you. Well, whether Lupin settles its patent suit with Pfizer or not, they are still blocked under FDA's interpretation by Teva's 180-day exclusivity. So... So the effect of the federal suit is going on now either way does not affect that USA. That is correct. Well, the analysis here. That is correct. From your perspective. Yeah. Not the others, because others have settled out and it's a dead-in-fact them. Well, my land and Watson may have settled, but they're still blocked by Teva's 180-day exclusivity. But here about what your client says about the ongoing lawsuit. In other words, the 48, the 48 patent, because that's not settled yet. I mean, that's not worked out yet, is it? It's not resolved yet. It's on appeal. That is correct. So none of those questions should be in front of us? I don't believe that what happens between Lupin or my land or Watson and Pfizer on the litigation of evolving the reissued patent has any real bearing on issues before the court, which is who gets 180-day exclusivity if anybody? Lupin agrees with all the parties in this case, in part, but we also disagree with all the parties in part. Our bottom line is that there is no remaining 180-day exclusivity today. And it is in you out, because the three of them say they have it after the reissued one, at least the ill side, and then Teva wants it just after the original one, but you don't fit in that scenario anywhere. That is correct. You say all of it is gone. I'll let it run. That's right. Our view is that it's all gone. And we get there by addressing the two separate but related questions that FDA teed up in its decision letter. First of all, we think FDA's single bond law patent rights approach for reissued patents is correct. And under that approach, 180-day exclusivity rights flow solely from the original patent, not the reissued patent. And on this issue, we think the statute is, in fact, ambiguous, we think FDA is... The second patent, the reissued one, for 48, is essentially the same as 68. It's the same patent. Well, and the use of this single term in the statute, even though there are two patents, you say that's ambiguous. That single term playing language, patent, eight patent, as opposed to patents, or patent and reissued patent, is just patent. Yeah, yes, Your Honor. We said ambiguous about a single word patent. Well, FDA looked at reissued patents and they concluded that the statute was... You can see that they got to look at the statute. They don't get to... We don't go into incentives and all this other stuff when we were looking at the statute. The first thing we do is determine that statute is ambiguous. Then we find it ambiguous. Then we get any other questions, you know, is it been there expertise in the Chevron deference and maybe some skidmo, I don't know if we find that. But we don't even get that if the statute is not ambiguous. And the statute says patent. Congress knows how to say poor stuff, don't we? I mean, he knows how to put it in there. And Judge Wilkeson alluded to the very essence of this hatch, Waxmanack, which is to move this thing along. So, I mean, how does it further it by putting in this, you know, bundling this all together? Well, FDA's bundle of patent rights approach. And on this issue, I agree with Judge Wilkeson and Judge Shed that..

. Deference is... I don't really agree with each other. Okay. Well, if I understand your comments, or your tentative comments correctly... I don't tell what you're agreeing with. Well, yeah, I don't think you can take me anything I've said what I agree with. Just ask this question. Is there an ambiguity in the statute? And, Ours, is that word patent? Is there something ambiguous about that? For this particular piece of the equation, we think the answer is yes. We agree with FDA. And FDA said the term is ambiguous. But you have to decide. What do you say it's ambiguous? And if my colleague would allow me, let me say the phrase, the patent, which is the subject of the certification, what is ambiguous about that? About that language? Well, I think it's a matter of looking at it in context. It's... Well, one in context in the statute makes you think the patent, which is a subject of a certification, is ambiguous. Well, it's whether the patent refers to the original patent, or the reissued patent, or as FDA... Is the certification the same for the original patent and the reissued patent? Well, under FDA's interpretation, every genetic sponsor has to... Well, you're not answering my question. As it is, how much variation is there in the certification between the original... The certification with regard to the original patent and the certification with respect to the reissued patent? Because there has to be a certification for the reissued patent. If a company is going to gain exclusivity. I know that my time is up, Your Honor. If I may continue. But just answer that question. Well, each ANDA sponsor has to certify to the original patent and the reissued patent, presumptively... Each generic who wants exclusivity has to certify as to the original patent to get exclusivity for that, and they have to certify as to the reissued patent in order to get certification for that. Am I right? Well, actually, under FDA's interpretation, there is no exclusivity associated with being the first to certify to the reissued patent. Are there any certifications with respect to the reissued patent? And what relationship do they bear to the certification for the original patent? Is it same? Is it significantly different? Is it different in what respects? How much was it different here? Well, that's going to be up to each sponsor. But I assume that any sponsor that certified that the original patent was invalid or not infringed with an all likelihood, make the same certification as to the reissued patent. And you have to give up the original patent to get a reissued one, don't you? That is my understanding of patent law, Your Honor. Yes. If it's the same, why is that necessary? I mean, if it's the same patent, you know, we have laws that General Simulies passed all the time and they amend them and they modify them, or they repeal them and enact a new law. I don't know anybody that goes back and say, well, that's the same law, and we're going to treat it the same. We've got two different patents here. One's been, you got to give it up, then you go and get a new one, a reissued one. That's what the word reissued means, new one. Right? Under substantive patent law, as I understand it, there is a new patent, and the original patent lives on in the form of the reissued patent. All right. Thank you, sir. Thank you, Your Honor. Yes, resurrect it. I'll take care of that for you. Mr. Taney. May I please the court? I want to just start with the part of the statute that everyone agrees is ambiguous, the ambiguity that we agree upon just to give context to this dispute. Is there a one agrees that the statute is ambiguous? You know, a certain respect, and I will explain it. What is it that they agree? Because I don't know who agrees. I'm not agreeing that statute is ambiguous. Well, of course, that it was unambiguous

. Well, I'm just saying in a certain respect, and I will explain. The question was put, and this is the question that was put in the apt-tox case, cited in the court. Where's the ambiguity in the language of the statute? So the statute is ambiguous as to when there is more than one patent, whether there are multiple periods of exclusivity or a single period of execution. That doesn't make the statute ambiguous. That makes FDA's application of the statute maybe troublesome. Where in the statute does that make it ambiguous? The statute says the patent, which is the subject of the certification. In this case, I'm talking about as to the first certification. Is there any question as to what that patent is? That's number 68, isn't it? The first certification is not the one that's referred to in the statute. I'm asking you, what is ambiguous about the patent, which is the subject of the certification? Which of those words, let's just start, we can work out. Which of those words happened to be ambiguous in your opinion? Well, the question, the thing that's ambiguous is... That's my question. Right, and the thing that's ambiguous is... Let me make this argument. Yeah, we're here. The thing that's ambiguous is whether when you're talking about... When the certification that we're talking about, when there is a certification to a patent that has been reissued, which is what we're talking about here. The question is whether what you're talking about there is only the patent in its reissued form, whether that's the patent, which is the subject of the certification, or whether you're talking about the patent through its entire life, including original and reissued. You have a certification only to a reissue patent. Well, could you have a certification under this section, only to the reissue patent? Never had one as to the original patent. You could do that. Well, then so it's not ambiguous. It applies when it applies. It's not anything difficult that I see about that. You want it, it may make it troublesome for some people in the real world and that they don't like the results of it. But if the reissue patent, you just said you could go through this certification procedure, then that would indicate that a reissue patent is a patent subject to certification. But the premise of that argument would be that every certification gives rise to a separate period of exclusivity. And that is the point that everyone agrees the statute is ambiguous on that point. That was what was in the Apatex case. Not even. What is that? It says the patent. I'm just still you have an answer to my question. What is the ambiguous? Is patent ambiguous? Which is the subject of the certification? No. Maybe we don't know much about other things too, but what is ambiguous about that? Well, I know you may not like the results, the way the... I'm not saying you have to agree with this, the way an unambiguous statute is applied. But what's ambiguous about that? Well, the portion. I just to be clear about what ambiguity we're talking about. That is the court decision trigger. That is, says, if we know that there is an exclusivity, when does it begin to run? Okay, now that is what is sort of the second question. The first question in the case, and let me just make this clear. The first issue is the beginning of the statute. I'm reading in A4 of our appendix. It says, if the application contains a certification, described in subclass four, that's a paragraph four certification. And is for a drug from to previous application has been submitted under this subsection. I think we all agree that those conditions are satisfied here. Containing such a certification, there's a typo that says continuing. It means containing. And then it says, the application shall be made effective, not earlier than 180 days after. And only then do we get to the language Urana was referring to. Okay, so the first question here is, we're saying, okay, the plaintiffs filed applications. It's not a free-floating 180-day exclusivity period that's granted to somebody when there's a decision. That's not the way it works. The way it works in Congress's words is, somebody has filed an application. The first question for FDA is, does that application contain a paragraph four certification? Answer yes. And the next question is, was there a previous application under that subsection with a certification? Now here is the point that the Apatex court said was ambiguous and that FDA was reasonably interpreting

. And the question is, when they say containing such a certification, do they mean another previous application that had any paragraph for certification to any patent? Or do they mean another previous certification to the same patent that you filed your certification for? That's the first ambiguity in the statute. The parties here are not disagreeing that there is an ambiguity there. So we know that the question and the result of that is that in some circumstances under FDA's approach agreed on by the parties and upheld by the DC Circuit. There might be some circumstances when there is more than one patent and then there is more than one exclusivity period that comes up. Now everyone agrees, I think that FDA also could have come out the other way on that question and could have said, no, there is only... The next step too, that step two. You say that the language that I've cited to you is made ambiguous by other language in the statute. Well, in order to interpret the language that you've cited to me, you have to understand the way it fits into that scheme. Okay, so... Within the context of the statute, other language in the statute makes this... Well, so just to march through it. You answer my question and you can march through it. You say there is other language in the statute which read with this creates an ambiguity. Well, let's start with this language alone. The answer is, I think, both the language alone and when you put it in context is ambiguous. Well, the language alone is ambiguous in your view because he's making a point about the patent for which the certification is issued. What they're saying is there are multiple patents and not only are there multiple patents, but there are multiple certifications. And so you've got to go back and take the particular patent. And you've got to go back and take them as multiple patents and multiple certifications. The statute makes that clear by using the singular. Certifications doesn't have an S after it and patents doesn't have an S after it. So, what if those two words don't aren't in the plural and don't have an S after them? Why is the statute ambiguous? Well, we've been dancing around, but I just wanted to direct the answer to that question. Well, if you're going to say it's unambiguous, then you have to say that it clearly refers to a particular patent. So the question then would be which patent is that? Is that the reissued patent or is that the original patent? If you're treating the two as distinct, if you treat the two together as FDA does, then you don't need to answer that question. But I understand the plaintiffs to be saying it's unambiguous because it unambiguously refers to a certain patent. And then which patent is that? Now, if it's the reissued patent, I think that might be what the... How would it refer to both? Well, if it refers to both, that is what FDA is coming out. FDA is saying if the patent... I mean, it refers to the one. It refers to the original patent when the original patent is the one that is underlying the exclusivity fight. And then when a reissued patent comes along, then it refers to the reissued patent. I mean, why wouldn't it refer to both the original patent and the reissued patent? Right. It refers to the version of whatever the patent is that is in force at the time that you're talking about this. That's right. So what if it does refer to whatever patent is a force at the time? Then the reissued patent just supersedes the original patent and the original patent becomes more bad. And then we are talking about the reissued patent. And that becomes the patent. In other words, the original patent becomes the patent for a time. And then the reissued patent becomes the patent for a time. And the original certification becomes the certification for a time. And then the certification is the reissued patent. That becomes the certification. But I don't understand why that makes it ambiguous. Why that singular, the, which precedes both patent and certification, doesn't refer to the one that is still alive and sort of in force at the time? Well, if you treat the statute that way, then FDA's decision in this case was correct. Because the question under this clause is whether there has been a decision of a court holding the patent, which is the subject of the certification to be invalid and not infringed. And so if you say that means whichever version of the patent is in force at the time, then everybody agrees that there has been no such decision. So, and that's what FDA concluded. They said this trigger for starting the 180 days. It was not such a decision on 68 in 2008. But that's if you're talking. But that would be the opposite of the hypothetical of the reading that was just proper to me as an unambiguous reading. I think it's completely consistent with it

. He's asking what I've been asking. What are two separate events, the D pattern, which we call number 68, the original pattern, and 48, the reissue pattern. That's two different ones. If you, and that's the case, there was a court, I thought it actually had not been a court decision on both of these. Well, the second court decision is under appeal. I understand that, but it's been a court decision. Well, the statute makes elsewhere, not in language I quoted right here. I know that it doesn't count. I just make that point with you. But on 2008, that decision's final, the decision rendered on number 68 in 2008, that certification is final, isn't it? FDA is not making a determination in 2008. And the question is, I said, isn't that, wasn't there a court determination in 2008 under that section? Was there, was there not? If you took the pattern, which is the subject of the certification, to mean the original pattern. How about the only pattern that existed then? Was there, wasn't it finalized to that? As to the pattern, as it existed then, yes. And the question is whether that is what you're trying to ask your team. Why would the question be? But that's not my question. The question is, why can't the statute be read just the way I'm reading it? I know you don't want to read it that way. I know you don't want to. I don't stand there. But why is that subject to any other reading other than, I guess, judge Robinson said the pattern is then existing? Why isn't that clear? The statute just applies to different patterns. Why isn't that clear from the statute now? Because the point, the portion of the statute you're focusing on, involves the question of when the 180-day period begins to run. And so there's an antecedent question, which is, is there a 180-day period that anybody is entitled to? Because you could have made exactly the same argument in the Apatex case and said, okay, they certified to this pattern. There was a decision about this pattern. But the reissued pattern and the new certification puts the original pattern and the original certification into mouthballs, doesn't it? Well, they no longer have any relevance. They essentially mooted out of the case, aren't they? Are there any relevance at all? At that point, once the reissued pattern takes goal? Well, FDA's view is that it is relevant who certified first to the original pattern, and that you have to keep up your certification even as the pattern is reissued. But is the new certification different from the original certification? Yes, because you have to describe why the, the, the, the, the, the, whatever you're certifying to is not, is invalid or not in fringe. In this case, of course, and in most cases, they're going to be very similar. I just want to say something else about reissued patterns, were generally, which is relevant to this discussion, which is, this is a case, which is an unusual case for an reissued pattern, in that the pattern was invalidated, and then they went back and got it reissued. Now, what happened after 2008, what did the FDA do then? Could it have done something then after the 2008 decision? Is there something it could have done to say, okay, you're now granted a 180 day exclusivity rule before then? What? Isn't that, no, wouldn't that be normal? No, because FDA, and this is on 46 of the joint appendix, I don't understand anyone to be disagreeing with this either, FDA makes decisions about, they don't say you get your 180 days now. What they do is, when they have two applications, and they're trying to decide whether to approve an application and when to make that approval effective, then... Is there an original, is there an original, there were two applications? There were plenty of applications, the problem was none of them, for reasons entirely unrelated to the speed we're talking about right now, there were these other patterns, so none of them were ready to be, be approved. Nobody was ready to be approved because they would be infringing these other patterns. I'm only talking about O16, right, but... Insofar as that particular pattern, when it expires, I know the other set to go to. Right, but you asked me the question of why FDA didn't take action at that time, and the reason is that there was no generic manufacturer that was ready for approval. They take action. They take action when a manufacturer would otherwise be ready for approval, and then there is a question about exclusivity. That's what the statute tells them to do. They say, if you've got an application, you're trying to figure out when it's effective, and if it's obvious that none of the applications can be approved at that time, there's no reason for FDA to take any action, and they didn't. Now, what practical problems, in your view, would the interpreting the pattern and the reissued pattern to be different patterns, and the certifications to be different certifications? What practical problems does that lead to in your view if we don't adopt the FDA's interpretation, and we just read the pattern to be both the original pattern and the reissued pattern? I say I'm over time, but if I may answer... The problem is really just whether what is the most faithful to the scheme that Congress has enacted, and to give an example, and I was alluding to this earlier, patterns are reissued at the instance of the pattern T, so what pattern doesn't have to be invalidated in order for someone to get a reissued pattern? They could just look at their own pattern to decide that it needs to be changed in some way, that they've made some error. So to take a simple example, which I expect would be the most common example, suppose a pattern T has a pattern, and then somebody file... They file it with FDA, someone files a paragraph for certification, okay? There may be litigation that's just starting off or hasn't started yet or whatever. They take a look at the pattern and they say, we've made an error, we want to fix our error in our pattern. Preasons either related or often unrelated to the litigation, they just want to fix their pattern. So they go to the pattern and trademark office and they say, okay, we made a mistake in our pattern. There's a defect in the drawing or specification, those are specific grounds for reissue. We want to fix it. So here's our reissue application. Then PTO says, okay, fair enough, here's your reissued pattern. Then they go back to FDA and they say, okay, it's been reissued, here's our new certification. Then everybody, whoever the first filer was on the original pattern, the one who's objected themselves to litigation. But then also everybody else who wants to free ride off of that comes in and they go, okay, we're filing certifications to the reissued pattern. And that scenario is the same as one of court has invalidated a pattern. Well... I mean, here it seems as though this pattern was... You had to give it up to be able to issue one. That scenario you gave is almost like there's a technical mistake or something that happened and you went and got it amended or the original. So in the scenario you gave, do you get a new number? You do get a new number. It's the same identical process we're talking about here in your scenario. Exactly identical. And you have to give up the original pattern in order to get the reissued version. And then... You don't get as a continued protection, though, I take it. If you didn't have protection back here, that new one's not going to give it based upon the one that was not good, right? Well, no, there are rules about under what circumstances, you know, things that infringed one or the other of the pattern. Now see how continuous it is. Well... If it's the same pattern, then I'm just wondering how much protection you're going to get from that original one that's been declared invalid when you get one reissued. Well, I think... Reissued pattern, I'm going to stand as protection for something that may have been an infringement known to peer it at the original one. Well, yes. In most circumstances there might be exceptions in certain cases. But... Well, if you look at section 252, it's quite clear on that. Let me ask you this. What if a company got 180 days under the certification of the statute? The only one at that time they could get to what we call the original statute. Number 68. And what if they use half of it, 90 days, and then there's a reissue, can they get more than 90 days on the reissue? Can somebody certify and get 180 days on the reissue? If you get... If you see they can, they or can't they? Once you get 180 days... Do you have to get it or use it? See, that's the problem with what use it means. Well, I'm going to tell you what I'm mean by using it. That means you use it, you take advantage of it, and you market a drug. That's what I mean. Well, once you market a drug, then the statute says the 180 days run from the period of commercial marketing. And then FDA's position in this case is that. And we believe that this is correct. Is that once somebody has gotten the 180 days, or once someone has been granted exclusivity at all, it's over. You don't get another period, even if the patent is reissued. And then when does that 180 days of exclusivity run from FDA's mind or application? Does it run from something other than the court decision holding the patent, which is the subject of the certification to be invalid or not infringed? Does it run from something other than that? Well, it depends. If they market before its final or on appeal, then you look at number one of that section. And it runs from the date of first commercial marketing. We had that in this case. We haven't yet. They will market commercially. They tell us in December of the year. I'm going to reissue patent if there's some defect in the original. I mean, then they wouldn't even bother with a reissue patent. If there wasn't some significant defect in the original. How significant. Well, there has to be some error, yes. There has to be some error in that. So why, you know, you guess the other argument is why wouldn't it be a new patent if the sole reason for its existence was the fact that the original patent was defective? To whatever extent we might debate

.. I mean, here it seems as though this pattern was... You had to give it up to be able to issue one. That scenario you gave is almost like there's a technical mistake or something that happened and you went and got it amended or the original. So in the scenario you gave, do you get a new number? You do get a new number. It's the same identical process we're talking about here in your scenario. Exactly identical. And you have to give up the original pattern in order to get the reissued version. And then... You don't get as a continued protection, though, I take it. If you didn't have protection back here, that new one's not going to give it based upon the one that was not good, right? Well, no, there are rules about under what circumstances, you know, things that infringed one or the other of the pattern. Now see how continuous it is. Well... If it's the same pattern, then I'm just wondering how much protection you're going to get from that original one that's been declared invalid when you get one reissued. Well, I think... Reissued pattern, I'm going to stand as protection for something that may have been an infringement known to peer it at the original one. Well, yes. In most circumstances there might be exceptions in certain cases. But... Well, if you look at section 252, it's quite clear on that. Let me ask you this. What if a company got 180 days under the certification of the statute? The only one at that time they could get to what we call the original statute. Number 68. And what if they use half of it, 90 days, and then there's a reissue, can they get more than 90 days on the reissue? Can somebody certify and get 180 days on the reissue? If you get... If you see they can, they or can't they? Once you get 180 days... Do you have to get it or use it? See, that's the problem with what use it means. Well, I'm going to tell you what I'm mean by using it. That means you use it, you take advantage of it, and you market a drug. That's what I mean. Well, once you market a drug, then the statute says the 180 days run from the period of commercial marketing. And then FDA's position in this case is that. And we believe that this is correct. Is that once somebody has gotten the 180 days, or once someone has been granted exclusivity at all, it's over. You don't get another period, even if the patent is reissued. And then when does that 180 days of exclusivity run from FDA's mind or application? Does it run from something other than the court decision holding the patent, which is the subject of the certification to be invalid or not infringed? Does it run from something other than that? Well, it depends. If they market before its final or on appeal, then you look at number one of that section. And it runs from the date of first commercial marketing. We had that in this case. We haven't yet. They will market commercially. They tell us in December of the year. I'm going to reissue patent if there's some defect in the original. I mean, then they wouldn't even bother with a reissue patent. If there wasn't some significant defect in the original. How significant. Well, there has to be some error, yes. There has to be some error in that. So why, you know, you guess the other argument is why wouldn't it be a new patent if the sole reason for its existence was the fact that the original patent was defective? To whatever extent we might debate. But the original patent was so defective that it was necessary to crank up the somewhat abbreviated process to get a reissued patent. I mean, doesn't the fact that it's a defect that puts the process in motion as to the reissued patent? That they should be treated as separate patents. Well, that might be an indication, you know, one indication of difference between them. But the commonalities that we know are always going to be the case far away that we know it has to be the same invention. We know they can't introduce new matter. And just to make this sort of more fundamental point, you know, the only reason there's any argument here on the other side at all today is that they call it a reissued patent. And they give it a new number. You could have exactly the same substantive effect if you just said under these circumstances you can amend your patent. And, you know, all the rules would be the same. If we call it an amended patent, we wouldn't be here. I think FDA would be self-evidently right if it was called an amended patent. And so the question is whether FDA was required to give dispositive significance to the fact that it has... If it was called an amended patent and the language of the statute, are you labeled an amended patent? I'm saying if the patent laws, if instead of saying re... No, no, no. As your argument, if the word amended appeared in the statute, or if it was just a term used outside the statute. If it appeared in the reissued provision. Well, then I don't think it... No, that didn't change the statute. You said everybody would agree with that. That's not correct. Then the question would be... It would be the same question. Is the amended the patent subject to the certification? All right. Well, they would... It might or might not be, but that'd be the question. Right. Okay. But they would at least lose their argument that the fact that there's a new number matters. Because there would be the same number. And my point is simply that as a matter of substance, what we're talking about here is a circumstance where somebody has a patent for an invention. And then they say, there's something wrong with it. I want to change it. I can't introduce new matter. That means I can't change sort of the thing that I've described that I've invented. The problem here is simply one of semantics. Well, I'm saying that... Oh, that is called a reissued patent instead of an amended patent. Well, I'm saying that the other side's argument is largely premised on semantics. And on the fact that they give a new patent number, that seems to be important to them. And the fact that they give a new patent number is also what requires you to file an entirely new certification with FDA. And so their point, as I understand it, is there's a new number. It's called, you know, for some purposes, we call it a new patent. Although the statute says reissued the patent, not issue a new patent. So I'm not sure that's a good point for them, but they make sort of these points. And my point is simply as a matter of substance, what we're talking about here is you've got a patent, and then you want to change it. There are lots of ways in which you're not allowed to change it under these rules. What you're saying is that a modification or a cure of a minor defect doesn't create a new animal. And right. And given just to get back to where I started, that everyone agrees that FDA doesn't have to give separate periods of the patent number. And it's a way of giving the patent number of different types of exclusivity under the statute, that it was ambiguous as to whether they have to give separate periods of exclusivity for two patents that are entirely unrelated

. But the original patent was so defective that it was necessary to crank up the somewhat abbreviated process to get a reissued patent. I mean, doesn't the fact that it's a defect that puts the process in motion as to the reissued patent? That they should be treated as separate patents. Well, that might be an indication, you know, one indication of difference between them. But the commonalities that we know are always going to be the case far away that we know it has to be the same invention. We know they can't introduce new matter. And just to make this sort of more fundamental point, you know, the only reason there's any argument here on the other side at all today is that they call it a reissued patent. And they give it a new number. You could have exactly the same substantive effect if you just said under these circumstances you can amend your patent. And, you know, all the rules would be the same. If we call it an amended patent, we wouldn't be here. I think FDA would be self-evidently right if it was called an amended patent. And so the question is whether FDA was required to give dispositive significance to the fact that it has... If it was called an amended patent and the language of the statute, are you labeled an amended patent? I'm saying if the patent laws, if instead of saying re... No, no, no. As your argument, if the word amended appeared in the statute, or if it was just a term used outside the statute. If it appeared in the reissued provision. Well, then I don't think it... No, that didn't change the statute. You said everybody would agree with that. That's not correct. Then the question would be... It would be the same question. Is the amended the patent subject to the certification? All right. Well, they would... It might or might not be, but that'd be the question. Right. Okay. But they would at least lose their argument that the fact that there's a new number matters. Because there would be the same number. And my point is simply that as a matter of substance, what we're talking about here is a circumstance where somebody has a patent for an invention. And then they say, there's something wrong with it. I want to change it. I can't introduce new matter. That means I can't change sort of the thing that I've described that I've invented. The problem here is simply one of semantics. Well, I'm saying that... Oh, that is called a reissued patent instead of an amended patent. Well, I'm saying that the other side's argument is largely premised on semantics. And on the fact that they give a new patent number, that seems to be important to them. And the fact that they give a new patent number is also what requires you to file an entirely new certification with FDA. And so their point, as I understand it, is there's a new number. It's called, you know, for some purposes, we call it a new patent. Although the statute says reissued the patent, not issue a new patent. So I'm not sure that's a good point for them, but they make sort of these points. And my point is simply as a matter of substance, what we're talking about here is you've got a patent, and then you want to change it. There are lots of ways in which you're not allowed to change it under these rules. What you're saying is that a modification or a cure of a minor defect doesn't create a new animal. And right. And given just to get back to where I started, that everyone agrees that FDA doesn't have to give separate periods of the patent number. And it's a way of giving the patent number of different types of exclusivity under the statute, that it was ambiguous as to whether they have to give separate periods of exclusivity for two patents that are entirely unrelated. And as a matter of discretion. I understand, and as you say, under your interpretation, TIVA is entitled to under this your scenario, the 180 day exclusivity rule here, based upon being the first for the original. That doesn't end it for them. If I understand your position, they now have to also make another ANDA to the reissue one to get 180 day exclusivity, but only they will get that. Is that right? They don't need to do a new application. They do need to do a new certification, which would be an amendment of their application, but to your fundamental point. You'll let her hear it is here in that the applicant must make a timeless submission of a paragraph for certification to the reissue patent to remain eligible for the 180 day exclusivity. That's right. Right. But the point that I'm making, if it's the same, because you always, because you always, whenever you file a paragraph for certification, you have to maintain a certification to the appropriate patent in the entire time. It's because you have a patent by patent approach, and you got another patent. And now they have to do something for this other patent. Well, with respect to your honor, it's not because we have a patent by patent approach, because everyone agrees that even if we didn't have a patent by patent approach, you still have to address every listing in the orange book separately. That statue is quite clear on that. And so the patent by patent approach doesn't go to to what extent you have to file certifications if they're submitting patents. You always have to file a certification. The statute is clear on that. The patent by patent approach goes to the question of, do we give more than one period of exclusivity? So if there's more than one patent in the world, do we give more than one period of exclusivity? And the answer to the problem, when I asked you the earlier question, then you told me there was a whole bunch of people out there who made these applications in the original form. And you had people here and not only Tivo here, we didn't talk about this patent approach then, which seems like to me, that would fix that problem. I'm not sure I'm entirely understanding the patent by patent approach. Basically, our fundamental point here is the statute is ambiguous as to whether if there are two patents in the world, forget reissue, just two patents at all, separate patents. The statute is ambiguous. The parties to this case agree, I think Council for the other side agreed with me on this. The statute is ambiguous as to whether there are two separate periods of exclusivity, one for patent A, one for patent B, even if the two are totally unrelated to each other, or whether the language, which is mostly the language in little... What is ambiguous if that term patent only refers to a particular patent? It is ambiguous. In the words if it just says a patent and the patent is a reissue to one because the other one has been taken away. If it says that, then it's not ambiguous in that light. And your light you give is ambiguous, but if you look at it that way, there's nothing ambiguous about that. It's an patent before the other one that exists. The other one doesn't exist anymore. It's been invalidated and has been resummitated. It's been withdrawn in order to get a new one. I don't think anybody is arguing that there have to be two separate periods of exclusivity when a patent is reissued, even though the one that had to be two separate periods. The other side's argument is premised on the idea that... I'm not making that statement. I want to deal with the ambiguity argument of the statute itself. You said this ambiguous, ambiguous, on a US and an area. I'm saying there's nothing ambiguous about it if a patent refers as touchwulcus and as alluded to, just shed as alluded to to the reissued patent. There's nothing ambiguous about that. It may not be something you want to be the result, but it's not ambiguous. Well, if FDA had decided under which everyone agrees would be permissing... I don't get to decide if that's the unambiguous. There's nothing to decide. You're on a... That's going to give you the answer to your question. If you say the reissued one, then we know what a 180-day period is. Because you don't have the element. Well, let me... Just stepping for one moment. Suppose that the FDA had decided the issue in the opposite text the other way. Everyone agrees that that would be within their authority. The court concluded that the statute was ambiguous

. And as a matter of discretion. I understand, and as you say, under your interpretation, TIVA is entitled to under this your scenario, the 180 day exclusivity rule here, based upon being the first for the original. That doesn't end it for them. If I understand your position, they now have to also make another ANDA to the reissue one to get 180 day exclusivity, but only they will get that. Is that right? They don't need to do a new application. They do need to do a new certification, which would be an amendment of their application, but to your fundamental point. You'll let her hear it is here in that the applicant must make a timeless submission of a paragraph for certification to the reissue patent to remain eligible for the 180 day exclusivity. That's right. Right. But the point that I'm making, if it's the same, because you always, because you always, whenever you file a paragraph for certification, you have to maintain a certification to the appropriate patent in the entire time. It's because you have a patent by patent approach, and you got another patent. And now they have to do something for this other patent. Well, with respect to your honor, it's not because we have a patent by patent approach, because everyone agrees that even if we didn't have a patent by patent approach, you still have to address every listing in the orange book separately. That statue is quite clear on that. And so the patent by patent approach doesn't go to to what extent you have to file certifications if they're submitting patents. You always have to file a certification. The statute is clear on that. The patent by patent approach goes to the question of, do we give more than one period of exclusivity? So if there's more than one patent in the world, do we give more than one period of exclusivity? And the answer to the problem, when I asked you the earlier question, then you told me there was a whole bunch of people out there who made these applications in the original form. And you had people here and not only Tivo here, we didn't talk about this patent approach then, which seems like to me, that would fix that problem. I'm not sure I'm entirely understanding the patent by patent approach. Basically, our fundamental point here is the statute is ambiguous as to whether if there are two patents in the world, forget reissue, just two patents at all, separate patents. The statute is ambiguous. The parties to this case agree, I think Council for the other side agreed with me on this. The statute is ambiguous as to whether there are two separate periods of exclusivity, one for patent A, one for patent B, even if the two are totally unrelated to each other, or whether the language, which is mostly the language in little... What is ambiguous if that term patent only refers to a particular patent? It is ambiguous. In the words if it just says a patent and the patent is a reissue to one because the other one has been taken away. If it says that, then it's not ambiguous in that light. And your light you give is ambiguous, but if you look at it that way, there's nothing ambiguous about that. It's an patent before the other one that exists. The other one doesn't exist anymore. It's been invalidated and has been resummitated. It's been withdrawn in order to get a new one. I don't think anybody is arguing that there have to be two separate periods of exclusivity when a patent is reissued, even though the one that had to be two separate periods. The other side's argument is premised on the idea that... I'm not making that statement. I want to deal with the ambiguity argument of the statute itself. You said this ambiguous, ambiguous, on a US and an area. I'm saying there's nothing ambiguous about it if a patent refers as touchwulcus and as alluded to, just shed as alluded to to the reissued patent. There's nothing ambiguous about that. It may not be something you want to be the result, but it's not ambiguous. Well, if FDA had decided under which everyone agrees would be permissing... I don't get to decide if that's the unambiguous. There's nothing to decide. You're on a... That's going to give you the answer to your question. If you say the reissued one, then we know what a 180-day period is. Because you don't have the element. Well, let me... Just stepping for one moment. Suppose that the FDA had decided the issue in the opposite text the other way. Everyone agrees that that would be within their authority. The court concluded that the statute was ambiguous. So suppose FDA had said... Even if there are multiple patents, we're only giving one period of exclusivity full stop, no matter how many different patents, no matter how distinct from each other there are. Everyone agrees FDA could do that. Now, if FDA did that, nobody could come in and then say, oh, but if a patent is reissued, then you have to give two separate periods of exclusivity for a reissued patent. That would be anomalous. That would suggest that... If there had been no reissued patent in this case, would Teeva's time have already run for exclusivity? They have an argument that it hadn't, it hasn't been presented to the agency. For purposes of the decision that FDA presumed that it would have already run, if it had not been reissued. Why should we give deference to the FDA in this situation given the fact that it's expertise in patent law is limited? Because there are no questions of patent law that are at issue here. There's no question of the scope of a patent. There's no question of whether a patent has been infringed. There's no question of validity of a patent. There's no question... I have about a question of whether or not a reissued patent is the same or a different patent. Is that a question of patent law? It has no consequences in a patent infringement action. The substantive consequences of a reissued patent in patent and infringement action could be resolved in a patent infringement that it has been issued. What is the purpose of this statute for the purpose of this statute? Do you think if there was undisputed evidence that when patent was used it meant patent and any reissues of that patent? You don't think that would matter in this case. You don't think that would help your argument in this case? The question here relates to the use of the term in the Hatch-Waxman amendments which are in the statute that FDA is called upon to administer. How does the FDA's expertise come into play here? The question here relates to the interpretation of the Hatch-Waxman scheme which is designed to determine when generic drugs should come on their kit, how what gives the right incentives for them to make challenges. If you said that this case wasn't governed by Chevron Deference which is not an argument that anybody has made at least in the briefs but if you said it wasn't covered by Chevron Deference you would be basically saying because Hatch-Waxman uses the term patent then FDA disclaims all expertise about how to interpret that scheme. The thing that FDA disclaims is... What you're saying is this really does fall into the heart of the FDA's competence because it concerns the incentive structure and the operation of how generic drugs come to market and the incentive structure is for generic manufacturers. And by what sequence we bring them into market and at what point the timing of when exclusivity periods begin and that's right at the heart of what the Food and Drug Administration does. That's correct and on the flip side it is not being called upon to resolve questions of who infringed whose patent or what the coverage of a patent is or any of those questions of patent law as to which the agency is disclaimed expertise. That's correct. I'm obviously way over my time so unless there are further questions. Thank you. Mr. Schumstein. Good afternoon and may it please the court. Let me cut right to the heart of the matter. Each of you has asked repeatedly during the course of this argument where is the ambiguity. There are two... There are two ambiguities and Judge Shadd I am going to answer that question for you. The first ambiguous term in this provision of the statute is what is the patent which is the subject of the certification. I can proper two reasonable definitions of the patent. On one hand, Milen and Watson's position which Teva concedes is a reasonable interpretation of the statute is that two patents are different because they bear different numbers. In other words, the patent is defined by the identifying number that FD or rather the PTO assigns to it. 0, 6, 8 and 0, 4, 8. There is an alternative way of understanding what the term the patent which is the subject of the certification. The alternative is to say a patent is an important because of the number that PTO puts on it. A patent confers certain exclusionary rights which under patent law are called claims. Because you can think of two different ways to read something in the statute that is applies, that does not create a ambiguity. No, Your Honor, with respect, it's not that I'm envisioning two different ways. That's what a patent is and if you look at the Federal Circuit case law and the sub... It is the patent then when did your time run? Your Honor, our time has not run yet and there are two reasons why and remember we're just talking about what the patent is. If you accept that a patent matters because of its substance, the particular exclusionary rights that it confers, then it's not enough to do what Milen and Watson do and say, well the 0, 4, 8, patent and the 0, 6, 8, patent are different. Instead, the question is, substantively are the exclusionary rights conferred by this patent the same or different? And what FDA said in this case is when you understand a little bit about reissue patents, when you look at 35 USC 251 and 35 USC 252 and decades of Federal Circuit and Supreme Court case law, there is continuity between reissue patents and original patents. In fact, reissue patents often confer exactly the same sub.

. So suppose FDA had said... Even if there are multiple patents, we're only giving one period of exclusivity full stop, no matter how many different patents, no matter how distinct from each other there are. Everyone agrees FDA could do that. Now, if FDA did that, nobody could come in and then say, oh, but if a patent is reissued, then you have to give two separate periods of exclusivity for a reissued patent. That would be anomalous. That would suggest that... If there had been no reissued patent in this case, would Teeva's time have already run for exclusivity? They have an argument that it hadn't, it hasn't been presented to the agency. For purposes of the decision that FDA presumed that it would have already run, if it had not been reissued. Why should we give deference to the FDA in this situation given the fact that it's expertise in patent law is limited? Because there are no questions of patent law that are at issue here. There's no question of the scope of a patent. There's no question of whether a patent has been infringed. There's no question of validity of a patent. There's no question... I have about a question of whether or not a reissued patent is the same or a different patent. Is that a question of patent law? It has no consequences in a patent infringement action. The substantive consequences of a reissued patent in patent and infringement action could be resolved in a patent infringement that it has been issued. What is the purpose of this statute for the purpose of this statute? Do you think if there was undisputed evidence that when patent was used it meant patent and any reissues of that patent? You don't think that would matter in this case. You don't think that would help your argument in this case? The question here relates to the use of the term in the Hatch-Waxman amendments which are in the statute that FDA is called upon to administer. How does the FDA's expertise come into play here? The question here relates to the interpretation of the Hatch-Waxman scheme which is designed to determine when generic drugs should come on their kit, how what gives the right incentives for them to make challenges. If you said that this case wasn't governed by Chevron Deference which is not an argument that anybody has made at least in the briefs but if you said it wasn't covered by Chevron Deference you would be basically saying because Hatch-Waxman uses the term patent then FDA disclaims all expertise about how to interpret that scheme. The thing that FDA disclaims is... What you're saying is this really does fall into the heart of the FDA's competence because it concerns the incentive structure and the operation of how generic drugs come to market and the incentive structure is for generic manufacturers. And by what sequence we bring them into market and at what point the timing of when exclusivity periods begin and that's right at the heart of what the Food and Drug Administration does. That's correct and on the flip side it is not being called upon to resolve questions of who infringed whose patent or what the coverage of a patent is or any of those questions of patent law as to which the agency is disclaimed expertise. That's correct. I'm obviously way over my time so unless there are further questions. Thank you. Mr. Schumstein. Good afternoon and may it please the court. Let me cut right to the heart of the matter. Each of you has asked repeatedly during the course of this argument where is the ambiguity. There are two... There are two ambiguities and Judge Shadd I am going to answer that question for you. The first ambiguous term in this provision of the statute is what is the patent which is the subject of the certification. I can proper two reasonable definitions of the patent. On one hand, Milen and Watson's position which Teva concedes is a reasonable interpretation of the statute is that two patents are different because they bear different numbers. In other words, the patent is defined by the identifying number that FD or rather the PTO assigns to it. 0, 6, 8 and 0, 4, 8. There is an alternative way of understanding what the term the patent which is the subject of the certification. The alternative is to say a patent is an important because of the number that PTO puts on it. A patent confers certain exclusionary rights which under patent law are called claims. Because you can think of two different ways to read something in the statute that is applies, that does not create a ambiguity. No, Your Honor, with respect, it's not that I'm envisioning two different ways. That's what a patent is and if you look at the Federal Circuit case law and the sub... It is the patent then when did your time run? Your Honor, our time has not run yet and there are two reasons why and remember we're just talking about what the patent is. If you accept that a patent matters because of its substance, the particular exclusionary rights that it confers, then it's not enough to do what Milen and Watson do and say, well the 0, 4, 8, patent and the 0, 6, 8, patent are different. Instead, the question is, substantively are the exclusionary rights conferred by this patent the same or different? And what FDA said in this case is when you understand a little bit about reissue patents, when you look at 35 USC 251 and 35 USC 252 and decades of Federal Circuit and Supreme Court case law, there is continuity between reissue patents and original patents. In fact, reissue patents often confer exactly the same sub... Your argument is reissue and patent, they're the same thing. Yes, as a substantive matter, Your Honor. And in those circumstances... Virginia, you really thought so because you sort of looked at it and said you did the same thing you did with the first one. Well, that's exactly right, Your Honor, and there are lots of circumstances and as FDA pointed out repeatedly in its letter decision, there's a very important patent law doctrine called claim continuity and that doctrine holds that if you had protection under the original patent, and that protection is carried over to the reissue without substantive alteration, then an alleged infringer can be held liable for infringing conduct that not only predated reissuance, but dates back to the original day that the original patent issued. The only entity which was subject to certification in 2008. It's prior to 2008, but the 06, the 06, 8 patent and Tevis Paragraph Force certification, so that you understand it was very specific. Tevis said we challenge via Paragraph Force certification claims one through 17 of the 06, 8 patent. Substantively, those are the claims of that patent we do not in French. What did the Federal Circuit hold in 2008? It held that claims one through far, one through four, and 11 through 17 were invalid. So my question is what was, you said because the patent, you started off by arguing this really an entity, a collection of rights. Is that understood you correctly? What matters is its substance, you are one of those claims. What is the substantive entity that was defined by the patent, which is the subject of the certification as for 2007-2008? What was it? Was it your bundle of rights? What that was the brand manufacturer, Pfizer's bundle of rights? You take it from them. Right, we said we don't think your claims are valid. Claims one, two, three, four all the way through 17. What did the Federal Circuit say it said? No, no, but you have to answer my question. What is the patent that was certified, subject of that certification from which the 180 days exclusivity runs? What is that? It's claims one through 17 of that patent. Those were the paragraph four certifications that have a filed. And the Federal Circuit's decision didn't say anything about claims through five, claims five through ten of that patent. So those were totally unaffected. So it's crazy to say there was even a court decision in this case. But what FDA said was irrespective of that issue, whether it addressed some of the claims or all of the claims. The FDA's position is there was no court determination under that section. What they said is if you take a substantive view of what a patent is, their answer would be yes or no. Their answer would be no, there was not a court decision. And the reason why is because those original claims were later revived. Because then you don't even need ambiguity. You just say the statute was never met. Well, you're on all right. You can think of it as six of one half dozen of the other. I'm not considering it on whether or not there was a certification as required for exclusivity. Your argument is no. There never was. There was no such court determination. You're right. There was no such court determination. But but had been a court determination in so far you your client had there been a court decision trigger, which of course we dispute. Then my clients exclusivity would have been triggered and it would have expired a hundred. Well, of course they do your honor. My client wants to be the only one on the market with this product and with respect it has already run or it's already run which we disagree with. But we think that the statute is highly ambiguous about what was the effect of that court decision. That's the kind of thing that keeps coming to me. I mean the court makes a decision. I've got three court makes a decision on something to invalidate this this patent. Whatever claim number claims you want to. What's the effect of that the effect of that decision? Did you win? Because it sounded like you meet you tell me you didn't we. Oh no, your honor. I don't I don't want to give you that impression. We did we did win that case and we had a. We had a court say if you were to market this product you would not in fringe claims one through four or claims 11 through 17th the patent. You have a one and eight a day exclusivity to proceed. No, we're talking about and it's very clear to be different. We're talking about. Okay, that's patent law, right? Whether or not Pfizer could get monetary damages if my client marketed its drug product. Today in court we're talking about a regulatory question, which is is my client alone eligible to be approved by the FDA given the way that 180 to exclusivity works. Or can other people join my client and free ride as judge Wilkinson put it earlier. I'll be in a question but and free ride on what tevd it and what is very important for you to keep sight of in this case is is FDA's explanation in its distance. I thought you were saying the court case didn't matter at all then I heard you say no, no, you did win. You won the court case

.. Your argument is reissue and patent, they're the same thing. Yes, as a substantive matter, Your Honor. And in those circumstances... Virginia, you really thought so because you sort of looked at it and said you did the same thing you did with the first one. Well, that's exactly right, Your Honor, and there are lots of circumstances and as FDA pointed out repeatedly in its letter decision, there's a very important patent law doctrine called claim continuity and that doctrine holds that if you had protection under the original patent, and that protection is carried over to the reissue without substantive alteration, then an alleged infringer can be held liable for infringing conduct that not only predated reissuance, but dates back to the original day that the original patent issued. The only entity which was subject to certification in 2008. It's prior to 2008, but the 06, the 06, 8 patent and Tevis Paragraph Force certification, so that you understand it was very specific. Tevis said we challenge via Paragraph Force certification claims one through 17 of the 06, 8 patent. Substantively, those are the claims of that patent we do not in French. What did the Federal Circuit hold in 2008? It held that claims one through far, one through four, and 11 through 17 were invalid. So my question is what was, you said because the patent, you started off by arguing this really an entity, a collection of rights. Is that understood you correctly? What matters is its substance, you are one of those claims. What is the substantive entity that was defined by the patent, which is the subject of the certification as for 2007-2008? What was it? Was it your bundle of rights? What that was the brand manufacturer, Pfizer's bundle of rights? You take it from them. Right, we said we don't think your claims are valid. Claims one, two, three, four all the way through 17. What did the Federal Circuit say it said? No, no, but you have to answer my question. What is the patent that was certified, subject of that certification from which the 180 days exclusivity runs? What is that? It's claims one through 17 of that patent. Those were the paragraph four certifications that have a filed. And the Federal Circuit's decision didn't say anything about claims through five, claims five through ten of that patent. So those were totally unaffected. So it's crazy to say there was even a court decision in this case. But what FDA said was irrespective of that issue, whether it addressed some of the claims or all of the claims. The FDA's position is there was no court determination under that section. What they said is if you take a substantive view of what a patent is, their answer would be yes or no. Their answer would be no, there was not a court decision. And the reason why is because those original claims were later revived. Because then you don't even need ambiguity. You just say the statute was never met. Well, you're on all right. You can think of it as six of one half dozen of the other. I'm not considering it on whether or not there was a certification as required for exclusivity. Your argument is no. There never was. There was no such court determination. You're right. There was no such court determination. But but had been a court determination in so far you your client had there been a court decision trigger, which of course we dispute. Then my clients exclusivity would have been triggered and it would have expired a hundred. Well, of course they do your honor. My client wants to be the only one on the market with this product and with respect it has already run or it's already run which we disagree with. But we think that the statute is highly ambiguous about what was the effect of that court decision. That's the kind of thing that keeps coming to me. I mean the court makes a decision. I've got three court makes a decision on something to invalidate this this patent. Whatever claim number claims you want to. What's the effect of that the effect of that decision? Did you win? Because it sounded like you meet you tell me you didn't we. Oh no, your honor. I don't I don't want to give you that impression. We did we did win that case and we had a. We had a court say if you were to market this product you would not in fringe claims one through four or claims 11 through 17th the patent. You have a one and eight a day exclusivity to proceed. No, we're talking about and it's very clear to be different. We're talking about. Okay, that's patent law, right? Whether or not Pfizer could get monetary damages if my client marketed its drug product. Today in court we're talking about a regulatory question, which is is my client alone eligible to be approved by the FDA given the way that 180 to exclusivity works. Or can other people join my client and free ride as judge Wilkinson put it earlier. I'll be in a question but and free ride on what tevd it and what is very important for you to keep sight of in this case is is FDA's explanation in its distance. I thought you were saying the court case didn't matter at all then I heard you say no, no, you did win. You won the court case. When did the 180 day start running or has it not started yet? Our position is that it has not started running. Based on what in the statute is our view is that there has not been a final court decision, which means the decision of a court of appeals, the federal circuit holding that the patent, which is the subject of the certification. Does it have to be the court of appeals? It does have to be the court of appeals. Your honor, there's a provision in the Medicare Modernization Act of 2003. I believe it's section 1102. So in other words, you can't have a court decision holding that a patent is invalid by anything other than a court of appeals. Correct. It has to be a final decision of a court of appeals from which no appeal other than to the Supreme Court by rid of. We move on down the road here. Maybe this whole idea of a single exclusivity period and a single exclusivity period which doesn't begin to run until the invalidation of the reissue product. There could be some problems. There could be some glitches and everything. So what's the proper entity to try to smooth those out or make the adjustments and modifications that might well need to be made when the operational problems of any particular regime? I mean, there are a lot of areas of confusion and I'm not sure how these things actually play out in practice. So, you know, we can give one answer today, but it may be unworkable or it may lead to adverse effects or it may not. What is the proper, how are the glitches and the wrinkles going to be ironed out as we go down the road? Is it reasonable to, I mean, the court is going to do it, and Congress is going to do it, is the FDA going to do it? How are the wrinkles going to be ironed out in your view? Well, your honor, it depends in part on what you decide today, but our position respectfully is that it's up to the agency. They're the experts. Sure, your honor. If the statute permits them to reach a result that favors us, which we think it does here. How's the agency going to work it out? Well, the agency has what I would call a quasi-adversarial process where any interested party who's affected by a decision that the FDA is contemplating making can raise an issue with them. That's what happened in this case. My client sent a letter to the FDA, Mylin sent a letter to the FDA. In fact, we decide that there's no ambiguity, and the statute is, as it says, you think FDA is talented enough to adjust their regulatory practices around that court. Your honor, I do, but I have to make one very important point, and I don't want to lose sight of this. It's very important for this court to understand the scope of review. I'm not talking Chevron. Understand the decision that's in front of the agency, and I want to echo something that Mr. Tennis said when he was arguing a little while ago. If you believe that FDA's view of reissues and original patents as being substantially identical, given all of the features they share in common, all you can do is vacate the agency's letter decision and remand this case to the agency at which point FDA is going to have to do one of two things. It's going to have to resolve, first of all, was there actually a court decision in 2008, given the undisputed fact that only certain claims of the 068 patent were invalidated? We say absolutely not. We think that's consistent. It wouldn't have run your honor because there wasn't a court decision not yet, but your honor, there wasn't a court decision on multiple claims that we challenged. It would run when my clients launched their drug product in December. What were you doing with paragraph four? What about when it expires? It would expire 180 days after my clients begin marketing this. Self expires. The pat. The our exclusivity will give us a full six months prior to the scheduled expiration of this patent. If it had just gone on and you get to the expiration of the patent, then it starts or you have a case for a dentist. Your honor, again, very complicated statute. One reason why we have so many questions. It's been settled since around 2003 that when a patent expires, there's no remaining exquisite. How does that, I'm not talking about serving the purpose of the statute, but FDA is and I think it you are, how is the purpose of the statute served when the question of whether or not generics are placed on the marketplace lie in the hand of one company which might never want for other reasons, it might never want the generic to hit the stand or the length of the patent. So your honor, let me answer it this way. It is a widely acknowledged feature of the original statute. Pre 2003, the one we're talking about. I'm just answering my question. Why does that put the hands of generic and generic availability in the hand of one manufacturer? It absolutely does your honor and I want to make clear you asked a very important question earlier which is are we controlled by intent or we controlled by the language. You did, but that's an important one that's relevant to this question. And the answer was it was widely acknowledged under the pre 2003 statute which is what we're dealing with that this can happen. It can take a very long time for the exclusivity entitled applicant to launch its product. And in 2003, Congress changed the statute and the MMA includes what are called forfeiture triggers. They're used or lose at provisions. I'm going to answer my question. We're kind of running late on. Oh, you're on a right. It has to how that doesn't maybe it should be placed in one company's hands. But why doesn't that lead your explanation or understanding? I'm just asking, I'm listening to what you say. Doesn't that lead to the fact that one manufacturer could in fact then wait and never produce the generic? It does your honor, but what the courts have recognized is that's totally legitimate under the original version of the statute. I do have a couple of other points I think are just very important to address because there's a policy issue here that I think is also responsive to that. When FDA said understand that what matters about a patent is not its number, but whether the rights are co extensive. What FDA is really saying is, Teva was first. They're the ones who mounted the first challenge to these patent claims to the brand manufacturer's rights. And it's the Johnny come lately's, myelin, Watson, Lupin that are piggybacking on that success

. When did the 180 day start running or has it not started yet? Our position is that it has not started running. Based on what in the statute is our view is that there has not been a final court decision, which means the decision of a court of appeals, the federal circuit holding that the patent, which is the subject of the certification. Does it have to be the court of appeals? It does have to be the court of appeals. Your honor, there's a provision in the Medicare Modernization Act of 2003. I believe it's section 1102. So in other words, you can't have a court decision holding that a patent is invalid by anything other than a court of appeals. Correct. It has to be a final decision of a court of appeals from which no appeal other than to the Supreme Court by rid of. We move on down the road here. Maybe this whole idea of a single exclusivity period and a single exclusivity period which doesn't begin to run until the invalidation of the reissue product. There could be some problems. There could be some glitches and everything. So what's the proper entity to try to smooth those out or make the adjustments and modifications that might well need to be made when the operational problems of any particular regime? I mean, there are a lot of areas of confusion and I'm not sure how these things actually play out in practice. So, you know, we can give one answer today, but it may be unworkable or it may lead to adverse effects or it may not. What is the proper, how are the glitches and the wrinkles going to be ironed out as we go down the road? Is it reasonable to, I mean, the court is going to do it, and Congress is going to do it, is the FDA going to do it? How are the wrinkles going to be ironed out in your view? Well, your honor, it depends in part on what you decide today, but our position respectfully is that it's up to the agency. They're the experts. Sure, your honor. If the statute permits them to reach a result that favors us, which we think it does here. How's the agency going to work it out? Well, the agency has what I would call a quasi-adversarial process where any interested party who's affected by a decision that the FDA is contemplating making can raise an issue with them. That's what happened in this case. My client sent a letter to the FDA, Mylin sent a letter to the FDA. In fact, we decide that there's no ambiguity, and the statute is, as it says, you think FDA is talented enough to adjust their regulatory practices around that court. Your honor, I do, but I have to make one very important point, and I don't want to lose sight of this. It's very important for this court to understand the scope of review. I'm not talking Chevron. Understand the decision that's in front of the agency, and I want to echo something that Mr. Tennis said when he was arguing a little while ago. If you believe that FDA's view of reissues and original patents as being substantially identical, given all of the features they share in common, all you can do is vacate the agency's letter decision and remand this case to the agency at which point FDA is going to have to do one of two things. It's going to have to resolve, first of all, was there actually a court decision in 2008, given the undisputed fact that only certain claims of the 068 patent were invalidated? We say absolutely not. We think that's consistent. It wouldn't have run your honor because there wasn't a court decision not yet, but your honor, there wasn't a court decision on multiple claims that we challenged. It would run when my clients launched their drug product in December. What were you doing with paragraph four? What about when it expires? It would expire 180 days after my clients begin marketing this. Self expires. The pat. The our exclusivity will give us a full six months prior to the scheduled expiration of this patent. If it had just gone on and you get to the expiration of the patent, then it starts or you have a case for a dentist. Your honor, again, very complicated statute. One reason why we have so many questions. It's been settled since around 2003 that when a patent expires, there's no remaining exquisite. How does that, I'm not talking about serving the purpose of the statute, but FDA is and I think it you are, how is the purpose of the statute served when the question of whether or not generics are placed on the marketplace lie in the hand of one company which might never want for other reasons, it might never want the generic to hit the stand or the length of the patent. So your honor, let me answer it this way. It is a widely acknowledged feature of the original statute. Pre 2003, the one we're talking about. I'm just answering my question. Why does that put the hands of generic and generic availability in the hand of one manufacturer? It absolutely does your honor and I want to make clear you asked a very important question earlier which is are we controlled by intent or we controlled by the language. You did, but that's an important one that's relevant to this question. And the answer was it was widely acknowledged under the pre 2003 statute which is what we're dealing with that this can happen. It can take a very long time for the exclusivity entitled applicant to launch its product. And in 2003, Congress changed the statute and the MMA includes what are called forfeiture triggers. They're used or lose at provisions. I'm going to answer my question. We're kind of running late on. Oh, you're on a right. It has to how that doesn't maybe it should be placed in one company's hands. But why doesn't that lead your explanation or understanding? I'm just asking, I'm listening to what you say. Doesn't that lead to the fact that one manufacturer could in fact then wait and never produce the generic? It does your honor, but what the courts have recognized is that's totally legitimate under the original version of the statute. I do have a couple of other points I think are just very important to address because there's a policy issue here that I think is also responsive to that. When FDA said understand that what matters about a patent is not its number, but whether the rights are co extensive. What FDA is really saying is, Teva was first. They're the ones who mounted the first challenge to these patent claims to the brand manufacturer's rights. And it's the Johnny come lately's, myelin, Watson, Lupin that are piggybacking on that success. Now to be sure, to be sure we're talking about a paragraph for certification to a patent that has a different number. But in substance, Teva was first. Judge Wayne, you asked why does FDA require a new certification under paragraph four to a reissue patent when it comes out? Very simple. If a manufacturer files a paragraph for certification to an original patent, that patent is reissued. And it fixes the patent so that you can no longer maintain a paragraph for certification. That's a pretty glaring sign that these patents are fundamentally different, right? But whereas here Teva could maintain its paragraph four and continue the challenge, well that's yet another indication in a very fact. In other words, to say, sure, your honor when we told the agency in the brand manufacturer is you didn't fix it, it's still invalid. We get to go to market. And so requiring that re-certification at the end is a way for the agency to confirm that the substance of these two patents matches up again taking the substantive view of what a patent is rather than a numerical view. Certification would have different, would raise different claims with respect to the patent. Not necessarily. Your honor, there can be and they're often our circumstances. And you're honor, you raise an excellent point, which is you could and FDA could have made that choice. But let's be clear about this. FDA could have said reissue patents in their original versions are always different. That's the simplistic, reductive argument that myelin and Watson make. It could have said as it did here, we think that they're often similar enough that we treat them the same. Absolutely, your honor, my client. Based on FDA's award of 180 day exclusivity, which by the way, that was based on the rationale set forth in this letter decision. Nothing to do with the court decision, your honor. But it's very important to understand that again, there's a third choice that FDA could have adopted. It could have said, we're going to look case by case. Are they the same? Are they different? Yes, came up with 180 day, is that what you got in your letter 180 day exclusivity? Correct. And they just picked that number of... No, no, no, 180 days comes right out of the statute. And it's the provision that Mr. Tenney was reading earlier, which says if you're an applicant with them... They're reading out the statute that gives you that 180 day. Absolutely, but nobody disputes that. The only question is, was there a court decision trigger? And as I said before, it depends on what the pattern is. And you say there was not, and FDA says there was not. Correct. That's exactly right, your honor. And... Mr. Early's date, FDA could have issued that letter. Do you give you that 180 day exclusivity? Since 2008, when is the early state could have done that? FDA could have issued that letter at any point it wanted to between... Your honor, they could have issued that letter in 2003 when my client submitted its ANDA. You were first, you have a paragraph for certification. That's that question, and it seems like to me they couldn't do it. I got a lot of bureaucratic stuff going on. No, Judge... I said after that 2008 decision, why didn't you just give the 180 day rule? Well, it's only so many claims or... Well, your honor, maybe I misunderstood your question. I'm questioning it, make sure I get the right answer. When is the earliest time period that FDA could have issued after 2008? Don't worry about 2003, could have issued that letter that you got in the record, right? Your honor, it could have issued at the same day that the decision came down. It chooses not to make decisions until multiple applications are ready and otherwise eligible for approval, because as we all know, facts change, things happen. Applicants who may have started out..

. Now to be sure, to be sure we're talking about a paragraph for certification to a patent that has a different number. But in substance, Teva was first. Judge Wayne, you asked why does FDA require a new certification under paragraph four to a reissue patent when it comes out? Very simple. If a manufacturer files a paragraph for certification to an original patent, that patent is reissued. And it fixes the patent so that you can no longer maintain a paragraph for certification. That's a pretty glaring sign that these patents are fundamentally different, right? But whereas here Teva could maintain its paragraph four and continue the challenge, well that's yet another indication in a very fact. In other words, to say, sure, your honor when we told the agency in the brand manufacturer is you didn't fix it, it's still invalid. We get to go to market. And so requiring that re-certification at the end is a way for the agency to confirm that the substance of these two patents matches up again taking the substantive view of what a patent is rather than a numerical view. Certification would have different, would raise different claims with respect to the patent. Not necessarily. Your honor, there can be and they're often our circumstances. And you're honor, you raise an excellent point, which is you could and FDA could have made that choice. But let's be clear about this. FDA could have said reissue patents in their original versions are always different. That's the simplistic, reductive argument that myelin and Watson make. It could have said as it did here, we think that they're often similar enough that we treat them the same. Absolutely, your honor, my client. Based on FDA's award of 180 day exclusivity, which by the way, that was based on the rationale set forth in this letter decision. Nothing to do with the court decision, your honor. But it's very important to understand that again, there's a third choice that FDA could have adopted. It could have said, we're going to look case by case. Are they the same? Are they different? Yes, came up with 180 day, is that what you got in your letter 180 day exclusivity? Correct. And they just picked that number of... No, no, no, 180 days comes right out of the statute. And it's the provision that Mr. Tenney was reading earlier, which says if you're an applicant with them... They're reading out the statute that gives you that 180 day. Absolutely, but nobody disputes that. The only question is, was there a court decision trigger? And as I said before, it depends on what the pattern is. And you say there was not, and FDA says there was not. Correct. That's exactly right, your honor. And... Mr. Early's date, FDA could have issued that letter. Do you give you that 180 day exclusivity? Since 2008, when is the early state could have done that? FDA could have issued that letter at any point it wanted to between... Your honor, they could have issued that letter in 2003 when my client submitted its ANDA. You were first, you have a paragraph for certification. That's that question, and it seems like to me they couldn't do it. I got a lot of bureaucratic stuff going on. No, Judge... I said after that 2008 decision, why didn't you just give the 180 day rule? Well, it's only so many claims or... Well, your honor, maybe I misunderstood your question. I'm questioning it, make sure I get the right answer. When is the earliest time period that FDA could have issued after 2008? Don't worry about 2003, could have issued that letter that you got in the record, right? Your honor, it could have issued at the same day that the decision came down. It chooses not to make decisions until multiple applications are ready and otherwise eligible for approval, because as we all know, facts change, things happen. Applicants who may have started out... You have already pointed... Did issued. Because as Mr. Farquhar pointed out in his argument, there were three patents that Pfizer had for this drug product. We'll call it 068 and the other two. And those other two didn't expire until November of 2013, and then they had a six-month extension. And so it was on May 30th of 2014 that the blocking patents, that is the patents that were still valid evaporated. And that point, FDA had to make a formal decision. Do we approve Tava alone, or do we approve Tava, Milen Watson, or Tava Milen Watson Lupin Apatex is another company that hasn't come to court to challenge this decision, but is similarly situated to Lupin? And FDA had to make the decision at that point, and that's when they chose to award 180-dexgusivity, but you're honor, they could have sent a letter at any point. I'm trying to say why FDA acted in a manner that did. So what is patent by patent approach? Sure, you're honor. If it's going to wait until these other two expire before it gives the letter, what's that mean? You're honor. There can be circumstances. That's a term of art. You guys use it all the time, and you said everybody agrees to it. So what does it mean? Patent by patent approach is... It doesn't, it doesn't, it doesn't, it doesn't. It wouldn't have been reasonable for them to give that letter back in 2008 on the patent by patent approach, even though it would have been subject to. Your honor, it would have been reasonable for them to issue that letter at any time between the day. They... Who that is, that this is consistent with you. They don't, as a manner of administrative policy, my clients and others have certainly pushed the agency to render decisions earlier than they do. In fact, I filed comments on behalf of Teva just the other day urging the agency to render these decisions earlier than it does. But that doesn't make anything that FDA actually said in its decision unreasonable. And as I said before, there's a basic ambiguity here, which is, is the patent the number only or its substance? And once you accept that you can legitimately choose between either of those options, all we look at is... You don't even need that argument, though. You don't need that argument at all, do you? No, because as I said before, a whole bunch of claims that we filed paragraph for certifications to weren't invalidated. Absolutely, Your Honor. And one very last thing about that, that I just want to highlight and not lose sight of today. As I said, I think the patent is ambiguous, but there's another ambiguity in the same provision of the statute, which is, what does it mean to have invalidated a patent claim that is later brought back to life that the patent law say is presumptively valid, which is enforceable, not only from the date that that reissued claim was issued by the PTA. Not only from the date of the decision that invalidated the original patent from which that claim came, but going back to the date that that original patent was issued. And as FDA said in its letter decision, when you understand that reissue patents can revive these claims, it doesn't make any sense to say that they were invalidated because they brought back to life. And Miley has a great phrase in their brief, they talk about zombie exclusivity, but zombie exclusivity is the pure product of zombie patent claims claims temporarily invalidated by a court, but brought back to life and under third. That's it, Your Honor. And maybe it was too long, I appreciate your indulgence. Thank you all. I'll try to be very brief, I know it's late. First of all, I mentioned as I was departing from the original argument, we made a mistake on page nine of our brief. I just noted as notes that last night, doesn't really substantively change. Can we submit an amended brief tomorrow with that work? And I have copies of the correct page. That's a devolumen if you want to. Okay. Thank you. The one thing that I wanted to point out very quickly is that Mr. Shomsky was suggesting that there wasn't a court decision invalidating the O68 patent. That is just simply not true. And there's no need to vacate and remand to the agency on that. They already decided and it's reflected in their letter that there was a court decision invalidating the patent. The only reason he says that they it wasn't a decision invalidating the patent is because the court didn't address claims five through ten. Well, Pfizer decided not to pursue claims five through ten in the patent infringement litigation that it brought against have a. Therefore, those claims are gone. There's not there's no action that's left for Pfizer on those claims. You know, the whole argument and some good questions, but it's kind of persuaded me that this is it's a it's a it's a very complicated statute and it's a very complicated process. And there are an awful lot of moving parts around this and you're saying the patent and the reissue patent are different and that's you know, that's not an unreasonable view of it at all

. You have already pointed... Did issued. Because as Mr. Farquhar pointed out in his argument, there were three patents that Pfizer had for this drug product. We'll call it 068 and the other two. And those other two didn't expire until November of 2013, and then they had a six-month extension. And so it was on May 30th of 2014 that the blocking patents, that is the patents that were still valid evaporated. And that point, FDA had to make a formal decision. Do we approve Tava alone, or do we approve Tava, Milen Watson, or Tava Milen Watson Lupin Apatex is another company that hasn't come to court to challenge this decision, but is similarly situated to Lupin? And FDA had to make the decision at that point, and that's when they chose to award 180-dexgusivity, but you're honor, they could have sent a letter at any point. I'm trying to say why FDA acted in a manner that did. So what is patent by patent approach? Sure, you're honor. If it's going to wait until these other two expire before it gives the letter, what's that mean? You're honor. There can be circumstances. That's a term of art. You guys use it all the time, and you said everybody agrees to it. So what does it mean? Patent by patent approach is... It doesn't, it doesn't, it doesn't, it doesn't. It wouldn't have been reasonable for them to give that letter back in 2008 on the patent by patent approach, even though it would have been subject to. Your honor, it would have been reasonable for them to issue that letter at any time between the day. They... Who that is, that this is consistent with you. They don't, as a manner of administrative policy, my clients and others have certainly pushed the agency to render decisions earlier than they do. In fact, I filed comments on behalf of Teva just the other day urging the agency to render these decisions earlier than it does. But that doesn't make anything that FDA actually said in its decision unreasonable. And as I said before, there's a basic ambiguity here, which is, is the patent the number only or its substance? And once you accept that you can legitimately choose between either of those options, all we look at is... You don't even need that argument, though. You don't need that argument at all, do you? No, because as I said before, a whole bunch of claims that we filed paragraph for certifications to weren't invalidated. Absolutely, Your Honor. And one very last thing about that, that I just want to highlight and not lose sight of today. As I said, I think the patent is ambiguous, but there's another ambiguity in the same provision of the statute, which is, what does it mean to have invalidated a patent claim that is later brought back to life that the patent law say is presumptively valid, which is enforceable, not only from the date that that reissued claim was issued by the PTA. Not only from the date of the decision that invalidated the original patent from which that claim came, but going back to the date that that original patent was issued. And as FDA said in its letter decision, when you understand that reissue patents can revive these claims, it doesn't make any sense to say that they were invalidated because they brought back to life. And Miley has a great phrase in their brief, they talk about zombie exclusivity, but zombie exclusivity is the pure product of zombie patent claims claims temporarily invalidated by a court, but brought back to life and under third. That's it, Your Honor. And maybe it was too long, I appreciate your indulgence. Thank you all. I'll try to be very brief, I know it's late. First of all, I mentioned as I was departing from the original argument, we made a mistake on page nine of our brief. I just noted as notes that last night, doesn't really substantively change. Can we submit an amended brief tomorrow with that work? And I have copies of the correct page. That's a devolumen if you want to. Okay. Thank you. The one thing that I wanted to point out very quickly is that Mr. Shomsky was suggesting that there wasn't a court decision invalidating the O68 patent. That is just simply not true. And there's no need to vacate and remand to the agency on that. They already decided and it's reflected in their letter that there was a court decision invalidating the patent. The only reason he says that they it wasn't a decision invalidating the patent is because the court didn't address claims five through ten. Well, Pfizer decided not to pursue claims five through ten in the patent infringement litigation that it brought against have a. Therefore, those claims are gone. There's not there's no action that's left for Pfizer on those claims. You know, the whole argument and some good questions, but it's kind of persuaded me that this is it's a it's a it's a very complicated statute and it's a very complicated process. And there are an awful lot of moving parts around this and you're saying the patent and the reissue patent are different and that's you know, that's not an unreasonable view of it at all. But to say that they are substantively the same, I don't understand why that is unreasonable either. I mean, they. And and to say that we shouldn't defer at all to the FDA because they don't really have any hand in this whole process. But they do have a lot to say about when and how generics come to to market. So how can you persuade me that we're not just wondering into some some very deep water and why wouldn't we allow normally in a in a process calling for significant expertise where the agency. Frankly does have a greater background in it than we do why wouldn't we exercise some respect for that for that letter ruling there been many many times when I've ruled from the. But I voted to bring agencies up short because I thought they were planning around with Supreme Court decisions or plan around with statutory language but this this problem seems somewhat murkier to me and I wonder if you just. Sure might address it. It's not that I think your views of it is unreasonable. It's just that I'm not sure. I want us to take step a I'm not sure what the falling dominoes are I'm not sure what what what goes from a I'm sure what happens in B or in C or in D. So first of all there have been seven cases that we cited in our briefs where courts have reversed FDA where it tried to manufacture ambiguity about language and hatchback's amendments and one of those cases came from this court the grand u tech decision where FDA doesn't follow clear statutory language they've been slapped back and that's what we're asking for you to do here. That big is a question does not well I just shows that there is a there is precedent it wasn't that earlier decision wasn't this statutory language that earlier statutory was in this particular statutory language on court decision but there have been two decisions the tour farm decision in 1997 and the mile and versus Shalala decision that where this particular language the court decision trigger language the court held that FDA was wrong in trying to make sure that the court decision was not going to be a part of the court decision. So we're going to exempt from the court decision trigger non final court decisions. But did it deal with the whole question of whether the patent referred to original and reissued patent? No the only case that did that actually is the apotex decision that Mr. Tene talked about and in that in that decision the court specifically said that the court decision trigger language is patent specific which supports our our case here not there. So you can see the begs the begs the question of what is a patent and and your point is that they're substantively the same you can look at this I mean they might be in they you know they do have different numbers they do have separate listings in the orange book. There's a there's a re you know there's a recertification right I'm so it's not and you know it's not that your view is a laffer it certainly isn't. No it isn't but yeah. I don't know but but you know sometimes and when we interpret contracts the fact that two people disagree over the meaning of a contract that doesn't make it ambiguous and the fact that that two parties disagree over the meaning of a statute that certainly doesn't make it ambiguous but sometimes there might be a genuine ambiguity. Well but here I really think there is not the languages which is the subject of the certification is a very clear structure there's a patent there's a listing there's a certification there's patent litigation that results from that there's a court decision done that expert that exclusivity period has expired 180 days after that court decision that's all we're saying it's very simple there's no dramatic results that occur from that that are antithetical to what the hatchback. That's what a man stands for it's that portion of the statute you're right there's a lot of moving parts when is exclusivity created there's some ambiguity about that but here and in fact there's some earlier questions from the court. We are not saying that Tevac does not have exclusivity on the original patent. They did have it. They did get it. They just couldn't use it and it expired under the terms of the statute. Just to be very clear about that, we are here because there was a court decision that triggered the running of that exclusivity in November and May of 2008, expired in November of 2008. It's over and done with. Even if you don't agree with us that the reissue patent deserves its own exclusivity period. The first issue is did that one expire and that's the only one where Tevac had solo exclusivity if you will. I hope that helps. The end result of that is then you agreeing with Lupin then. Well, that's right. On issue one, we do agree with Lupin. We then say that the second question is on the O68 patent, I'm sorry, I'm getting mixed up. On the O48 patent is their shared exclusivity. We admit that is a more difficult question than the first question. Your position is whatever Tevac had under the 28th decision, 2008 decision. They have lost it now. We may all disagree what happens now. But that's gone. Let's all fight it out and see what happens now. If we decided that one issue with you, would we just remand it to the court, let the court figure out? No, you're on it. No, you're on it. I think you should answer this. No, you wouldn't. You wouldn't remand what you would do is you would say you would reverse the court on its grant of summary judgment on that issue. And then in the opinion you would indicate that they were wrong on that issue. And then you would remand it to a wouldn't we? You know, I think when you reverse, I forget whether... Well, no, no, no, we send it back to a fore. For the proceedings. Oh, yes. Yeah, yeah, yeah, because we need to get then summary judgment entered on that point in our favor. So I hope that's what happens. And thank you very much for your time and your patience and for expediting this procedure. Thanks. We'll jump.

This must be a big case. Mr. Farquhar? Farquhar, right? He's it. Good. Good. Good afternoon. May please the court, Doug Farquhar, representing the plaintiff, Milen Pharmaceuticals Incorporated. I've wanted to begin by discussing what is a threshold issue, which is how many issues are there before the court at this time. All of the parties except have a agree that there are two issues for the court's decision. Teva claims that there is only one issue, but that claim is belied by a statement in their brief. If you were to look at page 60 of their brief, they say that if the court should determine, as we believe the court should, that Teva's exclusivity period to market the generic version of Celebrex expired in November of 2008, they say, quote, the only permissible alternative is that Teva, Milen and Watson should share exclusivity. That is exclusivity based on the O48 patent, the reissue patent. FDA doesn't agree with that statement, nor does Lupin, so that's the second issue. The first issue is whether the exclusivity period tied to the original patent expired in November of 2008, the reason that you've got so many speakers from the appellant side is, I'm gonna be addressing the first issue, Mr. Landman from Watson is gonna address the second issue, that is the issue about the shared exclusivity period, and then Mr. Chan will be making the argument for Lupin that the second issue should be decided differently from the way that we feel that it should be decided. Thank you very much, and George here in front of me. We'll have a hard job, that's good. Let's go to say, if everybody agrees, I can sit back down if it's a clear on issue. I don't agree with what you said, ask them to be presented. We are. All right. Well, it's a good start. What is the issue that you're gonna concentrate on? So the issue that I'm concentrating on is whether the Teva Marketing Exclusivity Period that was tied to the O68 patent, that is the original patent expired in November of 2008, and it did. The statutory language is very, very clear on that. We all agree on the facts that underlie this case, I think is the first argument today where you all don't have to get into all the details of the facts, it's all clear what happened, and I won't repeat it unless you have questions. But in May of 2008, the Federal Circuit Court mandate issued, which held that the O68 patent, the original patent, was invalid, and that qualified as a court decision trigger under... Is there one patent or two patents at issue in this case? There are two patents that were at issue in this case. There is the original patent, the O68 patent, and then the reissue patent, which is the O48 patent. And the... Is that because you think a reissue patent is nothing but a patent? A reissue patent is different from an original patent. No, but there are two of them. There are two of them. I'm saying for the purpose of this statute, you think a reissue patent is a patent. Yes, you're right. You have to have a separate certification for that. Exactly right. There is a separate certification under... This is Section 355 of Title 21. Under B1G, there is a separate listing requirement for... Doesn't your reading lead to some fairly odd results that the company, Tiva, doesn't get the benefit of what they took all the trouble for as to the 68 patent? They went to the trouble, I don't know all this, but to come up with a generic and then to push litigation so they can market that. Now take it that the purpose of the ex-usivity is to encourage people to do that. That's correct, Your Honor. And so they did everything right. They spent lots of money, but they get nothing for it. They did under the 68 patent. They didn't do everything right. Because they challenged three different patents. They lost on two of the patents, which there was no ex-usivity period for. But... But as to this, and as to this, where they were to get some exclusivity for something. I actually have two answers to that question from my Your Honor. The first is, when you failed to clear the patent cloud because of these two other patents that they didn't succeed against, you are blocked from marketing under the patent that you do get invalidated. What is that, they're followed? They didn't clear some bureaucratic obstacles. They lost to go, that's not their fault. It's them's the breaks, basically. No, that's different. That's different than saying they did something wrong. They didn't do anything wrong. They took a course of litigation that perhaps you wouldn't have taken. There was nothing irresponsible or illegal on ethical about that, wasn't it? That's correct, Your Honor. Somebody made a business decision to do it. And so they pursued it. Right. And then through the way the process worked, they could have won. Who knows? And once they cleared that thicket, they still might not get it as a exclusivity in that correct. No, if they had, first of all, they did get exclusivity as to that particular patent, right? You said something and I didn't quite, you about to finish it, you said you didn't get it as to the two that you did have it as to O-60. That's right. And that means you won't get it until O-60 expires. Is that right? No, no, it's the other way around, Your Honor. Well, the other two were 13. They put a lot of guess. Well, I see. In 13 they got it. Right, right, right. But the argument from the other side, at least in Teeva's perspective, or at least from Loopers, is that 13 is when the 180 day started. That's, well, not actually not even in 13 does the 180 start. It starts under their view, FDA is you in Tevavu, when they start commercial marketing. In other words, you flip to the other trigger because there's been no court decision trigger on the second patent, the reissued patent. The O-48 patent. But if I could get back to the point originally that the judge shed was raising, it is that, them's the brakes. The cases are clear. There are times where you get an exclusivity period and you can't use it. We cite the right. I mean, the thing that troubles me is, I can put it bluntly, is, you seem to be a little bit of a free rider because you have another company come in. And they file this paragraph for certification. And that involves a lot of expense on their part. And it involves, as well as expense, it involves a lot of risk. And they know that once they assert the invalidity of the patent, they're going to be sued. And so they're going to incur a large cost. They're going to incur a large risk. And then you come along in their wake and want shared exclusivity. And that's a little troubling. I mean, because even when the reissued patent comes down, they still have to file another paragraph for certification to update and maintain their eligibility. But if the whole purpose of, I think, I'm just reiterating what my good colleagues said, but if the whole purpose of Hatch Waxman is to encourage generics to get on the market so that people can buy a more, by drugs, a more reasonable price, it would seem to me that the purposes of the statute are furthered by giving some kind of respect in the form of a single exclusivity period to the company that actually did what the Hatch Waxman acted wanted them to do, which was to go and challenge those patents and get to the point where you have the incentive for these drugs to come on the market for consumers to get them at more reasonable prices. And what are we doing to that whole scheme if we undercut those incentives? That can't be in the public interest, is determined by Congress. It actually doesn't undercut the incentive. And if you'll permit me to explain why. First of all, let me address the point. We are not a free rider in the situation. Myelin and Watson actually carried the water in the challenge to the later patent in that patent proceeding. You were a free rider in this instance that you didn't file the initial paragraph for certification to the original patent. That's correct, Your Honor, but as to that patent, the courts have repeatedly recognized that basically what you're trying to do is to set up an incentive, as you mentioned, to get the generic companies to challenge a patent. Once that challenge has been made, the incentive is satisfied. Sometimes the incentive pays off. Sometimes companies do get the exclusivity period and going in, they never know whether they're gonna get the excessive. It's not satisfied if there's gonna be shared exclusivity after the point of a patentary issue. Well, I would disagree, Your Honor, because the incentive was there for the company that it would have the chance of getting exclusivity. That's not the having a chance, it's not the same as having a sure thing. If in the event of a patentary issue, you file another title paragraph for certification, which the original, the challenge or the original patent would need to do. But if the second stage, and I don't know how often reissue patents are issued, but if at this second stage, this company loses the challenger, the original patent, loses out because they're shared exclusivity. That's a whole lot of incentive for somebody to say, oh, well, let's sit back and wait for somebody else to take the risk, and then we'll come in and share the exclusivity in the event that there's some technical flaw in the pattern and the patent that requires a reissue. So two responses, if I might, Your Honor. The first is that the courts have recognized that there are times where because of the way that the statute operates, you can be the first filer, you can get exclusivity and you can't use it. We cite two cases where that happened, the Nostrum case and the high-tech pharmacal case. The other thing is, believe me, if a generic company is ready to file, they will file as quickly as they can because they have a huge incentive. When nobody's gonna stand back and let somebody else be the first filer and let them carry that heavy lifting because if you have a chance of being the first, you have to file on that first day that the patent is listed. Let me ask you this, isn't it your position that Tiva got exactly what it was entitled to on the statute, 180 days of exclusivity? That expired in November, two times a year. Okay, sorry. The fact that they couldn't take advantage of it has nothing to do with the statute, is that correct? That's correct. And we talked about the policy and the intent of Congress, how do we get to what seems to be a good policy and it looks like what Congress intended. Well, what do you say about that? Well, I said what Congress intended is precisely what the statute says, that if you get a court decision trigger that is on a and a decision that relates to a patent that is the subject of the certification, and I'm quoting from the statute here, which was what happened here. Maybe it may be for some discussion that maybe the policy doesn't reflect what Congress intended, but do we apply intent, or do we apply the words of the statute? You apply the words of the statute, and if the words of the statute would lead to a situation that would be an absurd result or that would clearly conflict with the intent of the numbers. Is there any absurd result here in saying there's one period under that O68? Is there any absurdity in that? There is not whatsoever, you're on. Let me ask you this, is there an absurdity with the application of the statute? There is not an absurdity with the application. Might somebody think the way the statute works in the real world is odd or not good? Might that be the case? Oh, sure. Well, if you're the injured party, you're gonna think it worked in a nod way. But there's another little point here that's a little bit, I think only a Hatchwaxman lawyer would know this, but the 180-day period was intended to be a very firm deadline. If you can't market within 180 days, then your exclusivity period is glad. That helps other generics to produce. I'm so general for. And what can happen is, and this does happen with some frequency. Company A, let's say Tevin, in this case, gets a first-file or status. So they're entitled to exclusivity. For some reason, the patent company doesn't sue them. So there is no court decision trigger to start their exclusivity period. So the only thing that triggers their exclusivity period is either commercial marketing and sometimes they're blocked from commercial marketing because they don't have the right application in. Is that an answer to the argument? Is that an answer to the argument? Yeah, well, it is if we're talking about the incentive. Well, we're talking about a very complicated situation here. And I don't know, sometimes, I don't know all the implications of it. But how can this, I don't understand the plain language argument. I don't know, the statute doesn't say anything about a reissue patent. And it's completely silent on that point. And what we really have to go by is that word, the patent. And you say that there, well, that means there are two, there must be two patents here. But that isn't at all clear to me that we're not talking about a single patent. I can make the arguments that I'm sure you would make about orange book registration and a different patent number. And I'm familiar with all those arguments because you've set them forth in your brief as to why they would be two patents. But there seem to be an awful lot of arguments as to why there would be just one patent. Because when you're talking about reissuing something, you reissue what? The, you know, you reissue the original patent. Well, hold on a second, you reissue an original patent. It's not something different. And this reissued patent thing, it's a slight error correction process. You can't introduce any new material. The reissue patent expires on the very same day as the original patent's term claims in the original patent litigation continue even when the reissue patent is issued. So what I'm saying is there are, five reasons over here to regard them as two patents. And there are five reasons over here to regard them as a single patent. The statute doesn't say, the statute doesn't exactly, the statute never addresses reissued patents. I don't understand why this wouldn't be a case in which we might show a certain a bit of modesty and let the agencies interpretation stand because I'm not confident there's any kind of really plain language argument here, but there is an ambiguity. That's what agencies are for as they work through the whole situation in their adjudicative and regulatory capacities. And I just don't understand why the statute is something we might defer on because we really don't have an awful lot of knowledge about it. We'll get into it episodically to say this and that, oh, this seems better to us, but the FDA is going to be dealing with this day after day after day. And it, Chevron One is always a little risky when you are trying to overcome the agency expertise and experience and something and trying to counterman what the agencies on the ground have interpreted the statute to me. And so Chevron One is always a little risky unless you really, really sure you know what you're doing. Sometimes it's better to say less rather than more and leave it up to the agency to work through the wrinkles and see how it works out in practice. Judge Wilkinson, I'm over my time. I take a little bit of time to respond to that. You made a lot of points. Thank you. The first thing is if you look at the language in the statute and not only says the patent, it says the patent, which is the subject of the certification. And it sets up a very precise structure. A patent is filed. There is a certification that is made to the patent by the generic drug company. That gives the opportunity for this patent litigation. The patent litigation occurs if it results in a court decision that triggers that specific period. So it's more than just the patent. It's the patent which is the subject of these sort of issues. I'm just going to perpetuate the ambiguity. Well, in your honor, if you look at what the FDA is saying, they are saying the patent, which is the subject of the certification, can be the patent which is not the subject of the certification. It has to be the reissue patent which was not the subject of the certification that led to this patent litigation. And that's just wrong. That contrabeens the statutory language. I'd also like you said there's five on this side. Why is it called a reissue patent, man? I mean, well, it is called a reissue patent because there are limitations on the term and it is the same invention. But that's true of any patent about any drug and there are periods where the FDA would concede and tevd it as well. If this was a new patent on the same drug, there could be in this pre-MMA context, there could be multiple periods of exclusivity. But if you look at this specific patent and you look at the use codes and you look at the claims that were made, it is a different patent. If you look at the form that was filed by Pfizer when they filed this patent, they said it was not the same patent. And if you look at the case, the Supreme Court case that we cite, the grant case, which was sort of the granddaddy of reissue patents, it refers to at least 13 times a reissue patent as being a new patent or a second patent. So it is a different patent and different patents have different periods of exclusivity that attach to them under the words of the statute. So they- Let me ask you this. If it's the same patent, which I think FDA would take that position, when does 180 days run? Well, they say it only- No, under the statute. I don't- When does it run? Well- Does the statute give you the same patent, to 180 day periods? Doesn't do that, does it? Well, the same patent, don't you get one? I'm sorry, if it's the same patent, what FDA is saying- No, I'm just asking you, let me ask you this. There, I know what the opposition is. Right. But I'm asking, where does that- Do you see in the authority for a second 180 day period taking one has been granted and it is run without marketing? Where's the any statutory authority for a second 180 day period? The courts have held that there is ambiguity in terms of whether- They're asking about ambiguity. I'm saying, where's that in the statute? Is it anywhere in the statute? Well, I'm trying to answer your question. But what courts have said is that when the term is used- the patent term is used in terms of the creation of a period of exclusivity, then that is an ambiguous term. An FDA has stepped in and said, there can be multiple periods of exclusivity. And the issue, they said, I asked you what you say about that. We have no argument that when there are multiple different patents, there can be multiple periods of exclusivity. One can get exhausted and one can- Then one can be acted upon. That's for different patents. That's for different patents, yes, you're right. And it's our contention. You missed it. No, you missed it, my question. I'm sorry, then. If in fact here, I just want- If FDA argues that the reissue is the same patent- It does. That's what they argue, I think. Yes. Where's the authority for their 180-day period to run? Because on that very same one patent, it ran for in 2008. That's correct, Your Honor. Is there any language in the statute? In the statute. I know what FDA's doing, and I know what someone to do. Gosh, it's kind of a big old mess. Let's just let them do it or let agencies do it. But don't they have to be authorized to do it? It has to be in the statutory language. It has to be authorized and it is not. And the statute says that the framework doesn't it? It does. And that framework in this case may be kind of sloppy and doesn't lead to the results some I won't. Is that correct? Only tell them. But you say that that is mandated by the statute. I do, and it's- And it- I'll read the answer any more for me. OK, great. Thank you. Well, thank you. I have a question. I want to go back to something you brought up early and dealing with the usage of security with hatch-waxman type folks. And that is when the brand company does not sue, that events occur then. And you mentioned the marketing aspect of it. And I think you were going somewhere else with that. I was. Thank you. You're on our appreciate the opportunity to answer that and complete that question. What will happen is the 180-day exclusivity period will never run because the commercial marketing has an occurred and the patent infringement case didn't occur. Other generic companies have the ability to file a declaratory judgment action to try to get the patent declared invalid to create the court decision that will then trigger the exclusivity period for the company that was the first filer. So there's a remedy in that situation. And that's why the- We also very quickly, and that is, we're got to potential Chevron deference. Even if we assume ambiguity, does that necessarily mean that we must give difference if we determine that the issue here is really one of patent law and not within the expertise of the FDA? Thank you, Rhonda. It was one of the points I wrote down to mention, and I ran out of time. But that's exactly right. You're saying that now. Yeah, thank you. The patent patent, you all have a lot more experience in patent law than FDA does. They have refused to exercise a review of patents in terms of what the claims are, whether they're different, that kind of thing in the past. What they look at is they got a form that's filed, and in this case, the form said it's a different patent. So therefore, they should be following the statute and saying that- We get all this expertise in patent law. Well, FDA doesn't have- Well, FDA disclaims at least. Let me put it out. I don't do ourselves when we wrote a case, at least one of the circuits, did that affect? Right. You didn't have expert teeth in patent law. There was a lot of cases on that. So a lot of cases on that. Thank you, Your Honor. I get your honor. There was one, I'm sorry. We made a mistake on page nine of our brief. I'll address that in my report. I'll put it in my comment. Mr. Landman. Thank you. May please the court. My name is Chad Landman. I'm with Axon, Velotrop, and Hark Rider. We represent Watson, Laboratories, Inc. And I'm here to address the second issue before the court, which is whether FDA is failure to follow its patent by patent approach to exclusivity with respect to the reissue patent should be reversed by this court. And a couple of these questions were actually already asked and addressed, but I wanted to circle back on a couple of them. Judge Wilkinson brought up the good question about the incentives. And what did Congress intend and what did they intend to inset? Well, they intended to incentivize prompt patent challenges. And what FDA then did, and it was a result of that, way back decades ago, said we should have patent by patent process and approach. So that every time there's a new patent, we are going to give a new period of exclusivity. FDA established that. There's a discussion in the Aepatex case and other cases in our papers. But once FDA establishes that, they can't deviate from it, because that's arbitrary and capricious. Is there any disagreement that there should be a patent by patent approach, at least as the earlier law before the amendment? Any in a disagreement on that in here? With respect to the parties here? Well, I think there is disagreement from FDA where they're not applying the patent by patent approach. I don't know how to apply it. There's the way it exists. That it should be. That is OK. The applications are different thing. I'm sorry. Yes. I don't believe any parties are here saying there shouldn't be patent by patent, exclusivity. So once FDA resolved that ambiguity, it can't depart from it here, because that's arbitrary and capricious. That is a reason for reversals. Now, the reason they established that was to provide an incentive for prompt patent challenges. So if a later filer to another patent, files first and challenges quickly, it will clear that later patent. So with respect to the reissue patent, thinking about the reissue patent, what that means is you want to incentivize companies to quickly file those. Yeah, in an agency change, it's position, and then that's subject to differences. Not without any reason to explanation. And reason explanation doesn't just mean, and we cite some cases, the effect, the Burlington case, doesn't just mean that you said forth an explanation. You have to actually explain why this patent. You're arguing it is letting this court take it that there's an ambiguity. Do you think there's an ambiguity in that statute? In the section of the statute that establishes, which says holding the patent, which is the subject of the certification, the patent, which is the subject of the certification, is there any ambiguity as to that? Well, I don't believe there is in the statute to a section about the court decision, and the patent, it's a subject to the certification. No, I don't believe there is. Why is this called a reissue patent? If it was a different patent, I would recall it. We call it the new patent. That's a great question, Your Honor. So part of it, we'll seeped in patent law, but that you go through a reissue proceeding, so you submit your application back to the PTO. And you would ask the question about the differences between the reissue and the original. So the reissue patent is just like a couple of other types of patents out there. There are patents called continuation patents. There are patents called divisional patents. They all stem from the original patent application. They all just like the reissue patent, get the same expiration date as the original patent. And just like a reissue patent, there's a prohibition against adding what's called new matter. There's no reissue patent without the original patent. Correct. And just like there can be, you'd be like constructing the second story of a house without the first story. Right. And it's the same as there can't be a divisional or a continuation patent without having the original patent application. Let me ask you this down the road. Who's going to be dealing with this whole matter on a day-to-day basis? Well, FDA and the pharmaceutical industry. All right. How's the FDA going to be dealing with it on a day-to-day basis? Reissues, you also asked this question, don't happen all the time, but to the extent that they happen, FDA will have to decide. Not nearly, and it's a due to couture and capacity or in its regulatory capacity or what. When it's deciding whether to grant new drug, or approvals of generic drug applications, correct? So is the, is the, is the FDA wholly devoid of any kind of patent experience that your, your, your colleagues suggest that they really know nothing? So as far as, as, as, as patents are concerned. Sure. And I smiled a little bit about the question. FDA has repeatedly said, and courts have repeatedly found that they have no patent expertise. They swear off having any patent expertise. And they, they are firm and courts have a firm that they have merely a ministerial role as it relates to patents. And I actually just one question. What's the point of the argument? I don't even know what you argued quite well. I mean, I heard you words, but how do you advance this argument at all? I'm sorry, Your Honor, so the point of the, it might be me, it might be me. I'm just going to give you 15 to 30 seconds. I appreciate that. The, the point of this argument is that we believe that all first paragraph four filers to the reissue patent and namely here that's our client Watson, Milen and Teva are entitled to a period of exclusivity on the reissue patent. Because FDA itself has been applying patent by patent experts. May I ask one question? Sure, ma'am. Is, is the reissue patent, I call that 48, is that the number? Correct. Is, has 48, has there been a determination made, a certification made as to 48? Correct, yes. Is that on appeal? I'm sorry, the patent challenge, yes. The patent decision, the certification decision. Yes. Is that on appeal to the federal circuit? Yes, there was a, what happens if the federal circuit reverses the finding by the district court? What happens then? Of invalidity? So that, that patent was found in valid. Who's that all the parties think? So many of the parties including our client have actually, including Teva, which is actually the reason we're here. I'm answering my question. I'm sorry, I was trying to get, I was trying to get at the practical realities as most of the companies have licenses that started a period to enter the market. Oh, you just walked that out, outside this framework. Correct. If in fact, Pfizer, Teva, if they worked arrangements with the all of you on how you're going to market it, is that correct? Why not this mood? Well, because don't you have authority to market it? No, because FDA only gives approvals based on it's looking at the regulation who has exclusivity. So even if Pfizer, which Pfizer has done granted licenses to parties to enter, that doesn't mean that FDA will actually approve the application. So under FDA's letter decisions. Because they protect the exclusivity? FDA will follow the exclusivity and under their letter decision. Wait a minute, wait a minute. You telling me that if a party gains exclusivity under the statute, there's no question about that. Doing that 180-day period, they can't license another four or five or eight companies to use their exclusivity period. So the branded company could in Teva itself could license its exclusivity period. You do that all the time. That's what's been here in the happen a lot now. Sometimes that... With the 100-day period. Yes. They all go out licensing of the companies. That does happen, Your Honor. Thank you. Right, thank you. Mr. Chairman. Good afternoon, Your Honor's Arthur Chan for appellate, Lupin Pharmaceuticals Inc. You're still in that federal suit that Judge Shed was talking about, aren't you? They didn't settle with you. Lupin has not yet settled. I understand. If it reverses in the case and the Judge Shed's analysis then for you. Well, whether Lupin settles its patent suit with Pfizer or not, they are still blocked under FDA's interpretation by Teva's 180-day exclusivity. So... So the effect of the federal suit is going on now either way does not affect that USA. That is correct. Well, the analysis here. That is correct. From your perspective. Yeah. Not the others, because others have settled out and it's a dead-in-fact them. Well, my land and Watson may have settled, but they're still blocked by Teva's 180-day exclusivity. But here about what your client says about the ongoing lawsuit. In other words, the 48, the 48 patent, because that's not settled yet. I mean, that's not worked out yet, is it? It's not resolved yet. It's on appeal. That is correct. So none of those questions should be in front of us? I don't believe that what happens between Lupin or my land or Watson and Pfizer on the litigation of evolving the reissued patent has any real bearing on issues before the court, which is who gets 180-day exclusivity if anybody? Lupin agrees with all the parties in this case, in part, but we also disagree with all the parties in part. Our bottom line is that there is no remaining 180-day exclusivity today. And it is in you out, because the three of them say they have it after the reissued one, at least the ill side, and then Teva wants it just after the original one, but you don't fit in that scenario anywhere. That is correct. You say all of it is gone. I'll let it run. That's right. Our view is that it's all gone. And we get there by addressing the two separate but related questions that FDA teed up in its decision letter. First of all, we think FDA's single bond law patent rights approach for reissued patents is correct. And under that approach, 180-day exclusivity rights flow solely from the original patent, not the reissued patent. And on this issue, we think the statute is, in fact, ambiguous, we think FDA is... The second patent, the reissued one, for 48, is essentially the same as 68. It's the same patent. Well, and the use of this single term in the statute, even though there are two patents, you say that's ambiguous. That single term playing language, patent, eight patent, as opposed to patents, or patent and reissued patent, is just patent. Yeah, yes, Your Honor. We said ambiguous about a single word patent. Well, FDA looked at reissued patents and they concluded that the statute was... You can see that they got to look at the statute. They don't get to... We don't go into incentives and all this other stuff when we were looking at the statute. The first thing we do is determine that statute is ambiguous. Then we find it ambiguous. Then we get any other questions, you know, is it been there expertise in the Chevron deference and maybe some skidmo, I don't know if we find that. But we don't even get that if the statute is not ambiguous. And the statute says patent. Congress knows how to say poor stuff, don't we? I mean, he knows how to put it in there. And Judge Wilkeson alluded to the very essence of this hatch, Waxmanack, which is to move this thing along. So, I mean, how does it further it by putting in this, you know, bundling this all together? Well, FDA's bundle of patent rights approach. And on this issue, I agree with Judge Wilkeson and Judge Shed that... Deference is... I don't really agree with each other. Okay. Well, if I understand your comments, or your tentative comments correctly... I don't tell what you're agreeing with. Well, yeah, I don't think you can take me anything I've said what I agree with. Just ask this question. Is there an ambiguity in the statute? And, Ours, is that word patent? Is there something ambiguous about that? For this particular piece of the equation, we think the answer is yes. We agree with FDA. And FDA said the term is ambiguous. But you have to decide. What do you say it's ambiguous? And if my colleague would allow me, let me say the phrase, the patent, which is the subject of the certification, what is ambiguous about that? About that language? Well, I think it's a matter of looking at it in context. It's... Well, one in context in the statute makes you think the patent, which is a subject of a certification, is ambiguous. Well, it's whether the patent refers to the original patent, or the reissued patent, or as FDA... Is the certification the same for the original patent and the reissued patent? Well, under FDA's interpretation, every genetic sponsor has to... Well, you're not answering my question. As it is, how much variation is there in the certification between the original... The certification with regard to the original patent and the certification with respect to the reissued patent? Because there has to be a certification for the reissued patent. If a company is going to gain exclusivity. I know that my time is up, Your Honor. If I may continue. But just answer that question. Well, each ANDA sponsor has to certify to the original patent and the reissued patent, presumptively... Each generic who wants exclusivity has to certify as to the original patent to get exclusivity for that, and they have to certify as to the reissued patent in order to get certification for that. Am I right? Well, actually, under FDA's interpretation, there is no exclusivity associated with being the first to certify to the reissued patent. Are there any certifications with respect to the reissued patent? And what relationship do they bear to the certification for the original patent? Is it same? Is it significantly different? Is it different in what respects? How much was it different here? Well, that's going to be up to each sponsor. But I assume that any sponsor that certified that the original patent was invalid or not infringed with an all likelihood, make the same certification as to the reissued patent. And you have to give up the original patent to get a reissued one, don't you? That is my understanding of patent law, Your Honor. Yes. If it's the same, why is that necessary? I mean, if it's the same patent, you know, we have laws that General Simulies passed all the time and they amend them and they modify them, or they repeal them and enact a new law. I don't know anybody that goes back and say, well, that's the same law, and we're going to treat it the same. We've got two different patents here. One's been, you got to give it up, then you go and get a new one, a reissued one. That's what the word reissued means, new one. Right? Under substantive patent law, as I understand it, there is a new patent, and the original patent lives on in the form of the reissued patent. All right. Thank you, sir. Thank you, Your Honor. Yes, resurrect it. I'll take care of that for you. Mr. Taney. May I please the court? I want to just start with the part of the statute that everyone agrees is ambiguous, the ambiguity that we agree upon just to give context to this dispute. Is there a one agrees that the statute is ambiguous? You know, a certain respect, and I will explain it. What is it that they agree? Because I don't know who agrees. I'm not agreeing that statute is ambiguous. Well, of course, that it was unambiguous. Well, I'm just saying in a certain respect, and I will explain. The question was put, and this is the question that was put in the apt-tox case, cited in the court. Where's the ambiguity in the language of the statute? So the statute is ambiguous as to when there is more than one patent, whether there are multiple periods of exclusivity or a single period of execution. That doesn't make the statute ambiguous. That makes FDA's application of the statute maybe troublesome. Where in the statute does that make it ambiguous? The statute says the patent, which is the subject of the certification. In this case, I'm talking about as to the first certification. Is there any question as to what that patent is? That's number 68, isn't it? The first certification is not the one that's referred to in the statute. I'm asking you, what is ambiguous about the patent, which is the subject of the certification? Which of those words, let's just start, we can work out. Which of those words happened to be ambiguous in your opinion? Well, the question, the thing that's ambiguous is... That's my question. Right, and the thing that's ambiguous is... Let me make this argument. Yeah, we're here. The thing that's ambiguous is whether when you're talking about... When the certification that we're talking about, when there is a certification to a patent that has been reissued, which is what we're talking about here. The question is whether what you're talking about there is only the patent in its reissued form, whether that's the patent, which is the subject of the certification, or whether you're talking about the patent through its entire life, including original and reissued. You have a certification only to a reissue patent. Well, could you have a certification under this section, only to the reissue patent? Never had one as to the original patent. You could do that. Well, then so it's not ambiguous. It applies when it applies. It's not anything difficult that I see about that. You want it, it may make it troublesome for some people in the real world and that they don't like the results of it. But if the reissue patent, you just said you could go through this certification procedure, then that would indicate that a reissue patent is a patent subject to certification. But the premise of that argument would be that every certification gives rise to a separate period of exclusivity. And that is the point that everyone agrees the statute is ambiguous on that point. That was what was in the Apatex case. Not even. What is that? It says the patent. I'm just still you have an answer to my question. What is the ambiguous? Is patent ambiguous? Which is the subject of the certification? No. Maybe we don't know much about other things too, but what is ambiguous about that? Well, I know you may not like the results, the way the... I'm not saying you have to agree with this, the way an unambiguous statute is applied. But what's ambiguous about that? Well, the portion. I just to be clear about what ambiguity we're talking about. That is the court decision trigger. That is, says, if we know that there is an exclusivity, when does it begin to run? Okay, now that is what is sort of the second question. The first question in the case, and let me just make this clear. The first issue is the beginning of the statute. I'm reading in A4 of our appendix. It says, if the application contains a certification, described in subclass four, that's a paragraph four certification. And is for a drug from to previous application has been submitted under this subsection. I think we all agree that those conditions are satisfied here. Containing such a certification, there's a typo that says continuing. It means containing. And then it says, the application shall be made effective, not earlier than 180 days after. And only then do we get to the language Urana was referring to. Okay, so the first question here is, we're saying, okay, the plaintiffs filed applications. It's not a free-floating 180-day exclusivity period that's granted to somebody when there's a decision. That's not the way it works. The way it works in Congress's words is, somebody has filed an application. The first question for FDA is, does that application contain a paragraph four certification? Answer yes. And the next question is, was there a previous application under that subsection with a certification? Now here is the point that the Apatex court said was ambiguous and that FDA was reasonably interpreting. And the question is, when they say containing such a certification, do they mean another previous application that had any paragraph for certification to any patent? Or do they mean another previous certification to the same patent that you filed your certification for? That's the first ambiguity in the statute. The parties here are not disagreeing that there is an ambiguity there. So we know that the question and the result of that is that in some circumstances under FDA's approach agreed on by the parties and upheld by the DC Circuit. There might be some circumstances when there is more than one patent and then there is more than one exclusivity period that comes up. Now everyone agrees, I think that FDA also could have come out the other way on that question and could have said, no, there is only... The next step too, that step two. You say that the language that I've cited to you is made ambiguous by other language in the statute. Well, in order to interpret the language that you've cited to me, you have to understand the way it fits into that scheme. Okay, so... Within the context of the statute, other language in the statute makes this... Well, so just to march through it. You answer my question and you can march through it. You say there is other language in the statute which read with this creates an ambiguity. Well, let's start with this language alone. The answer is, I think, both the language alone and when you put it in context is ambiguous. Well, the language alone is ambiguous in your view because he's making a point about the patent for which the certification is issued. What they're saying is there are multiple patents and not only are there multiple patents, but there are multiple certifications. And so you've got to go back and take the particular patent. And you've got to go back and take them as multiple patents and multiple certifications. The statute makes that clear by using the singular. Certifications doesn't have an S after it and patents doesn't have an S after it. So, what if those two words don't aren't in the plural and don't have an S after them? Why is the statute ambiguous? Well, we've been dancing around, but I just wanted to direct the answer to that question. Well, if you're going to say it's unambiguous, then you have to say that it clearly refers to a particular patent. So the question then would be which patent is that? Is that the reissued patent or is that the original patent? If you're treating the two as distinct, if you treat the two together as FDA does, then you don't need to answer that question. But I understand the plaintiffs to be saying it's unambiguous because it unambiguously refers to a certain patent. And then which patent is that? Now, if it's the reissued patent, I think that might be what the... How would it refer to both? Well, if it refers to both, that is what FDA is coming out. FDA is saying if the patent... I mean, it refers to the one. It refers to the original patent when the original patent is the one that is underlying the exclusivity fight. And then when a reissued patent comes along, then it refers to the reissued patent. I mean, why wouldn't it refer to both the original patent and the reissued patent? Right. It refers to the version of whatever the patent is that is in force at the time that you're talking about this. That's right. So what if it does refer to whatever patent is a force at the time? Then the reissued patent just supersedes the original patent and the original patent becomes more bad. And then we are talking about the reissued patent. And that becomes the patent. In other words, the original patent becomes the patent for a time. And then the reissued patent becomes the patent for a time. And the original certification becomes the certification for a time. And then the certification is the reissued patent. That becomes the certification. But I don't understand why that makes it ambiguous. Why that singular, the, which precedes both patent and certification, doesn't refer to the one that is still alive and sort of in force at the time? Well, if you treat the statute that way, then FDA's decision in this case was correct. Because the question under this clause is whether there has been a decision of a court holding the patent, which is the subject of the certification to be invalid and not infringed. And so if you say that means whichever version of the patent is in force at the time, then everybody agrees that there has been no such decision. So, and that's what FDA concluded. They said this trigger for starting the 180 days. It was not such a decision on 68 in 2008. But that's if you're talking. But that would be the opposite of the hypothetical of the reading that was just proper to me as an unambiguous reading. I think it's completely consistent with it. He's asking what I've been asking. What are two separate events, the D pattern, which we call number 68, the original pattern, and 48, the reissue pattern. That's two different ones. If you, and that's the case, there was a court, I thought it actually had not been a court decision on both of these. Well, the second court decision is under appeal. I understand that, but it's been a court decision. Well, the statute makes elsewhere, not in language I quoted right here. I know that it doesn't count. I just make that point with you. But on 2008, that decision's final, the decision rendered on number 68 in 2008, that certification is final, isn't it? FDA is not making a determination in 2008. And the question is, I said, isn't that, wasn't there a court determination in 2008 under that section? Was there, was there not? If you took the pattern, which is the subject of the certification, to mean the original pattern. How about the only pattern that existed then? Was there, wasn't it finalized to that? As to the pattern, as it existed then, yes. And the question is whether that is what you're trying to ask your team. Why would the question be? But that's not my question. The question is, why can't the statute be read just the way I'm reading it? I know you don't want to read it that way. I know you don't want to. I don't stand there. But why is that subject to any other reading other than, I guess, judge Robinson said the pattern is then existing? Why isn't that clear? The statute just applies to different patterns. Why isn't that clear from the statute now? Because the point, the portion of the statute you're focusing on, involves the question of when the 180-day period begins to run. And so there's an antecedent question, which is, is there a 180-day period that anybody is entitled to? Because you could have made exactly the same argument in the Apatex case and said, okay, they certified to this pattern. There was a decision about this pattern. But the reissued pattern and the new certification puts the original pattern and the original certification into mouthballs, doesn't it? Well, they no longer have any relevance. They essentially mooted out of the case, aren't they? Are there any relevance at all? At that point, once the reissued pattern takes goal? Well, FDA's view is that it is relevant who certified first to the original pattern, and that you have to keep up your certification even as the pattern is reissued. But is the new certification different from the original certification? Yes, because you have to describe why the, the, the, the, the, the, whatever you're certifying to is not, is invalid or not in fringe. In this case, of course, and in most cases, they're going to be very similar. I just want to say something else about reissued patterns, were generally, which is relevant to this discussion, which is, this is a case, which is an unusual case for an reissued pattern, in that the pattern was invalidated, and then they went back and got it reissued. Now, what happened after 2008, what did the FDA do then? Could it have done something then after the 2008 decision? Is there something it could have done to say, okay, you're now granted a 180 day exclusivity rule before then? What? Isn't that, no, wouldn't that be normal? No, because FDA, and this is on 46 of the joint appendix, I don't understand anyone to be disagreeing with this either, FDA makes decisions about, they don't say you get your 180 days now. What they do is, when they have two applications, and they're trying to decide whether to approve an application and when to make that approval effective, then... Is there an original, is there an original, there were two applications? There were plenty of applications, the problem was none of them, for reasons entirely unrelated to the speed we're talking about right now, there were these other patterns, so none of them were ready to be, be approved. Nobody was ready to be approved because they would be infringing these other patterns. I'm only talking about O16, right, but... Insofar as that particular pattern, when it expires, I know the other set to go to. Right, but you asked me the question of why FDA didn't take action at that time, and the reason is that there was no generic manufacturer that was ready for approval. They take action. They take action when a manufacturer would otherwise be ready for approval, and then there is a question about exclusivity. That's what the statute tells them to do. They say, if you've got an application, you're trying to figure out when it's effective, and if it's obvious that none of the applications can be approved at that time, there's no reason for FDA to take any action, and they didn't. Now, what practical problems, in your view, would the interpreting the pattern and the reissued pattern to be different patterns, and the certifications to be different certifications? What practical problems does that lead to in your view if we don't adopt the FDA's interpretation, and we just read the pattern to be both the original pattern and the reissued pattern? I say I'm over time, but if I may answer... The problem is really just whether what is the most faithful to the scheme that Congress has enacted, and to give an example, and I was alluding to this earlier, patterns are reissued at the instance of the pattern T, so what pattern doesn't have to be invalidated in order for someone to get a reissued pattern? They could just look at their own pattern to decide that it needs to be changed in some way, that they've made some error. So to take a simple example, which I expect would be the most common example, suppose a pattern T has a pattern, and then somebody file... They file it with FDA, someone files a paragraph for certification, okay? There may be litigation that's just starting off or hasn't started yet or whatever. They take a look at the pattern and they say, we've made an error, we want to fix our error in our pattern. Preasons either related or often unrelated to the litigation, they just want to fix their pattern. So they go to the pattern and trademark office and they say, okay, we made a mistake in our pattern. There's a defect in the drawing or specification, those are specific grounds for reissue. We want to fix it. So here's our reissue application. Then PTO says, okay, fair enough, here's your reissued pattern. Then they go back to FDA and they say, okay, it's been reissued, here's our new certification. Then everybody, whoever the first filer was on the original pattern, the one who's objected themselves to litigation. But then also everybody else who wants to free ride off of that comes in and they go, okay, we're filing certifications to the reissued pattern. And that scenario is the same as one of court has invalidated a pattern. Well... I mean, here it seems as though this pattern was... You had to give it up to be able to issue one. That scenario you gave is almost like there's a technical mistake or something that happened and you went and got it amended or the original. So in the scenario you gave, do you get a new number? You do get a new number. It's the same identical process we're talking about here in your scenario. Exactly identical. And you have to give up the original pattern in order to get the reissued version. And then... You don't get as a continued protection, though, I take it. If you didn't have protection back here, that new one's not going to give it based upon the one that was not good, right? Well, no, there are rules about under what circumstances, you know, things that infringed one or the other of the pattern. Now see how continuous it is. Well... If it's the same pattern, then I'm just wondering how much protection you're going to get from that original one that's been declared invalid when you get one reissued. Well, I think... Reissued pattern, I'm going to stand as protection for something that may have been an infringement known to peer it at the original one. Well, yes. In most circumstances there might be exceptions in certain cases. But... Well, if you look at section 252, it's quite clear on that. Let me ask you this. What if a company got 180 days under the certification of the statute? The only one at that time they could get to what we call the original statute. Number 68. And what if they use half of it, 90 days, and then there's a reissue, can they get more than 90 days on the reissue? Can somebody certify and get 180 days on the reissue? If you get... If you see they can, they or can't they? Once you get 180 days... Do you have to get it or use it? See, that's the problem with what use it means. Well, I'm going to tell you what I'm mean by using it. That means you use it, you take advantage of it, and you market a drug. That's what I mean. Well, once you market a drug, then the statute says the 180 days run from the period of commercial marketing. And then FDA's position in this case is that. And we believe that this is correct. Is that once somebody has gotten the 180 days, or once someone has been granted exclusivity at all, it's over. You don't get another period, even if the patent is reissued. And then when does that 180 days of exclusivity run from FDA's mind or application? Does it run from something other than the court decision holding the patent, which is the subject of the certification to be invalid or not infringed? Does it run from something other than that? Well, it depends. If they market before its final or on appeal, then you look at number one of that section. And it runs from the date of first commercial marketing. We had that in this case. We haven't yet. They will market commercially. They tell us in December of the year. I'm going to reissue patent if there's some defect in the original. I mean, then they wouldn't even bother with a reissue patent. If there wasn't some significant defect in the original. How significant. Well, there has to be some error, yes. There has to be some error in that. So why, you know, you guess the other argument is why wouldn't it be a new patent if the sole reason for its existence was the fact that the original patent was defective? To whatever extent we might debate. But the original patent was so defective that it was necessary to crank up the somewhat abbreviated process to get a reissued patent. I mean, doesn't the fact that it's a defect that puts the process in motion as to the reissued patent? That they should be treated as separate patents. Well, that might be an indication, you know, one indication of difference between them. But the commonalities that we know are always going to be the case far away that we know it has to be the same invention. We know they can't introduce new matter. And just to make this sort of more fundamental point, you know, the only reason there's any argument here on the other side at all today is that they call it a reissued patent. And they give it a new number. You could have exactly the same substantive effect if you just said under these circumstances you can amend your patent. And, you know, all the rules would be the same. If we call it an amended patent, we wouldn't be here. I think FDA would be self-evidently right if it was called an amended patent. And so the question is whether FDA was required to give dispositive significance to the fact that it has... If it was called an amended patent and the language of the statute, are you labeled an amended patent? I'm saying if the patent laws, if instead of saying re... No, no, no. As your argument, if the word amended appeared in the statute, or if it was just a term used outside the statute. If it appeared in the reissued provision. Well, then I don't think it... No, that didn't change the statute. You said everybody would agree with that. That's not correct. Then the question would be... It would be the same question. Is the amended the patent subject to the certification? All right. Well, they would... It might or might not be, but that'd be the question. Right. Okay. But they would at least lose their argument that the fact that there's a new number matters. Because there would be the same number. And my point is simply that as a matter of substance, what we're talking about here is a circumstance where somebody has a patent for an invention. And then they say, there's something wrong with it. I want to change it. I can't introduce new matter. That means I can't change sort of the thing that I've described that I've invented. The problem here is simply one of semantics. Well, I'm saying that... Oh, that is called a reissued patent instead of an amended patent. Well, I'm saying that the other side's argument is largely premised on semantics. And on the fact that they give a new patent number, that seems to be important to them. And the fact that they give a new patent number is also what requires you to file an entirely new certification with FDA. And so their point, as I understand it, is there's a new number. It's called, you know, for some purposes, we call it a new patent. Although the statute says reissued the patent, not issue a new patent. So I'm not sure that's a good point for them, but they make sort of these points. And my point is simply as a matter of substance, what we're talking about here is you've got a patent, and then you want to change it. There are lots of ways in which you're not allowed to change it under these rules. What you're saying is that a modification or a cure of a minor defect doesn't create a new animal. And right. And given just to get back to where I started, that everyone agrees that FDA doesn't have to give separate periods of the patent number. And it's a way of giving the patent number of different types of exclusivity under the statute, that it was ambiguous as to whether they have to give separate periods of exclusivity for two patents that are entirely unrelated. And as a matter of discretion. I understand, and as you say, under your interpretation, TIVA is entitled to under this your scenario, the 180 day exclusivity rule here, based upon being the first for the original. That doesn't end it for them. If I understand your position, they now have to also make another ANDA to the reissue one to get 180 day exclusivity, but only they will get that. Is that right? They don't need to do a new application. They do need to do a new certification, which would be an amendment of their application, but to your fundamental point. You'll let her hear it is here in that the applicant must make a timeless submission of a paragraph for certification to the reissue patent to remain eligible for the 180 day exclusivity. That's right. Right. But the point that I'm making, if it's the same, because you always, because you always, whenever you file a paragraph for certification, you have to maintain a certification to the appropriate patent in the entire time. It's because you have a patent by patent approach, and you got another patent. And now they have to do something for this other patent. Well, with respect to your honor, it's not because we have a patent by patent approach, because everyone agrees that even if we didn't have a patent by patent approach, you still have to address every listing in the orange book separately. That statue is quite clear on that. And so the patent by patent approach doesn't go to to what extent you have to file certifications if they're submitting patents. You always have to file a certification. The statute is clear on that. The patent by patent approach goes to the question of, do we give more than one period of exclusivity? So if there's more than one patent in the world, do we give more than one period of exclusivity? And the answer to the problem, when I asked you the earlier question, then you told me there was a whole bunch of people out there who made these applications in the original form. And you had people here and not only Tivo here, we didn't talk about this patent approach then, which seems like to me, that would fix that problem. I'm not sure I'm entirely understanding the patent by patent approach. Basically, our fundamental point here is the statute is ambiguous as to whether if there are two patents in the world, forget reissue, just two patents at all, separate patents. The statute is ambiguous. The parties to this case agree, I think Council for the other side agreed with me on this. The statute is ambiguous as to whether there are two separate periods of exclusivity, one for patent A, one for patent B, even if the two are totally unrelated to each other, or whether the language, which is mostly the language in little... What is ambiguous if that term patent only refers to a particular patent? It is ambiguous. In the words if it just says a patent and the patent is a reissue to one because the other one has been taken away. If it says that, then it's not ambiguous in that light. And your light you give is ambiguous, but if you look at it that way, there's nothing ambiguous about that. It's an patent before the other one that exists. The other one doesn't exist anymore. It's been invalidated and has been resummitated. It's been withdrawn in order to get a new one. I don't think anybody is arguing that there have to be two separate periods of exclusivity when a patent is reissued, even though the one that had to be two separate periods. The other side's argument is premised on the idea that... I'm not making that statement. I want to deal with the ambiguity argument of the statute itself. You said this ambiguous, ambiguous, on a US and an area. I'm saying there's nothing ambiguous about it if a patent refers as touchwulcus and as alluded to, just shed as alluded to to the reissued patent. There's nothing ambiguous about that. It may not be something you want to be the result, but it's not ambiguous. Well, if FDA had decided under which everyone agrees would be permissing... I don't get to decide if that's the unambiguous. There's nothing to decide. You're on a... That's going to give you the answer to your question. If you say the reissued one, then we know what a 180-day period is. Because you don't have the element. Well, let me... Just stepping for one moment. Suppose that the FDA had decided the issue in the opposite text the other way. Everyone agrees that that would be within their authority. The court concluded that the statute was ambiguous. So suppose FDA had said... Even if there are multiple patents, we're only giving one period of exclusivity full stop, no matter how many different patents, no matter how distinct from each other there are. Everyone agrees FDA could do that. Now, if FDA did that, nobody could come in and then say, oh, but if a patent is reissued, then you have to give two separate periods of exclusivity for a reissued patent. That would be anomalous. That would suggest that... If there had been no reissued patent in this case, would Teeva's time have already run for exclusivity? They have an argument that it hadn't, it hasn't been presented to the agency. For purposes of the decision that FDA presumed that it would have already run, if it had not been reissued. Why should we give deference to the FDA in this situation given the fact that it's expertise in patent law is limited? Because there are no questions of patent law that are at issue here. There's no question of the scope of a patent. There's no question of whether a patent has been infringed. There's no question of validity of a patent. There's no question... I have about a question of whether or not a reissued patent is the same or a different patent. Is that a question of patent law? It has no consequences in a patent infringement action. The substantive consequences of a reissued patent in patent and infringement action could be resolved in a patent infringement that it has been issued. What is the purpose of this statute for the purpose of this statute? Do you think if there was undisputed evidence that when patent was used it meant patent and any reissues of that patent? You don't think that would matter in this case. You don't think that would help your argument in this case? The question here relates to the use of the term in the Hatch-Waxman amendments which are in the statute that FDA is called upon to administer. How does the FDA's expertise come into play here? The question here relates to the interpretation of the Hatch-Waxman scheme which is designed to determine when generic drugs should come on their kit, how what gives the right incentives for them to make challenges. If you said that this case wasn't governed by Chevron Deference which is not an argument that anybody has made at least in the briefs but if you said it wasn't covered by Chevron Deference you would be basically saying because Hatch-Waxman uses the term patent then FDA disclaims all expertise about how to interpret that scheme. The thing that FDA disclaims is... What you're saying is this really does fall into the heart of the FDA's competence because it concerns the incentive structure and the operation of how generic drugs come to market and the incentive structure is for generic manufacturers. And by what sequence we bring them into market and at what point the timing of when exclusivity periods begin and that's right at the heart of what the Food and Drug Administration does. That's correct and on the flip side it is not being called upon to resolve questions of who infringed whose patent or what the coverage of a patent is or any of those questions of patent law as to which the agency is disclaimed expertise. That's correct. I'm obviously way over my time so unless there are further questions. Thank you. Mr. Schumstein. Good afternoon and may it please the court. Let me cut right to the heart of the matter. Each of you has asked repeatedly during the course of this argument where is the ambiguity. There are two... There are two ambiguities and Judge Shadd I am going to answer that question for you. The first ambiguous term in this provision of the statute is what is the patent which is the subject of the certification. I can proper two reasonable definitions of the patent. On one hand, Milen and Watson's position which Teva concedes is a reasonable interpretation of the statute is that two patents are different because they bear different numbers. In other words, the patent is defined by the identifying number that FD or rather the PTO assigns to it. 0, 6, 8 and 0, 4, 8. There is an alternative way of understanding what the term the patent which is the subject of the certification. The alternative is to say a patent is an important because of the number that PTO puts on it. A patent confers certain exclusionary rights which under patent law are called claims. Because you can think of two different ways to read something in the statute that is applies, that does not create a ambiguity. No, Your Honor, with respect, it's not that I'm envisioning two different ways. That's what a patent is and if you look at the Federal Circuit case law and the sub... It is the patent then when did your time run? Your Honor, our time has not run yet and there are two reasons why and remember we're just talking about what the patent is. If you accept that a patent matters because of its substance, the particular exclusionary rights that it confers, then it's not enough to do what Milen and Watson do and say, well the 0, 4, 8, patent and the 0, 6, 8, patent are different. Instead, the question is, substantively are the exclusionary rights conferred by this patent the same or different? And what FDA said in this case is when you understand a little bit about reissue patents, when you look at 35 USC 251 and 35 USC 252 and decades of Federal Circuit and Supreme Court case law, there is continuity between reissue patents and original patents. In fact, reissue patents often confer exactly the same sub... Your argument is reissue and patent, they're the same thing. Yes, as a substantive matter, Your Honor. And in those circumstances... Virginia, you really thought so because you sort of looked at it and said you did the same thing you did with the first one. Well, that's exactly right, Your Honor, and there are lots of circumstances and as FDA pointed out repeatedly in its letter decision, there's a very important patent law doctrine called claim continuity and that doctrine holds that if you had protection under the original patent, and that protection is carried over to the reissue without substantive alteration, then an alleged infringer can be held liable for infringing conduct that not only predated reissuance, but dates back to the original day that the original patent issued. The only entity which was subject to certification in 2008. It's prior to 2008, but the 06, the 06, 8 patent and Tevis Paragraph Force certification, so that you understand it was very specific. Tevis said we challenge via Paragraph Force certification claims one through 17 of the 06, 8 patent. Substantively, those are the claims of that patent we do not in French. What did the Federal Circuit hold in 2008? It held that claims one through far, one through four, and 11 through 17 were invalid. So my question is what was, you said because the patent, you started off by arguing this really an entity, a collection of rights. Is that understood you correctly? What matters is its substance, you are one of those claims. What is the substantive entity that was defined by the patent, which is the subject of the certification as for 2007-2008? What was it? Was it your bundle of rights? What that was the brand manufacturer, Pfizer's bundle of rights? You take it from them. Right, we said we don't think your claims are valid. Claims one, two, three, four all the way through 17. What did the Federal Circuit say it said? No, no, but you have to answer my question. What is the patent that was certified, subject of that certification from which the 180 days exclusivity runs? What is that? It's claims one through 17 of that patent. Those were the paragraph four certifications that have a filed. And the Federal Circuit's decision didn't say anything about claims through five, claims five through ten of that patent. So those were totally unaffected. So it's crazy to say there was even a court decision in this case. But what FDA said was irrespective of that issue, whether it addressed some of the claims or all of the claims. The FDA's position is there was no court determination under that section. What they said is if you take a substantive view of what a patent is, their answer would be yes or no. Their answer would be no, there was not a court decision. And the reason why is because those original claims were later revived. Because then you don't even need ambiguity. You just say the statute was never met. Well, you're on all right. You can think of it as six of one half dozen of the other. I'm not considering it on whether or not there was a certification as required for exclusivity. Your argument is no. There never was. There was no such court determination. You're right. There was no such court determination. But but had been a court determination in so far you your client had there been a court decision trigger, which of course we dispute. Then my clients exclusivity would have been triggered and it would have expired a hundred. Well, of course they do your honor. My client wants to be the only one on the market with this product and with respect it has already run or it's already run which we disagree with. But we think that the statute is highly ambiguous about what was the effect of that court decision. That's the kind of thing that keeps coming to me. I mean the court makes a decision. I've got three court makes a decision on something to invalidate this this patent. Whatever claim number claims you want to. What's the effect of that the effect of that decision? Did you win? Because it sounded like you meet you tell me you didn't we. Oh no, your honor. I don't I don't want to give you that impression. We did we did win that case and we had a. We had a court say if you were to market this product you would not in fringe claims one through four or claims 11 through 17th the patent. You have a one and eight a day exclusivity to proceed. No, we're talking about and it's very clear to be different. We're talking about. Okay, that's patent law, right? Whether or not Pfizer could get monetary damages if my client marketed its drug product. Today in court we're talking about a regulatory question, which is is my client alone eligible to be approved by the FDA given the way that 180 to exclusivity works. Or can other people join my client and free ride as judge Wilkinson put it earlier. I'll be in a question but and free ride on what tevd it and what is very important for you to keep sight of in this case is is FDA's explanation in its distance. I thought you were saying the court case didn't matter at all then I heard you say no, no, you did win. You won the court case. When did the 180 day start running or has it not started yet? Our position is that it has not started running. Based on what in the statute is our view is that there has not been a final court decision, which means the decision of a court of appeals, the federal circuit holding that the patent, which is the subject of the certification. Does it have to be the court of appeals? It does have to be the court of appeals. Your honor, there's a provision in the Medicare Modernization Act of 2003. I believe it's section 1102. So in other words, you can't have a court decision holding that a patent is invalid by anything other than a court of appeals. Correct. It has to be a final decision of a court of appeals from which no appeal other than to the Supreme Court by rid of. We move on down the road here. Maybe this whole idea of a single exclusivity period and a single exclusivity period which doesn't begin to run until the invalidation of the reissue product. There could be some problems. There could be some glitches and everything. So what's the proper entity to try to smooth those out or make the adjustments and modifications that might well need to be made when the operational problems of any particular regime? I mean, there are a lot of areas of confusion and I'm not sure how these things actually play out in practice. So, you know, we can give one answer today, but it may be unworkable or it may lead to adverse effects or it may not. What is the proper, how are the glitches and the wrinkles going to be ironed out as we go down the road? Is it reasonable to, I mean, the court is going to do it, and Congress is going to do it, is the FDA going to do it? How are the wrinkles going to be ironed out in your view? Well, your honor, it depends in part on what you decide today, but our position respectfully is that it's up to the agency. They're the experts. Sure, your honor. If the statute permits them to reach a result that favors us, which we think it does here. How's the agency going to work it out? Well, the agency has what I would call a quasi-adversarial process where any interested party who's affected by a decision that the FDA is contemplating making can raise an issue with them. That's what happened in this case. My client sent a letter to the FDA, Mylin sent a letter to the FDA. In fact, we decide that there's no ambiguity, and the statute is, as it says, you think FDA is talented enough to adjust their regulatory practices around that court. Your honor, I do, but I have to make one very important point, and I don't want to lose sight of this. It's very important for this court to understand the scope of review. I'm not talking Chevron. Understand the decision that's in front of the agency, and I want to echo something that Mr. Tennis said when he was arguing a little while ago. If you believe that FDA's view of reissues and original patents as being substantially identical, given all of the features they share in common, all you can do is vacate the agency's letter decision and remand this case to the agency at which point FDA is going to have to do one of two things. It's going to have to resolve, first of all, was there actually a court decision in 2008, given the undisputed fact that only certain claims of the 068 patent were invalidated? We say absolutely not. We think that's consistent. It wouldn't have run your honor because there wasn't a court decision not yet, but your honor, there wasn't a court decision on multiple claims that we challenged. It would run when my clients launched their drug product in December. What were you doing with paragraph four? What about when it expires? It would expire 180 days after my clients begin marketing this. Self expires. The pat. The our exclusivity will give us a full six months prior to the scheduled expiration of this patent. If it had just gone on and you get to the expiration of the patent, then it starts or you have a case for a dentist. Your honor, again, very complicated statute. One reason why we have so many questions. It's been settled since around 2003 that when a patent expires, there's no remaining exquisite. How does that, I'm not talking about serving the purpose of the statute, but FDA is and I think it you are, how is the purpose of the statute served when the question of whether or not generics are placed on the marketplace lie in the hand of one company which might never want for other reasons, it might never want the generic to hit the stand or the length of the patent. So your honor, let me answer it this way. It is a widely acknowledged feature of the original statute. Pre 2003, the one we're talking about. I'm just answering my question. Why does that put the hands of generic and generic availability in the hand of one manufacturer? It absolutely does your honor and I want to make clear you asked a very important question earlier which is are we controlled by intent or we controlled by the language. You did, but that's an important one that's relevant to this question. And the answer was it was widely acknowledged under the pre 2003 statute which is what we're dealing with that this can happen. It can take a very long time for the exclusivity entitled applicant to launch its product. And in 2003, Congress changed the statute and the MMA includes what are called forfeiture triggers. They're used or lose at provisions. I'm going to answer my question. We're kind of running late on. Oh, you're on a right. It has to how that doesn't maybe it should be placed in one company's hands. But why doesn't that lead your explanation or understanding? I'm just asking, I'm listening to what you say. Doesn't that lead to the fact that one manufacturer could in fact then wait and never produce the generic? It does your honor, but what the courts have recognized is that's totally legitimate under the original version of the statute. I do have a couple of other points I think are just very important to address because there's a policy issue here that I think is also responsive to that. When FDA said understand that what matters about a patent is not its number, but whether the rights are co extensive. What FDA is really saying is, Teva was first. They're the ones who mounted the first challenge to these patent claims to the brand manufacturer's rights. And it's the Johnny come lately's, myelin, Watson, Lupin that are piggybacking on that success. Now to be sure, to be sure we're talking about a paragraph for certification to a patent that has a different number. But in substance, Teva was first. Judge Wayne, you asked why does FDA require a new certification under paragraph four to a reissue patent when it comes out? Very simple. If a manufacturer files a paragraph for certification to an original patent, that patent is reissued. And it fixes the patent so that you can no longer maintain a paragraph for certification. That's a pretty glaring sign that these patents are fundamentally different, right? But whereas here Teva could maintain its paragraph four and continue the challenge, well that's yet another indication in a very fact. In other words, to say, sure, your honor when we told the agency in the brand manufacturer is you didn't fix it, it's still invalid. We get to go to market. And so requiring that re-certification at the end is a way for the agency to confirm that the substance of these two patents matches up again taking the substantive view of what a patent is rather than a numerical view. Certification would have different, would raise different claims with respect to the patent. Not necessarily. Your honor, there can be and they're often our circumstances. And you're honor, you raise an excellent point, which is you could and FDA could have made that choice. But let's be clear about this. FDA could have said reissue patents in their original versions are always different. That's the simplistic, reductive argument that myelin and Watson make. It could have said as it did here, we think that they're often similar enough that we treat them the same. Absolutely, your honor, my client. Based on FDA's award of 180 day exclusivity, which by the way, that was based on the rationale set forth in this letter decision. Nothing to do with the court decision, your honor. But it's very important to understand that again, there's a third choice that FDA could have adopted. It could have said, we're going to look case by case. Are they the same? Are they different? Yes, came up with 180 day, is that what you got in your letter 180 day exclusivity? Correct. And they just picked that number of... No, no, no, 180 days comes right out of the statute. And it's the provision that Mr. Tenney was reading earlier, which says if you're an applicant with them... They're reading out the statute that gives you that 180 day. Absolutely, but nobody disputes that. The only question is, was there a court decision trigger? And as I said before, it depends on what the pattern is. And you say there was not, and FDA says there was not. Correct. That's exactly right, your honor. And... Mr. Early's date, FDA could have issued that letter. Do you give you that 180 day exclusivity? Since 2008, when is the early state could have done that? FDA could have issued that letter at any point it wanted to between... Your honor, they could have issued that letter in 2003 when my client submitted its ANDA. You were first, you have a paragraph for certification. That's that question, and it seems like to me they couldn't do it. I got a lot of bureaucratic stuff going on. No, Judge... I said after that 2008 decision, why didn't you just give the 180 day rule? Well, it's only so many claims or... Well, your honor, maybe I misunderstood your question. I'm questioning it, make sure I get the right answer. When is the earliest time period that FDA could have issued after 2008? Don't worry about 2003, could have issued that letter that you got in the record, right? Your honor, it could have issued at the same day that the decision came down. It chooses not to make decisions until multiple applications are ready and otherwise eligible for approval, because as we all know, facts change, things happen. Applicants who may have started out... You have already pointed... Did issued. Because as Mr. Farquhar pointed out in his argument, there were three patents that Pfizer had for this drug product. We'll call it 068 and the other two. And those other two didn't expire until November of 2013, and then they had a six-month extension. And so it was on May 30th of 2014 that the blocking patents, that is the patents that were still valid evaporated. And that point, FDA had to make a formal decision. Do we approve Tava alone, or do we approve Tava, Milen Watson, or Tava Milen Watson Lupin Apatex is another company that hasn't come to court to challenge this decision, but is similarly situated to Lupin? And FDA had to make the decision at that point, and that's when they chose to award 180-dexgusivity, but you're honor, they could have sent a letter at any point. I'm trying to say why FDA acted in a manner that did. So what is patent by patent approach? Sure, you're honor. If it's going to wait until these other two expire before it gives the letter, what's that mean? You're honor. There can be circumstances. That's a term of art. You guys use it all the time, and you said everybody agrees to it. So what does it mean? Patent by patent approach is... It doesn't, it doesn't, it doesn't, it doesn't. It wouldn't have been reasonable for them to give that letter back in 2008 on the patent by patent approach, even though it would have been subject to. Your honor, it would have been reasonable for them to issue that letter at any time between the day. They... Who that is, that this is consistent with you. They don't, as a manner of administrative policy, my clients and others have certainly pushed the agency to render decisions earlier than they do. In fact, I filed comments on behalf of Teva just the other day urging the agency to render these decisions earlier than it does. But that doesn't make anything that FDA actually said in its decision unreasonable. And as I said before, there's a basic ambiguity here, which is, is the patent the number only or its substance? And once you accept that you can legitimately choose between either of those options, all we look at is... You don't even need that argument, though. You don't need that argument at all, do you? No, because as I said before, a whole bunch of claims that we filed paragraph for certifications to weren't invalidated. Absolutely, Your Honor. And one very last thing about that, that I just want to highlight and not lose sight of today. As I said, I think the patent is ambiguous, but there's another ambiguity in the same provision of the statute, which is, what does it mean to have invalidated a patent claim that is later brought back to life that the patent law say is presumptively valid, which is enforceable, not only from the date that that reissued claim was issued by the PTA. Not only from the date of the decision that invalidated the original patent from which that claim came, but going back to the date that that original patent was issued. And as FDA said in its letter decision, when you understand that reissue patents can revive these claims, it doesn't make any sense to say that they were invalidated because they brought back to life. And Miley has a great phrase in their brief, they talk about zombie exclusivity, but zombie exclusivity is the pure product of zombie patent claims claims temporarily invalidated by a court, but brought back to life and under third. That's it, Your Honor. And maybe it was too long, I appreciate your indulgence. Thank you all. I'll try to be very brief, I know it's late. First of all, I mentioned as I was departing from the original argument, we made a mistake on page nine of our brief. I just noted as notes that last night, doesn't really substantively change. Can we submit an amended brief tomorrow with that work? And I have copies of the correct page. That's a devolumen if you want to. Okay. Thank you. The one thing that I wanted to point out very quickly is that Mr. Shomsky was suggesting that there wasn't a court decision invalidating the O68 patent. That is just simply not true. And there's no need to vacate and remand to the agency on that. They already decided and it's reflected in their letter that there was a court decision invalidating the patent. The only reason he says that they it wasn't a decision invalidating the patent is because the court didn't address claims five through ten. Well, Pfizer decided not to pursue claims five through ten in the patent infringement litigation that it brought against have a. Therefore, those claims are gone. There's not there's no action that's left for Pfizer on those claims. You know, the whole argument and some good questions, but it's kind of persuaded me that this is it's a it's a it's a very complicated statute and it's a very complicated process. And there are an awful lot of moving parts around this and you're saying the patent and the reissue patent are different and that's you know, that's not an unreasonable view of it at all. But to say that they are substantively the same, I don't understand why that is unreasonable either. I mean, they. And and to say that we shouldn't defer at all to the FDA because they don't really have any hand in this whole process. But they do have a lot to say about when and how generics come to to market. So how can you persuade me that we're not just wondering into some some very deep water and why wouldn't we allow normally in a in a process calling for significant expertise where the agency. Frankly does have a greater background in it than we do why wouldn't we exercise some respect for that for that letter ruling there been many many times when I've ruled from the. But I voted to bring agencies up short because I thought they were planning around with Supreme Court decisions or plan around with statutory language but this this problem seems somewhat murkier to me and I wonder if you just. Sure might address it. It's not that I think your views of it is unreasonable. It's just that I'm not sure. I want us to take step a I'm not sure what the falling dominoes are I'm not sure what what what goes from a I'm sure what happens in B or in C or in D. So first of all there have been seven cases that we cited in our briefs where courts have reversed FDA where it tried to manufacture ambiguity about language and hatchback's amendments and one of those cases came from this court the grand u tech decision where FDA doesn't follow clear statutory language they've been slapped back and that's what we're asking for you to do here. That big is a question does not well I just shows that there is a there is precedent it wasn't that earlier decision wasn't this statutory language that earlier statutory was in this particular statutory language on court decision but there have been two decisions the tour farm decision in 1997 and the mile and versus Shalala decision that where this particular language the court decision trigger language the court held that FDA was wrong in trying to make sure that the court decision was not going to be a part of the court decision. So we're going to exempt from the court decision trigger non final court decisions. But did it deal with the whole question of whether the patent referred to original and reissued patent? No the only case that did that actually is the apotex decision that Mr. Tene talked about and in that in that decision the court specifically said that the court decision trigger language is patent specific which supports our our case here not there. So you can see the begs the begs the question of what is a patent and and your point is that they're substantively the same you can look at this I mean they might be in they you know they do have different numbers they do have separate listings in the orange book. There's a there's a re you know there's a recertification right I'm so it's not and you know it's not that your view is a laffer it certainly isn't. No it isn't but yeah. I don't know but but you know sometimes and when we interpret contracts the fact that two people disagree over the meaning of a contract that doesn't make it ambiguous and the fact that that two parties disagree over the meaning of a statute that certainly doesn't make it ambiguous but sometimes there might be a genuine ambiguity. Well but here I really think there is not the languages which is the subject of the certification is a very clear structure there's a patent there's a listing there's a certification there's patent litigation that results from that there's a court decision done that expert that exclusivity period has expired 180 days after that court decision that's all we're saying it's very simple there's no dramatic results that occur from that that are antithetical to what the hatchback. That's what a man stands for it's that portion of the statute you're right there's a lot of moving parts when is exclusivity created there's some ambiguity about that but here and in fact there's some earlier questions from the court. We are not saying that Tevac does not have exclusivity on the original patent. They did have it. They did get it. They just couldn't use it and it expired under the terms of the statute. Just to be very clear about that, we are here because there was a court decision that triggered the running of that exclusivity in November and May of 2008, expired in November of 2008. It's over and done with. Even if you don't agree with us that the reissue patent deserves its own exclusivity period. The first issue is did that one expire and that's the only one where Tevac had solo exclusivity if you will. I hope that helps. The end result of that is then you agreeing with Lupin then. Well, that's right. On issue one, we do agree with Lupin. We then say that the second question is on the O68 patent, I'm sorry, I'm getting mixed up. On the O48 patent is their shared exclusivity. We admit that is a more difficult question than the first question. Your position is whatever Tevac had under the 28th decision, 2008 decision. They have lost it now. We may all disagree what happens now. But that's gone. Let's all fight it out and see what happens now. If we decided that one issue with you, would we just remand it to the court, let the court figure out? No, you're on it. No, you're on it. I think you should answer this. No, you wouldn't. You wouldn't remand what you would do is you would say you would reverse the court on its grant of summary judgment on that issue. And then in the opinion you would indicate that they were wrong on that issue. And then you would remand it to a wouldn't we? You know, I think when you reverse, I forget whether... Well, no, no, no, we send it back to a fore. For the proceedings. Oh, yes. Yeah, yeah, yeah, because we need to get then summary judgment entered on that point in our favor. So I hope that's what happens. And thank you very much for your time and your patience and for expediting this procedure. Thanks. We'll jump

Legal Case Summary

Mylan Pharmaceuticals, Inc. v. FDA

Date Argued: Wed Sep 17 2014

Case Number: D-14-0002

Docket Number: 2591084

Judges:J. Harvie Wilkinson III, Dennis W. Shedd, James A. Wynn, Jr.

Duration: 106 minutes

Court Name: Court of Appeals for the Fourth Circuit

Case Summary

Mylan Pharmaceuticals, Inc. v. FDA

Oral Audio Transcript(Beta version)